APPROVED
DRUG
PRODUCTS
WITH
THERAPEUTIC
EQUIVALENCE
EVALUATIONS
35th EDITION
THE PRODUCTS IN THIS LIST HAVE BEEN APPROVED UNDER
SECTION 505 OF THE FEDERAL FOOD, DRUG, AND COSMETIC ACT.
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF MEDICAL PRODUCTS AND TOBACCO
OFFICE OF GENERIC DRUGS
2015
APPROVED DRUG PRODUCTS
with
THERAPEUTIC EQUIVALENCE EVALUATIONS
The products in this list have been approved under section 505 of the
Federal Food, Drug, and Cosmetic Act. This volume is current through
December 31, 2014.
35th EDITION
U.S. DEPARTMENT OF HEALTH AND HUMAN SERVICES
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
OFFICE OF MEDICAL PRODUCTS AND TOBACCO
OFFICE OF GENERIC DRUGS
2015
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
APPROVED DRUG PRODUCTS
with
Therapeutic Equivalence Evaluations
CONTENTS
PAGE
PREFACE TO THIRTY FIFTH EDITION……….………………………………..…................iv
1 INTRODUCTION................................................................................................................ vi
1.1 Content and Exclusion ................................................................................................... vi
1.2 Therapeutic Equivalence-Related Terms ....................................................................... vi
1.3 Statistical Criteria for Bioequivalence ............................................................................viii
1.4 Reference Listed Drug .................................................................................................... x
1.5 General Policies and Legal Status ................................................................................. xi
1.6 Practitioner/User Responsibilities .................................................................................. xi
1.7 Therapeutic Equivalence Evaluations Codes ................................................................xiii
1.8 Description of Special Situations...................................................................................xxi
1.9 Therapeutic Equivalence Code Change for a Drug Entity ........................................... xxiii
1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product .................... xxiv
1.11 Discontinued Section ..................................................................................................xxiv
1.12 Changes to the Orange Book......................................................................................xxiv
1.13 Availability of the Edition ..............................................................................................xxv
2 HOW TO USE THE DRUG PRODUCTS LISTS ..............................................................2-1
2.1 Key Sections for Using the Drug Product Lists …………………….….………………......2-1
2.2 Drug Product Illustration ……………………………………………..….…………….……..2-3
2.3 Therapeutic Equivalence Evaluations Illustration ………………….….…………..………2-4
DRUG PRODUCT LISTS
Prescription Drug Product List ……………………………………….…………….………………...3-1
OTC Drug Product List ……………………………………………….…………….…………………4-1
Drug Products with Approval under Section 505 of the Act Administered
by the Center for Biologics Evaluation and Research List ...……….…….………………...5-1
Discontinued Drug Product List .…………………………………………….…….………………....6-1
Orphan Products Designations and Approvals List …………….………….…….………………..7-1
Drug Products Which Must Demonstrate in vivo Bioavailability
Only if Product Fails to Achieve Adequate Dissolution …………………..………………………..8-1
APPENDICES
A. Product Name Index ……….…...………………………….………..……………………A-1
B. Product Name Index Listed by Applicant ………………….……..……………………..B-1
C. Uniform Terms …………………………………………….………..…………...………...C-1
PATENT AND EXCLUSIVITY INFORMATION ADDENDUM ……….……..………………..........AD1
A. Patent and Exclusivity Lists …………………………….…..……..……………..……ADA1
B. Patent and Exclusivity Terms ...……………………….….………...…………………ADB1
FOOD AND DRUG ADMINISTRATION
CENTER FOR DRUG EVALUATION AND RESEARCH
APPROVED DRUG PRODUCTS
with
Therapeutic Equivalence Evaluations
PREFACE TO THIRTY FIFTH EDITION
The publication, Approved Drug Products with Therapeutic Equivalence
Evaluations (the List, commonly known as the Orange Book), identifies drug
products approved on the basis of safety and effectiveness by the Food and
Drug Administration (FDA) under the Federal Food, Drug, and Cosmetic Act (the
Act). Drugs on the market approved only on the basis of safety (covered by
the ongoing Drug Efficacy Study Implementation [DESI] review [e.g., Donnatal®
Tablets and Librax® Capsules] or pre-1938 drugs [e.g., Phenobarbital
Tablets]) are not included in this publication. The main criterion for the
inclusion of any product is that the product is the subject of an application
with an effective approval that has not been withdrawn for safety or efficacy
reasons. Inclusion of products on the List is independent of any current
regulatory action through administrative or judicial means against a drug
product. In addition, the List contains therapeutic equivalence evaluations
for approved multisource prescription drug products. These evaluations have
been prepared to serve as public information and advice to state health
agencies, prescribers, and pharmacists to promote public education in the
area of drug product selection and to foster containment of health care
costs. Therapeutic equivalence evaluations in this publication are not
official FDA actions affecting the legal status of products under the Act.
Background of the Publication. To contain drug costs, virtually every
state has adopted laws and/or regulations that encourage the substitution of
drug products. These state laws generally require either that substitution
be limited to drugs on a specific list (the positive formulary approach) or
that it be permitted for all drugs except those prohibited by a particular
list (the negative formulary approach). Because of the number of requests in
the late 1970s for FDA assistance in preparing both positive and negative
formularies, it became apparent that FDA could not serve the needs of each
state on an individual basis. The Agency also recognized that providing a
single list based on common criteria would be preferable to evaluating drug
products on the basis of differing definitions and criteria in various state
laws. As a result, on May 31, 1978, the Commissioner of the Food and Drug
Administration sent a letter to officials of each state stating FDA's intent
to provide a list of all prescription drug products that are approved by FDA
for safety and effectiveness, along with therapeutic equivalence
determinations for multisource prescription products.
The List was distributed as a proposal in January l979. It included only
currently marketed prescription drug products approved by FDA through new
drug applications (NDAs) and abbreviated new drug applications (ANDAs) under
the provisions of Section 505 of the Act.
The therapeutic equivalence evaluations in the List reflect FDA's
application of specific criteria to the multisource prescription drug
products on the List approved under Section 505 of the Act. These
evaluations are presented in the form of code letters that indicate the basis
for the evaluation made. An explanation of the code appears in the
Introduction.
iv
A complete discussion of the background and basis of FDA's therapeutic
equivalence evaluation policy was published in the Federal Register on
January 12, 1979 (44 FR 2932). The final rule, which includes FDA's
responses to the public comments on the proposal, was published in the
Federal Register on October 31, 1980 (45 FR 72582). The first publication,
October 1980, of the final version of the List incorporated appropriate
corrections and additions. Each subsequent edition has included the new
approvals and made appropriate changes in data.
On September 24, 1984, the President signed into law the Drug Price
Competition and Patent Term Restoration Act (1984 Amendments). The 1984
Amendments require that FDA, among other things, make publicly available a
list of approved drug products with monthly supplements. The Approved Drug
Products with Therapeutic Equivalence Evaluations publication and its monthly
Cumulative Supplements satisfy this requirement. The Addendum to this
publication identifies drugs that qualify under the 1984 Amendments for
periods of exclusivity (during which ANDAs or applications described in
Section 505(b)(2) of the Act for those drugs may not be submitted for a
specified period of time and, if allowed to be submitted, would be
tentatively approved) and provides patent information concerning the listed
drugs which also may delay the approval of ANDAs or Section 505(b)(2)
applications. The Addendum also provides additional information that may be
helpful to those submitting a new drug application to the Agency.
The Agency intends to use this publication to further its objective of
obtaining input and comment on the publication itself and related Agency
procedures. Therefore, if you have comments on how the publication can be
improved, please send them to the Director, Division of Legal & Regulatory
Support, Office of Generic Drugs, Center for Drug and Evaluation and
Research, 7620 Standish Place, Rockville, MD 20855-2773. Comments received
are publicly available to the extent allowable under the Freedom of
Information regulations.
v
1. INTRODUCTION
1.1 Content and Exclusion
The List is composed of four parts: (1) approved prescription drug
products with therapeutic equivalence evaluations; (2) approved
over-the-counter (OTC) drug products for those drugs that may not be marketed
without NDAs or ANDAs because they are not covered under existing OTC
monographs; (3) drug products with approval under Section 505 of the Act
administered by the Center for Biologics Evaluation and Research; and (4) a
cumulative list of approved products that have never been marketed, are for
exportation, are for military use, have been discontinued from marketing, or
have had their approvals withdrawn for other than safety or efficacy reasons
subsequent to being discontinued from marketing. 1 This publication also
includes indices of prescription and OTC drug products by trade or
established name (if no trade name exists) and by applicant name (holder of
the approved application). All established names for active ingredients
generally conform to official compendial names or United States Adopted Names
(USAN) as prescribed in (21 CFR 299.4(e)). The latter list includes
applicants’ names as abbreviated in this publication; in addition, a list of
uniform terms is provided.
An Addendum contains drug patent and exclusivity information for the
Prescription, OTC, Discontinued Drug Product Lists, and for the Drug Products
with Approval under Section 505 of the Act Administered by the Center for
Biologics Evaluation and Research. The publication may include additional
information that the Agency deems appropriate to disseminate.
Prior to the 6th Edition, the publication had excluded OTC drug products
and drug products with approval under Section 505 of the Act administered by
the Center for Biologics Evaluation and Research because the main purpose of
the publication was to provide information to states regarding FDA's
recommendation as to which generic prescription drug products were acceptable
candidates for drug product selection. The 1984 Amendments required the
Agency to begin publishing an up-to-date list of all marketed drug products,
OTC as well as prescription, that have been approved for safety and efficacy
and for which new drug applications are required.
Under the 1984 Amendments, some drug products are given tentative
approvals. The Agency will not include drug products with tentative approval
in the List. Tentative approval lists are available at ANDA (Generic) Drug
Approvals. When the tentative approval becomes a full approval through a
subsequent action letter to the application holder, the Agency will list the
drug product and the final approval date in the appropriate approved drug
product list.
Distributors or repackagers of products on the List are not identified.
Because distributors or repackagers are not required to notify FDA when they
shift their sources of supply from one approved manufacturer to another, it
is not possible to maintain complete information linking product approval
with the distributor or repackager handling the products.
1.2 Therapeutic Equivalence-Related Terms
1
Newly approved products are added to parts 1, 2, or 3, of the List, depending on the dispensing
requirements (prescription or OTC) or approval authority, unless the Orange Book staff is
otherwise notified before publication.
vi
Pharmaceutical Equivalents. Drug products are considered pharmaceutical
equivalents if they contain the same active ingredient(s), are of the same
dosage form, route of administration and are identical in strength or
concentration (e.g., chlordiazepoxide hydrochloride, 5mg capsules).
Pharmaceutically equivalent drug products are formulated to contain the same
amount of active ingredient in the same dosage form and to meet the same or
compendial or other applicable standards (i.e., strength, quality, purity,
and identity), but they may differ in characteristics such as shape, scoring
configuration, release mechanisms, packaging, excipients (including colors,
flavors, preservatives), expiration time, and, within certain limits,
labeling.
Pharmaceutical Alternatives. Drug products are considered pharmaceutical
alternatives if they contain the same therapeutic moiety, but are different
salts, esters, or complexes of that moiety, or are different dosage forms or
strengths (e.g., tetracycline hydrochloride, 250mg capsules vs. tetracycline
phosphate complex, 250mg capsules; quinidine sulfate, 200mg tablets vs.
quinidine sulfate, 200mg capsules). Data are generally not available for FDA
to make the determination of tablet to capsule bioequivalence. Different
dosage forms and strengths within a product line by a single manufacturer are
thus pharmaceutical alternatives, as are extended-release products when
compared with immediate-release or standard-release formulations of the same
active ingredient.
Therapeutic Equivalents. Drug products are considered to be therapeutic
equivalents only if they are pharmaceutical equivalents and if they can be
expected to have the same clinical effect and safety profile when
administered to patients under the conditions specified in the labeling.
FDA classifies as therapeutically equivalent those products that meet the
following general criteria: (1) they are approved as safe and effective;
(2) they are pharmaceutical equivalents in that they (a) contain identical
amounts of the same active drug ingredient in the same dosage form and route
of administration, and (b) meet compendial or other applicable standards of
strength, quality, purity, and identity; (3) they are bioequivalent in that
(a) they do not present a known or potential bioequivalence problem, and they
meet an acceptable in vitro standard, or (b) if they do present such a known
or potential problem, they are shown to meet an appropriate bioequivalence
standard; (4) they are adequately labeled; (5) they are manufactured in
compliance with Current Good Manufacturing Practice regulations. The concept
of therapeutic equivalence, as used to develop the List, applies only to drug
products containing the same active ingredient(s) and does not encompass a
comparison of different therapeutic agents used for the same condition (e.g.,
propoxyphene hydrochloride vs. pentazocine hydrochloride for the treatment of
pain). Any drug product in the List repackaged and/or distributed by other
than the application holder is considered to be therapeutically equivalent to
the application holder's drug product even if the application holder's drug
product is single source or coded as non-equivalent (e.g., BN). Also,
distributors or repackagers of an application holder's drug product are
considered to have the same code as the application holder. Therapeutic
equivalence determinations are not made for unapproved, off-label
indications.
FDA considers drug products to be therapeutically equivalent if they meet
the criteria outlined above, even though they may differ in certain other
characteristics such as shape, scoring configuration, release mechanisms,
packaging, excipients (including colors, flavors, preservatives), expiration
date/time and minor aspects of labeling (e.g., the presence of specific
pharmacokinetic information) and storage conditions. When such differences
are important in the care of a particular patient, it may be appropriate for
vii
the prescribing physician to require that a particular brand be dispensed as
a medical necessity. With this limitation, however, FDA believes that
products classified as therapeutically equivalent can be substituted with the
full expectation that the substituted product will produce the same clinical
effect and safety profile as the prescribed product.
Bioavailability. This term means the rate and extent to which the active
ingredient or active moiety is absorbed from a drug product and becomes
available at the site of action. For drug products that are not intended to
be absorbed into the bloodstream, bioavailability may be assessed by
measurements intended to reflect the rate and extent to which the active
ingredient or active moiety becomes available at the site of action.
Bioequivalent Drug Products. This term describes pharmaceutical equivalent
or pharmaceutical alternative products that display comparable
bioavailability when studied under similar experimental conditions. Section
505 (j)(8)(B) of the Act describes one set of conditions under which a test
and reference listed drug (see Section 1.4) shall be considered
bioequivalent:
the rate and extent of absorption of the test drug do not show a
significant difference from the rate and extent of absorption of the
reference drug when administered at the same molar dose of the
therapeutic ingredient under similar experimental conditions in either
a single dose or multiple doses; or
the extent of absorption of the test drug does not show a significant
difference from the extent of absorption of the reference drug when
administered at the same molar dose of the therapeutic ingredient under
similar experimental conditions in either a single dose or multiple
doses and the difference from the reference drug in the rate of
absorption of the drug is intentional, is reflected in its proposed
labeling, is not essential to the attainment of effective body drug
concentrations on chronic use, and is considered medically
insignificant for the drug.
Where these above methods are not applicable (e.g., for drug products that
are not intended to be absorbed into the bloodstream), other in vivo or in
vitro test methods to demonstrate bioequivalence may be appropriate.
Bioequivalence may sometimes be demonstrated using an in vitro
bioequivalence standard, especially when such an in vitro test has been
correlated with human in vivo bioavailability data. In other situations,
bioequivalence may sometimes be demonstrated through comparative clinical
trials or pharmacodynamic studies.
1.3 Statistical Criteria for Bioequivalence
Under the Drug Price Competition and Patent Term Restoration Act of 1984,
manufacturers seeking approval to market a generic drug product must submit
data demonstrating that the drug product is bioequivalent to the pioneer
(innovator) drug product. A major premise underlying the 1984 law is that
bioequivalent drug products are therapeutically equivalent, and therefore,
interchangeable.
Bioavailability refers to the rate and extent to which the active
ingredient or therapeutic ingredient is absorbed from a drug product and
becomes available at the site of drug action (Federal Food, Drug and Cosmetic
Act, section 505(j)(8)). Bioequivalence refers to equivalent release of the
same drug substance from two or more drug products or formulations. This
viii
leads to an equivalent rate and extent of absorption from these formulations.
Underlying the concept of bioequivalence is the thesis that, if a drug
product contains a drug substance that is chemically identical and is
delivered to the site of action at the same rate and extent as another drug
product, then it is equivalent and can be substituted for that drug product.
Methods used to define bioequivalence can be found in 21 CFR 320.24, and
include (1) pharmacokinetic (PK) studies, (2) pharmacodynamic (PD) studies,
(3) comparative clinical trials, and (4) in-vitro studies. The choice of
study used is based on the site of action of the drug and the ability of the
study design to compare drug delivered to that site by the two products.
The standard bioequivalence (PK) study is conducted using a two-treatment
crossover study design in a limited number of volunteers, usually 24 to 36
adults. Alternately, a four-period, replicate design crossover study may
also be used. Single doses of the test and reference drug products are
administered and blood or plasma levels of the drug are measured over time.
Pharmacokinetic parameters characterizing rate and extent of drug absorption
are evaluated statistically. The PK parameters of interest are the resulting
area under the plasma concentration-time curve (AUC), calculated to the last
measured concentration (AUC(0-t)) and extrapolated to infinity (AUC(0-inf)), for
extent of absorption; and the maximum or peak drug concentrations (Cmax), for
rate of absorption. Crossover studies may not be practical in drugs with a
long half-life in the body, and a parallel study design may be used instead.
Alternate study methods, such as in-vitro studies or equivalence studies with
clinical or pharmacodynamic endpoints, are used for drug products where
plasma concentrations are not useful to determine delivery of the drug
substance to the site of activity (such as inhalers, nasal sprays and topical
products applied to the skin).
The statistical methodology for analyzing these bioequivalence studies is
called the two one-sided test procedure. Two situations are tested with this
statistical methodology. The first of the two one-sided tests determines
whether a generic product (test), when substituted for a brand-name product
(reference) is significantly less bioavailable. The second of the two one-
sided tests determines whether a brand-name product when substituted for a
generic product is significantly less bioavailable. Based on the opinions of
FDA medical experts, a difference of greater than 20% for each of the above
tests was determined to be significant, and therefore, undesirable for all
drug products. Numerically, this is expressed as a limit of test-product
average/reference-product average of 80% for the first statistical test and a
limit of reference-product average/test-product average of 80% for the second
statistical test. By convention, all data is expressed as a ratio of the
average response (AUC and Cmax) for test/reference, so the limit expressed in
the second statistical test is 125% (reciprocal of 80%).
For statistical reasons, all data is log-transformed prior to conducting
statistical testing. In practice, these statistical tests are carried out
using an analysis of variance procedure (ANOVA) and calculating a 90%
confidence interval for each pharmacokinetic parameter (Cmax and AUC). The
confidence interval for both pharmacokinetic parameters, AUC and Cmax, must
be entirely within the 80% to 125% boundaries cited above. Because the mean
of the study data lies in the center of the 90% confidence interval, the mean
of the data is usually close to 100% (a test/reference ratio of 1). Different
statistical criteria are sometimes used when bioequivalence is demonstrated
through comparative clinical trials pharmacodynamic studies, or comparative
in-vitro methodology.
The bioequivalence methodology and criteria described above simultaneously
control for both differences in the average response between test and
reference, as well as the precision with which the average response in the
population is estimated. This precision depends on the within-subject
ix
(normal volunteer or patient) variability in the pharmacokinetic parameters
(AUC and Cmax) of the two products and on the number of subjects in the
study. The width of the 90% confidence interval is a reflection in part of
the within-subject variability of the test and reference products in the
bioequivalence study. A test product with no differences in the average
response when compared to the reference might still fail to pass the
bioequivalence criteria if the variability of one or both products is high
and the bioequivalence study has insufficient statistical power (i.e.,
insufficient number of subjects). Likewise, a test product with low
variability may pass the bioequivalence criteria, when there are somewhat
larger differences in the average response.
This system of assessing bioequivalence of generic products assures that
these substitutable products do not deviate substantially in in-vivo
performance from the reference product. The Office of Generic Drugs has
conducted two surveys to quantify the differences between generic and brand
name products. The first survey included 224 bioequivalence studies
submitted in approved applications during 1985 and 1986. The observed
average differences between reference and generic products for AUC was 3.5%
(JAMA, Sept. 4, 1987, Vol. 258, No. 9). The second survey included 127
bioequivalence studies submitted to the agency in 273 ANDAs approved in 1997.
The three measures reviewed include AUC(0-t), AUC(0-inf), and Cmax. The observed
average differences between the reference and generic products were + 3.47%
(SD 2.84) for AUC(0-t), + 3.25% (SD 2.97) for AUC(0-inf), and + 4.29% (SD 3.72)
for Cmax (JAMA, Dec. 1, 1999, Vol. 282, No. 21).
The primary concern from the regulatory point of view is the protection of
the patient against approval of products that are not bioequivalent. The
current practice of carrying out two one-sided tests at the 0.05 level of
significance ensures that there is no more than a 5% chance that a generic
product that is not truly equivalent to the reference will be approved.
1.4 Reference Listed Drug
A reference listed drug (21 CFR 314.94(a)(3)) means the listed drug
identified by FDA as the drug product upon which an applicant relies in
seeking approval of its ANDA.
FDA has identified in the Prescription Drug Product and OTC Drug Product
Lists those reference listed drugs to which the in vivo bioequivalence
(reference standard) and, in some instances, the in vitro bioequivalence of
the applicant's product is compared. By designating a single reference
listed drug as the standard to which all generic versions must be shown to be
bioequivalent, FDA hopes to avoid possible significant variations among
generic drugs and their brand name counterpart. Such variations could result
if generic drugs were compared to different reference listed drugs. However,
in some instances when listed drugs are approved for a single drug product, a
product not designated as the reference listed drug and not shown to be
bioequivalent to the reference listed drug may be shielded from generic
competition. A firm wishing to market a generic version of a listed drug
that is not designated as the reference listed drug may petition the Agency
through the Citizen Petition procedure (see 21 CFR 10.25(a) and CFR 10.30).
When the Citizen Petition is approved, the second listed drug will be
designated as an additional reference listed drug and the petitioner may
submit an Abbreviated New Drug Application citing the designated reference
listed drug. Section 1.7, Therapeutic Equivalence Evaluations Codes products
meeting necessary bioequivalence requirements explains the (AB, AB1, AB2,
AB3... coding system for multisource drug products listed under the same
heading with two reference listed drugs.
x
In addition, there are two situations in which two listed drugs that have
been shown to be bioequivalent to each other may both be designated as
reference listed drugs. The first situation occurs when the in vivo
determination of bioequivalence is self-evident and a waiver of the in vivo
bioequivalence may be granted. The second situation occurs when the
bioequivalence of two listed products may be determined through in vitro
methodology. The reference listed drug is identified by the symbol "+" in
the Prescription and Over-the-Counter (OTC) Drug Product Lists. These
identified reference listed drugs represent the best judgment of the Division
of Bioequivalence at this time. The Prescription and OTC Drug Product Lists
identify reference drugs for oral dosage forms, Injectables, ophthalmics,
otics, and topical products. It is recommended that a firm planning to
conduct an in vivo bioequivalence study, or planning to manufacture a batch
of a drug product for which an in vivo waiver of bioequivalence will be
requested, contact the Division of Bioequivalence, Office of Generic Drugs,
to confirm the appropriate reference listed drug.
1.5 General Policies and Legal Status
The List contains public information and advice. It does not mandate the
drug products which is purchased, prescribed, dispensed, or substituted for
one another, nor does it, conversely, mandate the products that should be
avoided. To the extent that the List sets forth FDA's evaluations of the
therapeutic equivalence of drug products that have been approved, it contains
FDA's advice to the public, to practitioners and to the states regarding drug
product selection. These evaluations do not constitute determinations that
any product is in violation of the Act or that any product is preferable to
any other. Therapeutic equivalence evaluations are a scientific judgment
based upon evidence, while generic substitution may involve social and
economic policy administered by the states, intended to reduce the cost of
drugs to consumers. To the extent that the List identifies drug products
approved under Section 505 of the Act, it sets forth information that the
Agency is required to publish and that the public is entitled to under the
Freedom of Information Act. Exclusion of a drug product from the List does
not necessarily mean that the drug product is either in violation of Section
505 of the Act, or that such a product is not safe or effective, or that such
a product is not therapeutically equivalent to other drug products. Rather,
the exclusion is based on the fact that FDA has not evaluated the safety,
effectiveness, and quality of the drug product.
1.6 Practitioner/User Responsibilities
Professional care and judgment should be exercised in using the List.
Evaluations of therapeutic equivalence for prescription drugs are based on
scientific and medical evaluations by FDA. Products evaluated as
therapeutically equivalent can be expected, in the judgment of FDA, to have
equivalent clinical effect and no difference in their potential for adverse
effects when used under the conditions of their labeling. However, these
products may differ in other characteristics such as shape, scoring
configuration, release mechanisms, packaging, excipients (including colors,
flavors, preservatives), expiration date/time, and, in some instances,
labeling. If products with such differences are substituted for each other,
there is a potential for patient confusion due to differences in color or
shape of tablets, inability to provide a given dose using a partial tablet if
the proper scoring configuration is not available, or decreased patient
acceptance of certain products because of flavor. There may also be better
xi
stability of one product over another under adverse storage conditions, or
allergic reactions in rare cases due to a coloring or a preservative
ingredient, as well as differences in cost to the patient.
FDA evaluation of therapeutic equivalence in no way relieves practitioners
of their professional responsibilities in prescribing and dispensing such
products with due care and with appropriate information to individual
patients. In those circumstances where the characteristics of a specific
product, other than its active ingredient, are important in the therapy of a
particular patient, the physician's specification of that product is
appropriate. Pharmacists must also be familiar with the expiration
dates/times and labeling directions for storage of the different products,
particularly for reconstituted products, to assure that patients are properly
advised when one product is substituted for another.
Multisource and single-source drug products. FDA has evaluated for
therapeutic equivalence only multisource prescription drug products approved
under Section 505 of the Act, which in most instances means those
pharmaceutical equivalents available from more than one manufacturer. For
such products, a therapeutic equivalence code is included and, in addition,
product information is highlighted in bold face and underlined. Those
products with approved applications that are single-source (i.e., there is
only one approved product available for that active ingredient, dosage form,
route of administration, and strength) are also included on the List, but no
therapeutic equivalence code is included with such products. Any drug
product in the List repackaged and/or distributed by other than the
application holder is considered to be therapeutically equivalent to the
application holder's drug product even if the application holder's drug
product is single source or coded as non-equivalent (e.g., BN). Also,
although not identified in the List, distributors or repackagers of an
application holder's drug product are considered to have the same code as the
application holder. The details of these codes and the policies underlying
them are discussed in Section 1.7, Therapeutic Equivalence Evaluations Codes.
Products on the List are identified by the names of the holders of
approved applications (applicants) who may not necessarily be the
manufacturer of the product. The applicant may have had its product
manufactured by a contract manufacturer and may simply be distributing the
product for which it has obtained approval. In most instances, however, the
manufacturer of the product is also the applicant. The name of the
manufacturer is permitted by regulation to appear on the label, even when the
manufacturer is not the marketer.
Although the products on the List are identified by the names of the
applicants, circumstances, such as changing corporate ownership, have
sometimes made identification of the applicant difficult. The Agency
believes, based on continuing document review and communication with firms,
that the applicant designations on the List are, in most cases, correct.
To relate firm name information on a product label to that on the List,
the following should be noted: the applicant's name always appears on the
List. This applies whether the applicant (firm name on the Form FDA 356h in
the application) is the marketer (firm name in largest letters on the label)
or not. However, the applicant's name may not always appear on the label of
the product.
If the applicant is the marketer, its name appears on the List and on the
label; if the applicant is not the marketer, and the Agency is aware of a
corporate relationship (e.g., parent and subsidiary) between the applicant
and the marketer, the name of the applicant appears on the List and both firm
names may appear on the label. Firms with known corporate relationships are
xii
displayed in Appendix B. If there is no known corporate relationship between
the applicant and the marketer, the applicant's name appears on the List;
however, unless the applicant is the manufacturer, packager, or distributor,
the applicant's name may not appear on the label. In this case, the
practitioner, from labeling alone, will not be able to relate the marketed
product to an applicant cited in the List, and hence to a specific approved
drug product. In such cases, to assure that the product in question is the
subject of an approved application, the firm named on the label should be
contacted.
To relate trade name (proprietary name) information on a product label to
that on the List, the following should be noted: if the applicant is the
marketer, its name appears on the List and on the label; if the Agency is
aware of a corporate relationship between the applicant and the marketer, the
trade name (proprietary name) of the drug product (established drug name if
no trade name exists) appears on the List. If a corporate relationship
exists between an application holder and a marketer and both firms are
distributing the drug product, the FDA reserves the right to select the trade
name of either the marketer or the application holder to appear on the List.
If there is no known corporate relationship between the applicant and the
marketer, the established drug name appears on the List.
Every product on the List is subject at all times to regulatory action.
From time to time, approved products may be found in violation of one or more
provisions of the Act. In such circumstances, the Agency will commence
appropriate enforcement action to correct the violation, if necessary, by
securing removal of the product from the market by voluntary recall, seizure,
or other enforcement actions. Such regulatory actions are, however,
independent of the inclusion of a product on the List. The main criterion
for inclusion of a product is that it has an application with an effective
approval that has not been withdrawn for safety or efficacy reasons. FDA
believes that retention of a violative product on the List will not have any
significant adverse health consequences, because other legal mechanisms are
available to the Agency to prevent the product's actual marketing. FDA may
however, change a product's therapeutic equivalence rating if the
circumstances giving rise to the violation change or otherwise call into
question the data upon which the Agency's assessment of whether a product
meets the criteria for therapeutic equivalence was made.
1.7 Therapeutic Equivalence Evaluations Codes
The coding system for therapeutic equivalence evaluations is constructed
to allow users to determine quickly whether the Agency has evaluated a
particular approved product as therapeutically equivalent to other
pharmaceutically equivalent products (first letter) and to provide additional
information on the basis of FDA's evaluations (second letter). With few
exceptions, the therapeutic equivalence evaluation date is the same as the
approval date.
The two basic categories into which multisource drugs have been placed are
indicated by the first letter as follows:
A Drug products that FDA considers to be therapeutically equivalent to
other pharmaceutically equivalent products, i.e., drug products for which:
(1) there are no known or suspected bioequivalence problems. These are
designated AA, AN, AO, AP, or AT, depending on the dosage form; or
(2) actual or potential bioequivalence problems have been resolved with
adequate in vivo and/or in vitro evidence supporting
xiii
bioequivalence. These are designated AB.
B Drug products that FDA at this time, considers not to be
therapeutically equivalent to other pharmaceutically equivalent products,
i.e.,
drug products for which actual or potential bioequivalence problems
have not been resolved by adequate evidence of bioequivalence. Often
the problem is with specific dosage forms rather than with the active
ingredients. These are designated BC, BD, BE, BN, BP, BR, BS, BT, BX,
or B*.
Individual drug products have been evaluated as therapeutically equivalent
to the reference product in accordance with the definitions and policies
outlined below:
"A" CODES
Drug products that are considered to be therapeutically equivalent to other pharmaceutically
equivalent products.
"A" products are those for which actual or potential bioequivalence
problems have been resolved with adequate in vivo and/or in vitro evidence
supporting bio-equivalence. Drug products designated with an "A" code fall
under one of two main policies:
(1) for those active ingredients or dosage forms for which no in vivo
bioequivalence issue is known or suspected, the information necessary to
show bioequivalence between pharmaceutically equivalent products is
presumed and considered self-evident based on other data in the
application for some dosage forms (e.g., solutions) or satisfied for
solid oral dosage forms by a showing that an acceptable in vitro
dissolution standard is met. A therapeutically equivalent rating is
assigned such products so long as they are manufactured in accordance
with Current Good Manufacturing Practice regulations and meet the other
requirements of their approved applications (these are designated AA, AN,
AO, AP, or AT, depending on the dosage form, as described below); or
(2) for those DESI drug products containing active ingredients or dosage
forms that have been identified by FDA as having actual or potential
bioequivalence problems, and for post-1962 drug products in a dosage
form presenting a potential bioequivalence problem, an evaluation of
therapeutic equivalence is assigned to pharmaceutical equivalents only
if the approved application contains adequate scientific evidence
establishing through in vivo and/or in vitro studies the bioequivalence
of the product to a selected reference product (these products are
designated as AB).
There are some general principles that may affect the substitution of
pharmaceutically equivalent products in specific cases. Prescribers and
dispensers of drugs should be alert to these principles so as to deal
appropriately with situations that require professional judgment and
discretion.
There may be labeling differences among pharmaceutically equivalent
products that require attention on the part of the health professional. For
example, pharmaceutically equivalent powders to be reconstituted for
administration as oral or injectable liquids may vary with respect to their
expiration time or storage conditions after reconstitution. An FDA
evaluation that such products are therapeutically equivalent is applicable
xiv
only when each product is reconstituted, stored, and used under the
conditions specified in the labeling of that product.
The Agency will use notes in this publication to point out special
situations such as potential differences between two drug products that have
been evaluated as bioequivalent and otherwise therapeutically equivalent,
when they should be brought to the attention of health professionals. These
notes are contained in Section 1.8, Description of Special Situations.
For example, in rare instances, there may be variations among
therapeutically equivalent products in their use or in conditions of
administration. Such differences may be due to patent or exclusivity rights
associated with such use. When such variations may, in the Agency's opinion,
affect prescribing or substitution decisions by health professionals, a note
will be added to Section 1.8.
Also, occasionally a situation may arise in which changes in a listed drug
product after its approval (for example, a change in dosing interval) may
have an impact on the substitutability of already approved generic versions
of that product that were rated by the Agency as therapeutically equivalent
to the listed product. When such changes in the listed drug product are
considered by the Agency to have a significant impact on therapeutic
equivalence, the Agency will change the therapeutic equivalence ratings for
other versions of the drug product unless the manufacturers of those other
versions of the product provide additional information to assure equivalence
under the changed conditions. Pending receipt of the additional data, the
Agency may add a note to Section 1.8, or, in rare cases, may even change the
therapeutic equivalence rating.
In some cases (e.g., Isolyte® S w/ Dextrose 5% in Plastic Container and
Plasma-Lyte® 148 and Dextrose 5% in Plastic Container), closely related
products are listed as containing the same active ingredients, but in
somewhat different amounts. In determining which of these products are
pharmaceutically equivalent, the Agency has considered products to be
pharmaceutically equivalent with labeled strengths of an ingredient that do
not vary by more than 1%.
Different salts and esters of the same therapeutic moiety are regarded as
pharmaceutical alternatives. For the purpose of this publication, such
products are not considered to be therapeutically equivalent. There are no
instances in this List where pharmaceutical alternatives are evaluated or
coded with regard to therapeutic equivalence. Anhydrous and hydrated
entities, as well as different polymorphs, are considered pharmaceutical
equivalents and must meet the same standards and, where necessary, as in the
case of ampicillin/ampicillin trihydrate, their equivalence is supported by
appropriate bioavailability/bioequivalence studies.
The codes in this book are not intended to preclude health care
professionals from converting pharmaceutically different concentrations into
pharmaceutical equivalents using accepted professional practice.
Where package size variations have therapeutic implications, products so
packaged have not been considered pharmaceutically equivalent. For example,
some oral contraceptives are supplied in 21-tablet and 28-tablet packets; the
28-tablet packets contain 7 placebo or iron tablets. These two packaging
configurations are not regarded as pharmaceutically equivalent; thus, they
are not designated as therapeutically equivalent.
Preservatives may differ among some therapeutically equivalent drug
products. Differences in preservatives and other inactive ingredients do not
xv
affect FDA's evaluation of therapeutic equivalence except in cases where
these components may influence bioequivalence or routes of administration.
The specific sub-codes for those drugs evaluated as therapeutically
equivalent and the policies underlying these sub-codes follow:
AA Products in conventional dosage forms not presenting bioequivalence problems
Products coded as AA contain active ingredients and dosage forms that are
not regarded as presenting either actual or potential bioequivalence
problems or drug quality or standards issues. However, all oral dosage
forms must, nonetheless, meet an appropriate in vitro bioequivalence
standard that is acceptable to the Agency in order to be approved.
AB, AB1, AB2, AB3... Products meeting necessary bioequivalence requirements
Multisource drug products listed under the same heading (i.e., identical
active ingredients(s), dosage form, and route(s) of administration) and
having the same strength (see Section 1.2, Therapeutic Equivalence-Related
Terms, Pharmaceutical Equivalents) generally will be coded AB if a study
is submitted demonstrating bioequivalence.
In certain instances, a number is added to the end of the AB code to make
a three character code (i.e., AB1, AB2, AB3, etc.). Three-character codes
are assigned only in situations when more than one reference listed drug
of the same strength has been designated under the same heading. Two or
more reference listed drugs are generally selected only when there are at
least two potential reference drug products which are not bioequivalent to
each other. If a study is submitted that demonstrates bioequivalence to a
specific listed drug product, the generic product will be given the same
three-character code as the reference listed drug it was compared against.
For example, Adalat® CC (Miles) and Procardia XL® (Pfizer), extended-
release tablets, are listed under the active ingredient nifedipine. These
drug products, listed under the same heading, are not bioequivalent to
each other. Generic drug products deemed by FDA to be bioequivalent to
Adalat® CC and Procardia XL® have been approved, Adalat® CC and Procardia
XL® have been assigned ratings of AB1 and AB2, respectively. The generic
drug products bioequivalent to Adalat® CC would be assigned a rating of
AB1 and those bioequivalent to Procardia XL® would be assigned a rating of
AB2. (The assignment of an AB1 or AB2 rating to a specific product does
not imply product preference.) Even though drug products of distributors
and/or repackagers are not included in the List, they are considered
therapeutically equivalent to the application holder's drug product if the
application holder's drug product is rated either with an AB or three-
character code or is single source in the List. Drugs coded as AB under a
heading are considered therapeutically equivalent only to other drugs
coded as AB under that heading. Drugs coded with a three-character code
under a heading are considered therapeutically equivalent only to other
drugs coded with the same three-character code under that heading.
AN Solutions and powders for aerosolization
Uncertainty regarding the therapeutic equivalence of aerosolized products
arises primarily because of differences in the drug delivery system.
Solutions and powders intended for aerosolization that are marketed for
use in any of several delivery systems are considered to be
pharmaceutically and therapeutically equivalent and are coded AN. Those
products that are compatible only with a specific delivery system or those
products that are packaged in and with a specific delivery system are
xvi
coded BN, unless they have met an appropriate bioequivalence standard.
Solutions or suspensions in a specific delivery system will be coded AN if
the bioequivalence standard is based upon in vitro methodology, if
bioequivalence needs to be demonstrated by in vivo methodology then the
drug products will be coded AB.
AO Injectable oil solutions
The absorption of drugs in injectable (parenteral) oil solutions may vary
substantially with the type of oil employed as a vehicle and the
concentration of the active ingredient. Injectable oil solutions are
therefore considered to be pharmaceutically and therapeutically equivalent
only when the active ingredient, its concentration, and the type of oil
used as a vehicle are all identical.
AP Injectable aqueous solutions and, in certain instances, intravenous non-aqueous
solutions
It should be noted that even though injectable (parenteral) products under
a specific listing may be evaluated as therapeutically equivalent, there
may be important differences among the products in the general category,
Injectable; Injection. For example, some injectable products that are
rated therapeutically equivalent are labeled for different routes of
administration. In addition, some products evaluated as therapeutically
equivalent may have different preservatives or no preservatives at all.
Injectable products available as dry powders for reconstitution,
concentrated sterile solutions for dilution, or sterile solutions ready
for injection are pharmaceutical alternative drug products. They are not
rated as therapeutically equivalent (AP) to each other even if these
pharmaceutical alternative drug products are designed to produce the same
concentration prior to injection and are similarly labeled. Consistent
with accepted professional practice, it is the responsibility of the
prescriber, dispenser, or individual administering the product to be
familiar with a product's labeling to assure that it is given only by the
route(s) of administration stated in the labeling.
Certain commonly used large volume intravenous products in glass
containers are not included on the List (e.g., dextrose injection 5%,
dextrose injection 10%, sodium chloride injection 0.9%) since these
products are on the market without FDA approval and the FDA has not
published conditions for marketing such parenteral products under approved
NDAs. When packaged in plastic containers, however, FDA regulations
require approved applications prior to marketing. Approval then depends
on, among other things, the extent of the available safety data involving
the specific plastic component of the product. All large volume
parenteral products are manufactured under similar standards, regardless
of whether they are packaged in glass or plastic. Thus, FDA has no reason
to believe that the packaging container of large volume parenteral drug
products that are pharmaceutically equivalent would have any effect on
their therapeutic equivalence.
The strength of parenteral drugs products is defined as the total drug
content of the container. Until recently the strength of liquid
parenteral drug products in the Orange Book have not been displayed. The
concentration of the liquid parenteral drug product in the Orange Book has
been shown as xmg/ml. The amount of dry powder or freeze dried powder in
a container has always been identified as the strength.
xvii
With the finalization of the Waxman-Hatch amendments that characterized
each strength of a drug product as a listed drug, it became evident that
the format of the Orange Book should be changed to reflect each strength
of a parenteral solution. To this end the OGD has started to display the
strength of all new approvals of parenteral solutions. Previously we
would have displayed only the concentration of an approved parenteral
solution, e.g. 50mg/ml. If this drug product had a 20 ml and 60 ml
container approved the two products would be shown as 1Gm / 20ml (50mg/ml)
and 3Gm / 60ml (50mg/ml).
AT Topical products
There are a variety of topical dosage forms available for dermatologic,
ophthalmic, otic, rectal, and vaginal administration, including creams,
gels, lotions, oils, ointments, pastes, solutions, sprays and
suppositories. Even though different topical dosage forms may contain the
same active ingredient and potency, these dosage forms are not considered
pharmaceutically equivalent. Therefore, they are not considered
therapeutically equivalent. All solutions and DESI drug products
containing the same active ingredient in the same topical dosage form for
which a waiver of in vivo bioequivalence has been granted and for which
chemistry and manufacturing processes are adequate to demonstrate
bioequivalence, are considered therapeutically equivalent and coded AT.
Pharmaceutically equivalent topical products that raise questions of
bioequivalence, including all post-1962 non-solution topical drug
products, are coded AB when supported by adequate bioequivalence data, and
BT in the absence of such data.
"B" CODES
Drug products that FDA, at this time, considers not to be therapeutically equivalent to other
pharmaceutically equivalent products.
"B" products, for which actual or potential bioequivalence problems have
not been resolved by adequate evidence of bioequivalence, often have a
problem with specific dosage forms rather than with the active ingredients.
Drug products designated with a "B" code fall under one of three main
policies:
(1) the drug products contain active ingredients or are manufactured in
dosage forms that have been identified by the Agency as having
documented bio-equivalence problems or a significant potential for
such problems and for which no adequate studies demonstrating
bioequivalence have been submitted to FDA; or
(2) the quality standards are inadequate or FDA has an insufficient basis
to determine therapeutic equivalence; or
(3) the drug products are under regulatory review.
The specific coding definitions and policies for the "B" sub-codes are as
follows:
xviii
B* Drug products requiring further FDA investigation and review to determine therapeutic
equivalence
The code B* is assigned to products previously assigned an A or B code
when FDA receives new information that raises a significant question
regarding therapeutic equivalence that can be resolved only through
further Agency investigation and/or review of data and information
submitted by the applicant. The B* code signifies that the Agency will
take no position regarding the therapeutic equivalence of the product
until the Agency completes its investigation and review.
BC Extended-release dosage forms (capsules, injectables and tablets)
Extended-release tablets are formulated in such a manner as to make the
contained medicament available over an extended period of time following
ingestion.
Although bioavailability studies have been conducted on these dosage
forms, they may be subject to bioavailability differences, primarily
because firms developing extended-release products for the same active
ingredient rarely employ the same formulation approach. FDA, therefore,
does not consider different extended-release dosage forms containing the
same active ingredient in equal strength to be therapeutically equivalent
unless equivalence between individual products in both rate and extent has
been specifically demonstrated through appropriate bioequivalence studies.
Extended-release products for which such bioequivalence data have not been
submitted are coded BC, while those for which such data are available have
been coded AB.
BD Active ingredients and dosage forms with documented bioequivalence problems
The BD code denotes products containing active ingredients with known
bioequivalence problems and for which adequate studies have not been
submitted to FDA demonstrating bioequivalence. Where studies showing
bioequivalence have been submitted, the product has been coded AB.
BE Delayed-release oral dosage forms
Where the drug may be destroyed or inactivated by the gastric juice or
where it may irritate the gastric mucosa, the use of “enteric” coatings is
indicated. Such coatings are intended to delay the release of the
medication until the tablet has passed through the stomach. Drug products
in delayed-release dosage forms containing the same active ingredients are
subject to significant differences in absorption. Unless otherwise
specifically noted, the Agency considers different delayed-release
products containing the same active ingredients as presenting a potential
bioequivalence problem and codes these products BE in the absence of
in vivo studies showing bioequivalence. If adequate in vivo studies have
demonstrated the bioequivalence of specific delayed-release products, such
products are coded AB.
BN Products in aerosol-nebulizer drug delivery systems
This code applies to drug solutions or powders that are marketed only as a
component of, or as compatible with, a specific drug delivery system.
There may, for example, be significant differences in the dose of drug and
particle size delivered by different products of this type. Therefore,
xix
the Agency does not consider different metered aerosol dosage forms
containing the same active ingredient(s) in equal strengths to be
therapeutically equivalent unless the drug products meet an appropriate
bioequivalence standard, such products are coded AB.
BP Active ingredients and dosage forms with potential bioequivalence problems
FDA's bioequivalence regulations (21 CFR 320.33) contain criteria and
procedures for determining whether a specific active ingredient in a
specific dosage form has a potential for causing a bioequivalence problem.
It is FDA's policy to consider an ingredient meeting these criteria as
having a potential bioequivalence problem even in the absence of positive
data demonstrating inequivalence. Pharmaceutically equivalent products
containing these ingredients in oral dosage forms are coded BP until
adequate in vivo bioequivalence data are submitted, such products are
coded AB. Injectable suspensions containing an active ingredient
suspended in an aqueous or oleaginous vehicle have also been coded BP.
Injectable suspensions are subject to bioequivalence problems because
differences in particle size, polymorphic structure of the suspended
active ingredient, or the suspension formulation can significantly affect
the rate of release and absorption. FDA does not consider pharmaceutical
equivalents of these products bioequivalent without adequate evidence of
bioequivalence, such products would be coded AB.
BR Suppositories or enemas that deliver drugs for systemic absorption
The absorption of active ingredients from suppositories or enemas that are
intended to have a systemic effect (as distinct from suppositories
administered for local effect) can vary significantly from product to
product. Therefore, FDA considers pharmaceutically equivalent systemic
suppositories or enemas bio-equivalent only if in vivo evidence of
bioequivalence is available. In those cases where in vivo evidence is
available, the product is coded AB. If such evidence is not available,
the products are coded BR.
BS Products having drug standard deficiencies
If the drug standards for an active ingredient in a particular dosage form
are found by FDA to be deficient so as to prevent an FDA evaluation of
either pharmaceutical or therapeutic equivalence, all drug products
containing that active ingredient in that dosage form are coded BS. For
example, if the standards permit a wide variation in pharmacologically
active components of the active ingredient such that pharmaceutical
equivalence is in question, all products containing that active ingredient
in that dosage form are coded BS.
BT Topical products with bioequivalence issues
This code applies mainly to post-1962 dermatologic, ophthalmic, otic,
rectal, and vaginal products for topical administration, including creams,
ointments, gels, lotions, pastes, and sprays, as well as suppositories not
intended for systemic drug absorption. Topical products evaluated as
having acceptable clinical performance, but that are not bioequivalent to
other pharmaceutically equivalent products or that lack sufficient
evidence of bioequivalence, will be coded BT.
xx
BX Drug products for which the data are insufficient to determine therapeutic equivalence
The code BX is assigned to specific drug products for which the data that
have been reviewed by the Agency are insufficient to determine therapeutic
equivalence under the policies stated in this document. In these
situations, the drug products are presumed to be therapeutically
inequivalent until the Agency has determined that there is adequate
information to make a full evaluation of therapeutic equivalence.
1.8 Description of Special Situations
Certain drugs listed in the Orange Book present special situations that
merit further discussion. Following is a description of those special
situations:
Amino Acid and Protein Hydrolysate Injections. These products differ in
the amount and kinds of amino acids they contain and, therefore, are not
considered pharmaceutical equivalents. For this reason, these products are
not considered therapeutically equivalent. At the same time, the Agency
believes that it is appropriate to point out that where nitrogen balance is
the sole therapeutic objective and individual amino acid content is not a
consideration, pharmaceutical alternatives with the same total amount of
nitrogen content may be considered therapeutically equivalent.
Follitropin Alfa and Beta. Based on available data derived from physico
chemical tests and bioassay, follitropin alfa and follitropin beta are
indistinguishable.
Gaviscon®. Gaviscon® is an OTC product which has been marketed since
September 1970. The active ingredients in this product, aluminum hydroxide
and magnesium trisilicate, were reviewed by the Agency's OTC Antacid Panel
and were considered to be safe and effective ingredients (Category I) by that
Panel. However, the tablet failed to pass the antacid test which is required
of all antacid products. The Agency, therefore, placed the tablet in
Category III for lack of effectiveness. A full NDA with clinical studies was
submitted by Marion Laboratories, Inc., and approved by FDA on December 9,
1983. Gaviscon®’s activity in treating reflux acidity is made possible by
the physical-chemical properties of the inactive ingredients, sodium
bicarbonate and alginic acid. Therefore, all ANDAs which cite Gaviscon®
tablets as the listed drug must contain the inactive ingredients sodium
bicarbonate and alginic acid. A full NDA will be required to support the
effectiveness of the drug product if different inactive ingredients are to be
substituted for sodium bicarbonate or alginic acid or if different
proportions of these ingredients are to be used.
Levothyroxine Sodium. Because there are multiple reference listed drugs
of levothyroxine sodium tablets and some reference listed drugs' sponsors
have conducted studies to establish their drugs' therapeutic equivalence to
other reference listed drugs, FDA has determined that its usual practice of
assigning two or three character TE codes may be potentially confusing and
inadequate for these drug products. Accordingly, FDA provides the following
explanation and chart of therapeutic equivalence evaluations for
levothyroxine sodium drug products.
Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to be
therapeutically equivalent to corresponding strengths of Unithroid (Jerome
Stevens NDA 021210) tablets.
Levo-T (Alara NDA 021342), Levothyroxine Sodium (Mylan ANDA 76187), Unithroid
xxi
(Jerome Stevens NDA 021210), and Levothyroxine Sodium (Merck KGAA ANDA
76752)tablets have been determined to be therapeutically equivalent to
corresponding strengths of Synthroid (Abbott NDA 021402) tablets.
Levo-T (Alara NDA 021342), Unithroid (Jerome Stevens NDA 021210),
Levothyroxine Sodium (Mylan ANDA 076187), and Levothyroxine Sodium (Merck
KGAA ANDA 76752) tablets have been determined to be therapeutically
equivalent to corresponding strengths of Levoxyl (King Pharms NDA 021301)
tablets.
Levothyroxine Sodium (Mylan ANDA 76187) tablets have been determined to be
therapeutically equivalent to corresponding strengths of Levothroid (Lloyd
NDA 021116) tablets.
The chart outlines TE codes for all 0.025mg products. Other product
strengths may be similar. Therapeutic equivalence has been established
between products that have the same AB+number TE code. More than one TE code
may apply to some products. One common TE code indicates therapeutic
equivalence between products.
TE Appl Product
Trade Name Applicant Potency
Code No No
UNITHROID STEVENS J 0.025MG AB1 021210 001
LEVOTHYROXINE SODIUM MYLAN 0.025MG AB1 076187 001
LEVOXYL KING PHARMS 0.025MG AB1 021301 001
SYNTHROID ABBOTT 0.025MG AB1 021402 001
LEVO-T ALARA PHARM 0.025MG AB1 021342 001
SYNTHROID ABBOTT 0.025MG AB2 021402 001
LEVOTHYROXINE SODIUM MYLAN 0.025MG AB2 076187 001
LEVO-T ALARA PHARM 0.025MG AB2 021342 001
UNITHROID STEVENS J 0.025MG AB2 021210 001
LEVOXYL KING PHARMS 0.025MG AB3 021301 001
LEVO-T ALARA PHARM 0.025MG AB3 021342 001
UNITHROID STEVENS J 0.025MG AB3 021210 001
LEVOTHYROXINE SODIUM MYLAN 0.025MG AB3 076187 001
LEVOTHROID LLOYD 0.025MG AB4 021116 001
LEVOTHYROXINE SODIUM MYLAN 0.025MG AB4 076187 001
Patent Certification(s) Reference Listed Drug based upon a suitability
petition. An abbreviated new drug application that refers to a Reference
Listed Drug (RLD) approved pursuant to a suitability petition must
demonstrate that the proposed product is bioequivalent to the RLD, and it
must include appropriate patent certification(s) and an exclusivity statement
with respect to the listed drug which served as the basis for the approved
suitability petition. This concept also applies to an ANDA applicant that
cites a RLD that was based upon an NDA that is still covered by patent (s)
and/or exclusivity, e.g. a second RLD that was selected when the in vivo
determination of bioequivalence of the original RLD is self evident and the
waiver of the in vivo determination of bioequivalence may be granted.
Waived exclusivity. If a new drug application (NDA) submitted under
xxii
section 505(b) of the Federal Food, Drug, and Cosmetic Act (Act) qualifies
for exclusivity under sections 505(c)(3)(D) and 505(j)(5)(D), the exclusivity
is listed in the Patent and Exclusivity Section of the Orange Book. If a
drug product has received this exclusivity, the FDA will delay the approval
of a 505(b)(2) application or an abbreviated new drug application (ANDA)
under section 505(j) of the Act until the expiration of the exclusivity. If
the listed drug is also protected by one or more patents, the approval date
for the 505(b)(2) application or ANDA will be determined by the latest
expiring patent or exclusivity listed in the Orange Book. However, the
holder of the NDA may waiver its exclusivity as to any or all 505(b)(2) and
ANDA applications referencing the protected drug product. If an NDA sponsor
waivers its right to the exclusivity protection, qualified 505(b)(2) or ANDA
applications may be approved without regard to the NDA holder's exclusivity.
An NDA for which the holder has waived its exclusivity as to all 505(b)(2)
and ANDA applications will be coded with a W in the Patent and Exclusivity
Section of the Orange Book and be referred to this section. The applicant
referencing this listed drug should indicate in the exclusivity statement
that the holder of the listed drug has waived its exclusivity.
1.9 Therapeutic Equivalence Code Change for a Drug Entity
The Agency will use the following procedures when, in response to a
petition or on its own initiative, it is considering a change in the
therapeutic equivalence code for approved multi-source drug products. Such
changes will generally occur when the Agency becomes aware of new scientific
information affecting the therapeutic equivalence of an entire category of
drug products in the List (e.g., information concerning the active ingredient
or the dosage form), rather than information concerning a single drug product
within the category. These procedures will be used when a change in
therapeutic equivalence code is under consideration for all drug products
found in the Prescription Drug Product List under a specific drug entity and
dosage form. The change may be from the code signifying that the drug does
not present a bioequivalence problem (e.g., AA) to a code signifying a
bioequivalence problem (e.g., BP), or vice versa. This procedure does not
apply to a change of a particular product code (e.g., a change from BP to AB
or from AB to BX).
Before making a change in a therapeutic equivalence code for an entire
category of drugs, the Agency will announce in the Introduction to the
Cumulative Supplement that it is considering the change and will invite
comment. Comments, along with scientific data, may be sent to the Director,
Division of Bioequivalence, Office of Generic Drugs, Center for Drug
Evaluation and Research, HFD-650, 7620 Standish Place, Rockville, MD 20855.
The comment period will generally be 60 days in length, and the closing
date for comments will be listed in the description of the proposed change
for each drug entity.
The most useful type of scientific data submission is an in vivo
bioavailability/bioequivalence study conducted on batches of the subject drug
products. These submissions should present a full description of the
analytical procedures and equipment used, a validation of the analytical
methodology, including the standard curve, a description of the method of
calculating results, and a description of the pharmacokinetic and statistical
models used in analyzing the data. Anecdotal or testimonial information is
the least useful to the Agency, and such submissions are discouraged. Copies
xxiii
of supporting reports published in the scientific literature or unpublished
material, however, are welcome.
1.10 Change of the Therapeutic Equivalence Evaluation for a Single Product
The aforementioned procedure does not apply to a change in a single drug
product code. For example, a change in a single drug product's code from BP
to AB as a result of the submission of an acceptable bioequivalence study
ordinarily will not be the subject of notice and comment. Likewise, a change
in a single drug product's code from AB to BX (e.g., as a result of new
information raising a significant question as to bioequivalence) does not
require notice and comment. The Agency's responsibility to provide the
public with the Agency's most current information related to therapeutic
equivalence may require a change in a drug product's code prior to any formal
notice and opportunity for the applicant to be heard. The publication in the
Federal Register of a proposal to withdraw approval of a drug product will
ordinarily result in a change in a product's code from AB to BX if this
action has not already been taken.
1.11 Discontinued Section
Those drug products in the Discontinued Section of the Orange Book in
which a determination has already been made that the products were not
withdrawn for safety or efficacy reasons have “**Federal Register
determination that product was not discontinued or withdrawn for safety or
efficacy reasons**” following the product strength. Those drug products are
only reflective of citizen petitions determinations made since 1995. The
identification of these drug products in the Discontinued Section of the
Orange Book should avoid the submission of multiple citizen petitions for the
same drug product. FR notices no longer applicable are removed from the
Annual Edition (i.e., there is a currently marketed Reference Listed Drug and
no applicable patent or exclusivity). FR Safety or Effectiveness
Determinations List lists products that have current and removed notices.
The list is updated quarterly. Notices issued during the year are added to
the Electronic Orange Book Query in the month they become effective.
Generally, approved products are added to the Discontinued Section of the
Orange Book when the applicant holder notifies the Orange Book staff of the
products’ not marketed status. Products may also be added if annual reports
indicate the product is no longer marketed or other Agency administrative
action (e.g., Withdrawal of an Application). Changes to the Orange Book are
not affected by the drug registration and listing requirements of Section 510
of the Act.
1.12 Changes to the Orange Book
Every effort is made to ensure the Annual Edition is current and
accurate. Applicant holders are requested to inform the FDA Orange Book
Staff (OBS) of any changes or corrections. Please inform the OBS when
products are no longer marketed. Notification of the Orange Book staff to
include the newly approved product in the Discontinued Drug Product List
rather than parts 1, 2 or 3 of the List (as discussed in Section 1.1) must
occur by the end of the month in which the product is approved to ensure that
the product is not included in the “active” portions of the next published
Orange Book update
xxiv
We can be contacted by email at drugproducts@fda.hhs.gov. Send Changes by
FAX: 301-595-1446; mail to:
FDA/CDER Orange Book Staff
Office of Generic Drugs,
7620 Standish Place
Rockville, MD 20855-2773
1.13 Availability of the Edition
Commencing with the 25th edition, the Annual Edition and current monthly
Cumulative Supplement are available in a Portable Document Format (PDF) at
the EOB home page, Electronic Orange Book Query, by clicking on Publications.
The PDF annual format duplicates previous paper versions except for the
Orphan Products Designations and Approvals List. An annual subscription of
the PDF format may be obtained from the U.S. Government Printing Office, 866
512-1800.
xxv
2. HOW TO USE THE DRUG PRODUCT LISTS
2.1 Key Sections for Using the Drug Product Lists
This publication contains illustrations, along with Drug Product Lists,
indices, and lists of abbreviations and terms which facilitate their use.
Illustrations. The annotated Drug Product Illustration, see Section
2.2, and the Therapeutic Equivalence Evaluations Illustration, see
Section 2.3, are offered to provide further clarification. These depict the
format found in the Prescription Drug Product List (the only list in which
therapeutic equivalence evaluation codes are displayed).
Drug Product Lists. The Prescription and OTC Drug Product Lists,
arranged alphabetically by active ingredient(s), contain product
identification information (active ingredients, dosage forms, routes of
administration, product names, application holders, strengths) for single and
multiple ingredient drug products. Also shown are the application number and
drug product number (FDA internal computer data use only) and approval dates
for those drug products approved on or after January 1, 1982. The application
number preceded by “N” is a New Drug Application (NDA or commonly the
innovator). The application number preceded by an “A” is an Abbreviated New
Drug Application (ANDA or commonly the generic).
The Discontinued Product List, arranged alphabetically by active
ingredient(s), contains product identification information (dosage form,
product name, strength, and application number).
If a prescription drug product is available from more than one source
(multisource), a therapeutic equivalence code will appear in front of the
applicant's name. If a product is therapeutically equivalent to one or more
products or to an appropriate reference, it will be designated with a code
beginning with "A" and the entry will be underlined and printed in bold font
for emphasis.
Active ingredient headings for multiple ingredient (combination) drug
products are arranged alphabetically. For purposes of this publication, this
alphabetical sort takes precedence over United States Pharmacopeia official
monograph order (i.e., Reserpine, Hydralazine Hydrochloride,
Hydrochlorothiazide). For example, product information labeled as Reserpine,
Hydrochlorothiazide and Hydralazine Hydrochloride appears under the active
ingredient heading Hydralazine Hydrochloride; Hydrochlorothiazide; Reserpine.
A cross-reference to the product information (for prescription and OTC
products) appears for each additional active ingredient in the product. For
combination drug products, the ingredient strengths are separated by
semicolons and appear in the same relative sequence as the ingredients in the
heading. Available strengths of the dosage form from an applicant appear on
separate lines.
To use the Drug Product Lists, determine by alphabetical order the
ingredient under which the product information is listed, using the Product
Name Index, if necessary. Then, find the ingredient in the applicable Drug
Product List. Proceed to the dosage form and route of administration and
compare products within that ingredient heading only. Therapeutic equivalence
or inequivalence for prescription products is determined on the basis of the
therapeutic equivalence codes provided within that specific dosage form and
route heading. The OTC Drug Product List, Discontinued Drug Product List, and
2-1
Drug Products with Approval under Section 505 of the Act Administered by the
Center for Biologics Evaluation and Research List have their data arranged
similarly.
The Discontinued Drug Product List contains approved products that have
never been marketed, have been discontinued from marketing, are for military
use, or have had their approvals withdrawn for other than safety or efficacy
reasons subsequent to being discontinued from marketing. All products having
a "@" in the December Cumulative Supplement of the previous Edition List have
been added to the Discontinued Drug Product List appearing in this Edition.
In addition, approved drug products that are not in the commercial
distribution channel e.g., approved drug products in applications for export
only are also listed in the Discontinued Section of the Orange Book.
Product Name Index (Prescription and OTC Drug Product Lists). This is an
index of drug products by established or trade name. The second term of each
entry indicates the active ingredient name under which product information can
be found in the appropriate Drug Product List. For those drug products with
multiple active ingredients, only the first active ingredient (in alphabetical
order) will appear. OTC products are so designated.
Product Name Index Listed by Applicant (Prescription and OTC Drug
Product Lists). This is an index that cross-references applicants to drug
products. The bolded and underlined entry represents the applicant name
abbreviation used in this publication. Each complete applicant name that is
represented by the abbreviated name is marked with an asterisk (*). Listed
under each complete applicant name is the first alphabetically arranged
ingredient under which product information can be found in the appropriate
Drug Product List. OTC products are so designated. To use the Drug Product
Lists, determine by alphabetical order the ingredient under which the product
information is listed, using the Product Name Index, if appropriate.
Uniform Terms. To improve readability, uniform terms are used to
designate dosage forms, routes of administration, and abbreviations used to
express strengths. These terms are listed in Appendix C. In some cases, the
terms used may differ from those used in product labels and other labeling.
2-2
2.2 DRUG PRODUCT ILLUSTRATION
SINGLE INGREDIENT
ACTIVE INGREDIENT MEPERIDINE HYDROCHLORIDE
DOSAGE FORM; ROUTE OF ADMINISTRATION INJECTABLE;INJECTION
HEXANON
TRADE OR GENERIC NAMES
AP + PAGE PHARMA 25MG/ML N013111 001 AUG 22, 1983
AP + 50MG/ML N013111 002 AUG 22, 1983
REFERENCE LISTED DRUG AP + 75MG/ML N013111 003 AUG 22, 1983
AP + 100MG/ML N013111 004 JAN 04, 1989
MEPERIDINE HCL
AP GREENBERG PHARM 25MG/ML A064890 001 FEB 29, 1987
THERAPEUTIC EQUIVALENCE (TE) AP 50MG/ML A064890 002 FEB 29, 1987
CODE FOR MULTISOURCE PRODUCT AP 75MG/ML A064890 003 FEB 29, 1987
AP 100MG/ML A064890 004 MAR 08, 1992
SINGLE SOURCE PRODUCT (NO TE CODE) TIMOKIM LLC 10MG/ML A099225 001 DEC 12, 1995
AP JOHNSON MED 25MG/ML A099226 001 NOV 27, 1993
KENDRA PHARM 150MG/ML A079444 001 OCT 31, 1999
APPLICANT
AVAILABLE STRENGTH(S) OF A PRODUCT
APPLICATION NUMBER AND PRODUCT NUMBER
PRODUCT NUMBER IS FOR FDA INTERNAL COMPUTER DATA USE ONLY
APPROVAL DATE
MULTIPLE INGREDIENTS WITH PRODUCT INFORMATION
ALPHABETICALLY SORTED BY
ACTIVE INGREDIENT HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE
TABLET;ORAL
PRODUCT INFORMATION HYDROCHLOROTHIAZIDE, RESERPINE AND HYDRALAZINE HCL
REINWALD INC 25MG;15MG;0.1MG A069808 001 JAN 18, 1982
THIS EXAMPLE IS FOR PURPOSE OF ILLUSTRATION ONLY. IT DOES NOT REPRESENT ACTUAL PRODUCTS FROM THE
PRESCRIPTION DRUG PRODUCT LIST.
2.3 THERAPEUTIC EQUIVALENCE EVALUATIONS ILLUSTRATION
DRUG PRODUCTS CODED AB (OR ANY CODE BEGINNING WITH AN "A") UNDER AN INGREDIENT AND DOSAGE FORM HEADING
ARE CONSIDERED THERAPEUTICALLY EQUIVALENT ONLY TO OTHER PRODUCTS CODED AB (OR ANY CODE BEGINNING WITH AN
A") AND NOT TO THOSE CODED BP (OR ANY CODE BEGINNING WITH "B") AND ANY PRODUCTS NOT LISTED. DRUG
PRODUCTS CODED BP (OR ANY CODE BEGINNING WITH A "B") ARE NOT CONSIDERED THERAPEUTICALLY EQUIVALENT TO ANY
OTHER PRODUCT. FOR A COMPLETE EXPLANATION OF THE TE CODES REFER TO SECTION 1.7 OF THE INTRODUCTION.
SULFASALAZINE
TABLET; ORAL
FAZINE
AB PARKLAND 500MG A042999 001
PRODUCTS CONSIDERED THERAPEUTICALLY SULAZINE
EQUIVALENT TO EACH OTHER AB URSA 500MG A042222 001
SULFASALAZINE
PRODUCTS CONSIDERED NOT THERAPEUTICALLY BP BROWN 500MG A041297 001
EQUIVALENT TO ANY OTHER PRODUCTS LISTED
SULFASALAZINE
TABLET; ORAL
FAZINE
AB PARKLAND 500MG A042999 001
PRODUCTS CONSIDERED NOT THERAPEUTICALLY SULFASALAZINE
EQUIVALENT TO EACH OTHER BP BROWN 500MG A041297 001
SOUTH 500MG A067627 001
NOTE: BOLD FONT AND UNDERLINING DENOTES MULTISOURCE PRODUCTS WHICH ARE CONSIDERED THERAPEUTICALLY
EQUIVALENT.
THIS EXAMPLE IS FOR PURPOSES OF ILLUSTRATION ONLY. IT DOES NOT REPRESENT ACTUAL PRODUCTS FROM THE
PRESCRIPTION DRUG PRODUCT LIST.
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-1(of 371)
ABACAVIR SULFATE
SOLUTION;ORAL
ZIAGEN
+ VIIV HLTHCARE EQ 20MG BASE/ML N020978 001 Dec 17, 1998
TABLET;ORAL
ABACAVIR SULFATE
AB APOTEX INC EQ 300MG BASE A201570 001 Dec 17, 2012
AB AUROBINDO PHARMA LTD EQ 300MG BASE A077844 001 Dec 17, 2012
AB HETERO LABS LTD III EQ 300MG BASE A091560 001 Sep 13, 2013
AB MYLAN PHARMS INC EQ 300MG BASE A091294 001 Jun 18, 2012
ZIAGEN
AB + VIIV HLTHCARE EQ 300MG BASE N020977 001 Dec 17, 1998
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE
TABLET;ORAL
TRIUMEQ
+ VIIV HLTHCARE EQ 600MG BASE;EQ 50MG BASE;300MG N205551 001 Aug 22, 2014
ABACAVIR SULFATE; LAMIVUDINE
TABLET;ORAL
EPZICOM
+ VIIV HLTHCARE EQ 600MG BASE;300MG N021652 001 Aug 02, 2004
ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE
TABLET;ORAL
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE
AB LUPIN LTD EQ 300MG BASE;150MG;300MG A202912 001 Dec 05, 2013
TRIZIVIR
AB + VIIV HLTHCARE EQ 300MG BASE;150MG;300MG N021205 001 Nov 14, 2000
ABIRATERONE ACETATE
TABLET;ORAL
ZYTIGA
+ JANSSEN BIOTECH 250MG N202379 001 Apr 28, 2011
ACAMPROSATE CALCIUM
TABLET, DELAYED RELEASE;ORAL
ACAMPROSATE CALCIUM
AB BARR LABS DIV TEVA 333MG A200143 001 Nov 18, 2013
AB GLENMARK GENERICS 333MG A202229 001 Jul 16, 2013
AB MYLAN PHARMS INC 333MG A200142 001 Mar 11, 2014
CAMPRAL
AB + FOREST LABS 333MG N021431 001 Jul 29, 2004
ACARBOSE
TABLET;ORAL
ACARBOSE
AB EMCURE PHARMS LTD 25MG A202271 001 Feb 07, 2012
AB 50MG A202271 002 Feb 07, 2012
AB 100MG A202271 003 Feb 07, 2012
AB IMPAX LABS 25MG A078441 001 May 14, 2009
AB 50MG A078441 002 May 14, 2009
AB 100MG A078441 003 May 14, 2009
AB MYLAN 25MG A091053 001 Jan 06, 2011
AB 50MG A091053 002 Jan 06, 2011
AB 100MG A091053 003 Jan 06, 2011
AB ROXANE 25MG A078470 001 May 07, 2008
AB 50MG A078470 002 May 07, 2008
AB 100MG A078470 003 May 07, 2008
AB STRIDES PHARMA 25MG A090912 001 Jul 27, 2011
AB 50MG A090912 002 Jul 27, 2011
AB 100MG A090912 003 Jul 27, 2011
AB VIRTUS PHARM 25MG A091343 001 Oct 17, 2013
AB 50MG A091343 002 Oct 17, 2013
AB 100MG A091343 003 Oct 17, 2013
AB WATSON LABS 25MG A077532 001 May 07, 2008
AB 50MG A077532 002 May 07, 2008
AB 100MG A077532 003 May 07, 2008
PRECOSE
AB + BAYER HLTHCARE 25MG N020482 004 May 29, 1997
AB 50MG N020482 001 Sep 06, 1995
AB 100MG N020482 002 Sep 06, 1995
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-2(of 371)
ACEBUTOLOL HYDROCHLORIDE
CAPSULE;ORAL
ACEBUTOLOL HYDROCHLORIDE
AB AMNEAL PHARM EQ 200MG BASE A075047 001 Dec 30, 1999
AB EQ 400MG BASE A075047 002 Dec 30, 1999
AB MYLAN EQ 200MG BASE A074288 001 Apr 24, 1995
AB EQ 400MG BASE A074288 002 Apr 24, 1995
SECTRAL
AB PROMIUS PHARMA EQ 200MG BASE N018917 001 Dec 28, 1984
AB + EQ 400MG BASE N018917 003 Dec 28, 1984
ACETAMINOPHEN
SOLUTION;IV (INFUSION)
OFIRMEV
+ CADENCE PHARMS 1000MG/100ML (10MG/ML) N022450 001 Nov 02, 2010
ACETAMINOPHEN; BUTALBITAL
TABLET;ORAL
BUTALBITAL AND ACETAMINOPHEN
+ NEXGEN PHARMA 300MG;50MG A090956 001 Aug 23, 2011
BUTAPAP
+ MIKART 325MG;50MG A089987 001 Oct 26, 1992
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
CAPSULE;ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
+ MIKART 325MG;50MG;40MG A089007 001 Mar 17, 1986
+ NEXGEN PHARMA 300MG;50MG;40MG A040885 001 Nov 16, 2009
SOLUTION;ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
+ MIKART 325MG/15ML;50MG/15ML;40MG/15ML A040387 001 Jan 31, 2003
TABLET;ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
AA HIKMA PHARMS LLC 325MG;50MG;40MG A089718 001 Jun 12, 1995
AA LANNETT HOLDINGS INC 325MG;50MG;40MG A200243 001 Sep 13, 2012
AA MALLINCKRODT 325MG;50MG;40MG A087804 001 Jan 24, 1985
AA MIKART 325MG;50MG;40MG A089175 001 Jan 21, 1987
AA + VINTAGE PHARMS 325MG;50MG;40MG A040511 001 Aug 27, 2003
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
CAPSULE;ORAL
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
AB HIKMA INTL PHARMS 325MG;50MG;40MG;30MG A075618 001 Mar 23, 2001
AB NEXGEN PHARMA INC 325MG;50MG;40MG;30MG A076560 001 Jun 10, 2004
AB VINTAGE PHARMS 325MG;50MG;40MG;30MG A075929 001 Apr 22, 2002
FIORICET W/ CODEINE
AB + WATSON LABS INC 325MG;50MG;40MG;30MG N020232 001 Jul 30, 1992
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
NEXGEN PHARMA INC 300MG;50MG;40MG;30MG A076560 002 Jul 19, 2012
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
CAPSULE;ORAL
TREZIX
WRASER PHARMS LLC 320.5MG;30MG;16MG A204785 001 Nov 26, 2014
ACETAMINOPHEN; CODEINE PHOSPHATE
SOLUTION;ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
AA HI TECH PHARMA 120MG/5ML;12MG/5ML A040119 001 Apr 26, 1996
AA MIKART 120MG/5ML;12MG/5ML A089450 001 Oct 27, 1992
AA + PHARM ASSOC 120MG/5ML;12MG/5ML A087508 001
AA VINTAGE PHARMS 120MG/5ML;12MG/5ML A091238 001 Nov 10, 2011
AA WOCKHARDT 120MG/5ML;12MG/5ML A087006 001
SUSPENSION;ORAL
CAPITAL AND CODEINE
+ VALEANT PHARMS LLC 120MG/5ML;12MG/5ML A086024 001
TABLET;ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
AA AMNEAL PHARMS NY 300MG;30MG A040779 001 May 29, 2008
AA AUROLIFE PHARMA LLC 300MG;15MG A202800 001 Apr 15, 2013
AA 300MG;30MG A202800 002 Apr 15, 2013
AA 300MG;60MG A202800 003 Apr 15, 2013
AA + MALLINCKRODT INC 300MG;15MG A040419 001 May 31, 2001
AA 300MG;30MG A040419 002 May 31, 2001
AA 300MG;60MG A040419 003 May 31, 2001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-3(of 371)
ACETAMINOPHEN; CODEINE PHOSPHATE
TABLET;ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
AA RANBAXY 300MG;30MG A085868 001
AA 300MG;60MG A087083 001
AA TEVA 300MG;15MG A088627 001 Mar 06, 1985
AA 300MG;30MG A088628 001 Mar 06, 1985
AA + 300MG;60MG A088629 001 Mar 06, 1985
AA VINTAGE 300MG;15MG A089990 001 Sep 30, 1988
AA 300MG;30MG A089805 001 Sep 30, 1988
AA VINTAGE PHARMS 300MG;60MG A089828 001 Sep 30, 1988
TYLENOL W/ CODEINE NO. 3
AA + JANSSEN PHARMS 300MG;30MG A085055 003
TYLENOL W/ CODEINE NO. 4
AA JANSSEN PHARMS 300MG;60MG A085055 004
ACETAMINOPHEN; HYDROCODONE BITARTRATE
SOLUTION;ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
AA + MIKART 325MG/15ML;7.5MG/15ML A040482 001 Sep 25, 2003
AA PHARM ASSOC 325MG/15ML;7.5MG/15ML A040838 001 May 10, 2013
AA VINTAGE PHARMS 325MG/15ML;7.5MG/15ML A040894 001 Jul 19, 2011
AA VISTAPHARM 325MG/15ML;7.5MG/15ML A200343 001 Jan 25, 2012
+ MIKART 300MG/15ML;10MG/15ML A040881 001 Feb 25, 2010
+ PHARM ASSOC 325MG/15ML;10MG/15ML A040834 001 Apr 18, 2008
TABLET;ORAL
ANEXSIA 5/325
AA MALLINCKRODT 325MG;5MG A040409 001 Oct 20, 2000
ANEXSIA 7.5/325
AA MALLINCKRODT 325MG;7.5MG A040405 001 Sep 08, 2000
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
AA AMNEAL PHARMS NY 325MG;5MG A040736 001 Aug 25, 2006
AA 325MG;10MG A040746 001 Aug 25, 2006
AA AUROLIFE PHARMA LLC 325MG;5MG A201013 001 Apr 11, 2012
AA 325MG;7.5MG A201013 002 Apr 11, 2012
AA 325MG;10MG A201013 003 Apr 11, 2012
AA MALLINCKRODT 325MG;10MG A040400 001 Jul 26, 2000
AA + MIKART 300MG;5MG A040658 001 Jan 19, 2006
AA + 300MG;7.5MG A040556 002 Mar 24, 2006
AA + 300MG;10MG A040556 001 Jun 23, 2004
AA 325MG;7.5MG A040432 001 Jan 22, 2003
AA SUN PHARM INDS INC 325MG;5MG A090118 001 Dec 23, 2008
AA 325MG;7.5MG A090118 002 Dec 23, 2008
AA 325MG;10MG A090118 003 Dec 23, 2008
AA TRIS PHARMA INC 325MG;5MG A202214 001 Mar 27, 2013
AA 325MG;7.5MG A202214 002 Mar 27, 2013
AA 325MG;10MG A202214 003 Mar 27, 2013
AA VINTAGE PHARMS 300MG;5MG A090415 001 Jan 24, 2011
AA 300MG;7.5MG A090415 002 Jan 24, 2011
AA 300MG;10MG A090415 003 Jan 24, 2011
AA 325MG;5MG A040655 001 Jan 19, 2006
AA 325MG;7.5MG A040656 001 Jan 19, 2006
AA 325MG;10MG A040355 001 May 31, 2000
NORCO
AA + ACTAVIS LABS FL INC 325MG;7.5MG A040148 003 Sep 12, 2000
AA + 325MG;10MG A040148 001 Feb 14, 1997
AA + WATSON LABS 325MG;5MG A040099 001 Jun 25, 1997
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
+ MIKART 325MG;2.5MG A040846 001 Jun 09, 2010
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
SOLUTION;ORAL
OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN
AA VINTAGE PHARMS 325MG/5ML;5MG/5ML A203573 001 Dec 18, 2014
ROXICET
AA + ROXANE 325MG/5ML;5MG/5ML A089351 001 Dec 03, 1986
TABLET;ORAL
OXYCET
AA MALLINCKRODT 325MG;5MG A087463 001 Dec 07, 1983
OXYCODONE AND ACETAMINOPHEN
AA ACTAVIS ELIZABETH 325MG;2.5MG A201447 001 Apr 12, 2013
AA 325MG;5MG A201447 002 Apr 12, 2013
AA 325MG;7.5MG A201447 003 Apr 12, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-4(of 371)
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
TABLET;ORAL
OXYCODONE AND ACETAMINOPHEN
AA 325MG;10MG A201447 004 Apr 12, 2013
AA ALVOGEN INC 325MG;7.5MG A202677 001 Jul 26, 2012
AA 325MG;10MG A202677 002 Jul 26, 2012
AA AMNEAL PHARMS NY 325MG;5MG A040777 001 Nov 27, 2007
AA 325MG;10MG A040778 001 Nov 27, 2007
AA AUROLIFE PHARMA LLC 325MG;2.5MG A201972 001 Jul 15, 2013
AA 325MG;5MG A201972 002 Jul 15, 2013
AA 325MG;7.5MG A201972 003 Jul 15, 2013
AA 325MG;10MG A201972 004 Jul 15, 2013
AA COASTAL PHARMS 325MG;2.5MG A090177 001 Oct 20, 2008
AA 325MG;5MG A090177 002 Oct 20, 2008
AA 325MG;7.5MG A090177 003 Oct 20, 2008
AA 325MG;10MG A090177 004 Oct 20, 2008
AA MALLINCKRODT 325MG;7.5MG A040545 001 Jun 30, 2004
AA 325MG;10MG A040545 002 Jun 30, 2004
AA RHODES PHARMS 325MG;5MG A201278 001 Aug 28, 2014
AA 325MG;7.5MG A201278 002 Aug 28, 2014
AA 325MG;10MG A201278 003 Aug 28, 2014
AA SUN PHARM INDS INC 325MG;2.5MG A090535 001 Dec 26, 2013
AA 325MG;5MG A090535 002 Dec 26, 2013
AA 325MG;7.5MG A090535 003 Dec 26, 2013
AA 325MG;10MG A090535 004 Dec 26, 2013
AA VINTAGE PHARMS 325MG;2.5MG A090733 001 Jul 11, 2013
AA 325MG;5MG A040105 001 Jul 30, 1996
AA 325MG;7.5MG A090734 001 Jul 11, 2013
AA 325MG;10MG A090734 002 Jul 11, 2013
AA WATSON LABS 325MG;5MG A040171 001 Oct 30, 1997
AA 325MG;7.5MG A040535 001 Sep 05, 2003
AA 325MG;10MG A040535 002 Sep 05, 2003
PERCOCET
AA + VINTAGE PHARMS LLC 325MG;2.5MG A040330 001 Jun 25, 1999
AA + 325MG;5MG A040330 002 Jun 25, 1999
AA + 325MG;7.5MG A040434 001 Nov 23, 2001
AA + 325MG;10MG A040434 002 Nov 23, 2001
ROXICET
AA ROXANE 325MG;5MG A087003 001
OXYCODONE AND ACETAMINOPHEN
+ MIKART 300MG;2.5MG A040608 001 Dec 30, 2005
+ 300MG;5MG A040608 002 Dec 30, 2005
+ 300MG;7.5MG A040608 003 Dec 30, 2005
+ 300MG;10MG A040608 004 Dec 30, 2005
TABLET, EXTENDED RELEASE;ORAL
XARTEMIS XR
+ MALLINCKRODT INC 325MG;7.5MG N204031 001 Mar 11, 2014
ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE
TABLET;ORAL
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
MYLAN 325MG;32MG A083689 001
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
TABLET;ORAL
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
AB ALLIED PHARMA INC 325MG;37.5MG A202076 001 Mar 30, 2012
AB AMNEAL PHARMS 325MG;37.5MG A090485 001 Dec 09, 2009
AB APOTEX INC 325MG;37.5MG A078778 001 Apr 07, 2014
AB MICRO LABS LTD INDIA 325MG;37.5MG A201952 001 Dec 14, 2012
AB MYLAN 325MG;37.5MG A077858 001 Sep 26, 2008
AB PAR PHARM 325MG;37.5MG A076475 001 Apr 21, 2005
AB SUN PHARM INDS INC 325MG;37.5MG A077184 001 Dec 16, 2005
AB ZYDUS PHARMS USA INC 325MG;37.5MG A090460 001 Sep 06, 2012
ULTRACET
AB + JANSSEN PHARMS 325MG;37.5MG N021123 001 Aug 15, 2001
ACETAZOLAMIDE
CAPSULE, EXTENDED RELEASE;ORAL
ACETAZOLAMIDE
AB HERITAGE PHARMS INC 500MG A090779 001 Jul 14, 2011
AB ZYDUS PHARMS USA INC 500MG A040904 001 Dec 10, 2008
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-5(of 371)
ACETAZOLAMIDE
CAPSULE, EXTENDED RELEASE;ORAL
DIAMOX
AB + DURAMED PHARMS BARR 500MG N012945 001
TABLET;ORAL
ACETAZOLAMIDE
AB LANNETT 250MG A084840 001
AB MUTUAL PHARM 125MG A089752 001 Jun 22, 1988
AB TARO 125MG A040195 001 May 28, 1997
AB + 250MG A040195 002 May 28, 1997
ACETAZOLAMIDE SODIUM
INJECTABLE;INJECTION
ACETAZOLAMIDE SODIUM
AP EUROHLTH INTL EQ 500MG BASE/VIAL A040089 001 Feb 28, 1995
AP SAGENT AGILA EQ 500MG BASE/VIAL A200880 001 May 09, 2012
AP + X GEN PHARMS EQ 500MG BASE/VIAL A040784 001 Dec 10, 2008
ACETAZOLAMIDE SODIUM
AP EMCURE PHARMS LTD EQ 500MG BASE/VIAL A202693 001 Dec 19, 2014
ACETIC ACID, GLACIAL
SOLUTION;IRRIGATION, URETHRAL
ACETIC ACID 0.25% IN PLASTIC CONTAINER
AT B BRAUN 250MG/100ML N018161 001
AT BAXTER HLTHCARE 250MG/100ML N018523 001 Feb 19, 1982
AT HOSPIRA 250MG/100ML N017656 001
SOLUTION/DROPS;OTIC
ACETIC ACID
AT TARO 2% A088638 001 Sep 06, 1984
AT VINTAGE 2% A040607 001 Feb 24, 2005
AT + WOCKHARDT 2% A040166 001 Jul 26, 1996
VOSOL
AT HI TECH PHARMA 2% N012179 001
ACETIC ACID, GLACIAL; ALUMINUM ACETATE
SOLUTION/DROPS;OTIC
ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE
+ BAUSCH AND LOMB 2%;0.79% A040063 001 Feb 25, 1994
ACETIC ACID, GLACIAL; HYDROCORTISONE
SOLUTION/DROPS;OTIC
ACETASOL HC
AT ACTAVIS MID ATLANTIC 2%;1% A087143 001 Jan 13, 1982
HYDROCORTISONE AND ACETIC ACID
AT TARO 2%;1% A088759 001 Mar 04, 1985
AT VINTAGE 2%;1% A040609 001 Feb 06, 2006
VOSOL HC
AT + HI TECH PHARMA 2%;1% N012770 001
ACETOHYDROXAMIC ACID
TABLET;ORAL
LITHOSTAT
+ MISSION PHARMA 250MG N018749 001 May 31, 1983
ACETYLCHOLINE CHLORIDE
FOR SOLUTION;OPHTHALMIC
MIOCHOL-E
+ BAUSCH AND LOMB 20MG/VIAL N020213 001 Sep 22, 1993
ACETYLCYSTEINE
INJECTABLE;INTRAVENOUS
ACETADOTE
AP + CUMBERLAND PHARMS 6GM/30ML (200MG/ML) N021539 001 Jan 23, 2004
ACETYLCYSTEINE
AP INNOPHARMA LICENSING 6GM/30ML (200MG/ML) A200644 001 Nov 07, 2012
SOLUTION;INHALATION, ORAL
ACETYLCYSTEINE
AN HOSPIRA 10% A073664 001 Aug 30, 1994
AN 20% A074037 001 Aug 30, 1994
AN INNOPHARMA LICENSING 10% A204674 001 Feb 11, 2014
AN 20% A203853 001 Jun 21, 2012
AN + LUITPOLD 10% A072489 001 Jul 28, 1995
AN + 20% A072547 001 Jul 28, 1995
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-6(of 371)
ACITRETIN
CAPSULE;ORAL
ACITRETIN
AB BARR LABS INC 10MG A091455 001 Apr 04, 2013
AB 25MG A091455 002 Apr 04, 2013
AB TEVA PHARMS USA 17.5MG A202897 001 Apr 04, 2013
AB 22.5MG A202897 002 Apr 04, 2013
SORIATANE
AB STIEFEL LABS INC 10MG N019821 001 Oct 28, 1996
AB 17.5MG N019821 003 Aug 06, 2009
AB 22.5MG N019821 004 Aug 06, 2009
AB + 25MG N019821 002 Oct 28, 1996
ACLIDINIUM BROMIDE
POWDER, METERED;INHALATION
TUDORZA PRESSAIR
+ FOREST LABS INC 0.375MG/INH N202450 001 Jul 23, 2012
ACRIVASTINE; PSEUDOEPHEDRINE HYDROCHLORIDE
CAPSULE;ORAL
SEMPREX-D
+ AUXILIUM PHARMS LLC 8MG;60MG N019806 001 Mar 25, 1994
ACYCLOVIR
CAPSULE;ORAL
ACYCLOVIR
AB APOTEX INC 200MG A075677 001 Sep 28, 2005
AB CADILA PHARMS LTD 200MG A201445 001 Mar 06, 2014
AB DAVA PHARMS INC 200MG A074833 001 Apr 22, 1997
AB MYLAN 200MG A074727 001 Apr 22, 1997
AB RANBAXY 200MG A074975 001 Sep 30, 1998
AB STASON 200MG A075090 001 Jan 26, 1999
AB TEVA 200MG A074578 001 Apr 22, 1997
ZOVIRAX
AB + DELCOR ASSET 200MG N018828 001 Jan 25, 1985
CREAM;TOPICAL
ZOVIRAX
+ VALEANT BERMUDA 5% N021478 001 Dec 30, 2002
OINTMENT;TOPICAL
ACYCLOVIR
AB AMNEAL PHARMS 5% A204605 001 Jun 18, 2014
AB MYLAN PHARMS INC 5% A202459 001 Apr 03, 2013
ZOVIRAX
AB + VALEANT BERMUDA 5% N018604 001 Mar 29, 1982
SUSPENSION;ORAL
ACYCLOVIR
AB ACTAVIS MID ATLANTIC 200MG/5ML A074738 001 Apr 28, 1997
AB HI TECH PHARMA 200MG/5ML A077026 001 Jun 07, 2005
ZOVIRAX
AB + DELCOR ASSET 200MG/5ML N019909 001 Dec 22, 1989
TABLET;BUCCAL
SITAVIG
+ INNOCUTIS HOLDINGS 50MG N203791 001 Apr 12, 2013
TABLET;ORAL
ACYCLOVIR
AB APOTEX INC 400MG A077309 001 Sep 29, 2005
AB 800MG A077309 002 Sep 29, 2005
AB CADILA PHARMS LTD 400MG A202168 001 Nov 15, 2013
AB 800MG A202168 002 Nov 15, 2013
AB CARLSBAD 400MG A075382 001 Apr 30, 1999
AB 800MG A075382 002 Apr 30, 1999
AB DAVA PHARMS INC 400MG A074946 001 Nov 19, 1997
AB 800MG A074946 002 Nov 19, 1997
AB HETERO LABS LTD V 400MG A203834 001 Oct 29, 2013
AB 800MG A203834 002 Oct 29, 2013
AB MYLAN 400MG A075211 001 Sep 28, 1998
AB 800MG A075211 002 Sep 28, 1998
AB RANBAXY 400MG A074980 001 Sep 30, 1998
AB 800MG A074980 002 Sep 30, 1998
AB TEVA 400MG A074556 002 Apr 22, 1997
AB 800MG A074556 003 Apr 22, 1997
AB ZYDUS PHARMS USA INC 400MG A204314 001 Aug 19, 2014
AB 800MG A204314 002 Aug 19, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-7(of 371)
ACYCLOVIR
TABLET;ORAL
ZOVIRAX
AB DELCOR ASSET 400MG N020089 001 Apr 30, 1991
AB + 800MG N020089 002 Apr 30, 1991
ACYCLOVIR SODIUM
INJECTABLE;INJECTION
ACYCLOVIR SODIUM
AP AUROBINDO PHARMA LTD EQ 50MG BASE/ML A203701 001 Oct 11, 2013
AP BEDFORD EQ 500MG BASE/VIAL A074596 002 Apr 22, 1997
AP + FRESENIUS KABI USA EQ 50MG BASE/ML A074930 001 May 13, 1998
AP + EQ 500MG BASE/VIAL A075015 001 Apr 30, 1998
ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE
HIKMA MAPLE EQ 1GM BASE/VIAL A074885 002 Dec 19, 1997
+ EQ 500MG BASE/VIAL A074885 001 Dec 19, 1997
ACYCLOVIR SODIUM
+ BEDFORD EQ 1GM BASE/VIAL A074596 001 Apr 22, 1997
ACYCLOVIR; HYDROCORTISONE
CREAM;TOPICAL
XERESE
+ VALEANT BERMUDA 5%;1% N022436 001 Jul 31, 2009
ADAPALENE
CREAM;TOPICAL
ADAPALENE
AB FOUGERA PHARMS 0.1% A090824 001 Jun 30, 2010
DIFFERIN
AB + GALDERMA LABS LP 0.1% N020748 001 May 26, 2000
GEL;TOPICAL
ADAPALENE
AB ACTAVIS MID ATLANTIC 0.3% A201000 001 Oct 27, 2014
AB GLENMARK GENERICS 0.1% A091314 001 Jul 01, 2010
AB PLIVA HRVATSKA DOO 0.1% A090962 001 Jun 02, 2010
AB TOLMAR 0.3% A200298 001 Jun 14, 2012
DIFFERIN
AB + GALDERMA LABS LP 0.1% N020380 001 May 31, 1996
AB + 0.3% N021753 001 Jun 19, 2007
LOTION;TOPICAL
DIFFERIN
+ GALDERMA LABS LP 0.1% N022502 001 Mar 17, 2010
ADAPALENE; BENZOYL PEROXIDE
GEL;TOPICAL
EPIDUO
+ GALDERMA LABS LP 0.1%;2.5% N022320 001 Dec 08, 2008
ADEFOVIR DIPIVOXIL
TABLET;ORAL
ADEFOVIR DIPIVOXIL
AB SIGMAPHARM LABS LLC 10MG A202051 001 Aug 29, 2013
HEPSERA
AB + GILEAD 10MG N021449 001 Sep 20, 2002
ADENOSINE
INJECTABLE;INJECTION
ADENOCARD
AP + ASTELLAS 3MG/ML N019937 002 Oct 30, 1989
ADENOSINE
AP AGILA SPECLTS 3MG/ML A078640 001 Mar 21, 2014
AP 3MG/ML A078686 001 May 13, 2009
AP AKORN 3MG/ML A078076 001 Oct 31, 2008
AP BEDFORD 3MG/ML A076404 001 Jun 16, 2004
AP FRESENIUS KABI USA 3MG/ML A077133 001 Apr 27, 2005
AP GLAND PHARMA LTD 3MG/ML A077283 001 Jun 14, 2007
AP HIKMA MAPLE 3MG/ML A076500 001 Jun 16, 2004
AP LUITPOLD 3MG/ML A090010 001 Apr 28, 2009
AP WOCKHARDT 3MG/ML A090220 001 Jul 20, 2009
SOLUTION;IV (INFUSION)
ADENOSCAN
AP + ASTELLAS 60MG/20ML (3MG/ML) N020059 001 May 18, 1995
AP + 90MG/30ML (3MG/ML) N020059 002 May 18, 1995
ADENOSINE
AP AKORN 60MG/20ML (3MG/ML) A090450 001 Oct 02, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-8(of 371)
ADENOSINE
SOLUTION;IV (INFUSION)
ADENOSINE
AP 90MG/30ML (3MG/ML) A090450 002 Oct 02, 2014
AP EMCURE PHARMS LTD 60MG/20ML (3MG/ML) A202313 001 Sep 15, 2014
AP 90MG/30ML (3MG/ML) A202313 002 Sep 15, 2014
AP HOSPIRA INC 60MG/20ML (3MG/ML) A203883 001 Mar 24, 2014
AP 90MG/30ML (3MG/ML) A203883 002 Mar 24, 2014
AP SAGENT STRIDES 60MG/20ML (3MG/ML) A090212 001 Mar 28, 2014
AP 90MG/30ML (3MG/ML) A090212 002 Mar 28, 2014
AP TEVA PHARMS USA 60MG/20ML (3MG/ML) A077425 001 Aug 29, 2013
AP 90MG/30ML (3MG/ML) A077425 002 Aug 29, 2013
AFATINIB DIMALEATE
TABLET;ORAL
GILOTRIF
BOEHRINGER INGELHEIM EQ 20MG BASE N201292 001 Jul 12, 2013
EQ 30MG BASE N201292 002 Jul 12, 2013
+ EQ 40MG BASE N201292 003 Jul 12, 2013
ALBENDAZOLE
TABLET;ORAL
ALBENZA
+ AMEDRA PHARMS 200MG N020666 001 Jun 11, 1996
ALBUMIN HUMAN
INJECTABLE;INJECTION
OPTISON
+ GE HEALTHCARE 10MG/ML N020899 001 Dec 31, 1997
ALBUMIN IODINATED I-125 SERUM
INJECTABLE;INJECTION
JEANATOPE
ISO TEX 100uCi/10ML (10uCi/ML) N017836 003 Jun 08, 2004
500uCi/0.5ML N017836 001
+ 1,000uCi/ML N017836 002
ALBUMIN IODINATED I-131 SERUM
INJECTABLE;INJECTION
MEGATOPE
+ ISO TEX 0.5mCi/VIAL N017837 001
+ 1mCi/VIAL N017837 002
ALBUTEROL SULFATE
AEROSOL, METERED;INHALATION
PROAIR HFA
BX + TEVA BRANDED PHARM EQ 0.09MG BASE/INH N021457 001 Oct 29, 2004
PROVENTIL-HFA
BX + 3M EQ 0.09MG BASE/INH N020503 001 Aug 15, 1996
VENTOLIN HFA
BX + GLAXOSMITHKLINE EQ 0.09MG BASE/INH N020983 001 Apr 19, 2001
SOLUTION;INHALATION
ACCUNEB
AN + MYLAN SPECLT EQ 0.021% BASE N020949 002 Apr 30, 2001
AN + EQ 0.042% BASE N020949 001 Apr 30, 2001
ALBUTEROL SULFATE
AN + BAUSCH AND LOMB EQ 0.5% BASE A075050 001 Jun 18, 1998
AN HI TECH PHARMA EQ 0.083% BASE A075063 001 Feb 09, 1999
AN EQ 0.5% BASE A074543 001 Jan 15, 1998
AN LANDELA PHARM EQ 0.083% BASE A077569 001 Apr 04, 2006
AN + MYLAN SPECLT EQ 0.083% BASE A072652 001 Feb 21, 1992
AN NEPHRON EQ 0.021% BASE A076355 002 Mar 31, 2010
AN EQ 0.042% BASE A076355 001 Jun 28, 2004
AN EQ 0.083% BASE A074880 001 Sep 17, 1997
AN EQ 0.5% BASE A075664 001 Jun 26, 2001
AN RITEDOSE CORP EQ 0.083% BASE A077839 001 Dec 16, 2008
AN TEVA PHARMS EQ 0.083% BASE A075343 001 Nov 09, 1999
AN WATSON LABS EQ 0.021% BASE A077772 001 Sep 25, 2007
AN EQ 0.042% BASE A077772 002 Sep 25, 2007
AN WATSON LABS INC EQ 0.083% BASE A076370 001 Nov 24, 2003
SYRUP;ORAL
ALBUTEROL SULFATE
AA ACTAVIS MID ATLANTIC EQ 2MG BASE/5ML A074454 001 Sep 25, 1995
AA AMNEAL PHARMS EQ 2MG BASE/5ML A079241 001 May 12, 2010
AA HI TECH PHARMA EQ 2MG BASE/5ML A074749 001 Jan 30, 1998
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-9(of 371)
ALBUTEROL SULFATE
SYRUP;ORAL
ALBUTEROL SULFATE
AA + TEVA EQ 2MG BASE/5ML A073419 001 Mar 30, 1992
AA VINTAGE EQ 2MG BASE/5ML A078105 001 Dec 27, 2006
AA VISTAPHARM EQ 2MG BASE/5ML A077788 001 Jun 26, 2007
TABLET;ORAL
ALBUTEROL SULFATE
AB MUTUAL PHARM EQ 2MG BASE A072637 002 Dec 05, 1989
AB EQ 4MG BASE A072637 001 Dec 05, 1989
AB MYLAN EQ 2MG BASE A072894 002 Jan 17, 1991
AB + EQ 4MG BASE A072894 001 Jan 17, 1991
TABLET, EXTENDED RELEASE;ORAL
ALBUTEROL SULFATE
AB MYLAN EQ 4MG BASE A078092 002 Jan 29, 2007
AB EQ 8MG BASE A078092 001 Jan 29, 2007
VOSPIRE ER
AB DAVA PHARMS INC EQ 4MG BASE A076130 002 Sep 26, 2002
AB + EQ 8MG BASE A076130 003 Sep 26, 2002
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
AEROSOL, METERED;INHALATION
COMBIVENT
+ BOEHRINGER INGELHEIM EQ 0.09MG BASE/INH;0.018MG/INH N020291 001 Oct 24, 1996
SOLUTION;INHALATION
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
AN CIPLA LTD EQ 0.083% BASE;0.017% A077559 001 Dec 31, 2007
AN NEPHRON EQ 0.083% BASE;0.017% A076749 001 Dec 31, 2007
AN RITEDOSE CORP EQ 0.083% BASE;0.017% A202496 001 Oct 01, 2012
AN TEVA PHARMS EQ 0.083% BASE;0.017% A076724 001 Dec 31, 2007
AN WATSON LABS EQ 0.083% BASE;0.017% A077063 001 Dec 31, 2007
DUONEB
AN + MYLAN SPECLT EQ 0.083% BASE;0.017% N020950 001 Mar 21, 2001
SPRAY, METERED;INHALATION
COMBIVENT RESPIMAT
+ BOEHRINGER INGELHEIM EQ 0.1MG BASE/INH;0.02MG/INH N021747 001 Oct 07, 2011
ALCAFTADINE
SOLUTION/DROPS;OPHTHALMIC
LASTACAFT
+ ALLERGAN 0.25% N022134 001 Jul 28, 2010
ALCLOMETASONE DIPROPIONATE
CREAM;TOPICAL
ALCLOMETASONE DIPROPIONATE
AB + FOUGERA PHARMS 0.05% A076973 001 Jul 12, 2005
AB GLENMARK GENERICS 0.05% A079061 001 Jun 23, 2009
AB TARO 0.05% A076587 001 Sep 15, 2005
OINTMENT;TOPICAL
ALCLOMETASONE DIPROPIONATE
AB + FOUGERA PHARMS 0.05% A076884 001 Jul 18, 2005
AB GLENMARK GENERICS 0.05% A079227 001 Jul 30, 2009
AB TARO 0.05% A076730 001 Jul 29, 2004
ALCOHOL; DEXTROSE
INJECTABLE;INJECTION
ALCOHOL 5% AND DEXTROSE 5%
AP + B BRAUN 5ML/100ML;5GM/100ML N004589 004
ALCOHOL 10% AND DEXTROSE 5%
+ B BRAUN 10ML/100ML;5GM/100ML N004589 006
ALENDRONATE SODIUM
SOLUTION;ORAL
ALENDRONATE SODIUM
AA ROXANE EQ 70MG BASE/75ML A090520 001 Feb 25, 2013
FOSAMAX
AA + MERCK EQ 70MG BASE/75ML N021575 001 Sep 17, 2003
TABLET;ORAL
ALENDRONATE SODIUM
AB APOTEX EQ 5MG BASE A077982 001 Aug 04, 2008
AB EQ 10MG BASE A077982 002 Aug 04, 2008
AB EQ 35MG BASE A077982 003 Aug 04, 2008
AB EQ 70MG BASE A077982 004 Aug 04, 2008
AB AUROBINDO PHARMA EQ 10MG BASE A090124 001 Aug 04, 2008
AB EQ 35MG BASE A090124 002 Aug 04, 2008
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-10(of 371)
ALENDRONATE SODIUM
TABLET;ORAL
ALENDRONATE SODIUM
AB EQ 70MG BASE A090124 003 Aug 04, 2008
AB AUSTARPHARMA LLC EQ 5MG BASE A090258 001 Sep 24, 2009
AB EQ 10MG BASE A090258 002 Sep 24, 2009
AB EQ 35MG BASE A090258 003 Sep 24, 2009
AB EQ 70MG BASE A090258 004 Sep 24, 2009
AB CADISTA PHARMS EQ 5MG BASE A090557 001 Feb 18, 2010
AB EQ 10MG BASE A090557 002 Feb 18, 2010
AB EQ 35MG BASE A090557 003 Feb 18, 2010
AB EQ 70MG BASE A090557 004 Feb 18, 2010
AB CIPLA LTD EQ 5MG BASE A076768 001 Aug 04, 2008
AB EQ 10MG BASE A076768 002 Aug 04, 2008
AB EQ 35MG BASE A076768 003 Aug 04, 2008
AB EQ 40MG BASE A076768 004 Aug 04, 2008
AB EQ 70MG BASE A076768 005 Aug 04, 2008
AB DR REDDYS LABS LTD EQ 5MG BASE A079109 001 Aug 04, 2008
AB EQ 10MG BASE A079109 002 Aug 04, 2008
AB EQ 35MG BASE A079049 001 Aug 04, 2008
AB EQ 70MG BASE A079049 002 Aug 04, 2008
AB MYLAN EQ 5MG BASE A076584 001 Aug 04, 2008
AB EQ 10MG BASE A076584 002 Aug 04, 2008
AB EQ 35MG BASE A076584 003 Aug 04, 2008
AB EQ 70MG BASE A076584 004 Aug 04, 2008
AB SUN PHARMA GLOBAL EQ 5MG BASE A090022 001 Sep 10, 2008
AB EQ 10MG BASE A090022 002 Sep 10, 2008
AB EQ 35MG BASE A090022 003 Sep 10, 2008
AB EQ 70MG BASE A090022 004 Sep 10, 2008
AB TEVA PHARMS EQ 5MG BASE A075710 001 Feb 06, 2008
AB EQ 10MG BASE A075710 002 Feb 06, 2008
AB EQ 35MG BASE A075710 003 Feb 06, 2008
AB EQ 40MG BASE A075710 004 Feb 06, 2008
AB EQ 70MG BASE A075710 005 Feb 06, 2008
AB WATSON LABS EQ 35MG BASE A076984 001 Aug 04, 2008
AB EQ 40MG BASE A076984 002 Aug 04, 2008
AB EQ 70MG BASE A076984 003 Aug 04, 2008
FOSAMAX
AB + MERCK AND CO INC EQ 70MG BASE N020560 005 Oct 20, 2000
TABLET, EFFERVESCENT;ORAL
BINOSTO
+ MISSION PHARMA EQ 70MG BASE N202344 001 Mar 12, 2012
ALENDRONATE SODIUM; CHOLECALCIFEROL
TABLET;ORAL
FOSAMAX PLUS D
MERCK EQ 70MG BASE;2,800 IU N021762 001 Apr 07, 2005
+ EQ 70MG BASE;5,600 IU N021762 002 Apr 26, 2007
ALFENTANIL HYDROCHLORIDE
INJECTABLE;INJECTION
ALFENTA
AP + AKORN EQ 0.5MG BASE/ML N019353 001 Dec 29, 1986
ALFENTANIL
AP HOSPIRA EQ 0.5MG BASE/ML A075221 001 Oct 28, 1999
ALFUZOSIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
ALFUZOSIN HYDROCHLORIDE
AB APOTEX INC 10MG A079013 001 Jul 18, 2011
AB AUROBINDO PHARMA LTD 10MG A079060 001 Aug 30, 2012
AB INVAGEN PHARMS 10MG A090284 001 Jan 17, 2012
AB MYLAN 10MG A079014 001 Jul 18, 2011
AB SUN PHARMA GLOBAL 10MG A079057 001 Jul 18, 2011
AB TEVA PHARMS 10MG A079056 001 Jul 18, 2011
AB TORRENT PHARMS 10MG A079054 001 Jul 18, 2011
AB WOCKHARDT LTD 10MG A090221 001 Aug 10, 2012
UROXATRAL
AB + COVIS PHARMA SARL 10MG N021287 001 Jun 12, 2003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-11(of 371)
ALISKIREN HEMIFUMARATE
TABLET;ORAL
TEKTURNA
NOVARTIS EQ 150MG BASE N021985 001 Mar 05, 2007
+ EQ 300MG BASE N021985 002 Mar 05, 2007
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE
TABLET;ORAL
TEKAMLO
NOVARTIS EQ 150MG BASE;EQ 5MG BASE N022545 001 Aug 26, 2010
EQ 150MG BASE;EQ 10MG BASE N022545 002 Aug 26, 2010
EQ 300MG BASE;EQ 5MG BASE N022545 003 Aug 26, 2010
+ EQ 300MG BASE;EQ 10MG BASE N022545 004 Aug 26, 2010
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
AMTURNIDE
NOVARTIS EQ 150MG BASE;EQ 5MG BASE;12.5MG N200045 001 Dec 21, 2010
EQ 300MG BASE;EQ 5MG BASE;12.5MG N200045 002 Dec 21, 2010
EQ 300MG BASE;EQ 5MG BASE;25MG N200045 003 Dec 21, 2010
EQ 300MG BASE;EQ 10MG BASE;12.5MG N200045 004 Dec 21, 2010
+ EQ 300MG BASE;EQ 10MG BASE;25MG N200045 005 Dec 21, 2010
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
TEKTURNA HCT
NOVARTIS EQ 150MG BASE;12.5MG N022107 001 Jan 18, 2008
EQ 150MG BASE;25MG N022107 002 Jan 18, 2008
+ EQ 300MG BASE;12.5MG N022107 003 Jan 18, 2008
+ EQ 300MG BASE;25MG N022107 004 Jan 18, 2008
ALITRETINOIN
GEL;TOPICAL
PANRETIN
+ EISAI INC EQ 0.1% BASE N020886 001 Feb 02, 1999
ALLOPURINOL
TABLET;ORAL
ALLOPURINOL
AB ACCORD HLTHCARE 100MG A203154 001 May 06, 2013
AB 300MG A203154 002 May 06, 2013
AB APOTEX INC 100MG A077353 001 Sep 08, 2005
AB 300MG A077353 002 Sep 08, 2005
AB IPCA LABS LTD 100MG A090637 001 Mar 16, 2011
AB 300MG A090637 002 Mar 16, 2011
AB MUTUAL PHARM 100MG A071449 001 Jan 09, 1987
AB 300MG A071450 001 Jan 09, 1987
AB MYLAN 100MG A018659 001 Oct 24, 1986
AB 300MG A018659 002 Oct 24, 1986
AB NORTHSTAR HLTHCARE 100MG A078253 001 Sep 11, 2007
AB 300MG A078253 002 Sep 11, 2007
AB SUN PHARM INDS INC 100MG A078390 001 Aug 30, 2007
AB 300MG A078390 002 Aug 30, 2007
AB VINTAGE PHARMS 100MG A075798 001 Jun 27, 2003
AB 300MG A075798 002 Jun 27, 2003
AB WATSON LABS 100MG N018832 002 Sep 28, 1984
AB 300MG N018877 001 Sep 28, 1984
LOPURIN
AB DR REDDYS LA 100MG A071586 001 Apr 02, 1987
AB 300MG A071587 001 Apr 02, 1987
ZYLOPRIM
AB PROMETHEUS LABS 100MG N016084 001
AB + 300MG N016084 002
ALLOPURINOL SODIUM
INJECTABLE;INJECTION
ALLOPURINOL SODIUM
AP EUROHLTH INTL EQ 500MG BASE/VIAL A076870 001 Aug 26, 2004
ALOPRIM
AP + MYLAN INSTITUTIONAL EQ 500MG BASE/VIAL N020298 001 May 17, 1996
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-12(of 371)
ALMOTRIPTAN MALATE
TABLET;ORAL
AXERT
JANSSEN PHARMS EQ 6.25MG BASE N021001 001 May 07, 2001
+ EQ 12.5MG BASE N021001 002 May 07, 2001
ALOGLIPTIN BENZOATE
TABLET;ORAL
NESINA
TAKEDA PHARMS USA EQ 6.25MG BASE N022271 001 Jan 25, 2013
EQ 12.5MG BASE N022271 002 Jan 25, 2013
+ EQ 25MG BASE N022271 003 Jan 25, 2013
ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE
TABLET;ORAL
KAZANO
+ TAKEDA PHARMS USA EQ 12.5MG BASE;1GM N203414 002 Jan 25, 2013
EQ 12.5MG BASE;500MG N203414 001 Jan 25, 2013
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE
TABLET;ORAL
OSENI
TAKEDA PHARMS USA EQ 12.5MG BASE;EQ 15MG BASE N022426 004 Jan 25, 2013
EQ 12.5MG BASE;EQ 30MG BASE N022426 005 Jan 25, 2013
EQ 12.5MG BASE;EQ 45MG BASE N022426 006 Jan 25, 2013
EQ 25MG BASE;EQ 15MG BASE N022426 001 Jan 25, 2013
EQ 25MG BASE;EQ 30MG BASE N022426 002 Jan 25, 2013
+ EQ 25MG BASE;EQ 45MG BASE N022426 003 Jan 25, 2013
ALOSETRON HYDROCHLORIDE
TABLET;ORAL
LOTRONEX
PROMETHEUS LABS EQ 0.5MG BASE N021107 002 Dec 23, 2003
+ EQ 1MG BASE N021107 001 Feb 09, 2000
ALPHA-TOCOPHEROL ACETATE; ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL;
FOLIC ACID; NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE
HYDROCHLORIDE; VITAMIN A PALMITATE; VITAMIN K
INJECTABLE;INJECTION
INFUVITE ADULT
+ SANDOZ 2 IU/ML;40MG/ML;12MCG/ML;40 N021163 001 May 18, 2000
IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1
.2MG/ML;0.72MG/ML;1.2MG/ML;660
IU/ML;0.03MG/ML
INJECTABLE;IV (INFUSION)
INFUVITE ADULT
+ SANDOZ 2 IU/ML;40MG/ML;12MCG/ML;40 N021559 001 Jun 16, 2003
IU/ML;1MCG/ML;3MG/ML;120MCG/ML;8MG/ML;1
.2MG/ML;0.72MG/ML;1.2MG/ML;660
IU/ML;30MCG/ML
ALPRAZOLAM
CONCENTRATE;ORAL
ALPRAZOLAM
+ ROXANE 1MG/ML A074312 001 Oct 31, 1993
TABLET;ORAL
ALPRAZOLAM
AB ACTAVIS ELIZABETH 0.25MG A074342 001 Oct 31, 1993
AB 0.5MG A074342 002 Oct 31, 1993
AB 1MG A074342 003 Oct 31, 1993
AB 2MG A074342 004 Oct 31, 1993
AB APOTEX INC 0.25MG A077741 001 Jan 19, 2007
AB 0.5MG A077741 002 Jan 19, 2007
AB 1MG A077741 003 Jan 19, 2007
AB 2MG A077741 004 Jan 19, 2007
AB DAVA INTL INC 0.25MG A074174 001 Oct 19, 1993
AB 0.5MG A074174 002 Oct 19, 1993
AB 1MG A074174 003 Oct 19, 1993
AB 2MG A074174 004 Oct 19, 1993
AB MYLAN 0.25MG A074215 001 Jan 27, 1994
AB 0.5MG A074215 002 Jan 27, 1994
AB 1MG A074215 003 Jan 27, 1994
AB 2MG A074215 004 Jan 27, 1994
AB MYLAN PHARMS INC 0.25MG A074046 001 Oct 19, 1993
AB 0.5MG A074046 002 Oct 19, 1993
AB 1MG A074046 003 Oct 19, 1993
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-13(of 371)
ALPRAZOLAM
TABLET;ORAL
ALPRAZOLAM
AB 2MG A074046 004 May 07, 1997
AB SANDOZ 0.25MG A074112 001 Dec 29, 1995
AB 0.5MG A074112 002 Dec 29, 1995
AB 1MG A074112 003 Dec 29, 1995
AB 2MG A074909 001 Mar 25, 1998
AB SUN PHARMA GLOBAL 0.25MG A090082 001 Jun 17, 2010
AB 0.5MG A090082 002 Jun 17, 2010
AB 1MG A090082 003 Jun 17, 2010
AB 2MG A090082 004 Jun 17, 2010
AB VINTAGE 0.25MG A078491 001 Sep 25, 2008
AB 0.5MG A078491 002 Sep 25, 2008
AB 1MG A078491 003 Sep 25, 2008
AB 2MG A078491 004 Dec 12, 2008
AB VINTAGE PHARMS 0.25MG A090248 001 Sep 17, 2010
AB 0.5MG A090248 002 Sep 17, 2010
AB 1MG A090248 003 Sep 17, 2010
AB 2MG A090248 004 Sep 17, 2010
XANAX
AB PHARMACIA AND UPJOHN 0.25MG N018276 001
AB 0.5MG N018276 002
AB + 1MG N018276 003
AB 2MG N018276 004 Nov 27, 1985
TABLET, EXTENDED RELEASE;ORAL
ALPRAZOLAM
AB ACTAVIS ELIZABETH 0.5MG A078056 001 Feb 13, 2007
AB 1MG A078056 002 Feb 13, 2007
AB 2MG A078056 003 Feb 13, 2007
AB 3MG A078056 004 Feb 13, 2007
AB ACTAVIS LABS FL INC 0.5MG A077198 001 May 13, 2010
AB 1MG A077198 002 May 13, 2010
AB 2MG A077198 003 May 13, 2010
AB 3MG A077198 004 May 13, 2010
AB AMNEAL PHARMS NY 0.5MG A078387 001 May 30, 2008
AB 1MG A078387 002 May 30, 2008
AB 2MG A078387 003 May 30, 2008
AB 3MG A078387 004 May 30, 2008
AB ANCHEN PHARMS 0.5MG A078469 001 Sep 29, 2011
AB 1MG A078469 002 Sep 29, 2011
AB 2MG A078469 003 Sep 29, 2011
AB 3MG A078469 004 Sep 29, 2011
AB ANI PHARMS INC 0.5MG A077725 001 Jul 31, 2006
AB 1MG A077725 002 Jul 31, 2006
AB 2MG A077725 004 Jul 31, 2006
AB 3MG A077725 003 Jul 31, 2006
AB APOTEX INC 0.5MG A078449 001 Nov 12, 2008
AB 2MG A078449 002 Nov 12, 2008
AB 3MG A078449 003 Nov 12, 2008
AB AUROBINDO PHARMA USA 0.5MG A090871 001 Jun 07, 2011
AB 1MG A090871 002 Jun 07, 2011
AB 2MG A090871 003 Jun 07, 2011
AB 3MG A090871 004 Jun 07, 2011
AB COREPHARMA 0.5MG A077996 001 Jan 31, 2007
AB 1MG A077996 002 Jan 31, 2007
AB 2MG A077996 003 Jan 31, 2007
AB 3MG A077996 004 Jan 31, 2007
AB IMPAX LABS 0.5MG A077968 004 May 24, 2007
AB 1MG A077968 003 May 24, 2007
AB 2MG A077968 002 May 24, 2007
AB 3MG A077968 001 May 24, 2007
AB MYLAN 0.5MG A077391 002 Jan 26, 2006
AB 1MG A077391 003 Jan 26, 2006
AB 2MG A077391 004 Jan 26, 2006
AB 3MG A077391 001 Jan 26, 2006
AB ZYDUS PHARMS USA INC 0.5MG A078489 001 Oct 17, 2008
AB 1MG A078489 002 Oct 17, 2008
AB 2MG A078489 003 Oct 17, 2008
AB 3MG A078489 004 Oct 17, 2008
XANAX XR
AB PHARMACIA AND UPJOHN 0.5MG N021434 001 Jan 17, 2003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-14(of 371)
ALPRAZOLAM
TABLET, EXTENDED RELEASE;ORAL
XANAX XR
AB 1MG N021434 002 Jan 17, 2003
AB 2MG N021434 003 Jan 17, 2003
AB + 3MG N021434 004 Jan 17, 2003
TABLET, ORALLY DISINTEGRATING;ORAL
ALPRAZOLAM
AB ACTAVIS ELIZABETH 0.25MG A078561 001 Mar 16, 2010
AB 0.5MG A078561 002 Mar 16, 2010
AB 1MG A078561 003 Mar 16, 2010
AB 2MG A078561 004 Mar 16, 2010
AB PAR PHARM 0.25MG A078088 001 Jan 09, 2009
AB 0.5MG A078088 002 Jan 09, 2009
AB + 1MG A078088 003 Jan 09, 2009
AB 2MG A078088 004 Jan 09, 2009
ALPROSTADIL
INJECTABLE;INJECTION
ALPROSTADIL
AP EUROHLTH INTL 0.5MG/ML A074815 001 Jan 20, 1998
AP TEVA PHARMS USA 0.5MG/ML A075196 001 Apr 30, 1999
CAVERJECT
AP PHARMACIA AND UPJOHN 0.01MG/VIAL N020379 001 Jul 06, 1995
AP + 0.02MG/VIAL N020379 002 Jul 06, 1995
AP + 0.04MG/VIAL N020379 004 May 19, 1997
EDEX
AP AUXILIUM PHARMS LLC 0.01MG/VIAL N020649 002 Jun 12, 1997
AP 0.02MG/VIAL N020649 003 Jun 12, 1997
AP + 0.04MG/VIAL N020649 004 Jun 12, 1997
PROSTIN VR PEDIATRIC
AP + PHARMACIA AND UPJOHN 0.5MG/ML N018484 001
CAVERJECT
PHARMACIA AND UPJOHN 0.005MG/VIAL N020379 003 Jun 27, 1996
CAVERJECT IMPULSE
PHARMACIA AND UPJOHN 0.01MG/VIAL N021212 001 Jun 11, 2002
0.02MG/VIAL N021212 002 Jun 11, 2002
EDEX
+ AUXILIUM PHARMS LLC 0.01MG/VIAL N020649 005 Jul 30, 1998
+ 0.02MG/VIAL N020649 006 Jul 30, 1998
+ 0.04MG/VIAL N020649 007 Jul 30, 1998
SUPPOSITORY;URETHRAL
MUSE
MEDA PHARMS 0.125MG N020700 001 Nov 19, 1996
0.25MG N020700 002 Nov 19, 1996
0.5MG N020700 003 Nov 19, 1996
+ 1MG N020700 004 Nov 19, 1996
ALTRETAMINE
CAPSULE;ORAL
HEXALEN
+ EISAI INC 50MG N019926 001 Dec 26, 1990
ALVIMOPAN
CAPSULE;ORAL
ENTEREG
+ CUBIST PHARMS 12MG N021775 001 May 20, 2008
AMANTADINE HYDROCHLORIDE
CAPSULE;ORAL
AMANTADINE HYDROCHLORIDE
AB BANNER PHARMACAPS 100MG A078720 001 May 29, 2008
AB + SANDOZ 100MG A071293 001 Feb 18, 1987
AB USL PHARMA 100MG A070589 001 Aug 05, 1986
SYRUP;ORAL
AMANTADINE HYDROCHLORIDE
AA + CAROLINA MEDCL 50MG/5ML A075819 001 Sep 11, 2002
AA + HI TECH PHARMA 50MG/5ML A074170 001 Oct 28, 1994
AA + MIKART 50MG/5ML A074028 001 Jun 28, 1993
AA + PHARM ASSOC 50MG/5ML A074509 001 Jul 17, 1995
AA + SILARX 50MG/5ML A076352 001 Sep 10, 2004
AA + VINTAGE 50MG/5ML A077992 001 Dec 12, 2006
AA + WOCKHARDT 50MG/5ML A075060 001 Dec 24, 1998
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-15(of 371)
AMANTADINE HYDROCHLORIDE
TABLET;ORAL
AMANTADINE HYDROCHLORIDE
+ USL PHARMA 100MG A076186 001 Dec 16, 2002
AMBRISENTAN
TABLET;ORAL
LETAIRIS
GILEAD 5MG N022081 001 Jun 15, 2007
+ 10MG N022081 002 Jun 15, 2007
AMCINONIDE
CREAM;TOPICAL
AMCINONIDE
AB + FOUGERA PHARMS 0.1% A076065 001 May 15, 2003
AB TARO PHARM INDS 0.1% A076229 001 May 31, 2002
LOTION;TOPICAL
AMCINONIDE
+ FOUGERA PHARMS 0.1% A076329 001 Nov 06, 2002
OINTMENT;TOPICAL
AMCINONIDE
AB + FOUGERA PHARMS 0.1% A076096 001 Nov 19, 2002
AB TARO PHARM INDS 0.1% A076367 001 Mar 19, 2003
AMIFOSTINE
INJECTABLE;INJECTION
AMIFOSTINE
AP SUN PHARMA GLOBAL 500MG/VIAL A077126 001 Mar 14, 2008
ETHYOL
AP + CLINIGEN HLTHCARE 500MG/VIAL N020221 001 Dec 08, 1995
AMIKACIN SULFATE
INJECTABLE;INJECTION
AMIKACIN SULFATE
AP EMCURE PHARMS LTD EQ 250MG BASE/ML A204040 001 Dec 12, 2013
AP + EUROHLTH INTL EQ 50MG BASE/ML A063313 001 Apr 11, 1994
AP + EQ 250MG BASE/ML A063315 001 Apr 11, 1994
AP TEVA PHARMS USA EQ 250MG BASE/ML A064045 002 Sep 28, 1993
AMILORIDE HYDROCHLORIDE
TABLET;ORAL
AMILORIDE HYDROCHLORIDE
AB + PAR PHARM 5MG A070346 001 Jan 22, 1986
AB SIGMAPHARM LABS LLC 5MG A079133 001 Jan 30, 2009
MIDAMOR
AB PADDOCK LLC 5MG N018200 001
AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
AB BARR EQ 5MG ANHYDROUS;50MG A071111 001 May 10, 1988
AB + MYLAN EQ 5MG ANHYDROUS;50MG A073209 001 Oct 31, 1991
AMINO ACIDS
INJECTABLE;INJECTION
AMINO ACIDS
B BRAUN 15%(150GM/1000ML) A091112 001 Apr 13, 2012
15%(300GM/2000ML) A091112 002 Apr 13, 2012
AMINOSYN 10%
HOSPIRA 10% (10GM/100ML) N017673 003
AMINOSYN 10% (PH6)
HOSPIRA 10% (10GM/100ML) N017673 008 Nov 18, 1985
AMINOSYN 3.5%
HOSPIRA 3.5% (3.5GM/100ML) N017789 004
AMINOSYN 5%
HOSPIRA 5% (5GM/100ML) N017673 001
AMINOSYN 7%
HOSPIRA 7% (7GM/100ML) N017673 002
AMINOSYN 7% (PH6)
HOSPIRA 7% (7GM/100ML) N017673 006 Nov 18, 1985
AMINOSYN 8.5%
HOSPIRA 8.5% (8.5GM/100ML) N017673 004
AMINOSYN 8.5% (PH6)
HOSPIRA 8.5% (8.5GM/100ML) N017673 007 Nov 18, 1985
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-16(of 371)
AMINO ACIDS
INJECTABLE;INJECTION
AMINOSYN II 10%
HOSPIRA 10% (10GM/100ML)
N019438 005 Apr 03, 1986
AMINOSYN II 10% IN PLASTIC CONTAINER
HOSPIRA 10% (10GM/100ML)
N020015 001 Dec 19, 1991
AMINOSYN II 15% IN PLASTIC CONTAINER
HOSPIRA
15% (15GM/100ML)
N020041 001 Dec 19, 1991
AMINOSYN II 7%
HOSPIRA
7% (7GM/100ML)
N019438 003 Apr 03, 1986
AMINOSYN II 8.5%
HOSPIRA
8.5% (8.5GM/100ML)
N019438 004 Apr 03, 1986
AMINOSYN-HBC 7%
HOSPIRA
7% (7GM/100ML)
N019374 001 Jul 12, 1985
AMINOSYN-HF 8%
HOSPIRA
8% (8GM/100ML)
A020345 001 Apr 04, 1996
AMINOSYN-PF 10%
HOSPIRA
10% (10GM/100ML)
N019492 002 Oct 17, 1986
AMINOSYN-PF 7%
HOSPIRA
7% (7GM/100ML)
N019398 001 Sep 06, 1985
AMINOSYN-RF 5.2%
HOSPIRA
5.2% (5.2GM/100ML)
N018429 001
BRANCHAMIN 4% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4% (4GM/100ML)
N018684 001 Sep 28, 1984
CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER
BAXTER HLTHCARE
15% (15GM/100ML)
A020512 001 Aug 30, 1996
FREAMINE HBC 6.9%
B BRAUN
6.9% (6.9GM/100ML)
N016822 006 May 17, 1983
FREAMINE III 10%
B BRAUN
10% (10GM/100ML)
N016822 005
FREAMINE III 8.5%
B BRAUN
8.5% (8.5GM/100ML)
N016822 004
HEPATAMINE 8%
B BRAUN
8% (8GM/100ML)
N018676 001 Aug 03, 1982
NEPHRAMINE 5.4%
B BRAUN
5.4% (5.4GM/100ML)
N017766 001
PREMASOL 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 10% (10GM/100ML)
A075880 002 Jun 19, 2003
PREMASOL 6% IN PLASTIC CONTAINER
BAXTER HLTHCARE 6% (6GM/100ML)
A075880 001 Jun 19, 2003
PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 20% (20GM/100ML)
N020849 001 Aug 26, 1998
TRAVASOL 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 10% (10MG/100ML)
N018931 003 Aug 23, 1984
TRAVASOL 5.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5.5% (5.5GM/100ML)
N018931 001 Aug 23, 1984
TRAVASOL 8.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 8.5% (8.5GM/100ML)
N018931 002 Aug 23, 1984
TROPHAMINE
+ B BRAUN 6% (6GM/100ML)
N019018 001 Jul 20, 1984
TROPHAMINE 10%
+ B BRAUN 10% (10GM/100ML)
N019018 003 Sep 07, 1988
AMINO ACIDS; CALCIUM ACETATE; GLYCERIN; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE;
SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
PROCALAMINE
B BRAUN 3%;26MG/100ML;3GM/100ML;54MG/100ML;41MG N018582 001 May 08, 1982
/100ML;150MG/100ML;200MG/100ML;120MG/10
0ML
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM
ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
CLINIMIX E 2.75/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 2.75%;33MG/100ML;10GM/100ML;51MG/100ML; N020678 002 Mar 26, 1997
261MG/100ML;217MG/100ML;112MG/100ML
CLINIMIX E 2.75/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 2.75%;33MG/100ML;25GM/100ML;51MG/100ML; N020678 005 Mar 26, 1997
261MG/100ML;217MG/100ML;112MG/100ML
CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 2.75%;33MG/100ML;5GM/100ML;51MG/100ML;2 N020678 001 Mar 26, 1997
61MG/100ML;217MG/100ML;112MG/100ML
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-17(of 371)
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM
ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
CLINIMIX E 4.25/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 4.25%;33MG/100ML;10GM/100ML;51MG/100ML; N020678 009 Mar 26, 1997
261MG/100ML;297MG/100ML;77MG/100ML
CLINIMIX E 4.25/20 SULFITE-FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 4.25%;33MG/100ML;20GM/100ML;51MG/100ML; N020678 011 Mar 26, 1997
261MG/100ML;297MG/100ML;77MG/100ML
CLINIMIX E 4.25/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 4.25%;33MG/100ML;25GM/100ML;51MG/100ML; N020678 012 Mar 26, 1997
261MG/100ML;297MG/100ML;77MG/100ML
CLINIMIX E 4.25/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 4.25%;33MG/100ML;5GM/100ML;51MG/100ML;2 N020678 008 Mar 26, 1997
61MG/100ML;297MG/100ML;77MG/100ML
CLINIMIX E 5/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 5%;33MG/100ML;10GM/100ML;51MG/100ML;261 N020678 016 Mar 26, 1997
MG/100ML;340MG/100ML;59MG/100ML
CLINIMIX E 5/15 SULFITE-FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 5%;33MG/100ML;15GM/100ML;51MG/100ML;261 N020678 017 Mar 26, 1997
MG/100ML;340MG/100ML;59MG/100ML
CLINIMIX E 5/20 SULFITE-FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 5%;33MG/100ML;20GM/100ML;51MG/100ML;261 N020678 018 Mar 26, 1997
MG/100ML;340MG/100ML;59MG/100ML
CLINIMIX E 5/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 5%;33MG/100ML;25GM/100ML;51MG/100ML;261 N020678 019 Mar 26, 1997
MG/100ML;340MG/100ML;59MG/100ML
CLINIMIX E 5/35 SULFITE-FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 5%;33MG/100ML;35GM/100ML;51MG/100ML;261 N020678 021 Mar 26, 1997
MG/100ML;340MG/100ML;59MG/100ML
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM ACETATE;
SODIUM GLYCEROPHOSPHATE; SOYBEAN OIL
EMULSION;IV (INFUSION)
KABIVEN IN PLASTIC CONTAINER
FRESENIUS KABI USA 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML; N200656 004 Aug 25, 2014
174MG/100ML;239MG/100ML
;147MG/100ML;3.9GM/100ML (1026ML)
3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML; N200656 005 Aug 25, 2014
174MG/100ML;239MG/100ML;147MG/100ML;3.9
GM/100ML (1540ML)
3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML; N200656 006 Aug 25, 2014
174MG/100ML;239MG/100ML;147MG/100ML;3.9
GM/100ML (2053ML)
+ 3.3%;29MG/100ML;9.8GM/100ML;96MG/100ML; N200656 007 Aug 25, 2014
174MG/100ML;239MG/100ML;147MG/100ML;3.9
GM/100ML (2566ML)
PERIKABIVEN IN PLASTIC CONTAINER
FRESENIUS KABI USA 2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML; N200656 001 Aug 25, 2014
124MG/100ML;170MG/100ML;105MG/100ML;3.5
GM/100ML (1440ML)
2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML; N200656 002 Aug 25, 2014
124MG/100ML;170MG/100ML;105MG/100ML;3.5
GM/100ML (1920ML)
2.4%;20MG/100ML;6.8GM/100ML;68MG/100ML; N200656 003 Aug 25, 2014
124MG/100ML;170MG/100ML
;105MG/100ML;3.5GM/100ML (2400ML)
AMINO ACIDS; DEXTROSE
INJECTABLE;INJECTION
CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;10GM/100ML N020734 002 Sep 29, 1997
CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;25GM/100ML N020734 005 Sep 29, 1997
CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;5GM/100ML N020734 001 Sep 29, 1997
CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;10GM/100ML N020734 008 Sep 29, 1997
CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;20GM/100ML N020734 010 Sep 29, 1997
CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;25GM/100ML N020734 011 Sep 29, 1997
CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;5GM/100ML N020734 007 Sep 29, 1997
CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5%;10GM/100ML N020734 014 Sep 29, 1997
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-18(of 371)
AMINO ACIDS; DEXTROSE
INJECTABLE;INJECTION
CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5%;15GM/100ML
N020734 015 Sep 29, 1997
CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5%;20GM/100ML
N020734 016 Sep 29, 1997
CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5%;25GM/100ML
N020734 017 Sep 29, 1997
CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5%;35GM/100ML
N020734 018 Sep 29, 1997
AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM
ACETATE
INJECTABLE;INJECTION
FREAMINE III 8.5% W/ ELECTROLYTES
B BRAUN 8.5%;110MG/100ML;230MG/100ML;10MG/100ML N016822 007 Jul 01, 1988
;440MG/100ML;690MG/100ML
AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
AMINOSYN 3.5% M
HOSPIRA 3.5%;21MG/100ML;40MG/100ML;128MG/100ML; N017789 003
234MG/100ML
AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM
CHLORIDE
INJECTABLE;INJECTION
FREAMINE III 3% W/ ELECTROLYTES
B BRAUN 3%;54MG/100ML;40MG/100ML;150MG/100ML;20 N016822 003
0MG/100ML;120MG/100ML
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE;INJECTION
AMINOSYN II 10% W/ ELECTROLYTES
HOSPIRA 10%;102MG/100ML;45MG/100ML;522MG/100ML; N019437 004 Apr 03, 1986
410MG/100ML
AMINOSYN II 8.5% W/ ELECTROLYTES
HOSPIRA 8.5%;102MG/100ML;45MG/100ML;522MG/100ML N019437 005 Apr 03, 1986
;410MG/100ML
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
BAXTER HLTHCARE 3.5%;51MG/100ML;131MG/100ML;218MG/100ML
N020177 001 Oct 23, 1995
;35MG/100ML
TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
BAXTER HLTHCARE 5.5%;102MG/100ML;522MG/100ML;431MG/100M
N020173 001 Oct 27, 1995
L;224MG/100ML
TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER
BAXTER HLTHCARE 8.5%;102MG/100ML;522MG/100ML;594MG/100M
N020173 002 Oct 27, 1995
L;154MG/100ML
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE;INJECTION
AMINOSYN 7% W/ ELECTROLYTES
HOSPIRA 7%;102MG/100ML;522MG/100ML;410MG/100ML
N017789 002
AMINOSYN 8.5% W/ ELECTROLYTES
HOSPIRA 8.5%;102MG/100ML;522MG/100ML;410MG/100M N017673 005
L
AMINOCAPROIC ACID
INJECTABLE;INJECTION
AMINOCAPROIC ACID
AP LUITPOLD 250MG/ML A071192 001 Dec 01, 1987
AMINOCAPROIC ACID IN PLASTIC CONTAINER
AP + HOSPIRA
250MG/ML
A070010 001 Mar 09, 1987
SYRUP;ORAL
AMICAR
AA + CLOVER PHARMS 1.25GM/5ML
N015230 002
AMINOCAPROIC ACID
AA MIKART 1.25GM/5ML
A074759 001 Sep 02, 1998
TABLET;ORAL
AMICAR
AB CLOVER PHARMS
500MG
N015197 001
AMINOCAPROIC
AB MIKART
500MG
A075602 001 May 24, 2001
AMICAR
+ CLOVER PHARMS
1GM
N015197 002 Jun 24, 2004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-19(of 371)
AMINOLEVULINIC ACID HYDROCHLORIDE
SOLUTION;TOPICAL
LEVULAN
+ DUSA 20% N020965 001 Dec 03, 1999
AMINOPHYLLINE
INJECTABLE;INJECTION
AMINOPHYLLINE
AP + HOSPIRA 25MG/ML A087242 001 Oct 26, 1983
AP LUITPOLD 25MG/ML A087600 001
AMINOSALICYLIC ACID
GRANULE, DELAYED RELEASE;ORAL
PASER
+ JACOBUS 4GM/PACKET A074346 001 Jun 30, 1994
AMIODARONE HYDROCHLORIDE
INJECTABLE;INJECTION
AMIODARONE HYDROCHLORIDE
AP + AKORN 50MG/ML A076232 001 Jul 05, 2006
AP + FRESENIUS KABI USA 50MG/ML A075761 001 Oct 15, 2002
AP + GLAND PHARMA LTD 50MG/ML A077161 001 Apr 20, 2005
AP HIKMA FARMACEUTICA 50MG/ML A077234 001 Feb 25, 2008
AP + HOSPIRA 50MG/ML A075955 001 Oct 18, 2002
AP HOSPIRA INC 50MG/ML A203884 001 Nov 25, 2013
AP 50MG/ML A203885 001 Nov 25, 2013
AP + MYLAN INSTITUTIONAL 50MG/ML A076217 001 Oct 15, 2002
AP WOCKHARDT 50MG/ML A077610 001 Oct 30, 2008
AP 50MG/ML A077834 001 Oct 30, 2008
NEXTERONE
AP BAXTER HLTHCARE 50MG/ML N022325 001 Dec 24, 2008
+ 150MG/100ML (1.5MG/ML) N022325 002 Nov 16, 2010
+ 360MG/200ML (1.8MG/ML) N022325 003 Nov 16, 2010
TABLET;ORAL
AMIODARONE HYDROCHLORIDE
AB APOTEX CORP 200MG A078578 001 Nov 06, 2008
AB BARR 200MG A075389 001 Jan 25, 2001
AB MURTY PHARMS 200MG A077069 001 Apr 08, 2005
AB 400MG A077069 002 Apr 08, 2005
AB MYLAN 200MG A075188 001 Feb 24, 1999
AB SANDOZ 200MG A075315 001 Dec 23, 1998
AB 400MG A075315 002 Jun 30, 2000
AB TARO 100MG A075424 002 Dec 18, 2002
AB 200MG A075424 001 Mar 30, 2001
AB 400MG A076362 001 Nov 29, 2002
AB TEVA PHARMS 200MG A074739 001 Nov 30, 1998
AB ZYDUS PHARMS USA INC 200MG A079029 001 Sep 16, 2008
CORDARONE
AB + WYETH PHARMS INC 200MG N018972 001 Dec 24, 1985
PACERONE
AB UPSHER SMITH 100MG A075135 002 Apr 12, 2005
AB 200MG A075135 001 Apr 30, 1998
AMIODARONE HYDROCHLORIDE
TARO 300MG A076362 002 Dec 02, 2003
AMITRIPTYLINE HYDROCHLORIDE
TABLET;ORAL
AMITRIPTYLINE HYDROCHLORIDE
AB ACCORD HLTHCARE 10MG A202446 001 Jun 04, 2014
AB 25MG A202446 002 Jun 04, 2014
AB 50MG A202446 003 Jun 04, 2014
AB 75MG A202446 004 Jun 04, 2014
AB 100MG A202446 005 Jun 04, 2014
AB 150MG A202446 006 Jun 04, 2014
AB MUTUAL PHARM 10MG A089399 002 Jul 14, 1987
AB 25MG A089399 001 Jul 14, 1987
AB 50MG A089399 003 Jul 14, 1987
AB 75MG A089399 004 Jul 14, 1987
AB 100MG A089399 005 Jul 14, 1987
AB 150MG A089399 006 Jul 14, 1987
AB MYLAN 10MG A086009 002
AB 25MG A086009 003
AB 50MG A086009 001
AB 75MG A086009 004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-20(of 371)
AMITRIPTYLINE HYDROCHLORIDE
TABLET;ORAL
AMITRIPTYLINE HYDROCHLORIDE
AB 100MG
A086009 005
AB 150MG
A086009 006
AB SANDOZ 10MG
A085969 001
AB + 25MG
A085966 001
AB 50MG
A085968 001
AB 75MG
A085971 001
AB 100MG
A085967 001
AB 150MG
A085970 001
AB SUN PHARM INDS INC 10MG
A040816 002 Jun 27, 2008
AB 25MG
A040816 001 Jun 27, 2008
AB 50MG
A040816 003 Jun 27, 2008
AB 75MG
A040816 004 Jun 27, 2008
AB 100MG
A040816 005 Jun 27, 2008
AB 150MG
A040816 006 Jun 27, 2008
AB VINTAGE PHARMS 10MG
A040218 001 Sep 11, 1997
AB 25MG
A040218 002 Sep 11, 1997
AB 50MG
A040218 003 Sep 11, 1997
AB 75MG
A040218 004 Sep 11, 1997
AB 100MG
A040218 005 Sep 11, 1997
AB 150MG
A040218 006 Sep 11, 1997
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
TABLET;ORAL
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
MYLAN PHARMS INC EQ 12.5MG BASE;5MG
A071297 002 Dec 10, 1986
+ EQ 25MG BASE;10MG
A071297 001 Dec 10, 1986
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
TABLET;ORAL
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
MYLAN
10MG;2MG
A071443 002 Nov 10, 1988
10MG;4MG
A071443 003 Nov 10, 1988
+
25MG;2MG
A071443 004 Nov 10, 1988
+
25MG;4MG
A071443 005 Nov 10, 1988
+
50MG;4MG
A071443 001 Nov 10, 1988
AMLODIPINE BESYLATE
TABLET;ORAL
AMLODIPINE BESYLATE
AB ACCORD HLTHCARE EQ 2.5MG BASE
A202553 001 Apr 29, 2013
AB EQ 5MG BASE
A202553 002 Apr 29, 2013
AB EQ 10MG BASE
A202553 003 Apr 29, 2013
AB ALKEM EQ 2.5MG BASE
A078925 001 May 04, 2009
AB EQ 5MG BASE
A078925 002 May 04, 2009
AB EQ 10MG BASE
A078925 003 May 04, 2009
AB AMNEAL PHARMS NY EQ 2.5MG BASE
A078477 001 Jan 16, 2008
AB EQ 5MG BASE
A078477 002 Jan 16, 2008
AB EQ 10MG BASE
A078477 003 Jan 16, 2008
AB APOTEX EQ 2.5MG BASE
A076719 001 May 23, 2007
AB EQ 5MG BASE
A076719 002 May 23, 2007
AB EQ 10MG BASE
A076719 003 May 23, 2007
AB AUROBINDO PHARMA EQ 2.5MG BASE
A078021 001 Jul 17, 2007
AB EQ 5MG BASE
A078021 002 Jul 17, 2007
AB EQ 10MG BASE
A078021 003 Jul 17, 2007
AB CIPLA LTD EQ 2.5MG BASE
A077073 001 Sep 26, 2007
AB EQ 5MG BASE
A077073 002 Sep 26, 2007
AB EQ 10MG BASE
A077073 003 Sep 26, 2007
AB DR REDDYS LABS LTD EQ 2.5MG BASE
A076692 001 Jul 20, 2007
AB EQ 5MG BASE
A076692 002 Jul 20, 2007
AB EQ 10MG BASE
A076692 003 Jul 20, 2007
AB EPIC PHARMA LLC EQ 2.5MG BASE
A078552 001 Apr 08, 2009
AB EQ 5MG BASE
A078552 002 Apr 08, 2009
AB EQ 10MG BASE
A078552 003 Apr 08, 2009
AB HIKMA PHARMS EQ 2.5MG BASE
A077771 001 Apr 12, 2011
AB EQ 5MG BASE
A077771 002 Apr 12, 2011
AB EQ 10MG BASE
A077771 003 Apr 12, 2011
AB INVAGEN PHARMS EQ 2.5MG BASE
A077955 001 Aug 28, 2007
AB EQ 5MG BASE
A077955 002 Aug 28, 2007
AB EQ 10MG BASE
A077955 003 Aug 28, 2007
AB LUPIN EQ 2.5MG BASE
A078043 001 Jul 12, 2007
AB EQ 5MG BASE
A078043 002 Jul 12, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-21(of 371)
AMLODIPINE BESYLATE
TABLET;ORAL
AMLODIPINE BESYLATE
AB EQ 10MG BASE A078043 003 Jul 12, 2007
AB MACLEODS PHARMS LTD EQ 5MG BASE A201380 001 Apr 13, 2012
AB EQ 10MG BASE A201380 002 Apr 13, 2012
AB MATRIX LABS LTD EQ 2.5MG BASE A078224 001 Feb 27, 2008
AB EQ 5MG BASE A078224 002 Feb 27, 2008
AB EQ 10MG BASE A078224 003 Feb 27, 2008
AB MYLAN EQ 2.5MG BASE A076418 001 Oct 03, 2005
AB EQ 5MG BASE A076418 002 Oct 03, 2005
AB EQ 10MG BASE A076418 003 Oct 03, 2005
AB ORCHID HLTHCARE EQ 2.5MG BASE A078453 001 Jul 02, 2009
AB EQ 5MG BASE A078453 002 Jul 02, 2009
AB EQ 10MG BASE A078453 003 Jul 02, 2009
AB RANBAXY EQ 2.5MG BASE A077974 001 Jul 09, 2007
AB EQ 5MG BASE A077974 002 Jul 09, 2007
AB EQ 10MG BASE A077974 003 Jul 09, 2007
AB ROXANE EQ 2.5MG BASE A077262 001 Jul 09, 2007
AB EQ 5MG BASE A077262 002 Jul 09, 2007
AB EQ 10MG BASE A077262 003 Jul 09, 2007
AB SECAN PHARMS EQ 5MG BASE A090752 001 Apr 15, 2011
AB EQ 10MG BASE A090752 002 Apr 15, 2011
AB SUN PHARM INDS INC EQ 2.5MG BASE A078231 001 Nov 30, 2007
AB EQ 5MG BASE A078231 002 Nov 30, 2007
AB EQ 10MG BASE A078231 003 Nov 30, 2007
AB TEVA EQ 2.5MG BASE A076846 001 Jun 28, 2007
AB EQ 5MG BASE A076846 002 Jun 28, 2007
AB EQ 10MG BASE A076846 003 Jun 28, 2007
AB TORRENT PHARMS EQ 2.5MG BASE A078573 001 Sep 22, 2008
AB EQ 5MG BASE A078573 002 Sep 22, 2008
AB EQ 10MG BASE A078573 003 Sep 22, 2008
AB UNICHEM LABS LTD EQ 2.5MG BASE A203245 001 Oct 21, 2013
AB EQ 5MG BASE A203245 002 Oct 21, 2013
AB EQ 10MG BASE A203245 003 Oct 21, 2013
AB UPSHER SMITH EQ 2.5MG BASE A077759 001 Jul 09, 2007
AB EQ 5MG BASE A077759 002 Jul 09, 2007
AB EQ 10MG BASE A077759 003 Jul 09, 2007
AB VINTAGE EQ 2.5MG BASE A078414 001 Apr 07, 2010
AB EQ 5MG BASE A078414 002 Apr 07, 2010
AB EQ 10MG BASE A078414 003 Apr 07, 2010
AB VIVIMED LABS EQ 2.5MG BASE A077516 001 Jul 11, 2007
AB EQ 5MG BASE A077516 002 Jul 11, 2007
AB EQ 10MG BASE A077516 003 Jul 11, 2007
AB WATSON LABS EQ 2.5MG BASE A077671 001 Jul 19, 2007
AB EQ 5MG BASE A077671 002 Jul 19, 2007
AB EQ 10MG BASE A077671 003 Jul 19, 2007
AB WOCKHARDT EQ 2.5MG BASE A078500 001 Sep 06, 2007
AB EQ 5MG BASE A078500 002 Sep 06, 2007
AB EQ 10MG BASE A078500 003 Sep 06, 2007
AB ZYDUS PHARMS USA EQ 2.5MG BASE A078226 001 Jul 09, 2007
AB EQ 5MG BASE A078226 002 Jul 09, 2007
AB EQ 10MG BASE A078226 003 Jul 09, 2007
NORVASC
AB PFIZER EQ 2.5MG BASE N019787 001 Jul 31, 1992
AB EQ 5MG BASE N019787 002 Jul 31, 1992
AB + EQ 10MG BASE N019787 003 Jul 31, 1992
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
TABLET;ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
AB DR REDDYS LABS LTD EQ 2.5MG BASE;EQ 10MG BASE A203874 001 Mar 07, 2014
AB EQ 2.5MG BASE;EQ 20MG BASE A203874 002 Mar 07, 2014
AB EQ 2.5MG BASE;EQ 40MG BASE A203874 003 Mar 07, 2014
AB EQ 5MG BASE;EQ 10MG BASE A203874 004 Mar 07, 2014
AB EQ 5MG BASE;EQ 20MG BASE A203874 005 Mar 07, 2014
AB EQ 5MG BASE;EQ 40MG BASE A203874 006 Mar 07, 2014
AB EQ 5MG BASE;EQ 80MG BASE A203874 007 Mar 07, 2014
AB EQ 10MG BASE;EQ 10MG BASE A203874 008 Mar 07, 2014
AB EQ 10MG BASE;EQ 20MG BASE A203874 009 Mar 07, 2014
AB EQ 10MG BASE;EQ 40MG BASE A203874 010 Mar 07, 2014
AB EQ 10MG BASE;EQ 80MG BASE A203874 011 Mar 07, 2014
AB MYLAN PHARMS INC EQ 2.5MG BASE;EQ 10MG BASE A200465 001 Nov 29, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-22(of 371)
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM
TABLET;ORAL
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM
AB EQ 2.5MG BASE;EQ 20MG BASE
A200465 002 Nov 29, 2013
AB EQ 2.5MG BASE;EQ 40MG BASE
A200465 003 Nov 29, 2013
AB EQ 5MG BASE;EQ 10MG BASE
A200465 004 Nov 29, 2013
AB EQ 5MG BASE;EQ 20MG BASE
A200465 005 Nov 29, 2013
AB EQ 5MG BASE;EQ 40MG BASE
A200465 006 Nov 29, 2013
AB EQ 5MG BASE;EQ 80MG BASE
A200465 007 Nov 29, 2013
AB EQ 10MG BASE;EQ 10MG BASE
A200465 008 Nov 29, 2013
AB EQ 10MG BASE;EQ 20MG BASE
A200465 009 Nov 29, 2013
AB EQ 10MG BASE;EQ 40MG BASE
A200465 010 Nov 29, 2013
AB EQ 10MG BASE;EQ 80MG BASE
A200465 011 Nov 29, 2013
CADUET
AB PFIZER EQ 2.5MG BASE;EQ 10MG BASE
N021540 009 Jul 29, 2004
AB EQ 2.5MG BASE;EQ 20MG BASE
N021540 010 Jul 29, 2004
AB EQ 2.5MG BASE;EQ 40MG BASE
N021540 011 Jul 29, 2004
AB EQ 5MG BASE;EQ 10MG BASE
N021540 001 Jan 30, 2004
AB EQ 5MG BASE;EQ 20MG BASE
N021540 002 Jan 30, 2004
AB EQ 5MG BASE;EQ 40MG BASE
N021540 003 Jan 30, 2004
AB EQ 5MG BASE;EQ 80MG BASE
N021540 004 Jan 30, 2004
AB EQ 10MG BASE;EQ 10MG BASE
N021540 005 Jan 30, 2004
AB EQ 10MG BASE;EQ 20MG BASE
N021540 006 Jan 30, 2004
AB EQ 10MG BASE;EQ 40MG BASE
N021540 007 Jan 30, 2004
AB + EQ 10MG BASE;EQ 80MG BASE
N021540 008 Jan 30, 2004
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
CAPSULE;ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
AB APOTEX INC
EQ 2.5MG BASE;10MG
A091431 001 Dec 30, 2013
AB
EQ 5MG BASE;10MG
A091431 002 Dec 30, 2013
AB
EQ 5MG BASE;20MG
A091431 003 Dec 30, 2013
AB
EQ 5MG BASE;40MG
A091431 004 Dec 30, 2013
AB
EQ 10MG BASE;20MG
A091431 005 Dec 30, 2013
AB
EQ 10MG BASE;40MG
A091431 006 Dec 30, 2013
AB AUROBINDO PHARMA LTD
EQ 2.5MG BASE;10MG
A202239 001 Sep 05, 2012
AB
EQ 5MG BASE;10MG
A202239 002 Sep 05, 2012
AB
EQ 5MG BASE;20MG
A202239 003 Sep 05, 2012
AB
EQ 5MG BASE;40MG
A202239 004 Sep 05, 2012
AB
EQ 10MG BASE;20MG
A202239 005 Sep 05, 2012
AB
EQ 10MG BASE;40MG
A202239 006 Sep 05, 2012
AB DR REDDYS LABS INC
EQ 2.5MG BASE;10MG
A077183 001 Apr 15, 2010
AB
EQ 5MG BASE;10MG
A077183 002 Apr 15, 2010
AB
EQ 5MG BASE;20MG
A077183 003 Apr 15, 2010
AB
EQ 5MG BASE;40MG
A090149 001 Jul 05, 2011
AB
EQ 10MG BASE;20MG
A077183 004 Apr 15, 2010
AB
EQ 10MG BASE;40MG
A090149 002 Jul 05, 2011
AB LUPIN PHARMS
EQ 2.5MG BASE;10MG
A078466 001 Feb 05, 2010
AB
EQ 5MG BASE;10MG
A078466 002 Feb 05, 2010
AB
EQ 5MG BASE;20MG
A078466 003 Feb 05, 2010
AB
EQ 5MG BASE;40MG
A078466 005 Jul 05, 2011
AB
EQ 10MG BASE;20MG
A078466 004 Feb 05, 2010
AB
EQ 10MG BASE;40MG
A078466 006 Jul 05, 2011
AB MYLAN
EQ 2.5MG BASE;10MG
A077375 001 May 21, 2010
AB
EQ 5MG BASE;10MG
A077375 002 May 21, 2010
AB
EQ 5MG BASE;20MG
A077375 003 May 21, 2010
AB
EQ 5MG BASE;40MG
A079047 001 Jul 05, 2011
AB
EQ 10MG BASE;20MG
A077375 004 May 21, 2010
AB
EQ 10MG BASE;40MG
A079047 002 Jul 05, 2011
AB PAR PHARM
EQ 2.5MG BASE;10MG
A078381 001 Jul 29, 2010
AB
EQ 5MG BASE;10MG
A078381 002 Jul 29, 2010
AB
EQ 5MG BASE;20MG
A078381 003 Jul 29, 2010
AB
EQ 5MG BASE;40MG
A078381 005 Jul 29, 2010
AB
EQ 10MG BASE;20MG
A078381 004 Jul 29, 2010
AB
EQ 10MG BASE;40MG
A078381 006 Jul 29, 2010
AB TEVA PHARMS
EQ 2.5MG BASE;10MG
A077179 001 May 18, 2007
AB
EQ 5MG BASE;10MG
A077179 002 May 18, 2007
AB
EQ 5MG BASE;20MG
A077179 003 May 18, 2007
AB
EQ 5MG BASE;40MG
A077179 005 Jul 05, 2011
AB
EQ 10MG BASE;20MG
A077179 004 May 18, 2007
AB
EQ 10MG BASE;40MG
A077179 006 Jul 05, 2011
AB WATSON LABS
EQ 2.5MG BASE;10MG
A077890 001 Oct 14, 2010
AB
EQ 5MG BASE;10MG
A077890 002 Oct 14, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-23(of 371)
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE
CAPSULE;ORAL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE
AB EQ 5MG BASE;20MG A077890 003 Oct 14, 2010
AB EQ 10MG BASE;20MG A077890 004 Oct 14, 2010
AB WATSON LABS INC EQ 5MG BASE;40MG A090364 001 Jul 05, 2011
AB EQ 10MG BASE;40MG A090364 002 Jul 05, 2011
LOTREL
AB NOVARTIS EQ 2.5MG BASE;10MG N020364 002 Mar 03, 1995
AB EQ 5MG BASE;10MG N020364 003 Mar 03, 1995
AB EQ 5MG BASE;20MG N020364 004 Mar 03, 1995
AB EQ 5MG BASE;40MG N020364 007 Apr 11, 2006
AB EQ 10MG BASE;20MG N020364 005 Jun 20, 2002
AB + EQ 10MG BASE;40MG N020364 006 Apr 11, 2006
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
TABLET;ORAL
TRIBENZOR
DAIICHI SANKYO EQ 5MG BASE;12.5MG;20MG N200175 001 Jul 23, 2010
EQ 5MG BASE;12.5MG;40MG N200175 002 Jul 23, 2010
EQ 5MG BASE;25MG;40MG N200175 003 Jul 23, 2010
EQ 10MG BASE;12.5MG;40MG N200175 004 Jul 23, 2010
+ EQ 10MG BASE;25MG;40MG N200175 005 Jul 23, 2010
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN
TABLET;ORAL
EXFORGE HCT
AB NOVARTIS 5MG;12.5MG;160MG N022314 001 Apr 30, 2009
AB 5MG;25MG;160MG N022314 002 Apr 30, 2009
AB 10MG;12.5MG;160MG N022314 003 Apr 30, 2009
AB 10MG;25MG;160MG N022314 004 Apr 30, 2009
AB + 10MG;25MG;320MG N022314 005 Apr 30, 2009
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL
TABLET;ORAL
AZOR
DAIICHI SANKYO EQ 5MG BASE;20MG N022100 001 Sep 26, 2007
EQ 5MG BASE;40MG N022100 002 Sep 26, 2007
EQ 10MG BASE;20MG N022100 003 Sep 26, 2007
+ EQ 10MG BASE;40MG N022100 004 Sep 26, 2007
AMLODIPINE BESYLATE; TELMISARTAN
TABLET;ORAL
TELMISARTAN AND AMLODIPINE
AB LUPIN LTD EQ 5MG BASE;40MG A201586 001 Jan 08, 2014
AB EQ 5MG BASE;80MG A201586 003 Jan 08, 2014
AB EQ 10MG BASE;40MG A201586 002 Jan 08, 2014
AB EQ 10MG BASE;80MG A201586 004 Jan 08, 2014
AB MYLAN PHARMS INC EQ 5MG BASE;40MG A202516 001 Aug 26, 2014
AB EQ 5MG BASE;80MG A202516 003 Aug 26, 2014
AB EQ 10MG BASE;40MG A202516 002 Aug 26, 2014
AB EQ 10MG BASE;80MG A202516 004 Aug 26, 2014
AB TORRENT PHARMS LTD EQ 5MG BASE;40MG A202517 001 Jan 08, 2014
AB EQ 5MG BASE;80MG A202517 003 Jan 08, 2014
AB EQ 10MG BASE;40MG A202517 002 Jan 08, 2014
AB EQ 10MG BASE;80MG A202517 004 Jan 08, 2014
TWYNSTA
AB BOEHRINGER INGELHEIM EQ 5MG BASE;40MG N022401 001 Oct 16, 2009
AB EQ 5MG BASE;80MG N022401 003 Oct 16, 2009
AB EQ 10MG BASE;40MG N022401 002 Oct 16, 2009
AB + EQ 10MG BASE;80MG N022401 004 Oct 16, 2009
AMLODIPINE BESYLATE; VALSARTAN
TABLET;ORAL
AMLODIPINE BESYLATE AND VALSARTAN
AB PAR PHARM INC EQ 5MG BASE;160MG A090011 001 Mar 28, 2013
AB EQ 5MG BASE;320MG A090144 001 Mar 28, 2013
AB EQ 10MG BASE;160MG A090011 002 Mar 28, 2013
AB EQ 10MG BASE;320MG A090011 004 Mar 28, 2013
EXFORGE
AB NOVARTIS EQ 5MG BASE;160MG N021990 002 Jun 20, 2007
AB EQ 5MG BASE;320MG N021990 004 Jun 20, 2007
AB + EQ 10MG BASE;160MG N021990 003 Jun 20, 2007
AB + EQ 10MG BASE;320MG N021990 005 Jun 20, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-24(of 371)
AMLODIPINE; HYDROCHLOROTHIAZIDE; VALSARTAN
TABLET;ORAL
AMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDE
AB TEVA PHARMS 5MG;12.5MG;160MG A200435 001 Sep 25, 2012
AB 5MG;25MG;160MG A200435 002 Sep 25, 2012
AB 10MG;12.5MG;160MG A200435 005 Sep 25, 2012
AB 10MG;25MG;160MG A200435 003 Sep 25, 2012
AB 10MG;25MG;320MG A200435 004 Sep 25, 2012
AMMONIA N-13
INJECTABLE;INTRAVENOUS
AMMONIA N 13
AP BRIGHAM WOMENS HOSP 30mCi-300mCi/8ML (3.75-37.5mCi/ML) A203783 001 Oct 30, 2014
AP CARDINAL HEALTH 414 30mCi-300mCi/8ML (3.75-37.5mCi/ML) A203700 001 Feb 25, 2013
AP + FEINSTEIN 30mCi-300mCi/8ML (3.75-37.5mCi/ML) N022119 001 Aug 23, 2007
AP GLOBAL ISOTOPES LLC 30mCi-300mCi/8ML (3.75-37.5mCi/ML) A204465 001 Oct 23, 2014
AP JOHNS HOPKINS UNIV 30mCi-300mCi/8ML (3.75-37.5mCi/ML) A204514 001 Aug 19, 2014
AP KREITCHMAN PET CTR 30mCi-300mCi/8ML (3.75-37.5mCi/ML) A203938 001 Dec 09, 2013
AP MCPRF 30mCi-300mCi/8ML (3.75-37.5mCi/ML) A203321 001 Feb 25, 2013
AP MIPS CRF 30mCi-300mCi/8ML (3.75-37.5mCi/ML) A204535 001 Nov 20, 2014
AP UCLA BIOMEDICAL 30mCi-300mCi/8ML (3.75-37.5mCi/ML) A203812 001 Jun 27, 2013
AP UCSF RODIOPHARM 30mCi-300mCi/8ML (3.75-37.5mCi/ML) A204496 001 Mar 28, 2014
AP UNIV TX MD ANDERSON 30mCi-300mCi/8ML (3.75-37.5mCi/ML) A203933 001 Jun 27, 2014
AP WA UNIV SCH MED 30mCi-300mCi/8ML (3.75-37.5mCi/ML) A204506 001 Feb 07, 2014
HOUSTON CYCLOTRON 3.75-260mCi/ML A203543 001 Dec 14, 2012
SHERTECH LABS LLC 3.75-260mCi/ML A204366 001 Sep 19, 2014
WI MEDCL CYCLOTRON 3.75-260mCi/ML A204356 001 Dec 18, 2014
AMMONIUM CHLORIDE
INJECTABLE;INJECTION
AMMONIUM CHLORIDE IN PLASTIC CONTAINER
+ HOSPIRA 5MEQ/ML A088366 001 Jun 13, 1984
AMMONIUM LACTATE
CREAM;TOPICAL
AMMONIUM LACTATE
AB PERRIGO NEW YORK EQ 12% BASE A075774 001 May 01, 2002
AB TARO EQ 12% BASE A075883 001 Apr 10, 2003
AB WATSON LABS INC EQ 12% BASE A076829 001 Feb 07, 2006
LAC-HYDRIN
AB + RANBAXY EQ 12% BASE N020508 001 Aug 29, 1996
LOTION;TOPICAL
AMMONIUM LACTATE
AB PERRIGO NEW YORK EQ 12% BASE A075570 001 Jun 23, 2004
AB TARO EQ 12% BASE A076216 001 May 28, 2004
AB WATSON LABS INC EQ 12% BASE A075575 001 Jun 11, 2002
LAC-HYDRIN
AB + RANBAXY EQ 12% BASE N019155 001 Apr 24, 1985
AMOXAPINE
TABLET;ORAL
AMOXAPINE
WATSON LABS 25MG A072688 001 Aug 28, 1992
50MG A072689 001 Aug 28, 1992
100MG A072690 001 Aug 28, 1992
+ 150MG A072691 001 Aug 28, 1992
AMOXICILLIN
CAPSULE;ORAL
AMOXICILLIN
AB AM ANTIBIOTICS 250MG A062058 001
AB 500MG A062058 002
AB AUROBINDO 250MG A065271 001 Nov 09, 2005
AB 500MG A065271 002 Nov 09, 2005
AB DAVA PHARMS INC 250MG A062884 001 Feb 25, 1988
AB 500MG A062881 001 Feb 25, 1988
AB HIKMA PHARMS 250MG A065291 001 Feb 05, 2007
AB 500MG A065291 002 Feb 05, 2007
AB RANBAXY 250MG A065016 001 Apr 08, 1999
AB 500MG A065016 002 Apr 08, 1999
AB SANDOZ 250MG A064076 001 Sep 30, 1994
AB 500MG A064076 002 Sep 30, 1994
AB TEVA 250MG A061926 001
AB + 500MG A061926 003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-25(of 371)
AMOXICILLIN
CAPSULE;ORAL
AMOXIL
AB DR REDDYS LABS INC 250MG A062216 001
AB 500MG A062216 004
FOR SUSPENSION;ORAL
AMOXICILLIN
AB AUROBINDO 200MG/5ML A065334 001 Dec 28, 2006
AB 400MG/5ML A065334 002 Dec 28, 2006
AB AUROBINDO PHARMA LTD 125MG/5ML A204030 001 Sep 15, 2014
AB 250MG/5ML A204030 002 Sep 15, 2014
AB DAVA PHARMS INC 125MG/5ML A062927 001 Nov 25, 1988
AB 250MG/5ML A062927 002 Nov 25, 1988
AB HIKMA 125MG/5ML A065322 002 Jun 19, 2006
AB 200MG/5ML A065325 002 Jun 19, 2006
AB 250MG/5ML A065322 001 Jun 19, 2006
AB 400MG/5ML A065325 001 Jun 19, 2006
AB SANDOZ 125MG/5ML A065387 001 Mar 26, 2007
AB 200MG/5ML A065378 001 Mar 26, 2007
AB 250MG/5ML A065387 002 Mar 26, 2007
AB 400MG/5ML A065378 002 Mar 26, 2007
AB TEVA 125MG/5ML A061931 001
AB 200MG/5ML A065119 001 Dec 04, 2002
AB + 250MG/5ML A061931 002
AB + 400MG/5ML A065119 002 Dec 04, 2002
AB WOCKHARDT 400MG/5ML A065319 002 Jun 18, 2007
AMOXICILLIN PEDIATRIC
AB TEVA 50MG/ML A061931 003 Dec 01, 1982
AMOXIL
AB DR REDDYS LABS INC 50MG/ML A062226 005
AB 125MG/5ML A062226 001
AB 200MG/5ML N050760 001 Apr 15, 1999
AB 250MG/5ML A062226 002
AB 400MG/5ML N050760 002 Apr 15, 1999
LAROTID
AB DR REDDYS LABS INC 125MG/5ML A062226 003
AB 250MG/5ML A062226 004
TABLET;ORAL
AMOXICILLIN
AB AUROBINDO 500MG A065256 001 Nov 09, 2005
AB 875MG A065256 002 Nov 09, 2005
AB HIKMA 875MG A065255 001 Mar 29, 2006
AB RANBAXY 500MG A065059 001 Nov 24, 2000
AB 875MG A065059 002 Nov 24, 2000
AB SANDOZ 500MG A065228 001 Jul 13, 2005
AB 875MG A065228 002 Jul 13, 2005
AB TEVA 500MG A065056 001 Sep 18, 2000
AB + 875MG A065056 002 Sep 18, 2000
AMOXIL
AB DR REDDYS LABS INC 500MG N050754 002 Jul 10, 1998
AB 875MG N050754 001 Jul 10, 1998
TABLET, CHEWABLE;ORAL
AMOXICILLIN
AB RANBAXY 125MG A065021 001 Dec 23, 1999
AB 250MG A065021 002 Dec 23, 1999
AB TEVA 125MG A064013 002 Sep 11, 1995
AB + 250MG A064013 001 Dec 22, 1992
AMOXIL
AB DR REDDYS LABS INC 125MG N050542 002
AB 250MG N050542 001
TABLET, EXTENDED RELEASE;ORAL
MOXATAG
+ PRAGMA PHARMS LLC 775MG N050813 001 Jan 23, 2008
AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN
AB SANDOZ 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30M A202588 001 Mar 04, 2014
G
AB TEVA PHARMS USA 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,30M A200218 001 Aug 30, 2013
G
PREVPAC
AB + TAKEDA PHARMS USA 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A, N050757 001 Dec 02, 1997
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-26(of 371)
AMOXICILLIN; CLARITHROMYCIN; LANSOPRAZOLE
CAPSULE, CAPSULE, DELAYED REL PELLETS, TABLET;ORAL
PREVPAC
30MG
AMOXICILLIN; CLARITHROMYCIN; OMEPRAZOLE
CAPSULE, TABLET, CAPSULE, DELAYED RELEASE;ORAL
OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN
+ GASTROENTERO 500MG,N/A,N/A;N/A,500MG,N/A;N/A,N/A,20M N050824 001 Feb 08, 2011
G
AMOXICILLIN; CLAVULANATE POTASSIUM
FOR SUSPENSION;ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
AB HIKMA PHARMS 200MG/5ML;EQ 28.5MG BASE/5ML A065191 002 Jan 25, 2005
AB 400MG/5ML;EQ 57MG BASE/5ML A065191 001 Jan 25, 2005
AB 600MG/5ML;EQ 42.9MG BASE/5ML A065373 001 Nov 09, 2007
AB RANBAXY 200MG/5ML;EQ 28.5MG BASE/5ML A065132 001 Mar 19, 2003
AB 400MG/5ML;EQ 57MG BASE/5ML A065132 002 Mar 19, 2003
AB 600MG/5ML;EQ 42.9MG BASE/5ML A065207 002 Jan 30, 2007
AB SANDOZ 200MG/5ML;EQ 28.5MG BASE/5ML A065066 001 Jun 05, 2002
AB 400MG/5ML;EQ 57MG BASE/5ML A065066 002 Jun 05, 2002
AB SANDOZ INC 200MG/5ML;EQ 28.5MG BASE/5ML A065098 001 Dec 16, 2002
AB 400MG/5ML;EQ 57MG BASE/5ML A065098 002 Dec 16, 2002
AB 600MG/5ML;EQ 42.9MG BASE/5ML A065358 001 Aug 13, 2007
AB TEVA 200MG/5ML;EQ 28.5MG BASE/5ML A065089 001 May 25, 2004
AB + 400MG/5ML;EQ 57MG BASE/5ML A065089 002 May 25, 2004
AB + 600MG/5ML;EQ 42.9MG BASE/5ML A065162 001 Mar 12, 2004
AB WOCKHARDT 250MG/5ML;EQ 62.5MG BASE/5ML A065431 001 Nov 25, 2008
AB WOCKHARDT EU OPERATN 600MG/5ML;EQ 42.9MG BASE/5ML A065420 001 Dec 02, 2013
AUGMENTIN '125'
AB DR REDDYS LABS INC 125MG/5ML;EQ 31.25MG BASE/5ML N050575 001 Aug 06, 1984
AUGMENTIN '200'
AB DR REDDYS LABS INC 200MG/5ML;EQ 28.5MG BASE/5ML N050725 001 May 31, 1996
AUGMENTIN '250'
AB + DR REDDYS LABS INC 250MG/5ML;EQ 62.5MG BASE/5ML N050575 002 Aug 06, 1984
AUGMENTIN '400'
AB DR REDDYS LABS INC 400MG/5ML;EQ 57MG BASE/5ML N050725 002 May 31, 1996
AUGMENTIN ES-600
AB DR REDDYS LABS INC 600MG/5ML;EQ 42.9MG BASE/5ML N050755 001 Jun 22, 2001
SUSPENSION;ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
AB AUROBINDO PHARMA LTD 200MG/5ML;EQ 28.5MG BASE/5ML A201090 001 Dec 20, 2011
AB 400MG/5ML;EQ 57MG BASE/5ML A201090 002 Dec 20, 2011
AB 600MG/5ML;EQ 42.9MG BASE/5ML A201091 001 Dec 20, 2011
TABLET;ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
AB AUROBINDO PHARMA LTD 250MG;EQ 125MG BASE A091569 001 Jan 20, 2012
AB 500MG;EQ 125MG BASE A091569 002 Jan 20, 2012
AB 875MG;EQ 125MG BASE A091568 001 Jan 20, 2012
AB RANBAXY 875MG;EQ 125MG BASE A065102 001 Sep 17, 2002
AB SANDOZ 250MG;EQ 125MG BASE A065189 001 Aug 23, 2005
AB 500MG;EQ 125MG BASE A065064 001 Mar 15, 2002
AB 875MG;EQ 125MG BASE A065063 001 Mar 14, 2002
AB SANDOZ INC 500MG;EQ 125MG BASE A065117 001 Nov 27, 2002
AB 875MG;EQ 125MG BASE A065093 001 Nov 21, 2002
AB TEVA 500MG;EQ 125MG BASE A065101 001 Oct 30, 2002
AB TEVA PHARMS USA 875MG;EQ 125MG BASE A065096 001 Oct 29, 2002
AUGMENTIN '250'
AB + DR REDDYS LABS INC 250MG;EQ 125MG BASE N050564 001 Aug 06, 1984
AUGMENTIN '500'
AB + DR REDDYS LABS INC 500MG;EQ 125MG BASE N050564 002 Aug 06, 1984
AUGMENTIN '875'
AB + DR REDDYS LABS INC 875MG;EQ 125MG BASE N050720 001 Feb 13, 1996
TABLET, CHEWABLE;ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
AB RANBAXY 200MG;EQ 28.5MG BASE A065161 001 Dec 03, 2003
AB 400MG;EQ 57MG BASE A065161 002 Dec 03, 2003
AB SANDOZ 200MG;EQ 28.5MG BASE A065065 001 Apr 18, 2002
AB 400MG;EQ 57MG BASE A065065 002 Apr 18, 2002
AB TEVA 200MG;EQ 28.5MG BASE A065205 001 Feb 09, 2005
AB + 400MG;EQ 57MG BASE A065205 002 Feb 09, 2005
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-27(of 371)
AMOXICILLIN; CLAVULANATE POTASSIUM
TABLET, CHEWABLE;ORAL
AUGMENTIN '125'
AB DR REDDYS LABS INC 125MG;EQ 31.25MG BASE N050597 001 Jul 22, 1985
AUGMENTIN '200'
AB DR REDDYS LABS INC 200MG;EQ 28.5MG BASE N050726 001 May 31, 1996
AUGMENTIN '250'
AB DR REDDYS LABS INC 250MG;EQ 62.5MG BASE N050597 002 Jul 22, 1985
AUGMENTIN '400'
AB DR REDDYS LABS INC 400MG;EQ 57MG BASE N050726 002 May 31, 1996
TABLET, EXTENDED RELEASE;ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
AB SANDOZ 1GM;EQ 62.5MG BASE A090227 001 Apr 21, 2010
AUGMENTIN XR
AB + DR REDDYS LABS INC 1GM;EQ 62.5MG BASE N050785 001 Sep 25, 2002
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE
SULFATE
CAPSULE, EXTENDED RELEASE;ORAL
ADDERALL XR 10
AB SHIRE 2.5MG;2.5MG;2.5MG;2.5MG N021303 001 Oct 11, 2001
ADDERALL XR 15
AB SHIRE 3.75MG;3.75MG;3.75MG;3.75MG N021303 006 May 22, 2002
ADDERALL XR 20
AB SHIRE 5MG;5MG;5MG;5MG N021303 002 Oct 11, 2001
ADDERALL XR 25
AB SHIRE 6.25MG;6.25MG;6.25MG;6.25MG N021303 004 May 22, 2002
ADDERALL XR 30
AB + SHIRE 7.5MG;7.5MG;7.5MG;7.5MG N021303 003 Oct 11, 2001
ADDERALL XR 5
AB SHIRE 1.25MG;1.25MG;1.25MG;1.25MG N021303 005 May 22, 2002
AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF
AB TEVA 1.25MG;1.25MG;1.25MG;1.25MG A077488 001 Apr 29, 2013
AB 2.5MG;2.5MG;2.5MG;2.5MG A077488 002 Apr 29, 2013
AB 3.75MG;3.75MG;3.75MG;3.75MG A077488 003 Apr 29, 2013
AB 5MG;5MG;5MG;5MG A077488 004 Apr 29, 2013
AB 6.25MG;6.25MG;6.25MG;6.25MG A077488 005 Apr 29, 2013
AB 7.5MG;7.5MG;7.5MG;7.5MG A077488 006 Apr 29, 2013
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
AB ACTAVIS ELIZABETH 1.25MG;1.25MG;1.25MG;1.25MG A077302 001 Jun 22, 2012
AB 2.5MG;2.5MG;2.5MG;2.5MG A077302 002 Jun 22, 2012
AB 3.75MG;3.75MG;3.75MG;3.75MG A077302 003 Jun 22, 2012
AB 5MG;5MG;5MG;5MG A077302 004 Jun 22, 2012
AB 6.25MG;6.25MG;6.25MG;6.25MG A077302 005 Jun 22, 2012
AB 7.5MG;7.5MG;7.5MG;7.5MG A077302 006 Jun 22, 2012
DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE
AB BARR LABS INC 1.25MG;1.25MG;1.25MG;1.25MG A076536 001 Feb 12, 2013
AB 2.5MG;2.5MG;2.5MG;2.5MG A076536 002 Feb 12, 2013
AB 3.75MG;3.75MG;3.75MG;3.75MG A076536 003 Feb 12, 2013
AB 5MG;5MG;5MG;5MG A076536 004 Feb 12, 2013
AB 6.25MG;6.25MG;6.25MG;6.25MG A076536 005 Feb 12, 2013
AB 7.5MG;7.5MG;7.5MG;7.5MG A076536 006 Feb 12, 2013
TABLET;ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
AB ACTAVIS ELIZABETH 1.25MG;1.25MG;1.25MG;1.25MG A040456 001 May 06, 2003
AB 2.5MG;2.5MG;2.5MG;2.5MG A040456 002 May 06, 2003
AB 5MG;5MG;5MG;5MG A040456 003 May 06, 2003
AB 7.5MG;7.5MG;7.5MG;7.5MG A040456 004 May 06, 2003
AB AUROLIFE PHARMA LLC 1.25MG;1.25MG;1.25MG;1.25MG A202424 001 Nov 27, 2013
AB 1.875MG;1.875MG;1.875MG;1.875MG A202424 002 Nov 27, 2013
AB 2.5MG;2.5MG;2.5MG;2.5MG A202424 003 Nov 27, 2013
AB 3.125MG;3.125MG;3.125MG;3.125MG A202424 004 Nov 27, 2013
AB 3.75MG;3.75MG;3.75MG;3.75MG A202424 005 Nov 27, 2013
AB 5MG;5MG;5MG;5MG A202424 006 Nov 27, 2013
AB 7.5MG;7.5MG;7.5MG;7.5MG A202424 007 Nov 27, 2013
AB BARR 1.25MG;1.25MG;1.25MG;1.25MG A040422 001 Feb 11, 2002
AB 1.875MG;1.875MG;1.875MG;1.875MG A040422 005 Mar 19, 2003
AB 2.5MG;2.5MG;2.5MG;2.5MG A040422 002 Feb 11, 2002
AB 3.125MG;3.125MG;3.125MG;3.125MG A040422 006 Mar 19, 2003
AB 3.75MG;3.75MG;3.75MG;3.75MG A040422 007 Mar 19, 2003
AB 5MG;5MG;5MG;5MG A040422 003 Feb 11, 2002
AB + 7.5MG;7.5MG;7.5MG;7.5MG A040422 004 Feb 11, 2002
AB COREPHARMA 1.25MG;1.25MG;1.25MG;1.25MG A040444 001 Jun 19, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-28(of 371)
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE
SULFATE
TABLET;ORAL
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
AB 2.5MG;2.5MG;2.5MG;2.5MG A040444 002 Jun 19, 2002
AB 5MG;5MG;5MG;5MG A040444 003 Jun 19, 2002
AB 7.5MG;7.5MG;7.5MG;7.5MG A040444 004 Jun 19, 2002
AB MALLINCKRODT INC 1.25MG;1.25MG;1.25MG;1.25MG A040440 001 Oct 07, 2003
AB 1.875MG;1.875MG;1.875MG;1.875MG A040440 002 Oct 07, 2003
AB 2.5MG;2.5MG;2.5MG;2.5MG A040440 003 Oct 07, 2003
AB 3.125MG;3.125MG;3.125MG;3.125MG A040440 004 Oct 07, 2003
AB 3.75MG;3.75MG;3.75MG;3.75MG A040440 005 Oct 07, 2003
AB 5MG;5MG;5MG;5MG A040440 006 Oct 07, 2003
AB 7.5MG;7.5MG;7.5MG;7.5MG A040440 007 Oct 07, 2003
AB MUTUAL PHARM 1.25MG;1.25MG;1.25MG;1.25MG A040480 001 Sep 09, 2003
AB 1.875MG;1.875MG;1.875MG;1.875MG A040480 002 Sep 09, 2003
AB 2.5MG;2.5MG;2.5MG;2.5MG A040480 003 Sep 09, 2003
AB 3.125MG;3.125MG;3.125MG;3.125MG A040480 004 Sep 09, 2003
AB 3.75MG;3.75MG;3.75MG;3.75MG A040480 005 Sep 09, 2003
AB 5MG;5MG;5MG;5MG A040480 006 Sep 09, 2003
AB 7.5MG;7.5MG;7.5MG;7.5MG A040480 007 Sep 09, 2003
AB SANDOZ 1.25MG;1.25MG;1.25MG;1.25MG A040439 004 Sep 27, 2002
AB 2.5MG;2.5MG;2.5MG;2.5MG A040439 001 Jun 14, 2002
AB 5MG;5MG;5MG;5MG A040439 002 Jun 14, 2002
AB 7.5MG;7.5MG;7.5MG;7.5MG A040439 003 Jun 14, 2002
AMPHETAMINE SULFATE
TABLET;ORAL
AMPHETAMINE SULFATE
ARBOR PHARMS LLC 5MG A200166 001 Aug 09, 2012
+ 10MG A200166 002 Aug 09, 2012
AMPHOTERICIN B
INJECTABLE;INJECTION
AMPHOTERICIN B
+ X GEN PHARMS 50MG/VIAL A063206 001 Apr 29, 1992
INJECTABLE, LIPID COMPLEX;INJECTION
ABELCET
+ SIGMA TAU 5MG/ML N050724 001 Nov 20, 1995
AMPHOTEC
+ ALKOPHARMA USA 50MG/VIAL N050729 001 Nov 22, 1996
+ 100MG/VIAL N050729 002 Nov 22, 1996
INJECTABLE, LIPOSOMAL;INJECTION
AMBISOME
+ ASTELLAS 50MG/VIAL N050740 001 Aug 11, 1997
AMPICILLIN SODIUM
INJECTABLE;INJECTION
AMPICILLIN SODIUM
AP ACS DOBFAR SPA EQ 1GM BASE/VIAL A090884 002 Apr 03, 2013
AP EQ 2GM BASE/VIAL A090884 003 Apr 03, 2013
AP EQ 10GM BASE/VIAL A090889 001 Apr 03, 2013
AP EQ 500MG BASE/VIAL A090884 001 Apr 03, 2013
AP AGILA SPECLTS EQ 10GM BASE/VIAL A202198 001 Apr 07, 2014
AP ANTIBIOTICE EQ 1GM BASE/VIAL A090354 003 Dec 28, 2009
AP EQ 2GM BASE/VIAL A090354 004 Dec 28, 2009
AP EQ 250MG BASE/VIAL A090354 001 Dec 28, 2009
AP EQ 500MG BASE/VIAL A090354 002 Dec 28, 2009
AP AUROBINDO PHARMA EQ 1GM BASE/VIAL A065499 004 Aug 17, 2010
AP EQ 2GM BASE/VIAL A065499 005 Aug 17, 2010
AP EQ 10GM BASE/VIAL A065493 001 Aug 17, 2010
AP EQ 125MG BASE/VIAL A065499 001 Aug 17, 2010
AP EQ 250MG BASE/VIAL A065499 002 Aug 17, 2010
AP EQ 500MG BASE/VIAL A065499 003 Aug 17, 2010
AP HANFORD GC EQ 1GM BASE/VIAL A062772 001 Apr 15, 1993
AP EQ 2GM BASE/VIAL A063140 001 Apr 15, 1993
AP EQ 10GM BASE/VIAL A063142 001 Apr 15, 1993
AP EQ 250MG BASE/VIAL A063145 001 Apr 15, 1993
AP EQ 500MG BASE/VIAL A063146 001 Apr 15, 1993
AP ISTITUTO BIO ITA SPA EQ 1GM BASE/VIAL A062719 002 May 12, 1987
AP EQ 2GM BASE/VIAL A062797 002 Jul 12, 1993
AP EQ 10GM BASE/VIAL A201404 001 Dec 20, 2013
AP EQ 125MG BASE/VIAL A062797 001 Jul 12, 1993
AP EQ 250MG BASE/VIAL A062719 001 May 12, 1987
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-29(of 371)
AMPICILLIN SODIUM
INJECTABLE;INJECTION
AMPICILLIN SODIUM
AP EQ 500MG BASE/VIAL A062719 003 May 12, 1987
AP + SANDOZ EQ 1GM BASE/VIAL A061395 004
AP + EQ 2GM BASE/VIAL A061395 005
AP + EQ 10GM BASE/VIAL A061395 006
AP + EQ 125MG BASE/VIAL A061395 001
AP + EQ 250MG BASE/VIAL A061395 002
AP + EQ 500MG BASE/VIAL A061395 003
AP STRIDES ARCOLAB LTD EQ 1GM BASE/VIAL A201025 003 Apr 09, 2014
AP EQ 2GM BASE/VIAL A201025 004 Apr 09, 2014
AP EQ 250MG BASE/VIAL A201025 001 Apr 09, 2014
AP EQ 500MG BASE/VIAL A201025 002 Apr 09, 2014
POWDER;INTRAVENOUS
AMPICILLIN SODIUM
AP + SANDOZ EQ 1GM BASE/VIAL A062738 001 Feb 19, 1987
AP + EQ 2GM BASE/VIAL A062738 002 Feb 19, 1987
AMPICILLIN SODIUM; SULBACTAM SODIUM
INJECTABLE;INJECTION
AMPICILLIN AND SULBACTAM
AP ACS DOBFAR EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065406 001 Dec 22, 2009
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065406 002 Dec 22, 2009
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A065403 001 Dec 23, 2009
AP AGILA SPECLTS EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A201024 001 Apr 07, 2014
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A201024 002 Apr 07, 2014
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A202197 001 Apr 07, 2014
AP AUROBINDO PHARMA EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A090340 001 Sep 20, 2010
AP EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A090349 001 Sep 20, 2010
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A090340 002 Sep 20, 2010
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A090349 002 Sep 20, 2010
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A090339 001 Sep 20, 2010
AP HANFORD GC EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065176 001 Nov 30, 2005
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065176 002 Nov 30, 2005
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A065188 001 Nov 25, 2005
AP HIKMA MAPLE EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065074 001 Mar 19, 2002
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065074 002 Mar 19, 2002
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A065076 001 Mar 19, 2002
AP HOSPIRA INC EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A090375 001 Dec 21, 2011
AP EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A090653 001 Dec 21, 2011
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A090375 002 Dec 21, 2011
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A090653 002 Dec 21, 2011
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A090646 001 Dec 21, 2011
AP ISTITUTO BIO ITA SPA EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065222 001 Nov 29, 2005
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065222 002 Nov 29, 2005
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A065314 001 Nov 27, 2006
AP MUSTAFA NEVZAT ILAC EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065316 001 Jun 29, 2007
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065316 002 Jun 29, 2007
AP SANDOZ EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065241 001 Jul 25, 2006
AP EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A065310 001 Jul 25, 2006
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065241 002 Jul 25, 2006
AP EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A065310 002 Jul 25, 2006
AP EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL A065240 001 Jul 25, 2006
UNASYN
AP + PFIZER EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL A062901 002 Feb 27, 1992
AP + EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL A062901 001 Nov 23, 1988
AP + EQ 1GM BASE/VIAL;EQ 500MG BASE/VIAL N050608 002 Dec 31, 1986
AP + EQ 2GM BASE/VIAL;EQ 1GM BASE/VIAL N050608 001 Dec 31, 1986
AP + EQ 10GM BASE/VIAL;EQ 5GM BASE/VIAL N050608 005 Dec 10, 1993
AMPICILLIN/AMPICILLIN TRIHYDRATE
CAPSULE;ORAL
AMPICILLIN TRIHYDRATE
AB DAVA PHARMS INC EQ 250MG BASE A062883 001 Feb 25, 1988
AB + EQ 500MG BASE A062882 001 Feb 25, 1988
AB SANDOZ EQ 250MG BASE A064082 001 Aug 29, 1995
AB EQ 500MG BASE A064082 002 Aug 29, 1995
FOR SUSPENSION;ORAL
AMPICILLIN TRIHYDRATE
DAVA PHARMS INC EQ 125MG BASE/5ML A062982 001 Feb 10, 1989
+ EQ 250MG BASE/5ML A062982 002 Feb 10, 1989
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-30(of 371)
ANAGRELIDE HYDROCHLORIDE
CAPSULE;ORAL
AGRYLIN
AB SHIRE LLC EQ 0.5MG BASE N020333 001 Mar 14, 1997
ANAGRELIDE HYDROCHLORIDE
AB BARR EQ 0.5MG BASE A076530 001 Apr 18, 2005
AB EQ 1MG BASE A076530 002 Apr 18, 2005
AB IMPAX LABS EQ 0.5MG BASE A076910 001 Apr 18, 2005
AB EQ 1MG BASE A076910 002 Apr 18, 2005
AB IVAX SUB TEVA PHARMS EQ 0.5MG BASE A076468 001 Apr 18, 2005
AB + EQ 1MG BASE A076468 002 Apr 18, 2005
AB MYLAN EQ 0.5MG BASE A076811 001 Apr 18, 2005
AB EQ 1MG BASE A076811 002 Apr 18, 2005
AB MYLAN PHARMS INC EQ 0.5MG BASE A077613 001 Jun 27, 2006
AB EQ 1MG BASE A077613 002 Jun 27, 2006
ANASTROZOLE
TABLET;ORAL
ANASTROZOLE
AB ACCORD HLTHCARE 1MG A090568 001 Jun 28, 2010
AB APOTEX INC 1MG A200654 001 May 11, 2012
AB CIPLA LTD 1MG A091164 001 Jun 28, 2010
AB DR REDDYS LABS LTD 1MG A090732 001 Jun 28, 2010
AB FRESENIUS KABI ONCOL 1MG A090088 001 Jun 28, 2010
AB MYLAN 1MG A091051 001 Jun 28, 2010
AB NATCO PHARMA LTD 1MG A079220 001 Jun 28, 2010
AB ROXANE 1MG A078485 001 Jun 28, 2010
AB SANDOZ 1MG A079007 001 Jun 28, 2010
AB SANTOS BIOTECH 1MG A078944 001 Jun 28, 2010
AB SUN PHARM INDS LTD 1MG A091177 001 Jul 15, 2011
AB TEVA PHARMS 1MG A078058 001 Jun 28, 2010
AB ZYDUS PHARMS USA INC 1MG A078921 001 Jun 28, 2010
ARIMIDEX
AB + ASTRAZENECA 1MG N020541 001 Dec 27, 1995
ANIDULAFUNGIN
INJECTABLE;IV (INFUSION)
ERAXIS
+ VICURON 50MG/VIAL N021632 001 Feb 17, 2006
+ 100MG/VIAL N021632 002 Nov 14, 2006
APIXABAN
TABLET;ORAL
ELIQUIS
BRISTOL MYERS SQUIBB 2.5MG N202155 001 Dec 28, 2012
+ 5MG N202155 002 Dec 28, 2012
APOMORPHINE HYDROCHLORIDE
INJECTABLE;SUBCUTANEOUS
APOKYN
+ US WORLDMEDS 30MG/3ML (10MG/ML) N021264 002 Apr 20, 2004
APRACLONIDINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
APRACLONIDINE HYDROCHLORIDE
AT AKORN INC EQ 0.5% BASE A077764 001 Mar 12, 2009
IOPIDINE
AT + ALCON EQ 0.5% BASE N020258 001 Jul 30, 1993
+ EQ 1% BASE N019779 001 Dec 31, 1987
APREMILAST
TABLET;ORAL
OTEZLA
CELGENE CORP 10MG N205437 001 Mar 21, 2014
20MG N205437 002 Mar 21, 2014
+ 30MG N205437 003 Mar 21, 2014
APREPITANT
CAPSULE;ORAL
APREPITANT
AB SANDOZ 40MG A090999 001 Sep 24, 2012
AB 80MG A090999 002 Sep 24, 2012
AB 125MG A090999 003 Sep 24, 2012
EMEND
AB MERCK 40MG N021549 003 Jun 30, 2006
AB 80MG N021549 001 Mar 26, 2003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-31(of 371)
APREPITANT
CAPSULE;ORAL
EMEND
AB + 125MG N021549 002 Mar 26, 2003
ARFORMOTEROL TARTRATE
SOLUTION;INHALATION
BROVANA
+ SUNOVION EQ 0.015MG BASE/2ML N021912 001 Oct 06, 2006
ARGATROBAN
INJECTABLE;INJECTION
ACOVA
AP + PFIZER 250MG/2.5ML (100MG/ML) N020883 001 Jun 30, 2000
ARGATROBAN
AP HIKMA PHARM CO LTD 250MG/2.5ML (100MG/ML) N203049 001 Jan 05, 2012
AP MYLAN INSTITUTIONAL 250MG/2.5ML (100MG/ML) A202626 001 Jun 30, 2014
AP PAR STERILE PRODUCTS 250MG/2.5ML (100MG/ML) A091665 001 Jun 30, 2014
INJECTABLE;IV (INFUSION)
ARGATROBAN IN 0.9% SODIUM CHLORIDE
TEVA PHARMS USA 250MG/250ML (1MG/ML) N206769 001 Dec 15, 2014
ARGATROBAN IN SODIUM CHLORIDE
+ EAGLE PHARMS 50MG/50ML (1MG/ML) N022434 001 Jun 29, 2011
+ SANDOZ 125MG/125ML (1MG/ML) N022485 001 May 09, 2011
ARGININE HYDROCHLORIDE
INJECTABLE;INJECTION
R-GENE 10
+ PHARMACIA AND UPJOHN 10GM/100ML N016931 001
ARIPIPRAZOLE
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
ABILIFY MAINTENA KIT
OTSUKA PHARM CO LTD 300MG/VIAL N202971 001 Feb 28, 2013
300MG N202971 003 Sep 29, 2014
+ 400MG/VIAL N202971 002 Feb 28, 2013
400MG N202971 004 Sep 29, 2014
INJECTABLE;INTRAMUSCULAR
ABILIFY
+ OTSUKA 9.75MG/1.3ML (7.5MG/ML) N021866 001 Sep 20, 2006
SOLUTION;ORAL
ABILIFY
+ OTSUKA 1MG/ML N021713 001 Dec 10, 2004
TABLET;ORAL
ABILIFY
OTSUKA 2MG N021436 006 Nov 15, 2002
+ 5MG N021436 005 Nov 15, 2002
+ 10MG N021436 001 Nov 15, 2002
15MG N021436 002 Nov 15, 2002
20MG N021436 003 Nov 15, 2002
30MG N021436 004 Nov 15, 2002
TABLET, ORALLY DISINTEGRATING;ORAL
ABILIFY
+ OTSUKA 10MG N021729 002 Jun 07, 2006
15MG N021729 003 Jun 07, 2006
ARMODAFINIL
TABLET;ORAL
NUVIGIL
CEPHALON 50MG N021875 001 Jun 15, 2007
150MG N021875 003 Jun 15, 2007
200MG N021875 005 Mar 26, 2009
+ 250MG N021875 004 Jun 15, 2007
ARSENIC TRIOXIDE
INJECTABLE;INJECTION
TRISENOX
+ CEPHALON 1MG/ML N021248 001 Sep 25, 2000
ARTEMETHER; LUMEFANTRINE
TABLET;ORAL
COARTEM
+ NOVARTIS 20MG;120MG N022268 001 Apr 07, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-32(of 371)
ARTICAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
INJECTABLE;INJECTION
ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
AP HOSPIRA 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG A079138 001 Jun 18, 2010
BASE/ML)
SEPTOCAINE
AP + DEPROCO 4%;EQ 0.017MG BASE/1.7ML (4%;EQ 0.01MG N020971 001 Apr 03, 2000
BASE/ML)
ORABLOC
PIERREL 4%;EQ 0.009MG BASE/1.8ML (EQ 0.005MG N022466 001 Feb 26, 2010
BASE/ML)
+ 4%;EQ 0.018MG BASE/1.8ML (EQ 0.01MG N022466 002 Feb 26, 2010
BASE/ML)
SEPTOCAINE
+ DEPROCO 4%;EQ 0.0085MG BASE/1.7ML (4%;EQ N022010 001 Mar 30, 2006
0.005MG BASE/ML)
ASCORBIC ACID; BIOTIN; CHOLECALCIFEROL; CYANOCOBALAMIN; DEXPANTHENOL; FOLIC ACID; NIACINAMIDE;
PYRIDOXINE; RIBOFLAVIN; THIAMINE; TOCOPHEROL ACETATE; VITAMIN A; VITAMIN K
INJECTABLE;IV (INFUSION)
INFUVITE PEDIATRIC
+ SANDOZ 80MG/VIAL;0.02MG/VIAL;400 N021265 001 Feb 21, 2001
IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VI
AL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/
VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE)
+ SANDOZ 80MG/VIAL;0.02MG/VIAL;400 N021646 001 Jan 29, 2004
IU/VIAL;0.001MG/VIAL;5MG/VIAL;0.14MG/VI
AL;17MG/VIAL;1MG/VIAL;1.4MG/VIAL;1.2MG/
VIAL;7 IU/VIAL;2,300 IU/VIAL;0.2MG/VIAL
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;
PHYTONADIONE; PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE;
VITAMIN A; VITAMIN E
FOR SOLUTION;IV (INFUSION)
M.V.I. PEDIATRIC
+ HOSPIRA 80MG/VIAL;0.02MG/VIAL;0.001MG/VIAL;5MG/ N018920 001 Sep 21, 2000
VIAL;0.01MG/VIAL;0.14MG/VIAL;17MG/VIAL;
0.2MG/VIAL;1MG/VIAL;1.4MG/VIAL;EQ 1.2MG
BASE/VIAL;0.7MG/VIAL;7MG/VIAL
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;
PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A;
VITAMIN E
INJECTABLE;INJECTION
M.V.I.-12 (WITHOUT VITAMIN K)
+ HOSPIRA 20MG/ML;0.006MG/ML;0.05MCG/ML;1.5MG/ML; N008809 006 Sep 09, 2004
0.0005MG/ML;0.06MG/ML;4MG/ML;0.6MG/ML;0
.36MG/ML;0.6MG/ML;0.1MG/ML;1MG/ML
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;
PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A;
VITAMIN E; VITAMIN K
INJECTABLE;IV (INFUSION)
M.V.I. ADULT
+ HOSPIRA 200MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15M N021625 001 Jan 30, 2004
G/VIAL;0.005MG/VIAL;0.6MG/VIAL;40MG/VIA
L;6MG/VIAL;3.6MG/VIAL;6MG/VIAL;1MG/VIAL
;10MG/VIAL;0.15MG/VIAL
M.V.I. ADULT (PHARMACY BULK PACKAGE)
+ HOSPIRA 200MG/5ML;0.06MG/5ML;0.005MG/5ML;15MG/5 N021643 001 Feb 18, 2004
ML;0.005MG/5ML;0.6MG/5ML;40MG/5ML;6MG/5
ML;3.6MG/5ML;6MG/5ML;1MG/5ML;10MG/5ML;0
.15MG/5ML
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE;
SODIUM SULFATE
FOR SOLUTION;ORAL
MOVIPREP
+ SALIX PHARMS 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM N021881 001 Aug 02, 2006
ASENAPINE MALEATE
TABLET;SUBLINGUAL
SAPHRIS
FOREST LABS INC EQ 5MG BASE N022117 001 Aug 13, 2009
+ EQ 10MG BASE N022117 002 Aug 13, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-33(of 371)
ASPIRIN; BUTALBITAL; CAFFEINE
CAPSULE;ORAL
FIORINAL
AA + WATSON LABS INC 325MG;50MG;40MG N017534 005 Apr 16, 1986
LANORINAL
AA LANNETT 325MG;50MG;40MG A086996 002 Oct 11, 1985
TABLET;ORAL
BUTALBITAL, ASPIRIN AND CAFFEINE
AA + HIKMA INTL PHARMS 325MG;50MG;40MG
A086162 002 Feb 16, 1984
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
CAPSULE;ORAL
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
AB NEXGEN PHARMA INC 325MG;50MG;40MG;30MG
A075231 001 Nov 30, 2001
AB STEVENS J 325MG;50MG;40MG;30MG
A074951 001 Aug 31, 1998
FIORINAL W/CODEINE
AB + WATSON LABS INC 325MG;50MG;40MG;30MG
N019429 003 Oct 26, 1990
ASPIRIN; CAFFEINE; DIHYDROCODEINE BITARTRATE
CAPSULE;ORAL
SYNALGOS-DC
+ CARACO 356.4MG;30MG;16MG
N011483 004 Sep 06, 1983
ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE
TABLET;ORAL
NORGESIC
AB MEDICIS 385MG;30MG;25MG
N013416 003 Oct 27, 1982
NORGESIC FORTE
AB + MEDICIS 770MG;60MG;50MG
N013416 004 Oct 27, 1982
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE
AB SANDOZ
385MG;30MG;25MG
A074654 001 Dec 31, 1996
AB
770MG;60MG;50MG
A074654 002 Dec 31, 1996
ASPIRIN; CARISOPRODOL
TABLET;ORAL
CARISOPRODOL AND ASPIRIN
AB HERITAGE PHARMS INC 325MG;200MG
A089594 001 Mar 31, 1989
AB MIRROR PHARMS 325MG;200MG
A040832 001 Jan 07, 2010
AB PROSAM LABS 325MG;200MG
A040252 001 Dec 10, 1997
AB SANDOZ 325MG;200MG
A040116 001 Apr 25, 1996
SOMA COMPOUND
AB + MEDA PHARMS 325MG;200MG
N012365 005 Jul 11, 1983
ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE
TABLET;ORAL
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
AB SANDOZ 325MG;200MG;16MG
A040118 001 Apr 16, 1996
SOMA COMPOUND W/ CODEINE
AB + MEDA PHARMS 325MG;200MG;16MG
N012366 002 Jul 11, 1983
ASPIRIN; DIPYRIDAMOLE
CAPSULE, EXTENDED RELEASE;ORAL
AGGRENOX
AB + BOEHRINGER INGELHEIM 25MG;200MG
N020884 001 Nov 22, 1999
ASPIRIN AND DIPYRIDAMOLE
AB BARR 25MG;200MG
A078804 001 Aug 14, 2009
ASPIRIN; METHOCARBAMOL
TABLET;ORAL
METHOCARBAMOL AND ASPIRIN
+ STEVENS J 325MG;400MG
A081145 001 Jan 31, 1995
ASPIRIN; OXYCODONE HYDROCHLORIDE
TABLET;ORAL
OXYCODONE AND ASPIRIN
AA COASTAL PHARMS 325MG;4.8355MG
A091670 001 Mar 16, 2011
AA WATSON LABS 325MG;4.8355MG
A090084 001 Mar 22, 2011
PERCODAN
AA + ENDO PHARMS 325MG;4.8355MG
N007337 007 Aug 05, 2005
ATAZANAVIR SULFATE
CAPSULE;ORAL
ATAZANAVIR SULFATE
AB TEVA PHARMS USA
EQ 150MG BASE
A091673 002 Apr 22, 2014
AB
EQ 200MG BASE
A091673 003 Apr 22, 2014
AB
EQ 300MG BASE
A091673 004 Apr 22, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-34(of 371)
ATAZANAVIR SULFATE
CAPSULE;ORAL
REYATAZ
AB BRISTOL MYERS SQUIBB EQ 150MG BASE N021567 002 Jun 20, 2003
AB EQ 200MG BASE N021567 003 Jun 20, 2003
AB + EQ 300MG BASE N021567 004 Oct 16, 2006
ATAZANAVIR SULFATE
TEVA PHARMS USA EQ 100MG BASE A091673 001 Apr 22, 2014
POWDER;ORAL
REYATAZ
+ BRISTOL MYERS SQUIBB EQ 50MG BASE/PACKET N206352 001 Jun 02, 2014
ATENOLOL
TABLET;ORAL
ATENOLOL
AB AUROBINDO PHARMA 25MG A078512 001 Oct 31, 2007
AB 50MG A078512 002 Oct 31, 2007
AB 100MG A078512 003 Oct 31, 2007
AB DAVA PHARMS INC 25MG A074099 001 Apr 28, 1992
AB 50MG A073542 001 Dec 19, 1991
AB 100MG A073543 001 Dec 19, 1991
AB IPCA LABS LTD 25MG A077877 001 Dec 27, 2006
AB 50MG A077877 002 Dec 27, 2006
AB 100MG A077877 003 Dec 27, 2006
AB IPR 25MG A073646 001 Jul 31, 1992
AB 50MG A072303 001 Jul 15, 1988
AB 100MG A072304 001 Jul 15, 1988
AB MUTUAL PHARM 25MG A074499 001 Jul 30, 1997
AB 50MG A073475 001 Mar 30, 1993
AB 100MG A073476 001 Mar 30, 1993
AB MYLAN 25MG A073457 002 Apr 26, 1999
AB 50MG A073457 003 Jan 24, 1992
AB 100MG A073457 001 Jan 24, 1992
AB NORTHSTAR HLTHCARE 25MG A078254 001 Sep 25, 2009
AB 50MG A078254 002 Sep 25, 2009
AB 100MG A078254 003 Sep 25, 2009
AB SANDOZ 25MG A074052 001 May 01, 1992
AB 50MG A073025 001 Sep 17, 1991
AB 100MG A073026 001 Sep 17, 1991
AB SUN PHARM INDS INC 25MG A078210 001 Jul 10, 2007
AB 50MG A078210 002 Jul 10, 2007
AB 100MG A078210 003 Jul 10, 2007
AB TEVA 25MG A074056 003 Jul 19, 2004
AB 50MG A074056 001 Jan 18, 1995
AB 100MG A074056 002 Jan 18, 1995
AB UNIQUE PHARM LABS 25MG A077443 001 Sep 13, 2006
AB 50MG A077443 002 Sep 13, 2006
AB 100MG A077443 003 Sep 13, 2006
AB ZYDUS PHARMS USA 25MG A076900 001 Jan 28, 2005
AB 50MG A076900 002 Jan 28, 2005
AB 100MG A076900 003 Jan 28, 2005
TENORMIN
AB ASTRAZENECA 25MG N018240 004 Apr 09, 1990
AB 50MG N018240 001
AB + 100MG N018240 002
ATENOLOL; CHLORTHALIDONE
TABLET;ORAL
ATENOLOL AND CHLORTHALIDONE
AB IPR 50MG;25MG A072301 001 May 31, 1990
AB 100MG;25MG A072302 001 May 31, 1990
AB MUTUAL PHARM 50MG;25MG A073581 001 Apr 29, 1993
AB 100MG;25MG A073582 001 Apr 29, 1993
AB MYLAN 50MG;25MG A074203 001 Oct 31, 1993
AB 100MG;25MG A074203 002 Oct 31, 1993
AB WATSON LABS 50MG;25MG A073665 001 Jul 02, 1992
AB 100MG;25MG A073665 002 Jul 02, 1992
TENORETIC 100
AB + ASTRAZENECA 100MG;25MG N018760 001 Jun 08, 1984
TENORETIC 50
AB ASTRAZENECA 50MG;25MG N018760 002 Jun 08, 1984
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-35(of 371)
ATOMOXETINE HYDROCHLORIDE
CAPSULE;ORAL
STRATTERA
LILLY
10MG
N021411 002 Nov 26, 2002
18MG
N021411 003 Nov 26, 2002
25MG
N021411 004 Nov 26, 2002
40MG
N021411 005 Nov 26, 2002
+
60MG
N021411 006 Nov 26, 2002
80MG
N021411 007 Feb 14, 2005
100MG
N021411 008 Feb 14, 2005
ATORVASTATIN CALCIUM
TABLET;ORAL
ATORVASTATIN CALCIUM
AB APOTEX INC EQ 10MG BASE
A090548 001 May 29, 2012
AB EQ 20MG BASE
A090548 002 May 29, 2012
AB EQ 40MG BASE
A090548 003 May 29, 2012
AB EQ 80MG BASE
A090548 004 May 29, 2012
AB DR REDDYS LABS LTD EQ 10MG BASE
A091650 001 Jul 17, 2012
AB EQ 20MG BASE
A091650 002 Jul 17, 2012
AB EQ 40MG BASE
A091650 003 Jul 17, 2012
AB EQ 80MG BASE
A202357 001 Jul 17, 2012
AB KUDCO IRELAND EQ 10MG BASE
A091624 001 Apr 05, 2013
AB EQ 20MG BASE
A091624 002 Apr 05, 2013
AB EQ 40MG BASE
A091624 003 Apr 05, 2013
AB EQ 80MG BASE
A091624 004 Apr 05, 2013
AB MYLAN PHARMS INC EQ 10MG BASE
A091226 001 May 29, 2012
AB EQ 20MG BASE
A091226 002 May 29, 2012
AB EQ 40MG BASE
A091226 003 May 29, 2012
AB EQ 80MG BASE
A091226 004 May 29, 2012
AB RANBAXY LABS LTD EQ 10MG BASE
A076477 001 Nov 30, 2011
AB EQ 20MG BASE
A076477 002 Nov 30, 2011
AB EQ 40MG BASE
A076477 003 Nov 30, 2011
AB EQ 80MG BASE
A076477 004 Nov 30, 2011
AB SANDOZ INC EQ 10MG BASE
A077575 001 May 29, 2012
AB EQ 20MG BASE
A077575 002 May 29, 2012
AB EQ 40MG BASE
A077575 003 May 29, 2012
AB EQ 80MG BASE
A077575 004 May 29, 2012
LIPITOR
AB PFIZER EQ 10MG BASE
N020702 001 Dec 17, 1996
AB EQ 20MG BASE
N020702 002 Dec 17, 1996
AB EQ 40MG BASE
N020702 003 Dec 17, 1996
AB + EQ 80MG BASE
N020702 004 Apr 07, 2000
ATORVASTATIN CALCIUM; EZETIMIBE
TABLET;ORAL
LIPTRUZET
MERCK SHARP DOHME
EQ 10MG BASE;10MG
N200153 001 May 03, 2013
EQ 20MG BASE;10MG
N200153 002 May 03, 2013
EQ 40MG BASE;10MG
N200153 003 May 03, 2013
+
EQ 80MG BASE;10MG
N200153 004 May 03, 2013
ATOVAQUONE
SUSPENSION;ORAL
ATOVAQUONE
AB AMNEAL PHARMS
750MG/5ML
A202960 001 Mar 18, 2014
MEPRON
AB + GLAXOSMITHKLINE LLC
750MG/5ML
N020500 001 Feb 08, 1995
ATOVAQUONE; PROGUANIL HYDROCHLORIDE
TABLET;ORAL
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE
AB GLENMARK GENERICS
250MG;100MG
A091211 001 Jan 12, 2011
AB MYLAN PHARMS INC
62.5MG;25MG
A202362 001 May 27, 2014
AB
250MG;100MG
A202362 002 May 27, 2014
MALARONE
AB + GLAXOSMITHKLINE
250MG;100MG
N021078 001 Jul 14, 2000
MALARONE PEDIATRIC
AB GLAXOSMITHKLINE
62.5MG;25MG
N021078 002 Jul 14, 2000
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-36(of 371)
ATRACURIUM BESYLATE
INJECTABLE;INJECTION
ATRACURIUM BESYLATE
AP + EUROHLTH INTL 10MG/ML A074901 001 Jul 18, 1997
AP HOSPIRA INC 10MG/ML A090761 001 Oct 18, 2012
AP SAGENT PHARMS 10MG/ML A091489 001 Feb 17, 2012
ATRACURIUM BESYLATE PRESERVATIVE FREE
AP + EUROHLTH INTL 10MG/ML A074900 001 Jul 18, 1997
AP HOSPIRA INC 10MG/ML A090782 001 Oct 18, 2012
AP SAGENT PHARMS 10MG/ML A091488 001 Feb 17, 2012
ATROPINE
INJECTABLE;INJECTION
ATROPEN
+ MERIDIAN MEDCL TECHN EQ 0.25MG SULFATE/0.3ML N017106 004 Sep 17, 2004
+ EQ 0.5MG SULFATE/0.7ML N017106 003 Jun 19, 2003
+ EQ 1MG SULFATE/0.7ML N017106 002 Jun 19, 2003
+ EQ 2MG SULFATE/0.7ML N017106 001
ATROPINE SULFATE
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS, SUBCUTANEOUS
ATROPINE SULFATE ANSYR PLASTIC SYRINGE
+ HOSPIRA 0.05MG/ML N021146 002 Jul 09, 2001
+ 0.1MG/ML N021146 001 Jul 09, 2001
SOLUTION/DROPS;OPHTHALMIC
ATROPINE SULFATE
AKORN 1% N206289 001 Jul 18, 2014
ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE
TABLET;ORAL
MOTOFEN
+ VALEANT 0.025MG;1MG N017744 002
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
SOLUTION;ORAL
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
AA + ROXANE 0.025MG/5ML;2.5MG/5ML A087708 001 May 03, 1982
TABLET;ORAL
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
AA LANNETT 0.025MG;2.5MG A085372 001
AA MYLAN 0.025MG;2.5MG A085762 001
AA PAR PHARM 0.025MG;2.5MG A040357 001 May 02, 2000
LOMOTIL
AA + GD SEARLE LLC 0.025MG;2.5MG N012462 001
LONOX
AA SANDOZ 0.025MG;2.5MG A085311 002
ATROPINE SULFATE; EDROPHONIUM CHLORIDE
INJECTABLE;INJECTION
ENLON-PLUS
+ MYLAN INSTITUTIONAL 0.14MG/ML;10MG/ML N019678 001 Nov 06, 1991
ATROPINE; PRALIDOXIME CHLORIDE
INJECTABLE;INTRAMUSCULAR
DUODOTE
+ MERIDIAN MEDCL 2.1MG/0.7ML;600MG/2ML N021983 001 Sep 28, 2006
AURANOFIN
CAPSULE;ORAL
RIDAURA
+ PROMETHEUS LABS 3MG N018689 001 May 24, 1985
AVANAFIL
TABLET;ORAL
STENDRA
VIVUS 50MG N202276 001 Apr 27, 2012
100MG N202276 002 Apr 27, 2012
+ 200MG N202276 003 Apr 27, 2012
AXITINIB
TABLET;ORAL
INLYTA
PFIZER 1MG N202324 001 Jan 27, 2012
+ 5MG N202324 002 Jan 27, 2012
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-37(of 371)
AZACITIDINE
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
AZACITIDINE
AP DR REDDYS LABS LTD 100MG/VIAL A201537 001 Sep 16, 2013
VIDAZA
AP + CELGENE 100MG/VIAL N050794 001 May 19, 2004
AZATHIOPRINE
TABLET;ORAL
AZASAN
AB AAIPHARMA LLC 25MG A075252 002 Feb 03, 2003
AB 50MG A075252 001 Jun 07, 1999
AB 75MG A075252 003 Feb 03, 2003
AB 100MG A075252 004 Feb 03, 2003
AZATHIOPRINE
AB AMNEAL PHARMS LLC 50MG A074069 001 Feb 16, 1996
AB MYLAN 50MG A075568 001 Dec 13, 1999
AB ZYDUS PHARMS USA 25MG A077621 002 Sep 05, 2008
AB 50MG A077621 001 Mar 15, 2007
AB 75MG A077621 003 Sep 05, 2008
AB 100MG A077621 004 Sep 05, 2008
IMURAN
AB + PROMETHEUS LABS 50MG N016324 001
AZATHIOPRINE SODIUM
INJECTABLE;INJECTION
AZATHIOPRINE SODIUM
+ EUROHLTH INTL EQ 100MG BASE/VIAL A074419 001 Mar 31, 1995
AZELAIC ACID
CREAM;TOPICAL
AZELEX
+ ALLERGAN 20% N020428 001 Sep 13, 1995
GEL;TOPICAL
FINACEA
+ BAYER HLTHCARE 15% N021470 001 Dec 24, 2002
AZELASTINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
AZELASTINE HYDROCHLORIDE
AT ALCON PHARMA 0.05% A202305 001 May 31, 2012
AT APOTEX INC 0.05% A078621 001 Aug 03, 2009
AT SUN PHARMA GLOBAL 0.05% A078738 001 Jun 21, 2010
OPTIVAR
AT + MEDA PHARMS 0.05% N021127 001 May 22, 2000
SPRAY, METERED;NASAL
ASTELIN
AB + MEDA PHARMS EQ 0.125MG BASE/SPRAY N020114 001 Nov 01, 1996
ASTEPRO
AB + MEDA PHARMS EQ 0.1876MG BASE/SPRAY N022371 001 Aug 31, 2009
AZELASTINE HYDROCHLORIDE
AB APOTEX INC EQ 0.125MG BASE/SPRAY A077954 001 Apr 30, 2009
AB EQ 0.1876MG BASE/SPRAY A201846 001 Aug 31, 2012
AB PERRIGO ISRAEL EQ 0.1876MG BASE/SPRAY A202743 001 May 08, 2014
AB ROXANE EQ 0.125MG BASE/SPRAY A091444 001 Oct 24, 2014
AB SUN PHARMA GLOBAL EQ 0.125MG BASE/SPRAY A090423 001 May 23, 2012
AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE
SPRAY, METERED;NASAL
DYMISTA
+ MEDA PHARMS EQ 0.125MG BASE/SPRAY;0.05MG/SPRAY N202236 001 May 01, 2012
AZILSARTAN KAMEDOXOMIL
TABLET;ORAL
EDARBI
ARBOR PHARMS IRELAND EQ 40MG MEDOXOMIL N200796 001 Feb 25, 2011
+ EQ 80MG MEDOXOMIL N200796 002 Feb 25, 2011
AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE
TABLET;ORAL
EDARBYCLOR
ARBOR PHARMS IRELAND EQ 40MG MEDOXOMIL;12.5MG N202331 001 Dec 20, 2011
+ EQ 40MG MEDOXOMIL;25MG N202331 002 Dec 20, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-38(of 371)
AZITHROMYCIN
FOR SUSPENSION;ORAL
AZITHROMYCIN
AB PLIVA EQ 100MG BASE/5ML A065246 002 Jul 05, 2006
AB EQ 200MG BASE/5ML A065246 001 Jul 05, 2006
AB TEVA PHARMS EQ 100MG BASE/5ML A065419 001 Jun 24, 2008
AB EQ 200MG BASE/5ML A065419 002 Jun 24, 2008
ZITHROMAX
AB PFIZER EQ 100MG BASE/5ML N050710 001 Oct 19, 1995
AB + EQ 200MG BASE/5ML N050710 002 Oct 19, 1995
+ EQ 1GM BASE/PACKET N050693 001 Sep 28, 1994
FOR SUSPENSION, EXTENDED RELEASE;ORAL
ZMAX
+ PF PRISM CV EQ 2GM BASE/BOT N050797 001 Jun 10, 2005
INJECTABLE;INJECTION
AZITHROMYCIN
AP FRESENIUS KABI USA EQ 500MG BASE/VIAL A065179 001 Dec 13, 2005
AP GLAND PHARMA LTD EQ 500MG BASE/VIAL A065501 001 Nov 09, 2009
AP HOSPIRA EQ 500MG BASE/VIAL A065500 001 Jun 26, 2009
AP EQ 500MG BASE/VIAL A065511 001 Jun 26, 2009
AP SAGENT STRIDES EQ 500MG BASE/VIAL A065506 001 Mar 24, 2009
AP SUN PHARM INDS LTD EQ 500MG BASE/VIAL A090923 001 Apr 02, 2013
ZITHROMAX
AP + PFIZER EQ 500MG BASE/VIAL N050733 001 Jan 30, 1997
SOLUTION/DROPS;OPHTHALMIC
AZASITE
+ OAK PHARMS INC 1% N050810 001 Apr 27, 2007
TABLET;ORAL
AZITHROMYCIN
AB APOTEX CORP EQ 250MG BASE A065507 001 Jul 13, 2011
AB EQ 500MG BASE A065509 001 Jul 13, 2011
AB EQ 600MG BASE A065508 001 Jul 13, 2011
AB MYLAN EQ 250MG BASE A065365 001 May 30, 2007
AB EQ 500MG BASE A065366 001 May 30, 2007
AB EQ 600MG BASE A065360 001 Jan 08, 2007
AB PLIVA EQ 250MG BASE A065225 001 Nov 14, 2005
AB EQ 500MG BASE A065223 001 Nov 14, 2005
AB EQ 600MG BASE A065218 001 Nov 14, 2005
AB SANDOZ EQ 250MG BASE A065211 001 Nov 14, 2005
AB EQ 500MG BASE A065212 001 Nov 14, 2005
AB EQ 600MG BASE A065209 001 Nov 14, 2005
AB TEVA EQ 250MG BASE A065153 001 Nov 14, 2005
AB EQ 500MG BASE A065193 001 Nov 14, 2005
AB EQ 600MG BASE A065150 001 Nov 14, 2005
AB WOCKHARDT EQ 250MG BASE A065404 001 Feb 11, 2008
AB EQ 500MG BASE A065405 001 Feb 11, 2008
AB EQ 600MG BASE A065302 003 Feb 11, 2008
ZITHROMAX
AB PFIZER EQ 250MG BASE N050711 001 Jul 18, 1996
AB EQ 500MG BASE N050784 001 May 24, 2002
AB + EQ 600MG BASE N050730 001 Jun 12, 1996
AZTREONAM
FOR SOLUTION;INHALATION
CAYSTON
+ GILEAD 75MG/VIAL N050814 001 Feb 22, 2010
INJECTABLE;INJECTION
AZACTAM
AP + BRISTOL MYERS SQUIBB 1GM/VIAL N050580 002 Dec 31, 1986
AP + 2GM/VIAL N050580 003 Dec 31, 1986
AZTREONAM
AP EUROHLTH INTL 1GM/VIAL A065286 001 Mar 23, 2011
AP 2GM/VIAL A065286 002 Mar 23, 2011
AP FRESENIUS KABI USA 1GM/VIAL A065439 002 Jun 18, 2010
AP 2GM/VIAL A065439 003 Jun 18, 2010
AZACTAM IN PLASTIC CONTAINER
+ BRISTOL MYERS SQUIBB 20MG/ML N050632 002 May 24, 1989
+ 40MG/ML N050632 001 May 24, 1989
AZTREONAM
FRESENIUS KABI USA 500MG/VIAL A065439 001 Jun 18, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-39(of 371)
BACITRACIN
INJECTABLE;INJECTION
BACIIM
AP X GEN PHARMS 50,000 UNITS/VIAL A064153 001 May 09, 1997
BACITRACIN
AP FRESENIUS KABI USA 50,000 UNITS/VIAL A065116 001 Dec 03, 2002
AP + PHARMACIA AND UPJOHN 50,000 UNITS/VIAL A060733 002
AP SAGENT STRIDES 50,000 UNITS/VIAL A090211 001 May 11, 2010
AP XELLIA PHARMS APS 50,000 UNITS/VIAL A203177 001 Aug 25, 2014
PHARMACIA AND UPJOHN 10,000 UNITS/VIAL A060733 001
OINTMENT;OPHTHALMIC
BACITRACIN
+ PERRIGO CO TENNESSEE 500 UNITS/GM A061212 001
BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE
AT AKORN 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 A065213 001 Jul 25, 2012
UNITS/GM
AT + BAUSCH AND LOMB 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 A064068 001 Oct 30, 1995
UNITS/GM
OINTMENT;TOPICAL
CORTISPORIN
+ MONARCH PHARMS 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000 N050168 002 May 04, 1984
UNITS/GM
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC
AT AKORN 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 A065088 001 Feb 06, 2004
UNITS/GM
AT + BAUSCH AND LOMB 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000 A064064 001 Oct 30, 1995
UNITS/GM
AT PERRIGO CO TENNESSEE 400 UNITS/GM;EQ 3.5MG BASE;10,000 A060764 002
UNITS/GM
BACITRACIN ZINC; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
BACITRACIN ZINC AND POLYMYXIN B SULFATE
AT AKORN 500 UNITS/GM;10,000 UNITS/GM A064028 001 Jan 30, 1995
AT + BAUSCH AND LOMB 500 UNITS/GM;10,000 UNITS/GM A064046 001 Jan 26, 1995
AT PERRIGO CO TENNESSEE 500 UNITS/GM;10,000 UNITS/GM A065022 001 Feb 27, 2002
BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE
+ PERRIGO CO TENNESSEE 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000 A062166 002
UNITS/GM
BACLOFEN
INJECTABLE;INTRATHECAL
GABLOFEN
AP MALLINCKRODT INC 0.05MG/ML N022462 001 Nov 19, 2010
AP 0.5MG/ML N022462 002 Nov 19, 2010
AP 2MG/ML N022462 003 Nov 19, 2010
LIORESAL
AP + MEDTRONIC NEURO 0.05MG/ML N020075 003 Nov 07, 1996
AP + 0.5MG/ML N020075 001 Jun 17, 1992
AP + 2MG/ML N020075 002 Jun 17, 1992
GABLOFEN
MALLINCKRODT INC 1MG/ML N022462 004 Jun 22, 2012
TABLET;ORAL
BACLOFEN
AB CARACO 10MG A077984 001 Aug 14, 2006
AB IMPAX LABS 10MG A078146 001 Oct 26, 2007
AB 20MG A077971 002 Oct 26, 2007
AB IVAX SUB TEVA PHARMS 10MG A072234 001 Jul 21, 1988
AB + 20MG A072235 001 Jul 21, 1988
AB LANNETT 10MG A078220 001 Jul 06, 2007
AB 20MG A077241 001 Dec 20, 2005
AB MYLAN 10MG A077181 001 Jul 29, 2005
AB 20MG A077121 002 Jul 29, 2005
AB MYLAN PHARMS INC 10MG A090334 001 Feb 18, 2010
AB 20MG A090334 002 Feb 18, 2010
AB NORTHSTAR HLTHCARE 10MG A078504 001 Sep 18, 2009
AB 20MG A078401 001 Sep 18, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-40(of 371)
BACLOFEN
TABLET;ORAL
BACLOFEN
AB PROSAM LABS
10MG
A077089 001 Oct 31, 2007
AB
20MG
A077088 001 Oct 31, 2007
AB SUN PHARM INDS INC
20MG
A077862 002 Aug 14, 2006
AB USL PHARMA
10MG
A074584 001 Aug 19, 1996
AB
20MG
A074584 002 Aug 19, 1996
AB VINTAGE PHARMS
10MG
A077156 001 Aug 30, 2005
AB
20MG
A077068 001 Aug 30, 2005
AB WATSON LABS
10MG
A072824 001 Sep 18, 1991
AB
20MG
A072825 001 Sep 18, 1991
BALSALAZIDE DISODIUM
CAPSULE;ORAL
BALSALAZIDE DISODIUM
AB APOTEX INC
750MG
A077883 001 Dec 28, 2007
AB MYLAN
750MG
A077807 001 Dec 28, 2007
AB ROXANE
750MG
A077806 001 Dec 28, 2007
COLAZAL
AB + SALIX PHARMS
750MG
N020610 001 Jul 18, 2000
TABLET;ORAL
GIAZO
+ SALIX PHARMS
1.1GM
N022205 001 Feb 03, 2012
BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED
TABLET;ORAL
DUAVEE
+ WYETH PHARMS PFIZER
EQ 20MG BASE;0.45MG
N022247 001 Oct 03, 2013
BECLOMETHASONE DIPROPIONATE
AEROSOL, METERED;INHALATION
QVAR 40
+ TEVA BRANDED PHARM
0.04MG/INH
N020911 002 Sep 15, 2000
QVAR 80
+ TEVA BRANDED PHARM
0.08MG/INH
N020911 001 Sep 15, 2000
AEROSOL, METERED;NASAL
QNASL
TEVA BRANDED PHARM
0.04MG/ACTUATION
N202813 002 Dec 17, 2014
+
0.08MG/ACTUATION
N202813 001 Mar 23, 2012
BECLOMETHASONE DIPROPIONATE MONOHYDRATE
SPRAY, METERED;NASAL
BECONASE AQ
+ GLAXOSMITHKLINE
EQ 0.042MG DIPROP/SPRAY
N019389 001 Jul 27, 1987
BEDAQUILINE FUMARATE
TABLET;ORAL
SIRTURO
+ JANSSEN THERAP
EQ 100MG BASE
N204384 001 Dec 28, 2012
BELINOSTAT
POWDER;IV (INFUSION)
BELEODAQ
+ SPECTRUM PHARMS
500MG/VIAL
N206256 001 Jul 03, 2014
BENAZEPRIL HYDROCHLORIDE
TABLET;ORAL
BENAZEPRIL HYDROCHLORIDE
AB ACTAVIS LABS FL INC 5MG
A076267 001 Feb 11, 2004
AB 10MG
A076267 002 Feb 11, 2004
AB 20MG
A076267 003 Feb 11, 2004
AB 40MG
A076267 004 Feb 11, 2004
AB APOTEX INC 5MG
A077128 001 Mar 08, 2006
AB 10MG
A077128 002 Mar 08, 2006
AB 20MG
A077128 003 Mar 08, 2006
AB 40MG
A077128 004 Mar 08, 2006
AB AUROBINDO PHARMA 10MG
A078212 001 May 22, 2008
AB 20MG
A078212 002 May 22, 2008
AB 40MG
A078212 003 May 22, 2008
AB BIOKEY 5MG
A076820 001 Feb 03, 2006
AB 10MG
A076820 002 Feb 03, 2006
AB 20MG
A076820 003 Feb 03, 2006
AB 40MG
A076820 004 Feb 03, 2006
AB IVAX SUB TEVA PHARMS 5MG
A076333 001 Feb 11, 2004
AB 10MG
A076333 002 Feb 11, 2004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-41(of 371)
BENAZEPRIL HYDROCHLORIDE
TABLET;ORAL
BENAZEPRIL HYDROCHLORIDE
AB
20MG
A076333 003 Feb 11, 2004
AB
40MG
A076333 004 Feb 11, 2004
AB MYLAN
5MG
A076430 001 Feb 11, 2004
AB
10MG
A076430 002 Feb 11, 2004
AB
20MG
A076430 003 Feb 11, 2004
AB
40MG
A076430 004 Feb 11, 2004
AB PRINSTON INC
5MG
A076118 001 Feb 11, 2004
AB
10MG
A076118 002 Feb 11, 2004
AB
20MG
A076118 003 Feb 11, 2004
AB
40MG
A076118 004 Feb 11, 2004
AB RANBAXY
5MG
A076344 001 Feb 11, 2004
AB
10MG
A076344 002 Feb 11, 2004
AB
20MG
A076344 003 Feb 11, 2004
AB
40MG
A076344 004 Feb 11, 2004
AB SANDOZ
5MG
A076402 001 Feb 11, 2004
AB
10MG
A076402 002 Feb 11, 2004
AB
20MG
A076402 003 Feb 11, 2004
AB
40MG
A076402 004 Feb 11, 2004
AB TEVA
5MG
A076211 001 Feb 11, 2004
AB
10MG
A076211 002 Feb 11, 2004
AB
20MG
A076211 003 Feb 11, 2004
AB
40MG
A076211 004 Feb 11, 2004
AB ZYDUS PHARMS USA
5MG
A078848 001 May 23, 2008
AB
10MG
A078848 002 May 23, 2008
AB
20MG
A078848 003 May 23, 2008
AB
40MG
A078848 004 May 23, 2008
LOTENSIN
AB US PHARMS HOLDINGS I
5MG
N019851 001 Jun 25, 1991
AB
10MG
N019851 002 Jun 25, 1991
AB
20MG
N019851 003 Jun 25, 1991
AB +
40MG
N019851 004 Jun 25, 1991
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
AB ACTAVIS LABS FL INC
5MG;6.25MG
A076342 001 Feb 11, 2004
AB
10MG;12.5MG
A076342 002 Feb 11, 2004
AB
20MG;12.5MG
A076342 003 Feb 11, 2004
AB
20MG;25MG
A076342 004 Feb 11, 2004
AB APOTEX INC
5MG;6.25MG
A078794 001 Aug 21, 2014
AB
10MG;12.5MG
A078794 002 Aug 21, 2014
AB
20MG;12.5MG
A078794 003 Aug 21, 2014
AB
20MG;25MG
A078794 004 Aug 21, 2014
AB IVAX SUB TEVA PHARMS
5MG;6.25MG
A076348 001 Feb 11, 2004
AB
10MG;12.5MG
A076348 002 Feb 11, 2004
AB
20MG;12.5MG
A076348 003 Feb 11, 2004
AB
20MG;25MG
A076348 004 Feb 11, 2004
AB MYLAN
5MG;6.25MG
A076688 001 Feb 11, 2004
AB
10MG;12.5MG
A076688 002 Feb 11, 2004
AB
20MG;12.5MG
A076688 003 Feb 11, 2004
AB
20MG;25MG
A076688 004 Feb 11, 2004
AB RANBAXY
5MG;6.25MG
A077483 001 Sep 08, 2005
AB
10MG;12.5MG
A077483 002 Sep 08, 2005
AB
20MG;12.5MG
A077483 003 Sep 08, 2005
AB
20MG;25MG
A077483 004 Sep 08, 2005
AB SANDOZ
5MG;6.25MG
A076631 001 Feb 11, 2004
AB
10MG;12.5MG
A076631 002 Feb 11, 2004
AB
20MG;12.5MG
A076631 003 Feb 11, 2004
AB
20MG;25MG
A076631 004 Feb 11, 2004
LOTENSIN HCT
AB US PHARMS HOLDINGS I
5MG;6.25MG
N020033 001 May 19, 1992
AB
10MG;12.5MG
N020033 002 May 19, 1992
AB
20MG;12.5MG
N020033 004 May 19, 1992
AB +
20MG;25MG
N020033 003 May 19, 1992
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-42(of 371)
BENDAMUSTINE HYDROCHLORIDE
POWDER;IV (INFUSION)
TREANDA
+ CEPHALON 25MG/VIAL N022249 002 May 01, 2009
+ 100MG/VIAL N022249 001 Mar 20, 2008
SOLUTION;IV (INFUSION)
TREANDA
+ CEPHALON 45MG/0.5ML (90MG/ML) N022249 003 Sep 13, 2013
+ 180MG/2ML (90MG/ML) N022249 004 Sep 13, 2013
BENDROFLUMETHIAZIDE; NADOLOL
TABLET;ORAL
CORZIDE
AB KING PHARMS 5MG;40MG N018647 001 May 25, 1983
AB + 5MG;80MG N018647 002 May 25, 1983
NADOLOL AND BENDROFLUMETHIAZIDE
AB IMPAX LABS 5MG;40MG A077833 001 Mar 30, 2007
AB 5MG;80MG A077833 002 Mar 30, 2007
AB MYLAN 5MG;40MG A078688 001 Feb 15, 2008
AB 5MG;80MG A078688 002 Feb 15, 2008
BENZONATATE
CAPSULE;ORAL
BENZONATATE
AA BANNER PHARMACAPS 100MG A081297 001 Jan 29, 1993
AA 200MG A081297 002 Oct 30, 2007
AA MIKART 100MG A040851 001 Nov 09, 2009
AA 150MG A040851 002 Nov 09, 2009
AA 200MG A040851 003 Nov 09, 2009
AA ORIT LABS LLC 100MG A040682 001 Jul 30, 2007
AA 200MG A040682 002 Jul 30, 2007
AA SUN PHARM INDS INC 100MG A040587 001 Mar 19, 2008
AA 200MG A040587 002 Mar 19, 2008
AA + THE PHARMA NETWORK 100MG A040627 001 Mar 30, 2007
AA + 200MG A040749 001 Jul 25, 2007
AA + THEPHARMANETWORK LLC 150MG A201209 001 Sep 24, 2014
AA ZYDUS PHARMS USA 100MG A040597 001 Jun 08, 2007
AA 200MG A040597 002 Jun 08, 2007
TESSALON
AA PFIZER 100MG N011210 001
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
GEL;TOPICAL
BENZACLIN
AB + VALEANT BERMUDA 5%;EQ 1% BASE N050756 001 Dec 21, 2000
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE
AB MYLAN PHARMS INC 5%;EQ 1% BASE A065443 001 Aug 11, 2009
AB PERRIGO ISRAEL 5%;1.2% A090979 001 Jun 26, 2012
DUAC
AB + STIEFEL 5%;1.2% N050741 001 Aug 26, 2002
ACANYA
+ DOW PHARM 2.5%;EQ 1.2% BASE N050819 001 Oct 23, 2008
ONEXTON
DOW PHARM 3.75%;EQ 1.2% BASE N050819 002 Nov 24, 2014
BENZOYL PEROXIDE; ERYTHROMYCIN
GEL;TOPICAL
BENZAMYCIN
AB + VALEANT INTL 5%;3% N050557 001 Oct 26, 1984
ERYTHROMYCIN AND BENZOYL PEROXIDE
AB TOLMAR 5%;3% A065112 001 Mar 29, 2004
BENZAMYCIN PAK
+ VALEANT LUXEMBOURG 5%;3% N050769 001 Nov 27, 2000
BENZPHETAMINE HYDROCHLORIDE
TABLET;ORAL
BENZPHETAMINE HYDROCHLORIDE
AA EMCURE PHARMS LTD 50MG A202061 001 Jan 27, 2012
AA IMPAX LABS 50MG A040845 001 Nov 18, 2008
AA KVK TECH 50MG A090968 001 Jul 20, 2010
AA MALLINCKRODT INC 50MG A040773 001 Apr 25, 2007
AA MIKART 25MG A090473 001 Sep 15, 2010
AA 50MG A090473 002 Sep 15, 2010
AA PADDOCK 50MG A040578 001 Apr 17, 2006
AA TEDOR PHARM 50MG A040747 001 Mar 30, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-43(of 371)
BENZPHETAMINE HYDROCHLORIDE
TABLET;ORAL
DIDREX
AA + PHARMACIA AND UPJOHN
50MG
N012427 002
BENZTROPINE MESYLATE
INJECTABLE;INJECTION
BENZTROPINE MESYLATE
AP FRESENIUS KABI USA
1MG/ML
A090233 001 Jul 28, 2009
AP HIKMA FARMACEUTICA
1MG/ML
A090287 001 Aug 31, 2009
AP LUITPOLD
1MG/ML
A091152 001 Mar 29, 2010
AP NAVINTA LLC
1MG/ML
A091525 001 Feb 05, 2013
COGENTIN
AP + OAK PHARMS AKORN
1MG/ML
N012015 001
TABLET;ORAL
BENZTROPINE MESYLATE
AA COREPHARMA 0.5MG
A072264 001 Feb 27, 1989
AA 1MG
A072265 001 Feb 27, 1989
AA 2MG
A072266 001 Feb 27, 1989
AA EXCELLIUM 0.5MG
A090168 001 Nov 28, 2012
AA 1MG
A090168 002 Nov 28, 2012
AA 2MG
A090168 003 Nov 28, 2012
AA INVAGEN PHARMS 0.5MG
A090294 001 Mar 29, 2010
AA 1MG
A090294 002 Mar 29, 2010
AA 2MG
A090294 003 Mar 29, 2010
AA PLIVA 0.5MG
A089058 001 Aug 10, 1988
AA 1MG
A089059 001 Aug 10, 1988
AA 2MG
A089060 001 Aug 10, 1988
AA + USL PHARMA 0.5MG
A040103 001 Dec 12, 1996
AA + 1MG
A040103 002 Dec 12, 1996
AA + 2MG
A040103 003 Dec 12, 1996
AA VINTAGE 0.5MG
A040738 001 Aug 27, 2007
AA 1MG
A040742 001 Aug 27, 2007
AA 2MG
A040715 003 Aug 27, 2007
BENZYL ALCOHOL
LOTION;TOPICAL
ULESFIA
+ SHIONOGI INC
5%
N022129 001 Apr 09, 2009
BENZYLPENICILLOYL POLYLYSINE
INJECTABLE;INJECTION
PRE-PEN
+ ALLERQUEST
60UMOLAR
N050114 001
BEPOTASTINE BESILATE
SOLUTION/DROPS;OPHTHALMIC
BEPREVE
+ BAUSCH AND LOMB INC
1.5%
N022288 001 Sep 08, 2009
BERACTANT
SUSPENSION;INTRATRACHEAL
SURVANTA
+ ABBVIE
25MG/ML
N020032 001 Jul 01, 1991
BESIFLOXACIN HYDROCHLORIDE
SUSPENSION/DROPS;OPHTHALMIC
BESIVANCE
+ BAUSCH AND LOMB
EQ 0.6% BASE
N022308 001 May 28, 2009
BETAINE HYDROCHLORIDE
FOR SOLUTION;ORAL
CYSTADANE
+ RARE DIS THERAP
1GM/SCOOPFUL
N020576 001 Oct 25, 1996
BETAMETHASONE ACETATE; BETAMETHASONE SODIUM PHOSPHATE
INJECTABLE;INJECTION
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE
AB LUITPOLD 3MG/ML;EQ 3MG BASE/ML A090747 001 Jul 31, 2009
CELESTONE SOLUSPAN
AB + MERCK SHARP DOHME 3MG/ML;EQ 3MG BASE/ML N014602 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-44(of 371)
BETAMETHASONE DIPROPIONATE
CREAM;TOPICAL
BETAMETHASONE DIPROPIONATE
AB ACTAVIS MID ATLANTIC EQ 0.05% BASE A070885 001 Feb 03, 1987
AB + FOUGERA PHARMS EQ 0.05% BASE N019137 001 Jun 26, 1984
AB TARO EQ 0.05% BASE A073552 001 Apr 30, 1992
CREAM, AUGMENTED;TOPICAL
BETAMETHASONE DIPROPIONATE
AB FOUGERA PHARMS EQ 0.05% BASE A076215 001 Dec 09, 2003
AB GLENMARK GENERICS EQ 0.05% BASE A078930 001 Sep 23, 2008
AB PERRIGO NEW YORK EQ 0.05% BASE A076592 001 Dec 09, 2003
AB TARO EQ 0.05% BASE A076543 001 Dec 09, 2003
AB TOLMAR EQ 0.05% BASE A076603 001 Jan 23, 2004
DIPROLENE AF
AB + MERCK SHARP DOHME EQ 0.05% BASE N019555 001 Apr 27, 1987
GEL, AUGMENTED;TOPICAL
BETAMETHASONE DIPROPIONATE
AB + FOUGERA PHARMS EQ 0.05% BASE A075276 001 May 13, 2003
AB TARO EQ 0.05% BASE A076508 001 Dec 02, 2003
LOTION;TOPICAL
BETAMETHASONE DIPROPIONATE
AB ACTAVIS MID ATLANTIC EQ 0.05% BASE A070281 001 Jul 31, 1985
AB + FOUGERA EQ 0.05% BASE A070275 001 Aug 12, 1985
AB PERRIGO NEW YORK EQ 0.05% BASE A072538 001 Jan 31, 1990
AB TEVA EQ 0.05% BASE A071467 001 Aug 10, 1987
LOTION, AUGMENTED;TOPICAL
BETAMETHASONE DIPROPIONATE
AB FOUGERA PHARMS EQ 0.05% BASE A077111 001 May 21, 2007
AB TARO EQ 0.05% BASE A077477 001 May 21, 2007
DIPROLENE
AB + MERCK SHARP DOHME EQ 0.05% BASE N019716 001 Aug 01, 1988
OINTMENT;TOPICAL
BETAMETHASONE DIPROPIONATE
AB ACTAVIS MID ATLANTIC EQ 0.05% BASE A071012 001 Feb 03, 1987
AB + FOUGERA EQ 0.05% BASE N019141 001 Sep 04, 1984
AB TARO EQ 0.05% BASE A074271 001 Sep 15, 1994
OINTMENT, AUGMENTED;TOPICAL
BETAMETHASONE DIPROPIONATE
AB ACTAVIS MID ATLANTIC EQ 0.05% BASE A074304 001 Aug 31, 1995
AB FOUGERA PHARMS EQ 0.05% BASE A075373 001 Jun 22, 1999
AB TARO EQ 0.05% BASE A076753 001 Oct 12, 2004
DIPROLENE
AB + MERCK SHARP DOHME EQ 0.05% BASE N018741 001 Jul 27, 1983
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE
OINTMENT;TOPICAL
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
AB PERRIGO ISRAEL 0.064%;0.005% A200174 001 Dec 12, 2014
AB TOLMAR 0.064%;0.005% A201615 001 Jan 14, 2013
TACLONEX
AB + LEO PHARMA AS 0.064%;0.005% N021852 001 Jan 09, 2006
SUSPENSION;TOPICAL
TACLONEX
+ LEO PHARMA AS 0.064%;0.005% N022185 001 May 09, 2008
BETAMETHASONE DIPROPIONATE; CLOTRIMAZOLE
CREAM;TOPICAL
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
AB ACTAVIS MID ATLANTIC EQ 0.05% BASE;1% A076002 001 Aug 02, 2002
AB FOUGERA PHARMS EQ 0.05% BASE;1% A075502 001 Jun 05, 2001
AB TARO EQ 0.05% BASE;1% A075673 001 May 29, 2001
LOTRISONE
AB + MERCK SHARP DOHME EQ 0.05% BASE;1% N018827 001 Jul 10, 1984
LOTION;TOPICAL
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE
AB FOUGERA PHARMS EQ 0.05% BASE;1% A076516 001 Jun 16, 2005
AB TARO EQ 0.05% BASE;1% A076493 001 Jul 28, 2004
LOTRISONE
AB + MERCK SHARP DOHME EQ 0.05% BASE;1% N020010 001 Dec 08, 2000
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-45(of 371)
BETAMETHASONE VALERATE
AEROSOL, FOAM;TOPICAL
BETAMETHASONE VALERATE
AB PERRIGO 0.12% A078337 001 Nov 26, 2012
LUXIQ
AB + DELCOR ASSET 0.12% N020934 001 Feb 28, 1999
CREAM;TOPICAL
BETA-VAL
AB TEVA EQ 0.1% BASE N018642 001 Mar 24, 1983
BETAMETHASONE VALERATE
AB + FOUGERA EQ 0.1% BASE N018861 001 Aug 31, 1983
DERMABET
AB TARO EQ 0.1% BASE A072041 001 Jan 06, 1988
VALNAC
AB ACTAVIS MID ATLANTIC EQ 0.1% BASE A070050 001 Oct 10, 1984
LOTION;TOPICAL
BETA-VAL
AB TEVA EQ 0.1% BASE A070072 001 Jun 27, 1985
BETAMETHASONE VALERATE
AB + FOUGERA EQ 0.1% BASE N018866 001 Aug 31, 1983
AB STI PHARMA LLC EQ 0.1% BASE A070052 001 Jul 31, 1985
OINTMENT;TOPICAL
BETAMETHASONE VALERATE
AB ACTAVIS MID ATLANTIC EQ 0.1% BASE A070051 001 Oct 10, 1984
AB + FOUGERA EQ 0.1% BASE N018865 001 Aug 31, 1983
BETAXOLOL HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
BETAXOLOL HYDROCHLORIDE
AT AKORN EQ 0.5% BASE A075386 001 Jun 30, 2000
AT IGI LABS INC EQ 0.5% BASE A075630 001 Apr 12, 2001
AT WOCKHARDT EQ 0.5% BASE A078694 001 Nov 16, 2009
BETOPTIC
AT + ALCON EQ 0.5% BASE N019270 001 Aug 30, 1985
SUSPENSION/DROPS;OPHTHALMIC
BETOPTIC S
+ ALCON EQ 0.25% BASE N019845 001 Dec 29, 1989
TABLET;ORAL
BETAXOLOL HYDROCHLORIDE
AB EPIC PHARMA 10MG A075541 001 Oct 22, 1999
AB + 20MG A075541 002 Oct 22, 1999
AB KVK TECH 10MG A078962 001 Jun 27, 2008
AB 20MG A078962 002 Jun 27, 2008
BETHANECHOL CHLORIDE
TABLET;ORAL
BETHANECHOL CHLORIDE
AA AMNEAL PHARM 5MG A040855 001 Nov 21, 2007
AA 10MG A040855 002 Nov 21, 2007
AA 25MG A040855 003 Nov 21, 2007
AA 50MG A040855 004 Nov 21, 2007
AA EMCURE USA 5MG A091256 001 May 04, 2010
AA 10MG A091256 002 May 04, 2010
AA 25MG A091256 003 May 04, 2010
AA 50MG A091256 004 May 04, 2010
AA IMPAX LABS 5MG A040739 001 Nov 01, 2006
AA 10MG A040741 001 Nov 01, 2006
AA 25MG A040740 001 Nov 01, 2006
AA 50MG A040721 004 Nov 01, 2006
AA LANNETT 10MG A040704 001 Mar 27, 2008
AA 25MG A040678 003 Mar 27, 2008
AA PHARMAX 5MG A040725 001 Oct 26, 2007
AA 10MG A040726 001 Oct 26, 2007
AA 25MG A040727 001 Oct 26, 2007
AA 50MG A040728 001 Oct 26, 2007
AA SUN PHARM INDS INC 5MG A040897 001 Apr 22, 2009
AA 10MG A040897 002 Apr 22, 2009
AA 25MG A040897 003 Apr 22, 2009
AA 50MG A040897 004 Apr 22, 2009
AA UPSHER SMITH 5MG A040633 001 Jun 01, 2005
AA 10MG A040634 001 Jun 01, 2005
AA 25MG A040635 001 Jun 01, 2005
AA 50MG A040636 001 Jun 01, 2005
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-46(of 371)
BETHANECHOL CHLORIDE
TABLET;ORAL
BETHANECHOL CHLORIDE
AA WOCKHARDT 5MG A040532 001 Sep 29, 2003
AA 10MG A040533 001 Sep 29, 2003
AA 25MG A040534 001 Sep 29, 2003
AA 50MG A040518 001 Sep 29, 2003
URECHOLINE
AA + ODYSSEY PHARMS 5MG A089095 001 Dec 19, 1985
AA + 10MG A088440 001 May 29, 1984
AA + 25MG A088441 001 May 29, 1984
AA + 50MG A089096 001 Dec 19, 1985
BEXAROTENE
CAPSULE;ORAL
TARGRETIN
+ VALEANT LUXEMBOURG 75MG N021055 001 Dec 29, 1999
GEL;TOPICAL
TARGRETIN
+ VALEANT LUXEMBOURG 1% N021056 001 Jun 28, 2000
BICALUTAMIDE
TABLET;ORAL
BICALUTAMIDE
AB ACCORD HLTHCARE 50MG A078917 001 Jul 06, 2009
AB ACTAVIS TOTOWA 50MG A078634 001 Aug 28, 2009
AB FRESENIUS KABI ONCOL 50MG A079045 001 May 13, 2010
AB MYLAN 50MG A079185 001 Jul 06, 2009
AB SANDOZ 50MG A078575 001 Jul 06, 2009
AB SUN PHARMA GLOBAL 50MG A079110 001 Jul 06, 2009
AB TEVA 50MG A076932 001 Jul 06, 2009
AB ZYDUS PHARMS USA INC 50MG A079089 001 Jul 06, 2009
CASODEX
AB + ASTRAZENECA 50MG N020498 001 Oct 04, 1995
BIMATOPROST
SOLUTION/DROPS;OPHTHALMIC
LUMIGAN
+ ALLERGAN 0.01% N022184 001 Aug 31, 2010
SOLUTION/DROPS;TOPICAL
BIMATOPROST
AT APOTEX INC 0.03% A201894 001 Dec 01, 2014
LATISSE
AT + ALLERGAN 0.03% N022369 001 Dec 24, 2008
BIPERIDEN HYDROCHLORIDE
TABLET;ORAL
AKINETON
+ ABBVIE 2MG N012003 001
BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL
PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL
+ NOVEL LABS INC 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM A202217 001 Aug 20, 2014
;N/A,5.6GM
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE
CAPSULE;ORAL
PYLERA
+ FOREST LABS INC 140MG;125MG;125MG N050786 001 Sep 28, 2006
BISOPROLOL FUMARATE
TABLET;ORAL
BISOPROLOL FUMARATE
AB AUROBINDO PHARMA 5MG A077910 001 Dec 27, 2006
AB 10MG A077910 002 Dec 27, 2006
AB MYLAN 5MG A075831 001 Dec 14, 2005
AB 10MG A075831 002 Dec 14, 2005
AB SANDOZ 5MG A075643 001 Nov 16, 2000
AB 10MG A075643 002 Nov 16, 2000
AB TEVA PHARMS 5MG A075644 001 Jun 26, 2001
AB 10MG A075644 002 Jun 26, 2001
AB UNICHEM PHARMS (USA) 5MG A078635 001 Aug 18, 2009
AB 10MG A078635 002 Aug 18, 2009
ZEBETA
AB TEVA WOMENS 5MG N019982 002 Jul 31, 1992
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-47(of 371)
BISOPROLOL FUMARATE
TABLET;ORAL
ZEBETA
AB + 10MG N019982 001 Jul 31, 1992
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
AB MYLAN 2.5MG;6.25MG A075768 001 Sep 25, 2000
AB 5MG;6.25MG A075768 002 Sep 25, 2000
AB 10MG;6.25MG A075768 003 Sep 25, 2000
AB SANDOZ 2.5MG;6.25MG A075579 001 Sep 25, 2000
AB 5MG;6.25MG A075579 002 Sep 25, 2000
AB 10MG;6.25MG A075579 003 Sep 25, 2000
AB UNICHEM 2.5MG;6.25MG A079106 001 Jul 28, 2010
AB 5MG;6.25MG A079106 002 Jul 28, 2010
AB 10MG;6.25MG A079106 003 Jul 28, 2010
ZIAC
AB TEVA WOMENS 2.5MG;6.25MG N020186 003 Mar 26, 1993
AB 5MG;6.25MG N020186 001 Mar 26, 1993
AB + 10MG;6.25MG N020186 002 Mar 26, 1993
BIVALIRUDIN
INJECTABLE;INTRAVENOUS
ANGIOMAX
+ MEDICINES CO 250MG/VIAL N020873 001 Dec 15, 2000
BLEOMYCIN SULFATE
INJECTABLE;INJECTION
BLEOMYCIN SULFATE
AP EUROHLTH INTL EQ 15 UNITS BASE/VIAL A065042 002 Oct 17, 2001
AP EQ 30 UNITS BASE/VIAL A065042 001 Oct 17, 2001
AP + FRESENIUS KABI USA EQ 15 UNITS BASE/VIAL A065185 001 Jan 28, 2008
AP + EQ 30 UNITS BASE/VIAL A065185 002 Jan 28, 2008
AP HOSPIRA EQ 15 UNITS BASE/VIAL A065031 001 Mar 10, 2000
AP EQ 30 UNITS BASE/VIAL A065031 002 Mar 10, 2000
AP TEVA PHARMS USA EQ 15 UNITS BASE/VIAL A065033 001 Jun 27, 2000
AP EQ 30 UNITS BASE/VIAL A065033 002 Jun 27, 2000
BOCEPREVIR
CAPSULE;ORAL
VICTRELIS
+ MERCK SHARP DOHME 200MG N202258 001 May 13, 2011
BORTEZOMIB
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
VELCADE
+ MILLENNIUM PHARMS 3.5MG/VIAL N021602 001 May 13, 2003
BOSENTAN
TABLET;ORAL
TRACLEER
ACTELION PHARMS LTD 62.5MG N021290 001 Nov 20, 2001
+ 125MG N021290 002 Nov 20, 2001
BOSUTINIB MONOHYDRATE
TABLET;ORAL
BOSULIF
WYETH PHARMS INC EQ 100MG BASE N203341 001 Sep 04, 2012
+ EQ 500MG BASE N203341 002 Sep 04, 2012
BRETYLIUM TOSYLATE
INJECTABLE;INJECTION
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
+ B BRAUN 100MG/100ML N019121 001 Apr 29, 1986
+ 200MG/100ML N019121 002 Apr 29, 1986
+ 400MG/100ML N019121 003 Apr 29, 1986
BRIMONIDINE TARTRATE
GEL;TOPICAL
MIRVASO
+ GALDERMA LABS LP EQ 0.33% BASE N204708 001 Aug 23, 2013
SOLUTION/DROPS;OPHTHALMIC
ALPHAGAN P
AT + ALLERGAN 0.15% N021262 001 Mar 16, 2001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-48(of 371)
BRIMONIDINE TARTRATE
SOLUTION/DROPS;OPHTHALMIC
BRIMONIDINE TARTRATE
AT AKORN 0.2% A076439 001 Mar 14, 2006
AT ALCON PHARMS LTD 0.2% A076254 001 Sep 16, 2003
AT + BAUSCH AND LOMB 0.2% A076260 001 May 28, 2003
AT INDOCO REMEDIES 0.2% A091691 001 Nov 18, 2014
AT SANDOZ 0.2% A078075 001 Jan 30, 2008
QOLIANA
AT ALCON PHARMS LTD 0.15% N021764 001 May 22, 2006
ALPHAGAN P
+ ALLERGAN 0.1% N021770 001 Aug 19, 2005
BRIMONIDINE TARTRATE; BRINZOLAMIDE
SUSPENSION/DROPS;OPHTHALMIC
SIMBRINZA
+ ALCON RES LTD 0.2%;1% N204251 001 Apr 19, 2013
BRIMONIDINE TARTRATE; TIMOLOL MALEATE
SOLUTION/DROPS;OPHTHALMIC
COMBIGAN
+ ALLERGAN 0.2%;EQ 0.5% BASE N021398 001 Oct 30, 2007
BRINZOLAMIDE
SUSPENSION/DROPS;OPHTHALMIC
AZOPT
+ ALCON PHARMS LTD 1% N020816 001 Apr 01, 1998
BROMFENAC SODIUM
SOLUTION/DROPS;OPHTHALMIC
BROMDAY
AT + BAUSCH AND LOMB INC EQ 0.09% ACID N021664 002 Oct 16, 2010
BROMFENAC SODIUM
AT APOTEX INC EQ 0.09% ACID A202620 001 Jun 23, 2014
AT HI-TECH PHARMACAL EQ 0.09% ACID A203395 001 Jan 22, 2014
AT1 APOTEX INC EQ 0.09% ACID A202435 001 Jun 19, 2014
AT1 COASTAL PHARMS EQ 0.09% ACID A201211 001 May 11, 2011
AT1 LUITPOLD EQ 0.09% ACID A202030 001 Jan 09, 2013
PROLENSA
+ BAUSCH AND LOMB EQ 0.07% ACID N203168 001 Apr 05, 2013
BROMOCRIPTINE MESYLATE
CAPSULE;ORAL
BROMOCRIPTINE MESYLATE
AB MYLAN EQ 5MG BASE A077226 001 Apr 04, 2005
AB ZYDUS PHARMS USA INC EQ 5MG BASE A078899 001 Jul 30, 2008
PARLODEL
AB + US PHARMS HOLDINGS I EQ 5MG BASE N017962 002 Mar 01, 1982
TABLET;ORAL
BROMOCRIPTINE MESYLATE
AB LEK PHARMS EQ 2.5MG BASE A074631 001 Jan 13, 1998
AB MYLAN EQ 2.5MG BASE A076962 001 Sep 24, 2004
AB PADDOCK LLC EQ 2.5MG BASE A077646 001 Oct 01, 2008
PARLODEL
AB + US PHARMS HOLDINGS I EQ 2.5MG BASE N017962 001
CYCLOSET
+ VEROSCIENCE EQ 0.8MG BASE N020866 001 May 05, 2009
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
SYRUP;ORAL
BROMFED-DM
AA + WOCKHARDT 2MG/5ML;10MG/5ML;30MG/5ML A088811 001 Jun 07, 1985
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
AA PADDOCK LLC 2MG/5ML;10MG/5ML;30MG/5ML A205292 001 Jul 15, 2014
AA VINTAGE PHARMS 2MG/5ML;10MG/5ML;30MG/5ML A202940 001 Jul 21, 2014
BUDESONIDE
AEROSOL, FOAM;RECTAL
UCERIS
+ SALIX PHARMS INC 2MG/ACTUATION N205613 001 Oct 07, 2014
CAPSULE;ORAL
BUDESONIDE
AB BARR LABS DIV TEVA 3MG A090379 001 Apr 02, 2014
AB MYLAN 3MG A090410 001 May 16, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-49(of 371)
BUDESONIDE
CAPSULE;ORAL
ENTOCORT EC
AB + ASTRAZENECA 3MG N021324 001 Oct 02, 2001
POWDER, METERED;INHALATION
PULMICORT FLEXHALER
ASTRAZENECA 0.08MG/INH N021949 001 Jul 12, 2006
+ 0.16MG/INH N021949 002 Jul 12, 2006
SPRAY, METERED;NASAL
BUDESONIDE
AB APOTEX INC 0.032MG/INH A078949 001 May 12, 2014
RHINOCORT
AB + ASTRAZENECA PHARMS 0.032MG/INH N020746 001 Oct 01, 1999
SUSPENSION;INHALATION
BUDESONIDE
AN SANDOZ 0.25MG/2ML A201966 003 Sep 27, 2013
AN 0.5MG/2ML A201966 002 Sep 27, 2013
AN 1MG/2ML A201966 001 Sep 27, 2013
AN TEVA PHARMS 0.25MG/2ML A077519 001 Nov 18, 2008
AN 0.5MG/2ML A077519 002 Nov 18, 2008
AN WATSON LABS INC 0.25MG/2ML A078404 001 Jul 31, 2012
AN 0.5MG/2ML A078404 002 Jul 31, 2012
PULMICORT RESPULES
AN ASTRAZENECA PHARMS 0.25MG/2ML N020929 001 Aug 08, 2000
AN 0.5MG/2ML N020929 002 Aug 08, 2000
AN + 1MG/2ML N020929 003 Aug 08, 2000
TABLET, EXTENDED RELEASE;ORAL
UCERIS
+ SANTARUS INC 9MG N203634 001 Jan 14, 2013
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE
AEROSOL, METERED;INHALATION
SYMBICORT
+ ASTRAZENECA 0.08MG/INH;0.0045MG/INH N021929 001 Jul 21, 2006
+ 0.16MG/INH;0.0045MG/INH N021929 002 Jul 21, 2006
BUMETANIDE
INJECTABLE;INJECTION
BUMETANIDE
AP + BEDFORD 0.25MG/ML A074441 001 Jan 27, 1995
AP HIKMA MAPLE 0.25MG/ML A079196 001 Apr 30, 2008
AP HOSPIRA 0.25MG/ML A074332 001 Oct 31, 1994
TABLET;ORAL
BUMETANIDE
AB IVAX SUB TEVA PHARMS 0.5MG A074225 001 Apr 24, 1995
AB 1MG A074225 002 Apr 24, 1995
AB 2MG A074225 003 Apr 24, 1995
AB SANDOZ 0.5MG A074700 001 Nov 21, 1996
AB 1MG A074700 002 Nov 21, 1996
AB + 2MG A074700 003 Nov 21, 1996
BUPIVACAINE
INJECTABLE, LIPOSOMAL;INJECTION
EXPAREL
+ PACIRA PHARMS INC 266MG/20ML (13.3MG/ML) N022496 002 Oct 28, 2011
BUPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION
BUPIVACAINE HYDROCHLORIDE
AP HOSPIRA 0.25% A070583 001 Feb 17, 1987
AP 0.25% A070586 001 Mar 03, 1987
AP 0.25% A070590 001 Feb 17, 1987
AP 0.25% N018053 002
AP 0.5% A070584 001 Feb 17, 1986
AP 0.5% A070597 001 Mar 03, 1987
AP 0.5% A070609 001 Mar 03, 1987
AP 0.5% N018053 001
AP 0.75% A070585 001 Mar 03, 1987
AP 0.75% N018053 003
AP SAGENT AGILA 0.25% A091503 001 Oct 18, 2011
AP 0.5% A091503 002 Oct 18, 2011
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
AP AUROBINDO PHARMA LTD 0.25% A203895 001 Nov 05, 2013
AP 0.5% A203895 002 Nov 05, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-50(of 371)
BUPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
AP 0.75% A203895 003 Nov 05, 2013
AP SAGENT AGILA 0.25% A091487 002 Oct 18, 2011
AP 0.5% A091487 001 Oct 18, 2011
AP 0.75% A091487 003 Oct 18, 2011
MARCAINE HYDROCHLORIDE
AP + HOSPIRA 0.25% N016964 001
AP + 0.5% N016964 006
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE
AP + HOSPIRA 0.25% N016964 012
AP + 0.5% N016964 005
AP + 0.75% N016964 009
SENSORCAINE
AP FRESENIUS KABI USA 0.25% A070552 001 May 21, 1986
AP 0.25% N018304 001
AP 0.5% A070553 001 May 21, 1986
AP 0.5% N018304 002
AP 0.75% A070554 001 May 21, 1986
AP 0.75% N018304 003
INJECTABLE;SPINAL
BUPIVACAINE HYDROCHLORIDE
AP HOSPIRA 0.75% A071810 001 Dec 11, 1987
MARCAINE
AP + HOSPIRA 0.75% N018692 001 May 04, 1984
SENSORCAINE
AP FRESENIUS KABI USA 0.75% A071202 001 Apr 15, 1987
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE
INJECTABLE;INJECTION
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
AP + HOSPIRA 0.5%;0.005MG/ML A071168 001 Jun 16, 1988
AP 0.5%;0.005MG/ML A071170 001 Jun 16, 1988
+ 0.25%;0.005MG/ML A071165 001 Jun 16, 1988
0.25%;0.005MG/ML A071167 001 Jun 16, 1988
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE BITARTRATE
INJECTABLE;INJECTION
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
AP SEPTODONT 0.5%;0.0091MG/ML A077250 001 Sep 27, 2006
BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE
AP + HOSPIRA 0.5%;0.0091MG/ML N022046 001 Jul 13, 1983
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE
AP + HOSPIRA 0.25%;0.0091MG/ML N016964 004
AP + 0.5%;0.0091MG/ML N016964 008
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE
AP + HOSPIRA 0.25%;0.0091MG/ML N016964 013
AP + 0.5%;0.0091MG/ML N016964 007
AP + 0.75%;0.0091MG/ML N016964 010
SENSORCAINE
AP FRESENIUS KABI USA 0.25%;0.0091MG/ML A070966 001 Oct 13, 1987
AP 0.25%;0.0091MG/ML A070967 001 Oct 13, 1987
AP 0.5%;0.0091MG/ML A070968 001 Oct 13, 1987
AP 0.5%;0.0091MG/ML N018304 004 Sep 02, 1983
AP 0.75%;0.0091MG/ML N018304 005 Sep 02, 1983
BUPRENORPHINE
FILM, EXTENDED RELEASE;TRANSDERMAL
BUTRANS
PURDUE PHARMA LP 5MCG/HR N021306 001 Jun 30, 2010
7.5MCG/HR N021306 005 Jun 30, 2014
10MCG/HR N021306 002 Jun 30, 2010
15MCG/HR N021306 004 Jul 25, 2013
+ 20MCG/HR N021306 003 Jun 30, 2010
BUPRENORPHINE HYDROCHLORIDE
INJECTABLE;INJECTION
BUPRENEX
AP + RECKITT BENCKISER EQ 0.3MG BASE/ML N018401 001
BUPRENORPHINE HYDROCHLORIDE
AP EUROHLTH INTL EQ 0.3MG BASE/ML A076931 001 Mar 02, 2005
AP HOSPIRA EQ 0.3MG BASE/ML A074137 001 Jun 03, 1996
AP LUITPOLD EQ 0.3MG BASE/ML A078331 001 Mar 27, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-51(of 371)
BUPRENORPHINE HYDROCHLORIDE
TABLET;SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE
AB BARR EQ 2MG BASE A090360 001 May 07, 2010
AB EQ 8MG BASE A090360 002 May 07, 2010
AB ETHYPHARM EQ 2MG BASE A090622 001 Sep 24, 2010
AB EQ 8MG BASE A090622 002 Sep 24, 2010
AB ROXANE EQ 2MG BASE A078633 001 Oct 08, 2009
AB + EQ 8MG BASE A078633 002 Oct 08, 2009
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
FILM;BUCCAL
BUNAVAIL
BIODELIVERY SCI INTL EQ 2.1MG BASE;EQ 0.3MG BASE N205637 001 Jun 06, 2014
EQ 4.2MG BASE;EQ 0.7MG BASE N205637 002 Jun 06, 2014
+ EQ 6.3MG BASE;EQ 1MG BASE N205637 003 Jun 06, 2014
FILM;SUBLINGUAL
SUBOXONE
RECKITT BENCKISER EQ 2MG BASE;EQ 0.5MG BASE N022410 001 Aug 30, 2010
EQ 4MG BASE;EQ 1MG BASE N022410 003 Aug 10, 2012
EQ 8MG BASE;EQ 2MG BASE N022410 002 Aug 30, 2010
+ EQ 12MG BASE;EQ 3MG BASE N022410 004 Aug 10, 2012
TABLET;SUBLINGUAL
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
AB ACTAVIS ELIZABETH EQ 2MG BASE;EQ 0.5MG BASE A091422 001 Feb 22, 2013
AB + EQ 8MG BASE;EQ 2MG BASE A091422 002 Feb 22, 2013
AB AMNEAL PHARMS EQ 8MG BASE;EQ 2MG BASE A203136 002 Feb 22, 2013
AB ROXANE EQ 2MG BASE;EQ 0.5MG BASE A203326 001 Jun 27, 2014
AB EQ 8MG BASE;EQ 2MG BASE A203326 002 Jun 27, 2014
AB TEVA PHARMS USA EQ 2MG BASE;EQ 0.5MG BASE A091149 001 Sep 08, 2014
AB EQ 8MG BASE;EQ 2MG BASE A091149 002 Sep 08, 2014
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE
AB AMNEAL PHARMS EQ 2MG BASE;EQ 0.5MG BASE A203136 001 Feb 22, 2013
ZUBSOLV
OREXO AB EQ 1.4MG BASE;EQ 0.36MG BASE N204242 001 Jul 03, 2013
+ EQ 5.7MG BASE;EQ 1.4MG BASE N204242 002 Jul 03, 2013
EQ 8.6MG BASE;EQ 2.1MG BASE N204242 003 Dec 11, 2014
EQ 11.4MG BASE;EQ 2.9MG BASE N204242 004 Dec 11, 2014
BUPROPION HYDROBROMIDE
TABLET, EXTENDED RELEASE;ORAL
APLENZIN
VALEANT BERMUDA 174MG N022108 001 Apr 23, 2008
348MG N022108 002 Apr 23, 2008
+ 522MG N022108 003 Apr 23, 2008
BUPROPION HYDROCHLORIDE
TABLET;ORAL
BUPROPION HYDROCHLORIDE
AB APOTEX INC 75MG A076143 001 Jan 17, 2006
AB 100MG A076143 002 Jan 17, 2006
AB MYLAN 75MG A075491 001 Apr 17, 2000
AB 100MG A075491 002 Apr 17, 2000
AB SANDOZ 75MG A075584 001 Feb 07, 2000
AB 100MG A075584 002 Feb 07, 2000
WELLBUTRIN
AB GLAXOSMITHKLINE 75MG N018644 002 Dec 30, 1985
AB + 100MG N018644 003 Dec 30, 1985
TABLET, EXTENDED RELEASE;ORAL
BUPROPION HYDROCHLORIDE
AB1 ACTAVIS LABS FL INC 100MG A079095 001 Mar 24, 2009
AB1 150MG A079095 002 Mar 24, 2009
AB1 200MG A079095 003 Mar 24, 2009
AB1 ANCHEN PHARMS 100MG A091459 001 Jun 09, 2011
AB1 150MG A091459 002 Jun 09, 2011
AB1 200MG A091459 003 Jun 09, 2011
AB1 IMPAX LABS 100MG A075913 001 Jan 28, 2004
AB1 150MG A075913 002 Mar 22, 2004
AB1 200MG A076711 001 Dec 03, 2004
AB1 JUBILANT GENERICS 100MG A202774 001 Oct 11, 2013
AB1 150MG A202774 002 Oct 11, 2013
AB1 200MG A202774 003 Oct 11, 2013
AB1 MYLAN 100MG A090325 001 Apr 08, 2010
AB1 150MG A090325 002 Apr 08, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-52(of 371)
BUPROPION HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
BUPROPION HYDROCHLORIDE
AB1
200MG
A090325 003 Apr 08, 2010
AB1 SANDOZ
100MG
A075932 001 Nov 25, 2003
AB1
150MG
A075932 002 Mar 22, 2004
AB1
200MG
A075932 003 Jun 22, 2005
AB1 SUN PHARMA GLOBAL
100MG
A078866 001 Apr 06, 2010
AB1
150MG
A078866 002 Apr 06, 2010
AB1
200MG
A078866 003 Apr 06, 2010
AB1 TORRENT PHARMS LTD
100MG
A203969 001 Oct 31, 2014
AB1
150MG
A203969 002 Oct 31, 2014
AB1
200MG
A203969 003 Oct 31, 2014
AB1 WATSON LABS INC
100MG
A077455 001 Jul 19, 2010
AB1
150MG
A077455 002 Mar 12, 2008
AB1
200MG
A077455 003 Jul 19, 2010
AB1 WOCKHARDT LTD
100MG
A201331 001 Aug 30, 2012
AB1
150MG
A201331 002 Aug 30, 2012
AB1
200MG
A201331 003 Aug 30, 2012
WELLBUTRIN SR
AB1 GLAXOSMITHKLINE 100MG
N020358 002 Oct 04, 1996
AB1 150MG
N020358 003 Oct 04, 1996
AB1 + 200MG
N020358 004 Jun 14, 2002
BUPROPION HYDROCHLORIDE
AB2 ACTAVIS 150MG
A077475 001 Mar 12, 2008
AB2 ACTAVIS LABS FL INC 150MG
A079094 001 Mar 24, 2009
AB2 ANCHEN PHARMS 150MG
A091520 001 Jun 09, 2011
AB2 IMPAX LABS 150MG
A075914 001 May 27, 2004
AB2 JUBILANT GENERICS 150MG
A202775 001 Oct 11, 2013
AB2 MYLAN 150MG
A090941 001 May 03, 2010
ZYBAN
AB2 + GLAXOSMITHKLINE 150MG
N020711 003 May 14, 1997
BUPROPION HYDROCHLORIDE
AB3 ACTAVIS LABS FL INC 150MG
A077715 001 Nov 26, 2008
AB3 ANCHEN PHARMS 150MG
A077284 001 Dec 14, 2006
AB3 300MG
A077284 002 Dec 14, 2006
AB3 IMPAX LABS 150MG
A077415 001 Nov 26, 2008
AB3 MYLAN 150MG
A090942 001 Jul 14, 2010
AB3 300MG
A090942 002 Jul 14, 2010
AB3 SUN PHARMA GLOBAL 150MG
A200695 001 Dec 18, 2014
AB3 WATSON LABS INC 150MG
A077285 001 Nov 26, 2008
AB3 300MG
A077285 002 Aug 15, 2008
AB3 WOCKHARDT LTD 150MG
A202189 001 Nov 21, 2012
AB3 ZYDUS PHARMS USA INC 300MG
A201567 001 Jan 17, 2014
WELLBUTRIN XL
AB3 VALEANT INTL 150MG
N021515 001 Aug 28, 2003
AB3 + 300MG
N021515 002 Aug 28, 2003
FORFIVO XL
+ EDGEMONT PHARMS LLC 450MG
N022497 001 Nov 10, 2011
BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
CONTRAVE
+ TAKEDA PHARMS USA 90MG;8MG N200063 001 Sep 10, 2014
BUSPIRONE HYDROCHLORIDE
TABLET;ORAL
BUSPIRONE HYDROCHLORIDE
AB ACCORD HLTHCARE 5MG A202557 001 Dec 30, 2014
AB 7.5MG A202557 002 Dec 30, 2014
AB 10MG A202557 003 Dec 30, 2014
AB 15MG A202557 004 Dec 30, 2014
AB 30MG A202557 005 Dec 30, 2014
AB DR REDDYS LABS LTD 5MG A078246 001 Feb 27, 2009
AB 10MG A078246 002 Feb 27, 2009
AB 15MG A078246 003 Feb 27, 2009
AB 30MG A078246 004 Feb 27, 2009
AB MYLAN 5MG A075272 001 Mar 01, 2002
AB 5MG A075467 001 Feb 28, 2002
AB 7.5MG A075467 002 Mar 28, 2001
AB 10MG A075272 002 Mar 01, 2002
AB 10MG A075467 003 Feb 28, 2002
AB 15MG A075272 003 Mar 28, 2001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-53(of 371)
BUSPIRONE HYDROCHLORIDE
TABLET;ORAL
BUSPIRONE HYDROCHLORIDE
AB 15MG
A075467 004 Feb 28, 2002
AB 30MG
A076008 001 Jun 28, 2001
AB PROSAM LABS 30MG
A078302 001 Dec 17, 2007
AB STRIDES ARCOLAB LTD 5MG
A202330 001 Aug 25, 2014
AB 10MG
A202330 002 Aug 25, 2014
AB 15MG
A202330 003 Aug 25, 2014
AB 30MG
A202330 004 Aug 25, 2014
AB TEVA 5MG
A075022 001 Feb 28, 2002
AB 10MG
A075022 002 Feb 28, 2002
AB + 15MG
A075022 003 Feb 28, 2002
AB 30MG
A075022 004 Mar 25, 2004
AB WATSON LABS 5MG
A074253 001 Mar 28, 2001
AB 10MG
A074253 002 Mar 28, 2001
AB 15MG
A074253 003 Mar 13, 2002
AB ZYDUS PHARMS USA INC 5MG
A078888 001 Feb 07, 2014
AB 10MG
A078888 002 Feb 07, 2014
AB 15MG
A078888 003 Feb 07, 2014
AB 30MG
A078888 004 Feb 07, 2014
BUSULFAN
INJECTABLE;INJECTION
BUSULFEX
+ OTSUKA PHARM
6MG/ML
N020954 001 Feb 04, 1999
TABLET;ORAL
MYLERAN
+ ASPEN GLOBAL
2MG
N009386 001
BUTABARBITAL SODIUM
ELIXIR;ORAL
BUTISOL SODIUM
+ MEDA PHARMS
30MG/5ML
A085380 001
TABLET;ORAL
BUTISOL SODIUM
+ MEDA PHARMS
30MG
N000793 004
+
50MG
N000793 003
BUTENAFINE HYDROCHLORIDE
CREAM;TOPICAL
MENTAX
+ MYLAN
1%
N020524 001 Oct 18, 1996
BUTOCONAZOLE NITRATE
CREAM;VAGINAL
BUTOCONAZOLE NITRATE
+ PERRIGO ISRAEL
2%
A200923 001 May 18, 2012
BUTORPHANOL TARTRATE
INJECTABLE;INJECTION
BUTORPHANOL TARTRATE
AP BEDFORD
2MG/ML
A075046 001 Aug 12, 1998
AP HIKMA FARMACEUTICA
1MG/ML
A078400 001 May 01, 2009
AP
2MG/ML
A078400 002 May 01, 2009
BUTORPHANOL TARTRATE PRESERVATIVE FREE
AP BEDFORD
1MG/ML
A075045 001 Aug 12, 1998
AP
2MG/ML
A075045 002 Aug 12, 1998
AP HOSPIRA
1MG/ML
A074626 001 Jan 23, 1997
AP
2MG/ML
A074626 002 Jan 23, 1997
SPRAY, METERED;NASAL
BUTORPHANOL TARTRATE
AB + MYLAN 1MG/SPRAY
A075759 001 Aug 08, 2001
AB NOVEX 1MG/SPRAY
A075499 001 Dec 04, 2002
AB ROXANE 1MG/SPRAY
A075824 001 Mar 12, 2002
CABAZITAXEL
SOLUTION;IV (INFUSION)
JEVTANA KIT
+ SANOFI AVENTIS US
60MG/1.5ML (40MG/ML)
N201023 001 Jun 17, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-54(of 371)
CABERGOLINE
TABLET;ORAL
CABERGOLINE
AB ACTAVIS LABS FL INC 0.5MG A078035 001 Apr 21, 2008
AB APOTEX CORP 0.5MG A201503 001 Mar 08, 2013
AB IMPAX LABS INC 0.5MG A077843 001 Jul 03, 2007
AB IVAX SUB TEVA PHARMS 0.5MG A077750 001 Mar 07, 2007
AB MYLAN PHARMS INC 0.5MG A202947 001 Dec 02, 2013
AB + PAR PHARM 0.5MG A076310 001 Dec 29, 2005
CABOZANTINIB S-MALATE
CAPSULE;ORAL
COMETRIQ
EXELIXIS EQ 20MG BASE N203756 001 Nov 29, 2012
+ EQ 80MG BASE N203756 002 Nov 29, 2012
CAFFEINE CITRATE
SOLUTION;INTRAVENOUS
CAFCIT
AP + EUROHLTH INTL EQ 30MG BASE/3ML (EQ 10MG BASE/ML) N020793 001 Sep 21, 1999
CAFFEINE CITRATE
AP EXELA PHARMA SCIENCE EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A077233 001 Sep 21, 2006
AP FRESENIUS KABI USA EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A077997 001 Jul 20, 2007
AP LUITPOLD EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A077906 001 May 15, 2007
AP SAGENT PHARMS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A090827 001 Aug 29, 2012
AP SUN PHARMA GLOBAL EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A090077 001 Sep 30, 2009
SOLUTION;ORAL
CAFCIT
AA + EUROHLTH INTL EQ 30MG BASE/3ML (EQ 10MG BASE/ML) N020793 002 Apr 12, 2000
CAFFEINE CITRATE
AA EXELA PHARMA SCS LLC EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A077304 001 Sep 21, 2006
AA FRESENIUS KABI USA EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A078002 001 Jan 31, 2008
AA LUITPOLD EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A090064 001 Nov 20, 2009
AA SAGENT PHARMS EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A091102 001 Aug 29, 2012
AA SUN PHARMA GLOBAL EQ 30MG BASE/3ML (EQ 10MG BASE/ML) A090357 001 Sep 30, 2009
CAFFEINE; ERGOTAMINE TARTRATE
SUPPOSITORY;RECTAL
MIGERGOT
+ CREALTA PHARMS LLC 100MG;2MG A086557 001 Oct 04, 1983
TABLET;ORAL
CAFERGOT
AA + SANDOZ 100MG;1MG A084294 001
ERGOTAMINE TARTRATE AND CAFFEINE
AA HIKMA INTL PHARMS 100MG;1MG A040510 001 Sep 17, 2004
AA MIKART 100MG;1MG A040590 001 Sep 16, 2005
CALCIPOTRIENE
AEROSOL, FOAM;TOPICAL
SORILUX
+ STIEFEL LABS INC 0.005% N022563 001 Oct 06, 2010
CREAM;TOPICAL
CALCIPOTRIENE
AB TOLMAR 0.005% A200935 001 May 30, 2012
DOVONEX
AB + LEO PHARMA AS 0.005% N020554 001 Jul 22, 1996
OINTMENT;TOPICAL
CALCIPOTRIENE
+ GLENMARK GENERICS 0.005% A090633 001 Mar 24, 2010
SOLUTION;TOPICAL
CALCIPOTRIENE
AT FOUGERA PHARMS 0.005% A078305 001 May 06, 2008
AT G AND W LABS INC 0.005% A078468 001 Mar 24, 2011
AT HI TECH PHARMA 0.005% A077579 001 Nov 19, 2009
AT + TOLMAR 0.005% A077029 001 Nov 20, 2009
CALCITONIN SALMON
INJECTABLE;INJECTION
MIACALCIN
+ SEBELA IRELAND LTD 200 IU/ML N017808 002 Mar 29, 1991
SPRAY, METERED;NASAL
CALCITONIN-SALMON
AB APOTEX INC 200 IU/SPRAY A076396 001 Nov 17, 2008
AB PAR PHARM 200 IU/SPRAY A076979 001 Jun 08, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-55(of 371)
CALCITONIN SALMON
SPRAY, METERED;NASAL
MIACALCIN
AB + SEBELA IRELAND LTD 200 IU/SPRAY N020313 002 Aug 17, 1995
CALCITONIN SALMON RECOMBINANT
SPRAY, METERED;NASAL
FORTICAL
+ UPSHER SMITH 200 IU/SPRAY N021406 001 Aug 12, 2005
CALCITRIOL
CAPSULE;ORAL
CALCITRIOL
AB BANNER PHARMACAPS 0.25MCG A091174 001 May 24, 2013
AB 0.5MCG A091174 002 May 24, 2013
AB ROXANE 0.25MCG A076917 001 Mar 27, 2006
AB STRIDES ARCOLAB LTD 0.25MCG A091356 001 Dec 12, 2014
AB 0.5MCG A091356 002 Dec 12, 2014
AB TEVA 0.25MCG A075765 001 Oct 12, 2001
AB 0.5MCG A075765 002 Oct 12, 2001
ROCALTROL
AB VALIDUS PHARMS 0.25MCG N018044 001
AB + 0.5MCG N018044 002
INJECTABLE;INJECTION
CALCIJEX
AP + ABBVIE 0.001MG/ML N018874 001 Sep 25, 1986
AP + 0.002MG/ML N018874 002 Sep 25, 1986
CALCITRIOL
AP AKORN 0.001MG/ML A078066 001 Jan 29, 2008
AP 0.002MG/ML A078066 002 Jan 29, 2008
AP FRESENIUS KABI USA 0.001MG/ML A075836 001 Dec 31, 2002
AP 0.002MG/ML A075836 002 Dec 31, 2002
AP FRESENIUS MEDCL 0.001MG/ML A075766 001 Feb 20, 2003
AP 0.002MG/ML A075766 002 Feb 20, 2003
AP LUITPOLD 0.001MG/ML A075746 001 Sep 26, 2003
AP 0.002MG/ML A075746 002 Sep 26, 2003
AP ROCKWELL MEDCL 0.001MG/ML A076206 001 Sep 17, 2003
AP SAGENT PHARMS 0.001MG/ML A077102 001 Feb 08, 2006
OINTMENT;TOPICAL
VECTICAL
+ GALDERMA LABS LP 3MCG/GM N022087 001 Jan 23, 2009
SOLUTION;ORAL
CALCITRIOL
AA ROXANE 1MCG/ML A076242 001 Jul 18, 2003
ROCALTROL
AA + VALIDUS PHARMS 1MCG/ML N021068 001 Nov 20, 1998
CALCIUM ACETATE
CAPSULE;ORAL
CALCIUM ACETATE
AB AMNEAL PHARMS EQ 169MG CALCIUM A201658 001 Oct 06, 2014
AB INVAGEN PHARMS EQ 169MG CALCIUM A203135 001 Feb 07, 2013
AB PADDOCK LLC EQ 169MG CALCIUM A091312 001 Jun 01, 2012
AB ROXANE EQ 169MG CALCIUM A077728 001 Feb 26, 2008
PHOSLO GELCAPS
AB + FRESENIUS MEDCL EQ 169MG CALCIUM N021160 003 Apr 02, 2001
SOLUTION;ORAL
PHOSLYRA
+ FRESENIUS MEDCL EQ 169MG CALCIUM/5ML N022581 001 Apr 18, 2011
TABLET;ORAL
CALCIUM ACETATE
AB INVAGEN PHARMS EQ 169MG CALCIUM A202420 001 Feb 05, 2013
AB PADDOCK LLC EQ 169MG CALCIUM A091561 001 Apr 13, 2011
ELIPHOS
AB + CYPRESS PHARM EQ 169MG CALCIUM A078502 001 Nov 25, 2008
CALCIUM CHLORIDE
INJECTABLE;INJECTION
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER
+ HOSPIRA 100MG/ML N021117 001 Jan 28, 2000
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-56(of 371)
CALCIUM CHLORIDE; DEXTROSE; GLUTATHIONE DISULFIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM
BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE
SOLUTION;IRRIGATION
BSS PLUS
AT + ALCON 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/M N018469 001
L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M
L
ENDOSOL EXTRA
AT + AKORN 0.154MG/ML;0.92MG/ML;0.184MG/ML;0.2MG/M N020079 001 Nov 27, 1991
L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M
L
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM
BICARBONATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0
N021703 010 Oct 10, 2008
5GM/1000ML;0.157GM/1000ML;2.21GM/1000ML
;7.07GM/1000ML
PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0
N021703 011 Oct 10, 2008
5GM/1000ML;0.314GM/1000ML;2.21GM/1000ML
;7.07GM/1000ML
PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;
N021703 013 Oct 10, 2008
3.05GM/1000ML;0.314GM/1000ML;2.21GM/100
0ML;7.07GM/1000ML
PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;
N021703 006 Oct 25, 2006
3.05GM/1000ML;N/A/1000ML;3.09GM/1000ML;
6.46GM/1000ML
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.0
N021703 002 Oct 25, 2006
3GM/1000ML;0.157GM/1000ML;3.09GM/1000ML
;6.46GM/1000ML
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;
N021703 003 Oct 25, 2006
2.03GM/1000ML;0.157GM/1000ML;3.09GM/100
0ML;6.46GM/1000ML
PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS N/A/1000ML;20GM/1000ML;5.4GM/1000ML;2.4
N021703 015 Oct 10, 2008
4GM/1000ML;0.314GM/1000ML;3.09GM/1000ML
;6.46GM/1000ML
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;
N021703 004 Oct 25, 2006
3.05GM/1000ML;0.314GM/1000ML;3.09GM/100
0ML;6.46GM/1000ML
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS N/A/1000ML;N/A/1000ML;5.4GM/1000ML;2.44
N021703 014 Oct 10, 2008
GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46
GM/1000ML
PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER
+ GAMBRO RENAL PRODS 5.15GM/1000ML;N/A/1000ML;5.4GM/1000ML;2
N021703 001 Oct 25, 2006
.03GM/1000ML;N/A/1000ML;3.09GM/1000ML;6
.46GM/1000ML
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM
BICARBONATE; SODIUM CHLORIDE; SODIUM PHOSPHATE
SOLUTION;IRRIGATION
NAVSTEL
+ ALCON PHARMS LTD 0.154MG/ML;0.92MG/ML;0.2MG/ML;0.184MG/M N022193 001 Jul 24, 2008
L;0.38MG/ML;2.1MG/ML;7.14MG/ML;0.42MG/M
L
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM
CHLORIDE
INJECTABLE;INJECTION
ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER
+ B BRAUN 37MG/100ML;5GM/100ML;31MG/100ML;120MG/1 N019864 001 Jun 10, 1993
00ML;330MG/100ML;88MG/100ML
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM
CHLORIDE; SODIUM LACTATE
INJECTABLE;INJECTION
PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 37MG/100ML;5GM/100ML;30MG/100ML;119MG/1 N017390 001
00ML;161MG/100ML;94MG/100ML;138MG/100ML
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-57(of 371)
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
SOLUTION;INTRAPERITONEAL
DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER
+ B BRAUN 510MG/100ML;30GM/100ML;200MG/100ML;9.2G N018807 001 Aug 26, 1983
M/100ML;9.6GM/100ML
+ 510MG/100ML;30GM/100ML;200MG/100ML;9.4G N018807 003 Aug 26, 1983
M/100ML;11GM/100ML
DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER
+ B BRAUN 510MG/100ML;50GM/100ML;200MG/100ML;9.2G N018807 002 Aug 26, 1983
M/100ML;9.6GM/100ML
+ 510MG/100ML;50GM/100ML;200MG/100ML;9.4G N018807 004 Aug 26, 1983
M/100ML;11GM/100ML
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
SOLUTION;INTRAPERITONEAL
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5
N018379 002
67MG/100ML;392MG/100ML
AT 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5
N018883 001 Nov 30, 1984
67MG/100ML;392MG/100ML
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5
N018883 004 Nov 30, 1984
38MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;5
N020171 001 Aug 19, 1992
38MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5
N018379 003
67MG/100ML;392MG/100ML
AT 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5
N018883 002 Nov 30, 1984
67MG/100ML;392MG/100ML
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5
N018883 005 Nov 30, 1984
38MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;5
N020171 002 Aug 19, 1992
38MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;5
N018379 007 Jun 24, 1988
67MG/100ML;392MG/100ML
DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;
N018379 001
567MG/100ML;392MG/100ML
AT 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;
N018883 003 Nov 30, 1984
567MG/100ML;392MG/100ML
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;
N018883 006 Nov 30, 1984
538MG/100ML;448MG/100ML
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;
N020171 003 Aug 19, 1992
538MG/100ML;448MG/100ML
DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5
N018379 004 Jul 07, 1982
38MG/100ML;448MG/100ML
DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5
N018379 005 Jul 07, 1982
38MG/100ML;448MG/100ML
DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;5
N018379 008 Jun 24, 1988
38MG/100ML;448MG/100ML
DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
AT FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;
N018379 006 Jul 07, 1982
538MG/100ML;448MG/100ML
DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5
N017512 001
67MG/100ML;392MG/100ML
DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5
N017512 003
67MG/100ML;392MG/100ML
DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;
N017512 002
567MG/100ML;392MG/100ML
DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;5
N020183 001 Dec 04, 1992
38MG/100ML;448MG/100ML
DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;1.5GM/100ML;15.2MG/100ML;5
N017512 007 Jul 09, 1984
67MG/100ML;392MG/100ML
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-58(of 371)
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
SOLUTION;INTRAPERITONEAL
DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;2.5GM/100ML;15.2MG/100ML;5
N017512 008 Jul 09, 1984
67MG/100ML;392MG/100ML
DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;3.5GM/100ML;15.2MG/100ML;5
N017512 010 Nov 18, 1985
67MG/100ML;392MG/100ML
DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;4.25GM/100ML;15.2MG/100ML;
N017512 009 Jul 09, 1984
567MG/100ML;392MG/100ML
DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 18.3MG/100ML;1.5GM/100ML;5.08MG/100ML;5
N017512 004
38MG/100ML;448MG/100ML
AT 25.7MG/100ML;1.5GM/100ML;5.08MG/100ML;5
N020163 001 Dec 04, 1992
38MG/100ML;448MG/100ML
DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5
N017512 005
38MG/100ML;448MG/100ML
AT 25.7MG/100ML;2.5GM/100ML;5.08MG/100ML;5
N020163 002 Dec 04, 1992
38MG/100ML;448MG/100ML
DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;3.5GM/100ML;5.08MG/100ML;5
N017512 011 Nov 18, 1985
38MG/100ML;448MG/100ML
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;
N017512 006
538MG/100ML;448MG/100ML
AT 25.7MG/100ML;4.25GM/100ML;5.08MG/100ML;
N020163 003 Dec 04, 1992
538MG/100ML;448MG/100ML
DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER
B BRAUN 26MG/100ML;1.5GM/100ML;5MG/100ML;530MG/
N018460 007 Jan 29, 1986
100ML;450MG/100ML
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER
B BRAUN 26MG/100ML;2.5GM/100ML;5MG/100ML;530MG/
N018460 005 Nov 02, 1983
100ML;450MG/100ML
DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER
B BRAUN 26MG/100ML;4.25GM/100ML;5MG/100ML;530MG
N018460 009 Jan 29, 1986
/100ML;450MG/100ML
DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 18.3MG/100ML;2.5GM/100ML;5.08MG/100ML;5
N020183 002 Dec 04, 1992
38MG/100ML;448MG/100ML
DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 18.3MG/100ML;3.5GM/100ML;5.08MG/100ML;5
N020183 003 Dec 04, 1992
38MG/100ML;448MG/100ML
DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 18.3MG/100ML;4.25GM/100ML;5.08MG/100ML;
N020183 004 Dec 04, 1992
538MG/100ML;448MG/100ML
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM SULFATE; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM
CHLORIDE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE;INTRATHECAL
ELLIOTTS B SOLUTION
+ LUKARE MEDICAL LLC 0.2MG/ML;0.8MG/ML;0.3MG/ML;0.3MG/ML;1.9 N020577 001 Sep 27, 1996
MG/ML;7.3MG/ML;0.2MG/ML
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER
+ B BRAUN 20MG/100ML;5GM/100ML;30MG/100ML;380MG/1
N018258 001
00ML;600MG/100ML
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER
AP HOSPIRA 33MG/100ML;5GM/100ML;30MG/100ML;860MG/1 N018254 001
00ML
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER
AP B BRAUN 33MG/100ML;5GM/100ML;30MG/100ML;860MG/1 N020000 001 Apr 17, 1992
00ML
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
INJECTABLE;INJECTION
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
AP HOSPIRA 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N017608 001
00ML;310MG/100ML
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER
AP B BRAUN 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N019634 003 Feb 24, 1988
00ML;310MG/100ML
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-59(of 371)
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
INJECTABLE;INJECTION
LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1 N016679 001
00ML;310MG/100ML
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019367 006 Apr 05, 1985
100ML;310MG/100ML
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019367 004 Apr 05, 1985
100ML;310MG/100ML
AP 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019367 005 Apr 05, 1985
100ML;310MG/100ML
AP HOSPIRA 20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019685 002 Oct 17, 1988
100ML;310MG/100ML
AP 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019685 008 Oct 17, 1988
100ML;310MG/100ML
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019367 007 Apr 05, 1985
100ML;310MG/100ML
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019367 008 Apr 05, 1985
100ML;310MG/100ML
AP HOSPIRA 20MG/100ML;5GM/100ML;328MG/100ML;600MG/ N019685 004 Oct 17, 1988
100ML;310MG/100ML
DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER
B BRAUN 10MG/100ML;2.5GM/100ML;15MG/100ML;300MG N019634 001 Feb 24, 1988
/100ML;160MG/100ML
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
BAXTER HLTHCARE 20MG/100ML;5GM/100ML;105MG/100ML;600MG/ N019367 002 Apr 05, 1985
100ML;310MG/100ML
20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019367 003 Apr 05, 1985
100ML;310MG/100ML
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
BAXTER HLTHCARE 20MG/100ML;5GM/100ML;105MG/100ML;600MG/ N019367 001 Apr 05, 1985
100ML;310MG/100ML
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
TPN ELECTROLYTES IN PLASTIC CONTAINER
+ HOSPIRA 16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML; N018895 001 Jul 20, 1984
16.1MG/ML
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM
CITRATE
INJECTABLE;INJECTION
ISOLYTE E IN PLASTIC CONTAINER
+ B BRAUN 35MG/100ML;30MG/100ML;74MG/100ML;640MG/ N019718 001 Sep 29, 1989
100ML;500MG/100ML;74MG/100ML
SOLUTION;IRRIGATION
BALANCED SALT
AT AKORN 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6 A075503 001 Sep 27, 2006
.4MG/ML;1.7MG/ML
AT B BRAUN 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6 A091387 001 Feb 03, 2010
.4MG/ML;1.7MG/ML
BSS
AT + ALCON 0.48MG/ML;0.3MG/ML;0.75MG/ML;3.9MG/ML;6 N020742 001 Dec 10, 1997
.4MG/ML;1.7MG/ML
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM
LACTATE
INJECTABLE;INJECTION
PLASMA-LYTE R IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 36.8MG/100ML;30.5MG/100ML;74.6MG/100ML; N017438 001
640MG/100ML;496MG/100ML;89.6MG/100ML
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
SOLUTION;PERFUSION, CARDIAC
CARDIOPLEGIC IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 17.6MG/100ML;325.3MG/100ML;119.3MG/100M A075323 001 Apr 21, 2000
L;643MG/100ML
PLEGISOL IN PLASTIC CONTAINER
AT + HOSPIRA 17.6MG/100ML;325.3MG/100ML;119.3MG/100M N018608 001 Feb 26, 1982
L;643MG/100ML
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-60(of 371)
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
RINGER'S IN PLASTIC CONTAINER
AP B BRAUN 33MG/100ML;30MG/100ML;860MG/100ML N020002 001 Apr 17, 1992
AP BAXTER HLTHCARE 33MG/100ML;30MG/100ML;860MG/100ML N016693 001
AP HOSPIRA 33MG/100ML;30MG/100ML;860MG/100ML N018251 001
SOLUTION;IRRIGATION
RINGER'S IN PLASTIC CONTAINER
AT B BRAUN 33MG/100ML;30MG/100ML;860MG/100ML N018156 001
AT BAXTER HLTHCARE 33MG/100ML;30MG/100ML;860MG/100ML N018495 001 Feb 19, 1982
AT HOSPIRA 33MG/100ML;30MG/100ML;860MG/100ML N017635 001
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
INJECTABLE;INJECTION
LACTATED RINGER'S IN PLASTIC CONTAINER
AP B BRAUN 20MG/100ML;30MG/100ML;600MG/100ML;310MG N019632 001 Feb 29, 1988
/100ML
AP BAXTER HLTHCARE 20MG/100ML;30MG/100ML;600MG/100ML;310MG N016682 001
/100ML
AP HOSPIRA 20MG/100ML;30MG/100ML;600MG/100ML;310MG N017641 001
/100ML
SOLUTION;IRRIGATION
LACTATED RINGER'S IN PLASTIC CONTAINER
AT + B BRAUN 20MG/100ML;30MG/100ML;600MG/100ML;310MG N018681 001 Dec 27, 1982
/100ML
AT BAXTER HLTHCARE 20MG/100ML;30MG/100ML;600MG/100ML;310MG N018494 001 Feb 19, 1982
/100ML
AT + 20MG/100ML;30MG/100ML;600MG/100ML;310MG N018921 001 Apr 03, 1984
/100ML
AT + 20MG/100ML;30MG/100ML;600MG/100ML;310MG N019933 001 Aug 29, 1989
/100ML
AT + HOSPIRA 20MG/100ML;30MG/100ML;600MG/100ML;310MG N019416 001 Jan 17, 1986
/100ML
CALFACTANT
SUSPENSION;INTRATRACHEAL
INFASURF PRESERVATIVE FREE
+ ONY 35MG/ML N020521 001 Jul 01, 1998
CANAGLIFLOZIN
TABLET;ORAL
INVOKANA
JANSSEN PHARMS 100MG N204042 001 Mar 29, 2013
+ 300MG N204042 002 Mar 29, 2013
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE
TABLET;ORAL
INVOKAMET
JANSSEN PHARMS 50MG;500MG N204353 001 Aug 08, 2014
50MG;1GM N204353 002 Aug 08, 2014
150MG;500MG N204353 003 Aug 08, 2014
+ 150MG;1GM N204353 004 Aug 08, 2014
CANDESARTAN CILEXETIL
TABLET;ORAL
ATACAND
AB ASTRAZENECA 4MG N020838 001 Jun 04, 1998
AB 8MG N020838 002 Jun 04, 1998
AB 16MG N020838 003 Jun 04, 1998
AB + 32MG N020838 004 Jun 04, 1998
CANDESARTAN CILEXETIL
AB APOTEX INC 4MG A202079 001 Jan 10, 2014
AB 8MG A202079 002 Jan 10, 2014
AB 16MG A202079 003 Jan 10, 2014
AB 32MG A202079 004 Jan 10, 2014
AB SANDOZ 4MG A078702 001 May 03, 2013
AB 8MG A078702 002 May 03, 2013
AB 16MG A078702 003 May 03, 2013
AB 32MG A078702 004 May 03, 2013
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
TABLET;ORAL
ATACAND HCT
AB ASTRAZENECA 16MG;12.5MG N021093 001 Sep 05, 2000
AB 32MG;12.5MG N021093 002 Sep 05, 2000
AB + 32MG;25MG N021093 003 May 16, 2008
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-61(of 371)
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE
TABLET;ORAL
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE
AB APOTEX INC 16MG;12.5MG
A202884 001 Dec 04, 2012
AB 32MG;12.5MG
A202884 002 Dec 04, 2012
AB 32MG;25MG
A202884 003 Jun 03, 2013
AB DR REDDYS LABS LTD 16MG;12.5MG
A202965 001 Jun 03, 2013
AB 32MG;12.5MG
A202965 002 Jun 03, 2013
AB 32MG;25MG
A202965 003 Jun 03, 2013
AB MYLAN LABS 16MG;12.5MG
A090704 001 Dec 04, 2012
AB 32MG;12.5MG
A090704 002 Dec 04, 2012
AB 32MG;25MG
A090704 003 Dec 04, 2012
CAPECITABINE
TABLET;ORAL
CAPECITABINE
AB MYLAN PHARMS INC 150MG
A090943 001 Aug 08, 2014
AB 500MG
A090943 002 Aug 08, 2014
AB TEVA PHARMS USA 150MG
A091649 001 Sep 16, 2013
AB 500MG
A091649 002 Sep 16, 2013
XELODA
AB HOFFMANN LA ROCHE 150MG
N020896 001 Apr 30, 1998
AB + 500MG
N020896 002 Apr 30, 1998
CAPREOMYCIN SULFATE
INJECTABLE;INJECTION
CAPASTAT SULFATE
+ AKORN EQ 1GM BASE/VIAL
N050095 001
CAPSAICIN
PATCH;TOPICAL
QUTENZA
+ ACORDA 8%
N022395 001 Nov 16, 2009
CAPTOPRIL
TABLET;ORAL
CAPOTEN
AB PAR PHARM 12.5MG
N018343 005 Jan 17, 1985
AB 25MG
N018343 002
AB 50MG
N018343 001
AB + 100MG
N018343 003
CAPTOPRIL
AB APOTEX 12.5MG
A074737 001 Oct 28, 1998
AB 25MG
A074737 002 Oct 28, 1998
AB 50MG
A074737 003 Oct 28, 1998
AB 100MG
A074737 004 Oct 28, 1998
AB HIKMA PHARMS LLC 12.5MG
A074505 001 Feb 13, 1996
AB 25MG
A074505 002 Feb 13, 1996
AB 50MG
A074505 003 Feb 13, 1996
AB 100MG
A074505 004 Feb 13, 1996
AB MYLAN 12.5MG
A074434 001 Feb 13, 1996
AB 25MG
A074434 002 Feb 13, 1996
AB 50MG
A074434 003 Feb 13, 1996
AB 100MG
A074434 004 Feb 13, 1996
AB SANDOZ 12.5MG
A074363 001 Nov 09, 1995
AB 25MG
A074363 002 Nov 09, 1995
AB 50MG
A074363 003 Nov 09, 1995
AB 100MG
A074363 004 Nov 09, 1995
AB STASON 12.5MG
A074677 004 May 30, 1997
AB 25MG
A074677 002 May 30, 1997
AB 50MG
A074677 001 May 30, 1997
AB 100MG
A074677 003 May 30, 1997
AB TEVA 12.5MG
A074322 001 Feb 13, 1996
AB 25MG
A074322 002 Feb 13, 1996
AB 50MG
A074322 003 Feb 13, 1996
AB 100MG
A074322 004 Feb 13, 1996
AB WATSON LABS 12.5MG
A074386 001 May 23, 1996
AB 25MG
A074386 002 May 23, 1996
AB 50MG
A074386 003 May 23, 1996
AB 100MG
A074386 004 May 23, 1996
AB WOCKHARDT 12.5MG
A074532 001 Mar 28, 1997
AB 25MG
A074532 002 Mar 28, 1997
AB 50MG
A074532 003 Mar 28, 1997
AB 100MG
A074532 004 Mar 28, 1997
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-62(of 371)
CAPTOPRIL; HYDROCHLOROTHIAZIDE
TABLET;ORAL
CAPTOPRIL AND HYDROCHLOROTHIAZIDE
AB MYLAN 25MG;15MG A074896 001 Dec 29, 1997
AB + 25MG;25MG A074896 002 Dec 29, 1997
AB + 50MG;15MG A074896 004 Dec 29, 1997
AB 50MG;25MG A074896 003 Dec 29, 1997
AB TEVA 25MG;15MG A074827 001 Dec 29, 1997
AB 25MG;25MG A074827 002 Dec 29, 1997
AB 50MG;15MG A074827 004 Dec 29, 1997
AB 50MG;25MG A074827 003 Dec 29, 1997
CARBACHOL
SOLUTION;INTRAOCULAR
MIOSTAT
+ ALCON 0.01% N016968 001
CARBAMAZEPINE
CAPSULE, EXTENDED RELEASE;ORAL
CARBAMAZEPINE
AB APOTEX INC 100MG A078986 001 Nov 25, 2011
AB 200MG A078986 002 Nov 25, 2011
AB 300MG A078986 003 Nov 25, 2011
AB NOSTRUM 100MG A076697 001 May 20, 2011
AB 200MG A076697 002 May 20, 2011
AB 300MG A076697 003 May 20, 2011
AB TARO 100MG A201106 001 Jun 21, 2013
AB 200MG A201106 002 Jun 21, 2013
AB 300MG A201106 003 Jun 21, 2013
AB TEVA PHARMS 100MG A078592 001 Sep 20, 2012
AB 200MG A078592 002 Sep 20, 2012
AB 300MG A078592 003 Sep 20, 2012
CARBATROL
AB SHIRE 100MG N020712 003 Sep 30, 1997
AB 200MG N020712 001 Sep 30, 1997
AB + 300MG N020712 002 Sep 30, 1997
EQUETRO
VALIDUS PHARMS INC 100MG N021710 001 Dec 10, 2004
200MG N021710 002 Dec 10, 2004
+ 300MG N021710 003 Dec 10, 2004
SUSPENSION;ORAL
CARBAMAZEPINE
AB WOCKHARDT 100MG/5ML A075714 001 Jun 05, 2002
TEGRETOL
AB + NOVARTIS 100MG/5ML N018927 001 Dec 18, 1987
TERIL
AB TARO 100MG/5ML A076729 001 Sep 20, 2004
TABLET;ORAL
CARBAMAZEPINE
AB APOTEX INC 200MG A075948 001 Feb 27, 2002
AB TARO 200MG A074649 001 Oct 03, 1996
AB TORRENT PHARMS 200MG A077272 002 Dec 07, 2005
EPITOL
AB TEVA 200MG A070541 001 Sep 17, 1986
TEGRETOL
AB + NOVARTIS 200MG N016608 001
CARBAMAZEPINE
TORRENT PHARMS 100MG A077272 001 Dec 07, 2005
300MG A077272 003 Dec 07, 2005
400MG A077272 004 Dec 07, 2005
TABLET, CHEWABLE;ORAL
CARBAMAZEPINE
AB TARO PHARM INDS 100MG A075687 001 Oct 24, 2000
AB TORRENT PHARMS 100MG A075712 001 Jul 05, 2001
EPITOL
AB TEVA 100MG A073524 001 Jul 29, 1992
TEGRETOL
AB + NOVARTIS 100MG N018281 001
CARBAMAZEPINE
+ TARO PHARM INDS 200MG A075687 002 Jul 29, 2002
TABLET, EXTENDED RELEASE;ORAL
CARBAMAZEPINE
AB TARO 100MG A078115 001 Mar 31, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-63(of 371)
CARBAMAZEPINE
TABLET, EXTENDED RELEASE;ORAL
CARBAMAZEPINE
AB 200MG A078115 002 Mar 31, 2009
AB 400MG A078115 003 Mar 31, 2009
TEGRETOL-XR
AB NOVARTIS 100MG N020234 001 Mar 25, 1996
AB 200MG N020234 002 Mar 25, 1996
AB + 400MG N020234 003 Mar 25, 1996
CARBIDOPA
TABLET;ORAL
CARBIDOPA
AB AMERIGEN PHARMS LTD 25MG A203261 001 Mar 10, 2014
LODOSYN
AB + ATON 25MG N017830 001
CARBIDOPA; ENTACAPONE; LEVODOPA
TABLET;ORAL
CARBIDOPA, LEVODOPA AND ENTACAPONE
AB SUN PHARMA GLOBAL 25MG;200MG;100MG A079085 001 May 10, 2012
AB 37.5MG;200MG;150MG A079085 002 May 10, 2012
AB WOCKHARDT LTD 12.5MG;200MG;50MG A090786 001 Nov 20, 2012
AB 18.75MG;200MG;75MG A090833 001 Nov 20, 2012
AB 25MG;200MG;100MG A090833 002 Nov 20, 2012
AB 31.25MG;200MG;125MG A090833 003 Nov 20, 2012
AB 37.5MG;200MG;150MG A090833 004 Nov 20, 2012
AB 50MG;200MG;200MG A090833 005 Nov 20, 2012
STALEVO 100
AB ORION PHARMA 25MG;200MG;100MG N021485 002 Jun 11, 2003
STALEVO 125
AB ORION PHARMA 31.25MG;200MG;125MG N021485 006 Aug 29, 2008
STALEVO 150
AB ORION PHARMA 37.5MG;200MG;150MG N021485 003 Jun 11, 2003
STALEVO 200
AB + ORION PHARMA 50MG;200MG;200MG N021485 004 Aug 02, 2007
STALEVO 50
AB + ORION PHARMA 12.5MG;200MG;50MG N021485 001 Jun 11, 2003
STALEVO 75
AB ORION PHARMA 18.75MG;200MG;75MG N021485 005 Aug 29, 2008
CARBIDOPA; LEVODOPA
TABLET;ORAL
CARBIDOPA AND LEVODOPA
AB ACTAVIS ELIZABETH 10MG;100MG A074260 001 Sep 03, 1993
AB 25MG;100MG A074260 002 Sep 03, 1993
AB 25MG;250MG A074260 003 Sep 03, 1993
AB APOTEX INC 10MG;100MG A077120 001 Jun 02, 2008
AB 25MG;100MG A077120 002 Jun 02, 2008
AB 25MG;250MG A077120 003 Jun 02, 2008
AB MYLAN 10MG;100MG A090324 001 Sep 28, 2009
AB 25MG;100MG A090324 002 Sep 28, 2009
AB 25MG;250MG A090324 003 Sep 28, 2009
AB SUN PHARM INDS 10MG;100MG A078536 001 Oct 28, 2008
AB 25MG;100MG A078536 002 Oct 28, 2008
AB 25MG;250MG A078536 003 Oct 28, 2008
AB TEVA 10MG;100MG A073618 001 Aug 28, 1992
AB 25MG;100MG A073589 001 Aug 28, 1992
AB 25MG;250MG A073607 001 Aug 28, 1992
SINEMET
AB MERCK SHARP DOHME 10MG;100MG N017555 001
AB 25MG;100MG N017555 003
AB + 25MG;250MG N017555 002
TABLET, EXTENDED RELEASE;ORAL
CARBIDOPA AND LEVODOPA
AB ACCORD HLTHCARE 25MG;100MG A202323 001 Feb 08, 2013
AB 50MG;200MG A202323 002 Feb 08, 2013
AB APOTEX 25MG;100MG A076212 001 Jun 16, 2004
AB 50MG;200MG A076212 002 Jun 16, 2004
AB IMPAX LABS 25MG;100MG A076521 001 May 14, 2004
AB 50MG;200MG A076521 002 May 14, 2004
AB MYLAN 25MG;100MG A075091 002 Apr 21, 2000
AB 50MG;200MG A075091 001 Sep 30, 1999
AB SUN PHARM INDS 25MG;100MG A077828 001 Aug 23, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-64(of 371)
CARBIDOPA; LEVODOPA
TABLET, EXTENDED RELEASE;ORAL
CARBIDOPA AND LEVODOPA
AB 50MG;200MG A077828 002 Aug 23, 2007
SINEMET CR
AB MERCK SHARP DOHME 25MG;100MG N019856 002 Dec 24, 1992
AB + 50MG;200MG N019856 001 May 30, 1991
TABLET, ORALLY DISINTEGRATING;ORAL
CARBIDOPA AND LEVODOPA
AB MYLAN 10MG;100MG A078893 001 Sep 18, 2008
AB 25MG;100MG A078893 002 Sep 18, 2008
AB + 25MG;250MG A078893 003 Sep 18, 2008
AB SUN PHARMA GLOBAL 10MG;100MG A078690 001 Jul 31, 2009
AB 25MG;100MG A078690 002 Jul 31, 2009
AB 25MG;250MG A078690 003 Jul 31, 2009
CARBINOXAMINE MALEATE
SOLUTION;ORAL
CARBINOXAMINE MALEATE
AA CYPRESS PHARM 4MG/5ML A090418 001 May 04, 2010
AA + MIKART 4MG/5ML A040458 001 Apr 25, 2003
AA VINTAGE PHARMS 4MG/5ML A040814 001 Feb 26, 2008
SUSPENSION, EXTENDED RELEASE;ORAL
KARBINAL ER
+ TRIS PHARMA INC 4MG/5ML N022556 001 Mar 28, 2013
TABLET;ORAL
CARBINOXAMINE MALEATE
AA CYPRESS PHARM 4MG A090417 001 Aug 23, 2010
AA INVAGEN PHARMS 4MG A090435 001 Apr 15, 2010
AA + MIKART 4MG A040442 001 Mar 19, 2003
AA MISSION PHARMACAL CO 4MG A090756 001 May 27, 2011
AA VINTAGE PHARMS 4MG A040639 002 May 30, 2008
CARBOPLATIN
INJECTABLE;IV (INFUSION)
CARBOPLATIN
AP ACTAVIS TOTOWA 50MG/5ML (10MG/ML) A078732 001 Feb 06, 2012
AP 150MG/15ML (10MG/ML) A078732 002 Feb 06, 2012
AP 450MG/45ML (10MG/ML) A078732 003 Feb 06, 2012
AP 600MG/60ML (10MG/ML) A078732 004 Feb 06, 2012
AP AKORN 50MG/5ML (10MG/ML) A090475 001 Jul 29, 2009
AP 150MG/15ML (10MG/ML) A090475 002 Jul 29, 2009
AP 450MG/45ML (10MG/ML) A090475 003 Jul 29, 2009
AP 600MG/60ML (10MG/ML) A091268 002 Jul 28, 2010
AP CIPLA LTD 50MG/5ML (10MG/ML) A077861 001 Jan 18, 2007
AP 150MG/15ML (10MG/ML) A077861 002 Jan 18, 2007
AP 450MG/45ML (10MG/ML) A077861 003 Jan 18, 2007
AP 600MG/60ML (10MG/ML) A077861 004 Jan 18, 2007
AP EBEWE PHARMA 50MG/5ML (10MG/ML) A078280 001 May 08, 2008
AP 150MG/15ML (10MG/ML) A078280 002 May 08, 2008
AP 450MG/45ML (10MG/ML) A078280 003 May 08, 2008
AP EUROHLTH INTL 50MG/5ML (10MG/ML) A077244 001 Oct 15, 2004
AP 150MG/15ML (10MG/ML) A077244 002 Oct 15, 2004
AP 450MG/45ML (10MG/ML) A077244 003 Oct 15, 2004
AP 600MG/60ML (10MG/ML) A077244 004 Jan 20, 2006
AP FRESENIUS KABI ONCOL 50MG/5ML (10MG/ML) A077432 001 Sep 29, 2006
AP 150MG/15ML (10MG/ML) A077432 002 Sep 29, 2006
AP 450MG/45ML (10MG/ML) A077432 003 Sep 29, 2006
AP FRESENIUS KABI USA 450MG/45ML (10MG/ML) A077247 003 Oct 21, 2004
AP 450MG/45ML (10MG/ML) A077266 003 Feb 15, 2006
AP 600MG/60ML (10MG/ML) A077266 004 Feb 15, 2006
AP HOSPIRA 50MG/5ML (10MG/ML) A076517 001 Oct 14, 2004
AP 150MG/15ML (10MG/ML) A076517 002 Oct 14, 2004
AP 450MG/45ML (10MG/ML) A076517 003 Oct 14, 2004
AP 600MG/60ML (10MG/ML) A077059 001 Nov 23, 2004
AP MYLAN INSTITUTIONAL 50MG/5ML (10MG/ML) A077998 001 Apr 24, 2007
AP 150MG/15ML (10MG/ML) A077998 002 Apr 24, 2007
AP 450MG/45ML (10MG/ML) A077998 003 Apr 24, 2007
AP ONCO THERAPIES LTD 50MG/5ML (10MG/ML) A091063 001 Nov 09, 2011
AP 150MG/15ML (10MG/ML) A091063 002 Nov 09, 2011
AP 450MG/45ML (10MG/ML) A091063 003 Nov 09, 2011
AP 600MG/60ML (10MG/ML) A091063 004 Nov 09, 2011
AP + PHARMACHEMIE BV 50MG/5ML (10MG/ML) A077269 001 Oct 14, 2004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-65(of 371)
CARBOPLATIN
INJECTABLE;IV (INFUSION)
CARBOPLATIN
AP + 150MG/15ML (10MG/ML) A077269 002 Oct 14, 2004
AP + 450MG/45ML (10MG/ML) A077269 003 Oct 14, 2004
AP + 600MG/60ML (10MG/ML) A077269 004 Dec 28, 2007
AP PLIVA LACHEMA 50MG/5ML (10MG/ML) A078631 001 Dec 02, 2008
AP 150MG/15ML (10MG/ML) A078631 002 Dec 02, 2008
AP 450MG/45ML (10MG/ML) A078631 003 Dec 02, 2008
AP 600MG/60ML (10MG/ML) A078631 004 Dec 02, 2008
AP SAGENT PHARMS 50MG/5ML (10MG/ML) A077096 001 Jun 14, 2005
AP 150MG/15ML (10MG/ML) A077096 002 Jun 14, 2005
AP 450MG/45ML (10MG/ML) A077096 003 Jun 14, 2005
AP 600MG/60ML (10MG/ML) A077096 004 Jun 03, 2013
AP SUN PHARMA GLOBAL 50MG/5ML (10MG/ML) A077926 001 Sep 19, 2008
AP 150MG/15ML (10MG/ML) A077926 002 Sep 19, 2008
AP 450MG/45ML (10MG/ML) A077926 003 Sep 19, 2008
AP + TEVA PHARMS USA 50MG/5ML (10MG/ML) A077139 001 Sep 21, 2005
AP + 150MG/15ML (10MG/ML) A077139 002 Sep 21, 2005
AP + 450MG/45ML (10MG/ML) A077139 003 Sep 21, 2005
AP + 600MG/60ML (10MG/ML) A077139 004 Sep 21, 2005
+ ONCO THERAPIES LTD 1GM/100ML (10MG/ML) A091478 001 Nov 23, 2011
CARBOPROST TROMETHAMINE
INJECTABLE;INJECTION
HEMABATE
+ PHARMACIA AND UPJOHN EQ 0.25MG BASE/ML N017989 001
CARFILZOMIB
POWDER;INTRAVENOUS
KYPROLIS
+ ONYX PHARMS 60MG/VIAL N202714 001 Jul 20, 2012
CARGLUMIC ACID
TABLET;ORAL
CARBAGLU
+ ORPHAN EUROPE 200MG N022562 001 Mar 18, 2010
CARISOPRODOL
TABLET;ORAL
CARISOPRODOL
AA ACCELRX LABS 350MG A040576 001 Jun 07, 2005
AA AUROBINDO PHARMA 350MG A040792 001 Aug 06, 2009
AA MIRROR PHARMS 350MG A040823 001 Oct 22, 2008
AA MUTUAL PHARM 350MG A089346 001 Oct 17, 1991
AA NATCO PHARMA LTD 350MG A090988 001 Oct 28, 2014
AA ORIENT PHARMA CO LTD 350MG A205085 001 Oct 28, 2014
AA SCIEGEN PHARMS INC 350MG A203374 001 Jan 27, 2014
AA SUN PHARM INDS LTD 350MG A040755 001 Feb 27, 2007
AA VINTAGE PHARMS 350MG A040245 001 Sep 08, 1997
AA WATSON LABS 350MG A087499 001 Apr 20, 1982
SOMA
AA MEDA PHARMS 350MG N011792 001
+ 250MG N011792 004 Sep 13, 2007
CARMUSTINE
IMPLANT;INTRACRANIAL
GLIADEL
+ ARBOR PHARMS LLC 7.7MG N020637 001 Sep 23, 1996
INJECTABLE;INJECTION
BICNU
+ EMCURE PHARMS LTD 100MG/VIAL N017422 001
CARTEOLOL HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
CARTEOLOL HYDROCHLORIDE
AT ALCON 1% A075476 001 Jan 03, 2000
AT BAUSCH AND LOMB 1% A075546 001 Jan 20, 2000
OCUPRESS
AT + NOVARTIS 1% N019972 001 May 23, 1990
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-66(of 371)
CARVEDILOL
TABLET;ORAL
CARVEDILOL
AB APOTEX INC 3.125MG A078165 001 Sep 05, 2007
AB 6.25MG A078165 002 Sep 05, 2007
AB 12.5MG A078165 003 Sep 05, 2007
AB 25MG A078165 004 Sep 05, 2007
AB AUROBINDO PHARMA 3.125MG A078332 001 Sep 05, 2007
AB 6.25MG A078332 002 Sep 05, 2007
AB 12.5MG A078332 003 Sep 05, 2007
AB 25MG A078332 004 Sep 05, 2007
AB BEXIMCO USA 3.125MG A078384 001 Sep 05, 2007
AB 6.25MG A078384 002 Sep 05, 2007
AB 12.5MG A078384 003 Sep 05, 2007
AB 25MG A078384 004 Sep 05, 2007
AB CIPLA LTD 3.125MG A077474 001 Sep 05, 2007
AB 6.25MG A077474 002 Sep 05, 2007
AB 12.5MG A077474 003 Sep 05, 2007
AB 25MG A077474 004 Sep 05, 2007
AB DR REDDYS LABS LTD 3.125MG A076649 001 Sep 05, 2007
AB 6.25MG A076649 002 Sep 05, 2007
AB 12.5MG A076649 003 Sep 05, 2007
AB 25MG A076649 004 Sep 05, 2007
AB GLENMARK GENERICS 3.125MG A078251 001 Sep 05, 2007
AB 6.25MG A078251 002 Sep 05, 2007
AB 12.5MG A078251 003 Sep 05, 2007
AB 25MG A078251 004 Sep 05, 2007
AB HIKMA 3.125MG A077887 001 Sep 07, 2007
AB 6.25MG A077887 002 Sep 07, 2007
AB 12.5MG A077887 003 Sep 07, 2007
AB 25MG A077887 004 Sep 07, 2007
AB LUPIN 3.125MG A078217 001 Sep 05, 2007
AB 6.25MG A078217 002 Sep 05, 2007
AB 12.5MG A078217 003 Sep 05, 2007
AB 25MG A078217 004 Sep 05, 2007
AB MYLAN 3.125MG A077316 001 Sep 05, 2007
AB 6.25MG A077316 002 Sep 05, 2007
AB 12.5MG A077316 003 Sep 05, 2007
AB 25MG A077316 004 Sep 05, 2007
AB PLIVA HRVATSKA DOO 3.125MG A078240 001 Oct 30, 2007
AB 6.25MG A078240 002 Oct 30, 2007
AB 12.5MG A078240 003 Oct 30, 2007
AB 25MG A078240 004 Oct 30, 2007
AB RANBAXY 3.125MG A076989 001 Sep 05, 2007
AB 6.25MG A076989 002 Sep 05, 2007
AB 12.5MG A076989 003 Sep 05, 2007
AB 25MG A076989 004 Sep 05, 2007
AB SANDOZ 3.125MG A078227 001 Sep 05, 2007
AB 6.25MG A078227 002 Sep 05, 2007
AB 12.5MG A078227 003 Sep 05, 2007
AB 25MG A078227 004 Sep 05, 2007
AB SUN PHARM INDS INC 3.125MG A077346 004 Sep 05, 2007
AB 6.25MG A077346 001 Sep 05, 2007
AB 12.5MG A077346 002 Sep 05, 2007
AB 25MG A077346 003 Sep 05, 2007
AB TARO 3.125MG A077780 001 Sep 05, 2007
AB 6.25MG A077780 002 Sep 05, 2007
AB 12.5MG A077780 003 Sep 05, 2007
AB 25MG A077780 004 Sep 05, 2007
AB TEVA 3.125MG A076373 001 Sep 05, 2007
AB 6.25MG A076373 002 Sep 05, 2007
AB 12.5MG A076373 003 Sep 05, 2007
AB 25MG A076373 004 Sep 05, 2007
AB ZYDUS PHARMS USA INC 3.125MG A077614 004 Sep 05, 2007
AB 6.25MG A077614 001 Sep 05, 2007
AB 12.5MG A077614 002 Sep 05, 2007
AB 25MG A077614 003 Sep 05, 2007
COREG
AB SMITHKLINE BEECHAM 3.125MG N020297 004 May 29, 1997
AB 6.25MG N020297 003 Sep 14, 1995
AB + 12.5MG N020297 002 Sep 14, 1995
AB 25MG N020297 001 Sep 14, 1995
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-67(of 371)
CARVEDILOL PHOSPHATE
CAPSULE, EXTENDED RELEASE;ORAL
COREG CR
SB PHARMCO 10MG N022012 001 Oct 20, 2006
20MG N022012 002 Oct 20, 2006
+ 40MG N022012 003 Oct 20, 2006
80MG N022012 004 Oct 20, 2006
CASPOFUNGIN ACETATE
INJECTABLE;IV (INFUSION)
CANCIDAS
+ MERCK 50MG/VIAL N021227 001 Jan 26, 2001
+ 70MG/VIAL N021227 002 Jan 26, 2001
CEFACLOR
CAPSULE;ORAL
CEFACLOR
AB HIKMA EQ 250MG BASE A065350 001 Apr 03, 2007
AB + EQ 500MG BASE A065350 002 Apr 03, 2007
AB YUNG SHIN PHARM EQ 250MG BASE A065146 001 Jan 22, 2004
AB EQ 500MG BASE A065146 002 Jan 22, 2004
FOR SUSPENSION;ORAL
CEFACLOR
AB YUNG SHIN PHARM EQ 125MG BASE/5ML A065412 001 Feb 17, 2012
AB EQ 187MG BASE/5ML A065412 002 Feb 17, 2012
AB EQ 250MG BASE/5ML A065412 003 Feb 17, 2012
AB + EQ 375MG BASE/5ML A065412 004 Feb 17, 2012
TABLET, EXTENDED RELEASE;ORAL
CEFACLOR
TEVA EQ 375MG BASE A065058 001 Sep 04, 2002
+ EQ 500MG BASE A065058 002 Sep 04, 2002
CEFADROXIL/CEFADROXIL HEMIHYDRATE
CAPSULE;ORAL
CEFADROXIL
AB AUROBINDO PHARMA EQ 500MG BASE A065352 001 Jan 25, 2007
AB HIKMA EQ 500MG BASE A065311 001 Feb 07, 2006
AB LUPIN EQ 500MG BASE A065392 001 May 29, 2007
AB ORCHID HLTHCARE EQ 500MG BASE A065309 001 Sep 18, 2006
AB SANDOZ EQ 500MG BASE A062291 001
AB + TEVA PHARMS EQ 500MG BASE A065282 001 Jan 20, 2006
FOR SUSPENSION;ORAL
CEFADROXIL
AB AUROBINDO EQ 250MG BASE/5ML A065349 001 Apr 25, 2013
AB EQ 500MG BASE/5ML A065349 002 Apr 25, 2013
AB HIKMA PHARMS EQ 250MG BASE/5ML A091036 001 Nov 28, 2012
AB EQ 500MG BASE/5ML A091036 002 Nov 28, 2012
AB LUPIN EQ 250MG BASE/5ML A065396 001 Feb 21, 2008
AB + EQ 500MG BASE/5ML A065396 002 Feb 21, 2008
AB ORCHID HLTHCARE EQ 250MG BASE/5ML A065307 002 Oct 16, 2006
AB EQ 500MG BASE/5ML A065307 003 Oct 16, 2006
AB RANBAXY EQ 250MG BASE/5ML A065115 002 Mar 26, 2003
AB EQ 500MG BASE/5ML A065115 003 Mar 26, 2003
EQ 125MG BASE/5ML A065115 001 Mar 26, 2003
TABLET;ORAL
CEFADROXIL
AB HIKMA EQ 1GM BASE A065260 001 Mar 30, 2006
AB ORCHID HLTHCARE EQ 1GM BASE A065301 001 Sep 18, 2006
+ TEVA PHARMS EQ 1GM BASE A062774 001 Apr 08, 1987
CEFAZOLIN SODIUM
INJECTABLE;INJECTION
CEFAZOLIN SODIUM
AP ACS DOBFAR EQ 1GM BASE/VIAL A065303 002 Oct 22, 2008
AP EQ 10GM BASE/VIAL A065306 001 Oct 22, 2008
AP EQ 20GM BASE/VIAL A065306 002 Aug 18, 2014
AP EQ 500MG BASE/VIAL A065303 001 Oct 22, 2008
AP HIKMA FARMACEUTICA EQ 1GM BASE/VIAL A065047 002 Sep 18, 2001
AP EQ 10GM BASE/VIAL A065143 001 Oct 18, 2004
AP EQ 500MG BASE/VIAL A065047 001 Sep 18, 2001
AP + HOSPIRA INC EQ 1GM BASE/VIAL A065226 002 Apr 21, 2005
AP + EQ 1GM BASE/VIAL A065244 001 Aug 12, 2005
AP + EQ 10GM BASE/VIAL A065247 001 Aug 12, 2005
AP + EQ 500MG BASE/VIAL A065226 001 Apr 21, 2005
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-68(of 371)
CEFAZOLIN SODIUM
INJECTABLE;INJECTION
CEFAZOLIN SODIUM
AP SANDOZ EQ 1GM BASE/VIAL
A062831 002 Dec 09, 1988
AP EQ 1GM BASE/VIAL
A065345 001 May 09, 2007
AP EQ 10GM BASE/VIAL
A062831 003 Sep 25, 1992
AP EQ 500MG BASE/VIAL
A062831 001 Dec 09, 1988
AP STERI PHARMA EQ 1GM BASE/VIAL
A063207 001 Dec 27, 1991
AP EQ 10GM BASE/VIAL
A063209 001 Dec 27, 1991
AP + EQ 20GM BASE/VIAL
A063209 002 Apr 30, 1999
AP EQ 500MG BASE/VIAL
A063214 001 Dec 27, 1991
KEFZOL
AP ACS DOBFAR
EQ 1GM BASE/VIAL
A061773 003
AP
EQ 10GM BASE/VIAL
A061773 004
AP
EQ 500MG BASE/VIAL
A061773 002
ANCEF IN PLASTIC CONTAINER
+ BAXTER HLTHCARE
EQ 10MG BASE/ML
A063002 001 Mar 28, 1991
+
EQ 20MG BASE/ML
A063002 002 Mar 28, 1991
CEFAZOLIN AND DEXTROSE
+ B BRAUN
EQ 1GM BASE/VIAL
N050779 002 Jul 27, 2000
EQ 2GM BASE/VIAL
N050779 003 Jan 13, 2012
CEFAZOLIN SODIUM
+ SAMSON MEDCL
EQ 100GM BASE/VIAL
A065141 001 Nov 29, 2006
+
EQ 300GM BASE/VIAL
A065141 002 Nov 29, 2006
CEFDINIR
CAPSULE;ORAL
CEFDINIR
AB AUROBINDO PHARMA
300MG
A065434 001 Jan 07, 2008
AB LUPIN
300MG
A065264 001 May 19, 2006
AB ORCHID HLTHCARE
300MG
A065418 001 Jul 18, 2007
AB + SANDOZ
300MG
A065330 001 Apr 06, 2007
AB TEVA PHARMS
300MG
A065368 001 May 09, 2007
FOR SUSPENSION;ORAL
CEFDINIR
AB AUROBINDO PHARMA
125MG/5ML
A065473 001 Dec 14, 2007
AB
250MG/5ML
A065473 002 Dec 14, 2007
AB LUPIN
125MG/5ML
A065259 001 May 31, 2006
AB
250MG/5ML
A065259 002 May 07, 2007
AB ORCHID HLTHCARE
125MG/5ML
A065429 001 Jul 18, 2007
AB
250MG/5ML
A065429 002 Jul 18, 2007
AB SANDOZ
125MG/5ML
A065337 001 Apr 06, 2007
AB +
250MG/5ML
A065337 002 Apr 06, 2007
AB TEVA PHARMS
125MG/5ML
A065332 001 May 04, 2007
AB
250MG/5ML
A065332 002 May 04, 2007
CEFDITOREN PIVOXIL
TABLET;ORAL
SPECTRACEF
VANSEN PHARMA
200MG
N021222 001 Aug 29, 2001
+
400MG
N021222 002 Jul 21, 2008
CEFEPIME HYDROCHLORIDE
INJECTABLE;INJECTION
CEFEPIME HYDROCHLORIDE
AP ACS DOBFAR
EQ 1GM BASE/VIAL
A065441 001 Mar 20, 2008
AP
EQ 2GM BASE/VIAL
A065441 002 Mar 20, 2008
AP HOSPIRA INC
EQ 1GM BASE/VIAL
A065369 002 Jun 18, 2007
AP
EQ 1GM BASE/VIAL
A202268 001 Jul 30, 2012
AP
EQ 2GM BASE/VIAL
A065369 003 Jun 18, 2007
AP
EQ 2GM BASE/VIAL
A202268 002 Jul 30, 2012
AP
EQ 500MG BASE/VIAL
A065369 001 Jun 18, 2007
MAXIPIME
AP + HOSPIRA INC
EQ 1GM BASE/VIAL
N050679 002 Jan 18, 1996
AP +
EQ 2GM BASE/VIAL
N050679 003 Jan 18, 1996
AP +
EQ 500MG BASE/VIAL
N050679 001 Jan 18, 1996
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER
B BRAUN EQ 1GM BASE/VIAL N050821 001 May 06, 2010
EQ 2GM BASE/VIAL N050821 002 May 06, 2010
CEFEPIME IN PLASTIC CONTAINER
+ BAXTER HLTHCARE EQ 1GM BASE/50ML (EQ 20MG BASE/ML) N050817 001 Aug 05, 2008
+ EQ 2GM BASE/100ML (EQ 20MG BASE/ML) N050817 002 Aug 05, 2008
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-69(of 371)
CEFIXIME
CAPSULE;ORAL
SUPRAX
+ LUPIN LTD 400MG N203195 001 Jun 01, 2012
FOR SUSPENSION;ORAL
SUPRAX
+ LUPIN LTD 500MG/5ML N202091 001 Feb 20, 2013
LUPIN PHARMS 100MG/5ML A065129 001 Feb 23, 2004
200MG/5ML A065355 001 Apr 10, 2007
TABLET;ORAL
SUPRAX
+ LUPIN PHARMS 400MG A065130 001 Feb 12, 2004
TABLET, CHEWABLE;ORAL
SUPRAX
LUPIN LTD 100MG A065380 001 Oct 25, 2010
150MG A065380 002 Oct 25, 2010
+ 200MG A065380 003 Oct 25, 2010
CEFOTAXIME SODIUM
INJECTABLE;INJECTION
CEFOTAXIME
AP HIKMA EQ 1GM BASE/VIAL A065072 002 Nov 20, 2002
AP EQ 2GM BASE/VIAL A065072 003 Nov 20, 2002
AP EQ 10GM BASE/VIAL A065071 001 Nov 20, 2002
AP EQ 500MG BASE/VIAL A065072 001 Nov 20, 2002
AP WOCKHARDT EQ 1GM BASE/VIAL A065197 001 Aug 29, 2006
CEFOTAXIME SODIUM
AP HOSPIRA INC EQ 1GM BASE/VIAL A065290 002 Aug 11, 2006
AP EQ 1GM BASE/VIAL A065293 001 Aug 10, 2006
AP EQ 2GM BASE/VIAL A065290 003 Aug 11, 2006
AP EQ 2GM BASE/VIAL A065293 002 Aug 10, 2006
AP EQ 10GM BASE/VIAL A065292 001 Aug 10, 2006
AP EQ 500MG BASE/VIAL A065290 001 Aug 11, 2006
AP LUPIN EQ 1GM BASE/VIAL A065124 002 Sep 24, 2003
AP EQ 2GM BASE/VIAL A065124 003 Sep 24, 2003
AP EQ 500MG BASE/VIAL A065124 001 Sep 24, 2003
AP WOCKHARDT EQ 2GM BASE/VIAL A065197 003 Jun 20, 2008
AP EQ 500MG BASE/VIAL A065197 002 Jun 20, 2008
CLAFORAN
AP + SANOFI AVENTIS US EQ 1GM BASE/VIAL A062659 001 Jan 13, 1987
AP + EQ 1GM BASE/VIAL N050547 002
AP + EQ 2GM BASE/VIAL A062659 002 Jan 13, 1987
AP + EQ 2GM BASE/VIAL N050547 003
AP + EQ 10GM BASE/VIAL N050547 004 Dec 29, 1983
AP + EQ 500MG BASE/VIAL N050547 001
CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER
+ SANOFI AVENTIS US EQ 20MG BASE/ML N050596 002 May 20, 1985
+ EQ 40MG BASE/ML N050596 004 May 20, 1985
CEFOTETAN DISODIUM
INJECTABLE;INJECTION
CEFOTETAN
AP + FRESENIUS KABI USA EQ 1GM BASE/VIAL A065374 001 Aug 09, 2007
AP + EQ 2GM BASE/VIAL A065374 002 Aug 09, 2007
AP + EQ 10GM BASE/VIAL A065375 001 Aug 09, 2007
AP WEST-WARD PHARM CORP EQ 1GM BASE/VIAL A091031 001 Oct 26, 2011
AP EQ 2GM BASE/VIAL A091031 002 Oct 26, 2011
AP EQ 10GM BASE/VIAL A091030 001 Oct 26, 2011
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER
+ B BRAUN EQ 1GM BASE/VIAL A065430 001 Aug 09, 2007
+ EQ 2GM BASE/VIAL A065430 002 Aug 09, 2007
CEFOXITIN SODIUM
INJECTABLE;INJECTION
CEFOXITIN
AP + ACS DOBFAR EQ 1GM BASE/VIAL A065414 001 Jun 12, 2009
AP + EQ 2GM BASE/VIAL A065414 002 Jun 12, 2009
AP + EQ 10GM BASE/VIAL A065415 001 May 19, 2010
AP ANTIBIOTICOS BRASIL EQ 1GM BASE/VIAL A065467 001 Aug 31, 2011
AP EQ 2GM BASE/VIAL A065467 002 Aug 31, 2011
AP EQ 10GM BASE/VIAL A065464 001 Aug 31, 2011
AP HIKMA FARMACEUTICA EQ 1GM BASE/VIAL A065238 001 Mar 12, 2010
AP EQ 2GM BASE/VIAL A065238 002 Mar 12, 2010
AP EQ 10GM BASE/VIAL A065239 001 Mar 02, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-70(of 371)
CEFOXITIN SODIUM
INJECTABLE;INJECTION
CEFOXITIN
AP HIKMA MAPLE EQ 1GM BASE/VIAL A065051 001 Sep 11, 2000
AP EQ 2GM BASE/VIAL A065051 002 Sep 11, 2000
AP EQ 10GM BASE/VIAL A065050 001 Sep 11, 2000
AP HOSPIRA INC EQ 1GM BASE/VIAL A065313 001 Jan 23, 2006
AP EQ 2GM BASE/VIAL A065313 002 Jan 23, 2006
AP EQ 10GM BASE/VIAL A065312 001 Feb 13, 2006
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER
AP B BRAUN EQ 1GM BASE/VIAL A065214 001 Mar 10, 2006
AP EQ 2GM BASE/VIAL A065214 002 Mar 10, 2006
MEFOXIN IN PLASTIC CONTAINER
+ MYLAN INSTITUTIONAL EQ 20MG BASE/ML A063182 001 Jan 25, 1993
+ EQ 40MG BASE/ML A063182 002 Jan 25, 1993
CEFPODOXIME PROXETIL
FOR SUSPENSION;ORAL
CEFPODOXIME PROXETIL
AB AUROBINDO PHARMA LTD EQ 50MG BASE/5ML A065409 001 Jun 08, 2007
AB EQ 100MG BASE/5ML A065409 002 Jun 08, 2007
AB RANBAXY EQ 50MG BASE/5ML A065082 001 May 31, 2002
AB EQ 100MG BASE/5ML A065082 002 May 31, 2002
AB SANDOZ EQ 50MG BASE/5ML A090031 001 Jan 14, 2009
AB + EQ 100MG BASE/5ML A090031 002 Jan 14, 2009
TABLET;ORAL
CEFPODOXIME PROXETIL
AB AUROBINDO PHARMA EQ 100MG BASE A065370 001 Jun 11, 2007
AB EQ 200MG BASE A065370 002 Jun 11, 2007
AB ORCHID HLTHCARE EQ 100MG BASE A065388 001 Nov 14, 2007
AB EQ 200MG BASE A065388 002 Nov 14, 2007
AB RANBAXY EQ 100MG BASE A065083 001 Aug 20, 2003
AB EQ 200MG BASE A065083 002 Aug 20, 2003
AB SANDOZ EQ 100MG BASE A065462 001 May 28, 2008
AB + EQ 200MG BASE A065462 002 May 28, 2008
CEFPROZIL
FOR SUSPENSION;ORAL
CEFPROZIL
AB APOTEX INC 125MG/5ML A065351 001 Feb 29, 2012
AB 250MG/5ML A065351 002 Feb 29, 2012
AB AUROBINDO PHARMA 125MG/5ML A065381 001 Jan 30, 2007
AB 250MG/5ML A065381 002 Jan 30, 2007
AB LUPIN 125MG/5ML A065261 001 Dec 19, 2005
AB + 250MG/5ML A065261 002 Dec 19, 2005
AB ORCHID HLTHCARE 125MG/5ML A065284 002 Dec 30, 2005
AB 250MG/5ML A065284 001 Dec 30, 2005
AB SANDOZ 125MG/5ML A065257 001 Dec 08, 2005
AB 250MG/5ML A065257 002 Dec 08, 2005
AB TEVA PHARMS 125MG/5ML A065236 001 Dec 08, 2005
AB 250MG/5ML A065236 002 Dec 08, 2005
TABLET;ORAL
CEFPROZIL
AB APOTEX INC 250MG A065327 001 Mar 26, 2008
AB 500MG A065327 002 Mar 26, 2008
AB AUROBINDO PHARMA LTD 250MG A065340 001 May 24, 2007
AB 500MG A065340 002 May 24, 2007
AB LUPIN 250MG A065276 001 Dec 08, 2005
AB + 500MG A065276 002 Dec 08, 2005
AB ORCHID HLTHCARE 250MG A065267 001 Dec 19, 2005
AB 500MG A065267 002 Dec 19, 2005
AB SANDOZ 250MG A065235 001 Nov 14, 2005
AB 500MG A065235 002 Nov 14, 2005
AB TEVA 250MG A065208 001 Dec 06, 2005
AB 500MG A065208 002 Dec 06, 2005
AB WOCKHARDT 250MG A065428 001 Jun 14, 2007
AB 500MG A065428 002 Jun 14, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-71(of 371)
CEFTAROLINE FOSAMIL
POWDER;IV (INFUSION)
TEFLARO
CEREXA 400MG/VIAL N200327 001 Oct 29, 2010
+ 600MG/VIAL N200327 002 Oct 29, 2010
CEFTAZIDIME
INJECTABLE;INJECTION
CEFTAZIDIME
AP ACS DOBFAR 1GM/VIAL A062640 002 Nov 20, 1985
AP 2GM/VIAL A062640 003 Nov 20, 1985
AP 6GM/VIAL A062640 004 Feb 03, 1992
AP 500MG/VIAL A062640 001 Nov 20, 1985
AP WOCKHARDT 1GM/VIAL A065196 001 Oct 15, 2008
FORTAZ
AP + COVIS INJECTABLES 1GM/VIAL N050578 002 Jul 19, 1985
AP + 2GM/VIAL N050578 003 Jul 19, 1985
AP + 6GM/VIAL N050578 004 Jul 19, 1985
AP + 500MG/VIAL N050578 001 Jul 19, 1985
TAZICEF
AP HOSPIRA 1GM/VIAL A062662 002 Mar 06, 1986
AP 1GM/VIAL A064032 001 Oct 31, 1993
AP 2GM/VIAL A062662 003 Mar 06, 1986
AP 2GM/VIAL A064032 002 Oct 31, 1993
AP 6GM/VIAL A062662 004 Mar 06, 1986
AP 500MG/VIAL A062662 001 Mar 06, 1986
CEFTAZIDIME IN DEXTROSE CONTAINER
B BRAUN EQ 1GM BASE N050823 001 Jun 13, 2011
+ EQ 2GM BASE N050823 002 Jun 13, 2011
CEFTAZIDIME SODIUM
INJECTABLE;INJECTION
FORTAZ IN PLASTIC CONTAINER
+ COVIS INJECTABLES EQ 20MG BASE/ML N050634 002 Apr 28, 1989
+ EQ 40MG BASE/ML N050634 003 Apr 28, 1989
CEFTIBUTEN DIHYDRATE
CAPSULE;ORAL
CEDAX
+ PERNIX THERAP EQ 400MG BASE N050685 002 Dec 20, 1995
FOR SUSPENSION;ORAL
CEDAX
+ PERNIX THERAP EQ 90MG BASE/5ML N050686 001 Dec 20, 1995
+ EQ 180MG BASE/5ML N050686 002 Dec 20, 1995
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM
POWDER;IV (INFUSION)
ZERBAXA
+ CUBIST PHARMS EQ 1GM BASE/VIAL;EQ 0.5GM BASE/VIAL N206829 001 Dec 19, 2014
CEFTRIAXONE SODIUM
INJECTABLE;INJECTION
CEFTRIAXONE
AP ACS DOBFAR EQ 1GM BASE/VIAL A065329 002 Jul 24, 2008
AP EQ 2GM BASE/VIAL A065329 003 Jul 24, 2008
AP EQ 10GM BASE/VIAL A065328 001 Jul 24, 2008
AP EQ 500MG BASE/VIAL A065329 001 Jul 24, 2008
AP BEDFORD EQ 10GM BASE/VIAL A065475 001 Aug 18, 2008
AP HOSPIRA INC EQ 1GM BASE/VIAL A065231 001 Aug 02, 2005
AP EQ 1GM BASE/VIAL A202563 001 Aug 20, 2012
AP EQ 2GM BASE/VIAL A065231 002 Aug 02, 2005
AP EQ 2GM BASE/VIAL A202563 002 Aug 20, 2012
AP EQ 10GM BASE/VIAL A065232 001 Aug 02, 2005
AP LUPIN EQ 10GM BASE/VIAL A065263 001 Sep 12, 2006
AP + SANDOZ EQ 10GM BASE/VIAL A065168 001 May 17, 2005
AP + SANDOZ INC EQ 1GM BASE/VIAL A065204 001 May 03, 2005
AP + EQ 2GM BASE/VIAL A065204 002 May 03, 2005
AP STERI PHARMA EQ 10GM BASE/VIAL A065269 001 Feb 28, 2007
AP WOCKHARDT EQ 1GM BASE/VIAL A065180 001 May 12, 2006
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER
AP + B BRAUN EQ 1GM BASE/VIAL N050796 001 Apr 20, 2005
AP + EQ 2GM BASE/VIAL N050796 002 Apr 20, 2005
ROCEPHIN
AP + HOFFMANN LA ROCHE EQ 1GM BASE/VIAL A063239 003 Aug 13, 1993
AP + EQ 500MG BASE/VIAL A063239 002 Aug 13, 1993
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-72(of 371)
CEFTRIAXONE SODIUM
INJECTABLE;INJECTION
CEFTRIAXONE
SAMSON MEDCL EQ 100GM BASE/VIAL A090057 001 Apr 25, 2014
CEFTRIAXONE IN PLASTIC CONTAINER
+ BAXTER HLTHCARE EQ 20MG BASE/ML A065224 001 Aug 23, 2005
+ EQ 40MG BASE/ML A065224 002 Aug 23, 2005
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
CEFTRIAXONE
AP AKORN INC EQ 1GM BASE/VIAL A065305 003 Jan 11, 2008
AP EQ 2GM BASE/VIAL A065305 004 Jan 11, 2008
AP EQ 250MG BASE/VIAL A065305 001 Jan 11, 2008
AP EQ 500MG BASE/VIAL A065305 002 Jan 11, 2008
AP BEDFORD EQ 1GM BASE/VIAL A065465 003 Aug 18, 2008
AP EQ 2GM BASE/VIAL A065465 004 Aug 18, 2008
AP EQ 250MG BASE/VIAL A065465 001 Aug 18, 2008
AP EQ 500MG BASE/VIAL A065465 002 Aug 18, 2008
AP FRESENIUS KABI USA EQ 250MG BASE/VIAL A065245 001 Feb 15, 2006
AP HIKMA FARMACEUTICA EQ 1GM BASE/VIAL A065342 003 Jan 10, 2008
AP EQ 2GM BASE/VIAL A065342 004 Jan 10, 2008
AP EQ 250MG BASE/VIAL A065342 001 Jan 10, 2008
AP EQ 500MG BASE/VIAL A065342 002 Jan 10, 2008
AP HOSPIRA INC EQ 1GM BASE/VIAL A065230 003 Aug 02, 2005
AP EQ 2GM BASE/VIAL A065230 004 Aug 02, 2005
AP EQ 250MG BASE/VIAL A065230 001 Aug 02, 2005
AP EQ 500MG BASE/VIAL A065230 002 Aug 02, 2005
AP LUPIN EQ 1GM BASE/VIAL A065125 003 Sep 30, 2003
AP EQ 2GM BASE/VIAL A065125 004 Sep 30, 2003
AP EQ 250MG BASE/VIAL A065125 001 Sep 30, 2003
AP EQ 500MG BASE/VIAL A065125 002 Sep 30, 2003
AP + SANDOZ EQ 1GM BASE/VIAL A065169 003 May 09, 2005
AP + EQ 2GM BASE/VIAL A065169 004 May 09, 2005
AP + EQ 250MG BASE/VIAL A065169 001 May 09, 2005
AP + EQ 500MG BASE/VIAL A065169 002 May 09, 2005
AP WOCKHARDT EQ 2GM BASE/VIAL A065391 003 Apr 12, 2007
AP EQ 250MG BASE/VIAL A065391 001 Apr 12, 2007
AP EQ 500MG BASE/VIAL A065391 002 Apr 12, 2007
CEFUROXIME AXETIL
FOR SUSPENSION;ORAL
CEFTIN
AB GLAXOSMITHKLINE EQ 125MG BASE/5ML N050672 001 Jun 30, 1994
AB + EQ 250MG BASE/5ML N050672 002 Apr 29, 1997
CEFUROXIME AXETIL
AB RANBAXY EQ 125MG BASE/5ML A065323 001 Feb 05, 2008
AB EQ 250MG BASE/5ML A065323 002 Feb 05, 2008
TABLET;ORAL
CEFTIN
AB GLAXOSMITHKLINE EQ 125MG BASE N050605 001 Dec 28, 1987
AB EQ 250MG BASE N050605 002 Dec 28, 1987
AB + EQ 500MG BASE N050605 003 Dec 28, 1987
CEFUROXIME AXETIL
AB ALKEM LABS LTD EQ 250MG BASE A065496 001 Jun 07, 2010
AB EQ 500MG BASE A065496 002 Jun 07, 2010
AB APOTEX EQ 250MG BASE A065069 001 Oct 02, 2002
AB EQ 500MG BASE A065069 002 Oct 02, 2002
AB AUROBINDO PHARMA LTD EQ 125MG BASE A065308 001 Mar 29, 2006
AB EQ 250MG BASE A065308 002 Mar 29, 2006
AB EQ 500MG BASE A065308 003 Mar 29, 2006
AB LUPIN EQ 250MG BASE A065135 001 Jul 25, 2003
AB EQ 500MG BASE A065135 002 Jul 25, 2003
AB ORCHID HLTHCARE EQ 125MG BASE A065359 001 Feb 15, 2008
AB EQ 250MG BASE A065359 002 Feb 15, 2008
AB EQ 500MG BASE A065359 003 Feb 15, 2008
AB RANBAXY EQ 125MG BASE A065118 001 Apr 25, 2003
AB EQ 250MG BASE A065118 002 Apr 25, 2003
AB EQ 500MG BASE A065118 003 Apr 25, 2003
AB TEVA EQ 250MG BASE A065190 001 Oct 18, 2004
AB EQ 500MG BASE A065190 002 Oct 18, 2004
AB WOCKHARDT EQ 125MG BASE A065166 001 Jul 29, 2005
AB EQ 250MG BASE A065166 002 Jul 29, 2005
AB EQ 500MG BASE A065166 003 Jul 29, 2005
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-73(of 371)
CEFUROXIME SODIUM
INJECTABLE;INJECTION
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER
AP + B BRAUN EQ 1.5GM BASE/VIAL N050780 002 Feb 21, 2001
AP + EQ 750MG BASE/VIAL N050780 001 Feb 21, 2001
CEFUROXIME SODIUM
AP HIKMA FARMACEUTICA EQ 1.5GM BASE/VIAL A065048 002 Jan 09, 2004
AP EQ 7.5GM BASE/VIAL A065046 001 Jan 09, 2004
AP HOSPIRA INC EQ 1.5GM BASE/VIAL A065483 002 Oct 15, 2008
AP EQ 1.5GM BASE/VIAL A065503 001 Oct 15, 2008
AP EQ 7.5GM BASE/VIAL A065484 001 Oct 15, 2008
AP STERI PHARMA EQ 1.5GM BASE/VIAL A064125 002 May 30, 1997
AP EQ 7.5GM BASE/VIAL A064124 001 May 30, 1997
ZINACEF
AP + COVIS INJECTABLES EQ 1.5GM BASE/VIAL N050558 003 Oct 19, 1983
AP + EQ 7.5GM BASE/VIAL N050558 004 Oct 23, 1986
ZINACEF IN PLASTIC CONTAINER
+ COVIS INJECTABLES EQ 30MG BASE/ML N050643 002 Apr 28, 1989
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
CEFUROXIME SODIUM
AB HIKMA FARMACEUTICA EQ 750MG BASE/VIAL A065048 001 Jan 09, 2004
AB STERI PHARMA EQ 750MG BASE/VIAL A064125 001 May 30, 1997
ZINACEF
AB + COVIS INJECTABLES EQ 750MG BASE/VIAL N050558 002 Oct 19, 1983
CEFUROXIME SODIUM
AP HOSPIRA INC EQ 750MG BASE/VIAL A065483 001 Oct 15, 2008
CELECOXIB
CAPSULE;ORAL
CELEBREX
AB GD SEARLE 50MG N020998 004 Dec 15, 2006
AB 100MG N020998 001 Dec 31, 1998
AB 200MG N020998 002 Dec 31, 1998
AB + 400MG N020998 003 Aug 29, 2002
CELECOXIB
AB LUPIN LTD 50MG A202240 001 Oct 29, 2014
AB MYLAN PHARMS INC 50MG A078857 001 May 30, 2014
AB TEVA 50MG A076898 001 May 30, 2014
AB 100MG A076898 002 May 30, 2014
AB 200MG A076898 003 May 30, 2014
AB 400MG A076898 004 May 30, 2014
CEPHALEXIN
CAPSULE;ORAL
CEPHALEXIN
AB ALKEM LABS LTD EQ 250MG BASE A090836 001 Dec 20, 2010
AB EQ 500MG BASE A090836 002 Dec 20, 2010
AB EQ 750MG BASE A090836 004 Mar 29, 2013
AB AUROBINDO PHARMA LTD EQ 250MG BASE A065253 001 Nov 16, 2005
AB EQ 500MG BASE A065253 002 Nov 16, 2005
AB BELCHER PHARMS EQ 250MG BASE A062713 001 Jul 15, 1988
AB EQ 500MG BASE A062713 002 Jul 15, 1988
AB HIKMA EQ 250MG BASE A065215 001 Jan 24, 2006
AB EQ 500MG BASE A065215 002 Jan 24, 2006
AB LUPIN EQ 250MG BASE A065229 001 Nov 25, 2005
AB EQ 500MG BASE A065229 002 Nov 25, 2005
AB ORCHID HLTHCARE EQ 250MG BASE A065248 001 Jun 28, 2005
AB EQ 500MG BASE A065248 002 Jun 28, 2005
AB RANBAXY EQ 250MG BASE A065007 001 Sep 16, 1999
AB EQ 500MG BASE A065007 002 Sep 16, 1999
AB SUN PHARM INDS (IN) EQ 250MG BASE A062791 001 Jun 11, 1987
AB EQ 500MG BASE A062791 002 Jun 11, 1987
AB TEVA EQ 250MG BASE A062702 001 Feb 13, 1987
AB EQ 500MG BASE A062702 002 Feb 13, 1987
AB YUNG SHIN PHARM EQ 250MG BASE A065152 001 Feb 24, 2005
AB EQ 500MG BASE A065152 002 Feb 24, 2005
KEFLEX
AB SHIONOGI INC EQ 250MG BASE N050405 002
AB EQ 500MG BASE N050405 003
AB + EQ 750MG BASE N050405 005 May 12, 2006
CEPHALEXIN
ALKEM LABS LTD EQ 333MG BASE A090836 003 Mar 29, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-74(of 371)
CEPHALEXIN
FOR SUSPENSION;ORAL
CEPHALEXIN
AB LUPIN EQ 125MG BASE/5ML A065234 001 Aug 17, 2005
AB EQ 250MG BASE/5ML A065234 002 Aug 17, 2005
AB ORCHID HLTHCARE EQ 125MG BASE/5ML A065326 001 Jul 10, 2006
AB EQ 250MG BASE/5ML A065326 002 Jul 10, 2006
AB TEVA EQ 125MG BASE/5ML A062703 001 Feb 13, 1987
AB + EQ 250MG BASE/5ML A062703 002 Feb 13, 1987
TABLET;ORAL
CEPHALEXIN
TEVA EQ 250MG BASE A063023 001 Jan 12, 1989
+ EQ 500MG BASE A063024 001 Jan 12, 1989
CERITINIB
CAPSULE;ORAL
ZYKADIA
+ NOVARTIS PHARMS CORP 150MG N205755 001 Apr 29, 2014
CETIRIZINE HYDROCHLORIDE
SYRUP;ORAL
CETIRIZINE HYDROCHLORIDE
AA AMNEAL PHARMS 5MG/5ML A090766 001 Oct 07, 2009
AA BIO PHARM INC 5MG/5ML A078870 001 Apr 27, 2009
AA BRECKENRIDGE PHARM 5MG/5ML A078488 001 Oct 06, 2008
AA PERRIGO R AND D 5MG/5ML A078398 001 Jun 17, 2008
AA SILARX 5MG/5ML A078876 001 May 11, 2012
AA SUN PHARM INDS INC 5MG/5ML A090191 001 Nov 12, 2009
AA TARO 5MG/5ML A076601 001 Jun 20, 2008
AA TEVA PHARMS 5MG/5ML A077279 001 May 27, 2008
AA VINTAGE 5MG/5ML A078496 001 Sep 25, 2009
AA WOCKHARDT 5MG/5ML A078757 001 Aug 28, 2009
ZYRTEC
AA + MCNEIL CONSUMER 5MG/5ML N020346 001 Sep 27, 1996
CETRORELIX
INJECTABLE;INJECTION
CETROTIDE
+ EMD SERONO INC EQ 0.25MG BASE/ML N021197 001 Aug 11, 2000
CEVIMELINE HYDROCHLORIDE
CAPSULE;ORAL
CEVIMELINE
AB APOTEX INC 30MG A091260 001 Aug 25, 2011
CEVIMELINE HYDROCHLORIDE
AB PACK PHARMS LLC 30MG A203775 001 Jun 04, 2014
AB ROXANE 30MG A091591 001 Jul 08, 2013
EVOXAC
AB + DAIICHI SANKYO 30MG N020989 002 Jan 11, 2000
CHENODIOL
TABLET;ORAL
CHENODIOL
+ NEXGEN PHARMA 250MG A091019 001 Oct 22, 2009
CHLORAMBUCIL
TABLET;ORAL
LEUKERAN
+ ASPEN GLOBAL INC 2MG N010669 002
CHLORAMPHENICOL SODIUM SUCCINATE
INJECTABLE;INJECTION
CHLORAMPHENICOL SODIUM SUCCINATE
+ FRESENIUS KABI USA EQ 1GM BASE/VIAL A062365 001 Aug 25, 1982
CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE;ORAL
CHLORDIAZEPOXIDE HYDROCHLORIDE
AB BARR 5MG A084768 001
AB 10MG A083116 001
AB 25MG A084769 001
AB USL PHARMA 10MG A084623 001
LIBRIUM
AB VALEANT PHARM INTL 5MG A085461 001
AB 10MG A085472 001
AB + 25MG A085475 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-75(of 371)
CHLORHEXIDINE GLUCONATE
SOLUTION;DENTAL
CHLORHEXIDINE GLUCONATE
AT HI TECH PHARMA 0.12% A074356 001 May 07, 1996
AT LYNE 0.12% A074291 001 Dec 28, 1995
AT TEVA 0.12% A074522 001 Dec 15, 1995
AT WOCKHARDT 0.12% A075006 001 Mar 03, 2004
AT XTTRIUM 0.12% A077789 001 Jun 18, 2009
PAROEX
AT SUNSTAR AMERICAS 0.12% A076434 001 Nov 29, 2005
PERIDEX
AT + 3M 0.12% N019028 001 Aug 13, 1986
PERIOGARD
AT COLGATE 0.12% A073695 001 Jan 14, 1994
TABLET;DENTAL
PERIOCHIP
+ DEXCEL PHARMA 2.5MG N020774 001 May 15, 1998
CHLOROPROCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
CHLOROPROCAINE HYDROCHLORIDE
AP EUROHLTH INTL 2% A040273 001 Sep 09, 1998
AP 3% A040273 002 Sep 09, 1998
AP HOSPIRA 2% A087447 001 Apr 16, 1982
AP 3% A087446 001 Apr 16, 1982
NESACAINE
AP FRESENIUS KABI USA 2% N009435 002
NESACAINE-MPF
AP + FRESENIUS KABI USA 2% N009435 006 May 02, 1996
AP + 3% N009435 007 May 02, 1996
NESACAINE
+ FRESENIUS KABI USA 1% N009435 001
CHLOROQUINE PHOSPHATE
TABLET;ORAL
ARALEN
AA + SANOFI AVENTIS US EQ 300MG BASE N006002 001
CHLOROQUINE PHOSPHATE
AA + HIKMA PHARMS LLC EQ 150MG BASE A083082 001
AA EQ 300MG BASE A083082 002 Sep 17, 1999
AA IMPAX LABS EQ 150MG BASE A080880 001
AA EQ 300MG BASE A040516 001 Aug 29, 2003
AA IPCA LABS LTD EQ 150MG BASE A090610 001 Dec 03, 2009
AA EQ 300MG BASE A090249 001 Dec 03, 2009
AA NATCO PHARMA LTD EQ 150MG BASE A091621 001 Jan 21, 2011
AA EQ 300MG BASE A090612 001 Jan 21, 2011
CHLOROTHIAZIDE
SUSPENSION;ORAL
DIURIL
+ SALIX PHARMS 250MG/5ML N011870 001
TABLET;ORAL
CHLOROTHIAZIDE
+ MYLAN 250MG A084388 001
500MG A084217 001
CHLOROTHIAZIDE SODIUM
INJECTABLE;INJECTION
CHLOROTHIAZIDE SODIUM
AP FRESENIUS KABI USA EQ 500MG BASE/VIAL A090896 001 Oct 16, 2009
AP LUITPOLD EQ 500MG BASE/VIAL A202561 001 Apr 22, 2013
AP MYLAN INSTITUTIONAL EQ 500MG BASE/VIAL A202493 001 Jun 18, 2014
AP SUN PHARMA GLOBAL EQ 500MG BASE/VIAL A091546 001 Jul 26, 2011
DIURIL
AP + OAK PHARMS AKORN EQ 500MG BASE/VIAL N011145 005
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE
SOLUTION;ORAL
VITUZ
+ CYPRESS PHARM 4MG/5ML;5MG/5ML N204307 001 Feb 20, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-76(of 371)
CHLORPHENIRAMINE MALEATE; HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE
SOLUTION;ORAL
HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
AA TRIS PHARMA INC 4MG/5ML;5MG/5ML;60MG/5ML A203838 001 Nov 26, 2014
HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
AA PADDOCK LLC 4MG/5ML;5MG/5ML;60MG/5ML A204627 001 Apr 29, 2014
ZUTRIPRO
AA + CYPRESS PHARM 4MG/5ML;5MG/5ML;60MG/5ML N022439 001 Jun 08, 2011
CHLORPHENIRAMINE POLISTIREX; HYDROCODONE POLISTIREX
CAPSULE, EXTENDED RELEASE;ORAL
TUSSICAPS
ECR PHARMA EQ 4MG MALEATE;EQ 5MG BITARTRATE A077273 002 Sep 24, 2007
+ EQ 8MG MALEATE;EQ 10MG BITARTRATE A077273 001 Sep 24, 2007
SUSPENSION, EXTENDED RELEASE;ORAL
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX
AB TRIS PHARMA INC EQ 8MG MALEATE/5ML;EQ 10MG A091632 001 Oct 01, 2010
BITARTRATE/5ML
HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX
AB NEOS THERAP INC EQ 8MG MALEATE/5ML;EQ 10MG A091671 001 Jun 29, 2012
BITARTRATE/5ML
TUSSIONEX PENNKINETIC
AB + UCB INC EQ 8MG MALEATE/5ML;EQ 10MG N019111 001 Dec 31, 1987
BITARTRATE/5ML
CHLORPROMAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
CHLORPROMAZINE HYDROCHLORIDE
+ HIKMA MAPLE 25MG/ML A083329 001
TABLET;ORAL
CHLORPROMAZINE HYDROCHLORIDE
BP SANDOZ 10MG A080439 001
BP 25MG A080439 002
BP 50MG A080439 003
BP + 100MG A080439 004
BP 200MG A080439 005
BP USL PHARMA 10MG A083386 001
BP 25MG A084112 001
BP 50MG A084113 001
BP 100MG A084114 001
BP 200MG A084115 001
CHLORPROPAMIDE
TABLET;ORAL
CHLORPROPAMIDE
AB ANI PHARMS INC 100MG A088921 001 Apr 12, 1985
AB 250MG A088922 001 Apr 12, 1985
AB MYLAN 100MG A088549 002 Jun 01, 1984
AB 250MG A088549 001 Jun 01, 1984
DIABINESE
AB PFIZER 100MG N011641 003
AB + 250MG N011641 006
CHLORTHALIDONE
TABLET;ORAL
CHLORTHALIDONE
MYLAN 25MG A086831 002
+ 50MG A086831 001
THALITONE
+ CITRON PHARMA LLC 15MG N019574 001 Dec 20, 1988
CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE
TABLET;ORAL
CLORPRES
MYLAN 15MG;0.1MG A071325 003 Feb 09, 1987
15MG;0.2MG A071325 002 Feb 09, 1987
+ 15MG;0.3MG A071325 001 Feb 09, 1987
CHLORZOXAZONE
TABLET;ORAL
CHLORZOXAZONE
AA BARR 500MG A089895 001 May 04, 1988
AA WATSON LABS 500MG A089859 001 May 04, 1988
PARAFON FORTE DSC
AA + JANSSEN R AND D 500MG N011529 002 Jun 15, 1987
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-77(of 371)
CHLORZOXAZONE
TABLET;ORAL
CHLORZOXAZONE
MIKART 375MG A040861 001 Jun 01, 2010
750MG A040861 002 Jun 01, 2010
CHOLESTYRAMINE
POWDER;ORAL
CHOLESTYRAMINE
AB PAR PHARM EQ 4GM RESIN/PACKET A077204 001 Aug 26, 2005
AB EQ 4GM RESIN/SCOOPFUL A077204 002 Aug 26, 2005
AB + SANDOZ EQ 4GM RESIN/PACKET A074557 001 Aug 15, 1996
AB EQ 4GM RESIN/SCOOPFUL A074557 002 Aug 15, 1996
CHOLESTYRAMINE LIGHT
AB PAR PHARM EQ 4GM RESIN/PACKET A077203 001 Aug 26, 2005
AB EQ 4GM RESIN/SCOOPFUL A077203 002 Aug 26, 2005
AB + SANDOZ EQ 4GM RESIN/PACKET A074558 001 Aug 15, 1996
AB EQ 4GM RESIN/SCOOPFUL A074558 002 Aug 15, 1996
PREVALITE
AB UPSHER SMITH EQ 4GM RESIN/PACKET A073263 001 Feb 22, 1996
AB EQ 4GM RESIN/SCOOPFUL A073263 002 Oct 30, 1997
CHOLINE C-11
INJECTABLE;INTRAVENOUS
CHOLINE C-11
+ MCPRF 4-33.1mCi/ML N203155 001 Sep 12, 2012
CHOLINE FENOFIBRATE
CAPSULE, DELAYED RELEASE;ORAL
FENOFIBRIC ACID
AB ANCHEN PHARMS EQ 45MG FENOFIBRIC ACID A201573 002 Jul 18, 2013
AB EQ 135MG FENOFIBRIC ACID A201573 001 Jul 18, 2013
AB LUPIN LTD EQ 45MG FENOFIBRIC ACID A200750 001 Dec 04, 2013
AB EQ 135MG FENOFIBRIC ACID A200750 002 Dec 04, 2013
AB MYLAN PHARMS INC EQ 45MG FENOFIBRIC ACID A200913 001 Mar 25, 2013
AB EQ 135MG FENOFIBRIC ACID A200913 002 Mar 25, 2013
TRILIPIX
AB ABBVIE EQ 45MG FENOFIBRIC ACID N022224 001 Dec 15, 2008
AB + EQ 135MG FENOFIBRIC ACID N022224 002 Dec 15, 2008
CHORIOGONADOTROPIN ALFA
INJECTABLE;SUBCUTANEOUS
OVIDREL
+ EMD SERONO EQ 0.25MG /0.5ML N021149 002 Oct 06, 2003
CHROMIC CHLORIDE
INJECTABLE;INJECTION
CHROMIC CHLORIDE IN PLASTIC CONTAINER
+ HOSPIRA EQ 0.004MG CHROMIUM/ML N018961 001 Jun 26, 1986
CICLESONIDE
AEROSOL, METERED;INHALATION
ALVESCO
TAKEDA GMBH 0.08MG/INH N021658 002 Jan 10, 2008
+ 0.16MG/INH N021658 003 Jan 10, 2008
AEROSOL, METERED;NASAL
ZETONNA
+ TAKEDA GMBH 0.037MG/INH N202129 001 Jan 20, 2012
SPRAY, METERED;NASAL
OMNARIS
+ TAKEDA GMBH 0.05MG/INH N022004 001 Oct 20, 2006
CICLOPIROX
CREAM;TOPICAL
CICLOPIROX
AB FOUGERA PHARMS 0.77% A076435 001 Dec 29, 2004
AB G AND W LABS INC 0.77% A078463 001 Dec 20, 2010
AB GLENMARK PHARMS 0.77% A090273 001 Nov 10, 2009
AB PERRIGO 0.77% A077364 001 Mar 03, 2006
AB TARO 0.77% A076790 001 Apr 12, 2005
LOPROX
AB + MEDIMETRIKS PHARMS 0.77% N018748 001 Dec 30, 1982
GEL;TOPICAL
CICLOPIROX
AB FOUGERA PHARMS 0.77% A077896 001 Jun 10, 2008
AB GLENMARK GENERICS 0.77% A091595 001 Feb 29, 2012
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-78(of 371)
CICLOPIROX
GEL;TOPICAL
CICLOPIROX
AB PADDOCK LLC 0.77% A078266 001 Jan 07, 2009
LOPROX
AB + CNTY LINE PHARMS 0.77% N020519 001 Jul 21, 1997
SHAMPOO;TOPICAL
CICLOPIROX
AT ACTAVIS MID ATLANTIC 1% A090490 001 Nov 24, 2009
AT FOUGERA PHARMS 1% A090146 001 May 25, 2010
AT PERRIGO 1% A078594 001 Feb 16, 2010
AT TARO 1% A090269 001 Feb 23, 2011
LOPROX
AT + MEDICIS 1% N021159 001 Feb 28, 2003
SOLUTION;TOPICAL
CICLOPIROX
AT ACTAVIS MID ATLANTIC 8% A078046 001 Sep 18, 2007
AT CIPLA LTD 8% A078124 001 Sep 18, 2007
AT G AND W LABS 8% A078233 001 Sep 18, 2007
AT HI TECH PHARMA 8% A078270 001 Sep 18, 2007
AT PERRIGO NEW YORK 8% A077623 001 Sep 18, 2007
AT TARO PHARM INDS 8% A078144 001 Sep 18, 2007
AT TOLMAR 8% A077687 001 Sep 18, 2007
AT VERSAPHARM 8% A078975 001 Feb 17, 2010
PENLAC
AT + VALEANT BERMUDA 8% N021022 001 Dec 17, 1999
SUSPENSION;TOPICAL
CICLOPIROX
AB FOUGERA PHARMS 0.77% A076422 001 Aug 06, 2004
AB PERRIGO NEW YORK 0.77% A077676 001 Dec 15, 2006
AB TARO 0.77% A077092 001 Aug 10, 2005
LOPROX
AB + MEDIMETRIKS PHARMS 0.77% N019824 001 Dec 30, 1988
CIDOFOVIR
INJECTABLE;INJECTION
CIDOFOVIR
AP EMCURE PHARMS LTD EQ 75MG BASE/ML A202501 001 Jul 26, 2012
AP MYLAN INSTITUTIONAL EQ 75MG BASE/ML A201276 001 Jun 27, 2012
VISTIDE
AP + GILEAD SCIENCES INC EQ 75MG BASE/ML N020638 001 Jun 26, 1996
CILASTATIN SODIUM; IMIPENEM
POWDER;INTRAMUSCULAR
PRIMAXIN
MERCK EQ 500MG BASE/VIAL;500MG/VIAL N050630 001 Dec 14, 1990
POWDER;INTRAVENOUS
IMIPENEM AND CILASTATIN
AP ACS DOBFAR EQ 250MG BASE/VIAL;250MG/VIAL A090577 001 Dec 21, 2011
AP EQ 500MG BASE/VIAL;500MG/VIAL A090577 002 Dec 21, 2011
AP HOSPIRA INC EQ 250MG BASE/VIAL;250MG/VIAL A090825 001 Nov 16, 2011
AP EQ 500MG BASE/VIAL;500MG/VIAL A090825 002 Nov 16, 2011
AP EQ 500MG BASE/VIAL;500MG/VIAL A091007 001 Nov 16, 2011
PRIMAXIN
AP + MERCK EQ 250MG BASE/VIAL;250MG/VIAL N050587 001 Nov 26, 1985
AP + EQ 500MG BASE/VIAL;500MG/VIAL N050587 002 Nov 26, 1985
CILOSTAZOL
TABLET;ORAL
CILOSTAZOL
AB APOTEX INC 50MG A077030 001 Dec 10, 2004
AB 100MG A077030 002 Dec 10, 2004
AB BIOKEY 50MG A077722 001 Sep 24, 2012
AB 100MG A077831 001 Sep 24, 2012
AB BRECKENRIDGE PHARM 50MG A077708 001 Sep 28, 2009
AB 100MG A077708 002 Sep 28, 2009
AB MYLAN 50MG A077323 002 Apr 20, 2006
AB 100MG A077323 001 Apr 20, 2006
AB MYLAN PHARMS INC 50MG A077019 001 Nov 23, 2004
AB 100MG A077019 002 Nov 23, 2004
AB PLIVA HRVATSKA DOO 50MG A077898 001 Oct 29, 2007
AB 100MG A077898 002 Oct 29, 2007
AB ROXANE 50MG A077024 001 May 17, 2005
AB 100MG A077024 002 May 17, 2005
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-79(of 371)
CILOSTAZOL
TABLET;ORAL
CILOSTAZOL
AB SANDOZ 50MG A077310 001 Nov 08, 2005
AB 100MG A077021 001 Nov 23, 2004
AB TEVA 50MG A077027 001 Nov 24, 2004
AB 100MG A077027 002 Nov 24, 2004
PLETAL
AB + OTSUKA 50MG N020863 001 Jan 15, 1999
AB + 100MG N020863 002 Jan 15, 1999
CIMETIDINE
TABLET;ORAL
CIMETIDINE
AB APOTEX 200MG A074890 001 Dec 18, 1998
AB 300MG A074890 002 Dec 18, 1998
AB 400MG A074890 003 Dec 18, 1998
AB 800MG A074890 004 Dec 18, 1998
AB MYLAN 200MG A074246 001 May 17, 1994
AB 300MG A074246 002 May 17, 1994
AB 400MG A074246 003 May 17, 1994
AB + 800MG A074246 004 May 17, 1994
AB PLIVA 800MG A074566 001 Feb 27, 1997
AB TEVA 200MG A074151 001 May 17, 1994
AB 300MG A074151 002 May 17, 1994
AB 400MG A074151 003 May 17, 1994
AB 800MG A074463 001 May 17, 1994
CIMETIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
CIMETIDINE HYDROCHLORIDE
AP DAVA PHARMS INC EQ 300MG BASE/2ML A074428 001 Apr 25, 1996
SOLUTION;ORAL
CIMETIDINE HYDROCHLORIDE
AA ANI PHARMS INC EQ 300MG BASE/5ML A074610 001 Sep 26, 1996
AA + HI TECH PHARMA EQ 300MG BASE/5ML A074664 001 Oct 28, 1997
AA PHARM ASSOC EQ 300MG BASE/5ML A074553 001 Jan 27, 1997
AA WOCKHARDT EQ 300MG BASE/5ML A074757 001 Oct 17, 1997
CINACALCET HYDROCHLORIDE
TABLET;ORAL
SENSIPAR
AMGEN EQ 30MG BASE N021688 001 Mar 08, 2004
EQ 60MG BASE N021688 002 Mar 08, 2004
+ EQ 90MG BASE N021688 003 Mar 08, 2004
CIPROFLOXACIN
FOR SUSPENSION;ORAL
CIPRO
AB BAYER HLTHCARE 250MG/5ML N020780 001 Sep 26, 1997
AB + 500MG/5ML N020780 002 Sep 26, 1997
CIPROFLOXACIN
AB LUPIN LTD 250MG/5ML A200563 001 Mar 05, 2014
AB 500MG/5ML A200563 002 Mar 05, 2014
INJECTABLE;INJECTION
CIPRO
AP + BAYER HLTHCARE 400MG/40ML (10MG/ML) N019847 001 Dec 26, 1990
AP + 200MG/20ML (10MG/ML) N019847 002 Dec 26, 1990
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + BAYER HLTHCARE 200MG/100ML N019857 001 Dec 26, 1990
AP + 400MG/200ML N019857 002 Dec 26, 1990
CIPROFLOXACIN
AP CLARIS LIFESCIENCES 200MG/20ML (10MG/ML) A078062 001 Apr 29, 2008
AP 400MG/40ML (10MG/ML) A078062 002 Apr 29, 2008
AP HIKMA FARMACEUTICA 200MG/20ML (10MG/ML) A076717 001 Dec 22, 2009
AP 400MG/40ML (10MG/ML) A076717 002 Dec 22, 2009
AP HOSPIRA 200MG/20ML (10MG/ML) A077245 001 Aug 28, 2006
AP 400MG/40ML (10MG/ML) A077245 002 Aug 28, 2006
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
AP ACS DOBFAR INFO SA 200MG/100ML A078252 001 Mar 18, 2008
AP 400MG/200ML A078252 002 Mar 18, 2008
AP CLARIS LIFESCIENCES 200MG/100ML A078024 001 Mar 18, 2008
AP 400MG/200ML A078024 002 Mar 18, 2008
AP HIKMA FARMACEUTICA 400MG/200ML A078431 001 Nov 18, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-80(of 371)
CIPROFLOXACIN
INJECTABLE;INJECTION
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
AP HOSPIRA
200MG/100ML
A077753 001 Mar 18, 2008
AP
400MG/200ML
A077753 002 Mar 18, 2008
CIPROFLOXACIN HYDROCHLORIDE
OINTMENT;OPHTHALMIC
CILOXAN
+ ALCON PHARMS LTD
EQ 0.3% BASE
N020369 001 Mar 30, 1998
SOLUTION/DROPS;OPHTHALMIC
CILOXAN
AT + ALCON PHARMS LTD
EQ 0.3% BASE
N019992 001 Dec 31, 1990
CIPROFLOXACIN HYDROCHLORIDE
AT AKORN INC
EQ 0.3% BASE
A076555 001 Dec 11, 2008
AT FDC LTD
EQ 0.3% BASE
A077568 001 Jun 30, 2008
AT IGI LABS INC
EQ 0.3% BASE
A076754 001 Jun 09, 2004
AT NEXUS PHARMS
EQ 0.3% BASE
A077689 001 Dec 13, 2006
AT PHARMAFORCE
EQ 0.3% BASE
A078598 001 Jan 16, 2008
AT WATSON LABS INC
EQ 0.3% BASE
A076673 001 Jan 21, 2005
SOLUTION/DROPS;OTIC
CETRAXAL
+ WRASER PHARMS
EQ 0.2% BASE
N021918 001 May 01, 2009
TABLET;ORAL
CIPRO
AB BAYER HLTHCARE
EQ 100MG BASE
N019537 001 Apr 08, 1996
AB
EQ 250MG BASE
N019537 002 Oct 22, 1987
AB +
EQ 500MG BASE
N019537 003 Oct 22, 1987
AB
EQ 750MG BASE
N019537 004 Oct 22, 1987
CIPROFLOXACIN HYDROCHLORIDE
AB APOTEX
EQ 250MG BASE
A076896 001 Nov 04, 2004
AB
EQ 500MG BASE
A076896 002 Nov 04, 2004
AB
EQ 750MG BASE
A076896 003 Nov 04, 2004
AB AUROBINDO PHARMA
EQ 250MG BASE
A077859 001 Apr 26, 2007
AB
EQ 500MG BASE
A077859 002 Apr 26, 2007
AB
EQ 750MG BASE
A077859 003 Apr 26, 2007
AB CARLSBAD
EQ 250MG BASE
A076126 002 Jun 09, 2004
AB
EQ 500MG BASE
A076126 003 Jun 09, 2004
AB
EQ 750MG BASE
A076126 004 Jun 09, 2004
AB DR REDDYS LABS LTD
EQ 100MG BASE
A075593 002 Jun 09, 2004
AB
EQ 250MG BASE
A075593 003 Jun 09, 2004
AB
EQ 500MG BASE
A075593 004 Jun 09, 2004
AB
EQ 750MG BASE
A075593 001 Jun 09, 2004
AB HIKMA
EQ 250MG BASE
A076558 002 Jun 09, 2004
AB
EQ 500MG BASE
A076558 003 Jun 09, 2004
AB
EQ 750MG BASE
A076558 004 Jun 09, 2004
AB IVAX SUB TEVA PHARMS
EQ 250MG BASE
A076089 002 Jun 09, 2004
AB
EQ 500MG BASE
A076089 003 Jun 09, 2004
AB
EQ 750MG BASE
A076089 004 Jun 09, 2004
AB MYLAN
EQ 100MG BASE
A075817 001 Jun 25, 2007
AB
EQ 250MG BASE
A075685 002 Jun 09, 2004
AB
EQ 250MG BASE
A075817 002 Jun 09, 2004
AB
EQ 500MG BASE
A075685 003 Jun 09, 2004
AB
EQ 500MG BASE
A075817 003 Jun 09, 2004
AB
EQ 750MG BASE
A075685 001 Jun 09, 2004
AB
EQ 750MG BASE
A075817 004 Jun 09, 2004
AB RANBAXY
EQ 250MG BASE
A075747 001 Jun 09, 2004
AB
EQ 500MG BASE
A075747 002 Jun 09, 2004
AB
EQ 750MG BASE
A075747 003 Jun 09, 2004
AB TARO
EQ 100MG BASE
A076912 001 Feb 18, 2005
AB
EQ 250MG BASE
A076912 002 Oct 06, 2004
AB
EQ 500MG BASE
A076912 003 Oct 06, 2004
AB
EQ 750MG BASE
A076912 004 Oct 06, 2004
AB UNIQUE PHARM LABS
EQ 250MG BASE
A076639 001 Sep 10, 2004
AB
EQ 500MG BASE
A076639 002 Sep 10, 2004
AB
EQ 750MG BASE
A076639 003 Sep 10, 2004
AB WATSON LABS
EQ 100MG BASE
A076794 001 Feb 10, 2005
AB
EQ 250MG BASE
A076794 002 Jun 09, 2004
AB
EQ 500MG BASE
A076794 003 Jun 09, 2004
AB
EQ 750MG BASE
A076794 004 Jun 09, 2004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-81(of 371)
CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE
SUSPENSION/DROPS;OTIC
CIPRO HC
+ ALCON PHARMS LTD EQ 0.2% BASE;1% N020805 001 Feb 10, 1998
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
CIPROFLOXACIN EXTENDED RELEASE
AB ACTAVIS LABS FL INC 212.6MG;EQ 287.5MG BASE A077417 001 Nov 30, 2010
AB 425.2MG;EQ 574.9MG BASE A077809 001 Nov 30, 2010
AB ANCHEN PHARMS 212.6MG;EQ 287.5MG BASE A078166 002 Nov 27, 2007
AB 425.2MG;EQ 574.9MG BASE A078166 001 Nov 27, 2007
AB DR REDDYS LABS LTD 425.2MG;EQ 574.9MG BASE A077701 001 Mar 26, 2007
AB + MYLAN PHARMS INC 212.6MG;EQ 287.5MG BASE A078183 001 Mar 22, 2007
AB + 425.2MG;EQ 574.9MG BASE A078183 002 Mar 22, 2007
CIPROFLOXACIN; DEXAMETHASONE
SUSPENSION/DROPS;OTIC
CIPRODEX
+ ALCON PHARMS LTD 0.3%;0.1% N021537 001 Jul 18, 2003
CISATRACURIUM BESYLATE
INJECTABLE;INJECTION
CISATRACURIUM BESYLATE
AP SANDOZ INC EQ 2MG BASE/ML A200159 001 Feb 03, 2012
CISATRACURIUM BESYLATE PRESERVATIVE FREE
AP SANDOZ INC EQ 2MG BASE/ML A200154 001 Feb 03, 2012
AP EQ 10MG BASE/ML A200154 002 Feb 03, 2012
NIMBEX
AP + ABBVIE EQ 2MG BASE/ML N020551 001 Dec 15, 1995
NIMBEX PRESERVATIVE FREE
AP + ABBVIE EQ 2MG BASE/ML N020551 003 Dec 15, 1995
AP + EQ 10MG BASE/ML N020551 002 Dec 15, 1995
CISPLATIN
INJECTABLE;INJECTION
CISPLATIN
AP EUROHLTH INTL 1MG/ML A075036 001 Nov 07, 2000
AP + FRESENIUS KABI USA 1MG/ML A074735 001 Jul 16, 1999
AP HQ SPCLT PHARMA 1MG/ML N018057 004 Nov 08, 1988
AP ONCO THERAPIES LTD 1MG/ML A091062 001 Apr 18, 2012
AP PHARMACHEMIE BV 1MG/ML A074656 001 May 16, 2000
CITALOPRAM HYDROBROMIDE
CAPSULE;ORAL
CITALOPRAM HYDROBROMIDE
MYLAN PHARMS INC EQ 10MG BASE A077668 001 Feb 28, 2007
EQ 20MG BASE A077668 002 Feb 28, 2007
+ EQ 40MG BASE A077668 003 Feb 28, 2007
SOLUTION;ORAL
CITALOPRAM HYDROBROMIDE
AA AUROBINDO PHARMA LTD EQ 10MG BASE/5ML A077812 001 Aug 28, 2006
AA + ROXANE EQ 10MG BASE/5ML A077043 001 Dec 13, 2004
AA SILARX EQ 10MG BASE/5ML A077629 001 Jun 15, 2006
TABLET;ORAL
CELEXA
AB FOREST LABS EQ 10MG BASE N020822 001 Apr 27, 2000
AB EQ 20MG BASE N020822 002 Jul 17, 1998
AB + EQ 40MG BASE N020822 003 Jul 17, 1998
CITALOPRAM HYDROBROMIDE
AB AMNEAL PHARMS NY EQ 10MG BASE A077289 001 Nov 30, 2006
AB EQ 20MG BASE A077289 002 Nov 30, 2006
AB EQ 40MG BASE A077289 003 Nov 30, 2006
AB APOTEX INC EQ 10MG BASE A077046 001 Nov 24, 2004
AB EQ 20MG BASE A077046 002 Nov 24, 2004
AB EQ 40MG BASE A077046 003 Nov 24, 2004
AB AUROBINDO EQ 10MG BASE A077031 001 Oct 28, 2004
AB EQ 20MG BASE A077031 002 Oct 28, 2004
AB EQ 40MG BASE A077031 003 Oct 28, 2004
AB CIPLA LTD EQ 10MG BASE A077044 001 Nov 05, 2004
AB EQ 20MG BASE A077044 002 Nov 05, 2004
AB EQ 40MG BASE A077044 003 Nov 05, 2004
AB DR REDDYS LABS LTD EQ 10MG BASE A077038 001 Oct 28, 2004
AB EQ 20MG BASE A077038 002 Oct 28, 2004
AB EQ 40MG BASE A077038 003 Oct 28, 2004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-82(of 371)
CITALOPRAM HYDROBROMIDE
TABLET;ORAL
CITALOPRAM HYDROBROMIDE
AB EPIC PHARMA EQ 10MG BASE A077045 003 Apr 29, 2005
AB EQ 20MG BASE A077045 002 Apr 29, 2005
AB EQ 40MG BASE A077045 001 Apr 29, 2005
AB GLENMARK GENERICS EQ 10MG BASE A077654 001 Feb 27, 2009
AB EQ 20MG BASE A077654 002 Feb 27, 2009
AB EQ 40MG BASE A077654 003 Feb 27, 2009
AB INVAGEN PHARMS EQ 10MG BASE A077534 001 Oct 03, 2006
AB EQ 20MG BASE A077534 002 Oct 03, 2006
AB EQ 40MG BASE A077534 003 Oct 03, 2006
AB MYLAN EQ 10MG BASE A077039 001 Feb 03, 2005
AB EQ 10MG BASE A077042 001 Nov 05, 2004
AB EQ 20MG BASE A077039 002 Feb 03, 2005
AB EQ 20MG BASE A077042 002 Nov 05, 2004
AB EQ 40MG BASE A077039 003 Feb 03, 2005
AB EQ 40MG BASE A077042 003 Nov 05, 2004
AB MYLAN PHARMS INC EQ 10MG BASE A077037 001 Nov 05, 2004
AB EQ 20MG BASE A077037 002 Nov 05, 2004
AB EQ 40MG BASE A077037 003 Nov 05, 2004
AB PLIVA EQ 10MG BASE A077232 001 Oct 31, 2005
AB EQ 20MG BASE A077232 002 Oct 31, 2005
AB EQ 40MG BASE A077232 003 Oct 31, 2005
AB SUN PHARM INDS INC EQ 10MG BASE A077032 001 Nov 12, 2004
AB EQ 20MG BASE A077032 002 Nov 12, 2004
AB EQ 40MG BASE A077032 003 Nov 12, 2004
AB TEVA PHARMS EQ 10MG BASE A077048 001 Nov 16, 2004
AB EQ 20MG BASE A077048 002 Nov 16, 2004
AB EQ 40MG BASE A077048 003 Nov 16, 2004
AB TORRENT PHARMS EQ 10MG BASE A078216 001 Mar 27, 2007
AB EQ 20MG BASE A078216 002 Mar 27, 2007
AB EQ 40MG BASE A078216 003 Mar 27, 2007
CITRIC ACID; GLUCONOLACTONE; MAGNESIUM CARBONATE
SOLUTION;IRRIGATION
RENACIDIN
+ UNITED GUARDIAN 6.602GM/100ML;198MG/100ML;3.177GM/100ML N019481 001 Oct 02, 1990
CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE
FOR SOLUTION;ORAL
PREPOPIK
+ FERRING PHARMS AS 12GM/PACKET;3.5GM/PACKET;10MG/PACKET N202535 001 Jul 16, 2012
CITRIC ACID; UREA C-13
FOR SOLUTION, TABLET, FOR SOLUTION;ORAL
IDKIT:HP
+ EXALENZ BIOSCIENCE N/A,4GM;75MG,N/A N021314 001 Dec 17, 2002
CLADRIBINE
INJECTABLE;INJECTION
CLADRIBINE
AP EUROHLTH INTL 1MG/ML A075405 001 Feb 28, 2000
AP + FRESENIUS KABI USA 1MG/ML A076571 001 Apr 22, 2004
AP ONCO THERAPIES LTD 1MG/ML A200510 001 Oct 06, 2011
CLARITHROMYCIN
FOR SUSPENSION;ORAL
BIAXIN
AB ABBVIE 125MG/5ML N050698 001 Dec 23, 1993
AB + 250MG/5ML N050698 002 Dec 23, 1993
CLARITHROMYCIN
AB RANBAXY 125MG/5ML A065382 001 Aug 30, 2007
AB 250MG/5ML A065382 002 Aug 30, 2007
AB SANDOZ 125MG/5ML A065283 002 Sep 04, 2007
AB 250MG/5ML A065283 003 Sep 04, 2007
TABLET;ORAL
BIAXIN
AB + ABBVIE 250MG N050662 001 Oct 31, 1991
AB + 500MG N050662 002 Oct 31, 1991
CLARITHROMYCIN
AB ALLIED PHARMA INC 250MG A202710 001 Jun 10, 2013
AB 500MG A202710 002 Jun 10, 2013
AB APOTEX CORP 250MG A065384 001 Aug 20, 2007
AB 500MG A065384 002 Aug 20, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-83(of 371)
CLARITHROMYCIN
TABLET;ORAL
CLARITHROMYCIN
AB AUROBINDO 250MG A065489 001 Jul 25, 2012
AB 500MG A065489 002 Jul 25, 2012
AB MYLAN 250MG A065195 001 Mar 11, 2005
AB 500MG A065195 002 Mar 11, 2005
AB RANBAXY 250MG A065174 001 Sep 24, 2004
AB 500MG A065174 002 Sep 24, 2004
AB ROXANE 250MG A065178 002 May 25, 2004
AB 500MG A065178 001 May 25, 2004
AB SANDOZ 250MG A065144 001 Oct 18, 2005
AB 500MG A065136 001 Aug 25, 2005
AB TEVA 250MG A065155 001 May 31, 2005
AB 500MG A065155 002 May 31, 2005
AB WOCKHARDT 250MG A065266 001 May 31, 2006
AB 500MG A065266 002 May 31, 2006
TABLET, EXTENDED RELEASE;ORAL
BIAXIN XL
AB + ABBVIE 500MG N050775 001 Mar 03, 2000
CLARITHROMYCIN
AB ACTAVIS LABS FL INC 500MG A065145 001 Jun 24, 2004
AB TEVA 500MG A065154 001 May 18, 2005
CLAVULANATE POTASSIUM; TICARCILLIN DISODIUM
INJECTABLE;INJECTION
TIMENTIN
+ GLAXOSMITHKLINE EQ 1GM BASE/VIAL;EQ 30GM BASE/VIAL N050590 003 Aug 18, 1987
EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL A062691 001 Dec 19, 1986
+ EQ 100MG BASE/VIAL;EQ 3GM BASE/VIAL N050590 001 Apr 01, 1985
+ EQ 200MG BASE/VIAL;EQ 3GM BASE/VIAL N050590 002 Apr 01, 1985
TIMENTIN IN PLASTIC CONTAINER
+ GLAXOSMITHKLINE EQ 100MG BASE/100ML;EQ 3GM BASE/100ML N050658 001 Dec 15, 1989
CLEMASTINE FUMARATE
SYRUP;ORAL
CLEMASTINE FUMARATE
AA + TEVA EQ 0.5MG BASE/5ML A073399 001 Jun 30, 1994
AA WOCKHARDT EQ 0.5MG BASE/5ML A074863 001 Mar 13, 1998
TABLET;ORAL
CLEMASTINE FUMARATE
AB SANDOZ 2.68MG A073459 001 Oct 31, 1993
AB + TEVA 2.68MG A073283 001 Jan 31, 1992
CLEVIDIPINE
EMULSION;INTRAVENOUS
CLEVIPREX
+ MEDICINES CO 25MG/50ML (0.5MG/ML) N022156 001 Aug 01, 2008
+ 50MG/100ML (0.5MG/ML) N022156 002 Aug 01, 2008
+ 125MG/250ML (0.5MG/ML) N022156 003 Nov 08, 2013
CLINDAMYCIN HYDROCHLORIDE
CAPSULE;ORAL
CLEOCIN HYDROCHLORIDE
AB PHARMACIA AND UPJOHN EQ 75MG BASE N050162 001
AB EQ 150MG BASE N050162 002
AB + EQ 300MG BASE N050162 003 Apr 14, 1988
CLINDAMYCIN HYDROCHLORIDE
AB AUROBINDO PHARMA EQ 150MG BASE A065442 001 Aug 26, 2009
AB EQ 300MG BASE A065442 002 Aug 26, 2009
AB COREPHARMA EQ 150MG BASE A065194 001 Mar 22, 2004
AB EQ 300MG BASE A065194 002 Mar 22, 2004
AB LANNETT EQ 75MG BASE A065242 001 Aug 12, 2005
AB EQ 150MG BASE A065242 002 Aug 12, 2005
AB EQ 300MG BASE A065243 001 Aug 12, 2005
AB MYLAN PHARMS INC EQ 75MG BASE A091225 001 May 31, 2011
AB EQ 150MG BASE A091225 002 May 31, 2011
AB EQ 300MG BASE A091225 003 May 31, 2011
AB RANBAXY EQ 150MG BASE A065061 001 Feb 02, 2001
AB EQ 300MG BASE A065061 002 Feb 02, 2001
AB TEVA EQ 150MG BASE A063029 001 Sep 20, 1989
AB EQ 300MG BASE A063029 002 Aug 05, 2005
AB WATSON LABS EQ 150MG BASE A063083 001 Jul 31, 1991
AB EQ 300MG BASE A063083 002 Mar 18, 2003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-84(of 371)
CLINDAMYCIN HYDROCHLORIDE
CAPSULE;ORAL
CLINDAMYCIN HYDROCHLORIDE
AB ZYDUS PHARMS USA EQ 75MG BASE A065217 001 Jan 31, 2005
AB EQ 150MG BASE A065217 002 Jan 31, 2005
AB EQ 300MG BASE A065217 003 Jan 31, 2005
CLINDAMYCIN PALMITATE HYDROCHLORIDE
FOR SOLUTION;ORAL
CLEOCIN
AA + PHARMACIA AND UPJOHN EQ 75MG BASE/5ML A062644 001 Apr 07, 1986
CLINDAMYCIN PALMITATE HYDROCHLORIDE
AA AMNEAL PHARMS EQ 75MG BASE/5ML A203513 001 Mar 13, 2014
AA AUROBINDO PHARMA LTD EQ 75MG BASE/5ML A202409 001 Apr 30, 2013
AA LYNE EQ 75MG BASE/5ML A201821 001 Aug 28, 2012
AA PADDOCK LABS EQ 75MG BASE/5ML A090902 001 Jul 07, 2010
CLINDAMYCIN PHOSPHATE
AEROSOL, FOAM;TOPICAL
CLINDAMYCIN PHOSPHATE
AT PERRIGO UK FINCO 1% A090785 001 Mar 31, 2010
EVOCLIN
AT + DELCOR ASSET 1% N050801 001 Oct 22, 2004
CREAM;VAGINAL
CLEOCIN
AB + PHARMACIA AND UPJOHN EQ 2% BASE N050680 002 Mar 02, 1998
CLINDAMYCIN PHOSPHATE
AB FOUGERA PHARMS EQ 2% BASE A065139 001 Dec 27, 2004
CLINDESSE
+ ELAN PHARMA INTL LTD EQ 2% BASE N050793 001 Nov 30, 2004
GEL;TOPICAL
CLEOCIN T
AB + PHARMACIA AND UPJOHN EQ 1% BASE N050615 001 Jan 07, 1987
CLINDAMYCIN PHOSPHATE
AB FOUGERA PHARMS EQ 1% BASE A064160 001 Jan 28, 2000
CLINDAGEL
BT + PRECISION DERMAT EQ 1% BASE N050782 001 Nov 27, 2000
INJECTABLE;INJECTION
CLEOCIN PHOSPHATE
AP PHARMACIA AND UPJOHN EQ 150MG BASE/ML A062803 001 Oct 16, 1987
AP + EQ 150MG BASE/ML N050441 001
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + PHARMACIA AND UPJOHN EQ 6MG BASE/ML N050639 001 Aug 30, 1989
AP + EQ 12MG BASE/ML N050639 002 Aug 30, 1989
AP + EQ 18MG BASE/ML N050639 003 Apr 10, 1991
CLINDAMYCIN PHOSPHATE
AP BEDFORD EQ 150MG BASE/ML A065206 001 Sep 24, 2004
AP FRESENIUS KABI USA EQ 150MG BASE/ML A065346 001 Mar 29, 2007
AP EQ 150MG BASE/ML A065347 001 May 09, 2007
AP HIKMA MAPLE EQ 150MG BASE/ML A062889 001 Apr 25, 1988
AP HOSPIRA EQ 150MG BASE/ML A062800 001 Jul 24, 1987
AP EQ 150MG BASE/ML A062801 001 Jul 24, 1987
AP EQ 150MG BASE/ML A062943 001 Sep 29, 1988
AP SAGENT PHARMS EQ 150MG BASE/ML A090108 001 Sep 30, 2011
AP SAGENT STRIDES EQ 150MG BASE/ML A090109 001 Sep 30, 2011
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER
AP AKORN INC EQ 6MG BASE/ML A203048 001 Apr 04, 2013
AP EQ 12MG BASE/ML A203048 002 Apr 04, 2013
AP EQ 18MG BASE/ML A203048 003 Apr 04, 2013
AP SANDOZ INC EQ 6MG BASE/ML A201692 001 May 31, 2012
AP EQ 12MG BASE/ML A201692 002 May 31, 2012
AP EQ 18MG BASE/ML A201692 003 May 31, 2012
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
+ ABRAXIS PHARM EQ 900MG BASE/100ML N050635 001 Dec 22, 1989
LOTION;TOPICAL
CLEOCIN T
AB + PHARMACIA AND UPJOHN EQ 1% BASE N050600 001 May 31, 1989
CLINDAMYCIN PHOSPHATE
AB FOUGERA PHARMS EQ 1% BASE A065067 001 Jan 31, 2002
SOLUTION;TOPICAL
CLEOCIN T
AT + PHARMACIA AND UPJOHN EQ 1% BASE N050537 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-85(of 371)
CLINDAMYCIN PHOSPHATE
SOLUTION;TOPICAL
CLINDA-DERM
AT PADDOCK LLC EQ 1% BASE A063329 001 Sep 30, 1992
CLINDAMYCIN PHOSPHATE
AT FOUGERA EQ 1% BASE A064159 001 Jun 05, 1997
AT FOUGERA PHARMS EQ 1% BASE A065254 001 Feb 14, 2006
AT G AND W LABS INC EQ 1% BASE A062811 001 Sep 01, 1988
AT PERRIGO NEW YORK EQ 1% BASE A064050 001 Nov 30, 1995
AT TARO PHARM INDS EQ 1% BASE A065184 001 Mar 31, 2004
AT WOCKHARDT EQ 1% BASE A063304 001 Jul 15, 1997
SUPPOSITORY;VAGINAL
CLEOCIN
+ PHARMACIA AND UPJOHN 100MG N050767 001 Aug 13, 1999
SWAB;TOPICAL
CLEOCIN
AT PHARMACIA AND UPJOHN EQ 1% BASE N050537 002 Feb 22, 1994
CLINDAMYCIN PHOSPHATE
AT PERRIGO NEW YORK EQ 1% BASE A065049 001 May 25, 2000
AT VERSAPHARM EQ 1% BASE A065513 001 Jun 17, 2010
CLINDETS
AT PERRIGO EQ 1% BASE A064136 001 Sep 30, 1996
CLINDAMYCIN PHOSPHATE; TRETINOIN
GEL;TOPICAL
VELTIN
BX + STIEFEL GSK 1.2%;0.025% N050803 001 Jul 16, 2010
ZIANA
BX + MEDICIS 1.2%;0.025% N050802 001 Nov 07, 2006
CLOBAZAM
SUSPENSION;ORAL
ONFI
+ LUNDBECK LLC 2.5MG/ML N203993 001 Dec 14, 2012
TABLET;ORAL
ONFI
LUNDBECK LLC 10MG N202067 002 Oct 21, 2011
+ 20MG N202067 003 Oct 21, 2011
CLOBETASOL PROPIONATE
AEROSOL, FOAM;TOPICAL
CLOBETASOL PROPIONATE
AB1 PERRIGO ISRAEL 0.05% A077763 001 Mar 10, 2008
OLUX
AB1 + DELCOR ASSET 0.05% N021142 001 May 26, 2000
CLOBETASOL PROPIONATE
AB2 PERRIGO ISRAEL 0.05% A201402 001 Aug 14, 2012
OLUX E
AB2 + DELCOR ASSET 0.05% N022013 001 Jan 12, 2007
CREAM;TOPICAL
CLOBETASOL PROPIONATE
AB1 FOUGERA 0.05% A074392 001 Sep 30, 1996
AB1 G AND W LABS INC 0.05% A074139 001 Aug 03, 1994
AB1 TARO 0.05% A074249 001 Jul 08, 1996
CORMAX
AB1 HI TECH PHARMA 0.05% A074220 001 May 16, 1997
TEMOVATE
AB1 + FOUGERA PHARMS 0.05% N019322 001 Dec 27, 1985
CLOBETASOL PROPIONATE (EMOLLIENT)
AB2 FOUGERA PHARMS 0.05% A075430 001 May 26, 1999
AB2 TARO 0.05% A075633 001 May 17, 2000
EMBELINE E
AB2 HI TECH PHARMA 0.05% A075325 001 Dec 24, 1998
TEMOVATE E
AB2 + FOUGERA PHARMS 0.05% N020340 001 Jun 17, 1994
GEL;TOPICAL
CLOBETASOL PROPIONATE
AB FOUGERA PHARMS 0.05% A075368 001 Feb 15, 2000
AB PERRIGO 0.05% A075027 001 Oct 31, 1997
AB TARO 0.05% A075279 001 May 28, 1999
EMBELINE
AB HI TECH PHARMA 0.05% A076141 001 Apr 12, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-86(of 371)
CLOBETASOL PROPIONATE
GEL;TOPICAL
TEMOVATE
AB + FOUGERA PHARMS 0.05% N020337 001 Apr 29, 1994
LOTION;TOPICAL
CLOBETASOL PROPIONATE
AB ACTAVIS MID ATLANTIC 0.05% A078223 001 Dec 04, 2008
AB TARO 0.05% A200302 001 Jul 02, 2012
CLOBEX
AB + GALDERMA LABS LP 0.05% N021535 001 Jul 24, 2003
OINTMENT;TOPICAL
CLOBETASOL PROPIONATE
AB FOUGERA PHARMS 0.05% A074407 001 Feb 23, 1996
AB TARO 0.05% A074248 001 Jul 12, 1996
AB TEVA PHARMS 0.05% A074089 001 Feb 16, 1994
EMBELINE
AB HI TECH PHARMA 0.05% A074221 001 Mar 31, 1995
TEMOVATE
AB + FOUGERA PHARMS 0.05% N019323 001 Dec 27, 1985
SHAMPOO;TOPICAL
CLOBETASOL PROPIONATE
AB ACTAVIS MID ATLANTIC 0.05% A078854 001 Jun 07, 2011
AB PERRIGO ISRAEL 0.05% A090974 001 Aug 09, 2012
CLOBEX
AB + GALDERMA LABS 0.05% N021644 001 Feb 05, 2004
SOLUTION;TOPICAL
CLOBETASOL PROPIONATE
AT FOUGERA PHARMS 0.05% A075391 001 Feb 08, 1999
AT TARO 0.05% A075224 001 Nov 16, 1998
AT 0.05% A075363 001 Dec 29, 2000
AT TOLMAR 0.05% A076977 001 Aug 05, 2005
AT WOCKHARDT 0.05% A075205 001 Nov 13, 1998
EMBELINE
AT + HI TECH PHARMA 0.05% A074222 001 Dec 06, 1995
SPRAY;TOPICAL
CLOBETASOL PROPIONATE
AT PADDOCK LLC 0.05% A090898 001 Jun 16, 2011
CLOBEX
AT + GALDERMA LABS LP 0.05% N021835 001 Oct 27, 2005
CLOCORTOLONE PIVALATE
CREAM;TOPICAL
CLODERM
+ PROMIUS PHARMA LLC 0.1% N017765 001
CLOFARABINE
INJECTABLE;IV (INFUSION)
CLOLAR
+ GENZYME 20MG/20ML (1MG/ML) N021673 001 Dec 28, 2004
CLOFAZIMINE
CAPSULE;ORAL
LAMPRENE
+ NOVARTIS 50MG N019500 002 Dec 15, 1986
CLOMIPHENE CITRATE
TABLET;ORAL
CLOMID
AB + SANOFI AVENTIS US 50MG N016131 002
CLOMIPHENE CITRATE
AB PAR PHARM 50MG A075528 001 Aug 30, 1999
SEROPHENE
AB EMD SERONO 50MG N018361 001 Mar 22, 1982
CLOMIPRAMINE HYDROCHLORIDE
CAPSULE;ORAL
ANAFRANIL
AB MALLINCKRODT LLC 25MG N019906 001 Dec 29, 1989
AB + 50MG N019906 002 Dec 29, 1989
AB 75MG N019906 003 Dec 29, 1989
CLOMIPRAMINE HYDROCHLORIDE
AB MYLAN 25MG A074947 001 Apr 30, 1998
AB 50MG A074947 002 Apr 30, 1998
AB 75MG A074947 003 Apr 30, 1998
AB SANDOZ 25MG A074364 001 Mar 29, 1996
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-87(of 371)
CLOMIPRAMINE HYDROCHLORIDE
CAPSULE;ORAL
CLOMIPRAMINE HYDROCHLORIDE
AB 50MG A074364 002 Mar 29, 1996
AB 75MG A074364 003 Mar 29, 1996
AB TARO 25MG A074694 001 Dec 31, 1996
AB 50MG A074694 002 Dec 31, 1996
AB 75MG A074694 003 Dec 31, 1996
AB TEVA 25MG A074958 001 Aug 26, 1997
AB 50MG A074958 002 Aug 26, 1997
AB 75MG A074958 003 Aug 26, 1997
CLONAZEPAM
TABLET;ORAL
CLONAZEPAM
AB ACCORD HLTHCARE 0.5MG A077147 001 May 02, 2005
AB 1MG A077147 002 May 02, 2005
AB 2MG A077147 003 May 02, 2005
AB ACTAVIS ELIZABETH 0.5MG A074869 001 Oct 31, 1996
AB 1MG A074869 002 Oct 31, 1996
AB 2MG A074869 003 Oct 31, 1996
AB MYLAN 0.5MG A075150 001 Oct 05, 1998
AB 1MG A075150 002 Oct 05, 1998
AB 2MG A075150 003 Oct 05, 1998
AB MYLAN PHARMS INC 0.5MG A074940 001 Oct 30, 1997
AB 1MG A074940 002 Oct 30, 1997
AB 2MG A074940 003 Oct 30, 1997
AB SANDOZ 0.5MG A074979 001 Aug 29, 1997
AB 1MG A074979 002 Aug 29, 1997
AB 2MG A074979 003 Aug 29, 1997
AB SUN PHARM INDS INC 0.5MG A075423 001 Apr 27, 2001
AB 1MG A075423 002 Apr 27, 2001
AB 2MG A075423 003 Apr 27, 2001
AB TEVA 0.5MG A074569 001 Sep 10, 1996
AB 1MG A074569 002 Sep 10, 1996
AB 2MG A074569 003 Sep 10, 1996
AB VINTAGE PHARMS 0.5MG A077856 001 Jun 28, 2006
AB 1MG A077856 002 Jun 28, 2006
AB 2MG A077856 003 Jun 28, 2006
AB WATSON LABS 0.5MG A074964 001 Dec 30, 1997
AB 1MG A074964 002 Dec 30, 1997
AB 2MG A074964 003 Dec 30, 1997
KLONOPIN
AB ROCHE 0.5MG N017533 001
AB + 1MG N017533 002
AB 2MG N017533 003
TABLET, ORALLY DISINTEGRATING;ORAL
CLONAZEPAM
AB BARR 0.125MG A077194 001 Aug 10, 2005
AB 0.25MG A077194 002 Aug 10, 2005
AB 0.5MG A077194 003 Aug 10, 2005
AB 1MG A077194 004 Aug 10, 2005
AB 2MG A077194 005 Aug 10, 2005
AB PAR PHARM 0.125MG A077171 001 Aug 03, 2005
AB 0.25MG A077171 002 Aug 03, 2005
AB 0.5MG A077171 003 Aug 03, 2005
AB + 1MG A077171 004 Aug 03, 2005
AB 2MG A077171 005 Aug 03, 2005
AB SUN PHARM INDS INC 0.125MG A078654 001 Aug 27, 2014
AB 0.25MG A078654 002 Aug 27, 2014
AB 0.5MG A078654 003 Aug 27, 2014
AB 1MG A078654 004 Aug 27, 2014
AB 2MG A078654 005 Aug 27, 2014
CLONIDINE
FILM, EXTENDED RELEASE;TRANSDERMAL
CATAPRES-TTS-1
AB BOEHRINGER INGELHEIM 0.1MG/24HR N018891 001 Oct 10, 1984
CATAPRES-TTS-2
AB BOEHRINGER INGELHEIM 0.2MG/24HR N018891 002 Oct 10, 1984
CATAPRES-TTS-3
AB + BOEHRINGER INGELHEIM 0.3MG/24HR N018891 003 Oct 10, 1984
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-88(of 371)
CLONIDINE
FILM, EXTENDED RELEASE;TRANSDERMAL
CLONIDINE
AB AVEVA
0.1MG/24HR
A076157 001 Aug 18, 2009
AB
0.2MG/24HR
A076157 002 Aug 18, 2009
AB
0.3MG/24HR
A076157 003 Aug 18, 2009
AB BARR
0.1MG/24HR
A079090 001 Aug 20, 2010
AB
0.2MG/24HR
A079090 002 Aug 20, 2010
AB
0.3MG/24HR
A079090 003 Aug 20, 2010
AB MYLAN TECHNOLOGIES
0.1MG/24HR
A076166 001 Jul 16, 2010
AB
0.2MG/24HR
A076166 002 Jul 16, 2010
AB
0.3MG/24HR
A076166 003 Jul 16, 2010
AB WATSON LABS INC
0.1MG/24HR
A090873 001 May 06, 2014
AB
0.2MG/24HR
A090873 002 May 06, 2014
AB
0.3MG/24HR
A090873 003 May 06, 2014
CLONIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
CLONIDINE HYDROCHLORIDE
AP EXELA PHARMA SCS LLC
1MG/10ML (0.1MG/ML)
A203167 001 Oct 29, 2013
AP
5MG/10ML (0.5MG/ML)
A203167 002 Oct 29, 2013
AP FRESENIUS KABI USA
1MG/10ML (0.1MG/ML)
A200673 001 Jul 08, 2011
AP
5MG/10ML (0.5MG/ML)
A200673 002 Jul 08, 2011
AP HIKMA FARMACEUTICA
1MG/10ML (0.1MG/ML)
A200300 001 Jan 26, 2011
AP
5MG/10ML (0.5MG/ML)
A200300 002 Jan 26, 2011
AP LUITPOLD
1MG/10ML (0.1MG/ML)
A091104 001 Oct 08, 2009
AP
5MG/10ML (0.5MG/ML)
A091104 002 Oct 08, 2009
AP ZYDUS PHARMS USA INC
1MG/10ML (0.1MG/ML)
A202601 001 Feb 20, 2014
AP
5MG/10ML (0.5MG/ML)
A202601 002 Feb 20, 2014
DURACLON
AP MYLAN INSTITUTIONAL
1MG/10ML (0.1MG/ML)
N020615 001 Oct 02, 1996
AP +
5MG/10ML (0.5MG/ML)
N020615 002 Apr 27, 1999
TABLET;ORAL
CATAPRES
AB BOEHRINGER INGELHEIM
0.1MG
N017407 001
AB
0.2MG
N017407 002
AB +
0.3MG
N017407 003
CLONIDINE HYDROCHLORIDE
AB ACTAVIS ELIZABETH
0.1MG
A070974 001 Dec 16, 1986
AB
0.2MG
A070975 001 Dec 16, 1986
AB
0.3MG
A070976 001 Dec 16, 1986
AB ALEMBIC PHARMS LTD
0.1MG
A091368 001 Dec 06, 2011
AB
0.2MG
A091368 002 Dec 06, 2011
AB
0.3MG
A091368 003 Dec 06, 2011
AB CARLSBAD
0.1MG
A202297 001 Jun 13, 2013
AB
0.2MG
A202297 002 Jun 13, 2013
AB
0.3MG
A202297 003 Jun 13, 2013
AB DAVA PHARMS INC
0.1MG
A071783 001 Apr 05, 1988
AB
0.2MG
A071784 001 Apr 05, 1988
AB
0.3MG
A071785 001 Apr 05, 1988
AB IMPAX LABS
0.1MG
A078099 001 Aug 27, 2009
AB
0.2MG
A078099 002 Aug 27, 2009
AB
0.3MG
A078099 003 Aug 27, 2009
AB MUTUAL PHARM
0.1MG
A070925 001 Sep 04, 1987
AB
0.2MG
A070924 001 Sep 04, 1987
AB
0.3MG
A070923 001 Sep 04, 1987
AB MYLAN
0.1MG
A070317 002 Jul 09, 1987
AB
0.2MG
A070317 003 Jun 09, 1987
AB
0.3MG
A070317 001 Jun 09, 1987
AB SUN PHARM INDS INC
0.1MG
A090329 001 Jul 03, 2014
AB
0.2MG
A090329 002 Jul 03, 2014
AB
0.3MG
A090329 003 Jul 03, 2014
AB UNICHEM
0.1MG
A078895 001 Aug 26, 2009
AB
0.2MG
A078895 002 Aug 26, 2009
AB
0.3MG
A078895 003 Aug 26, 2009
AB VINTAGE
0.1MG
A077901 001 Mar 09, 2007
AB
0.2MG
A077901 002 Mar 09, 2007
AB
0.3MG
A077901 003 Mar 09, 2007
TABLET, EXTENDED RELEASE;ORAL
CLONIDINE HYDROCHLORIDE
AB ANCHEN PHARMS
0.1MG
A202983 001 Apr 02, 2014
AB
0.2MG
A202983 002 Apr 02, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-89(of 371)
CLONIDINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
CLONIDINE HYDROCHLORIDE
AB ANCHEN PHARMS
0.1MG
A202984 001 Sep 30, 2013
AB
0.2MG
A202984 002 Sep 30, 2013
KAPVAY
AB + CONCORDIA PHARMS INC
0.1MG
N022331 003 Sep 28, 2010
AB
0.2MG
N022331 004 Sep 28, 2010
CLOPIDOGREL
TABLET;ORAL
CLOPIDOGREL
AB AMNEAL PHARMS
75MG
A203751 001 Apr 11, 2014
CLOPIDOGREL BISULFATE
TABLET;ORAL
CLOPIDOGREL BISULFATE
AB ACCORD HLTHCARE
EQ 75MG BASE
A202925 001 Mar 27, 2013
AB
EQ 300MG BASE
A202925 002 Mar 27, 2013
AB ACTAVIS TOTOWA
EQ 75MG BASE
A090307 001 May 28, 2013
AB APOTEX INC
EQ 75MG BASE
A076274 001 May 17, 2012
AB
EQ 300MG BASE
A076274 002 Mar 04, 2014
AB AUROBINDO PHARMA LTD
EQ 75MG BASE
A090540 001 May 17, 2012
AB DR REDDYS LABS INC
EQ 75MG BASE
A076273 001 Jan 14, 2008
AB DR REDDYS LABS LTD
EQ 300MG BASE
A091023 001 May 17, 2012
AB GATE PHARMS
EQ 300MG BASE
A091216 001 May 17, 2012
AB MACLEODS PHARMS LTD
EQ 75MG BASE
A202928 001 Feb 10, 2014
AB MUTUAL PHARM
EQ 75MG BASE
A078133 001 Jun 10, 2013
AB MYLAN PHARMS INC
EQ 75MG BASE
A077665 001 May 17, 2012
AB
EQ 300MG BASE
A077665 002 May 17, 2012
AB ROXANE
EQ 75MG BASE
A078004 001 May 17, 2012
AB SCIEGEN PHARMS INC
EQ 75MG BASE
A204165 001 Sep 15, 2014
AB
EQ 300MG BASE
A204165 002 Sep 15, 2014
AB SUN PHARMA GLOBAL
EQ 75MG BASE
A090494 001 May 17, 2012
AB TEVA
EQ 75MG BASE
A076999 001 May 17, 2012
AB TEVA PHARMS
EQ 300MG BASE
A090625 001 May 17, 2012
AB TORRENT PHARMS LTD
EQ 75MG BASE
A090844 001 May 17, 2012
AB WOCKHARDT LTD
EQ 75MG BASE
A202266 001 Aug 14, 2012
AB
EQ 300MG BASE
A202266 002 Nov 20, 2012
AB ZYDUS PHARMS USA INC
EQ 75MG BASE
A201686 001 Oct 10, 2012
PLAVIX
AB SANOFI AVENTIS US
EQ 75MG BASE
N020839 001 Nov 17, 1997
AB +
EQ 300MG BASE
N020839 002 Sep 20, 2007
CLORAZEPATE DIPOTASSIUM
TABLET;ORAL
CLORAZEPATE DIPOTASSIUM
AB MYLAN
3.75MG
A071858 002 Jul 17, 1987
AB
7.5MG
A071858 003 Jul 17, 1987
AB
15MG
A071858 001 Jul 17, 1987
AB RANBAXY
3.75MG
A076911 001 Sep 29, 2004
AB
7.5MG
A076911 002 Sep 29, 2004
AB
15MG
A076911 003 Sep 29, 2004
AB TARO
3.75MG
A075731 003 Apr 27, 2000
AB
7.5MG
A075731 002 Apr 27, 2000
AB
15MG
A075731 001 Apr 27, 2000
GEN-XENE
AB ALRA
3.75MG
A071787 001 Apr 26, 1988
AB
7.5MG
A071788 001 Apr 26, 1988
AB
15MG
A071789 001 Apr 26, 1988
TRANXENE
AB RECORDATI RARE
3.75MG
N017105 006
AB
7.5MG
N017105 007
AB +
15MG
N017105 008
CLOTRIMAZOLE
CREAM;TOPICAL
CLOTRIMAZOLE
AB FOUGERA PHARMS
1%
A078338 001 Sep 02, 2008
AB GLENMARK PHARMS
1%
A090219 001 Aug 03, 2010
AB + TARO
1%
A072640 001 Aug 31, 1993
SOLUTION;TOPICAL
CLOTRIMAZOLE
AT + TARO
1%
A074580 001 Jul 29, 1996
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-90(of 371)
CLOTRIMAZOLE
SOLUTION;TOPICAL
CLOTRIMAZOLE
AT TEVA
1%
A073306 001 Feb 28, 1995
TROCHE/LOZENGE;ORAL
CLOTRIMAZOLE
AB PADDOCK LLC
10MG
A076763 001 Oct 28, 2005
AB + ROXANE
10MG
A076387 001 Jul 29, 2004
CLOZAPINE
SUSPENSION;ORAL
VERSACLOZ
+ JAZZ PHARMS III
50MG/ML
N203479 001 Feb 06, 2013
TABLET;ORAL
CLOZAPINE
AB IVAX SUB TEVA PHARMS 12.5MG
A074949 003 Jul 31, 2003
AB 25MG
A074949 001 Nov 26, 1997
AB 50MG
A074949 004 Apr 25, 2005
AB 50MG
A076809 003 Dec 16, 2005
AB 100MG
A074949 002 Nov 26, 1997
AB 100MG
A076809 002 Dec 16, 2005
AB 200MG
A076809 001 Dec 16, 2005
AB MYLAN 12.5MG
A075417 003 Apr 15, 2010
AB 25MG
A075417 001 May 27, 1999
AB 50MG
A075417 004 Apr 15, 2010
AB 100MG
A075417 002 May 27, 1999
AB 200MG
A075417 005 Apr 15, 2010
AB SUN PHARM INDS INC 25MG
A075713 001 Nov 15, 2002
AB 50MG
A075713 003 Aug 19, 2005
AB 100MG
A075713 002 Nov 15, 2002
CLOZARIL
AB NOVARTIS 25MG
N019758 001 Sep 26, 1989
AB + 100MG
N019758 002 Sep 26, 1989
TABLET, ORALLY DISINTEGRATING;ORAL
FAZACLO ODT
JAZZ PHARMS III 12.5MG
N021590 004 May 30, 2007
25MG
N021590 001 Feb 10, 2004
+ 100MG
N021590 002 Feb 10, 2004
150MG
N021590 005 Jul 09, 2010
200MG
N021590 006 Jul 09, 2010
COBICISTAT
TABLET;ORAL
TYBOST
+ GILEAD SCIENCES INC 150MG
N203094 001 Sep 24, 2014
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
TABLET;ORAL
STRIBILD
+ GILEAD SCIENCES INC 150MG;150MG;200MG;300MG
N203100 001 Aug 27, 2012
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
SYRUP;ORAL
PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
AA VINTAGE 10MG/5ML;5MG/5ML;6.25MG/5ML A040660 001 Dec 07, 2006
PROMETH VC W/ CODEINE
AA + ACTAVIS MID ATLANTIC 10MG/5ML;5MG/5ML;6.25MG/5ML A088764 001 Oct 31, 1984
PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE
AA HI-TECH PHARMA CO 10MG/5ML;5MG/5ML;6.25MG/5ML A040674 001 Dec 23, 2014
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
SYRUP;ORAL
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
AA + ACTAVIS MID ATLANTIC 10MG/5ML;6.25MG/5ML A088763 001 Oct 31, 1984
AA AMNEAL PHARMS 10MG/5ML;6.25MG/5ML A200894 001 Apr 24, 2013
AA HI TECH PHARMA 10MG/5ML;6.25MG/5ML A040151 001 Aug 26, 1997
AA SUN PHARM INDS INC 10MG/5ML;6.25MG/5ML A090180 001 Mar 17, 2010
AA TRIS PHARMA INC 10MG/5ML;6.25MG/5ML A200386 001 Jun 29, 2012
AA WOCKHARDT 10MG/5ML;6.25MG/5ML A088875 001 Dec 17, 1984
PROMETHAZINE WITH CODEINE
AA VINTAGE 10MG/5ML;6.25MG/5ML A040650 001 Jan 31, 2006
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-91(of 371)
CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
SYRUP;ORAL
TRIACIN-C
+ STI PHARMA LLC
10MG/5ML;30MG/5ML;1.25MG/5ML
A088704 001 Mar 22, 1985
CODEINE SULFATE
SOLUTION;ORAL
CODEINE SULFATE
+ ROXANE
30MG/5ML
N202245 001 Jun 30, 2011
TABLET;ORAL
CODEINE SULFATE
AB LANNETT HOLDINGS INC 15MG
A203046 001 Jun 13, 2014
AB 30MG
A203046 002 Jun 13, 2014
AB 60MG
A203046 003 Jun 13, 2014
AB ROXANE 15MG
N022402 001 Jul 16, 2009
AB 30MG
N022402 002 Jul 16, 2009
AB + 60MG
N022402 003 Jul 16, 2009
COLCHICINE
CAPSULE;ORAL
MITIGARE
HIKMA PHARMS LLC
0.6MG
N204820 001 Sep 26, 2014
TABLET;ORAL
COLCRYS
+ TAKEDA PHARMS USA
0.6MG
N022352 001 Jul 29, 2009
COLCHICINE; PROBENECID
TABLET;ORAL
COL-PROBENECID
AB + WATSON LABS
0.5MG;500MG
A084279 001
PROBENECID AND COLCHICINE
AB MIRROR PHARMS
0.5MG;500MG
A040618 001 May 13, 2008
COLESEVELAM HYDROCHLORIDE
FOR SUSPENSION;ORAL
WELCHOL
DAIICHI SANKYO
1.875GM/PACKET
N022362 001 Oct 02, 2009
+
3.75GM/PACKET
N022362 002 Oct 02, 2009
TABLET;ORAL
WELCHOL
+ DAIICHI SANKYO
625MG
N021176 001 May 26, 2000
COLESTIPOL HYDROCHLORIDE
GRANULE;ORAL
COLESTID
AB PHARMACIA AND UPJOHN
5GM/SCOOPFUL
N017563 003 Sep 22, 1995
AB +
5GM/PACKET
N017563 004 Sep 22, 1995
COLESTIPOL HYDROCHLORIDE
AB IMPAX LABS
5GM/SCOOPFUL
A077277 001 May 02, 2006
AB
5GM/PACKET
A077277 002 May 02, 2006
FLAVORED COLESTID
PHARMACIA AND UPJOHN
5GM/PACKET
N017563 001
5GM/SCOOPFUL
N017563 002
TABLET;ORAL
COLESTID
AB + PHARMACIA AND UPJOHN
1GM
N020222 001 Jul 19, 1994
COLESTIPOL HYDROCHLORIDE
AB IMPAX LABS
1GM
A077510 001 Oct 24, 2006
COLISTIMETHATE SODIUM
INJECTABLE;INJECTION
COLISTIMETHATE SODIUM
AP EMCURE PHARMS LTD
EQ 150MG BASE/VIAL
A202359 001 Sep 28, 2012
AP FRESENIUS KABI USA
EQ 150MG BASE/VIAL
A065364 001 Apr 17, 2008
AP PADDOCK LLC
EQ 150MG BASE/VIAL
A065177 001 Mar 19, 2004
AP SAGENT PHARMS
EQ 150MG BASE/VIAL
A201365 001 Feb 19, 2014
AP X GEN PHARMS
EQ 150MG BASE/VIAL
A064216 001 Feb 26, 1999
COLY-MYCIN M
AP + PAR STERILE PRODUCTS
EQ 150MG BASE/VIAL
N050108 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-92(of 371)
COLISTIN SULFATE; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; THONZONIUM BROMIDE
SUSPENSION/DROPS;OTIC
COLY-MYCIN S
+ PAR STERILE PRODUCTS EQ 3MG BASE/ML;10MG/ML;EQ 3.3MG N050356 001
BASE/ML;0.5MG/ML
CONIVAPTAN HYDROCHLORIDE
INJECTABLE;IV (INFUSION)
VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER
+ CUMBERLAND PHARMS 20MG/100ML (0.2MG/ML) N021697 002 Oct 08, 2008
COPPER
INTRAUTERINE DEVICE;INTRAUTERINE
PARAGARD T 380A
+ TEVA WOMENS 309MG/COPPER N018680 001 Nov 15, 1984
CORTICORELIN OVINE TRIFLUTATE
INJECTABLE;INJECTION
ACTHREL
+ FERRING EQ 0.1MG BASE/VIAL N020162 001 May 23, 1996
CORTICOTROPIN
INJECTABLE;INJECTION
H.P. ACTHAR GEL
+ QUESTCOR PHARMS 80 UNITS/ML N008372 008
CORTISONE ACETATE
TABLET;ORAL
CORTISONE ACETATE
+ HIKMA INTL PHARMS 25MG A080776 002
COSYNTROPIN
INJECTABLE;INJECTION
CORTROSYN
AP + AMPHASTAR PHARMS INC 0.25MG/VIAL N016750 001
COSYNTROPIN
AP MYLAN INSTITUTIONAL 0.25MG/VIAL A090574 001 Dec 17, 2009
AP SANDOZ 0.25MG/VIAL A202147 001 Jun 29, 2012
CRIZOTINIB
CAPSULE;ORAL
XALKORI
PF PRISM CV 200MG N202570 001 Aug 26, 2011
+ 250MG N202570 002 Aug 26, 2011
CROFELEMER
TABLET, DELAYED RELEASE;ORAL
FULYZAQ
+ SALIX PHARMS 125MG N202292 001 Dec 31, 2012
CROMOLYN SODIUM
CONCENTRATE;ORAL
CROMOLYN SODIUM
AA MICRO LABS LTD INDIA 100MG/5ML A202745 001 Apr 04, 2013
AA PACK PHARMS LLC 100MG/5ML A202583 001 Oct 27, 2011
GASTROCROM
AA + MEDA PHARMS 100MG/5ML N020479 001 Feb 29, 1996
SOLUTION;INHALATION
CROMOLYN SODIUM
AN BAUSCH AND LOMB 10MG/ML A075585 001 Dec 21, 2000
AN MYLAN SPECLT 10MG/ML A074209 001 Apr 26, 1994
AN + TEVA PHARMS 10MG/ML A075271 001 Jan 18, 2000
AN WOCKHARDT 10MG/ML A075346 001 Oct 25, 1999
SOLUTION/DROPS;OPHTHALMIC
CROLOM
AT BAUSCH AND LOMB 4% A074443 001 Jan 30, 1995
CROMOLYN SODIUM
AT + AKORN 4% A074706 001 Apr 29, 1998
AT ALCON 4% A075282 001 Jun 16, 1999
CROTAMITON
CREAM;TOPICAL
EURAX
+ RANBAXY 10% N006927 001
LOTION;TOPICAL
CROTAN
AT SUMMERS 10% A087204 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-93(of 371)
CROTAMITON
LOTION;TOPICAL
EURAX
AT + RANBAXY 10% N009112 003
CUPRIC CHLORIDE
INJECTABLE;INJECTION
CUPRIC CHLORIDE IN PLASTIC CONTAINER
+ HOSPIRA EQ 0.4MG COPPER/ML N018960 001 Jun 26, 1986
CYANOCOBALAMIN
INJECTABLE;INJECTION
CYANOCOBALAMIN
AP + LUITPOLD 1MG/ML A080737 001
VIBISONE
AP + FRESENIUS KABI USA 1MG/ML A080557 003
SPRAY, METERED;NASAL
NASCOBAL
+ PAR PHARM 0.5MG/SPRAY N021642 001 Jan 31, 2005
CYCLOBENZAPRINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
AMRIX
AB IVAX INTL 15MG N021777 001 Feb 01, 2007
AB + 30MG N021777 002 Feb 01, 2007
CYCLOBENZAPRINE HYDROCHLORIDE
AB TWI PHARMS INC 15MG A091281 001 Jan 31, 2013
AB 30MG A091281 002 Jan 31, 2013
TABLET;ORAL
CYCLOBENZAPRINE HYDROCHLORIDE
AB ACTAVIS LABS FL INC 5MG A071611 002 Feb 03, 2006
AB 7.5MG A071611 003 Feb 03, 2006
AB 10MG A071611 001 May 03, 1989
AB AUROBINDO PHARMA 5MG A078643 001 Sep 26, 2008
AB 10MG A078643 002 Sep 26, 2008
AB INVAGEN PHARMS 5MG A090478 001 Jul 23, 2010
AB 10MG A090478 002 Jul 23, 2010
AB JUBILANT CADISTA 5MG A077563 001 Apr 19, 2006
AB 10MG A077563 002 Apr 19, 2006
AB KVK TECH 5MG A078048 001 Feb 28, 2011
AB 10MG A078048 002 Feb 28, 2011
AB MUTUAL PHARM 5MG A073541 002 Apr 06, 2006
AB 10MG A073541 001 May 23, 1995
AB MYLAN PHARMS INC 5MG A073144 002 Feb 03, 2006
AB 7.5MG A073144 003 Mar 25, 2013
AB + 10MG A073144 001 May 30, 1991
AB ORIT LABS LLC 10MG A078218 001 Apr 18, 2008
AB PLIVA 10MG A074421 001 Sep 29, 1995
AB PROSAM LABS 10MG A077209 001 Oct 04, 2005
AB RANBAXY 5MG A078722 001 May 12, 2008
AB 7.5MG A078722 002 May 12, 2008
AB 10MG A078722 003 May 12, 2008
AB VINTAGE PHARMS 5MG A077797 001 Feb 28, 2007
AB 10MG A077797 002 Feb 28, 2007
CYCLOPENTOLATE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
AKPENTOLATE
AT AKORN 1% A040164 001 Jan 13, 1997
CYCLOGYL
AT + ALCON 1% A084110 001
PENTOLAIR
AT BAUSCH AND LOMB 1% A040075 001 Apr 29, 1994
CYCLOGYL
+ ALCON 0.5% A084109 001
+ ALCON LABS INC 2% A084108 001
CYCLOPENTOLATE HYDROCHLORIDE; PHENYLEPHRINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
CYCLOMYDRIL
+ ALCON 0.2%;1% A084300 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-94(of 371)
CYCLOPHOSPHAMIDE
CAPSULE;ORAL
CYCLOPHOSPHAMIDE
ROXANE 25MG N203856 001 Sep 16, 2013
+ 50MG N203856 002 Sep 16, 2013
INJECTABLE;INJECTION
CYCLOPHOSPHAMIDE
AP + BAXTER HLTHCARE 1GM/VIAL A040745 002 May 21, 2008
AP + 2GM/VIAL A040745 003 May 21, 2008
AP + 500MG/VIAL A040745 001 May 21, 2008
AP JIANGSU HENGRUI MED 1GM/VIAL A204555 002 Oct 31, 2014
AP 2GM/VIAL A204555 003 Oct 31, 2014
AP 500MG/VIAL A204555 001 Oct 31, 2014
CYTOXAN (LYOPHILIZED)
AP + BAXTER HLTHCARE 1GM/VIAL N012142 004 Aug 30, 1982
AP + 2GM/VIAL N012142 005 Aug 30, 1982
AP + 500MG/VIAL N012142 003
TABLET;ORAL
CYCLOPHOSPHAMIDE
ROXANE 25MG A040032 001 Aug 17, 1999
+ 50MG A040032 002 Aug 17, 1999
CYCLOSERINE
CAPSULE;ORAL
SEROMYCIN
+ PURDUE GMP 250MG A060593 001
CYCLOSPORINE
CAPSULE;ORAL
CYCLOSPORINE
AB1 IVAX SUB TEVA PHARMS 25MG A065110 003 Mar 29, 2005
AB1 50MG A065110 001 Mar 29, 2005
AB1 100MG A065110 002 Mar 29, 2005
AB1 SANDOZ 25MG A065017 002 Jan 13, 2000
AB1 100MG A065017 001 Jan 13, 2000
AB1 WATSON LABS INC 25MG A065044 002 Dec 20, 2000
AB1 100MG A065044 001 Dec 20, 2000
GENGRAF
AB1 ABBVIE 25MG A065003 001 May 12, 2000
AB1 50MG A065003 002 May 12, 2000
AB1 100MG A065003 003 May 12, 2000
NEORAL
AB1 NOVARTIS 25MG N050715 001 Jul 14, 1995
AB1 + 100MG N050715 002 Jul 14, 1995
CYCLOSPORINE
AB2 APOTEX 25MG A065040 001 May 09, 2002
AB2 100MG A065040 002 May 09, 2002
SANDIMMUNE
AB2 NOVARTIS 25MG N050625 001 Mar 02, 1990
AB2 + 100MG N050625 002 Mar 02, 1990
BX 50MG N050625 003 Nov 23, 1992
EMULSION;OPHTHALMIC
RESTASIS
+ ALLERGAN 0.05% N050790 001 Dec 23, 2002
INJECTABLE;INJECTION
CYCLOSPORINE
AP EUROHLTH INTL 50MG/ML A065004 001 Oct 29, 1999
AP LUITPOLD 50MG/ML A065151 001 Oct 07, 2003
SANDIMMUNE
AP + NOVARTIS 50MG/ML N050573 001 Nov 14, 1983
SOLUTION;ORAL
CYCLOSPORINE
AB1 ABBVIE 100MG/ML A065025 001 Mar 03, 2000
AB1 IVAX SUB TEVA PHARMS 100MG/ML A065078 001 Mar 25, 2005
AB1 WATSON LABS 100MG/ML A065054 001 Dec 18, 2001
NEORAL
AB1 + NOVARTIS 100MG/ML N050716 001 Jul 14, 1995
CYCLOSPORINE
AB2 WOCKHARDT 100MG/ML A065133 001 Sep 17, 2004
SANDIMMUNE
AB2 + NOVARTIS 100MG/ML N050574 001 Nov 14, 1983
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-95(of 371)
CYPROHEPTADINE HYDROCHLORIDE
SYRUP;ORAL
CYPROHEPTADINE HYDROCHLORIDE
AA + LYNE 2MG/5ML A040668 001 Jun 28, 2006
AA PHARM ASSOC 2MG/5ML A091295 001 Mar 28, 2013
TABLET;ORAL
CYPROHEPTADINE HYDROCHLORIDE
AA COREPHARMA 4MG A040537 001 Sep 30, 2003
AA + IVAX SUB TEVA PHARMS 4MG A087056 001
AA PAR PHARM 4MG A087129 001
AA STASON PHARMS 4MG A040644 001 May 30, 2006
CYSTEAMINE BITARTRATE
CAPSULE;ORAL
CYSTAGON
MYLAN EQ 50MG BASE N020392 001 Aug 15, 1994
+ EQ 150MG BASE N020392 002 Aug 15, 1994
CAPSULE, DELAYED RELEASE;ORAL
PROCYSBI
RAPTOR INC EQ 25MG BASE N203389 001 Apr 30, 2013
+ EQ 75MG BASE N203389 002 Apr 30, 2013
CYSTEAMINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
CYSTARAN
+ SIGMA TAU EQ 0.44% BASE N200740 001 Oct 02, 2012
CYTARABINE
INJECTABLE;INJECTION
CYTARABINE
AP EUROHLTH INTL 1GM/VIAL A074245 001 Aug 31, 1994
AP 2GM/VIAL A074245 002 Aug 31, 1994
AP 100MG/VIAL A071471 001 Aug 02, 1989
AP 500MG/VIAL A071472 001 Aug 02, 1989
AP + FRESENIUS KABI USA 100MG/ML A076512 001 Jan 15, 2004
AP + HOSPIRA 20MG/ML A071868 001 Jun 04, 1990
AP + 20MG/ML A072168 001 Aug 31, 1990
AP + 20MG/ML A072945 001 Feb 28, 1994
AP 100MG/ML A075383 001 Nov 22, 1999
AP ONCO THERAPIES LTD 20MG/ML A200914 001 Dec 13, 2011
AP 20MG/ML A200915 001 Dec 13, 2011
AP 20MG/ML A200916 001 Dec 13, 2011
AP 100MG/ML A201784 001 Jan 30, 2012
CYTOSAR-U
AP + TEVA PHARMS USA 1GM/VIAL A075206 004 Dec 30, 1998
AP + 2GM/VIAL A075206 003 Dec 30, 1998
AP 100MG/VIAL A075206 001 Dec 30, 1998
AP + 500MG/VIAL A075206 002 Dec 30, 1998
INJECTABLE, LIPOSOMAL;INJECTION
DEPOCYT
+ PACIRA PHARMS INC 10MG/ML N021041 001 Apr 01, 1999
DABIGATRAN ETEXILATE MESYLATE
CAPSULE;ORAL
PRADAXA
BOEHRINGER INGELHEIM EQ 75MG BASE N022512 001 Oct 19, 2010
+ EQ 150MG BASE N022512 002 Oct 19, 2010
DABRAFENIB MESYLATE
CAPSULE;ORAL
TAFINLAR
GLAXOSMITHKLINE EQ 50MG BASE N202806 001 May 29, 2013
+ EQ 75MG BASE N202806 002 May 29, 2013
DACARBAZINE
INJECTABLE;INJECTION
DACARBAZINE
AP EUROHLTH INTL 200MG/VIAL A075812 001 Jun 15, 2001
AP 500MG/VIAL A075812 002 Oct 31, 2002
AP FRESENIUS KABI USA 100MG/VIAL A075371 001 Aug 27, 1999
AP 200MG/VIAL A075371 002 Aug 27, 1999
AP HOSPIRA 200MG/VIAL A075940 001 Oct 18, 2001
AP TEVA PHARMS USA 200MG/VIAL A075259 002 Aug 27, 1998
AP + 500MG/VIAL A075259 001 Sep 22, 2000
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-96(of 371)
DACARBAZINE
INJECTABLE;INJECTION
DTIC-DOME
AP + BAYER HLTHCARE 100MG/VIAL N017575 001
AP + 200MG/VIAL N017575 002
DACTINOMYCIN
INJECTABLE;INJECTION
COSMEGEN
AP + RECORDATI RARE 0.5MG/VIAL N050682 001
DACTINOMYCIN
AP EUROHLTH INTL 0.5MG/VIAL A090304 001 Mar 16, 2010
AP LUITPOLD 0.5MG/VIAL A202562 001 Aug 23, 2013
DALBAVANCIN HYDROCHLORIDE
INJECTABLE;IV (INFUSION)
DALVANCE
+ DURATA THERAPS INTL EQ 500MG BASE/VIAL N021883 001 May 23, 2014
DALFAMPRIDINE
TABLET, EXTENDED RELEASE;ORAL
AMPYRA
+ ACORDA 10MG N022250 001 Jan 22, 2010
DALFOPRISTIN; QUINUPRISTIN
INJECTABLE;IV (INFUSION)
SYNERCID
+ KING PHARMS 350MG/VIAL;150MG/VIAL N050748 001 Sep 21, 1999
DALTEPARIN SODIUM
INJECTABLE;SUBCUTANEOUS
FRAGMIN
EISAI INC 2,500IU/0.2ML (12,500IU/ML) N020287 001 Dec 22, 1994
5,000IU/0.2ML (25,000IU/ML) N020287 003 Mar 18, 1996
7,500IU/0.3ML (25,000IU/ML) N020287 005 Apr 04, 2002
10,000IU/ML (10,000IU/ML) N020287 004 Jan 30, 1998
12,500IU/0.5ML (25,000IU/ML) N020287 009 May 01, 2007
15,000IU/0.6ML (25,000IU/ML) N020287 010 May 01, 2007
18,000IU/0.72ML (25,000IU/ML) N020287 011 May 01, 2007
+ 95,000IU/3.8ML (25,000IU/ML) N020287 006 Apr 04, 2002
DANAZOL
CAPSULE;ORAL
DANAZOL
AB BARR 50MG A074582 003 May 29, 1998
AB 100MG A074582 002 May 29, 1998
AB + 200MG A074582 001 Aug 09, 1996
AB LANNETT 50MG A078214 001 Apr 19, 2007
AB 100MG A078214 002 Apr 19, 2007
AB 200MG A077246 001 Sep 28, 2005
DANTROLENE SODIUM
CAPSULE;ORAL
DANTRIUM
AB PAR STERILE PRODUCTS 25MG N017443 001
AB 50MG N017443 003
AB + 100MG N017443 002
DANTROLENE SODIUM
AB IMPAX LABS 25MG A076856 001 Mar 01, 2005
AB 50MG A076856 002 Mar 01, 2005
AB 100MG A076856 003 Mar 01, 2005
AB MIKAH PHARMA 25MG A076686 001 Oct 24, 2005
AB 50MG A076686 002 Oct 24, 2005
AB 100MG A076686 003 Oct 24, 2005
FOR SUSPENSION;INTRAVENOUS
RYANODEX
EAGLE PHARMS 250MG/VIAL N205579 001 Jul 22, 2014
INJECTABLE;INJECTION
DANTRIUM
AP + PAR STERILE PRODUCTS 20MG/VIAL N018264 001
REVONTO
AP US WORLDMEDS 20MG/VIAL A078378 001 Jul 24, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-97(of 371)
DAPAGLIFLOZIN
TABLET;ORAL
FARXIGA
ASTRAZENECA AB 5MG N202293 001 Jan 08, 2014
+ 10MG N202293 002 Jan 08, 2014
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
XIGDUO XR
ASTRAZENECA AB 5MG;1GM N205649 002 Oct 29, 2014
5MG;500MG N205649 001 Oct 29, 2014
+ 10MG;1GM N205649 004 Oct 29, 2014
10MG;500MG N205649 003 Oct 29, 2014
DAPSONE
GEL;TOPICAL
ACZONE
+ ALLERGAN 5% N021794 001 Jul 07, 2005
TABLET;ORAL
DAPSONE
JACOBUS 25MG A086841 001
+ 100MG A086842 001
DAPTOMYCIN
INJECTABLE;IV (INFUSION)
CUBICIN
AP + CUBIST 500MG/VIAL N021572 002 Sep 12, 2003
DAPTOMYCIN
AP HOSPIRA INC 500MG/VIAL A202857 001 Sep 12, 2014
DARIFENACIN HYDROBROMIDE
TABLET, EXTENDED RELEASE;ORAL
ENABLEX
WARNER CHILCOTT LLC EQ 7.5MG BASE N021513 001 Dec 22, 2004
+ EQ 15MG BASE N021513 002 Dec 22, 2004
DARUNAVIR ETHANOLATE
SUSPENSION;ORAL
PREZISTA
+ JANSSEN PRODS EQ 100MG BASE/ML N202895 001 Dec 16, 2011
TABLET;ORAL
PREZISTA
JANSSEN PRODS EQ 75MG BASE N021976 004 Dec 18, 2008
EQ 150MG BASE N021976 005 Dec 18, 2008
EQ 600MG BASE N021976 002 Feb 25, 2008
+ EQ 800MG BASE N021976 006 Nov 09, 2012
DASABUVIR SODIUM ; OMBITASVIR; PARITAPREVIR; RITONAVIR
TABLET, TABLET;ORAL
VIEKIRA PAK (COPACKAGED)
+ ABBVIE INC EQ 250MG BASE,N/A,N/A,N/A; N206619 001 Dec 19, 2014
N/A,12.5MG,75MG,50MG
DASATINIB
TABLET;ORAL
SPRYCEL
BRISTOL MYERS SQUIBB 20MG N021986 001 Jun 28, 2006
50MG N021986 002 Jun 28, 2006
70MG N021986 003 Jun 28, 2006
80MG N021986 005 Oct 28, 2010
100MG N021986 004 May 30, 2008
+ 140MG N021986 006 Oct 28, 2010
DAUNORUBICIN CITRATE
INJECTABLE, LIPOSOMAL;INJECTION
DAUNOXOME
+ GALEN (UK) EQ 2MG BASE/ML N050704 002 Apr 08, 1996
DAUNORUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
CERUBIDINE
AP + EUROHLTH INTL EQ 20MG BASE/VIAL A064103 001 Feb 03, 1995
DAUNORUBICIN HYDROCHLORIDE
AP + EUROHLTH INTL EQ 5MG BASE/ML N050731 001 Jan 30, 1998
AP FRESENIUS KABI USA EQ 20MG BASE/VIAL A065000 001 May 25, 1999
AP TEVA PHARMS USA EQ 5MG BASE/ML A065035 001 Jan 24, 2000
FRESENIUS KABI USA EQ 5MG BASE/VIAL A065034 001 Nov 20, 2001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-98(of 371)
DECITABINE
INJECTABLE;INTRAVENOUS
DACOGEN
AP + EISAI INC 50MG/VIAL N021790 001 May 02, 2006
DECITABINE
AP DR REDDYS LABS LTD 50MG/VIAL A203131 001 Jul 11, 2013
AP SANDOZ 50MG/VIAL A202969 001 Aug 28, 2014
POWDER;INTRAVENOUS
DECITABINE
+ SUN PHARMA GLOBAL 50MG/VIAL N205582 001 Jan 28, 2014
DEFERASIROX
TABLET, FOR SUSPENSION;ORAL
EXJADE
NOVARTIS 125MG N021882 001 Nov 02, 2005
250MG N021882 002 Nov 02, 2005
+ 500MG N021882 003 Nov 02, 2005
DEFERIPRONE
TABLET;ORAL
FERRIPROX
+ APOPHARMA INC 500MG N021825 001 Oct 14, 2011
DEFEROXAMINE MESYLATE
INJECTABLE;INJECTION
DEFEROXAMINE MESYLATE
AP EUROHLTH INTL 2GM/VIAL A078086 002 May 30, 2007
AP 500MG/VIAL A078086 001 May 30, 2007
AP FRESENIUS KABI USA 2GM/VIAL A078718 002 Sep 15, 2009
AP 500MG/VIAL A078718 001 Sep 15, 2009
AP HOSPIRA 2GM/VIAL A076019 002 Mar 17, 2004
AP 500MG/VIAL A076019 001 Mar 17, 2004
DESFERAL
AP + NOVARTIS 2GM/VIAL N016267 002 May 25, 2000
AP + 500MG/VIAL N016267 001
DEGARELIX ACETATE
POWDER;SUBCUTANEOUS
FIRMAGON
FERRING EQ 80MG BASE/VIAL N022201 001 Dec 24, 2008
+ EQ 120MG BASE/VIAL N022201 002 Dec 24, 2008
DELAVIRDINE MESYLATE
TABLET;ORAL
RESCRIPTOR
VIIV HLTHCARE 100MG N020705 001 Apr 04, 1997
+ 200MG N020705 002 Jul 14, 1999
DEMECLOCYCLINE HYDROCHLORIDE
TABLET;ORAL
DEMECLOCYCLINE HYDROCHLORIDE
AB AMNEAL PHARM 150MG A065425 001 Feb 27, 2008
AB + 300MG A065425 002 Feb 27, 2008
AB BARR 150MG A065171 001 Dec 13, 2004
AB 300MG A065171 002 Dec 13, 2004
AB IMPAX LABS 150MG A065094 001 Mar 22, 2004
AB 300MG A065094 002 Mar 22, 2004
AB VERSAPHARM 150MG A065389 001 Dec 01, 2008
AB 300MG A065389 002 Dec 01, 2008
DESFLURANE
LIQUID;INHALATION
SUPRANE
+ BAXTER HLTHCARE 99.9% N020118 001 Sep 18, 1992
DESIPRAMINE HYDROCHLORIDE
TABLET;ORAL
DESIPRAMINE HYDROCHLORIDE
AB ACTAVIS TOTOWA 10MG A074430 001 Feb 09, 1996
AB 25MG A071601 001 Jun 05, 1987
AB 50MG A071588 001 Jun 05, 1987
AB 75MG A071602 001 Oct 05, 1987
AB 100MG A071766 001 Oct 05, 1987
AB 150MG A074430 002 Feb 09, 1996
AB SANDOZ 10MG A072099 001 May 24, 1988
AB 25MG A072100 001 May 24, 1988
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-99(of 371)
DESIPRAMINE HYDROCHLORIDE
TABLET;ORAL
DESIPRAMINE HYDROCHLORIDE
AB 50MG A072101 001 May 24, 1988
AB 75MG A072102 001 Jun 20, 1988
AB 100MG A072103 001 Jun 20, 1988
AB 150MG A072104 001 Jun 20, 1988
NORPRAMIN
AB SANOFI AVENTIS US 10MG N014399 007 Feb 11, 1982
AB 25MG N014399 001
AB 50MG N014399 003
AB 75MG N014399 004
AB + 100MG N014399 005
AB 150MG N014399 006
DESIRUDIN RECOMBINANT
INJECTABLE;SUBCUTANEOUS
IPRIVASK
+ MARATHON PHARMS LLC 15MG/VIAL N021271 001 Apr 04, 2003
DESLORATADINE
SOLUTION;ORAL
CLARINEX
+ MERCK SHARP DOHME 0.5MG/ML N021300 001 Sep 01, 2004
TABLET;ORAL
CLARINEX
AB + MERCK SHARP DOHME 5MG N021165 001 Dec 21, 2001
DESLORATADINE
AB BELCHER PHARMS 5MG A078355 001 Apr 19, 2012
AB DR REDDYS LABS LTD 5MG A078365 001 Mar 08, 2011
AB LUPIN PHARMS 5MG A078352 001 Oct 25, 2010
AB MYLAN PHARMS INC 5MG A078351 001 Feb 10, 2012
AB ORCHID HLTHCARE 5MG A078357 001 Feb 19, 2010
AB PERRIGO R AND D 5MG A078361 001 Dec 22, 2011
AB SANDOZ 5MG A078364 001 Dec 03, 2010
AB SUN PHARM INDS 5MG A078359 001 Nov 16, 2010
TABLET, ORALLY DISINTEGRATING;ORAL
CLARINEX
AB MERCK SHARP DOHME 2.5MG N021312 002 Jul 14, 2005
AB + 5MG N021312 001 Jun 26, 2002
DESLORATADINE
AB REDDYS 2.5MG A078367 001 Jul 12, 2010
AB 5MG A078367 002 Jul 12, 2010
DESLORATADINE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
CLARINEX D 24 HOUR
AB + MERCK SHARP DOHME 5MG;240MG N021605 001 Mar 03, 2005
DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR
AB DR REDDYS LABS LTD 5MG;240MG A078366 001 Apr 26, 2011
CLARINEX-D 12 HOUR
+ MERCK SHARP DOHME 2.5MG;120MG N021313 001 Feb 01, 2006
DESMOPRESSIN ACETATE
INJECTABLE;INJECTION
DDAVP
AP + FERRING PHARMS INC 0.004MG/ML N018938 001 Mar 30, 1984
DESMOPRESSIN ACETATE
AP HOSPIRA 0.004MG/ML A075220 001 Aug 28, 2000
AP SUN PHARM INDS LTD 0.004MG/ML A091280 001 Jan 25, 2013
AP TEVA PHARMS USA 0.004MG/ML A074888 001 Oct 15, 1997
SOLUTION;NASAL
DDAVP
AB + FERRING PHARMS INC 0.01% N017922 001
DESMOPRESSIN ACETATE
AB SUN PHARM INDS 0.01% A077212 001 Apr 12, 2012
SPRAY, METERED;NASAL
DDAVP (NEEDS NO REFRIGERATION)
AB + FERRING PHARMS INC 0.01MG/SPRAY N017922 003 Aug 07, 1996
DESMOPRESSIN ACETATE
AB + BAUSCH AND LOMB 0.01MG/SPRAY A074830 001 Jan 25, 1999
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION)
AB APOTEX INC 0.01MG/SPRAY A076703 001 Jan 27, 2005
AB SUN PHARMA GLOBAL 0.01MG/SPRAY A078271 001 Dec 23, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-100(of 371)
DESMOPRESSIN ACETATE
SPRAY, METERED;NASAL
MINIRIN
AB + FERRING 0.01MG/SPRAY N021333 001 Sep 16, 2002
STIMATE (NEEDS NO REFRIGERATION)
+ CSL BEHRING 1.5MG/SPRAY N020355 002 Oct 24, 2007
TABLET;ORAL
DDAVP
AB SANOFI AVENTIS US 0.1MG N019955 001 Sep 06, 1995
AB + 0.2MG N019955 002 Sep 06, 1995
DESMOPRESSIN ACETATE
AB ACTAVIS LABS FL INC 0.1MG A076470 001 Jul 01, 2005
AB 0.2MG A076470 002 Jul 01, 2005
AB APOTEX INC 0.1MG A077414 001 Mar 07, 2006
AB 0.2MG A077414 002 Mar 07, 2006
AB MYLAN PHARMS INC 0.1MG A200653 001 Jun 27, 2014
AB 0.2MG A200653 002 Jun 27, 2014
AB TEVA PHARMS 0.1MG A077122 001 Jan 25, 2006
AB 0.2MG A077122 002 Jan 25, 2006
FERRING 0.1MG N021795 001 May 08, 2008
+ 0.2MG N021795 002 May 08, 2008
DESOGESTREL; ETHINYL ESTRADIOL
TABLET;ORAL-28
CYCLESSA
AB + ORGANON USA INC 0.125MG;0.15MG;0.1MG;0.025MG;0.025MG;0. N021090 001 Dec 20, 2000
025MG
DESOGEN
AB ORGANON USA INC 0.15MG;0.03MG N020071 002 Dec 10, 1992
DESOGESTREL AND ETHINYL ESTRADIOL
AB DURAMED PHARMS BARR 0.15MG;0.03MG A075256 002 Aug 12, 1999
AB FAMY CARE LTD 0.15MG,N/A;0.02MG,0.01MG A202296 001 Aug 30, 2013
AB NOVAST LABS LTD 0.15MG;0.03MG A091234 001 Jul 12, 2013
AB WATSON LABS 0.15MG,N/A;0.02MG,0.01MG;0.02MG,0.01MG A076916 001 Dec 29, 2008
AB 0.1MG,0.125MG,0.15MG;0.025MG,0.025MG,0. A077182 001 Jan 24, 2006
025MG
AB 0.15MG;0.03MG A076915 001 Jul 29, 2005
EMOQUETTE
AB VINTAGE PHARMS LLC 0.15MG;0.03MG A076675 001 Feb 25, 2011
ENSKYCE
AB LUPIN LTD 0.15MG;0.03MG A201887 001 Mar 07, 2013
ORTHO-CEPT
AB + JANSSEN PHARMS 0.15MG;0.03MG N020301 002 Dec 14, 1992
PIMTREA
AB NOVAST LABS LTD 0.15MG,N/A;0.02MG,0.01MG A091247 001 Aug 01, 2013
VELIVET
AB DURAMED PHARMS BARR 0.125MG;0.15MG;0.1MG;0.025MG;0.025MG;0. A076455 001 Feb 24, 2004
025MG
VIORELE
AB GLENMARK GENERICS 0.15MG,N/A;0.02MG,0.01MG A091346 001 Apr 02, 2012
KARIVA
+ BARR 0.15MG,N/A;0.02MG,0.01MG;0.02MG,0.01MG A075863 001 Apr 05, 2002
DESONIDE
AEROSOL, FOAM;TOPICAL
VERDESO
+ AQUA PHARMS 0.05% N021978 001 Sep 19, 2006
CREAM;TOPICAL
DESONIDE
AB + PERRIGO NEW YORK 0.05% N017010 001
AB TARO 0.05% A073548 001 Jun 30, 1992
DESOWEN
AB GALDERMA LABS LP 0.05% N019048 001 Dec 14, 1984
GEL;TOPICAL
DESONATE
+ BAYER HLTHCARE 0.05% N021844 001 Oct 20, 2006
LOTION;TOPICAL
DESONIDE
AB FOUGERA PHARMS 0.05% A075860 001 Mar 19, 2002
AB TARO 0.05% A202161 001 Oct 31, 2014
DESOWEN
AB + GALDERMA LABS LP 0.05% A072354 001 Jan 24, 1992
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-101(of 371)
DESONIDE
OINTMENT;TOPICAL
DESONIDE
AB FOUGERA PHARMS 0.05% A075751 001 Mar 12, 2001
AB + PERRIGO NEW YORK 0.05% N017426 001
AB TARO 0.05% A074254 001 Aug 03, 1994
DESOWEN
AB GALDERMA LABS LP 0.05% A071425 001 Jun 15, 1988
DESOXIMETASONE
CREAM;TOPICAL
DESOXIMETASONE
AB FOUGERA PHARMS 0.25% A078369 001 Jun 29, 2010
AB PERRIGO NEW YORK 0.25% A076510 001 Jul 01, 2003
TOPICORT
AB + TARO 0.25% A073193 001 Nov 30, 1990
+ 0.05% A073210 001 Nov 30, 1990
GEL;TOPICAL
DESOXIMETASONE
AB PERRIGO NEW YORK 0.05% A077552 001 Jan 09, 2006
AB VERSAPHARM 0.05% A090727 001 Mar 10, 2011
TOPICORT
AB + TARO 0.05% A074904 001 Jul 14, 1998
OINTMENT;TOPICAL
DESOXIMETASONE
AB FOUGERA PHARMS 0.25% A078657 001 Sep 28, 2012
AB GLENMARK GENERICS 0.25% A202838 001 Sep 20, 2013
AB VERSAPHARM INC 0.25% A201005 001 Apr 24, 2014
TOPICORT
AB + TARO 0.25% A074286 001 Jun 07, 1996
+ TARO PHARMS NORTH 0.05% N018594 001 Jan 17, 1985
SPRAY;TOPICAL
TOPICORT
+ TARO 0.25% N204141 001 Apr 11, 2013
DESVENLAFAXINE
TABLET, EXTENDED RELEASE;ORAL
DESVENLAFAXINE
BC + ALEMBIC PHARMS LTD 50MG N204150 001 Mar 04, 2013
BC + 100MG N204150 002 Mar 04, 2013
KHEDEZLA
BC OSMOTICA PHARM CORP 50MG N204683 001 Jul 10, 2013
BC 100MG N204683 002 Jul 10, 2013
DESVENLAFAXINE FUMARATE
TABLET, EXTENDED RELEASE;ORAL
DESVENLAFAXINE
+ SUN PHARMA GLOBAL EQ 50MG BASE N205583 001 Jan 28, 2014
+ EQ 100MG BASE N205583 002 Jan 28, 2014
DESVENLAFAXINE SUCCINATE
TABLET, EXTENDED RELEASE;ORAL
PRISTIQ
WYETH PHARMS INC EQ 25MG BASE N021992 003 Aug 20, 2014
+ EQ 50MG BASE N021992 001 Feb 29, 2008
+ EQ 100MG BASE N021992 002 Feb 29, 2008
DEXAMETHASONE
CONCENTRATE;ORAL
DEXAMETHASONE INTENSOL
+ ROXANE 1MG/ML A088252 001 Sep 01, 1983
ELIXIR;ORAL
DEXAMETHASONE
AA LYNE 0.5MG/5ML A090891 001 Jul 12, 2011
AA + STI PHARMA LLC 0.5MG/5ML A084754 001
AA VINTAGE PHARMS 0.5MG/5ML A091188 001 May 11, 2011
AA WOCKHARDT EU OPERATN 0.5MG/5ML A088254 001 Jul 27, 1983
IMPLANT;INTRAVITREAL
OZURDEX
+ ALLERGAN 0.7MG N022315 001 Jun 17, 2009
SOLUTION;ORAL
DEXAMETHASONE
+ ROXANE 0.5MG/5ML A088248 001 Sep 01, 1983
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-102(of 371)
DEXAMETHASONE
SUSPENSION/DROPS;OPHTHALMIC
MAXIDEX
+ ALCON 0.1% N013422 001
TABLET;ORAL
DEXAMETHASONE
AB ECR 1.5MG A040700 001 Aug 15, 2008
AB ROXANE 1.5MG A084610 001
BP PAR PHARM 0.5MG A088148 001 Apr 28, 1983
BP 0.75MG A088160 001 Apr 28, 1983
BP 1.5MG A088237 001 Apr 28, 1983
BP 4MG A088238 001 Apr 28, 1983
BP + 6MG A088481 001 Nov 28, 1983
BP ROXANE 0.5MG A084611 001
BP 0.75MG A084613 001
BP 1MG A088306 001 Sep 15, 1983
BP 2MG A087916 001 Aug 26, 1982
BP 4MG A084612 001
BP + 6MG A088316 001 Sep 15, 1983
DEXAMETHASONE SODIUM PHOSPHATE
INJECTABLE;INJECTION
DEXAMETHASONE SODIUM PHOSPHATE
AP AGILA SPECLTS EQ 4MG PHOSPHATE/ML A040803 001 Aug 29, 2008
AP EQ 10MG PHOSPHATE/ML A040802 001 Aug 29, 2008
AP FRESENIUS KABI USA EQ 4MG PHOSPHATE/ML A084916 001
AP + EQ 10MG PHOSPHATE/ML A040491 001 Apr 11, 2003
AP + EQ 10MG PHOSPHATE/ML A040572 001 Apr 22, 2005
AP + HIKMA MAPLE EQ 10MG PHOSPHATE/ML A087702 001 Sep 07, 1982
AP + LUITPOLD EQ 4MG PHOSPHATE/ML A087440 001 Jul 21, 1982
SOLUTION/DROPS;OPHTHALMIC, OTIC
DEXAMETHASONE SODIUM PHOSPHATE
AT + ALCON PHARMS LTD EQ 0.1% PHOSPHATE A088771 001 Jan 16, 1985
AT BAUSCH AND LOMB EQ 0.1% PHOSPHATE A040069 001 Jul 26, 1996
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
MAXITROL
AT + FALCON PHARMS 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM N050065 002
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
AT BAUSCH AND LOMB 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM A064063 001 Jul 25, 1994
AT PERRIGO CO TENNESSEE 0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM A062938 001 Jul 31, 1989
SUSPENSION/DROPS;OPHTHALMIC
DEXASPORIN
AT BAUSCH AND LOMB 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A064135 001 Sep 13, 1995
MAXITROL
AT ALCON 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062341 001 May 22, 1984
AT + FALCON PHARMS 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N050023 002
DEXAMETHASONE; TOBRAMYCIN
OINTMENT;OPHTHALMIC
TOBRADEX
+ ALCON 0.1%;0.3% N050616 001 Sep 28, 1988
SUSPENSION/DROPS;OPHTHALMIC
TOBRADEX
AB + ALCON 0.1%;0.3% N050592 001 Aug 18, 1988
TOBRAMYCIN AND DEXAMETHASONE
AB BAUSCH AND LOMB 0.1%;0.3% A064134 001 Oct 27, 1999
TOBRADEX ST
+ ALCON PHARMS LTD 0.05%;0.3% N050818 001 Feb 13, 2009
DEXCHLORPHENIRAMINE MALEATE
SYRUP;ORAL
DEXCHLORPHENIRAMINE MALEATE
+ WOCKHARDT 2MG/5ML A088251 001 Mar 23, 1984
DEXLANSOPRAZOLE
CAPSULE, DELAYED RELEASE;ORAL
DEXILANT
TAKEDA PHARMS USA 30MG N022287 001 Jan 30, 2009
+ 60MG N022287 002 Jan 30, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-103(of 371)
DEXMEDETOMIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
DEXMEDETOMIDINE HYDROCHLORIDE
AP AKORN INC EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) A202585 001 Nov 24, 2014
AP MYLAN INSTITUTIONAL EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) A202881 001 Aug 18, 2014
AP PAR STERILE PRODUCTS EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) A203972 001 Aug 18, 2014
PRECEDEX
AP + HOSPIRA EQ 200MCG BASE/2ML (EQ 100MCG BASE/ML) N021038 001 Dec 17, 1999
+ EQ 200MCG BASE/50ML (EQ 4MCG BASE/ML) N021038 002 Mar 13, 2013
+ EQ 400MCG BASE/100ML (EQ 4MCG BASE/ML) N021038 003 Mar 13, 2013
DEXMETHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDE
AB INTELLIPHARMACEUTICS 15MG A078992 003 Nov 18, 2013
AB 30MG A078992 004 Nov 18, 2013
AB MYLAN PHARMS INC 30MG A202580 001 Aug 28, 2013
AB TEVA PHARMS USA 5MG A078908 001 Nov 19, 2013
AB 10MG A078908 002 Nov 19, 2013
AB 15MG A078908 004 May 19, 2014
AB 20MG A078908 003 Nov 19, 2013
AB 30MG A202731 003 May 19, 2014
AB 40MG A202731 002 Nov 19, 2013
AB WATSON LABS INC 15MG A079108 003 May 19, 2014
AB 30MG A079108 005 Nov 21, 2013
FOCALIN XR
AB NOVARTIS 5MG N021802 001 May 26, 2005
AB 10MG N021802 002 May 26, 2005
AB 15MG N021802 004 Aug 01, 2006
AB 20MG N021802 003 May 26, 2005
AB 30MG N021802 005 Oct 23, 2009
AB + 40MG N021802 006 Aug 11, 2010
25MG N021802 008 Apr 21, 2011
35MG N021802 007 Apr 21, 2011
TABLET;ORAL
DEXMETHYLPHENIDATE HYDROCHLORIDE
AB TEVA PHARMS 2.5MG A077107 003 Jan 29, 2007
AB 5MG A077107 001 Jan 29, 2007
AB 10MG A077107 002 Jan 29, 2007
FOCALIN
AB NOVARTIS 2.5MG N021278 001 Nov 13, 2001
AB 5MG N021278 002 Nov 13, 2001
AB + 10MG N021278 003 Nov 13, 2001
DEXRAZOXANE HYDROCHLORIDE
INJECTABLE;INJECTION
DEXRAZOXANE HYDROCHLORIDE
AP EUROHLTH INTL EQ 250MG BASE/VIAL A076068 001 Sep 28, 2004
AP EQ 500MG BASE/VIAL A076068 002 Sep 28, 2004
AP MYLAN INSTITUTIONAL EQ 250MG BASE/VIAL A200752 001 Oct 19, 2011
AP EQ 500MG BASE/VIAL A200752 002 Oct 19, 2011
ZINECARD
AP + PHARMACIA AND UPJOHN EQ 250MG BASE/VIAL N020212 001 May 26, 1995
AP + EQ 500MG BASE/VIAL N020212 002 May 26, 1995
TOTECT
+ BIOCODEX INC EQ 500MG BASE/VIAL N022025 001 Sep 06, 2007
DEXTROAMPHETAMINE SULFATE
CAPSULE, EXTENDED RELEASE;ORAL
DEXEDRINE
AB AMEDRA PHARMS 5MG N017078 001
AB 10MG N017078 002
AB + 15MG N017078 003
DEXTROAMPHETAMINE SULFATE
AB ACTAVIS ELIZABETH 5MG A203901 001 Nov 30, 2012
AB 10MG A203901 002 Nov 30, 2012
AB 15MG A203901 003 Nov 30, 2012
AB BARR 5MG A076137 001 Jan 18, 2002
AB 10MG A076137 002 Jan 18, 2002
AB 15MG A076137 003 Jan 18, 2002
AB MALLINCKRODT 5MG A076353 001 May 06, 2003
AB 10MG A076353 002 May 06, 2003
AB 15MG A076353 003 May 06, 2003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-104(of 371)
DEXTROAMPHETAMINE SULFATE
SOLUTION;ORAL
DEXTROAMPHETAMINE SULFATE
AA + OUTLOOK PHARMS 5MG/5ML A040776 001 Jan 29, 2008
AA TRIS PHARMA INC 5MG/5ML A203644 001 May 29, 2013
TABLET;ORAL
DEXTROAMPHETAMINE SULFATE
AA AUROLIFE PHARMA LLC 5MG A202893 001 Jul 31, 2013
AA 10MG A202893 002 Jul 31, 2013
AA BARR 5MG A040361 001 Jan 31, 2001
AA + 10MG A040361 002 Jan 31, 2001
AA COREPHARMA 5MG A090652 001 Mar 07, 2014
AA 10MG A090652 002 Mar 07, 2014
AA MALLINCKRODT 5MG A040436 001 Jan 29, 2002
AA 10MG A040436 002 Jan 29, 2002
AA MIKART 5MG A090533 002 Oct 25, 2011
AA 10MG A090533 004 Oct 25, 2011
2.5MG A090533 001 Oct 25, 2011
7.5MG A090533 003 Oct 25, 2011
15MG A090533 005 Oct 25, 2011
20MG A090533 006 Oct 25, 2011
30MG A090533 007 Oct 25, 2011
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
SYRUP;ORAL
PROMETHAZINE DM
AA + VINTAGE 15MG/5ML;6.25MG/5ML A040649 001 Feb 14, 2006
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
AA HI TECH PHARMA 15MG/5ML;6.25MG/5ML A040027 001 Jul 31, 1996
PROMETHAZINE W/ DEXTROMETHORPHAN
AA WOCKHARDT 15MG/5ML;6.25MG/5ML A088864 001 Jan 04, 1985
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE
CAPSULE;ORAL
NUEDEXTA
+ AVANIR PHARMS 20MG;10MG N021879 001 Oct 29, 2010
DEXTROSE
INJECTABLE;INJECTION
DEXTROSE 10% IN PLASTIC CONTAINER
AP + B BRAUN 10GM/100ML N019626 004 Feb 02, 1988
AP + BAXTER HLTHCARE 10GM/100ML N016694 001
AP + HOSPIRA 10GM/100ML N018080 001
DEXTROSE 20% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 20GM/100ML N017521 004
AP + HOSPIRA 20GM/100ML N018564 001 Mar 23, 1982
DEXTROSE 30% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 30GM/100ML N017521 003
AP + HOSPIRA 30GM/100ML N019345 001 Jan 26, 1985
DEXTROSE 40% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 40GM/100ML N017521 002
AP + HOSPIRA 40GM/100ML N018562 001 Mar 23, 1982
DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 5GM/100ML N016730 001
AP + 5GM/100ML N019626 002 Feb 02, 1988
AP + 50MG/ML N016730 002
AP + BAXTER HLTHCARE 5GM/100ML N016673 001
AP + 5GM/100ML N020179 001 Dec 07, 1992
AP + 50MG/ML N016673 003 Oct 30, 1985
AP + 50MG/ML N020179 002 Dec 07, 1992
AP + HOSPIRA 5GM/100ML N019466 001 Jul 15, 1985
AP + 5GM/100ML N019479 001 Sep 17, 1985
AP + 50MG/ML N016367 002
AP + 50MG/ML N019222 001 Jul 13, 1984
DEXTROSE 50% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 50GM/100ML N017521 001
AP + 50GM/100ML N020047 001 Jul 02, 1991
AP + HOSPIRA 50GM/100ML N018563 001 Mar 23, 1982
AP + 50GM/100ML N019894 001 Dec 26, 1989
AP 500MG/ML N019445 001 Jun 03, 1986
DEXTROSE 60% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 60GM/100ML N017521 005 Mar 26, 1982
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-105(of 371)
DEXTROSE
INJECTABLE;INJECTION
DEXTROSE 70% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 70GM/100ML
N017521 006 Mar 26, 1982
AP + 70GM/100ML
N020047 003 Jul 02, 1991
AP + HOSPIRA 70GM/100ML
N018561 001 Mar 23, 1982
AP + 70GM/100ML
N019893 001 Dec 26, 1989
DEXTROSE 25%
+ HOSPIRA 250MG/ML
N019445 002 Nov 23, 1998
DEXTROSE; MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;32MG/100ML;128MG/100ML;234MG/ N017385 001
100ML
DEXTROSE; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;21MG/100ML;128MG/100ML;234MG/ N017610 001
100ML
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE
INJECTABLE;INJECTION
ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;31MG/100ML;130MG/100ML;26MG/1 N019873 001 Jun 10, 1993
00ML;320MG/100ML
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE;
SODIUM LACTATE; SODIUM PHOSPHATE, MONOBASIC ANHYDROUS
INJECTABLE;INJECTION
IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;53MG/100ML;100MG/100ML;100MG/ N019515 001 May 08, 1986
100ML;180MG/100ML;280MG/100ML;16MG/100M
L
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE;
SODIUM LACTATE
INJECTABLE;INJECTION
DEXTROSE 5% AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;31MG/100ML;141MG/100ML;20MG/1 N017484 001
00ML;12MG/100ML;260MG/100ML
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM LACTATE;
SODIUM PHOSPHATE, MONOBASIC ANHYDROUS
INJECTABLE;INJECTION
IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;30MG/100ML;141MG/100ML;15MG/1 N019513 001 May 08, 1986
00ML;260MG/100ML;25MG/100ML
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;30MG/100ML;97MG/100ML;220MG/1 N019844 001 Jun 10, 1993
00ML;140MG/100ML
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM
GLUCONATE
INJECTABLE;INJECTION
ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;30MG/100ML;37MG/100ML;370MG/1
N019843 001 Aug 09, 1993
00ML;530MG/100ML;500MG/100ML
NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;30MG/100ML;37MG/100ML;222MG/1
N017609 001
00ML;526MG/100ML;502MG/100ML
PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;30MG/100ML;37MG/100ML;368MG/1 N017451 001
00ML;526MG/100ML;502MG/100ML
DEXTROSE; POTASSIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML
N017634 004
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML
N017634 001
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML
N017634 003
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML
N017634 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-106(of 371)
DEXTROSE; POTASSIUM CHLORIDE
INJECTABLE;INJECTION
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;75MG/100ML N018744 001 Nov 09, 1982
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML N018744 002 Nov 09, 1982
AP 5GM/100ML;150MG/100ML N019699 004 Sep 29, 1989
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;300MG/100ML N018744 004 Nov 09, 1982
AP 5GM/100ML;300MG/100ML N019699 006 Sep 29, 1989
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
AP HOSPIRA 5GM/100ML;224MG/100ML N018371 003
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;149MG/100ML N018371 001
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;298MG/100ML N018371 002
DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;150MG/100ML;130MG/100ML;280MG N019870 001 Jun 10, 1993
/100ML;91MG/100ML
DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM LACTATE
INJECTABLE;INJECTION
DEXTROSE 5% AND ELECTROLYTE NO 75 IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;205MG/100ML;100MG/100ML;120MG N018840 001 Jun 29, 1983
/100ML;220MG/100ML
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ
AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;200MG/100ML N018037 006 Apr 13, 1982
AP 5GM/100ML;150MG/100ML;200MG/100ML N018037 007 Apr 13, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K)
AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;200MG/100ML N018037 004
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;200MG/100ML N018037 008 Apr 13, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K)
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;200MG/100ML N018037 001
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ
AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;200MG/100ML N018037 005 Apr 13, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;200MG/100ML N018037 009 Apr 13, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ
AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;200MG/100ML N018037 002
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K)
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;200MG/100ML N018037 003
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;330MG/100ML N018629 005 Mar 23, 1982
AP 5GM/100ML;150MG/100ML;330MG/100ML N018629 002 Mar 23, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;330MG/100ML N018629 003 Mar 23, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;330MG/100ML N018629 004 Mar 23, 1982
AP 5GM/100ML;300MG/100ML;330MG/100ML N018629 006 Mar 23, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;330MG/100ML N018629 007 Mar 23, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;330MG/100ML N018629 008 Mar 23, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;330MG/100ML N018629 001 Mar 23, 1982
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;450MG/100ML N018008 010
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;75MG/100ML;200MG/100ML N019630 008 Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;75MG/100ML;330MG/100ML N019630 014 Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;75MG/100ML;450MG/100ML N019630 020 Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;75MG/100ML;900MG/100ML N019630 026 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML;200MG/100ML N019630 010 Feb 17, 1988
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-107(of 371)
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML;330MG/100ML N019630 016 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML;450MG/100ML N019630 022 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;150MG/100ML;900MG/100ML N019630 028 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;300MG/100ML;200MG/100ML N019630 012 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;300MG/100ML;330MG/100ML N019630 018 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;300MG/100ML;450MG/100ML N019630 024 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;300MG/100ML;900MG/100ML N019630 030 Feb 17, 1988
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;450MG/100ML N018008 005 Apr 28, 1982
AP 5GM/100ML;150MG/100ML;450MG/100ML N018008 006 Apr 28, 1982
AP HOSPIRA 5GM/100ML;74.5MG/100ML;450MG/100ML N018362 005 Mar 28, 1988
AP 5GM/100ML;74.5MG/100ML;450MG/100ML N018362 009 Jul 05, 1983
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;75MG/100ML;900MG/100ML N019308 004 Apr 05, 1985
AP 5GM/100ML;150MG/100ML;900MG/100ML N019308 002 Apr 05, 1985
AP HOSPIRA 5GM/100ML;74.5MG/100ML;900MG/100ML N019691 002 Mar 24, 1988
AP 5GM/100ML;149MG/100ML;900MG/100ML N019691 004 Mar 24, 1988
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP HOSPIRA 5GM/100ML;224MG/100ML;450MG/100ML N018362 006 Mar 28, 1988
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP HOSPIRA 5GM/100ML;224MG/100ML;900MG/100ML N019691 006 Mar 24, 1988
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;450MG/100ML N018008 007 Apr 28, 1982
AP HOSPIRA 5GM/100ML;149MG/100ML;450MG/100ML N018362 010 Jul 05, 1983
AP 5GM/100ML;298MG/100ML;450MG/100ML N018362 007 Mar 28, 1988
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;900MG/100ML N019308 005 Apr 05, 1985
AP 5GM/100ML;300MG/100ML;900MG/100ML N019308 003 Apr 05, 1985
AP HOSPIRA 5GM/100ML;149MG/100ML;900MG/100ML N019691 005 Mar 24, 1988
AP 5GM/100ML;298MG/100ML;900MG/100ML N019691 008 Mar 24, 1988
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;450MG/100ML N018008 008 Apr 28, 1982
AP HOSPIRA 5GM/100ML;224MG/100ML;450MG/100ML N018362 002
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;224MG/100ML;900MG/100ML N019308 006 Apr 05, 1985
AP HOSPIRA 5GM/100ML;224MG/100ML;900MG/100ML N019691 007 Mar 24, 1988
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;450MG/100ML N018008 009 Apr 28, 1982
AP HOSPIRA 5GM/100ML;298MG/100ML;450MG/100ML N018362 003
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;300MG/100ML;900MG/100ML N019308 007 Apr 05, 1985
AP HOSPIRA 5GM/100ML;298MG/100ML;900MG/100ML N019691 009 Mar 24, 1988
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;450MG/100ML N018008 004
AP HOSPIRA 5GM/100ML;74.5MG/100ML;450MG/100ML N018362 008 Mar 28, 1988
AP 5GM/100ML;149MG/100ML;450MG/100ML N018362 004 Mar 28, 1988
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;150MG/100ML;900MG/100ML N019308 001 Apr 05, 1985
AP HOSPIRA 5GM/100ML;74.5MG/100ML;900MG/100ML N019691 001 Mar 24, 1988
AP 5GM/100ML;149MG/100ML;900MG/100ML N019691 003 Mar 24, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;37MG/100ML;200MG/100ML N019630 031 Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;37MG/100ML;450MG/100ML N019630 037 Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;37MG/100ML;900MG/100ML N019630 043 Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;37MG/100ML;110MG/100ML N019630 001 Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;37MG/100ML;200MG/100ML N019630 007 Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;37MG/100ML;330MG/100ML N019630 013 Feb 17, 1988
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-108(of 371)
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;37MG/100ML;450MG/100ML N019630 019 Feb 17, 1988
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;37MG/100ML;900MG/100ML N019630 025 Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;75MG/100ML;200MG/100ML N019630 032 Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;75MG/100ML;450MG/100ML N019630 038 Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;75MG/100ML;900MG/100ML N019630 044 Feb 17, 1988
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN 3.3GM/100ML;75MG/100ML;300MG/100ML N019630 049 May 07, 1992
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;75MG/100ML;110MG/100ML N019630 002 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;110MG/100ML;200MG/100ML N019630 033 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;110MG/100ML;450MG/100ML N019630 039 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;110MG/100ML;900MG/100ML N019630 045 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN 3.3GM/100ML;110MG/100ML;300MG/100ML N019630 050 May 07, 1992
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;110MG/100ML;110MG/100ML N019630 003 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;110MG/100ML;200MG/100ML N019630 009 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;110MG/100ML;330MG/100ML N019630 015 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;110MG/100ML;450MG/100ML N019630 021 Feb 17, 1988
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;110MG/100ML;900MG/100ML N019630 027 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;150MG/100ML;200MG/100ML N019630 034 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;150MG/100ML;450MG/100ML N019630 040 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;150MG/100ML;900MG/100ML N019630 046 Feb 17, 1988
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN 3.3GM/100ML;150MG/100ML;300MG/100ML N019630 051 May 07, 1992
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;150MG/100ML;110MG/100ML N019630 004 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;220MG/100ML;200MG/100ML N019630 035 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;220MG/100ML;450MG/100ML N019630 041 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;220MG/100ML;900MG/100ML N019630 047 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN 3.3GM/100ML;220MG/100ML;300MG/100ML N019630 052 May 07, 1992
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML;110MG/100ML N019630 005 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML;200MG/100ML N019630 011 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML;330MG/100ML N019630 017 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML;450MG/100ML N019630 023 Feb 17, 1988
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML;900MG/100ML N019630 029 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;300MG/100ML;200MG/100ML N019630 036 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;300MG/100ML;450MG/100ML N019630 042 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;300MG/100ML;900MG/100ML N019630 048 Feb 17, 1988
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN 3.3GM/100ML;300MG/100ML;300MG/100ML N019630 053 May 07, 1992
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;300MG/100ML;110MG/100ML N019630 006 Feb 17, 1988
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-109(of 371)
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;74.5MG/100ML;225MG/100ML N018365 002 Jul 05, 1983
5GM/100ML;149MG/100ML;225MG/100ML N018365 006 Mar 28, 1988
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;74.5MG/100ML;300MG/100ML N018876 001 Jan 17, 1986
5GM/100ML;149MG/100ML;300MG/100ML N018876 006 Mar 28, 1988
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;224MG/100ML;225MG/100ML N018365 008 Mar 28, 1988
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;224MG/100ML;300MG/100ML N018876 007 Mar 28, 1988
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;149MG/100ML;225MG/100ML N018365 001
5GM/100ML;298MG/100ML;225MG/100ML N018365 009 Mar 28, 1988
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;298MG/100ML;300MG/100ML N018876 008 Mar 28, 1988
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;149MG/100ML;300MG/100ML N018876 002 Jan 17, 1986
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;224MG/100ML;225MG/100ML N018365 003 Jul 05, 1983
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;224MG/100ML;300MG/100ML N018876 003 Jan 17, 1986
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;298MG/100ML;225MG/100ML N018365 004 Jul 05, 1983
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;298MG/100ML;300MG/100ML N018876 004 Mar 28, 1988
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;74.5MG/100ML;225MG/100ML N018365 005 Mar 28, 1988
5GM/100ML;149MG/100ML;225MG/100ML N018365 007 Mar 28, 1988
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;74.5MG/100ML;300MG/100ML N018876 005 Mar 28, 1988
5GM/100ML;149MG/100ML;300MG/100ML N018876 009 Mar 28, 1988
DEXTROSE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 10GM/100ML;900MG/100ML N019631 015 Feb 24, 1988
AP BAXTER HLTHCARE 10GM/100ML;900MG/100ML N016696 001
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 2.5GM/100ML;450MG/100ML N019631 004 Feb 24, 1988
AP BAXTER HLTHCARE 2.5GM/100ML;450MG/100ML N016697 001
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;200MG/100ML N019631 007 Feb 24, 1988
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;330MG/100ML N019631 008 Feb 24, 1988
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;450MG/100ML N019631 009 Feb 24, 1988
AP HOSPIRA 5GM/100ML;450MG/100ML N017607 001
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML;900MG/100ML N019631 010 Feb 24, 1988
AP HOSPIRA 5GM/100ML;900MG/100ML N017585 001
DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;200MG/100ML N016689 001
DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;330MG/100ML N016687 001
DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;450MG/100ML N016683 001
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML;900MG/100ML N016678 001
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;110MG/100ML N019631 011 Feb 24, 1988
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;200MG/100ML N019631 012 Feb 24, 1988
DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;330MG/100ML N019631 013 Feb 24, 1988
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;450MG/100ML N019631 014 Feb 24, 1988
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN 2.5GM/100ML;110MG/100ML N019631 001 Feb 24, 1988
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 2.5GM/100ML;200MG/100ML N019631 002 Feb 24, 1988
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-110(of 371)
DEXTROSE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
B BRAUN 2.5GM/100ML;330MG/100ML
N019631 003 Feb 24, 1988
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 2.5GM/100ML;900MG/100ML
N019631 005 Feb 24, 1988
DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN 3.3GM/100ML;300MG/100ML
N019631 016 Jan 19, 1990
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;110MG/100ML
N019631 006 Feb 24, 1988
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;225MG/100ML
N017606 001
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
HOSPIRA
5GM/100ML;300MG/100ML
N017799 001
DIATRIZOATE MEGLUMINE
SOLUTION;URETHRAL
CYSTOGRAFIN
BRACCO
30%
N010040 018
CYSTOGRAFIN DILUTE
BRACCO
18%
N010040 022 Nov 09, 1982
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
INJECTABLE;INJECTION
MD-76R
AP + MALLINCKRODT
66%;10%
N019292 001 Sep 29, 1989
RENOGRAFIN-76
AP + BRACCO
66%;10%
N010040 001
SOLUTION;ORAL, RECTAL
GASTROGRAFIN
AA + BRACCO
66%;10%
N011245 003
MD-GASTROVIEW
AA MALLINCKRODT
66%;10%
A087388 001
DIATRIZOATE MEGLUMINE; IODIPAMIDE MEGLUMINE
SOLUTION;INTRAUTERINE
SINOGRAFIN
+ BRACCO
52.7%;26.8%
N011324 002
DIAZEPAM
CONCENTRATE;ORAL
DIAZEPAM
AA LANNETT HOLDINGS INC
5MG/ML
A204433 001 Apr 14, 2014
DIAZEPAM INTENSOL
AA + ROXANE
5MG/ML
A071415 001 Apr 03, 1987
GEL;RECTAL
DIASTAT
VALEANT PHARMS NORTH
2.5MG/0.5ML (5MG/ML)
N020648 001 Jul 29, 1997
DIASTAT ACUDIAL
VALEANT PHARMS NORTH
10MG/2ML (5MG/ML)
N020648 007 Sep 15, 2005
+
20MG/4ML (5MG/ML)
N020648 006 Sep 15, 2005
INJECTABLE;INJECTION
DIAZEPAM
AP + HOSPIRA
5MG/ML
A071583 001 Oct 13, 1987
AP
5MG/ML
A072079 001 Dec 20, 1988
SOLUTION;ORAL
DIAZEPAM
+ ROXANE
5MG/5ML
A070928 001 Apr 03, 1987
TABLET;ORAL
DIAZEPAM
AB BARR
2MG
A070152 001 Nov 01, 1985
AB
10MG
A070154 001 Nov 01, 1985
AB IVAX SUB TEVA PHARMS
2MG
A071307 001 Dec 10, 1986
AB
5MG
A071321 001 Dec 10, 1986
AB
10MG
A071322 001 Dec 10, 1986
AB MYLAN
2MG
A070325 002 Sep 04, 1985
AB
5MG
A070325 003 Sep 04, 1985
AB
10MG
A070325 001 Sep 04, 1985
AB VINTAGE PHARMS
2MG
A077749 001 Mar 31, 2006
AB
5MG
A077749 002 Mar 31, 2006
AB
10MG
A077749 003 Mar 31, 2006
AB WATSON LABS
2MG
A071134 001 Feb 03, 1987
AB
5MG
A071135 001 Feb 03, 1987
AB
10MG
A071136 001 Feb 03, 1987
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-111(of 371)
DIAZEPAM
TABLET;ORAL
VALIUM
AB ROCHE 2MG N013263 002
AB 5MG N013263 004
AB + 10MG N013263 006
DIAZOXIDE
SUSPENSION;ORAL
PROGLYCEM
+ TEVA BRANDED PHARM 50MG/ML N017453 001
DICLOFENAC
CAPSULE;ORAL
ZORVOLEX
IROKO PHARMS LLC 18MG N204592 001 Oct 18, 2013
+ 35MG N204592 002 Oct 18, 2013
DICLOFENAC EPOLAMINE
PATCH;TOPICAL
FLECTOR
+ INST BIOCHEM 1.3% N021234 001 Jan 31, 2007
DICLOFENAC POTASSIUM
CAPSULE;ORAL
ZIPSOR
+ DEPOMED INC 25MG N022202 001 Jun 16, 2009
FOR SOLUTION;ORAL
CAMBIA
+ DEPOMED INC 50MG N022165 001 Jun 17, 2009
TABLET;ORAL
CATAFLAM
AB + NOVARTIS 50MG N020142 002 Nov 24, 1993
DICLOFENAC POTASSIUM
AB APOTEX 50MG A076561 001 Mar 18, 2004
AB MYLAN 50MG A075463 001 Jul 26, 1999
AB SANDOZ 50MG A075229 001 Nov 20, 1998
AB TEVA 50MG A075219 001 Aug 06, 1998
DICLOFENAC SODIUM
GEL;TOPICAL
DICLOFENAC SODIUM
AB TOLMAR 3% A200936 001 Oct 28, 2013
SOLARAZE
AB + FOUGERA PHARMS 3% N021005 001 Oct 16, 2000
VOLTAREN
+ NOVARTIS 1% N022122 001 Oct 17, 2007
SOLUTION;INTRAVENOUS
DYLOJECT
+ JAVELIN PHARMS INC 37.5MG/ML (37.5MG/ML) N022396 001 Dec 23, 2014
SOLUTION;TOPICAL
DICLOFENAC SODIUM
AT APOTEX INC 1.5% A202027 001 May 27, 2014
AT PADDOCK LLC 1.5% A202393 001 Nov 24, 2014
AT TARO 1.5% A203818 001 Nov 26, 2014
AT WATSON LABS INC 1.5% A202852 001 Nov 24, 2014
PENNSAID
AT + NUVO RES INC 1.5% N020947 001 Nov 04, 2009
+ HORIZON PHARMA 2% N204623 001 Jan 16, 2014
SOLUTION/DROPS;OPHTHALMIC
DICLOFENAC SODIUM
AT AKORN 0.1% A077845 001 Apr 17, 2008
AT ALCON PHARMS LTD 0.1% A078031 001 Feb 06, 2008
AT BAUSCH AND LOMB 0.1% A078792 001 Dec 28, 2007
AT NEXUS PHARMS 0.1% A078553 001 Dec 28, 2007
VOLTAREN
AT + NOVARTIS 0.1% N020037 001 Mar 28, 1991
TABLET, DELAYED RELEASE;ORAL
DICLOFENAC SODIUM
AB ACTAVIS ELIZABETH 50MG A074514 001 Mar 26, 1996
AB 75MG A074514 002 Mar 26, 1996
AB CARLSBAD 25MG A075185 002 Nov 13, 1998
AB 50MG A075185 003 Nov 13, 1998
AB 75MG A075185 001 Nov 13, 1998
AB MYLAN PHARMS INC 50MG A075281 002 Feb 12, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-112(of 371)
DICLOFENAC SODIUM
TABLET, DELAYED RELEASE;ORAL
DICLOFENAC SODIUM
AB 75MG A075281 003 Feb 12, 2002
AB + SANDOZ 25MG A074376 001 Sep 28, 1995
AB + 50MG A074376 002 Sep 28, 1995
AB + 75MG A074394 001 Nov 30, 1995
AB UNIQUE PHARM LABS 25MG A090066 001 Dec 01, 2010
AB 50MG A090066 002 Dec 01, 2010
AB 75MG A077863 003 Jun 08, 2007
TABLET, EXTENDED RELEASE;ORAL
DICLOFENAC SODIUM
AB ACTAVIS ELIZABETH 100MG A075910 001 Jan 07, 2002
AB DEXCEL LTD 100MG A076201 001 Nov 06, 2002
AB MYLAN 100MG A076152 001 Dec 13, 2001
AB VALEANT INTL 100MG A075492 001 Feb 11, 2000
VOLTAREN-XR
AB + NOVARTIS 100MG N020254 001 Mar 08, 1996
DICLOFENAC SODIUM; MISOPROSTOL
TABLET, DELAYED RELEASE;ORAL
ARTHROTEC
AB GD SEARLE LLC 50MG;0.2MG N020607 001 Dec 24, 1997
AB + 75MG;0.2MG N020607 002 Dec 24, 1997
DICLOFENAC SODIUM AND MISOPROSTOL
AB ACTAVIS LABS FL INC 50MG;0.2MG A201089 001 Jul 09, 2012
AB 75MG;0.2MG A201089 002 Jul 09, 2012
AB EAGLE PHARMS 50MG;0.2MG A200540 001 Mar 14, 2014
AB 75MG;0.2MG A200540 002 Mar 14, 2014
AB SANDOZ 50MG;0.2MG A200158 001 May 09, 2013
AB 75MG;0.2MG A200158 002 May 09, 2013
DICLOXACILLIN SODIUM
CAPSULE;ORAL
DICLOXACILLIN SODIUM
AB SANDOZ EQ 250MG BASE A061454 001
AB + EQ 500MG BASE A061454 003
AB TEVA EQ 250MG BASE A062286 001 Jun 03, 1982
AB EQ 500MG BASE A062286 002 Jun 03, 1982
SANDOZ EQ 125MG BASE A061454 002
DICYCLOMINE HYDROCHLORIDE
CAPSULE;ORAL
BENTYL
AB + FOREST LABS INC 10MG N007409 003 Oct 15, 1984
DICYCLOMINE HYDROCHLORIDE
AB LANNETT 10MG A084285 001
AB MYLAN 10MG A040319 001 Sep 07, 1999
AB WATSON LABS 10MG A085082 001 Jun 19, 1986
INJECTABLE;INJECTION
BENTYL
AP + FOREST LABS INC 10MG/ML N008370 001 Oct 15, 1984
BENTYL PRESERVATIVE FREE
AP + FOREST LABS INC 10MG/ML N008370 002 Oct 15, 1984
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE)
AP EUROHLTH INTL 10MG/ML A040465 001 Jun 30, 2003
SYRUP;ORAL
BENTYL
AA + APTALIS PHARMA US 10MG/5ML N007961 002 Oct 15, 1984
DICYCLOMINE HYDROCHLORIDE
AA MIKART 10MG/5ML A040169 001 Mar 24, 2005
TABLET;ORAL
BENTYL
AB + FOREST LABS INC 20MG N007409 001 Oct 15, 1984
DICYCLOMINE HYDROCHLORIDE
AB LANNETT 20MG A040230 001 Feb 26, 1999
AB MYLAN 20MG A040317 001 Sep 07, 1999
AB WATSON LABS 20MG A085223 001 Jul 30, 1986
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-113(of 371)
DIDANOSINE
CAPSULE, DELAYED REL PELLETS;ORAL
DIDANOSINE
AB AUROBINDO PHARMA 125MG A090094 001 Sep 24, 2008
AB 200MG A090094 002 Sep 24, 2008
AB 250MG A090094 003 Sep 24, 2008
AB 400MG A090094 004 Sep 24, 2008
AB BARR 200MG A077167 001 Dec 03, 2004
AB 250MG A077167 002 Dec 03, 2004
AB 400MG A077167 003 Dec 03, 2004
AB MYLAN PHARMS INC 125MG A090788 001 Apr 08, 2010
AB 200MG A090788 002 Apr 08, 2010
AB 250MG A090788 003 Apr 08, 2010
AB 400MG A090788 004 Apr 08, 2010
VIDEX EC
AB BRISTOL MYERS SQUIBB 125MG N021183 001 Oct 31, 2000
AB 200MG N021183 002 Oct 31, 2000
AB 250MG N021183 003 Oct 31, 2000
AB + 400MG N021183 004 Oct 31, 2000
FOR SOLUTION;ORAL
DIDANOSINE
AA AUROBINDO PHARMA 10MG/ML A078112 001 Mar 08, 2007
VIDEX
AA + BRISTOL MYERS SQUIBB 10MG/ML N020156 001 Oct 09, 1991
TABLET, FOR SUSPENSION;ORAL
DIDANOSINE
AUROBINDO 100MG A077275 001 Aug 14, 2012
150MG A077275 002 Aug 14, 2012
+ 200MG A077275 003 Aug 14, 2012
DIENOGEST; ESTRADIOL VALERATE
TABLET;ORAL
NATAZIA
+ BAYER HLTHCARE 2MG;3MG;N/A;1MG;2MG;2MG;3MG;N/A N022252 001 May 06, 2010
DIETHYLPROPION HYDROCHLORIDE
TABLET;ORAL
DIETHYLPROPION HYDROCHLORIDE
AA AVANTHI INC 25MG A201212 001 Dec 22, 2010
AA COREPHARMA 25MG A040828 001 Nov 05, 2008
AA LANNETT HOLDINGS INC 25MG A200177 001 Jul 18, 2011
TENUATE
AA + WATSON PHARMS 25MG N011722 002
TABLET, EXTENDED RELEASE;ORAL
DIETHYLPROPION HYDROCHLORIDE
AB LANNETT HOLDINGS INC 75MG A091680 001 Oct 24, 2011
TENUATE DOSPAN
AB + WATSON PHARMS 75MG N012546 001
DIFLORASONE DIACETATE
CREAM;TOPICAL
DIFLORASONE DIACETATE
BX + FOUGERA PHARMS 0.05% A076263 001 Dec 20, 2002
BX + TARO 0.05% A075508 001 Apr 24, 2000
OINTMENT;TOPICAL
DIFLORASONE DIACETATE
AB FOUGERA PHARMS 0.05% A075374 001 Apr 27, 1999
AB + TARO 0.05% A075331 001 May 14, 1999
DIFLUNISAL
TABLET;ORAL
DIFLUNISAL
AB EMCURE PHARMS USA 500MG A202845 001 Mar 08, 2012
AB + TEVA 500MG A073673 001 Jul 31, 1992
DIFLUPREDNATE
EMULSION;OPHTHALMIC
DUREZOL
+ ALCON PHARMS LTD 0.05% N022212 001 Jun 23, 2008
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-114(of 371)
DIGOXIN
ELIXIR;ORAL
DIGOXIN
+ ROXANE 0.05MG/ML N021648 001 Aug 26, 2004
INJECTABLE;INJECTION
DIGOXIN
AP HIKMA MAPLE 0.25MG/ML A083391 001
AP SANDOZ 0.25MG/ML A040481 001 Aug 21, 2003
LANOXIN
AP + COVIS INJECTABLES 0.25MG/ML N009330 002
LANOXIN PEDIATRIC
+ COVIS INJECTABLES 0.1MG/ML N009330 004
TABLET;ORAL
DIGOXIN
AB HIKMA INTL PHARMS 0.125MG A077002 002 Oct 30, 2007
AB 0.25MG A077002 001 Oct 30, 2007
AB IMPAX LABS 0.125MG A078556 001 Jul 20, 2009
AB 0.25MG A078556 002 Jul 20, 2009
AB STEVENS J 0.125MG A076268 001 Jul 26, 2002
AB 0.25MG A076268 002 Jul 26, 2002
LANOXIN
AB COVIS PHARMA 0.125MG N020405 002 Sep 30, 1997
AB + 0.25MG N020405 004 Sep 30, 1997
DIGOXIN
MYLAN PHARMS INC 0.125MG A040282 001 Dec 23, 1999
0.25MG A040282 002 Dec 23, 1999
LANOXIN
COVIS PHARMA 0.0625MG N020405 001 Sep 30, 1997
0.1875MG N020405 003 Sep 30, 1997
DIHYDROERGOTAMINE MESYLATE
INJECTABLE;INJECTION
D.H.E. 45
AP + VALEANT 1MG/ML N005929 001
DIHYDROERGOTAMINE MESYLATE
AP BEDFORD LABS 1MG/ML A040453 001 Jun 09, 2003
AP PADDOCK LLC 1MG/ML A040475 001 Apr 28, 2003
SPRAY, METERED;NASAL
MIGRANAL
+ VALEANT 0.5MG/INH N020148 001 Dec 08, 1997
DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
DILACOR XR
AB2 WATSON LABS 120MG N020092 001 May 29, 1992
AB2 180MG N020092 002 May 29, 1992
AB2 + 240MG N020092 003 May 29, 1992
DILTIAZEM HYDROCHLORIDE
AB2 ACTAVIS LABS FL INC 120MG A074852 001 Oct 10, 1997
AB2 180MG A074852 002 Oct 10, 1997
AB2 240MG A074852 003 Oct 10, 1997
AB2 APOTEX 120MG A074943 003 Dec 19, 2000
AB2 180MG A074943 002 Dec 19, 2000
AB2 240MG A074943 001 Aug 06, 1998
AB2 MYLAN 120MG A075124 002 Mar 18, 1998
AB2 180MG A075124 003 Mar 18, 1998
AB2 240MG A075124 001 Mar 18, 1998
CARDIZEM CD
AB3 VALEANT INTL 120MG N020062 001 Aug 10, 1992
AB3 180MG N020062 002 Dec 27, 1991
AB3 240MG N020062 003 Dec 27, 1991
AB3 300MG N020062 004 Dec 27, 1991
AB3 + 360MG N020062 005 Aug 24, 1999
CARTIA XT
AB3 ACTAVIS LABS FL INC 120MG A074752 002 Jul 09, 1998
AB3 180MG A074752 001 Jul 09, 1998
AB3 240MG A074752 003 Jul 09, 1998
AB3 300MG A074752 004 Jul 09, 1998
DILT-CD
AB3 APOTEX 120MG A076151 001 May 20, 2004
AB3 180MG A076151 002 May 20, 2004
AB3 240MG A076151 003 May 20, 2004
AB3 300MG A076151 004 May 20, 2004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-115(of 371)
DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
DILTIAZEM HYDROCHLORIDE
AB3 ACTAVIS ELIZABETH 360MG A202463 001 Dec 07, 2012
AB3 PAR PHARM 120MG A074984 001 Dec 20, 1999
AB3 180MG A074984 002 Dec 20, 1999
AB3 240MG A074984 003 Dec 20, 1999
AB3 300MG A074984 004 Dec 20, 1999
AB3 SUN PHARMA GLOBAL 120MG A090492 001 Oct 28, 2011
AB3 180MG A090492 002 Oct 28, 2011
AB3 240MG A090492 003 Oct 28, 2011
AB3 300MG A090492 004 Oct 28, 2011
AB3 360MG A090492 005 Oct 28, 2011
AB3 VALEANT INTL 120MG A075116 001 Dec 23, 1999
AB3 180MG A075116 002 Dec 23, 1999
AB3 240MG A075116 003 Dec 23, 1999
AB3 300MG A075116 004 Dec 23, 1999
AB4 SANDOZ 120MG A091022 001 Sep 28, 2012
AB4 180MG A091022 002 Sep 28, 2012
AB4 240MG A091022 003 Sep 28, 2012
AB4 300MG A091022 004 Sep 28, 2012
AB4 360MG A091022 005 Sep 28, 2012
AB4 420MG A091022 006 Sep 28, 2012
AB4 SUN PHARMA GLOBAL 120MG A090421 001 Nov 15, 2010
AB4 180MG A090421 002 Nov 15, 2010
AB4 240MG A090421 003 Nov 15, 2010
AB4 300MG A090421 004 Nov 15, 2010
AB4 360MG A090421 005 Nov 15, 2010
DILTZAC
AB4 APOTEX INC 120MG A076395 001 Feb 01, 2006
AB4 180MG A076395 002 Feb 01, 2006
AB4 240MG A076395 003 Feb 01, 2006
AB4 300MG A076395 004 Feb 01, 2006
AB4 360MG A076395 005 Feb 01, 2006
TAZTIA XT
AB4 ACTAVIS LABS FL INC 120MG A075401 001 Apr 10, 2003
AB4 180MG A075401 002 Apr 10, 2003
AB4 240MG A075401 003 Apr 10, 2003
AB4 300MG A075401 004 Apr 10, 2003
AB4 360MG A075401 005 Apr 10, 2003
TIAZAC
AB4 VALEANT INTL 120MG N020401 001 Sep 11, 1995
AB4 180MG N020401 002 Sep 11, 1995
AB4 240MG N020401 003 Sep 11, 1995
AB4 300MG N020401 004 Sep 11, 1995
AB4 360MG N020401 005 Sep 11, 1995
AB4 + 420MG N020401 006 Oct 16, 1998
DILTIAZEM HYDROCHLORIDE
BC + MYLAN 120MG A074910 003 May 02, 1997
60MG A074910 001 May 02, 1997
90MG A074910 002 May 02, 1997
INJECTABLE;INJECTION
DILTIAZEM HYDROCHLORIDE
AP AKORN INC 5MG/ML A075086 001 Apr 09, 1998
AP + BEDFORD 5MG/ML A074617 001 Feb 28, 1996
AP HIKMA FARMACEUTICA 5MG/ML A202651 001 Aug 09, 2012
AP HIKMA MAPLE 5MG/ML A078538 001 Dec 17, 2008
AP HOSPIRA 5MG/ML A074941 001 Apr 15, 1998
AP INTL MEDICATION 5MG/ML A075749 001 Nov 21, 2001
+ HOSPIRA 100MG/VIAL A075853 001 Dec 17, 2002
+ TEVA PHARMS USA 10MG/ML A074894 002 Apr 19, 2002
TABLET;ORAL
CARDIZEM
AB VALEANT INTL 30MG N018602 001 Nov 05, 1982
AB 60MG N018602 002 Nov 05, 1982
AB 90MG N018602 003 Dec 08, 1986
AB + 120MG N018602 004 Dec 08, 1986
DILTIAZEM HYDROCHLORIDE
AB MYLAN 30MG A072838 004 Nov 05, 1992
AB 60MG A072838 003 Nov 05, 1992
AB 90MG A072838 002 Nov 05, 1992
AB 120MG A072838 001 Nov 05, 1992
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-116(of 371)
DILTIAZEM HYDROCHLORIDE
TABLET;ORAL
DILTIAZEM HYDROCHLORIDE
AB TEVA 30MG
A074185 001 May 31, 1995
AB 60MG
A074185 002 May 31, 1995
AB 90MG
A074185 003 May 31, 1995
AB 120MG
A074185 004 May 31, 1995
TABLET, EXTENDED RELEASE;ORAL
CARDIZEM LA
AB VALEANT INTL
120MG
N021392 001 Feb 06, 2003
AB
180MG
N021392 002 Feb 06, 2003
AB
240MG
N021392 003 Feb 06, 2003
AB
300MG
N021392 004 Feb 06, 2003
AB
360MG
N021392 005 Feb 06, 2003
AB +
420MG
N021392 006 Feb 06, 2003
DILTIAZEM HYDROCHLORIDE
AB ACTAVIS LABS FL INC
120MG
A077686 006 Mar 15, 2010
AB
180MG
A077686 005 Mar 15, 2010
AB
240MG
A077686 004 Mar 15, 2010
AB
300MG
A077686 003 Mar 15, 2010
AB
360MG
A077686 002 Mar 15, 2010
AB
420MG
A077686 001 Mar 15, 2010
DIMENHYDRINATE
INJECTABLE;INJECTION
DIMENHYDRINATE
+ FRESENIUS KABI USA
50MG/ML
A040519 001 Jun 23, 2004
DIMERCAPROL
INJECTABLE;INJECTION
BAL
+ AKORN
10%
N005939 001
DIMETHYL FUMARATE
CAPSULE, DELAYED RELEASE;ORAL
TECFIDERA
BIOGEN IDEC INC
120MG
N204063 001 Mar 27, 2013
+
240MG
N204063 002 Mar 27, 2013
DIMETHYL SULFOXIDE
SOLUTION;INTRAVESICAL
DIMETHYL SULFOXIDE
AT MYLAN INSTITUTIONAL
50%
A076185 001 Nov 29, 2002
RIMSO-50
AT + MYLAN INSTITUTIONAL
50%
N017788 001
DINOPROSTONE
GEL;ENDOCERVICAL
PREPIDIL
+ PHARMACIA AND UPJOHN
0.5MG/3GM
N019617 001 Dec 09, 1992
INSERT, EXTENDED RELEASE;VAGINAL
CERVIDIL
+ FERRING CONTROLLED 10MG
N020411 001 Mar 30, 1995
SUPPOSITORY;VAGINAL
PROSTIN E2
+ PHARMACIA AND UPJOHN 20MG
N017810 001
DIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE;ORAL
DIPHENHYDRAMINE HYDROCHLORIDE
+ BARR 50MG
A080738 001
ELIXIR;ORAL
DIPHENHYDRAMINE HYDROCHLORIDE
+ PHARM ASSOC 12.5MG/5ML
A087513 001 Feb 10, 1982
INJECTABLE;INJECTION
DIPHENHYDRAMINE HYDROCHLORIDE
AP APP PHARMS 50MG/ML
A040466 001 May 28, 2002
AP + HIKMA MAPLE 50MG/ML
A080817 002
AP HOSPIRA 50MG/ML
A040140 001 Nov 20, 1998
AP MYLAN INSTITUTIONAL 50MG/ML
A040498 001 Jul 12, 2005
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
AP BD RX 50MG/ML
A091526 001 Mar 26, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-117(of 371)
DIPYRIDAMOLE
INJECTABLE;INJECTION
DIPYRIDAMOLE
AP + BEDFORD 5MG/ML A074939 001 Apr 13, 1998
AP FRESENIUS KABI USA 5MG/ML A074956 001 Sep 30, 1998
AP HIKMA MAPLE 5MG/ML A074521 001 Oct 18, 1996
TABLET;ORAL
DIPYRIDAMOLE
AB BARR 25MG A087184 001 Oct 03, 1990
AB 50MG A087716 001 Oct 03, 1990
AB 75MG A087717 001 Oct 03, 1990
AB IMPAX LABS 25MG A040782 001 Jul 18, 2007
AB 50MG A040782 002 Jul 18, 2007
AB 75MG A040782 003 Jul 18, 2007
AB LANNETT 25MG A040898 001 Apr 23, 2008
AB 50MG A040898 002 Apr 23, 2008
AB 75MG A040898 003 Apr 23, 2008
AB MURTY PHARMS 25MG A040733 001 Feb 13, 2007
AB 50MG A040733 002 Feb 13, 2007
AB 75MG A040733 003 Feb 13, 2007
AB PUREPAC PHARM 25MG A089425 001 Jul 12, 1990
AB ZYDUS PHARMS USA INC 25MG A040874 001 Jan 28, 2008
AB 50MG A040874 002 Jan 28, 2008
AB 75MG A040874 003 Jan 28, 2008
PERSANTINE
AB BOEHRINGER INGELHEIM 25MG N012836 003 Dec 22, 1986
AB 50MG N012836 004 Feb 06, 1987
AB + 75MG N012836 005 Feb 06, 1987
DISOPYRAMIDE PHOSPHATE
CAPSULE;ORAL
DISOPYRAMIDE PHOSPHATE
AB TEVA EQ 100MG BASE A070101 001 Feb 22, 1985
AB EQ 150MG BASE A070102 001 Feb 22, 1985
AB WATSON LABS EQ 100MG BASE A070173 001 May 31, 1985
AB EQ 150MG BASE A070174 001 May 31, 1985
NORPACE
AB GD SEARLE LLC EQ 100MG BASE N017447 001
AB + EQ 150MG BASE N017447 002
CAPSULE, EXTENDED RELEASE;ORAL
NORPACE CR
AB + GD SEARLE LLC EQ 150MG BASE N018655 002 Jul 20, 1982
EQ 100MG BASE N018655 001 Jul 20, 1982
DISULFIRAM
TABLET;ORAL
ANTABUSE
AB ODYSSEY PHARMS 250MG A088482 001 Dec 08, 1983
AB + 500MG A088483 001 Dec 08, 1983
DISULFIRAM
AB ROXANE 250MG A202652 001 Feb 05, 2014
AB 500MG A202652 002 Feb 05, 2014
AB SIGMAPHARM LABS LLC 250MG A091619 001 Mar 28, 2011
AB 500MG A091619 002 Mar 28, 2011
AB VINTAGE PHARMS 250MG A091563 001 Dec 31, 2012
AB 500MG A091563 002 Dec 31, 2012
DISULFIRAM
AB ALVOGEN PINE BROOK 250MG A091681 001 Aug 08, 2013
DIVALPROEX SODIUM
CAPSULE, DELAYED REL PELLETS;ORAL
DEPAKOTE
AB + ABBVIE EQ 125MG VALPROIC ACID N019680 001 Sep 12, 1989
DIVALPROEX SODIUM
AB DR REDDYS LABS LTD EQ 125MG VALPROIC ACID A078979 001 Jan 23, 2009
AB MYLAN EQ 125MG VALPROIC ACID A090407 001 Mar 28, 2011
AB ZYDUS PHARMS USA INC EQ 125MG VALPROIC ACID A078919 001 Jan 27, 2009
TABLET, DELAYED RELEASE;ORAL
DEPAKOTE
AB ABBVIE EQ 125MG VALPROIC ACID N018723 003 Oct 26, 1984
AB EQ 250MG VALPROIC ACID N018723 001 Mar 10, 1983
AB + EQ 500MG VALPROIC ACID N018723 002 Mar 10, 1983
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-118(of 371)
DIVALPROEX SODIUM
TABLET, DELAYED RELEASE;ORAL
DIVALPROEX SODIUM
AB ACTAVIS LABS FL INC EQ 500MG VALPROIC ACID A079080 001 Feb 25, 2011
AB ANCHEN PHARMS EQ 500MG VALPROIC ACID A078411 001 Nov 03, 2008
AB AUROBINDO PHARMA LTD EQ 125MG VALPROIC ACID A090554 001 Apr 21, 2011
AB EQ 250MG VALPROIC ACID A090554 002 Apr 21, 2011
AB EQ 500MG VALPROIC ACID A090554 003 Apr 21, 2011
AB DR REDDYS LABS LTD EQ 125MG VALPROIC ACID A078755 001 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A078755 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A078755 003 Jul 29, 2008
AB LUPIN EQ 125MG VALPROIC ACID A078790 001 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A078790 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A078790 003 Jul 29, 2008
AB MYLAN EQ 125MG VALPROIC ACID A090062 001 Mar 17, 2009
AB EQ 250MG VALPROIC ACID A090062 002 Mar 17, 2009
AB EQ 500MG VALPROIC ACID A090062 003 Mar 17, 2009
AB NU PHARM EQ 125MG VALPROIC ACID A077615 003 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A077615 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A077615 001 Jul 29, 2008
AB ORCHID HLTHCARE EQ 125MG VALPROIC ACID A078853 001 Nov 25, 2008
AB EQ 250MG VALPROIC ACID A078853 002 Nov 25, 2008
AB EQ 500MG VALPROIC ACID A078853 003 Nov 25, 2008
AB SANDOZ EQ 125MG VALPROIC ACID A078290 003 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A078290 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A078290 001 Jul 29, 2008
AB SUN PHARM INDS EQ 125MG VALPROIC ACID A078597 001 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A078597 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A078597 003 Jul 29, 2008
AB TEVA EQ 125MG VALPROIC ACID A076941 001 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A076941 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A076941 003 Jul 29, 2008
AB UNICHEM LABS LTD EQ 125MG VALPROIC ACID A079163 001 Apr 05, 2011
AB EQ 250MG VALPROIC ACID A079163 002 Apr 05, 2011
AB EQ 500MG VALPROIC ACID A079163 003 Apr 05, 2011
AB UPSHER SMITH EQ 125MG VALPROIC ACID A078182 001 Jul 29, 2008
AB EQ 250MG VALPROIC ACID A078182 002 Jul 29, 2008
AB EQ 500MG VALPROIC ACID A078182 003 Jul 29, 2008
AB VINTAGE EQ 125MG VALPROIC ACID A090210 001 Nov 30, 2009
AB EQ 250MG VALPROIC ACID A090210 002 Nov 30, 2009
AB EQ 500MG VALPROIC ACID A090210 003 Nov 30, 2009
AB WOCKHARDT EQ 125MG VALPROIC ACID A077296 001 Jul 31, 2008
AB EQ 250MG VALPROIC ACID A077296 002 Jul 31, 2008
AB EQ 500MG VALPROIC ACID A077296 003 Jul 31, 2008
AB ZYDUS PHARMS USA INC EQ 125MG VALPROIC ACID A077100 001 Mar 05, 2009
AB EQ 250MG VALPROIC ACID A077100 002 Mar 05, 2009
AB EQ 500MG VALPROIC ACID A077100 003 Mar 05, 2009
TABLET, EXTENDED RELEASE;ORAL
DEPAKOTE ER
AB ABBVIE EQ 250MG VALPROIC ACID N021168 002 May 31, 2002
AB + EQ 500MG VALPROIC ACID N021168 001 Aug 04, 2000
DIVALPROEX SODIUM
AB ANCHEN PHARMS EQ 250MG VALPROIC ACID A078445 001 Feb 26, 2009
AB EQ 500MG VALPROIC ACID A078445 002 Aug 04, 2009
AB AUROBINDO PHARMA LTD EQ 250MG VALPROIC ACID A202419 001 Jun 02, 2014
AB EQ 500MG VALPROIC ACID A202419 002 Jun 02, 2014
AB DR REDDYS LABS LTD EQ 250MG VALPROIC ACID A090161 001 Mar 15, 2012
AB IMPAX LABS EQ 250MG VALPROIC ACID A078791 001 May 06, 2009
AB EQ 500MG VALPROIC ACID A078791 002 Aug 04, 2009
AB MYLAN EQ 250MG VALPROIC ACID A077567 001 Jan 29, 2009
AB EQ 500MG VALPROIC ACID A077567 002 Jan 29, 2009
AB REDDYS EQ 500MG VALPROIC ACID A090070 001 Mar 12, 2012
AB WOCKHARDT EQ 250MG VALPROIC ACID A078705 002 Feb 10, 2009
AB EQ 500MG VALPROIC ACID A078705 001 Aug 04, 2009
AB ZYDUS PHARMS USA INC EQ 250MG VALPROIC ACID A078239 001 Feb 27, 2009
AB EQ 500MG VALPROIC ACID A078239 002 Aug 04, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-119(of 371)
DOBUTAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
DOBUTAMINE HYDROCHLORIDE
AP EUROHLTH INTL EQ 12.5MG BASE/ML A074277 001 Oct 31, 1994
AP HOSPIRA EQ 12.5MG BASE/ML A074086 001 Nov 29, 1993
AP + EQ 12.5MG BASE/ML A074292 001 Feb 16, 1995
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE EQ 50MG BASE/100ML N020255 001 Oct 19, 1993
AP + EQ 100MG BASE/100ML N020255 003 Oct 19, 1993
AP + EQ 200MG BASE/100ML N020255 004 Oct 19, 1993
AP + EQ 400MG BASE/100ML N020255 005 Oct 19, 1993
AP + HOSPIRA EQ 50MG BASE/100ML N020201 003 Oct 19, 1993
AP + EQ 100MG BASE/100ML N020201 002 Oct 19, 1993
AP + EQ 200MG BASE/100ML N020201 001 Oct 19, 1993
AP + EQ 400MG BASE/100ML N020201 006 Jul 07, 1994
DOCETAXEL
INJECTABLE;INJECTION
DOCETAXEL
AP ACCORD HLTHCARE 20MG/ML (20MG/ML) N201195 003 Apr 20, 2012
AP 80MG/4ML (20MG/ML) N201195 004 Apr 20, 2012
AP + 160MG/8ML (20MG/ML) N201195 005 Apr 20, 2012
AP ACTAVIS INC 20MG/ML (20MG/ML) N203551 001 Apr 12, 2013
AP 80MG/4ML (20MG/ML) N203551 002 Apr 12, 2013
AP DR REDDYS LABS LTD 20MG/ML (20MG/ML) A204193 001 Nov 05, 2014
AP 80MG/4ML (20MG/ML) A204193 002 Nov 05, 2014
AP + HOSPIRA INC 20MG/2ML (10MG/ML) N022234 001 Mar 08, 2011
AP + 80MG/8ML (10MG/ML) N022234 002 Mar 08, 2011
AP + 160MG/16ML (10MG/ML) N022234 003 Mar 08, 2011
AP SANDOZ 20MG/2ML (10MG/ML) N201525 001 Jun 29, 2011
AP 80MG/8ML (10MG/ML) N201525 002 Jun 29, 2011
AP 160MG/16ML (10MG/ML) N201525 003 Jun 29, 2011
TAXOTERE
AP + SANOFI AVENTIS US 20MG/ML (20MG/ML) N020449 003 Aug 03, 2010
AP + 80MG/4ML (20MG/ML) N020449 004 Aug 02, 2010
AP + 160MG/8ML (20MG/ML) N020449 005 Apr 13, 2012
DOCEFREZ
+ SUN PHARMA GLOBAL 20MG/VIAL N022534 001 May 03, 2011
+ 80MG/VIAL N022534 002 May 03, 2011
DOCETAXEL
ACCORD HLTHCARE 20MG/0.5ML (40MG/ML) N201195 001 Jun 08, 2011
80MG/2ML (40MG/ML) N201195 002 Jun 08, 2011
ACTAVIS INC 140MG/7ML (20MG/ML) N203551 003 Apr 12, 2013
PFIZER LABS 20MG/2ML (10MG/ML) N202356 001 Mar 13, 2014
80MG/8ML (10MG/ML) N202356 002 Mar 13, 2014
130MG/13ML (10MG/ML) N202356 003 Mar 13, 2014
200MG/20ML (10MG/ML) N202356 004 Mar 13, 2014
DOFETILIDE
CAPSULE;ORAL
TIKOSYN
PFIZER 0.125MG N020931 001 Oct 01, 1999
0.25MG N020931 002 Oct 01, 1999
+ 0.5MG N020931 003 Oct 01, 1999
DOLASETRON MESYLATE
INJECTABLE;INJECTION
ANZEMET
+ SANOFI AVENTIS US 12.5MG/0.625ML (20MG/ML) N020624 002 Sep 11, 1997
+ 100MG/5ML (20MG/ML) N020624 001 Sep 11, 1997
+ 500MG/25ML (20MG/ML) N020624 003 Dec 11, 2001
TABLET;ORAL
ANZEMET
SANOFI AVENTIS US 50MG N020623 001 Sep 11, 1997
+ 100MG N020623 002 Sep 11, 1997
DOLUTEGRAVIR SODIUM
TABLET;ORAL
TIVICAY
+ VIIV HLTHCARE EQ 50MG BASE N204790 001 Aug 12, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-120(of 371)
DONEPEZIL HYDROCHLORIDE
TABLET;ORAL
ARICEPT
AB EISAI INC 5MG N020690 002 Nov 25, 1996
AB + 10MG N020690 001 Nov 25, 1996
AB + 23MG N022568 001 Jul 23, 2010
DONEPEZIL HYDROCHLORIDE
AB ALEMBIC PHARMS LTD 5MG A201724 001 Feb 25, 2013
AB 10MG A201724 002 Feb 25, 2013
AB APOTEX 5MG A078841 001 Jun 02, 2011
AB 10MG A078841 002 Jun 02, 2011
AB AUROBINDO 5MG A090056 001 May 31, 2011
AB 10MG A090056 002 May 31, 2011
AB CIPLA LTD 5MG A077518 001 May 31, 2011
AB 10MG A077518 002 May 31, 2011
AB CSPC OUYI PHARM CO 5MG A202114 001 Jul 05, 2013
AB 10MG A202114 002 Jul 05, 2013
AB DR REDDYS LABS LTD 5MG A201001 001 May 31, 2011
AB 10MG A201001 002 May 31, 2011
AB 23MG A202723 001 Jul 24, 2013
AB HIKMA PHARMS 5MG A090247 001 May 31, 2011
AB 10MG A090247 002 May 31, 2011
AB INDICUS PHARMA 5MG A201634 001 Jun 13, 2012
AB 10MG A201634 002 Jun 13, 2012
AB JUBILANT GENERICS 5MG A090768 001 May 31, 2011
AB 10MG A090768 002 May 31, 2011
AB MACLEODS PHARMS LTD 5MG A201146 001 Aug 17, 2012
AB 10MG A201146 002 Aug 17, 2012
AB 23MG A202631 001 Jan 22, 2014
AB MYLAN PHARMS INC 5MG A090521 001 May 31, 2011
AB 10MG A090521 002 May 31, 2011
AB PAR PHARM 23MG A202542 001 Jul 24, 2013
AB PLIVA HRVATSKA DOO 5MG A090425 001 May 31, 2011
AB 10MG A090425 002 May 31, 2011
AB PRINSTON INC 5MG A200292 001 May 31, 2011
AB 10MG A200292 002 May 31, 2011
AB RANBAXY 5MG A076786 001 Nov 26, 2010
AB 10MG A076786 002 Nov 26, 2010
AB ROXANE 5MG A078662 001 May 31, 2011
AB 10MG A078662 002 May 31, 2011
AB SANDOZ 5MG A090290 001 May 31, 2011
AB 10MG A090290 002 May 31, 2011
AB SCIEGEN PHARMS INC 5MG A203907 001 Oct 29, 2014
AB 10MG A203907 002 Oct 29, 2014
AB SUN PHARM INDS 5MG A090493 001 May 31, 2011
AB 10MG A090493 002 May 31, 2011
AB TEVA 5MG A077344 001 May 31, 2011
AB 10MG A077344 002 May 31, 2011
AB TORRENT PHARMS 5MG A090686 001 May 31, 2011
AB 10MG A090686 002 May 31, 2011
AB TWI PHARMS INC 23MG A203104 001 Oct 29, 2014
AB VIVIMED LABS 5MG A090551 001 May 31, 2011
AB 10MG A090551 002 May 31, 2011
AB WOCKHARDT 5MG A091267 001 May 31, 2011
AB 10MG A091267 002 May 31, 2011
AB ZYDUS PHARMS USA INC 5MG A090100 001 Oct 24, 2012
AB 10MG A090100 002 Oct 24, 2012
TABLET, ORALLY DISINTEGRATING;ORAL
ARICEPT ODT
AB EISAI INC 5MG N021720 001 Oct 18, 2004
AB + 10MG N021720 002 Oct 18, 2004
DONEPEZIL HYDROCHLORIDE
AB BARR 5MG A078388 002 Nov 26, 2010
AB 10MG A078388 001 Nov 26, 2010
AB MACLEODS PHARMS LTD 5MG A201787 001 Dec 14, 2012
AB 10MG A201787 002 Dec 14, 2012
AB SANDOZ 5MG A091198 001 May 10, 2011
AB 10MG A091198 002 May 10, 2011
AB ZYDUS PHARMS USA INC 5MG A090175 001 May 10, 2011
AB 10MG A090175 002 May 10, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-121(of 371)
DONEPEZIL HYDROCHLORIDE; MEMANTINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
NAMZARIC
FOREST LABS INC 10MG;14MG N206439 001 Dec 23, 2014
+ 10MG;28MG N206439 002 Dec 23, 2014
DOPAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
DOPAMINE HYDROCHLORIDE
AP + HOSPIRA 40MG/ML N018132 001
AP + 80MG/100ML N018132 002 Feb 04, 1982
AP + 80MG/ML N018132 004 Jul 09, 1982
AP + 160MG/100ML N018132 003 Feb 04, 1982
AP + LUITPOLD 40MG/ML A070799 001 Feb 11, 1987
AP + 80MG/ML A070820 001 Feb 11, 1987
AP + 160MG/ML A070826 001 Feb 11, 1987
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%
AP + B BRAUN 80MG/100ML N019099 002 Oct 15, 1986
AP + 320MG/100ML N019099 004 Oct 15, 1986
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 160MG/100ML N019099 003 Oct 15, 1986
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 80MG/100ML N019615 001 Mar 27, 1987
AP + 160MG/100ML N019615 002 Mar 27, 1987
AP + 320MG/100ML N019615 003 Mar 27, 1987
AP + HOSPIRA 80MG/100ML N018826 001 Sep 30, 1983
AP + 160MG/100ML N018826 002 Sep 30, 1983
AP + 320MG/100ML N018826 003 Sep 30, 1983
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER
+ B BRAUN 40MG/100ML N019099 001 Oct 15, 1986
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 640MG/100ML N019615 004 Mar 27, 1987
DORIPENEM
INJECTABLE;IV (INFUSION)
DORIBAX
SHIONOGI INC 250MG/VIAL N022106 002 Oct 05, 2010
+ 500MG/VIAL N022106 001 Oct 12, 2007
DORZOLAMIDE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
DORZOLAMIDE HYDROCHLORIDE
AT ALCON PHARMS LTD EQ 2% BASE A078981 001 Apr 13, 2009
AT BAUSCH AND LOMB EQ 2% BASE A090143 001 Jun 25, 2009
AT HI TECH PHARMA EQ 2% BASE A077846 001 Oct 28, 2008
AT LUITPOLD EQ 2% BASE A079186 001 Nov 18, 2009
AT SANDOZ EQ 2% BASE A078748 001 Nov 06, 2008
AT TEVA PHARMS EQ 2% BASE A078756 001 Dec 04, 2008
AT WATSON LABS INC EQ 2% BASE A202053 001 Sep 11, 2014
AT ZACH SYSTEMS EQ 2% BASE A091034 001 Dec 04, 2013
TRUSOPT
AT + MERCK EQ 2% BASE N020408 001 Dec 09, 1994
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
SOLUTION/DROPS;OPHTHALMIC
COSOPT
AT + OAK PHARMS INC EQ 2% BASE;EQ 0.5% BASE N020869 001 Apr 07, 1998
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
AT AKORN INC EQ 2% BASE;EQ 0.5% BASE A203058 001 Sep 22, 2014
AT ALCON RES EQ 2% BASE;EQ 0.5% BASE A090604 001 Nov 18, 2009
AT BAUSCH AND LOMB EQ 2% BASE;EQ 0.5% BASE A090037 001 Jul 14, 2009
AT HI TECH PHARMA EQ 2% BASE;EQ 0.5% BASE A077847 001 Oct 28, 2008
AT LANNETT HOLDINGS INC EQ 2% BASE;EQ 0.5% BASE A201998 001 Dec 17, 2014
AT SANDOZ EQ 2% BASE;EQ 0.5% BASE A078749 001 Nov 06, 2008
AT TEVA PHARMS EQ 2% BASE;EQ 0.5% BASE A078704 001 Sep 28, 2009
AT WATSON LABS INC EQ 2% BASE;EQ 0.5% BASE A202054 001 Sep 03, 2014
AT ZACH SYSTEMS EQ 2% BASE;EQ 0.5% BASE A091180 001 Dec 04, 2013
COSOPT PF
+ OAK PHARMS INC EQ 2% BASE;EQ 0.5% BASE N202667 001 Feb 01, 2012
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-122(of 371)
DOXAPRAM HYDROCHLORIDE
INJECTABLE;INJECTION
DOPRAM
AP + HIKMA MAPLE
20MG/ML
N014879 001
DOXAPRAM HYDROCHLORIDE
AP BEDFORD
20MG/ML
A076266 001 Jan 10, 2003
DOXAZOSIN MESYLATE
TABLET;ORAL
CARDURA
AB + PFIZER
EQ 1MG BASE
N019668 001 Nov 02, 1990
AB
EQ 2MG BASE
N019668 002 Nov 02, 1990
AB
EQ 4MG BASE
N019668 003 Nov 02, 1990
AB
EQ 8MG BASE
N019668 004 Nov 02, 1990
DOXAZOSIN MESYLATE
AB ACCORD HLTHCARE
EQ 1MG BASE
A202824 001 Jun 11, 2014
AB
EQ 2MG BASE
A202824 002 Jun 11, 2014
AB
EQ 4MG BASE
A202824 003 Jun 11, 2014
AB
EQ 8MG BASE
A202824 004 Jun 11, 2014
AB APOTEX
EQ 1MG BASE
A075580 001 Oct 18, 2000
AB
EQ 2MG BASE
A075580 002 Oct 18, 2000
AB
EQ 4MG BASE
A075580 003 Oct 18, 2000
AB
EQ 8MG BASE
A075580 004 Oct 18, 2000
AB DAVA PHARMS INC
EQ 1MG BASE
A076161 001 Jun 10, 2004
AB
EQ 2MG BASE
A076161 002 Jun 10, 2004
AB
EQ 4MG BASE
A076161 003 Jun 10, 2004
AB
EQ 8MG BASE
A076161 004 Jun 10, 2004
AB MYLAN
EQ 1MG BASE
A075509 001 Oct 19, 2000
AB
EQ 2MG BASE
A075509 002 Oct 19, 2000
AB
EQ 4MG BASE
A075509 003 Oct 19, 2000
AB
EQ 8MG BASE
A075509 004 Oct 19, 2000
AB PLIVA
EQ 1MG BASE
A075750 001 Jun 08, 2001
AB
EQ 2MG BASE
A075750 002 Jun 08, 2001
AB
EQ 4MG BASE
A075750 003 Jun 08, 2001
AB
EQ 8MG BASE
A075750 004 Jun 08, 2001
AB TEVA
EQ 1MG BASE
A075536 001 Oct 18, 2000
AB
EQ 2MG BASE
A075536 002 Oct 18, 2000
AB
EQ 4MG BASE
A075536 003 Oct 18, 2000
AB
EQ 8MG BASE
A075536 004 Oct 18, 2000
TABLET, EXTENDED RELEASE;ORAL
CARDURA XL
PFIZER
EQ 4MG BASE
N021269 001 Feb 22, 2005
+
EQ 8MG BASE
N021269 002 Feb 22, 2005
DOXEPIN HYDROCHLORIDE
CAPSULE;ORAL
DOXEPIN HYDROCHLORIDE
AB MYLAN PHARMS INC
EQ 10MG BASE
A070791 002 May 13, 1986
AB +
EQ 25MG BASE
A070791 003 May 13, 1986
AB
EQ 50MG BASE
A070791 001 May 13, 1986
AB
EQ 75MG BASE
A070791 004 May 13, 1986
AB
EQ 100MG BASE
A070791 005 May 13, 1986
PAR PHARM
EQ 150MG BASE
A071669 001 Nov 09, 1987
CONCENTRATE;ORAL
DOXEPIN HYDROCHLORIDE
AA SILARX
EQ 10MG BASE/ML
A074721 001 Dec 29, 1998
AA + TEVA PHARMS
EQ 10MG BASE/ML
A071609 001 Nov 09, 1987
AA WOCKHARDT
EQ 10MG BASE/ML
A071918 001 Jul 20, 1988
CREAM;TOPICAL
ZONALON
+ FOUGERA PHARMS
5%
N020126 001 Apr 01, 1994
TABLET;ORAL
DOXEPIN HYDROCHLORIDE
AB ACTAVIS ELIZABETH
EQ 3MG BASE
A201951 001 Jul 26, 2013
AB
EQ 6MG BASE
A201951 002 Jul 26, 2013
SILENOR
AB PERNIX THERAPS LLC
EQ 3MG BASE
N022036 001 Mar 17, 2010
AB +
EQ 6MG BASE
N022036 002 Mar 17, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-123(of 371)
DOXERCALCIFEROL
CAPSULE;ORAL
DOXERCALCIFEROL
AB ROXANE 0.5MCG A091433 001 Sep 23, 2011
AB 1MCG A091433 002 Jan 14, 2014
AB 2.5MCG A091433 003 Jan 14, 2014
HECTOROL
AB GENZYME CORP 0.5MCG N020862 002 Apr 23, 2004
AB 1MCG N020862 003 Jul 13, 2009
AB + 2.5MCG N020862 001 Jun 09, 1999
INJECTABLE;INJECTION
DOXERCALCIFEROL
AP HIKMA PHARMS LLC 4MCG/2ML (2MCG/ML) A091101 001 Aug 30, 2013
AP SANDOZ 4MCG/2ML (2MCG/ML) A091333 001 May 05, 2014
AP 4MCG/2ML (2MCG/ML) A200926 001 Feb 04, 2014
HECTOROL
AP + GENZYME CORP 4MCG/2ML (2MCG/ML) N021027 001 Apr 06, 2000
2MCG/ML (2MCG/ML) N021027 002 Apr 06, 2000
DOXORUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
DOXORUBICIN HYDROCHLORIDE
AP ACTAVIS INC 2MG/ML A203622 001 Jun 27, 2014
AP ALVOGEN INC 2MG/ML A065515 001 Nov 08, 2012
AP + EUROHLTH INTL 2MG/ML A062975 001 Mar 17, 1989
AP + 10MG/VIAL A062921 001 Mar 17, 1989
AP + 20MG/VIAL A062921 002 Mar 17, 1989
AP + 50MG/VIAL A062921 003 Mar 17, 1989
AP + 200MG/100ML A064097 001 Sep 13, 1994
AP FRESENIUS KABI USA 2MG/ML A063277 001 Oct 26, 1995
AP ONCO THERAPIES LTD 2MG/ML A200901 001 Feb 14, 2012
AP 10MG/VIAL A200170 001 Oct 28, 2011
AP 50MG/VIAL A200170 002 Oct 28, 2011
AP PHARMACHEMIE BV 2MG/ML A063336 001 Feb 28, 1995
AP 10MG/VIAL A063097 001 May 21, 1990
AP 20MG/VIAL A063097 002 May 21, 1990
AP 50MG/VIAL A063097 003 May 21, 1990
AP 200MG/100ML A063336 004 Feb 28, 1995
AP SAGENT PHARMS 2MG/ML A091495 001 Mar 18, 2013
AP SANDOZ INC 2MG/ML A200146 001 Jul 18, 2012
AP SUN PHARM INDS 2MG/ML A091418 001 Feb 15, 2012
AP TEVA PHARMS USA 2MG/ML A064140 001 Jul 28, 1995
AP 200MG/100ML A064140 002 Jul 28, 1995
INJECTABLE, LIPOSOMAL;INJECTION
DOXIL (LIPOSOMAL)
AB JANSSEN RES AND DEV 20MG/10ML (2MG/ML) N050718 001 Nov 17, 1995
AB 50MG/25ML (2MG/ML) N050718 002 Jun 13, 2000
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL)
AB + SUN PHARMA GLOBAL 20MG/10ML (2MG/ML) A203263 001 Feb 04, 2013
AB + 50MG/25ML (2MG/ML) A203263 002 Feb 04, 2013
DOXYCYCLINE
CAPSULE;ORAL
DOXYCYCLINE
AB IMPAX LABS INC EQ 150MG BASE A200065 001 Feb 17, 2011
AB LUPIN LTD EQ 50MG BASE A204234 001 Mar 05, 2014
AB EQ 75MG BASE A204234 002 Mar 05, 2014
AB EQ 100MG BASE A204234 003 Mar 05, 2014
AB MYLAN PHARMS INC EQ 150MG BASE A202778 001 Jun 08, 2012
AB PAR PHARM EQ 50MG BASE A065055 001 Dec 01, 2000
AB EQ 100MG BASE A065055 002 Dec 01, 2000
AB + EQ 150MG BASE A065055 003 Jul 15, 2005
AB RANBAXY EQ 50MG BASE A065053 001 Nov 22, 2000
AB EQ 75MG BASE A065053 003 Sep 10, 2003
AB EQ 100MG BASE A065053 002 Nov 22, 2000
MONODOX
AB AQUA PHARMS EQ 50MG BASE N050641 002 Feb 10, 1992
AB EQ 75MG BASE N050641 003 Oct 18, 2006
AB + EQ 100MG BASE N050641 001 Dec 29, 1989
ORACEA
+ GALDERMA LABS LP 40MG N050805 001 May 26, 2006
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-124(of 371)
DOXYCYCLINE
FOR SUSPENSION;ORAL
DOXYCYCLINE
AB CHARTWELL LIFE SCI EQ 25MG BASE/5ML A065454 001 Jul 16, 2008
AB LUPIN LTD EQ 25MG BASE/5ML A201678 001 Mar 18, 2013
VIBRAMYCIN
AB + PFIZER EQ 25MG BASE/5ML N050006 001
TABLET;ORAL
DOXYCYCLINE
AB HERITAGE PHARMS INC EQ 50MG BASE A091605 001 Dec 20, 2011
AB EQ 75MG BASE A091605 002 Dec 20, 2011
AB EQ 100MG BASE A091605 003 Dec 20, 2011
AB EQ 150MG BASE A091605 004 Dec 20, 2011
AB LANNETT EQ 50MG BASE A065285 001 Dec 08, 2005
AB EQ 75MG BASE A065285 003 Jul 30, 2008
AB EQ 100MG BASE A065285 002 Dec 08, 2005
AB EQ 150MG BASE A065285 004 Jul 30, 2008
AB MYLAN EQ 50MG BASE A065377 001 Nov 07, 2006
AB EQ 75MG BASE A065377 002 Nov 07, 2006
AB EQ 100MG BASE A065377 003 Nov 07, 2006
AB EQ 150MG BASE A065427 001 Jun 07, 2007
AB PAR PHARM EQ 50MG BASE A065070 001 Dec 15, 2000
AB EQ 75MG BASE A065070 003 Dec 30, 2002
AB EQ 100MG BASE A065070 002 Dec 15, 2000
AB + EQ 150MG BASE A065070 004 Jul 14, 2005
AB RANBAXY EQ 50MG BASE A065356 001 May 31, 2006
AB EQ 75MG BASE A065356 002 May 31, 2006
AB EQ 100MG BASE A065356 003 May 31, 2006
DOXYCYCLINE CALCIUM
SUSPENSION;ORAL
VIBRAMYCIN
+ PFIZER EQ 50MG BASE/5ML N050480 001
DOXYCYCLINE HYCLATE
CAPSULE;ORAL
DOXYCYCLINE HYCLATE
AB ACTAVIS LABS FL INC EQ 50MG BASE A062031 002 Oct 13, 1982
AB EQ 100MG BASE A062031 001
AB CHARTWELL LIFE SCI EQ 50MG BASE A062500 001 Sep 11, 1984
AB EQ 100MG BASE A062500 002 Sep 11, 1984
AB HIKMA INTL PHARMS EQ 50MG BASE A062396 002 Nov 07, 1984
AB EQ 100MG BASE A062396 001 May 07, 1984
AB MUTUAL PHARM EQ 50MG BASE A062675 001 Jul 10, 1986
AB EQ 100MG BASE A062676 001 Jul 10, 1986
AB MYLAN EQ 50MG BASE A062337 001 Mar 29, 1982
AB EQ 100MG BASE A062337 002 Mar 29, 1982
VIBRAMYCIN
AB PFIZER EQ 50MG BASE N050007 001
AB + EQ 100MG BASE N050007 002
DOXYCYCLINE HYCLATE
+ HIKMA INTL PHARMS EQ 20MG BASE A065103 001 May 13, 2005
CAPSULE, DELAYED RELEASE;ORAL
DOXYCYCLINE HYCLATE
MEDICIS EQ 75MG BASE A065281 001 Dec 21, 2005
+ EQ 100MG BASE A065281 002 Dec 21, 2005
INJECTABLE;INJECTION
DOXY 100
AP + FRESENIUS KABI USA EQ 100MG BASE/VIAL A062475 001 Dec 09, 1983
DOXYCYCLINE
AP AGILA SPECLTS EQ 100MG BASE/VIAL A091406 001 Aug 21, 2012
AP + EUROHLTH INTL EQ 100MG BASE/VIAL A062569 001 Mar 09, 1988
DOXY 200
+ FRESENIUS KABI USA EQ 200MG BASE/VIAL A062475 002 Dec 09, 1983
SYSTEM, EXTENDED RELEASE;PERIODONTAL
ATRIDOX
+ TOLMAR 50MG N050751 001 Sep 03, 1998
TABLET;ORAL
DOXYCYCLINE HYCLATE
AB ACTAVIS LABS FL INC EQ 100MG BASE A062421 001 Feb 02, 1983
AB BLU CARIBE INC EQ 100MG BASE A062269 002 Nov 08, 1982
AB CHARTWELL LIFE SCI EQ 100MG BASE A062505 001 Sep 11, 1984
AB COREPHARMA EQ 20MG BASE A065182 001 May 13, 2005
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-125(of 371)
DOXYCYCLINE HYCLATE
TABLET;ORAL
DOXYCYCLINE HYCLATE
AB + HIKMA INTL PHARMS EQ 100MG BASE A065095 001 Jul 02, 2003
AB IVAX SUB TEVA PHARMS EQ 20MG BASE A065163 001 May 13, 2005
AB + LANNETT EQ 20MG BASE A065277 001 Nov 10, 2005
AB LARKEN LABS EQ 20MG BASE A065287 001 Feb 28, 2006
AB MUTUAL PHARM EQ 100MG BASE A062677 001 Jul 10, 1986
AB MUTUAL PHARMA EQ 20MG BASE A065134 001 May 13, 2005
AB MYLAN EQ 100MG BASE A062432 001 Feb 15, 1983
AB VINTAGE PHARMS EQ 100MG BASE A062538 001 Apr 07, 1986
ACTICLATE
AQUA PHARMS LLC EQ 75MG BASE N205931 001 Jul 25, 2014
+ EQ 150MG BASE N205931 002 Jul 25, 2014
TABLET, DELAYED RELEASE;ORAL
DORYX
AB MAYNE PHARMA EQ 75MG BASE N050795 001 May 06, 2005
AB EQ 100MG BASE N050795 002 May 06, 2005
AB EQ 150MG BASE N050795 003 Jun 20, 2008
DOXYCYCLINE HYCLATE
AB ACTAVIS ELIZABETH EQ 75MG BASE A090134 001 Dec 14, 2011
AB EQ 100MG BASE A090134 002 Dec 14, 2011
AB HERITAGE PHARMS INC EQ 75MG BASE A200856 001 Apr 30, 2013
AB EQ 100MG BASE A200856 002 Apr 30, 2013
AB EQ 150MG BASE A200856 003 Apr 30, 2013
AB IMPAX LABS INC EQ 75MG BASE A090505 001 Dec 28, 2010
AB EQ 100MG BASE A090505 002 Dec 28, 2010
AB MYLAN EQ 75MG BASE A090431 001 Dec 28, 2010
AB EQ 100MG BASE A090431 002 Dec 28, 2010
AB MYLAN PHARMS INC EQ 150MG BASE A091052 001 Feb 08, 2012
DORYX
MAYNE PHARMA EQ 80MG BASE N050795 004 Apr 11, 2013
+ EQ 200MG BASE N050795 005 Apr 11, 2013
DOXTERIC
MAYNE PHARMA EQ 50MG BASE N050795 006 Dec 19, 2014
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
TABLET, DELAYED RELEASE;ORAL
DICLEGIS
+ DUCHESNAY 10MG;10MG N021876 001 Apr 08, 2013
DRONABINOL
CAPSULE;ORAL
DRONABINOL
AB AKORN INC 2.5MG A079217 001 Jun 20, 2014
AB 5MG A079217 002 Jun 20, 2014
AB 10MG A079217 003 Jun 20, 2014
AB INSYS THERAP 2.5MG A078501 001 Aug 19, 2011
AB 5MG A078501 002 Aug 19, 2011
AB 10MG A078501 003 Aug 19, 2011
AB SVC PHARMA 2.5MG A078292 001 Jun 27, 2008
AB 5MG A078292 002 Jun 27, 2008
AB 10MG A078292 003 Jun 27, 2008
MARINOL
AB ABBVIE 2.5MG N018651 001 May 31, 1985
AB + 5MG N018651 002 May 31, 1985
AB 10MG N018651 003 May 31, 1985
DRONEDARONE HYDROCHLORIDE
TABLET;ORAL
MULTAQ
+ SANOFI AVENTIS US EQ 400MG BASE N022425 001 Jul 01, 2009
DROPERIDOL
INJECTABLE;INJECTION
DROPERIDOL
AP HOSPIRA 2.5MG/ML A071981 001 Feb 29, 1988
AP LUITPOLD 2.5MG/ML A072123 001 Oct 24, 1988
INAPSINE
AP + AKORN INC 2.5MG/ML N016796 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-126(of 371)
DROSPIRENONE; ESTRADIOL
TABLET;ORAL
ANGELIQ
BAYER HLTHCARE 0.25MG;0.5MG N021355 001 Feb 29, 2012
+ 0.5MG;1MG N021355 002 Sep 28, 2005
DROSPIRENONE; ETHINYL ESTRADIOL
TABLET;ORAL
DROSPIRENONE AND ETHINYL ESTRADIOL
AB BARR 3MG;0.02MG A078515 001 Mar 30, 2009
AB WATSON LABS 3MG;0.02MG A078833 001 Nov 28, 2011
LORYNA
AB SANDOZ 3MG;0.02MG A079221 001 Mar 28, 2011
NIKKI
AB LUPIN LTD 3MG;0.02MG A201661 001 May 27, 2014
YAZ
AB + BAYER HLTHCARE 3MG;0.02MG N021676 001 Mar 16, 2006
TABLET;ORAL-28
DROSPIRENONE AND ETHINYL ESTRADIOL
AB BARR 3MG;0.03MG A077527 001 May 09, 2008
AB LUPIN LTD 3MG;0.03MG A201663 001 Dec 18, 2012
AB WATSON LABS 3MG;0.03MG A090081 001 Sep 07, 2010
SYEDA
AB SANDOZ 3MG;0.03MG A090114 001 Mar 28, 2011
YAELA
AB NOVAST LABS LTD 3MG;0.03MG A202015 001 Nov 19, 2014
YASMIN
AB + BAYER HLTHCARE 3MG;0.03MG N021098 001 May 11, 2001
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM
TABLET;ORAL
BEYAZ
BAYER HLTHCARE 3MG,N/A;0.02MG,N/A;0.451MG,0.451MG N022532 001 Sep 24, 2010
SAFYRAL
+ BAYER HLTHCARE 3MG,N/A;0.03MG,N/A;0.451MG,0.451MG N022574 001 Dec 16, 2010
DROXIDOPA
CAPSULE;ORAL
NORTHERA
LUNDBECK NA LTD 100MG N203202 001 Feb 18, 2014
200MG N203202 002 Feb 18, 2014
+ 300MG N203202 003 Feb 18, 2014
DULOXETINE HYDROCHLORIDE
CAPSULE, DELAYED REL PELLETS;ORAL
CYMBALTA
AB LILLY EQ 20MG BASE N021427 001 Aug 03, 2004
AB EQ 30MG BASE N021427 002 Aug 03, 2004
AB + EQ 60MG BASE N021427 004 Aug 03, 2004
DULOXETINE HYDROCHLORIDE
AB ACTAVIS ELIZABETH EQ 20MG BASE A090776 001 Dec 17, 2013
AB EQ 30MG BASE A090776 002 Dec 17, 2013
AB EQ 60MG BASE A090776 003 Dec 17, 2013
AB ALEMBIC PHARMS LTD EQ 20MG BASE A202949 001 Jun 09, 2014
AB EQ 30MG BASE A202949 002 Jun 09, 2014
AB EQ 60MG BASE A202949 003 Jun 09, 2014
AB APOTEX INC EQ 20MG BASE A202045 001 Jun 11, 2014
AB EQ 30MG BASE A202045 002 Jun 11, 2014
AB EQ 60MG BASE A202045 003 Jun 11, 2014
AB AUROBINDO PHARMA LTD EQ 20MG BASE A090778 001 Dec 11, 2013
AB EQ 30MG BASE A090778 002 Dec 11, 2013
AB EQ 60MG BASE A090778 003 Dec 11, 2013
AB BRECKENRIDGE PHARM EQ 20MG BASE A203088 001 Jun 11, 2014
AB EQ 30MG BASE A203088 002 Jun 11, 2014
AB EQ 60MG BASE A203088 003 Jun 11, 2014
AB DR REDDYS LABS LTD EQ 20MG BASE A090723 001 Dec 11, 2013
AB EQ 30MG BASE A090723 002 Dec 11, 2013
AB EQ 60MG BASE A090723 003 Dec 11, 2013
AB LUPIN LTD EQ 20MG BASE A090694 001 Dec 11, 2013
AB EQ 30MG BASE A090694 002 Dec 11, 2013
AB EQ 60MG BASE A090694 004 Dec 11, 2013
AB SUN PHARMA GLOBAL EQ 20MG BASE A090745 001 Dec 11, 2013
AB EQ 30MG BASE A090745 002 Dec 11, 2013
AB EQ 60MG BASE A090745 003 Dec 11, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-127(of 371)
DULOXETINE HYDROCHLORIDE
CAPSULE, DELAYED REL PELLETS;ORAL
DULOXETINE HYDROCHLORIDE
AB TEVA PHARMS USA EQ 20MG BASE
A090783 001 Dec 11, 2013
AB EQ 30MG BASE
A090783 002 Dec 11, 2013
AB EQ 60MG BASE
A090783 003 Dec 11, 2013
AB TORRENT PHARMS LTD EQ 20MG BASE
A090774 001 Dec 11, 2013
AB EQ 30MG BASE
A090774 002 Dec 11, 2013
AB EQ 60MG BASE
A090774 003 Dec 11, 2013
AB ZYDUS PHARMS USA INC EQ 20MG BASE
A090728 001 Jan 08, 2014
AB EQ 20MG BASE
A090739 001 Jan 08, 2014
AB EQ 30MG BASE
A090728 002 Jan 08, 2014
AB EQ 30MG BASE
A090739 002 Jan 08, 2014
AB EQ 60MG BASE
A090728 003 Jan 08, 2014
AB EQ 60MG BASE
A090739 003 Jan 08, 2014
LUPIN LTD EQ 40MG BASE
A090694 003 Dec 11, 2013
DUTASTERIDE
CAPSULE;ORAL
AVODART
AB + GLAXOSMITHKLINE
0.5MG
N021319 001 Nov 20, 2001
DUTASTERIDE
AB BARR
0.5MG
A090095 001 Dec 21, 2010
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE
CAPSULE;ORAL
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE
AB ANCHEN PHARMS
0.5MG;0.4MG
A202509 001 Feb 26, 2014
JALYN
AB + GLAXOSMITHKLINE
0.5MG;0.4MG
N022460 001 Jun 14, 2010
DYPHYLLINE
TABLET;ORAL
LUFYLLIN
MEDA PHARMS
200MG
A084566 001
+
400MG
A084566 002
ECHOTHIOPHATE IODIDE
FOR SOLUTION;OPHTHALMIC
PHOSPHOLINE IODIDE
+ WYETH PHARMS INC
0.125%
N011963 001
ECONAZOLE NITRATE
AEROSOL, FOAM;TOPICAL
ECOZA
+ VELDANA MEDICAL SA
1%
N205175 001 Oct 24, 2013
CREAM;TOPICAL
ECONAZOLE NITRATE
AB + FOUGERA PHARMS 1%
A076075 001 Nov 26, 2002
AB IGI LABS INC 1%
A076574 001 Dec 17, 2004
AB PERRIGO NEW YORK 1%
A076479 001 Jun 23, 2004
AB TARO 1%
A076005 001 Nov 26, 2002
EDETATE CALCIUM DISODIUM
INJECTABLE;INJECTION
CALCIUM DISODIUM VERSENATE
+ MEDICIS
200MG/ML
N008922 001
EDROPHONIUM CHLORIDE
INJECTABLE;INJECTION
ENLON
AP MYLAN INSTITUTIONAL
10MG/ML
A088873 001 Aug 06, 1985
TENSILON
AP + VALEANT PHARMS
10MG/ML
N007959 001
TENSILON PRESERVATIVE FREE
AP + VALEANT PHARMS
10MG/ML
N007959 002
EFAVIRENZ
CAPSULE;ORAL
SUSTIVA
BRISTOL MYERS SQUIBB
50MG
N020972 001 Sep 17, 1998
+
200MG
N020972 003 Sep 17, 1998
TABLET;ORAL
SUSTIVA
+ BRISTOL MYERS SQUIBB
600MG
N021360 002 Feb 01, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-128(of 371)
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
TABLET;ORAL
ATRIPLA
+ GILEAD
600MG;200MG;300MG
N021937 001 Jul 12, 2006
EFINACONAZOLE
SOLUTION;TOPICAL
JUBLIA
+ DOW PHARM
10%
N203567 001 Jun 06, 2014
EFLORNITHINE HYDROCHLORIDE
CREAM;TOPICAL
VANIQA
+ SKINMEDICA
13.9%
N021145 001 Jul 27, 2000
ELETRIPTAN HYDROBROMIDE
TABLET;ORAL
RELPAX
PFIZER IRELAND
EQ 20MG BASE
N021016 001 Dec 26, 2002
+
EQ 40MG BASE
N021016 002 Dec 26, 2002
ELIGLUSTAT TARTRATE
CAPSULE;ORAL
CERDELGA
+ GENZYME CORP
EQ 84MG BASE
N205494 001 Aug 19, 2014
ELTROMBOPAG OLAMINE
TABLET;ORAL
PROMACTA
GLAXOSMITHKLINE
EQ 12.5MG ACID
N022291 004 Oct 20, 2011
EQ 25MG ACID
N022291 001 Nov 20, 2008
+
EQ 50MG ACID
N022291 002 Nov 20, 2008
EQ 75MG ACID
N022291 003 Sep 08, 2009
EQ 100MG ACID
N022291 005 Nov 16, 2012
ELVITEGRAVIR
TABLET;ORAL
VITEKTA
GILEAD SCIENCES INC
85MG
N203093 001 Sep 24, 2014
+
150MG
N203093 002 Sep 24, 2014
EMEDASTINE DIFUMARATE
SOLUTION/DROPS;OPHTHALMIC
EMADINE
+ ALCON
0.05%
N020706 001 Dec 29, 1997
EMPAGLIFLOZIN
TABLET;ORAL
JARDIANCE
BOEHRINGER INGELHEIM
10MG
N204629 001 Aug 01, 2014
+
25MG
N204629 002 Aug 01, 2014
EMTRICITABINE
CAPSULE;ORAL
EMTRIVA
+ GILEAD
200MG
N021500 001 Jul 02, 2003
SOLUTION;ORAL
EMTRIVA
+ GILEAD
10MG/ML
N021896 001 Sep 28, 2005
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE
TABLET;ORAL
COMPLERA
+ GILEAD SCIENCES INC 200MG;EQ 25MG BASE;300MG
N202123 001 Aug 10, 2011
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE
TABLET;ORAL
TRUVADA
+ GILEAD
200MG;300MG
N021752 001 Aug 02, 2004
ENALAPRIL MALEATE
FOR SOLUTION;ORAL
EPANED KIT
+ SILVERGATE PHARMS
1MG/ML
N204308 001 Aug 13, 2013
TABLET;ORAL
ENALAPRIL MALEATE
AB APOTEX
2.5MG
A075178 002 Mar 23, 2001
AB
5MG
A075178 001 Mar 23, 2001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-129(of 371)
ENALAPRIL MALEATE
TABLET;ORAL
ENALAPRIL MALEATE
AB 10MG
A075178 003 Mar 23, 2001
AB 20MG
A075178 004 Mar 23, 2001
AB MYLAN 2.5MG
A075480 001 Aug 22, 2000
AB 5MG
A075480 002 Aug 22, 2000
AB 10MG
A075480 003 Aug 22, 2000
AB 20MG
A075480 004 Aug 22, 2000
AB TARO 2.5MG
A075657 001 Jan 23, 2001
AB 5MG
A075657 002 Jan 23, 2001
AB 10MG
A075657 003 Jan 23, 2001
AB 20MG
A075657 004 Jan 23, 2001
AB TEVA 2.5MG
A075479 001 Aug 22, 2000
AB 5MG
A075479 002 Aug 22, 2000
AB 10MG
A075479 003 Aug 22, 2000
AB 20MG
A075479 004 Aug 22, 2000
AB WOCKHARDT USA 2.5MG
A075483 001 Aug 22, 2000
AB 5MG
A075483 002 Aug 22, 2000
AB 10MG
A075483 003 Aug 22, 2000
AB 20MG
A075483 004 Aug 22, 2000
VASOTEC
AB VALEANT INTL 2.5MG
N018998 005 Jul 26, 1988
AB 5MG
N018998 001 Dec 24, 1985
AB 10MG
N018998 002 Dec 24, 1985
AB + 20MG
N018998 003 Dec 24, 1985
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
AB APOTEX INC
5MG;12.5MG
A076486 001 Oct 27, 2004
AB
10MG;25MG
A076486 002 Oct 27, 2004
AB DR REDDYS LABS LTD
5MG;12.5MG
A075909 001 Oct 15, 2001
AB
10MG;25MG
A075909 002 Oct 15, 2001
AB MYLAN
5MG;12.5MG
A075624 001 Sep 18, 2001
AB
10MG;25MG
A075624 002 Sep 18, 2001
AB TARO PHARM INDS
5MG;12.5MG
A075788 001 Sep 18, 2001
AB
10MG;25MG
A075788 002 Sep 18, 2001
AB TEVA
5MG;12.5MG
A075727 001 Sep 18, 2001
AB
10MG;25MG
A075727 002 Sep 18, 2001
VASERETIC
AB VALEANT INTL
5MG;12.5MG
N019221 003 Jul 12, 1995
AB +
10MG;25MG
N019221 001 Oct 31, 1986
ENALAPRILAT
INJECTABLE;INJECTION
ENALAPRILAT
AP + BEDFORD 1.25MG/ML
A075634 001 Aug 22, 2000
AP HIKMA FARMACEUTICA 1.25MG/ML
A078687 001 Dec 23, 2008
AP + HOSPIRA 1.25MG/ML
A075458 001 Aug 22, 2000
AP TEVA PHARMS USA 1.25MG/ML
A075578 001 Aug 22, 2000
ENFLURANE
LIQUID;INHALATION
ENFLURANE
AN PIRAMAL CRITICAL
99.9%
A074396 001 Jul 29, 1994
ETHRANE
AN + BAXTER HLTHCARE
99.9%
N017087 001
ENFUVIRTIDE
INJECTABLE;SUBCUTANEOUS
FUZEON
+ ROCHE
90MG/VIAL
N021481 001 Mar 13, 2003
ENOXAPARIN SODIUM
INJECTABLE;INTRAVENOUS, SUBCUTANEOUS
ENOXAPARIN SODIUM
AB SANDOZ INC 300MG/3ML (100MG/ML)
A078660 001 Nov 28, 2011
LOVENOX
AB SANOFI AVENTIS US 300MG/3ML (100MG/ML)
N020164 009 Jan 23, 2003
INJECTABLE;SUBCUTANEOUS
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
AP AMPHASTAR PHARM 30MG/0.3ML (100MG/ML)
A076684 001 Sep 19, 2011
AP 40MG/0.4ML (100MG/ML)
A076684 002 Sep 19, 2011
AP 60MG/0.6ML (100MG/ML)
A076684 003 Sep 19, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-130(of 371)
ENOXAPARIN SODIUM
INJECTABLE;SUBCUTANEOUS
ENOXAPARIN SODIUM (PRESERVATIVE FREE)
AP 80MG/0.8ML (100MG/ML)
A076684 004 Sep 19, 2011
AP 100MG/ML (100MG/ML)
A076684 005 Sep 19, 2011
AP 120MG/0.8ML (150MG/ML)
A076684 006 Sep 19, 2011
AP 150MG/ML (150MG/ML)
A076684 007 Sep 19, 2011
AP SANDOZ 30MG/0.3ML (100MG/ML)
A077857 002 Jul 23, 2010
AP 40MG/0.4ML (100MG/ML)
A077857 003 Jul 23, 2010
AP 60MG/0.6ML (100MG/ML)
A077857 004 Jul 23, 2010
AP 80MG/0.8ML (100MG/ML)
A077857 005 Jul 23, 2010
AP 100MG/ML (100MG/ML)
A077857 001 Jul 23, 2010
AP 120MG/0.8ML (150MG/ML)
A077857 006 Jul 23, 2010
AP 150MG/ML (150MG/ML)
A077857 007 Jul 23, 2010
AP TEVA 30MG/0.3ML (100MG/ML)
A076726 001 Jun 23, 2014
AP 40MG/0.4ML (100MG/ML)
A076726 002 Jun 23, 2014
AP 60MG/0.6ML (100MG/ML)
A076726 003 Jun 23, 2014
AP 80MG/0.8ML (100MG/ML)
A076726 004 Jun 23, 2014
AP 100MG/ML (100MG/ML)
A076726 005 Jun 23, 2014
AP 120MG/0.8ML (150MG/ML)
A076726 006 Jun 23, 2014
AP 150MG/ML (150MG/ML)
A076726 007 Jun 23, 2014
LOVENOX (PRESERVATIVE FREE)
AP SANOFI AVENTIS US 30MG/0.3ML (100MG/ML)
N020164 001 Mar 29, 1993
AP 40MG/0.4ML (100MG/ML)
N020164 002 Jan 30, 1998
AP 60MG/0.6ML (100MG/ML)
N020164 003 Mar 27, 1998
AP 80MG/0.8ML (100MG/ML)
N020164 004 Mar 27, 1998
AP + 100MG/ML (100MG/ML)
N020164 005 Mar 27, 1998
AP 120MG/0.8ML (150MG/ML)
N020164 007 Jun 02, 2000
AP 150MG/ML (150MG/ML)
N020164 008 Jun 02, 2000
ENTACAPONE
TABLET;ORAL
COMTAN
AB + ORION PHARMA
200MG
N020796 001 Oct 19, 1999
ENTACAPONE
AB MYLAN PHARMS INC
200MG
A202394 001 May 13, 2013
AB SUN PHARMA GLOBAL
200MG
A090690 001 Jul 16, 2012
AB WOCKHARDT LTD
200MG
A078941 001 Aug 16, 2012
ENTECAVIR
SOLUTION;ORAL
BARACLUDE
+ BRISTOL MYERS SQUIBB
0.05MG/ML
N021798 001 Mar 29, 2005
TABLET;ORAL
BARACLUDE
AB BRISTOL MYERS SQUIBB
0.5MG
N021797 001 Mar 29, 2005
AB +
1MG
N021797 002 Mar 29, 2005
ENTECAVIR
AB TEVA PHARMS USA
0.5MG
A202122 001 Aug 26, 2014
AB
1MG
A202122 002 Aug 26, 2014
ENZALUTAMIDE
CAPSULE;ORAL
XTANDI
+ ASTELLAS
40MG
N203415 001 Aug 31, 2012
EPINASTINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
ELESTAT
AT + ALLERGAN
0.05%
N021565 001 Oct 16, 2003
EPINASTINE HYDROCHLORIDE
AT APOTEX
0.05%
A090919 001 Oct 31, 2011
AT BRECKENRIDGE PHARM
0.05%
A090870 001 Mar 14, 2011
AT GAVIS PHARMS LLC
0.05%
A090951 001 Oct 31, 2011
AT SUN PHARM INDS
0.05%
A091626 001 Oct 31, 2011
EPINEPHRINE
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS
ADRENACLICK
BX + AMEDRA PHARMS EQ 0.15MG/DELIVERY N020800 003 Nov 25, 2009
BX + EQ 0.3MG/DELIVERY N020800 004 Nov 25, 2009
AUVI-Q
BX + SANOFI AVENTIS US EQ 0.15MG/DELIVERY N201739 002 Aug 10, 2012
BX EQ 0.3MG/DELIVERY N201739 001 Aug 10, 2012
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-131(of 371)
EPINEPHRINE
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS
EPIPEN
BX + MYLAN SPECLT 0.3MG/DELIVERY N019430 001 Dec 22, 1987
EPIPEN JR.
BX + MYLAN SPECLT 0.15MG/DELIVERY N019430 002 Dec 22, 1987
TWINJECT 0.15
BX + AMEDRA PHARMS EQ 0.15MG/DELIVERY N020800 002 May 28, 2004
TWINJECT 0.3
BX + AMEDRA PHARMS EQ 0.3MG/DELIVERY N020800 001 May 30, 2003
EPINEPHRINE BITARTRATE; LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
LIGNOSPAN FORTE
+ DEPROCO EQ 0.02MG BASE/ML;2% A088389 001 Jan 22, 1985
LIGNOSPAN STANDARD
+ DEPROCO EQ 0.01MG BASE/ML;2% A088390 001 Jan 22, 1985
EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
CITANEST FORTE DENTAL
AP + DENTSPLY PHARM 0.005MG/ML;4% N021383 001
PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE
AP SEPTODONT INC 0.005MG/ML;4% A078959 001 Aug 30, 2011
EPINEPHRINE HYDROCHLORIDE
INJECTABLE;INTRAMUSCULAR, INTRAOCULAR, SUBCUTANEOUS
ADRENALIN
+ PAR STERILE PRODUCTS EQ 1MG BASE/ML (EQ 1MG BASE/ML) N204200 001 Dec 07, 2012
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS
ADRENALIN
+ PAR STERILE PRODUCTS EQ 30MG BASE/30ML (EQ 1MG BASE/ML) N204640 001 Dec 18, 2013
SOLUTION;IV (INFUSION)
EPINEPHRINE
BELCHER PHARMS LLC EQ 1MG BASE/ML (EQ 1MG BASE/ML) N205029 001 Jul 29, 2014
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
AP EASTMAN KODAK 0.01MG/ML;2% A040057 002 Feb 26, 1993
AP 0.02MG/ML;2% A040057 001 Feb 26, 1993
AP HOSPIRA 0.005MG/ML;0.5% A089635 001 Jun 21, 1988
AP 0.005MG/ML;1.5% A088571 001 Sep 13, 1985
AP 0.005MG/ML;1.5% A089645 001 Jun 21, 1988
AP 0.005MG/ML;2% A089651 001 Jun 21, 1988
AP 0.01MG/ML;1% A089644 001 Jun 21, 1988
AP 0.01MG/ML;2% A078772 001 May 12, 2008
AP 0.01MG/ML;2% A089646 001 Jun 21, 1988
AP 0.02MG/ML;2% A078772 002 May 12, 2008
OCTOCAINE
AP + SEPTODONT 0.01MG/ML;2% A084048 001
AP + 0.02MG/ML;2% A084048 002
XYLOCAINE W/ EPINEPHRINE
AP + FRESENIUS KABI USA 0.005MG/ML;0.5% N006488 012
AP + 0.005MG/ML;1% N006488 018 Nov 13, 1986
AP + 0.005MG/ML;1.5% N006488 017
AP + 0.005MG/ML;2% N006488 019 Nov 13, 1986
AP + 0.01MG/ML;1% N006488 004
AP + 0.02MG/ML;2% N006488 005
EPIRUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
ELLENCE
AP + PFIZER INC 200MG/100ML (2MG/ML) N050778 001 Sep 15, 1999
AP 50MG/25ML (2MG/ML) N050778 002 Sep 15, 1999
EPIRUBICIN HYDROCHLORIDE
AP ACTAVIS TOTOWA 10MG/5ML (2MG/ML) A065445 001 Sep 18, 2008
AP 50MG/25ML (2MG/ML) A065445 002 Sep 18, 2008
AP 200MG/100ML (2MG/ML) A065445 003 Sep 18, 2008
AP AKORN INC 50MG/25ML (2MG/ML) A090163 001 Jun 24, 2009
AP CIPLA LTD 50MG/25ML (2MG/ML) A065361 001 Oct 22, 2007
AP 200MG/100ML (2MG/ML) A065361 002 Oct 22, 2007
AP EUROHLTH INTL 50MG/25ML (2MG/ML) A065289 001 Jun 27, 2007
AP 200MG/100ML (2MG/ML) A065289 002 Jun 27, 2007
AP FRESENIUS KABI ONCOL 200MG/100ML (2MG/ML) A065411 001 Aug 20, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-132(of 371)
EPIRUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
EPIRUBICIN HYDROCHLORIDE
AP 50MG/25ML (2MG/ML)
A065411 002 Aug 20, 2007
AP FRESENIUS KABI USA 10MG/5ML (2MG/ML)
A065408 001 Oct 15, 2007
AP 50MG/25ML (2MG/ML)
A065408 002 Oct 15, 2007
AP 150MG/75ML (2MG/ML)
A065408 003 Oct 15, 2007
AP 200MG/100ML (2MG/ML)
A065408 004 Oct 15, 2007
AP HISUN PHARM HANGZHOU 50MG/25ML (2MG/ML)
A090075 001 Mar 25, 2010
AP 200MG/100ML (2MG/ML)
A090075 002 Mar 25, 2010
AP HOSPIRA 10MG/5ML (2MG/ML)
A065343 001 Apr 19, 2007
AP 150MG/75ML (2MG/ML)
A065343 003 Apr 19, 2007
AP 200MG/100ML (2MG/ML)
A065343 004 Apr 19, 2007
AP ONCO THERAPIES LTD 50MG/25ML (2MG/ML)
A091599 001 Mar 12, 2012
AP 200MG/100ML (2MG/ML)
A091599 002 Mar 12, 2012
AP TEVA PHARMS USA 50MG/25ML (2MG/ML)
A065331 001 Aug 09, 2007
AP 200MG/100ML (2MG/ML)
A065331 002 Aug 09, 2007
EPLERENONE
TABLET;ORAL
EPLERENONE
AB APOTEX
25MG
A078482 001 Jul 30, 2008
AB
50MG
A078482 002 Jul 30, 2008
AB SANDOZ
25MG
A078510 001 Aug 01, 2008
AB
50MG
A078510 002 Aug 01, 2008
INSPRA
AB GD SEARLE LLC
25MG
N021437 001 Sep 27, 2002
AB +
50MG
N021437 002 Sep 27, 2002
EPOPROSTENOL SODIUM
INJECTABLE;INJECTION
EPOPROSTENOL SODIUM
AP TEVA PHARMS USA
EQ 0.5MG BASE/VIAL
A078396 001 Apr 23, 2008
AP
EQ 1.5MG BASE/VIAL
A078396 002 Apr 23, 2008
FLOLAN
AP + GLAXOSMITHKLINE LLC
EQ 0.5MG BASE/VIAL
N020444 001 Sep 20, 1995
AP +
EQ 1.5MG BASE/VIAL
N020444 002 Sep 20, 1995
VELETRI
ACTELION PHARMS LTD
EQ 0.5MG BASE/VIAL
N022260 002 Jun 28, 2012
+
EQ 1.5MG BASE/VIAL
N022260 001 Jun 27, 2008
EPROSARTAN MESYLATE
TABLET;ORAL
EPROSARTAN MESYLATE
AB MYLAN PHARMS INC
EQ 400MG BASE
A202012 001 Nov 16, 2011
AB
EQ 600MG BASE
A202012 002 Nov 16, 2011
TEVETEN
AB ABBVIE
EQ 400MG BASE
N020738 005 Dec 22, 1997
AB +
EQ 600MG BASE
N020738 006 May 27, 1999
EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
TEVETEN HCT
ABBVIE
600MG;12.5MG
N021268 001 Nov 01, 2001
+
600MG;25MG
N021268 002 Nov 01, 2001
EPTIFIBATIDE
INJECTABLE;INJECTION
INTEGRILIN
+ SCHERING
2MG/ML
N020718 001 May 18, 1998
+
75MG/100ML
N020718 002 May 18, 1998
ERGOCALCIFEROL
CAPSULE;ORAL
DRISDOL
AA + SANOFI AVENTIS US 50,000 IU
N003444 001
ERGOCALCIFEROL
AA ORIT LABS LLC 50,000 IU
A040833 001 May 20, 2009
AA SIGMAPHARM LABS LLC 50,000 IU
A091004 001 Jul 14, 2010
AA STRIDES PHARMA 50,000 IU
A090455 001 Aug 03, 2010
AA SUN PHARM INDS INC 50,000 IU
A040865 001 Dec 29, 2009
VITAMIN D
AA BANNER PHARMACAPS 50,000 IU
A080704 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-133(of 371)
ERGOLOID MESYLATES
TABLET;ORAL
ERGOLOID MESYLATES
AB MUTUAL PHARM 1MG A081113 001 Oct 31, 1991
HYDERGINE
AB + NOVARTIS 1MG N017993 001
ERGOTAMINE TARTRATE
TABLET;SUBLINGUAL
ERGOMAR
+ ROSEDALE THERAPEUTIC 2MG A087693 001 Feb 24, 1983
ERIBULIN MESYLATE
SOLUTION;INTRAVENOUS
HALAVEN
+ EISAI INC 1MG/2ML (0.5MG/ML) N201532 001 Nov 15, 2010
ERLOTINIB HYDROCHLORIDE
TABLET;ORAL
ERLOTINIB HYDROCHLORIDE
AB MYLAN PHARMS INC EQ 25MG BASE A091002 001 Jun 11, 2014
AB EQ 100MG BASE A091002 002 Jun 11, 2014
AB EQ 150MG BASE A091002 003 Jun 11, 2014
TARCEVA
AB OSI PHARMS EQ 25MG BASE N021743 001 Nov 18, 2004
AB EQ 100MG BASE N021743 002 Nov 18, 2004
AB + EQ 150MG BASE N021743 003 Nov 18, 2004
ERTAPENEM SODIUM
INJECTABLE;INTRAMUSCULAR, IV (INFUSION)
INVANZ
+ MERCK SHARP DOHME EQ 1GM BASE/VIAL N021337 001 Nov 21, 2001
ERYTHROMYCIN
CAPSULE, DELAYED REL PELLETS;ORAL
ERYC
AB + MAYNE PHARMA 250MG N050536 001
ERYTHROMYCIN
AB ARBOR PHARMS LLC 250MG A062746 001 Dec 22, 1986
GEL;TOPICAL
ERYGEL
AT + DELCOR ASSET CORP 2% N050617 001 Oct 21, 1987
ERYTHROMYCIN
AT FOUGERA PHARMS 2% A064184 001 Sep 30, 1997
AT PERRIGO 2% A063211 001 Jan 29, 1993
OINTMENT;OPHTHALMIC
ERYTHROMYCIN
AT AKORN 0.5% A064030 001 Jul 18, 1996
AT BAUSCH AND LOMB 0.5% A064067 001 Jul 29, 1994
AT + PERRIGO CO TENNESSEE 0.5% A062447 001 Sep 26, 1983
OINTMENT;TOPICAL
AKNE-MYCIN
+ DOW PHARM 2% N050584 001 Jan 10, 1985
SOLUTION;TOPICAL
C-SOLVE-2
AT FOUGERA PHARMS 2% A062468 001 Jul 03, 1985
ERYTHRA-DERM
AT PADDOCK LLC 2% A062687 001 Feb 05, 1988
ERYTHRO-STATIN
AT HI TECH PHARMA 2% A064101 001 Oct 22, 1996
ERYTHROMYCIN
AT + FOUGERA PHARMS 2% A064187 001 Sep 30, 1997
AT PERRIGO NEW YORK 2% A063038 001 Jan 11, 1991
AT WOCKHARDT 2% A062825 001 Oct 23, 1987
SWAB;TOPICAL
ERYTHROMYCIN
AT + PERRIGO 2% A064126 001 Jul 03, 1996
AT VERSAPHARM 2% A090215 001 May 12, 2010
TABLET;ORAL
ERYTHROMYCIN
ARBOR PHARMS LLC 250MG A061621 001
+ 500MG A061621 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-134(of 371)
ERYTHROMYCIN
TABLET, COATED PARTICLES;ORAL
PCE
ARBOR PHARMS LLC 333MG N050611 001 Sep 09, 1986
+ 500MG N050611 002 Aug 22, 1990
TABLET, DELAYED RELEASE;ORAL
ERY-TAB
ARBOR PHARMS LLC 250MG A062298 001
333MG A062298 003 Mar 29, 1982
+ 500MG A062298 002
ERYTHROMYCIN ETHYLSUCCINATE
GRANULE;ORAL
E.E.S.
AB ARBOR PHARMS LLC EQ 200MG BASE/5ML N050207 001
ERYPED
AB ARBOR PHARMS LLC EQ 200MG BASE/5ML N050207 003 Mar 30, 1987
+ EQ 400MG BASE/5ML N050207 002
SUSPENSION;ORAL
E.E.S. 200
AB ARBOR PHARMS LLC EQ 200MG BASE/5ML A061639 001
E.E.S. 400
AB + ARBOR PHARMS LLC EQ 400MG BASE/5ML A061639 002
PEDIAMYCIN
AB ARBOR PHARMS LLC EQ 200MG BASE/5ML A062304 001
PEDIAMYCIN 400
AB ARBOR PHARMS LLC EQ 400MG BASE/5ML A062304 002
TABLET;ORAL
E.E.S. 400
BX + ARBOR PHARMS LLC EQ 400MG BASE A061905 002 Aug 12, 1982
ERYTHROMYCIN ETHYLSUCCINATE
BX + ARBOR PHARMS LLC EQ 400MG BASE A061904 001
ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL
GRANULE;ORAL
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL
+ BARR EQ 200MG BASE/5ML;EQ 600MG BASE/5ML A062759 001 May 20, 1988
ERYTHROMYCIN LACTOBIONATE
INJECTABLE;INJECTION
ERYTHROCIN
AP HOSPIRA EQ 500MG BASE/VIAL A062638 001 Oct 31, 1986
AP + EQ 500MG BASE/VIAL N050609 001 Sep 24, 1986
+ EQ 1GM BASE/VIAL A062638 002 Oct 31, 1986
ERYTHROMYCIN STEARATE
TABLET;ORAL
ERYTHROCIN STEARATE
+ ARBOR PHARMS LLC EQ 250MG BASE A060359 001
ESCITALOPRAM OXALATE
SOLUTION;ORAL
ESCITALOPRAM OXALATE
AA AMNEAL PHARMS EQ 5MG BASE/5ML A202227 001 Mar 14, 2012
AA AUROBINDO PHARMA LTD EQ 5MG BASE/5ML A079062 001 Apr 02, 2012
AA HETERO LABS LTD III EQ 5MG BASE/5ML A202221 001 Jun 12, 2012
AA SILARX PHARMS INC EQ 5MG BASE/5ML A090477 001 Jun 12, 2013
AA TARO EQ 5MG BASE/5ML A079121 001 May 03, 2012
LEXAPRO
AA + FOREST LABS EQ 5MG BASE/5ML N021365 001 Nov 27, 2002
TABLET;ORAL
ESCITALOPRAM OXALATE
AB ACCORD HLTHCARE EQ 5MG BASE A202389 001 Sep 11, 2012
AB EQ 10MG BASE A202389 002 Sep 11, 2012
AB EQ 20MG BASE A202389 003 Sep 11, 2012
AB APOTEX INC EQ 5MG BASE A078777 001 Sep 11, 2012
AB EQ 10MG BASE A078777 002 Sep 11, 2012
AB EQ 20MG BASE A078777 003 Sep 11, 2012
AB AUROBINDO PHARMA LTD EQ 5MG BASE A090432 001 Sep 11, 2012
AB EQ 10MG BASE A090432 002 Sep 11, 2012
AB EQ 20MG BASE A090432 003 Sep 11, 2012
AB HIKMA PHARMS EQ 5MG BASE A078766 001 Sep 11, 2012
AB EQ 10MG BASE A078766 002 Sep 11, 2012
AB EQ 20MG BASE A078766 003 Sep 11, 2012
AB INVAGEN PHARMS EQ 5MG BASE A078604 001 Sep 11, 2012
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-135(of 371)
ESCITALOPRAM OXALATE
TABLET;ORAL
ESCITALOPRAM OXALATE
AB EQ 10MG BASE A078604 002 Sep 11, 2012
AB EQ 20MG BASE A078604 003 Sep 11, 2012
AB JUBILANT GENERICS EQ 5MG BASE A202280 001 Sep 12, 2012
AB EQ 10MG BASE A202280 002 Sep 12, 2012
AB EQ 20MG BASE A202280 003 Sep 12, 2012
AB LUPIN LTD EQ 5MG BASE A078169 001 Sep 11, 2012
AB EQ 10MG BASE A078169 002 Sep 11, 2012
AB EQ 20MG BASE A078169 003 Sep 11, 2012
AB MACLEODS PHARMS LTD EQ 5MG BASE A202210 001 Sep 11, 2012
AB EQ 10MG BASE A202210 002 Sep 11, 2012
AB EQ 20MG BASE A202210 003 Sep 11, 2012
AB STI PHARMA LLC EQ 5MG BASE A077512 001 Sep 12, 2012
AB EQ 10MG BASE A077512 002 Sep 12, 2012
AB EQ 20MG BASE A077512 003 Sep 12, 2012
AB TEVA PHARMS USA EQ 5MG BASE A076765 001 Mar 14, 2012
AB EQ 10MG BASE A076765 002 Mar 14, 2012
AB EQ 20MG BASE A076765 003 Mar 14, 2012
AB TORRENT PHARMS LTD EQ 5MG BASE A090939 001 Sep 11, 2012
AB EQ 10MG BASE A090939 002 Sep 11, 2012
AB EQ 20MG BASE A090939 003 Sep 11, 2012
AB ZYDUS PHARMS USA INC EQ 5MG BASE A077734 001 Sep 11, 2012
AB EQ 10MG BASE A077734 002 Sep 11, 2012
AB EQ 20MG BASE A077734 003 Sep 11, 2012
LEXAPRO
AB FOREST LABS EQ 5MG BASE N021323 001 Aug 14, 2002
AB EQ 10MG BASE N021323 002 Aug 14, 2002
AB + EQ 20MG BASE N021323 003 Aug 14, 2002
ESLICARBAZEPINE ACETATE
TABLET;ORAL
APTIOM
SUNOVION PHARMS INC 200MG N022416 001 Nov 08, 2013
400MG N022416 002 Nov 08, 2013
600MG N022416 003 Nov 08, 2013
+ 800MG N022416 004 Nov 08, 2013
ESMOLOL HYDROCHLORIDE
INJECTABLE;INJECTION
BREVIBLOC
AP + BAXTER HLTHCARE 10MG/ML N019386 006 Feb 25, 2003
ESMOLOL HYDROCHLORIDE
AP EUROHLTH INTL 10MG/ML A076323 001 Aug 10, 2004
AP FRESENIUS KABI USA 10MG/ML A076573 001 May 02, 2005
AP MYLAN INSTITUTIONAL 10MG/ML A076474 001 May 02, 2005
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 2GM/100ML N019386 005 Jan 27, 2003
BREVIBLOC IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 1GM/100ML N019386 004 Feb 16, 2001
ESOMEPRAZOLE MAGNESIUM
CAPSULE, DELAYED REL PELLETS;ORAL
NEXIUM
ASTRAZENECA PHARMS EQ 20MG BASE N021153 001 Feb 20, 2001
+ EQ 40MG BASE N021153 002 Feb 20, 2001
FOR SUSPENSION, DELAYED RELEASE;ORAL
NEXIUM
ASTRAZENECA PHARMS EQ 2.5MG BASE/PACKET N021957 003 Dec 15, 2011
EQ 5MG BASE/PACKET N021957 004 Dec 15, 2011
EQ 10MG BASE/PACKET N022101 001 Feb 27, 2008
EQ 20MG BASE/PACKET N021957 001 Oct 20, 2006
+ EQ 40MG BASE/PACKET N021957 002 Oct 20, 2006
ESOMEPRAZOLE MAGNESIUM; NAPROXEN
TABLET, DELAYED RELEASE;ORAL
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM
AB DR REDDYS LABS LTD EQ 20MG BASE;375MG A202461 001 Sep 27, 2013
AB EQ 20MG BASE;500MG A202461 002 Sep 27, 2013
VIMOVO
AB HORIZON PHARMA EQ 20MG BASE;375MG N022511 002 Apr 30, 2010
AB + EQ 20MG BASE;500MG N022511 001 Apr 30, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-136(of 371)
ESOMEPRAZOLE SODIUM
INJECTABLE;INTRAVENOUS
ESOMEPRAZOLE SODIUM
AP SUN PHARMA GLOBAL EQ 20MG BASE/VIAL A200882 001 Mar 18, 2013
AP EQ 40MG BASE/VIAL A200882 002 Mar 18, 2013
NEXIUM IV
AP + ASTRAZENECA PHARMS EQ 20MG BASE/VIAL N021689 001 Mar 31, 2005
AP + EQ 40MG BASE/VIAL N021689 002 Mar 31, 2005
ESOMEPRAZOLE STRONTIUM
CAPSULE, DELAYED RELEASE;ORAL
ESOMEPRAZOLE STRONTIUM
HANMI PHARM CO LTD EQ 20MG BASE N202342 001 Aug 06, 2013
+ EQ 40MG BASE N202342 002 Aug 06, 2013
ESTAZOLAM
TABLET;ORAL
ESTAZOLAM
AB PAR PHARM 1MG A074826 001 Jul 03, 1997
AB 2MG A074826 002 Jul 03, 1997
AB TEVA 1MG A074921 001 Jul 10, 1997
AB + 2MG A074921 002 Jul 10, 1997
AB WATSON LABS 1MG A074818 001 Aug 19, 1997
AB 2MG A074818 002 Aug 19, 1997
ESTRADIOL
CREAM;VAGINAL
ESTRACE
+ WARNER CHILCOTT US 0.01% A086069 001 Jan 31, 1984
FILM, EXTENDED RELEASE;TRANSDERMAL
CLIMARA
AB BAYER HLTHCARE 0.0375MG/24HR N020375 005 May 27, 2003
AB 0.06MG/24HR N020375 006 May 27, 2003
ESTRADIOL
AB MYLAN TECHNOLOGIES 0.0375MG/24HR A075182 004 Jul 20, 2006
AB 0.06MG/24HR A075182 005 Jul 20, 2006
AB1 0.025MG/24HR A201675 001 Dec 19, 2014
AB1 0.0375MG/24HR A201675 002 Dec 19, 2014
AB1 0.05MG/24HR A201675 003 Dec 19, 2014
AB1 0.075MG/24HR A201675 004 Dec 19, 2014
AB1 0.1MG/24HR A201675 005 Dec 19, 2014
VIVELLE
AB1 NOVARTIS 0.05MG/24HR N020323 002 Oct 28, 1994
AB1 0.1MG/24HR N020323 004 Oct 28, 1994
VIVELLE-DOT
AB1 NOVARTIS 0.025MG/24HR N020538 009 May 03, 2002
AB1 0.0375MG/24HR N020538 005 Jan 08, 1999
AB1 0.05MG/24HR N020538 006 Jan 08, 1999
AB1 0.075MG/24HR N020538 007 Jan 08, 1999
AB1 + 0.1MG/24HR N020538 008 Jan 08, 1999
CLIMARA
AB2 BAYER HLTHCARE 0.025MG/24HR N020375 004 Mar 05, 1999
AB2 0.05MG/24HR N020375 001 Dec 22, 1994
AB2 0.075MG/24HR N020375 003 Mar 23, 1998
AB2 + 0.1MG/24HR N020375 002 Dec 22, 1994
ESTRADIOL
AB2 MYLAN TECHNOLOGIES 0.025MG/24HR A075182 003 Jan 26, 2005
AB2 0.05MG/24HR A075182 006 Feb 24, 2000
AB2 0.075MG/24HR A075182 002 Jan 26, 2005
AB2 0.1MG/24HR A075182 001 Feb 24, 2000
ALORA
BX WATSON LABS 0.025MG/24HR N020655 004 Apr 05, 2002
BX 0.05MG/24HR N020655 001 Dec 20, 1996
BX 0.075MG/24HR N020655 002 Dec 20, 1996
BX 0.1MG/24HR N020655 003 Dec 20, 1996
ESTRADERM
BX NOVARTIS 0.05MG/24HR N019081 002 Sep 10, 1986
BX + 0.1MG/24HR N019081 003 Sep 10, 1986
MENOSTAR
+ BAYER HLTHCARE 0.014MG/24HR N021674 001 Jun 08, 2004
MINIVELLE
NOVEN 0.0375MG/24HR N203752 001 Oct 29, 2012
0.05MG/24HR N203752 003 Oct 29, 2012
0.075MG/24HR N203752 002 Oct 29, 2012
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-137(of 371)
ESTRADIOL
FILM, EXTENDED RELEASE;TRANSDERMAL
MINIVELLE
+ 0.1MG/24HR N203752 004 Oct 29, 2012
GEL;TRANSDERMAL
DIVIGEL
VERTICAL PHARMS LLC 0.1% (0.25GM/PACKET) N022038 001 Jun 04, 2007
0.1% (0.5GM/PACKET) N022038 002 Jun 04, 2007
+ 0.1% (1GM/PACKET) N022038 003 Jun 04, 2007
GEL, METERED;TRANSDERMAL
ELESTRIN
+ MEDA PHARMS 0.06% (0.87GM/ACTIVATION) N021813 001 Dec 15, 2006
ESTROGEL
+ ASCEND THERAPS US 0.06% (1.25GM/ACTIVATION) N021166 002 Feb 09, 2004
INSERT, EXTENDED RELEASE;VAGINAL
ESTRING
+ PHARMACIA AND UPJOHN 0.0075MG/24HR N020472 001 Apr 26, 1996
SPRAY;TRANSDERMAL
EVAMIST
+ ELAN PHARMA INTL LTD 1.53MG/SPRAY N022014 001 Jul 27, 2007
TABLET;ORAL
ESTRADIOL
AB BARR LABS INC 0.5MG A040197 001 Oct 22, 1997
AB 1MG A040197 002 Oct 22, 1997
AB + 2MG A040197 003 Oct 22, 1997
AB MYLAN 0.5MG A040326 001 Apr 21, 1999
AB 1MG A040326 002 Apr 21, 1999
AB 2MG A040326 003 Apr 21, 1999
AB USL PHARMA 0.5MG A040297 001 Apr 17, 2002
AB 1MG A040297 002 Apr 17, 2002
AB 2MG A040297 003 Apr 17, 2002
AB WATSON LABS 0.5MG A040114 003 Mar 14, 1996
AB 1MG A040114 001 Mar 14, 1996
AB 2MG A040114 002 Mar 14, 1996
TABLET;VAGINAL
VAGIFEM
+ NOVO NORDISK INC 10MCG N020908 002 Nov 25, 2009
ESTRADIOL ACETATE
INSERT, EXTENDED RELEASE;VAGINAL
FEMRING
WARNER IRELAND EQ 0.05MG BASE/24HR N021367 001 Mar 20, 2003
+ EQ 0.1MG BASE/24HR N021367 002 Mar 20, 2003
TABLET;ORAL
FEMTRACE
WARNER CHILCOTT LLC 0.45MG N021633 001 Aug 20, 2004
0.9MG N021633 002 Aug 20, 2004
+ 1.8MG N021633 003 Aug 20, 2004
ESTRADIOL CYPIONATE
INJECTABLE;INJECTION
DEPO-ESTRADIOL
+ PHARMACIA AND UPJOHN 5MG/ML A085470 003
ESTRADIOL HEMIHYDRATE
EMULSION;TOPICAL
ESTRASORB
+ MEDICIS 0.25% N021371 001 Oct 09, 2003
ESTRADIOL VALERATE
INJECTABLE;INJECTION
DELESTROGEN
AO + PAR STERILE PRODUCTS 20MG/ML N009402 004
AO + 40MG/ML N009402 003
ESTRADIOL VALERATE
AO LUITPOLD 20MG/ML A090920 001 Jan 19, 2010
AO 40MG/ML A090920 002 Jan 19, 2010
DELESTROGEN
+ PAR STERILE PRODUCTS 10MG/ML N009402 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-138(of 371)
ESTRADIOL; LEVONORGESTREL
FILM, EXTENDED RELEASE;TRANSDERMAL
CLIMARA PRO
+ BAYER HLTHCARE 0.045MG/24HR;0.015MG/24HR N021258 001 Nov 21, 2003
ESTRADIOL; NORETHINDRONE ACETATE
FILM, EXTENDED RELEASE;TRANSDERMAL
COMBIPATCH
NOVEN PHARMS INC 0.05MG/24HR;0.14MG/24HR N020870 001 Aug 07, 1998
+ 0.05MG/24HR;0.25MG/24HR N020870 002 Aug 07, 1998
TABLET;ORAL
ACTIVELLA
AB AMNEAL PHARMS LLC 0.5MG;0.1MG N020907 002 Dec 28, 2006
AB + 1MG;0.5MG N020907 001 Nov 18, 1998
ESTRADIOL AND NORETHINDRONE ACETATE
AB BARR 1MG;0.5MG A079193 001 May 11, 2010
AB BRECKENRIDGE PHARM 0.5MG;0.1MG A078324 002 Jun 09, 2011
AB 1MG;0.5MG A078324 001 Apr 17, 2008
AB TEVA PHARMS USA 0.5MG;0.1MG A200747 001 Mar 08, 2012
ESTRADIOL; NORGESTIMATE
TABLET;ORAL
ESTRADIOL AND NORGESTIMATE
+ BARR 1MG,1MG;1MG,1MG;N/A,0.09MG A076812 001 Apr 29, 2005
ESTRAMUSTINE PHOSPHATE SODIUM
CAPSULE;ORAL
EMCYT
+ PHARMACIA AND UPJOHN EQ 140MG PHOSPHATE N018045 001
ESTROGENS, CONJUGATED
CREAM;TOPICAL, VAGINAL
PREMARIN
+ WYETH PHARMS INC 0.625MG/GM N020216 001
INJECTABLE;INJECTION
PREMARIN
+ WYETH PHARMS INC 25MG/VIAL N010402 001
TABLET;ORAL
PREMARIN
WYETH PHARMS INC 0.3MG N004782 003
0.45MG N004782 006 Jul 16, 2003
+ 0.625MG N004782 004
+ 0.9MG N004782 005 Jan 26, 1984
+ 1.25MG N004782 001
ESTROGENS, CONJUGATED SYNTHETIC A
TABLET;ORAL
CENESTIN
TEVA BRANDED PHARM 0.3MG N020992 001 Jun 21, 2002
0.45MG N020992 005 Feb 05, 2004
0.625MG N020992 002 Mar 24, 1999
0.9MG N020992 003 Mar 24, 1999
+ 1.25MG N020992 004 Mar 13, 2000
ESTROGENS, CONJUGATED SYNTHETIC B
TABLET;ORAL
ENJUVIA
TEVA WOMENS 0.3MG N021443 001 Dec 20, 2004
0.45MG N021443 002 Dec 20, 2004
0.625MG N021443 003 May 10, 2004
0.9MG N021443 005 Apr 27, 2007
+ 1.25MG N021443 004 May 10, 2004
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
TABLET;ORAL-28
PREMPHASE 14/14
+ WYETH PHARMS INC 0.625MG,0.625MG;0.625MG,0.625MG;N/A,5MG N020527 002 Nov 17, 1995
PREMPRO
+ WYETH PHARMS INC 0.3MG;1.5MG N020527 005 Jun 04, 2003
+ 0.45MG;1.5MG N020527 004 Mar 12, 2003
+ 0.625MG;0.625MG;2.5MG;2.5MG N020527 001 Nov 17, 1995
+ 0.625MG;0.625MG;5MG;5MG N020527 003 Jan 09, 1998
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-139(of 371)
ESTROGENS, ESTERIFIED
TABLET;ORAL
MENEST
MONARCH PHARMS
0.3MG
A084951 001
0.625MG
A084948 001
1.25MG
A084950 001
+
2.5MG
A084949 001
ESTROPIPATE
TABLET;ORAL
ESTROPIPATE
AB BARR
0.75MG
A040135 001 Nov 27, 1996
AB
1.5MG
A040135 002 Nov 27, 1996
AB
3MG
A040135 003 Nov 27, 1996
AB MYLAN
0.75MG
A040359 001 Aug 26, 1999
AB
1.5MG
A040359 002 Aug 26, 1999
AB WATSON LABS
0.75MG
A081213 001 Sep 23, 1993
AB
1.5MG
A081214 001 Sep 23, 1993
AB
3MG
A081215 001 Sep 23, 1993
OGEN .625
AB PHARMACIA AND UPJOHN
0.75MG
A083220 001
OGEN 1.25
AB PHARMACIA AND UPJOHN
1.5MG
A083220 002
OGEN 2.5
AB + PHARMACIA AND UPJOHN
3MG
A083220 003
OGEN 5
PHARMACIA AND UPJOHN
6MG
A083220 004
ESZOPICLONE
TABLET;ORAL
ESZOPICLONE
AB DR REDDYS LABS LTD
1MG
A091024 001 Apr 15, 2014
AB
2MG
A091024 002 Apr 15, 2014
AB
3MG
A091024 003 Apr 15, 2014
AB GLENMARK GENERICS
1MG
A091166 001 Apr 15, 2014
AB
2MG
A091166 002 Apr 15, 2014
AB
3MG
A091166 003 Apr 15, 2014
AB LUPIN LTD
1MG
A091124 001 Sep 13, 2011
AB
2MG
A091124 002 Sep 13, 2011
AB
3MG
A091124 003 Sep 13, 2011
AB MYLAN PHARMS INC
1MG
A091151 001 Mar 26, 2013
AB
2MG
A091151 002 Mar 26, 2013
AB
3MG
A091151 003 Mar 26, 2013
AB ORCHID HLTHCARE
1MG
A091113 001 Jun 10, 2014
AB
2MG
A091113 002 Jun 10, 2014
AB
3MG
A091113 003 Jun 10, 2014
AB ROXANE
1MG
A091153 001 Apr 15, 2014
AB
2MG
A091153 002 Apr 15, 2014
AB
3MG
A091153 003 Apr 15, 2014
AB SUN PHARMA GLOBAL
1MG
A091103 001 Apr 03, 2013
AB
2MG
A091103 002 Apr 03, 2013
AB
3MG
A091103 003 Apr 03, 2013
AB TEVA
1MG
A091169 001 May 23, 2011
AB
2MG
A091169 002 May 23, 2011
AB
3MG
A091169 003 May 23, 2011
LUNESTA
AB SUNOVION PHARMS INC
1MG
N021476 001 Dec 15, 2004
AB
2MG
N021476 002 Dec 15, 2004
AB +
3MG
N021476 003 Dec 15, 2004
ETHACRYNATE SODIUM
INJECTABLE;INJECTION
EDECRIN
+ ATON
EQ 50MG BASE/VIAL
N016093 001
ETHACRYNIC ACID
TABLET;ORAL
EDECRIN
+ ATON
25MG
N016092 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-140(of 371)
ETHAMBUTOL HYDROCHLORIDE
TABLET;ORAL
ETHAMBUTOL HYDROCHLORIDE
AB BARR 400MG A076057 001 Nov 26, 2001
AB LUPIN 100MG A078939 001 Jun 17, 2009
AB 400MG A078939 002 Jun 17, 2009
MYAMBUTOL
AB STI PHARMA LLC 100MG N016320 001
AB + 400MG N016320 003
ETHANOLAMINE OLEATE
INJECTABLE;INJECTION
ETHAMOLIN
+ QOL MEDCL 50MG/ML N019357 001 Dec 22, 1988
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE
TABLET;ORAL-28
KELNOR
AB BARR 0.035MG;1MG A076785 001 May 23, 2005
ZOVIA 1/35E-28
AB WATSON LABS 0.035MG;1MG A072721 001 Dec 30, 1991
ZOVIA 1/50E-28
+ WATSON LABS 0.05MG;1MG A072723 001 Dec 30, 1991
ETHINYL ESTRADIOL; ETONOGESTREL
RING;VAGINAL
NUVARING
+ ORGANON USA INC 0.015MG/24HR;0.12MG/24HR N021187 001 Oct 03, 2001
ETHINYL ESTRADIOL; LEVONORGESTREL
TABLET;ORAL
DAYSEE
AB LUPIN LTD 0.03MG,0.01MG;0.15MG,N/A A091467 001 Apr 10, 2013
INTROVALE
AB SANDOZ 0.03MG;0.15MG A079064 001 Sep 27, 2010
LEVONORGESTREL AND ETHINYL ESTRADIOL
AB LUPIN LTD 0.02MG,0.01MG;0.1MG,N/A A091674 001 Oct 26, 2011
AB 0.03MG;0.15MG A091440 001 Oct 23, 2012
AB WATSON LABS 0.02MG,0.01MG;0.1MG,N/A A200407 001 Oct 25, 2011
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL
AB WATSON LABS 0.03MG,0.01MG;0.15MG,N/A A078834 001 May 31, 2011
LOSEASONIQUE
AB TEVA BRANDED PHARM 0.01MG;0.02MG;0.1MG N022262 001 Oct 24, 2008
QUASENSE
AB WATSON LABS 0.03MG;0.15MG A077101 001 Sep 06, 2006
SEASONALE
AB + TEVA BRANDED PHARM 0.03MG;0.15MG N021544 001 Sep 05, 2003
SEASONIQUE
AB + TEVA BRANDED PHARM 0.03MG,0.01MG;0.03MG,0.01MG;0.15MG,N/A N021840 001 May 25, 2006
SETLAKIN
AB NOVAST LABS LTD 0.03MG;0.15MG A090716 001 Sep 15, 2014
LEVONORGESTREL AND ETHINYL ESTRADIOL
+ WATSON LABS 0.02MG;0.09MG A079218 001 Jun 06, 2011
QUARTETTE
+ TEVA BRANDED PHARM 0.02MG;0.15MG N204061 001 Mar 28, 2013
TABLET;ORAL-28
ALTAVERA
AB SANDOZ 0.03MG;0.15MG A079102 001 Aug 03, 2010
ENPRESSE-28
AB DURAMED PHARMS BARR 0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1 A075809 002 Jul 16, 2001
25MG
KURVELO
AB LUPIN LTD 0.03MG;0.15MG A091408 001 Oct 17, 2012
LEVONEST
AB NOVAST LABS LTD 0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1 A090719 001 Dec 29, 2010
25MG
LEVONORGESTREL AND ETHINYL ESTRADIOL
AB FAMY CARE LTD 0.03MG;0.15MG A091663 001 Dec 21, 2012
AB HAUPT PHARMA 0.03MG;0.15MG A201095 001 Dec 08, 2014
LEVORA 0.15/30-28
AB WATSON LABS 0.03MG;0.15MG A073594 001 Dec 13, 1993
MARLISSA
AB GLENMARK GENERICS 0.03MG;0.15MG A091452 001 Feb 29, 2012
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-141(of 371)
ETHINYL ESTRADIOL; LEVONORGESTREL
TABLET;ORAL-28
MYZILRA
AB VINTAGE PHARMS LLC 0.03MG,0.04MG,0.03MG;0.05MG,0.075MG,0.1 A077502 001 Nov 23, 2011
25MG
NORDETTE-28
AB + TEVA BRANDED PHARM 0.03MG;0.15MG N018782 001 Jul 21, 1982
PORTIA-28
AB BARR 0.03MG;0.15MG A075866 002 May 23, 2002
TRIVORA-28
AB + WATSON LABS 0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1 A074538 002 Dec 18, 1997
25MG
AVIANE-28
AB1 DURAMED PHARMS BARR 0.02MG;0.1MG A075796 001 Apr 30, 2001
FALMINA
AB1 NOVAST LABS LTD 0.02MG;0.1MG A090721 001 Mar 28, 2012
LEVONORGESTREL AND ETHINYL ESTRADIOL
AB1 FAMY CARE LTD 0.02MG;0.1MG A200245 001 Oct 09, 2013
AB1 HAUPT PHARMA 0.02MG;0.1MG A201108 001 Feb 05, 2014
AB1 LUPIN LTD 0.02MG;0.1MG A091425 001 Jan 18, 2013
AB1 + WATSON LABS 0.02MG;0.1MG A076625 001 Nov 18, 2004
ORSYTHIA
AB1 VINTAGE PHARMS LLC 0.02MG;0.1MG A077099 001 May 11, 2011
LESSINA-28
AB2 BARR 0.02MG;0.1MG A075803 002 Mar 20, 2002
LEVONORGESTREL AND ETHINYL ESTRADIOL
AB2 FAMY CARE LTD 0.02MG;0.1MG A202247 001 Dec 08, 2014
AB2 + WATSON LABS 0.02MG;0.1MG A077681 001 May 31, 2006
ETHINYL ESTRADIOL; NORELGESTROMIN
FILM, EXTENDED RELEASE;TRANSDERMAL
ORTHO EVRA
AB + JANSSEN PHARMS 0.035MG/24HR;0.15MG/24HR N021180 001 Nov 20, 2001
XULANE
AB MYLAN TECHNOLOGIES 0.035MG/24HR;0.15MG/24HR A200910 001 Apr 16, 2014
ETHINYL ESTRADIOL; NORETHINDRONE
TABLET;ORAL-21
NORINYL 1+35 21-DAY
AB WATSON LABS 0.035MG;1MG N017565 001
NORTREL 1/35-21
AB BARR 0.035MG;1MG A072693 001 Feb 28, 1992
NORTREL 7/7/7
BARR 0.035MG;0.035MG;0.035MG;0.5MG;0.75MG;1M A075478 001 Aug 30, 2002
G
TABLET;ORAL-28
ALYACEN 1/35
AB GLENMARK GENERICS 0.035MG;1MG A091634 001 Jan 19, 2012
ALYACEN 7/7/7
AB GLENMARK GENERICS 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M A091636 001 Jan 19, 2012
G
ARANELLE
AB BARR 0.035MG;0.035MG;0.035MG;0.5MG;0.5MG;1MG A076783 001 Sep 29, 2004
BALZIVA-28
AB BARR 0.035MG;0.4MG A076238 001 Apr 22, 2004
BREVICON 28-DAY
AB WATSON LABS 0.035MG;0.5MG N017743 001
BRIELLYN
AB GLENMARK GENERICS 0.035MG;0.4MG A090538 001 Mar 22, 2011
CYCLAFEM 1/35
AB VINTAGE PHARMS LLC 0.035MG;1MG A076337 001 Nov 12, 2010
CYCLAFEM 7/7/7
AB VINTAGE PHARMS LLC 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M A076338 001 Nov 16, 2010
G
DASETTA 1/35
AB NOVAST LABS LTD 0.035MG;1MG A090948 001 Dec 22, 2011
DASETTA 7/7/7
AB NOVAST LABS LTD 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M A090946 001 Dec 22, 2011
G
GILDAGIA
AB VINTAGE PHARMS 0.035MG;0.4MG A078376 001 Nov 06, 2012
MODICON 28
AB + JANSSEN PHARMS 0.035MG;0.5MG N017735 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-142(of 371)
ETHINYL ESTRADIOL; NORETHINDRONE
TABLET;ORAL-28
NORETHINDRONE AND ETHINYL ESTRADIOL
AB + FAMY CARE LTD 0.05MG;1MG A203006 001 Aug 05, 2013
AB WATSON LABS 0.035MG;0.4MG A078323 001 Feb 04, 2010
AB 0.035MG;0.5MG A070686 001 Jan 29, 1987
AB 0.035MG;1MG A070687 001 Jan 29, 1987
NORINYL 1+35 28-DAY
AB WATSON LABS 0.035MG;1MG N017565 002
NORTREL 0.5/35-28
AB BARR 0.035MG;0.5MG A072695 001 Feb 28, 1992
NORTREL 1/35-28
AB BARR 0.035MG;1MG A072696 001 Feb 28, 1992
NORTREL 7/7/7
AB BARR 0.035MG;0.035MG;0.035MG;0.5MG;0.75MG;1M A075478 002 Aug 30, 2002
G
ORTHO-NOVUM 1/35-28
AB + JANSSEN PHARMS 0.035MG;1MG N017919 002
ORTHO-NOVUM 7/7/7-28
AB + JANSSEN PHARMS 0.035MG;0.035MG;0.035MG;0.5MG;0.75MG;1M N018985 002 Apr 04, 1984
G
OVCON-35
AB + WARNER CHILCOTT LLC 0.035MG;0.4MG N017716 001
PHILITH
AB NOVAST LABS LTD 0.035MG;0.4MG A090947 001 Dec 22, 2011
PIRMELLA 1/35
AB LUPIN LTD 0.035MG;1MG A201512 001 Apr 24, 2013
PIRMELLA 7/7/7
AB LUPIN LTD 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M A201510 001 Apr 24, 2013
G
TRI-NORINYL 28-DAY
AB + WATSON LABS 0.035MG;0.035MG;0.035MG;0.5MG;0.5MG;1MG N018977 002 Apr 13, 1984
VYFEMLA
AB LUPIN LTD 0.035MG;0.4MG A201886 001 Sep 26, 2013
WERA
AB NOVAST LABS LTD 0.035MG;0.5MG A091204 001 Mar 27, 2012
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)
WATSON LABS 0.035MG;0.035MG;0.5MG;1MG A071044 001 Apr 01, 1988
TABLET, CHEWABLE;ORAL
FEMCON FE
AB + WARNER CHILCOTT LLC 0.035MG;0.4MG N021490 001 Nov 14, 2003
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
AB AMNEAL PHARMS 0.035MG;0.4MG A078892 001 Sep 26, 2011
AB BARR 0.035MG;0.4MG A078965 001 Aug 05, 2010
AB FAMY CARE LTD 0.025MG;0.8MG A203371 001 Apr 23, 2014
AB + WARNER CHILCOTT 0.025MG;0.8MG N022573 001 Dec 22, 2010
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
TABLET;ORAL
GILDESS 24 FE
AB VINTAGE PHARMS 0.02MG;1MG A090293 001 Dec 01, 2014
LOESTRIN 24 FE
AB + WARNER CHILCOTT 0.02MG;1MG N021871 001 Feb 17, 2006
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
AB AMNEAL PHARMS 0.02MG;1MG A078267 001 Sep 01, 2009
AB BARR LABS INC 0.02MG;1MG A090938 001 Dec 01, 2014
AB FAMY CARE LTD 0.02MG;1MG A202742 001 Oct 30, 2014
FEMHRT
WARNER CHILCOTT LLC 0.0025MG;0.5MG N021065 001 Jan 14, 2005
LO LOESTRIN FE
+ WARNER CHILCOTT LLC 0.01MG,0.01MG;1MG,N/A N022501 001 Oct 21, 2010
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
+ BARR LABS INC 0.005MG;1MG A076221 001 Nov 06, 2009
TABLET;ORAL-21
GILDESS 1.5/30
AB VINTAGE PHARMS LLC 0.03MG;1.5MG A077075 002 Jul 24, 2012
GILDESS 1/20
AB VINTAGE PHARMS LLC 0.02MG;1MG A077077 002 Jul 24, 2012
JUNEL 1.5/30
AB BARR 0.03MG;1.5MG A076381 001 May 30, 2003
JUNEL 1/20
AB BARR 0.02MG;1MG A076380 001 May 30, 2003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-143(of 371)
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
TABLET;ORAL-21
LARIN 1.5/30
AB NOVAST LABS LTD 0.03MG;1.5MG A202996 001 Mar 20, 2014
LARIN 1/20
AB NOVAST LABS LTD 0.02MG;1MG A202995 001 Dec 04, 2013
LOESTRIN 21 1.5/30
AB WARNER CHILCOTT LLC 0.03MG;1.5MG N017875 001
LOESTRIN 21 1/20
AB WARNER CHILCOTT LLC 0.02MG;1MG N017876 001
MICROGESTIN 1.5/30
AB WATSON LABS 0.03MG;1.5MG A075548 002 Jul 30, 2003
MICROGESTIN 1/20
AB WATSON LABS 0.02MG;1MG A075647 002 Jul 30, 2003
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
AB FAMY CARE LTD 0.02MG;1MG A202771 001 Nov 06, 2013
TRI-LEGEST 21
BARR 0.02MG;0.035MG;0.03MG;1MG;1MG;1MG A076405 001 Oct 26, 2007
TABLET;ORAL-28
ESTROSTEP FE
AB + WARNER CHILCOTT LLC 0.02MG;0.035MG;0.03MG;1MG;1MG;1MG N020130 002 Oct 09, 1996
GILDESS FE 1.5/30
AB VINTAGE PHARMS LLC 0.03MG;1.5MG A077075 001 Apr 28, 2005
GILDESS FE 1/20
AB VINTAGE PHARMS LLC 0.02MG;1MG A077077 001 May 20, 2005
JUNEL FE 1.5/30
AB BARR 0.03MG;1.5MG A076064 001 Sep 18, 2003
JUNEL FE 1/20
AB BARR 0.02MG;1MG A076081 001 Sep 18, 2003
LARIN FE 1.5/30
AB NOVAST LABS LTD 0.03MG;1.5MG A091453 001 Aug 23, 2013
LARIN FE 1/20
AB NOVAST LABS LTD 0.02MG;1MG A091454 001 Aug 26, 2013
LOESTRIN FE 1.5/30
AB + WARNER CHILCOTT LLC 0.03MG;1.5MG N017355 001
LOESTRIN FE 1/20
AB WARNER CHILCOTT 0.02MG;1MG N017354 001
MICROGESTIN FE 1.5/30
AB WATSON LABS 0.03MG;1.5MG A075548 001 Feb 05, 2001
MICROGESTIN FE 1/20
AB WATSON LABS 0.02MG;1MG A075647 001 Feb 05, 2001
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL
AB FAMY CARE LTD 0.02MG;1MG A202772 001 Nov 14, 2013
AB WATSON LABS 0.02MG,0.03MG,0.035MG;1MG,1MG,1MG A076629 001 Mar 18, 2010
TRI-LEGEST FE
AB BARR 0.02MG;0.035MG;0.03MG;1MG;1MG;1MG A076105 001 Oct 26, 2007
TABLET, CHEWABLE;ORAL
MINASTRIN 24 FE
+ WARNER CHILCOTT LLC 0.02MG;1MG N203667 001 May 08, 2013
TABLET, CHEWABLE, TABLET;ORAL
LO MINASTRIN FE
+ WARNER CHILCOTT 0.01MG,0.01MG,N/A;1MG,N/A,N/A N204654 001 Jul 24, 2013
ETHINYL ESTRADIOL; NORGESTIMATE
TABLET;ORAL
NORGESTIMATE AND ETHINYL ESTRADIOL
AB GLENMARK GENERICS 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG, A200494 001 Jun 17, 2011
0.25MG
TABLET;ORAL-28
ESTARYLLA
AB SANDOZ 0.035MG;0.25MG A090794 001 Jan 30, 2013
MONO-LINYAH
AB NOVAST LABS LTD 0.035MG;0.25MG A090523 001 May 23, 2012
NORGESTIMATE AND ETHINYL ESTRADIOL
AB GLENMARK GENERICS 0.035MG;0.25MG A200538 001 Apr 05, 2012
AB LUPIN PHARMS 0.025MG,0.025MG,0.025MG;0.18MG,0.215MG, A200541 001 Jun 25, 2012
0.25MG
ORTHO CYCLEN-28
AB + JANSSEN PHARMS 0.035MG;0.25MG N019653 002 Dec 29, 1989
ORTHO TRI-CYCLEN
AB + JANSSEN PHARMS 0.035MG;0.035MG;0.035MG;0.18MG;0.215MG; N019697 001 Jul 03, 1992
0.25MG
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-144(of 371)
ETHINYL ESTRADIOL; NORGESTIMATE
TABLET;ORAL-28
ORTHO TRI-CYCLEN LO
AB + JANSSEN PHARMS 0.025MG;0.025MG;0.025MG;0.18MG;0.215MG;
N021241 001 Aug 22, 2002
0.25MG
PREVIFEM
AB VINTAGE PHARMS LLC 0.035MG;0.25MG
A076334 001 Jan 09, 2004
SPRINTEC
AB BARR 0.035MG;0.25MG
A075804 001 Sep 25, 2002
TRI-ESTARYLLA
AB SANDOZ 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,
A090793 001 Jan 30, 2013
0.25MG
TRI-LINYAH
AB NOVAST LABS LTD 0.035MG,0.035MG,0.035MG;0.18MG,0.215MG,
A090524 001 May 30, 2012
0.25MG
TRI-PREVIFEM
AB VINTAGE PHARMS LLC 0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;
A076335 001 Mar 26, 2004
0.25MG
TRI-SPRINTEC
AB BARR 0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;
A075808 001 Dec 29, 2003
0.25MG
ETHINYL ESTRADIOL; NORGESTREL
TABLET;ORAL-21
CRYSELLE
AB DURAMED PHARMS BARR
0.03MG;0.3MG
A075840 001 Nov 30, 2001
TABLET;ORAL-28
CRYSELLE
AB DURAMED PHARMS BARR
0.03MG;0.3MG
A075840 002 Nov 30, 2001
ELINEST
AB NOVAST LABS LTD
0.03MG;0.3MG
A091105 001 Mar 28, 2012
LO/OVRAL-28
AB WYETH PHARMS
0.03MG;0.3MG
N017802 001
OGESTREL 0.5/50-28
+ WATSON LABS
0.05MG;0.5MG
A075406 002 Dec 15, 1999
ETHIODIZED OIL
OIL;INTRALYMPHATIC, INTRAUTERINE
LIPIODOL
+ GUERBET
99%
N009190 001
ETHIONAMIDE
TABLET;ORAL
TRECATOR
+ WYETH PHARMS INC
250MG
N013026 002
ETHOSUXIMIDE
CAPSULE;ORAL
ETHOSUXIMIDE
AB BANNER PHARMACAPS 250MG
A040430 001 Oct 28, 2002
AB VERSAPHARM 250MG
A040686 001 May 28, 2008
AB ZYDUS PHARMS USA INC 250MG
A200892 001 Sep 25, 2012
ZARONTIN
AB + PARKE DAVIS 250MG
N012380 001
SYRUP;ORAL
ETHOSUXIMIDE
AA MIKART
250MG/5ML
A040506 001 Dec 22, 2003
AA PHARM ASSOC
250MG/5ML
A040253 001 Nov 22, 2000
AA TEVA PHARMS
250MG/5ML
A081306 001 Jul 30, 1993
ZARONTIN
AA + PARKE DAVIS
250MG/5ML
A080258 001
ETHOTOIN
TABLET;ORAL
PEGANONE
+ RECORDATI RARE
250MG
N010841 001
ETIDRONATE DISODIUM
TABLET;ORAL
DIDRONEL
AB PROCTER AND GAMBLE
200MG
N017831 001
AB +
400MG
N017831 002
ETIDRONATE DISODIUM
AB MYLAN
200MG
A075800 001 Jan 24, 2003
AB
400MG
A075800 002 Jan 24, 2003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-145(of 371)
ETODOLAC
CAPSULE;ORAL
ETODOLAC
AB ANI PHARMS INC 200MG A075126 001 Sep 16, 1999
AB 300MG A075126 002 Sep 16, 1999
AB APOTEX 200MG A075419 001 Jul 28, 2000
AB 300MG A075419 002 Jul 28, 2000
AB TARO 200MG A075078 001 Apr 30, 1998
AB + 300MG A075078 002 Apr 30, 1998
TABLET;ORAL
ETODOLAC
AB APOTEX INC 400MG A076004 001 Dec 03, 2002
AB 500MG A076004 002 Dec 03, 2002
AB MYLAN 400MG A075104 001 Feb 06, 1998
AB 500MG A075104 002 Nov 20, 1998
AB SANDOZ 400MG A074903 001 Apr 11, 1997
AB 500MG A074903 002 Apr 19, 1999
AB TARO PHARM INDS 400MG A075074 001 Mar 11, 1998
AB + 500MG A075074 002 Apr 25, 2000
AB TEVA 400MG A075009 001 Nov 26, 1997
AB 500MG A075009 002 Dec 28, 1999
TABLET, EXTENDED RELEASE;ORAL
ETODOLAC
AB TARO 400MG A076174 001 Mar 13, 2003
AB 500MG A076174 002 Mar 13, 2003
AB 600MG A076174 003 Mar 13, 2003
AB TEVA 400MG A075665 003 Feb 05, 2001
AB 500MG A075665 002 Jul 31, 2000
AB + 600MG A075665 001 Jul 31, 2000
AB ZYDUS PHARMS USA INC 400MG A091134 001 Jan 23, 2014
AB 500MG A091134 002 Jan 23, 2014
AB 600MG A091134 003 Jan 23, 2014
ETOMIDATE
INJECTABLE;INJECTION
AMIDATE
AP + HOSPIRA 2MG/ML N018227 001 Sep 07, 1982
ETOMIDATE
AP AGILA SPECLTS 2MG/ML A078289 001 Jan 02, 2009
AP BEDFORD 2MG/ML A074593 001 Nov 04, 1996
AP EMCURE PHARMS LTD 2MG/ML A204618 001 Aug 13, 2014
AP LUITPOLD 2MG/ML A078867 001 Dec 22, 2009
AP PAR STERILE PRODUCTS 2MG/ML A091297 001 Jun 20, 2012
AP ZYDUS PHARMS USA INC 2MG/ML A202360 001 Jul 18, 2014
ETONOGESTREL
IMPLANT;IMPLANTATION
IMPLANON
+ ORGANON USA INC 68MG/IMPLANT N021529 001 Jul 17, 2006
NEXPLANON
+ ORGANON USA INC 68MG/IMPLANT N021529 002 May 31, 2011
ETOPOSIDE
CAPSULE;ORAL
ETOPOSIDE
+ MYLAN 50MG A075635 001 Sep 19, 2001
INJECTABLE;INJECTION
ETOPOSIDE
AP ACCORD HLTHCARE 20MG/ML A074513 001 Mar 14, 1996
AP EUROHLTH INTL 20MG/ML A074290 001 Jul 17, 1995
AP + FRESENIUS KABI USA 20MG/ML A074983 001 Sep 30, 1998
AP TEVA PHARMS USA 20MG/ML A074529 001 Jul 24, 1996
ETOPOSIDE PHOSPHATE
INJECTABLE;INJECTION
ETOPOPHOS PRESERVATIVE FREE
+ BRISTOL MYERS SQUIBB EQ 100MG BASE/VIAL N020457 001 May 17, 1996
ETRAVIRINE
TABLET;ORAL
INTELENCE
JANSSEN R AND D 25MG N022187 003 Mar 26, 2012
100MG N022187 001 Jan 18, 2008
+ 200MG N022187 002 Dec 22, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-146(of 371)
EVEROLIMUS
TABLET;ORAL
AFINITOR
NOVARTIS 2.5MG N022334 003 Jul 09, 2010
5MG N022334 001 Mar 30, 2009
7.5MG N022334 004 Mar 30, 2012
+ 10MG N022334 002 Mar 30, 2009
ZORTRESS
NOVARTIS 0.25MG N021560 001 Apr 20, 2010
0.5MG N021560 002 Apr 20, 2010
+ 0.75MG N021560 003 Apr 20, 2010
TABLET, FOR SUSPENSION;ORAL
AFINITOR DISPERZ
NOVARTIS PHARM 2MG N203985 001 Aug 29, 2012
3MG N203985 002 Aug 29, 2012
+ 5MG N203985 003 Aug 29, 2012
EXEMESTANE
TABLET;ORAL
AROMASIN
AB + PHARMACIA AND UPJOHN 25MG N020753 001 Oct 21, 1999
EXEMESTANE
AB ALVOGEN INC 25MG A200898 001 Jul 28, 2014
AB ROXANE 25MG A077431 001 Apr 01, 2011
EXENATIDE SYNTHETIC
FOR SUSPENSION, EXTENDED RELEASE;SUBCUTANEOUS
BYDUREON
+ ASTRAZENECA AB 2MG/VIAL N022200 001 Jan 27, 2012
INJECTABLE;SUBCUTANEOUS
BYETTA
+ ASTRAZENECA AB 300MCG/1.2ML (250MCG/ML) N021773 001 Apr 28, 2005
+ 600MCG/2.4ML (250MCG/ML) N021773 002 Apr 28, 2005
EZETIMIBE
TABLET;ORAL
ZETIA
+ MSD INTL GMBH 10MG N021445 001 Oct 25, 2002
EZETIMIBE; SIMVASTATIN
TABLET;ORAL
VYTORIN
MSD INTL 10MG;10MG N021687 001 Jul 23, 2004
10MG;20MG N021687 002 Jul 23, 2004
10MG;40MG N021687 003 Jul 23, 2004
+ 10MG;80MG N021687 004 Jul 23, 2004
EZOGABINE
TABLET;ORAL
POTIGA
GLAXOSMITHKLINE 50MG N022345 001 Jun 10, 2011
200MG N022345 002 Jun 10, 2011
300MG N022345 003 Jun 10, 2011
+ 400MG N022345 004 Jun 10, 2011
FAMCICLOVIR
TABLET;ORAL
FAMCICLOVIR
AB APOTEX 125MG A091480 001 Jul 22, 2011
AB 250MG A091480 002 Jul 22, 2011
AB 500MG A091480 003 Jul 22, 2011
AB AUROBINDO PHARMA LTD 125MG A091114 001 Mar 21, 2011
AB 250MG A091114 002 Mar 21, 2011
AB 500MG A091114 003 Mar 21, 2011
AB CIPLA LTD 125MG A078278 001 Mar 21, 2011
AB 250MG A078278 002 Mar 21, 2011
AB 500MG A078278 003 Mar 21, 2011
AB HETERO LABS LTD V 125MG A202438 001 Sep 10, 2014
AB 250MG A202438 002 Sep 10, 2014
AB 500MG A202438 003 Sep 10, 2014
AB MACLEODS PHARMS LTD 125MG A201022 001 Jan 12, 2012
AB 250MG A201022 002 Jan 12, 2012
AB 500MG A201022 003 Jan 12, 2012
AB MYLAN 125MG A201333 001 Mar 24, 2011
AB 250MG A201333 002 Mar 24, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-147(of 371)
FAMCICLOVIR
TABLET;ORAL
FAMCICLOVIR
AB 500MG A201333 003 Mar 24, 2011
AB ROXANE 125MG A090128 001 Mar 21, 2011
AB 250MG A090128 002 Mar 21, 2011
AB 500MG A090128 003 Mar 21, 2011
AB TEVA PHARMS 125MG A077487 001 Aug 24, 2007
AB 250MG A077487 002 Aug 24, 2007
AB 500MG A077487 003 Aug 24, 2007
FAMVIR
AB NOVARTIS 125MG N020363 003 Dec 11, 1995
AB 250MG N020363 001 Apr 26, 1996
AB + 500MG N020363 002 Jun 29, 1994
FAMOTIDINE
FOR SUSPENSION;ORAL
FAMOTIDINE
AB HI-TECH PHARMA CO 40MG/5ML A201995 001 May 30, 2014
AB LUPIN LTD 40MG/5ML A090440 001 Jun 29, 2010
AB NAVINTA LLC 40MG/5ML A091020 001 May 27, 2010
PEPCID
AB + SALIX PHARMS 40MG/5ML N019527 001 Feb 02, 1987
INJECTABLE;INJECTION
FAMOTIDINE
AP AGILA SPECLTS 10MG/ML A078641 001 Jun 25, 2008
AP BEDFORD 10MG/ML A075651 001 Apr 16, 2001
AP 10MG/ML A075684 001 Apr 16, 2001
AP FRESENIUS KABI USA 10MG/ML A075709 001 Apr 16, 2001
AP + HIKMA MAPLE 10MG/ML A075488 001 Apr 16, 2001
FAMOTIDINE PRESERVATIVE FREE
AP AGILA SPECLTS 10MG/ML A078642 001 Jun 25, 2008
AP BEDFORD 10MG/ML A075622 001 Apr 16, 2001
AP BEDFORD LABS 10MG/ML A075825 001 Apr 17, 2001
AP FRESENIUS KABI USA 10MG/ML A075813 001 Apr 16, 2001
AP + HIKMA MAPLE 10MG/ML A075486 001 Apr 16, 2001
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 0.4MG/ML A075591 001 May 10, 2001
SUSPENSION;ORAL
FAMOTIDINE
AB NOVEL LABS INC 40MG/5ML A201695 001 Dec 17, 2012
TABLET;ORAL
FAMOTIDINE
AB ALEMBIC PHARMS LTD 20MG A078916 001 May 22, 2009
AB 40MG A078916 002 May 22, 2009
AB APOTEX 20MG A075611 001 Jul 23, 2001
AB 40MG A075611 002 Jul 23, 2001
AB CARLSBAD 20MG A075805 001 Apr 16, 2001
AB 40MG A075805 002 Apr 16, 2001
AB DR REDDYS LABS LTD 20MG A075718 001 Apr 16, 2001
AB 40MG A075718 002 Apr 16, 2001
AB IVAX SUB TEVA PHARMS 20MG A075511 001 Apr 16, 2001
AB 40MG A075511 002 Apr 16, 2001
AB MYLAN 20MG A075704 001 Apr 16, 2001
AB 40MG A075704 002 Apr 16, 2001
AB PERRIGO 20MG A077352 002 Jul 27, 2005
AB 40MG A077352 001 Jul 27, 2005
AB TEVA 20MG A075311 001 Apr 16, 2001
AB 40MG A075311 002 Apr 16, 2001
AB WOCKHARDT 20MG A075786 001 Apr 16, 2001
AB 40MG A075786 002 Apr 16, 2001
PEPCID
AB MARATHON PHARMS 20MG N019462 001 Oct 15, 1986
AB + 40MG N019462 002 Oct 15, 1986
FAMOTIDINE; IBUPROFEN
TABLET;ORAL
DUEXIS
+ HORIZON PHARMA 26.6MG;800MG N022519 001 Apr 23, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-148(of 371)
FEBUXOSTAT
TABLET;ORAL
ULORIC
TAKEDA PHARMS USA 40MG N021856 001 Feb 13, 2009
+ 80MG N021856 002 Feb 13, 2009
FELBAMATE
SUSPENSION;ORAL
FELBAMATE
AB AMNEAL PHARMS 600MG/5ML A202385 001 Dec 16, 2011
FELBATOL
AB + MEDA PHARMS 600MG/5ML N020189 003 Jul 29, 1993
TABLET;ORAL
FELBAMATE
AB AMNEAL PHARMS 400MG A201680 001 Sep 13, 2011
AB 600MG A201680 002 Sep 13, 2011
FELBATOL
AB MEDA PHARMS 400MG N020189 001 Jul 29, 1993
AB + 600MG N020189 002 Jul 29, 1993
FELODIPINE
TABLET, EXTENDED RELEASE;ORAL
FELODIPINE
AB AUROBINDO PHARMA LTD 2.5MG A203417 001 Jan 17, 2013
AB 5MG A203417 002 Jan 17, 2013
AB 10MG A203417 003 Jan 17, 2013
AB GLENMARK GENERICS 2.5MG A090365 001 Dec 17, 2010
AB 5MG A090365 002 Dec 17, 2010
AB 10MG A090365 003 Dec 17, 2010
AB HERITAGE PHARMS INC 2.5MG A201964 001 Nov 08, 2013
AB 5MG A201964 002 Nov 08, 2013
AB 10MG A201964 003 Nov 08, 2013
AB MUTUAL PHARM 2.5MG A075896 001 Nov 02, 2004
AB 5MG A075896 002 Nov 02, 2004
AB 10MG A075896 003 Nov 02, 2004
AB MYLAN 2.5MG A078855 001 Apr 17, 2008
AB 5MG A078855 002 Apr 17, 2008
AB + 10MG A078855 003 Apr 17, 2008
AB RANBAXY LABS LTD 2.5MG A091200 001 Dec 13, 2013
AB 5MG A091200 002 Dec 13, 2013
AB 10MG A091200 003 Dec 13, 2013
AB TORRENT PHARMS LTD 2.5MG A202170 001 Nov 28, 2011
AB 5MG A202170 002 Nov 28, 2011
AB 10MG A202170 003 Nov 28, 2011
AB VINTAGE PHARMS LLC 2.5MG A200815 001 Oct 28, 2011
AB 5MG A200815 002 Oct 28, 2011
AB 10MG A200815 003 Oct 28, 2011
PLENDIL
AB ASTRAZENECA 2.5MG N019834 004 Sep 22, 1994
AB 5MG N019834 001 Jul 25, 1991
AB 10MG N019834 002 Jul 25, 1991
FENOFIBRATE
CAPSULE;ORAL
ANTARA (MICRONIZED)
AB LUPIN ATLANTIS 43MG N021695 001 Nov 30, 2004
AB + 130MG N021695 003 Nov 30, 2004
FENOFIBRATE
AB RANBAXY LABS LTD 43MG A201748 001 Oct 31, 2014
AB 130MG A201748 002 Oct 31, 2014
FENOFIBRATE (MICRONIZED)
AB APOTEX INC 43MG A202252 001 Jul 26, 2013
AB 130MG A202252 002 Jul 26, 2013
AB DR REDDYS LABS SA 43MG A090859 001 Mar 01, 2012
AB 130MG A090859 002 Mar 01, 2012
AB IMPAX LABS 67MG A075868 001 Oct 27, 2003
AB 134MG A075868 002 Oct 27, 2003
AB 200MG A075868 003 Oct 27, 2003
AB MYLAN PHARMS INC 43MG A202579 001 Jan 10, 2013
AB 67MG A202676 001 Oct 23, 2012
AB 130MG A202579 002 Jan 10, 2013
AB 134MG A202676 002 Oct 23, 2012
AB 200MG A202676 003 Oct 23, 2012
AB TEVA 67MG A075753 001 Sep 03, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-149(of 371)
FENOFIBRATE
CAPSULE;ORAL
FENOFIBRATE (MICRONIZED)
AB 134MG A075753 002 Apr 09, 2002
AB + 200MG A075753 003 Apr 09, 2002
ANTARA (MICRONIZED)
LUPIN ATLANTIS 30MG N021695 004 Oct 18, 2013
90MG N021695 005 Oct 18, 2013
LIPOFEN
CIPHER PHARMS INC 50MG N021612 001 Jan 11, 2006
+ 150MG N021612 003 Jan 11, 2006
TABLET;ORAL
FENOFIBRATE
AB IMPAX LABS 54MG A076509 001 Mar 26, 2008
AB 160MG A076509 002 Mar 26, 2008
AB LUPIN LTD 48MG A090856 001 Dec 23, 2011
AB 145MG A090856 002 Dec 23, 2011
AB MYLAN 54MG A076520 001 Oct 25, 2007
AB 160MG A076520 003 Oct 25, 2007
AB MYLAN PHARMS INC 48MG A202856 001 Dec 07, 2012
AB 145MG A202856 002 Dec 07, 2012
AB RANBAXY 54MG A076635 001 Oct 31, 2005
AB 160MG A076635 003 Oct 31, 2005
AB TEVA 54MG A076433 001 May 13, 2005
AB + 160MG A076433 002 May 13, 2005
AB VALEANT INTL 48MG A090715 001 Apr 05, 2012
AB 145MG A090715 002 Apr 05, 2012
TRICOR
AB ABBVIE 48MG N021656 001 Nov 05, 2004
AB + 145MG N021656 002 Nov 05, 2004
TRIGLIDE
BX + SKYEPHARMA AG 160MG N021350 002 May 07, 2005
FENOFIBRATE
RANBAXY 107MG A076635 002 Oct 31, 2005
FENOGLIDE
SANTARUS INC 40MG N022118 001 Aug 10, 2007
+ 120MG N022118 002 Aug 10, 2007
FENOFIBRIC ACID
TABLET;ORAL
FIBRICOR
MUTUAL PHARM CO INC 35MG N022418 001 Aug 14, 2009
+ 105MG N022418 002 Aug 14, 2009
FENOLDOPAM MESYLATE
INJECTABLE;INJECTION
CORLOPAM
AP + HOSPIRA EQ 10MG BASE/ML N019922 001 Sep 23, 1997
FENOLDOPAM MESYLATE
AP EUROHLTH INTL EQ 10MG BASE/ML A076582 001 Oct 12, 2004
AP SANDOZ EQ 10MG BASE/ML A077155 001 Feb 15, 2005
FENOPROFEN CALCIUM
CAPSULE;ORAL
NALFON
+ XSPIRE EQ 200MG BASE N017604 003
EQ 400MG BASE N017604 004 Jul 21, 2009
TABLET;ORAL
FENOPROFEN CALCIUM
+ MYLAN PHARMS INC EQ 600MG BASE A072267 001 Aug 17, 1988
FENTANYL
FILM, EXTENDED RELEASE;TRANSDERMAL
DURAGESIC-100
AB JANSSEN PHARMS 100MCG/HR N019813 001 Aug 07, 1990
DURAGESIC-12
AB JANSSEN PHARMS 12.5MCG/HR N019813 005 Feb 04, 2005
DURAGESIC-25
AB + JANSSEN PHARMS 25MCG/HR N019813 004 Aug 07, 1990
DURAGESIC-50
AB JANSSEN PHARMS 50MCG/HR N019813 003 Aug 07, 1990
DURAGESIC-75
AB JANSSEN PHARMS 75MCG/HR N019813 002 Aug 07, 1990
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-150(of 371)
FENTANYL
FILM, EXTENDED RELEASE;TRANSDERMAL
FENTANYL-100
AB AVEVA 100MCG/HR
A077449 004 Oct 20, 2008
AB LAVIPHARM LABS 100MCG/HR
A077051 004 Aug 04, 2006
AB MALLINCKRODT INC 100MCG/HR
A077154 004 Feb 09, 2011
AB MYLAN TECHNOLOGIES 100MCG/HR
A076258 004 Jan 28, 2005
AB PAR PHARM INC 100MCG/HR
A077062 004 Aug 20, 2007
AB WATSON LABS 100MCG/HR
A076709 004 Aug 20, 2007
FENTANYL-12
AB MYLAN TECHNOLOGIES 12.5MCG/HR
A076258 005 Jan 23, 2007
FENTANYL-25
AB AVEVA 25MCG/HR
A077449 001 Oct 20, 2008
AB LAVIPHARM LABS 25MCG/HR
A077051 001 Aug 04, 2006
AB MALLINCKRODT INC 25MCG/HR
A077154 001 Feb 09, 2011
AB MYLAN TECHNOLOGIES 25MCG/HR
A076258 001 Jan 28, 2005
AB PAR PHARM INC 25MCG/HR
A077062 001 Aug 20, 2007
AB WATSON LABS 25MCG/HR
A076709 001 Aug 20, 2007
FENTANYL-50
AB AVEVA 50MCG/HR
A077449 002 Oct 20, 2008
AB LAVIPHARM LABS 50MCG/HR
A077051 002 Aug 04, 2006
AB MALLINCKRODT INC 50MCG/HR
A077154 002 Feb 09, 2011
AB MYLAN TECHNOLOGIES 50MCG/HR
A076258 002 Jan 28, 2005
AB PAR PHARM INC 50MCG/HR
A077062 002 Aug 20, 2007
AB WATSON LABS 50MCG/HR
A076709 002 Aug 20, 2007
FENTANYL-75
AB AVEVA 75MCG/HR
A077449 003 Oct 20, 2008
AB LAVIPHARM LABS 75MCG/HR
A077051 003 Aug 04, 2006
AB MALLINCKRODT INC 75MCG/HR
A077154 003 Feb 09, 2011
AB MYLAN TECHNOLOGIES 75MCG/HR
A076258 003 Jan 28, 2005
AB PAR PHARM INC 75MCG/HR
A077062 003 Aug 20, 2007
AB WATSON LABS 75MCG/HR
A076709 003 Aug 20, 2007
FENTANYL-37
MYLAN TECHNOLOGIES 37.5MCG/HR
A076258 006 Dec 29, 2014
FENTANYL-62
MYLAN TECHNOLOGIES 62.5MCG/HR
A076258 007 Dec 29, 2014
FENTANYL-87
MYLAN TECHNOLOGIES 87.5MCG/HR
A076258 008 Dec 29, 2014
SPRAY;SUBLINGUAL
SUBSYS
INSYS THERAP
0.1MG
N202788 001 Jan 04, 2012
0.2MG
N202788 002 Jan 04, 2012
+
0.4MG
N202788 003 Jan 04, 2012
0.6MG
N202788 004 Jan 04, 2012
0.8MG
N202788 005 Jan 04, 2012
1.2MG
N202788 006 Aug 30, 2012
1.6MG
N202788 007 Aug 30, 2012
FENTANYL CITRATE
INJECTABLE;INJECTION
FENTANYL CITRATE
AP HOSPIRA
EQ 0.05MG BASE/ML
N019115 001 Jan 12, 1985
FENTANYL CITRATE PRESERVATIVE FREE
AP + HIKMA MAPLE
EQ 0.05MG BASE/ML
N019101 001 Jul 11, 1984
AP HOSPIRA
EQ 0.05MG BASE/ML
A072786 001 Sep 24, 1991
SUBLIMAZE PRESERVATIVE FREE
AP + AKORN
EQ 0.05MG BASE/ML
N016619 001
SPRAY, METERED;NASAL
LAZANDA
DEPOMED INC
EQ 0.1MG BASE
N022569 001 Jun 30, 2011
+
EQ 0.4MG BASE
N022569 002 Jun 30, 2011
TABLET;BUCCAL, SUBLINGUAL
FENTORA
CEPHALON
EQ 0.1MG BASE
N021947 001 Sep 25, 2006
EQ 0.2MG BASE
N021947 002 Sep 25, 2006
+
EQ 0.4MG BASE
N021947 003 Sep 25, 2006
EQ 0.6MG BASE
N021947 004 Sep 25, 2006
EQ 0.8MG BASE
N021947 005 Sep 25, 2006
TABLET;SUBLINGUAL
ABSTRAL
GALENA BIOPHARMA
EQ 0.1MG BASE
N022510 001 Jan 07, 2011
EQ 0.2MG BASE
N022510 002 Jan 07, 2011
EQ 0.3MG BASE
N022510 003 Jan 07, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-151(of 371)
FENTANYL CITRATE
TABLET;SUBLINGUAL
ABSTRAL
+
EQ 0.4MG BASE
N022510 004 Jan 07, 2011
EQ 0.6MG BASE
N022510 005 Jan 07, 2011
EQ 0.8MG BASE
N022510 006 Jan 07, 2011
TROCHE/LOZENGE;TRANSMUCOSAL
ACTIQ
AB CEPHALON
EQ 0.2MG BASE
N020747 001 Nov 04, 1998
AB +
EQ 0.4MG BASE
N020747 002 Nov 04, 1998
AB
EQ 0.6MG BASE
N020747 003 Nov 04, 1998
AB
EQ 0.8MG BASE
N020747 004 Nov 04, 1998
AB
EQ 1.2MG BASE
N020747 005 Nov 04, 1998
AB
EQ 1.6MG BASE
N020747 006 Nov 04, 1998
FENTANYL CITRATE
AB MALLINCKRODT
EQ 0.2MG BASE
A078907 001 Oct 30, 2009
AB
EQ 0.4MG BASE
A078907 002 Oct 30, 2009
AB
EQ 0.6MG BASE
A078907 003 Oct 30, 2009
AB
EQ 0.8MG BASE
A078907 004 Oct 30, 2009
AB
EQ 1.2MG BASE
A078907 005 Oct 30, 2009
AB
EQ 1.6MG BASE
A078907 006 Oct 30, 2009
AB PAR PHARM
EQ 0.2MG BASE
A077312 001 Oct 30, 2009
AB
EQ 0.4MG BASE
A077312 002 Oct 30, 2009
AB
EQ 0.6MG BASE
A077312 003 Oct 30, 2009
AB
EQ 0.8MG BASE
A077312 004 Oct 30, 2009
AB
EQ 1.2MG BASE
A077312 005 Oct 30, 2009
AB
EQ 1.6MG BASE
A077312 006 Oct 30, 2009
FERRIC CARBOXYMALTOSE
INJECTABLE;INTRAVENOUS
INJECTAFER
+ LUITPOLD
750MG IRON/15ML (50MG IRON/ML)
N203565 001 Jul 25, 2013
FERRIC CITRATE
TABLET;ORAL
FERRIC CITRATE
+ KERYX BIOPHARMS
EQ 210MG IRON
N205874 001 Sep 05, 2014
FERRIC HEXACYANOFERRATE(II)
CAPSULE;ORAL
RADIOGARDASE (PRUSSIAN BLUE)
+ HEYL CHEMISCH
500MG
N021626 001 Oct 02, 2003
FERUMOXYTOL
SOLUTION;INTRAVENOUS
FERAHEME
+ AMAG PHARMS INC
EQ 510MG IRON/17ML (EQ 30MG IRON/ML)
N022180 001 Jun 30, 2009
FESOTERODINE FUMARATE
TABLET, EXTENDED RELEASE;ORAL
TOVIAZ
PFIZER
4MG
N022030 001 Oct 31, 2008
+
8MG
N022030 002 Oct 31, 2008
FEXOFENADINE HYDROCHLORIDE
SUSPENSION;ORAL
ALLEGRA
AB + SANOFI AVENTIS US 30MG/5ML
N021963 001 Oct 16, 2006
FEXOFENADINE HYDROCHLORIDE
AB ACTAVIS MID ATLANTIC 30MG/5ML
A201311 001 Jul 25, 2012
TABLET;ORAL
FEXOFENADINE HYDROCHLORIDE
AB BARR
30MG
A076191 001 Aug 31, 2005
AB
60MG
A076191 002 Aug 31, 2005
AB
180MG
A076191 003 Aug 31, 2005
AB DR REDDYS LABS LTD
30MG
A076502 001 Apr 11, 2006
AB
60MG
A076502 002 Apr 11, 2006
AB
180MG
A076502 003 Apr 11, 2006
AB MYLAN
30MG
A077081 002 Apr 11, 2008
AB
60MG
A077081 003 Apr 11, 2008
AB
180MG
A077081 001 Apr 16, 2007
AB TEVA
30MG
A076447 001 Sep 01, 2005
AB
60MG
A076447 002 Sep 01, 2005
AB
180MG
A076447 003 Sep 01, 2005
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-152(of 371)
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
AB BARR
60MG;120MG
A076236 001 Apr 14, 2005
AB IMPAX PHARMS
60MG;120MG
A076298 001 Nov 12, 2010
FIDAXOMICIN
TABLET;ORAL
DIFICID
+ CUBIST PHARMS
200MG
N201699 001 May 27, 2011
FINAFLOXACIN
SUSPENSION/DROPS;OTIC
XTORO
+ ALCON RES LTD
0.3%
N206307 001 Dec 17, 2014
FINASTERIDE
TABLET;ORAL
FINASTERIDE
AB ACCORD HLTHCARE
5MG
A090121 001 Feb 23, 2010
AB ACCORD HLTHCARE INC
1MG
A091643 001 Nov 05, 2013
AB ACTAVIS TOTOWA
1MG
A078371 001 Nov 05, 2013
AB
5MG
A077914 001 Mar 28, 2007
AB AUROBINDO PHARMA
5MG
A078341 001 Oct 30, 2007
AB AUROBINDO PHARMA LTD
1MG
A203687 001 Nov 05, 2013
AB CIPLA LTD
1MG
A077335 001 Nov 20, 2014
AB DR REDDYS LABS INC
1MG
A076436 001 Jul 28, 2006
AB DR REDDYS LABS LTD
5MG
A076437 001 Feb 28, 2007
AB GEDEON RICHTER USA
5MG
A077251 001 Dec 22, 2006
AB HETERO LABS LTD III
1MG
A090060 001 Jul 01, 2013
AB
5MG
A090061 001 Jun 07, 2010
AB MYLAN
5MG
A077578 001 Dec 18, 2006
AB MYLAN PHARMS INC
1MG
A078161 001 Nov 05, 2013
AB SUN PHARMA GLOBAL
1MG
A090508 001 Jul 01, 2013
AB
5MG
A090507 001 Aug 16, 2011
AB TEVA
1MG
A076905 001 Nov 05, 2013
AB
5MG
A076511 001 Dec 15, 2006
AB ZYDUS PHARMS USA INC
5MG
A078900 001 Dec 28, 2009
PROPECIA
AB + MERCK
1MG
N020788 001 Dec 19, 1997
PROSCAR
AB + MERCK
5MG
N020180 001 Jun 19, 1992
FINGOLIMOD
CAPSULE;ORAL
GILENYA
+ NOVARTIS
0.5MG
N022527 001 Sep 21, 2010
FLAVOXATE HYDROCHLORIDE
TABLET;ORAL
FLAVOXATE HYDROCHLORIDE
AB EPIC PHARMA 100MG
A076835 001 Nov 30, 2005
AB IMPAX PHARMS 100MG
A076234 001 Aug 28, 2003
AB + PADDOCK LLC 100MG
A076831 001 Dec 16, 2004
FLECAINIDE ACETATE
TABLET;ORAL
FLECAINIDE ACETATE
AB AMNEAL PHARM
50MG
A075442 001 Jul 31, 2001
AB
100MG
A075442 002 Jul 31, 2001
AB
150MG
A075442 003 Jul 31, 2001
AB BARR
50MG
A075882 001 Oct 28, 2002
AB
100MG
A075882 002 Oct 28, 2002
AB
150MG
A075882 003 Oct 28, 2002
AB RANBAXY
50MG
A076421 001 Mar 28, 2003
AB
100MG
A076421 002 Mar 28, 2003
AB
150MG
A076421 003 Mar 28, 2003
AB ROXANE
50MG
A076278 001 Jan 14, 2003
AB
100MG
A076278 002 Jan 14, 2003
AB +
150MG
A076278 003 Jan 14, 2003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-153(of 371)
FLORBETABEN F-18
SOLUTION;INTRAVENOUS
NEURACEQ
+ PIRAMAL IMAGING 30ML (1.4-135mCi/ML) N204677 001 Mar 19, 2014
FLORBETAPIR F-18
SOLUTION;INTRAVENOUS
AMYVID
+ AVID RADIOPHARMS INC 10ML (13.5-51mCi/ML) N202008 001 Apr 06, 2012
+ 10-30ML (13.5-51mCi/ML) N202008 002 Apr 06, 2012
+ 10-50ML (13.5-51mCi/ML) N202008 003 Apr 06, 2012
FLOXURIDINE
INJECTABLE;INJECTION
FLOXURIDINE
AP + EUROHLTH INTL 500MG/VIAL A075387 001 Apr 16, 2000
AP FRESENIUS KABI USA 500MG/VIAL A075837 001 Feb 22, 2001
FLUCONAZOLE
FOR SUSPENSION;ORAL
DIFLUCAN
AB PFIZER 50MG/5ML N020090 001 Dec 23, 1993
AB + 200MG/5ML N020090 002 Dec 23, 1993
FLUCONAZOLE
AB AUROBINDO PHARM 50MG/5ML A079150 001 Sep 18, 2009
AB 200MG/5ML A079150 002 Sep 18, 2009
AB IVAX SUB TEVA PHARMS 50MG/5ML A077523 001 Sep 12, 2007
AB 200MG/5ML A077523 002 Sep 12, 2007
AB RANBAXY 50MG/5ML A076332 001 Jul 29, 2004
AB 200MG/5ML A076332 002 Jul 29, 2004
AB ROXANE 50MG/5ML A076246 001 Jul 29, 2004
AB 200MG/5ML A076246 002 Jul 29, 2004
INJECTABLE;INJECTION
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + PFIZER 200MG/100ML (2MG/ML) N019950 003 Sep 29, 1992
AP + 400MG/200ML (2MG/ML) N019950 005 Jul 08, 1994
DIFLUCAN IN SODIUM CHLORIDE 0.9%
AP + PFIZER 200MG/100ML (2MG/ML) N019950 001 Jan 29, 1990
AP + 400MG/200ML (2MG/ML) N019950 006 Jan 29, 1990
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP + PFIZER 200MG/100ML (2MG/ML) N019950 002 Jan 29, 1990
AP + 400MG/200ML (2MG/ML) N019950 004 Jan 29, 1990
FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP ACS DOBFAR INFO SA 200MG/100ML (2MG/ML) A079104 001 Jul 30, 2009
AP 400MG/200ML (2MG/ML) A079104 002 Jul 30, 2009
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
AP CLARIS LIFESCIENCES 200MG/100ML (2MG/ML) A077988 001 May 26, 2010
AP 400MG/200ML (2MG/ML) A077988 002 May 26, 2010
AP HIKMA FARMACEUTICA 200MG/100ML (2MG/ML) A078764 001 Jan 30, 2012
AP 400MG/200ML (2MG/ML) A078764 002 Jan 30, 2012
AP HOSPIRA 200MG/100ML (2MG/ML) A076304 001 Jul 29, 2004
AP 400MG/200ML (2MG/ML) A076304 002 Jul 29, 2004
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
AP BEDFORD 200MG/100ML (2MG/ML) A076087 001 Jul 29, 2004
AP 400MG/200ML (2MG/ML) A076087 003 Jul 29, 2004
AP CLARIS LIFESCIENCES 200MG/100ML (2MG/ML) A077947 001 May 26, 2010
AP 400MG/200ML (2MG/ML) A077947 002 May 26, 2010
AP FRESENIUS KABI USA 200MG/100ML (2MG/ML) A076145 001 Jul 29, 2004
AP 400MG/200ML (2MG/ML) A076145 002 Jul 29, 2004
AP HIKMA FARMACEUTICA 200MG/100ML (2MG/ML) A076736 001 Aug 23, 2005
AP TEVA PHARMS USA 200MG/100ML (2MG/ML) A076653 001 Jul 29, 2004
AP 400MG/200ML (2MG/ML) A076653 002 Jul 29, 2004
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 200MG/100ML (2MG/ML) A076766 001 Jul 29, 2004
AP 400MG/200ML (2MG/ML) A076766 002 Jul 29, 2004
AP BEDFORD LABS 200MG/100ML (2MG/ML) A078107 001 Jul 30, 2008
AP 400MG/200ML (2MG/ML) A078107 002 Jul 30, 2008
AP CLARIS LIFESCIENCES 200MG/100ML (2MG/ML) A077909 001 May 26, 2010
AP 400MG/200ML (2MG/ML) A077909 002 May 26, 2010
AP HIKMA FARMACEUTICA 200MG/100ML (2MG/ML) A078698 001 Jan 30, 2012
AP 400MG/200ML (2MG/ML) A078698 002 Jan 30, 2012
AP HOSPIRA 200MG/100ML (2MG/ML) A076303 001 Jul 29, 2004
AP 400MG/200ML (2MG/ML) A076303 002 Jul 29, 2004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-154(of 371)
FLUCONAZOLE
INJECTABLE;INJECTION
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%
BEDFORD 100MG/50ML (2MG/ML) A076087 002 Sep 26, 2008
TABLET;ORAL
DIFLUCAN
AB PFIZER 50MG N019949 001 Jan 29, 1990
AB 100MG N019949 002 Jan 29, 1990
AB 150MG N019949 004 Jun 30, 1994
AB + 200MG N019949 003 Jan 29, 1990
FLUCONAZOLE
AB APOTEX 50MG A076665 001 Jul 29, 2004
AB 100MG A076665 002 Jul 29, 2004
AB 150MG A076665 003 Jul 29, 2004
AB 200MG A076665 004 Jul 29, 2004
AB AUROBINDO PHARMA 50MG A077731 001 Oct 07, 2008
AB 100MG A077731 002 Oct 07, 2008
AB 150MG A077731 003 Oct 07, 2008
AB 200MG A077731 004 Oct 07, 2008
AB DR REDDYS LABS INC 50MG A076658 001 Jul 29, 2004
AB 100MG A076658 002 Jul 29, 2004
AB 150MG A076658 003 Jul 29, 2004
AB 200MG A076658 004 Jul 29, 2004
AB GLENMARK GENERICS 50MG A077253 001 Jan 25, 2006
AB 100MG A077253 002 Jan 25, 2006
AB 150MG A077253 003 Jan 25, 2006
AB 200MG A077253 004 Jan 25, 2006
AB IVAX SUB TEVA PHARMS 50MG A076077 001 Jul 29, 2004
AB 100MG A076077 002 Jul 29, 2004
AB 150MG A076077 003 Jul 29, 2004
AB 200MG A076077 004 Jul 29, 2004
AB MYLAN 50MG A076351 001 Jul 29, 2004
AB 100MG A076351 002 Jul 29, 2004
AB 150MG A076351 003 Jul 29, 2004
AB 200MG A076351 004 Jul 29, 2004
AB TARO 50MG A076507 001 Jul 29, 2004
AB 100MG A076507 002 Jul 29, 2004
AB 150MG A076507 003 Jul 29, 2004
AB 200MG A076507 004 Jul 29, 2004
AB TEVA 50MG A074681 001 Jul 29, 2004
AB 100MG A074681 002 Jul 29, 2004
AB 150MG A074681 003 Jul 29, 2004
AB 200MG A074681 004 Jul 29, 2004
AB UNIQUE PHARM LABS 50MG A076957 001 Sep 28, 2005
AB 100MG A076957 002 Sep 28, 2005
AB 200MG A076957 003 Sep 28, 2005
FLUCYTOSINE
CAPSULE;ORAL
ANCOBON
AB VALEANT 250MG N017001 001
AB + 500MG N017001 002
FLUCYTOSINE
AB SIGMAPHARM LABS LLC 250MG A201566 001 Jun 28, 2011
AB 500MG A201566 002 Jun 28, 2011
FLUDARABINE PHOSPHATE
INJECTABLE;INJECTION
FLUDARABINE PHOSPHATE
AP ACTAVIS TOTOWA 50MG/VIAL A078610 001 Feb 11, 2009
AP + FRESENIUS KABI USA 50MG/2ML (25MG/ML) A078393 001 Oct 15, 2007
AP 50MG/VIAL A078544 001 Oct 15, 2007
AP + HOSPIRA 50MG/VIAL A077790 001 Apr 06, 2007
AP MUSTAFA NEVZAT ILAC 50MG/2ML (25MG/ML) A090724 001 Sep 27, 2010
AP ONCO THERAPIES LTD 50MG/2ML (25MG/ML) A200647 001 Dec 21, 2011
AP 50MG/VIAL A200648 001 Oct 16, 2012
AP + SANDOZ 50MG/2ML (25MG/ML) N022137 001 Sep 21, 2007
AP TEVA PHARMS USA 50MG/VIAL A076349 001 Aug 28, 2003
AP 50MG/2ML (25MG/ML) A076661 001 Apr 28, 2004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-155(of 371)
FLUDEOXYGLUCOSE F-18
INJECTABLE;INTRAVENOUS
FLUDEOXYGLUCOSE F18
AP BRIGHAM WOMENS 20-300mCi/ML A203816 001 Oct 30, 2014
AP CHILDRENS HOSP MI 20-300mCi/ML A204385 001 Oct 29, 2014
AP CPDC 20-300mCi/ML A204525 001 Oct 29, 2014
AP ESSENTIAL ISOTOPES 20-300mCi/ML A203946 001 Feb 05, 2014
AP + FEINSTEIN 20-200mCi/ML N021870 001 Aug 19, 2005
AP + 20-400mCi/ML N021870 002 Nov 21, 2008
AP GLOBAL ISOTOPES LLC 20-300mCi/ML A204463 001 Oct 21, 2014
AP + HOUSTON CYCLOTRON 20-500mCi/ML A203665 001 Feb 14, 2013
AP LANTHEUS MEDICAL 20-200mCi/ML A203664 001 Feb 04, 2014
AP MA GENERAL HOSP 20-300mCi/ML A204333 001 Sep 25, 2014
AP MCPRF 20-240mCi/ML A203612 001 Aug 05, 2013
AP NCM USA BRONX LLC 20-300mCi/ML A204512 001 Jan 07, 2015
AP PETNET 20-200mCi/ML A079086 001 Feb 25, 2011
AP SHERTECH LABS LLC 20-300mCi/ML A204264 001 Dec 18, 2014
AP TRUSTEES UNIV PA 20-200mCi/ML A203801 001 Oct 29, 2014
AP UCSF RODIOPHARM 20-300mCi/ML A203902 001 May 09, 2014
AP UIHC PET IMAGING 20-300mCi/ML A203990 001 Aug 06, 2014
AP UNIV TX MD ANDERSON 20-300mCi/ML A203246 002 Jan 13, 2014
AP WI MEDCL CYCLOTRON 20-500mCi/ML A203709 001 Oct 23, 2013
AP WUSM CYCLOTRON 20-300mCi/ML A203935 001 Feb 05, 2014
HOT SHOTS NM LLC 4-500mCi/ML A203937 001 Oct 30, 2014
+ UCLA BIOMEDICAL 4-40mCi/ML A203811 001 Jun 27, 2013
UNIV TX MD ANDERSON 20-150mCi/ML A203246 001 Jan 13, 2014
FLUDROCORTISONE ACETATE
TABLET;ORAL
FLUDROCORTISONE ACETATE
AB BARR 0.1MG A040425 001 Jan 21, 2003
AB HIKMA PHARMS 0.1MG A091302 001 Jul 22, 2011
AB + IMPAX LABS 0.1MG A040431 001 Mar 18, 2002
FLUMAZENIL
INJECTABLE;INJECTION
FLUMAZENIL
AP AGILA SPECLTS 0.5MG/5ML (0.1MG/ML) A078595 001 May 13, 2008
AP + 1MG/10ML (0.1MG/ML) A078595 002 May 13, 2008
AP BEDFORD LABS 0.5MG/5ML (0.1MG/ML) A076256 002 Oct 12, 2004
AP 1MG/10ML (0.1MG/ML) A076256 001 Oct 12, 2004
AP FRESENIUS KABI USA 0.5MG/5ML (0.1MG/ML) A076955 002 Oct 12, 2004
AP 1MG/10ML (0.1MG/ML) A076955 001 Oct 12, 2004
AP HIKMA FARMACEUTICA 0.5MG/5ML (0.1MG/ML) A078527 001 Mar 23, 2009
AP 1MG/10ML (0.1MG/ML) A078527 002 Mar 23, 2009
AP HIKMA MAPLE 0.5MG/5ML (0.1MG/ML) A076787 002 Oct 12, 2004
AP 1MG/10ML (0.1MG/ML) A076787 001 Oct 12, 2004
AP SAGENT PHARMS 0.5MG/5ML (0.1MG/ML) A090584 001 Aug 28, 2012
AP 1MG/10ML (0.1MG/ML) A090584 002 Aug 28, 2012
AP SANDOZ 0.5MG/5ML (0.1MG/ML) A077071 001 May 03, 2005
AP 1MG/10ML (0.1MG/ML) A077071 002 May 03, 2005
FLUNISOLIDE
AEROSOL, METERED;INHALATION
AEROSPAN HFA
+ MEDA PHARMS INC 0.078MG/INH N021247 001 Jan 27, 2006
SPRAY, METERED;NASAL
FLUNISOLIDE
AB + BAUSCH AND LOMB 0.025MG/SPRAY A074805 001 Feb 20, 2002
AB HI TECH PHARMA CO 0.025MG/SPRAY A077704 001 Aug 03, 2006
+ APOTEX INC 0.029MG/SPRAY A077436 001 Aug 09, 2007
FLUOCINOLONE ACETONIDE
CREAM;TOPICAL
FLUOCINOLONE ACETONIDE
AT FOUGERA 0.01% A088170 001 Dec 16, 1982
AT 0.025% A088169 001 Dec 16, 1982
AT G AND W LABS 0.01% A089526 001 Jul 26, 1988
AT 0.025% A089525 001 Jul 26, 1988
AT TARO 0.025% A087104 001 Apr 27, 1982
SYNALAR
AT + MEDIMETRIKS PHARMS 0.01% N012787 004
AT + 0.025% N012787 002
AT + 0.025% N012787 005
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-156(of 371)
FLUOCINOLONE ACETONIDE
IMPLANT;INTRAVITREAL
ILUVIEN
+ ALIMERA SCIENCES INC 0.19MG N201923 001 Sep 26, 2014
RETISERT
+ BAUSCH AND LOMB 0.59MG N021737 001 Apr 08, 2005
OIL;TOPICAL
DERMA-SMOOTHE/FS
AT + HILL DERMAC 0.01% N019452 001 Feb 03, 1988
AT + 0.01% N019452 002 Nov 09, 2005
FLUOCINOLONE ACETONIDE
AT IDENTI PHARMS INC 0.01% A201759 001 Oct 17, 2011
AT 0.01% A201764 001 Oct 17, 2011
AT PERRIGO ISRAEL 0.01% A202847 001 Aug 09, 2013
AT 0.01% A202848 001 Aug 09, 2013
OIL/DROPS;OTIC
DERMOTIC
AT + HILL DERMAC 0.01% N019452 003 Nov 09, 2005
FLUOCINOLONE ACETONIDE
AT IDENTI PHARMS INC 0.01% A091306 001 Oct 17, 2011
OINTMENT;TOPICAL
FLUOCINOLONE ACETONIDE
AT FOUGERA 0.025% A088168 001 Dec 16, 1982
AT G AND W LABS 0.025% A089524 001 Jul 26, 1988
AT TARO 0.025% A040041 001 Sep 15, 1994
SYNALAR
AT + MEDIMETRIKS PHARMS 0.025% N013960 001
SHAMPOO;TOPICAL
CAPEX
+ GALDERMA LABS LP 0.01% N020001 001 Aug 27, 1990
SOLUTION;TOPICAL
FLUOCINOLONE ACETONIDE
AT FOUGERA 0.01% A088167 001 Dec 16, 1982
AT TARO 0.01% A089124 001 Sep 11, 1985
SYNALAR
AT + MEDIMETRIKS PHARMS 0.01% N015296 001
FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN
CREAM;TOPICAL
TRI-LUMA
+ GALDERMA LABS LP 0.01%;4%;0.05% N021112 001 Jan 18, 2002
FLUOCINOLONE ACETONIDE; NEOMYCIN SULFATE
CREAM;TOPICAL
NEO-SYNALAR
+ MEDIMETRIKS PHARMS 0.025%;EQ 3.5MG BASE/GM A060700 001
FLUOCINONIDE
CREAM;TOPICAL
FLUOCINONIDE
AB FOUGERA PHARMS INC 0.1% A200735 001 Jul 14, 2014
AB GLENMARK GENERICS 0.1% A091282 001 Jul 14, 2014
AB PERRIGO ISRAEL 0.1% A090256 001 Jan 14, 2014
AB TARO 0.1% A200734 001 Jul 14, 2014
VANOS
AB + MEDICIS 0.1% N021758 001 Feb 11, 2005
FLUOCINONIDE
AB1 FOUGERA 0.05% A073030 001 Oct 17, 1994
AB1 G AND W LABS INC 0.05% A073085 001 Feb 14, 1992
AB1 + TARO 0.05% N019117 001 Jun 26, 1984
AB1 TEVA 0.05% A072488 001 Feb 06, 1989
FLUOCINONIDE EMULSIFIED BASE
AB2 FOUGERA PHARMS 0.05% A076586 001 Jun 23, 2004
AB2 + TARO 0.05% A072494 001 Jan 19, 1989
AB2 TEVA 0.05% A072490 001 Feb 07, 1989
GEL;TOPICAL
FLUOCINONIDE
AB FOUGERA 0.05% A072933 001 Dec 30, 1994
AB + TARO 0.05% A074935 001 Jul 29, 1997
AB TEVA 0.05% A072537 001 Feb 07, 1989
OINTMENT;TOPICAL
FLUOCINONIDE
AB FOUGERA PHARMS 0.05% A074905 001 Aug 26, 1997
AB + TARO 0.05% A075008 001 Jun 30, 1999
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-157(of 371)
FLUOCINONIDE
OINTMENT;TOPICAL
FLUOCINONIDE
AB TEVA 0.05% A073481 001 Dec 27, 1991
SOLUTION;TOPICAL
FLUOCINONIDE
AT FOUGERA 0.05% A072934 001 Feb 27, 1995
AT G AND W LABS INC 0.05% A071535 001 Dec 02, 1988
AT + TARO 0.05% A074799 001 Dec 31, 1996
AT TEVA 0.05% A072511 001 Feb 07, 1989
LIDEX
AT CNTY LINE PHARMS 0.05% N018849 001 Apr 06, 1984
FLUORESCEIN SODIUM
INJECTABLE;INTRAVENOUS
AK-FLUOR 10%
AP AKORN EQ 500MG BASE/5ML (EQ 100MG BASE/ML) N022186 001 Aug 08, 2008
FLUORESCITE
AP + ALCON PHARMS LTD EQ 500MG BASE/5ML (EQ 100MG BASE/ML) N021980 001 Mar 28, 2006
AK-FLUOR 25%
+ AKORN EQ 500MG BASE/2ML (EQ 250MG BASE/ML) N022186 002 Aug 08, 2008
FLUOROMETHOLONE
OINTMENT;OPHTHALMIC
FML
+ ALLERGAN 0.1% N017760 001 Sep 04, 1985
SUSPENSION/DROPS;OPHTHALMIC
FML
+ ALLERGAN 0.1% N016851 002 Jul 28, 1982
FML FORTE
ALLERGAN 0.25% N019216 001 Apr 23, 1986
FLUOROMETHOLONE ACETATE
SUSPENSION/DROPS;OPHTHALMIC
FLAREX
+ ALCON 0.1% N019079 001 Feb 11, 1986
FLUOROURACIL
CREAM;TOPICAL
EFUDEX
AB + VALEANT PHARM INTL 5% N016831 003
FLUOROURACIL
AB SPEAR PHARMS 5% A077524 001 Apr 11, 2008
AB TARO 5% A090368 001 Mar 05, 2010
CARAC
+ VALEANT BERMUDA 0.5% N020985 001 Oct 27, 2000
FLUOROPLEX
+ AQUA PHARMS 1% N016988 001
INJECTABLE;INJECTION
FLUOROURACIL
AP + ACCORD HLTHCARE 1GM/20ML (50MG/ML) A040743 001 Apr 26, 2007
AP + 2.5GM/50ML (50MG/ML) A040798 002 Apr 26, 2007
AP + 5GM/100ML (50MG/ML) A040798 001 Apr 26, 2007
AP + 500MG/10ML (50MG/ML) A040743 002 Apr 26, 2007
AP + FRESENIUS KABI USA 1GM/20ML (50MG/ML) A040279 001 Sep 30, 1998
AP + 2.5GM/50ML (50MG/ML) A040278 001 Sep 30, 1998
AP + 5GM/100ML (50MG/ML) A040278 002 Sep 30, 1998
AP + 500MG/10ML (50MG/ML) A040279 002 Sep 30, 1998
AP ONCO THERAPIES LTD 1GM/20ML (50MG/ML) A202668 002 Jul 17, 2012
AP 2.5GM/50ML (50MG/ML) A202669 001 Jul 17, 2012
AP 5GM/100ML (50MG/ML) A202669 002 Jul 17, 2012
AP 500MG/10ML (50MG/ML) A202668 001 Jul 17, 2012
AP SANDOZ 2.5GM/50ML (50MG/ML) A091299 001 May 02, 2011
AP 5GM/100ML (50MG/ML) A091299 002 May 02, 2011
AP + TEVA PHARMS USA 2.5GM/50ML (50MG/ML) A040334 001 Feb 25, 2000
AP + 5GM/100ML (50MG/ML) A040334 002 Feb 25, 2000
AP + 500MG/10ML (50MG/ML) A040333 001 Jan 27, 2000
SOLUTION;TOPICAL
EFUDEX
AT + VALEANT PHARM INTL 2% N016831 001
AT + 5% N016831 002
FLUOROURACIL
AT TARO 2% A076526 001 Nov 05, 2003
AT 5% A076526 002 Nov 05, 2003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-158(of 371)
FLUOXETINE HYDROCHLORIDE
CAPSULE;ORAL
FLUOXETINE HYDROCHLORIDE
AB ALEMBIC PHARMS LTD EQ 40MG BASE
A090223 003 Mar 19, 2009
AB AUROBINDO PHARMA EQ 40MG BASE
A078619 003 Jan 31, 2008
AB DR REDDYS LABS LTD EQ 40MG BASE
A075465 003 Aug 02, 2001
AB HERITAGE PHARMS INC EQ 40MG BASE
A201336 003 Oct 01, 2012
AB IVAX SUB TEVA PHARMS EQ 40MG BASE
A075245 003 Sep 28, 2004
AB MYLAN EQ 40MG BASE
A075207 003 May 25, 2007
AB PAR PHARM EQ 40MG BASE
A076922 003 Dec 16, 2004
AB RANBAXY EQ 40MG BASE
A076990 001 Dec 13, 2004
AB SANDOZ EQ 40MG BASE
A075049 003 Jan 29, 2002
AB TEVA EQ 40MG BASE
A075452 003 Jan 29, 2002
PROZAC
AB + ELI LILLY AND CO EQ 40MG BASE
N018936 003 Jun 15, 1999
FLUOXETINE HYDROCHLORIDE
AB1 ALEMBIC PHARMS LTD EQ 10MG BASE
A090223 001 Mar 19, 2009
AB1 EQ 20MG BASE
A090223 002 Mar 19, 2009
AB1 AUROBINDO PHARMA EQ 10MG BASE
A078619 001 Jan 31, 2008
AB1 EQ 20MG BASE
A078619 002 Jan 31, 2008
AB1 BARR EQ 10MG BASE
A074803 002 Jan 30, 2002
AB1 EQ 20MG BASE
A074803 001 Aug 02, 2001
AB1 DR REDDYS LABS LTD EQ 10MG BASE
A075465 001 Jan 29, 2002
AB1 EQ 20MG BASE
A075465 002 Jan 29, 2002
AB1 HERITAGE PHARMS INC EQ 10MG BASE
A201336 001 Oct 01, 2012
AB1 EQ 20MG BASE
A201336 002 Oct 01, 2012
AB1 IVAX SUB TEVA PHARMS EQ 10MG BASE
A075245 002 Jan 31, 2002
AB1 EQ 20MG BASE
A075245 001 Jan 31, 2002
AB1 LANDELA PHARM EQ 10MG BASE
A075464 001 Jan 30, 2002
AB1 EQ 20MG BASE
A075464 002 Jan 30, 2002
AB1 MALLINCKRODT EQ 10MG BASE
A075658 001 Jan 29, 2002
AB1 EQ 20MG BASE
A075658 002 Jan 29, 2002
AB1 MYLAN EQ 10MG BASE
A075207 001 Jan 30, 2002
AB1 EQ 20MG BASE
A075207 002 Jan 30, 2002
AB1 MYLAN PHARMS INC EQ 10MG BASE
A075577 001 Jan 29, 2002
AB1 EQ 20MG BASE
A075577 002 Jan 29, 2002
AB1 SANDOZ EQ 10MG BASE
A075049 001 Aug 02, 2001
AB1 EQ 20MG BASE
A075049 002 Jan 29, 2002
AB1 TEVA EQ 10MG BASE
A075452 001 Jan 29, 2002
AB1 EQ 20MG BASE
A075452 002 Jan 29, 2002
AB1 TEVA PHARMS USA EQ 10MG BASE
A076001 001 Jan 29, 2002
AB1 EQ 20MG BASE
A076001 002 Jan 29, 2002
PROZAC
AB1 ELI LILLY AND CO EQ 10MG BASE
N018936 006 Dec 23, 1992
AB1 EQ 20MG BASE
N018936 001 Dec 29, 1987
FLUOXETINE HYDROCHLORIDE
AB2 ANI PHARMS INC EQ 10MG BASE
A076287 001 May 20, 2008
AB2 EQ 20MG BASE
A076287 002 May 20, 2008
AB2 MYLAN EQ 10MG BASE
A078045 001 Nov 17, 2008
AB2 EQ 20MG BASE
A078045 002 Nov 17, 2008
AB2 SANDOZ EQ 10MG BASE
A077469 001 Nov 17, 2008
AB2 EQ 20MG BASE
A077469 002 Nov 17, 2008
SARAFEM
AB2 ELI LILLY AND CO EQ 10MG BASE
N018936 007 Jul 06, 2000
AB2 + EQ 20MG BASE
N018936 008 Jul 06, 2000
CAPSULE, DELAYED REL PELLETS;ORAL
FLUOXETINE HYDROCHLORIDE
AB BARR
EQ 90MG BASE
A076237 001 Mar 24, 2010
AB DR REDDYS LABS LTD
EQ 90MG BASE
A078572 001 Mar 22, 2010
PROZAC WEEKLY
AB + LILLY
EQ 90MG BASE
N021235 001 Feb 26, 2001
SOLUTION;ORAL
FLUOXETINE HYDROCHLORIDE
AA AUROBINDO PHARM EQ 20MG BASE/5ML
A079209 001 Mar 20, 2009
AA LANNETT EQ 20MG BASE/5ML
A076458 001 May 14, 2004
AA MALLINCKRODT EQ 20MG BASE/5ML
A075920 001 Jan 29, 2002
AA + PHARM ASSOC EQ 20MG BASE/5ML
A076015 001 Jan 30, 2002
AA SILARX EQ 20MG BASE/5ML
A077849 001 Feb 09, 2007
AA TEVA EQ 20MG BASE/5ML
A075506 001 Aug 02, 2001
AA WOCKHARDT EQ 20MG BASE/5ML
A075514 001 Aug 29, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-159(of 371)
FLUOXETINE HYDROCHLORIDE
TABLET;ORAL
FLUOXETINE HYDROCHLORIDE
AB DR REDDYS LABS INC
EQ 10MG BASE
A076006 001 Jan 30, 2002
AB MYLAN
EQ 10MG BASE
A075755 001 Aug 02, 2001
AB TEVA
EQ 10MG BASE
A075872 001 Jan 29, 2002
SARAFEM
AB1 WARNER CHILCOTT LLC
EQ 10MG BASE
N021860 001 May 19, 2006
AB1
EQ 15MG BASE
N021860 002 May 19, 2006
AB1 +
EQ 20MG BASE
N021860 003 May 19, 2006
SELFEMRA
AB1 TEVA PHARMS USA
EQ 10MG BASE
A200151 001 Feb 03, 2014
AB1
EQ 15MG BASE
A200151 002 Feb 03, 2014
AB1
EQ 20MG BASE
A200151 003 Feb 03, 2014
FLUOXETINE HYDROCHLORIDE
EDGEMONT PHARMS LLC
EQ 60MG BASE
N202133 001 Oct 06, 2011
+ MYLAN
EQ 20MG BASE
A075755 002 Aug 02, 2001
FLUOXETINE HYDROCHLORIDE; OLANZAPINE
CAPSULE;ORAL
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE
AB PAR PHARM
EQ 25MG BASE;EQ 3MG BASE
A077742 001 Nov 02, 2012
AB
EQ 25MG BASE;EQ 6MG BASE
A077742 002 Nov 02, 2012
AB
EQ 25MG BASE;EQ 12MG BASE
A077742 003 Nov 02, 2012
AB
EQ 50MG BASE;EQ 6MG BASE
A077742 004 Nov 02, 2012
AB
EQ 50MG BASE;EQ 12MG BASE
A077742 005 Nov 02, 2012
AB SANDOZ
EQ 25MG BASE;EQ 3MG BASE
A078901 005 Nov 16, 2012
AB
EQ 25MG BASE;EQ 6MG BASE
A078901 001 Nov 16, 2012
AB
EQ 25MG BASE;EQ 12MG BASE
A078901 003 Nov 16, 2012
AB
EQ 50MG BASE;EQ 6MG BASE
A078901 002 Nov 16, 2012
AB
EQ 50MG BASE;EQ 12MG BASE
A078901 004 Nov 16, 2012
AB TEVA PHARMS
EQ 25MG BASE;EQ 3MG BASE
A202074 001 Mar 25, 2013
AB
EQ 25MG BASE;EQ 6MG BASE
A077528 001 Jun 19, 2012
AB
EQ 25MG BASE;EQ 12MG BASE
A077528 002 Jun 19, 2012
AB
EQ 50MG BASE;EQ 6MG BASE
A077528 003 Jun 19, 2012
AB
EQ 50MG BASE;EQ 12MG BASE
A077528 004 Jun 19, 2012
SYMBYAX
AB LILLY
EQ 25MG BASE;EQ 3MG BASE
N021520 001 Apr 09, 2007
AB
EQ 25MG BASE;EQ 6MG BASE
N021520 002 Dec 24, 2003
AB
EQ 25MG BASE;EQ 12MG BASE
N021520 004 Dec 24, 2003
AB +
EQ 50MG BASE;EQ 6MG BASE
N021520 003 Dec 24, 2003
AB
EQ 50MG BASE;EQ 12MG BASE
N021520 005 Dec 24, 2003
FLUOXYMESTERONE
TABLET;ORAL
FLUOXYMESTERONE
+ USL PHARMA
10MG
A088342 001 Oct 21, 1983
FLUPHENAZINE DECANOATE
INJECTABLE;INJECTION
FLUPHENAZINE DECANOATE
AO EUROHLTH INTL 25MG/ML
A074531 001 Aug 30, 1996
AO + FRESENIUS KABI USA 25MG/ML
A071413 001 Jul 14, 1987
AO PAR STERILE PRODUCTS 25MG/ML
A203732 001 Jul 03, 2014
FLUPHENAZINE HYDROCHLORIDE
CONCENTRATE;ORAL
FLUPHENAZINE HYDROCHLORIDE
+ PHARM ASSOC
5MG/ML
A074725 001 Sep 16, 1996
ELIXIR;ORAL
FLUPHENAZINE HYDROCHLORIDE
+ PHARM ASSOC
2.5MG/5ML
A040146 001 Aug 21, 1996
INJECTABLE;INJECTION
FLUPHENAZINE HYDROCHLORIDE
+ FRESENIUS KABI USA
2.5MG/ML
A089556 001 Apr 16, 1987
TABLET;ORAL
FLUPHENAZINE HYDROCHLORIDE
AB LANNETT
1MG
A089740 001 Aug 25, 1988
AB
2.5MG
A089741 001 Aug 25, 1988
AB
5MG
A089742 001 Aug 25, 1988
AB
10MG
A089743 001 Aug 25, 1988
AB MYLAN
1MG
A089804 002 Aug 12, 1988
AB
2.5MG
A089804 003 Aug 12, 1988
AB
5MG
A089804 004 Aug 12, 1988
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-160(of 371)
FLUPHENAZINE HYDROCHLORIDE
TABLET;ORAL
FLUPHENAZINE HYDROCHLORIDE
AB +
10MG
A089804 001 Aug 12, 1988
AB SANDOZ
1MG
A089583 001 Oct 16, 1987
AB
2.5MG
A089584 001 Oct 16, 1987
AB
5MG
A089585 001 Oct 16, 1987
AB
10MG
A089586 001 Oct 16, 1987
FLURANDRENOLIDE
CREAM;TOPICAL
CORDRAN SP
+ AQUA PHARMS
0.025%
N012806 003
+
0.05%
N012806 002
LOTION;TOPICAL
CORDRAN
+ AQUA PHARMS
0.05%
N013790 001
TAPE;TOPICAL
CORDRAN
+ WATSON LABS INC
0.004MG/SQ CM
N016455 001
FLURAZEPAM HYDROCHLORIDE
CAPSULE;ORAL
FLURAZEPAM HYDROCHLORIDE
MYLAN PHARMS INC
15MG
A070345 002 Nov 27, 1985
+
30MG
A070345 001 Nov 27, 1985
FLURBIPROFEN
TABLET;ORAL
ANSAID
AB PHARMACIA AND UPJOHN
50MG
N018766 002 Oct 31, 1988
AB +
100MG
N018766 003 Oct 31, 1988
FLURBIPROFEN
AB MYLAN
50MG
A074358 001 Jun 20, 1994
AB
100MG
A074358 002 Jun 20, 1994
AB SUN PHARM INDS INC
50MG
A075058 001 Apr 27, 2001
AB
100MG
A075058 002 Apr 27, 2001
AB TEVA
100MG
A074431 001 May 31, 1995
FLURBIPROFEN SODIUM
SOLUTION/DROPS;OPHTHALMIC
FLURBIPROFEN SODIUM
AT BAUSCH AND LOMB
0.03%
A074447 001 Jan 04, 1995
OCUFEN
AT + ALLERGAN
0.03%
N019404 001 Dec 31, 1986
FLUTAMIDE
CAPSULE;ORAL
FLUTAMIDE
AB ACTAVIS LABS FL INC 125MG
A075820 001 Sep 18, 2001
AB + IVAX SUB TEVA PHARMS 125MG
A075780 001 Sep 19, 2001
AB MYLAN 125MG
A076224 001 May 09, 2003
AB PAR PHARM 125MG
A075298 001 Sep 18, 2001
FLUTEMETAMOL F-18
INJECTABLE;INTRAVENOUS
VIZAMYL
+ GE HEALTHCARE
40.5mCi/10ML (4.05mCi/ML)
N203137 001 Oct 25, 2013
+
121.5mCi/30ML (4.05mCi/ML)
N203137 002 Oct 25, 2013
FLUTICASONE FUROATE
POWDER;INHALATION
ARNUITY ELLIPTA
GLAXOSMITHKLINE
0.1MG/INH
N205625 001 Aug 20, 2014
+
0.2MG/INH
N205625 002 Aug 20, 2014
SPRAY, METERED;NASAL
VERAMYST
+ GLAXOSMITHKLINE
0.0275MG/INH
N022051 001 Apr 27, 2007
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE
POWDER;INHALATION
BREO ELLIPTA
+ GLAXO GRP LTD 0.1MG/INH;EQ 0.025MG BASE/INH N204275 001 May 10, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-161(of 371)
FLUTICASONE PROPIONATE
AEROSOL, METERED;INHALATION
FLOVENT HFA
+ GLAXO GRP LTD 0.044MG/INH N021433 003 May 14, 2004
+ 0.11MG/INH N021433 002 May 14, 2004
+ 0.22MG/INH N021433 001 May 14, 2004
CREAM;TOPICAL
FLUTICASONE PROPIONATE
AB FOUGERA PHARMS 0.05% A076451 001 May 14, 2004
AB G AND W LABS 0.05% A077055 001 Jun 30, 2006
AB PERRIGO NEW YORK 0.05% A076793 001 May 14, 2004
AB TOLMAR 0.05% A076633 001 May 14, 2004
LOTION;TOPICAL
CUTIVATE
AB + FOUGERA PHARMS 0.05% N021152 001 Mar 31, 2005
FLUTICASONE PROPIONATE
AB GLENMARK GENERICS 0.05% A090759 001 May 02, 2011
AB PERRIGO ISRAEL 0.05% A091553 001 Jul 30, 2013
OINTMENT;TOPICAL
CUTIVATE
AB + FOUGERA PHARMS 0.005% N019957 001 Dec 14, 1990
FLUTICASONE PROPIONATE
AB FOUGERA PHARMS 0.005% A076300 001 May 14, 2004
AB G AND W LABS 0.005% A077168 001 Mar 03, 2006
AB PERRIGO NEW YORK 0.005% A076668 001 May 14, 2004
POWDER;INHALATION
FLOVENT DISKUS 100
+ GLAXO GRP LTD 0.1MG/INH N020833 002 Sep 29, 2000
FLOVENT DISKUS 250
+ GLAXO GRP LTD 0.25MG/INH N020833 003 Sep 29, 2000
FLOVENT DISKUS 50
+ GLAXO GRP LTD 0.05MG/INH N020833 001 Sep 29, 2000
SPRAY, METERED;NASAL
FLONASE
AB + GLAXOSMITHKLINE 0.05MG/SPRAY N020121 001 Oct 19, 1994
FLUTICASONE PROPIONATE
AB APOTEX INC 0.05MG/SPRAY A077538 001 Sep 12, 2007
AB HI TECH PHARMA 0.05MG/SPRAY A077570 001 Jan 16, 2008
AB ROXANE 0.05MG/SPRAY A076504 001 Feb 22, 2006
AB WOCKHARDT 0.05MG/SPRAY A078492 001 Jan 09, 2012
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE
AEROSOL, METERED;INHALATION
ADVAIR HFA
+ GLAXO GRP LTD 0.045MG/INH;EQ 0.021MG BASE/INH N021254 001 Jun 08, 2006
+ 0.115MG/INH;EQ 0.021MG BASE/INH N021254 002 Jun 08, 2006
+ 0.23MG/INH;EQ 0.021MG BASE/INH N021254 003 Jun 08, 2006
POWDER;INHALATION
ADVAIR DISKUS 100/50
+ GLAXO GRP LTD 0.1MG/INH;EQ 0.05MG BASE/INH N021077 001 Aug 24, 2000
ADVAIR DISKUS 250/50
+ GLAXO GRP LTD 0.25MG/INH;EQ 0.05MG BASE/INH N021077 002 Aug 24, 2000
ADVAIR DISKUS 500/50
+ GLAXO GRP LTD 0.5MG/INH;EQ 0.05MG BASE/INH N021077 003 Aug 24, 2000
FLUVASTATIN SODIUM
CAPSULE;ORAL
FLUVASTATIN SODIUM
AB MYLAN PHARMS INC EQ 20MG BASE A090595 001 Apr 11, 2012
AB EQ 40MG BASE A090595 002 Apr 11, 2012
AB TEVA PHARMS EQ 20MG BASE A078407 001 Jun 12, 2012
AB EQ 40MG BASE A078407 002 Jun 12, 2012
LESCOL
AB NOVARTIS EQ 20MG BASE N020261 001 Dec 31, 1993
AB + EQ 40MG BASE N020261 002 Dec 31, 1993
TABLET, EXTENDED RELEASE;ORAL
LESCOL XL
+ NOVARTIS 80MG N021192 001 Oct 06, 2000
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-162(of 371)
FLUVOXAMINE MALEATE
CAPSULE, EXTENDED RELEASE;ORAL
FLUVOXAMINE MALEATE
AB ACTAVIS ELIZABETH 100MG A091482 001 Apr 23, 2013
AB 150MG A091482 002 Nov 18, 2013
AB ANCHEN PHARMS 100MG A091476 001 Mar 13, 2013
AB 150MG A091476 002 Mar 13, 2013
AB TORRENT PHARMS LTD 100MG A203240 001 Oct 31, 2014
AB 150MG A203240 002 Oct 31, 2014
LUVOX CR
AB JAZZ PHARMS 100MG N022033 001 Feb 28, 2008
AB + 150MG N022033 002 Feb 28, 2008
TABLET;ORAL
FLUVOXAMINE MALEATE
AB APOTEX 25MG A075902 001 May 07, 2001
AB 50MG A075902 002 May 07, 2001
AB 100MG A075902 003 May 07, 2001
AB BARR 25MG A075897 001 Jan 25, 2001
AB 50MG A075897 002 Jan 25, 2001
AB 100MG A075897 003 Jan 25, 2001
AB MYLAN 25MG A075889 001 Nov 29, 2000
AB 50MG A075889 002 Nov 29, 2000
AB 100MG A075889 003 Nov 29, 2000
AB SANDOZ 25MG A075888 001 Nov 29, 2000
AB 50MG A075888 002 Nov 29, 2000
AB + 100MG A075888 003 Nov 29, 2000
AB TEVA 25MG A075893 001 Sep 10, 2002
AB 50MG A075893 002 Sep 10, 2002
AB 100MG A075893 003 Sep 10, 2002
LUVOX
AB ANI PHARMS 25MG N021519 001 Dec 20, 2007
AB 50MG N021519 002 Dec 20, 2007
AB 100MG N021519 003 Dec 20, 2007
FOLIC ACID
INJECTABLE;INJECTION
FOLIC ACID
+ FRESENIUS KABI USA 5MG/ML A089202 001 Feb 18, 1986
TABLET;ORAL
FOLIC ACID
AA + AMNEAL PHARM 1MG A040625 001 Jul 21, 2005
AA BICON PHARM 1MG A091145 001 Jul 12, 2013
AA CADILA PHARMS LTD 1 MG A202437 001 Jan 27, 2014
AA CONTRACT PHARMACAL 1MG A085061 001
AA EXCELLIUM 1MG A040796 001 Jan 12, 2009
AA HIKMA PHARMS LLC 1MG A080600 001
AA INVAGEN PHARMS 1MG A090035 001 Jun 09, 2009
AA VINTAGE 1MG A040756 001 Jun 04, 2010
AA + WATSON LABS 1MG A080680 001
FOLLITROPIN ALFA/BETA
INJECTABLE;SUBCUTANEOUS
FOLLISTIM AQ
+ ORGANON USA INC 75 IU/0.5ML N021273 001 Aug 26, 2005
+ 150 IU/0.5ML N021273 002 Aug 26, 2005
+ 300 IU/0.36ML N021211 001 Mar 23, 2004
+ 600 IU/0.72ML N021211 002 Mar 23, 2004
+ 900 IU/1.08ML N021211 004 Feb 11, 2005
GONAL-F
+ EMD SERONO 450 IU/VIAL N020378 005 Mar 26, 2004
1,050 IU/VIAL N020378 004 Feb 28, 2001
GONAL-F RFF
+ EMD SERONO 75 IU/VIAL N021765 002 Mar 25, 2004
GONAL-F RFF REDI-JECT
+ EMD SERONO 300 IU/0.5ML N021684 001 May 25, 2004
+ 450 IU/0.75ML N021684 002 May 25, 2004
+ 900 IU/1.5ML N021684 003 May 25, 2004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-163(of 371)
FOMEPIZOLE
INJECTABLE;INJECTION
ANTIZOL
AP + PALADIN LABS
1.5GM/1.5ML (1GM/ML)
N020696 001 Dec 04, 1997
FOMEPIZOLE
AP LUITPOLD
1.5GM/1.5ML (1GM/ML)
A078368 001 Dec 14, 2007
AP MYLAN INSTITUTIONAL
1.5GM/1.5ML (1GM/ML)
A078639 001 Mar 03, 2008
AP NAVINTA LLC
1.5GM/1.5ML (1GM/ML)
A078537 001 Mar 06, 2008
FONDAPARINUX SODIUM
INJECTABLE;SUBCUTANEOUS
ARIXTRA
AP + MYLAN IRELAND LTD
2.5MG/0.5ML
N021345 001 Dec 07, 2001
AP +
5MG/0.4ML
N021345 002 May 28, 2004
AP +
7.5MG/0.6ML
N021345 003 May 28, 2004
AP +
10MG/0.8ML
N021345 004 May 28, 2004
FONDAPARINUX SODIUM
AP DR REDDYS LABS LTD
2.5MG/0.5ML
A091316 001 Jul 11, 2011
AP
5MG/0.4ML
A091316 002 Jul 11, 2011
AP
7.5MG/0.6ML
A091316 003 Jul 11, 2011
AP
10MG/0.8ML
A091316 004 Jul 11, 2011
FORMOTEROL FUMARATE
POWDER;INHALATION
FORADIL
+ NOVARTIS
0.012MG/INH
N020831 001 Feb 16, 2001
SOLUTION;INHALATION
PERFOROMIST
+ MYLAN SPECLT
0.02MG/2ML
N022007 001 May 11, 2007
FORMOTEROL FUMARATE; MOMETASONE FUROATE
AEROSOL, METERED;INHALATION
DULERA
+ MERCK SHARP DOHME
0.005MG/INH;0.1MG/INH
N022518 001 Jun 22, 2010
+
0.005MG/INH;0.2MG/INH
N022518 002 Jun 22, 2010
FOSAMPRENAVIR CALCIUM
SUSPENSION;ORAL
LEXIVA
+ VIIV HLTHCARE
EQ 50MG BASE/ML
N022116 001 Jun 14, 2007
TABLET;ORAL
LEXIVA
+ VIIV HLTHCARE
EQ 700MG BASE
N021548 001 Oct 20, 2003
FOSAPREPITANT DIMEGLUMINE
POWDER;INTRAVENOUS
EMEND
+ MERCK AND CO INC
EQ 150MG BASE/VIAL
N022023 002 Nov 12, 2010
FOSCARNET SODIUM
INJECTABLE;INJECTION
FOSCARNET SODIUM
AP HOSPIRA 2.4GM/100ML
A077174 001 May 31, 2005
FOSCAVIR
AP + CLINIGEN HLTHCARE 2.4GM/100ML
N020068 001 Sep 27, 1991
FOSFOMYCIN TROMETHAMINE
FOR SUSPENSION;ORAL
MONUROL
+ ZAMBON SPA
EQ 3GM BASE/PACKET
N050717 001 Dec 19, 1996
FOSINOPRIL SODIUM
TABLET;ORAL
FOSINOPRIL SODIUM
AB ACTAVIS LABS FL INC
10MG
A076620 001 Oct 15, 2004
AB
20MG
A076620 002 Oct 15, 2004
AB
40MG
A076620 003 Oct 15, 2004
AB APOTEX INC
10MG
A076906 001 May 17, 2005
AB
20MG
A076906 002 May 17, 2005
AB
40MG
A076906 003 May 17, 2005
AB AUROBINDO PHARMA LTD
10MG
A091163 001 Mar 30, 2011
AB
20MG
A091163 002 Mar 30, 2011
AB
40MG
A091163 003 Mar 30, 2011
AB INVAGEN PHARMS
10MG
A077222 001 Apr 20, 2005
AB
20MG
A077222 002 Apr 20, 2005
AB
40MG
A077222 003 Apr 20, 2005
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-164(of 371)
FOSINOPRIL SODIUM
TABLET;ORAL
FOSINOPRIL SODIUM
AB SANDOZ 10MG A076483 001 Apr 23, 2004
AB 20MG A076483 002 Apr 23, 2004
AB 40MG A076483 003 Apr 23, 2004
AB TEVA 10MG A076139 001 Nov 25, 2003
AB 20MG A076139 002 Nov 25, 2003
AB + 40MG A076139 003 Nov 25, 2003
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
TABLET;ORAL
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
AB ACTAVIS LABS FL INC 10MG;12.5MG
A076608 001 Dec 03, 2004
AB 20MG;12.5MG
A076608 002 Dec 03, 2004
AB AUROBINDO PHARMA 10MG;12.5MG
A079245 001 Jul 09, 2009
AB 20MG;12.5MG
A079245 002 Jul 09, 2009
AB EMCURE PHARMS INDIA 10MG;12.5MG
A079025 001 Sep 17, 2010
AB + 20MG;12.5MG
A079025 002 Sep 17, 2010
AB INVAGEN PHARMS 10MG;12.5MG
A090228 001 Jul 09, 2009
AB 20MG;12.5MG
A090228 002 Jul 09, 2009
AB RANBAXY 10MG;12.5MG
A076739 001 Dec 17, 2004
AB 20MG;12.5MG
A076739 002 Dec 17, 2004
AB SANDOZ 10MG;12.5MG
A076961 001 Sep 28, 2005
AB 20MG;12.5MG
A076961 002 Sep 28, 2005
FOSPHENYTOIN SODIUM
INJECTABLE;INJECTION
CEREBYX
AP PARKE DAVIS
EQ 50MG PHENYTOIN NA/ML
N020450 001 Aug 05, 1996
FOSPHENYTOIN SODIUM
AP AGILA SPECLTS
EQ 50MG PHENYTOIN NA/ML
A078736 001 Jun 08, 2010
AP AMNEAL PHARMS CO
EQ 50MG PHENYTOIN NA/ML
A078476 001 Mar 18, 2008
AP BEDFORD
EQ 50MG PHENYTOIN NA/ML
A077481 001 Aug 06, 2007
AP + FRESENIUS KABI USA
EQ 50MG PHENYTOIN NA/ML
A078052 001 Aug 06, 2007
AP HIKMA FARMACEUTICA
EQ 50MG PHENYTOIN NA/ML
A078765 001 Dec 02, 2009
AP HIKMA MAPLE
EQ 50MG PHENYTOIN NA/ML
A077989 001 Aug 06, 2007
AP HOSPIRA
EQ 50MG PHENYTOIN NA/ML
A078158 001 Aug 06, 2007
AP LUITPOLD
EQ 50MG PHENYTOIN NA/ML
A078277 001 Aug 06, 2007
AP
EQ 50MG PHENYTOIN NA/ML
A090099 001 May 13, 2010
AP SUN PHARMA GLOBAL
EQ 50MG PHENYTOIN NA/ML
A078417 001 Mar 18, 2008
AP WOCKHARDT
EQ 50MG PHENYTOIN NA/ML
A078137 001 Aug 06, 2007
FROVATRIPTAN SUCCINATE
TABLET;ORAL
FROVA
AB + ENDO PHARMS
EQ 2.5MG BASE
N021006 001 Nov 08, 2001
FROVATRIPTAN SUCCINATE
AB MYLAN PHARMS INC
EQ 2.5MG BASE
A202931 001 Aug 28, 2014
FULVESTRANT
INJECTABLE;INTRAMUSCULAR
FASLODEX
+ ASTRAZENECA
50MG/ML
N021344 001 Apr 25, 2002
FUROSEMIDE
INJECTABLE;INJECTION
FUROSEMIDE
AP CLARIS LIFESCIENCES
10MG/ML
A202747 001 Jan 27, 2014
AP EMCURE PHARMS LTD
10MG/ML
A203428 001 Aug 26, 2014
AP FRESENIUS KABI USA
10MG/ML
N018902 001 May 22, 1984
AP HOSPIRA
10MG/ML
A075241 001 May 28, 1999
AP
10MG/ML
N018667 001 May 28, 1982
AP + LUITPOLD
10MG/ML
N018579 001 Nov 30, 1983
AP WOCKHARDT
10MG/ML
A077941 001 Mar 22, 2007
SOLUTION;ORAL
FUROSEMIDE
AA + ROXANE
10MG/ML
A070434 001 Apr 22, 1987
AA WOCKHARDT
10MG/ML
A070655 001 Oct 02, 1987
ROXANE
40MG/5ML
A070433 001 Apr 22, 1987
TABLET;ORAL
FUROSEMIDE
AB EXCELLIUM
20MG
A077293 001 Nov 09, 2005
AB
40MG
A077293 002 Nov 09, 2005
AB
80MG
A077293 003 Nov 09, 2005
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-165(of 371)
FUROSEMIDE
TABLET;ORAL
FUROSEMIDE
AB IPCA LABS LTD 20MG A078010 001 Sep 18, 2006
AB 40MG A078010 002 Sep 18, 2006
AB 80MG A078010 003 Sep 18, 2006
AB IVAX SUB TEVA PHARMS 20MG N018413 001 Nov 30, 1983
AB 40MG N018413 002 Nov 30, 1983
AB MYLAN 20MG N018487 001
AB 40MG N018487 002
AB 80MG A070082 001 Oct 29, 1986
AB ROXANE 20MG N018823 001 Nov 10, 1983
AB 40MG N018823 002 Nov 10, 1983
AB 80MG A070086 001 Jan 24, 1986
AB SANDOZ 20MG N018569 002
AB 40MG N018569 001
AB 80MG N018569 005 Aug 14, 1984
AB SUN PHARM INDS INC 20MG A091258 001 Apr 01, 2014
AB 40MG A091258 002 Apr 01, 2014
AB 80MG A091258 003 Apr 01, 2014
AB VINTAGE PHARMS 20MG A076796 001 Mar 26, 2004
AB 40MG A076796 002 Mar 26, 2004
AB 80MG A076796 003 Mar 26, 2004
LASIX
AB SANOFI AVENTIS US 20MG N016273 002
AB 40MG N016273 001
AB + 80MG N016273 003
GABAPENTIN
CAPSULE;ORAL
GABAPENTIN
AB ACTAVIS ELIZABETH 100MG A075350 001 Sep 12, 2003
AB 300MG A075350 002 Sep 12, 2003
AB 400MG A075350 003 Sep 12, 2003
AB ALKEM 100MG A090858 001 Dec 17, 2010
AB 300MG A090858 002 Dec 17, 2010
AB 400MG A090858 003 Dec 17, 2010
AB AMNEAL PHARMS NY 100MG A078428 001 Jul 25, 2007
AB 300MG A078428 002 Jul 25, 2007
AB 400MG A078428 003 Jul 25, 2007
AB APOTEX INC 100MG A075360 001 Apr 06, 2005
AB 300MG A075360 002 Apr 06, 2005
AB 400MG A075360 003 Apr 06, 2005
AB AUROBINDO PHARM 100MG A078787 001 Jan 31, 2008
AB 300MG A078787 002 Jan 31, 2008
AB 400MG A078787 003 Jan 31, 2008
AB HIKMA 100MG A078150 001 Sep 25, 2007
AB 300MG A078150 002 Sep 25, 2007
AB 400MG A078150 003 Sep 25, 2007
AB INVAGEN PHARMS 100MG A090705 001 Dec 30, 2009
AB 300MG A090705 002 Dec 30, 2009
AB 400MG A090705 003 Dec 30, 2009
AB MARKSANS PHARMA 100MG A090007 001 Jul 21, 2011
AB 300MG A090007 002 Jul 21, 2011
AB 400MG A090007 003 Jul 21, 2011
AB MYLAN 100MG A090158 001 Feb 14, 2011
AB 300MG A090158 002 Feb 14, 2011
AB 400MG A090158 003 Feb 14, 2011
AB RANBAXY 100MG A076606 001 Oct 07, 2005
AB 300MG A076606 002 Oct 07, 2005
AB 400MG A076606 003 Oct 07, 2005
AB SUN PHARM INDS LTD 100MG A077242 001 Aug 24, 2006
AB 300MG A077242 002 Aug 24, 2006
AB 400MG A077242 003 Aug 24, 2006
AB TARO 100MG A077261 001 Aug 02, 2013
AB 300MG A077261 002 Aug 02, 2013
AB 400MG A077261 003 Aug 02, 2013
AB TEVA PHARMS 100MG A075435 001 Oct 08, 2004
AB 300MG A075435 002 Oct 08, 2004
AB 400MG A075435 003 Oct 08, 2004
NEURONTIN
AB PFIZER PHARMS 100MG N020235 001 Dec 30, 1993
AB 300MG N020235 002 Dec 30, 1993
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-166(of 371)
GABAPENTIN
CAPSULE;ORAL
NEURONTIN
AB + 400MG N020235 003 Dec 30, 1993
SOLUTION;ORAL
GABAPENTIN
AA ACELLA PHARMS LLC 250MG/5ML A076403 001 May 01, 2012
AA AMNEAL PHARMS 250MG/5ML A202024 001 Mar 23, 2012
AA HI TECH PHARMA 250MG/5ML A078974 001 Feb 18, 2011
AA TARO 250MG/5ML A076672 001 Jul 03, 2013
NEURONTIN
AA + PARKE DAVIS 250MG/5ML N021129 001 Mar 02, 2000
TABLET;ORAL
GABAPENTIN
AB ACI HEALTHCARE LTD 600MG A203244 002 Jul 12, 2013
AB 800MG A203244 001 Jul 12, 2013
AB ACTAVIS ELIZABETH 600MG A075694 001 Oct 21, 2004
AB 800MG A075694 002 Oct 21, 2004
AB APOTEX INC 100MG A077894 001 Oct 10, 2006
AB 300MG A077894 002 Oct 10, 2006
AB 400MG A077894 003 Oct 10, 2006
AB 600MG A077661 004 Sep 13, 2006
AB 800MG A077661 005 Sep 13, 2006
AB AUROBINDO PHARMA LTD 600MG A200651 001 Oct 06, 2011
AB 800MG A200651 002 Oct 06, 2011
AB GLENMARK GENERICS 600MG A077662 001 Aug 18, 2006
AB 800MG A077662 002 Aug 18, 2006
AB HIKMA PHARMS 600MG A078782 001 Jul 21, 2011
AB 800MG A078782 002 Jul 21, 2011
AB INVAGEN PHARMS 600MG A202764 001 Oct 16, 2012
AB 800MG A202764 002 Oct 16, 2012
AB IVAX SUB TEVA PHARMS 100MG A076017 001 Apr 28, 2004
AB 300MG A076017 002 Apr 28, 2004
AB 400MG A076017 003 Apr 28, 2004
AB 600MG A076017 004 Apr 29, 2005
AB 800MG A076017 005 Apr 29, 2005
AB MYLAN PHARMS INC 600MG A090335 001 Jun 01, 2010
AB 800MG A090335 002 Jun 01, 2010
AB SUN PHARM INDS LTD 600MG A077525 001 Aug 24, 2006
AB 800MG A077525 002 Aug 24, 2006
AB ZYDUS PHARMS USA INC 600MG A078926 001 Feb 11, 2011
AB 800MG A078926 002 Feb 11, 2011
NEURONTIN
AB PFIZER PHARMS 600MG N020882 001 Oct 09, 1998
AB + 800MG N020882 002 Oct 09, 1998
GRALISE
BX + DEPOMED INC 300MG N022544 001 Jan 28, 2011
BX + 600MG N022544 002 Jan 28, 2011
GABAPENTIN ENACARBIL
TABLET, EXTENDED RELEASE;ORAL
HORIZANT
XENOPORT INC 300MG N022399 002 Dec 13, 2011
+ 600MG N022399 001 Apr 06, 2011
GADOBENATE DIMEGLUMINE
INJECTABLE;INTRAVENOUS
MULTIHANCE
+ BRACCO 2.645GM/5ML (529MG/ML) N021357 001 Nov 23, 2004
+ 5.29GM/10ML (529MG/ML) N021357 002 Nov 23, 2004
+ 7.935GM/15ML (529MG/ML) N021357 003 Nov 23, 2004
+ 10.58GM/20ML (529MG/ML) N021357 004 Nov 23, 2004
MULTIHANCE MULTIPACK
+ BRACCO 26.45GM/50ML (529MG/ML) N021358 001 Nov 23, 2004
+ 52.9GM/100ML (529MG/ML) N021358 002 Nov 23, 2004
GADOBUTROL
SOLUTION;INTRAVENOUS
GADAVIST
+ BAYER HLTHCARE 1.20944GM/2ML (604.72MG/ML) N201277 006 Dec 18, 2013
+ 4.5354GM/7.5ML (604.72MG/ML) N201277 001 Mar 14, 2011
+ 6.0472GM/10ML (604.72MG/ML) N201277 002 Mar 14, 2011
+ 9.0708GM/15ML (604.72MG/ML) N201277 003 Mar 14, 2011
+ 18.1416GM/30ML (604.72MG/ML) N201277 004 Mar 14, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-167(of 371)
GADOBUTROL
SOLUTION;INTRAVENOUS
GADAVIST
+ 39.3068GM/65ML (604.72MG/ML) N201277 005 Mar 14, 2011
GADODIAMIDE
INJECTABLE;INJECTION
OMNISCAN
+ GE HEALTHCARE 28.7GM/100ML (287MG/ML) N022066 002 Sep 05, 2007
+ 287MG/ML N020123 001 Jan 08, 1993
GADOFOSVESET TRISODIUM
SOLUTION;INTRAVENOUS
ABLAVAR
LANTHEUS MEDCL 2440MG/10ML (244MG/ML) N021711 001 Dec 22, 2008
+ 3660MG/15ML (244MG/ML) N021711 002 Dec 22, 2008
GADOPENTETATE DIMEGLUMINE
INJECTABLE;INJECTION
MAGNEVIST
+ BAYER HLTHCARE 469.01MG/ML N019596 001 Jun 02, 1988
+ 469.01MG/ML N021037 001 Mar 10, 2000
GADOTERATE MEGLUMINE
SOLUTION;INTRAVENOUS
DOTAREM
+ GUERBET 3.769GM/10ML (376.9MG/ML) N204781 002 Mar 20, 2013
+ 5.6535GM/15ML (376.9MG/ML) N204781 003 Mar 20, 2013
+ 7.538GM/20ML (376.9MG/ML) N204781 004 Mar 20, 2013
+ 37.69GM/100ML (376.9MG/ML) N204781 001 Mar 20, 2013
GADOTERIDOL
INJECTABLE;INJECTION
PROHANCE
+ BRACCO 279.3MG/ML N020131 001 Nov 16, 1992
PROHANCE MULTIPACK
+ BRACCO 279.3MG/ML N021489 001 Oct 09, 2003
GADOVERSETAMIDE
INJECTABLE;INJECTION
OPTIMARK
+ MALLINCKRODT 16.545GM/50ML (330.9MG/ML) N020975 001 Dec 08, 1999
+ 1654.5MG/5ML (330.9MG/ML) N020937 001 Dec 08, 1999
+ 3309MG/10ML (330.9MG/ML) N020937 002 Dec 08, 1999
+ 4963.5MG/15ML (330.9MG/ML) N020937 003 Dec 08, 1999
+ 6618MG/20ML (330.9MG/ML) N020937 004 Dec 08, 1999
OPTIMARK IN PLASTIC CONTAINER
+ MALLINCKRODT 3309MG/10ML (330.9MG/ML) N020976 002 Dec 08, 1999
+ 4963.5MG/15ML (330.9MG/ML) N020976 003 Dec 08, 1999
+ 6618MG/20ML (330.9MG/ML) N020976 004 Dec 08, 1999
+ 9927MG/30ML (330.9MG/ML) N020976 001 Dec 08, 1999
GADOXETATE DISODIUM
SOLUTION;INTRAVENOUS
EOVIST
+ BAYER HLTHCARE 1.8143GM/10ML (181.43MG/ML) N022090 001 Jul 03, 2008
2.72145GM/15ML (181.43MG/ML) N022090 002 Feb 04, 2013
GALANTAMINE HYDROBROMIDE
CAPSULE, EXTENDED RELEASE;ORAL
GALANTAMINE HYDROBROMIDE
AB BARR EQ 8MG BASE A078189 001 Sep 15, 2008
AB EQ 16MG BASE A078189 002 Sep 15, 2008
AB EQ 24MG BASE A078189 003 Sep 15, 2008
AB IMPAX LABS EQ 8MG BASE A078484 001 May 27, 2009
AB EQ 16MG BASE A078484 002 May 27, 2009
AB EQ 24MG BASE A078484 003 May 27, 2009
AB MYLAN EQ 8MG BASE A090900 001 Jan 24, 2011
AB EQ 16MG BASE A090900 002 Jan 24, 2011
AB EQ 24MG BASE A090900 003 Jan 24, 2011
AB SUN PHARMA GLOBAL EQ 8MG BASE A090178 001 Feb 02, 2011
AB EQ 16MG BASE A090178 002 Feb 02, 2011
AB EQ 24MG BASE A090178 003 Feb 02, 2011
AB WATSON LABS EQ 8MG BASE A079028 001 Dec 15, 2008
AB EQ 16MG BASE A079028 002 Dec 15, 2008
AB EQ 24MG BASE A079028 003 Dec 15, 2008
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-168(of 371)
GALANTAMINE HYDROBROMIDE
CAPSULE, EXTENDED RELEASE;ORAL
RAZADYNE ER
AB + JANSSEN PHARMS EQ 8MG BASE N021615 001 Apr 01, 2005
AB EQ 16MG BASE N021615 002 Apr 01, 2005
AB EQ 24MG BASE N021615 003 Apr 01, 2005
SOLUTION;ORAL
GALANTAMINE HYDROBROMIDE
AA ROXANE 4MG/ML A078185 001 Jan 30, 2009
RAZADYNE
AA + JANSSEN PHARMS 4MG/ML N021224 001 Jun 22, 2001
TABLET;ORAL
GALANTAMINE HYDROBROMIDE
AB APOTEX INC EQ 4MG BASE A077781 001 Sep 27, 2011
AB EQ 8MG BASE A077781 002 Sep 27, 2011
AB EQ 12MG BASE A077781 003 Sep 27, 2011
AB AUROBINDO PHARMA LTD EQ 4MG BASE A090957 001 Mar 29, 2011
AB EQ 8MG BASE A090957 002 Mar 29, 2011
AB EQ 12MG BASE A090957 003 Mar 29, 2011
AB BARR EQ 4MG BASE A077605 001 Aug 28, 2008
AB EQ 8MG BASE A077605 002 Aug 28, 2008
AB EQ 12MG BASE A077605 003 Aug 28, 2008
AB DR REDDYS LABS LTD EQ 4MG BASE A077593 001 Sep 11, 2008
AB EQ 8MG BASE A077593 002 Sep 11, 2008
AB EQ 12MG BASE A077593 003 Sep 11, 2008
AB MYLAN EQ 4MG BASE A077590 001 May 29, 2009
AB EQ 4MG BASE A077603 001 Aug 28, 2008
AB EQ 8MG BASE A077590 002 May 29, 2009
AB EQ 8MG BASE A077603 002 Aug 28, 2008
AB EQ 12MG BASE A077590 003 May 29, 2009
AB EQ 12MG BASE A077603 003 Aug 28, 2008
AB ROXANE EQ 4MG BASE A077608 001 Feb 11, 2009
AB EQ 8MG BASE A077608 002 Feb 11, 2009
AB EQ 12MG BASE A077608 003 Feb 11, 2009
AB SANDOZ EQ 4MG BASE A077589 001 Jun 22, 2009
AB EQ 8MG BASE A077589 002 Jun 22, 2009
AB EQ 12MG BASE A077589 003 Jun 22, 2009
AB TEVA PHARMS EQ 4MG BASE A077587 001 Jul 09, 2009
AB EQ 8MG BASE A077587 002 Jul 09, 2009
AB EQ 12MG BASE A077587 003 Jul 09, 2009
AB ZYDUS PHARMS USA INC EQ 4MG BASE A078898 001 Feb 17, 2011
AB EQ 8MG BASE A078898 002 Feb 17, 2011
AB EQ 12MG BASE A078898 003 Feb 17, 2011
RAZADYNE
AB + JANSSEN PHARMS EQ 4MG BASE N021169 001 Feb 28, 2001
AB EQ 8MG BASE N021169 002 Feb 28, 2001
AB EQ 12MG BASE N021169 003 Feb 28, 2001
GALLIUM CITRATE GA-67
INJECTABLE;INJECTION
GALLIUM CITRATE GA 67
BS LANTHEUS MEDCL 2mCi/ML N017478 001
BS MALLINCKRODT 2mCi/ML N018058 001
GANCICLOVIR
GEL;OPHTHALMIC
ZIRGAN
+ BAUSCH AND LOMB 0.15% N022211 001 Sep 15, 2009
GANCICLOVIR SODIUM
INJECTABLE;INJECTION
CYTOVENE
AP + ROCHE PALO EQ 500MG BASE/VIAL N019661 001 Jun 23, 1989
GANCICLOVIR
AP FRESENIUS KABI USA EQ 500MG BASE/VIAL A090658 001 Jun 21, 2010
AP LUITPOLD EQ 500MG BASE/VIAL A202624 001 Sep 18, 2013
GANIRELIX ACETATE
INJECTABLE;INJECTION
GANIRELIX ACETATE
+ ORGANON USA INC EQ 250MCG BASE/0.5ML N021057 001 Jul 29, 1999
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-169(of 371)
GATIFLOXACIN
SOLUTION/DROPS;OPHTHALMIC
GATIFLOXACIN
AT HI-TECH PHARMA CO 0.5% A203189 001 Sep 03, 2014
AT LUPIN LTD 0.5% A202653 001 Aug 28, 2013
ZYMAXID
AT + ALLERGAN 0.5% N022548 001 May 18, 2010
ZYMAR
+ ALLERGAN 0.3% N021493 001 Mar 28, 2003
GEMCITABINE HYDROCHLORIDE
INJECTABLE;INJECTION
GEMCITABINE HYDROCHLORIDE
AP ACCORD HLTHCARE EQ 1GM BASE/VIAL A091594 002 Jul 25, 2011
AP EQ 2GM BASE/VIAL A091594 003 Jul 25, 2011
AP EQ 200MG BASE/VIAL A091594 001 Jul 25, 2011
AP ACTAVIS TOTOWA EQ 1GM BASE/VIAL A079160 002 Jul 25, 2011
AP EQ 200MG BASE/VIAL A079160 001 Jul 25, 2011
AP CIPLA LTD EQ 1GM BASE/VIAL A078759 002 Jul 25, 2011
AP EQ 200MG BASE/VIAL A078759 001 Jul 25, 2011
AP DR REDDYS LABS LTD EQ 1GM BASE/VIAL A091365 002 Jul 25, 2011
AP EQ 2GM BASE/VIAL A202997 001 May 07, 2013
AP EQ 200MG BASE/VIAL A091365 001 Jul 25, 2011
AP EMCURE PHARMS LTD EQ 1GM BASE/VIAL A202063 002 Sep 11, 2012
AP EQ 200MG BASE/VIAL A202063 001 Sep 11, 2012
AP FRESENIUS KABI ONCOL EQ 1GM BASE/VIAL A090799 002 Jul 25, 2011
AP EQ 2GM BASE/VIAL A090799 003 May 16, 2011
AP EQ 200MG BASE/VIAL A090799 001 Jul 25, 2011
AP FRESENIUS KABI USA EQ 2GM BASE/VIAL A090242 003 May 16, 2011
AP HAMELN RDS GMBH EQ 1GM BASE/VIAL A090663 002 Sep 10, 2012
AP EQ 200MG BASE/VIAL A090663 001 Sep 10, 2012
AP HOSPIRA EQ 1GM BASE/VIAL A078339 002 Jul 25, 2011
AP EQ 200MG BASE/VIAL A078339 001 Jul 25, 2011
AP + HOSPIRA INC EQ 2GM BASE/VIAL A079183 001 Nov 15, 2010
AP JIANGSU HANSOH PHARM EQ 1GM BASE/VIAL A202485 002 May 07, 2013
AP EQ 200MG BASE/VIAL A202485 001 May 07, 2013
AP LUITPOLD EQ 1GM BASE/VIAL A202031 002 May 07, 2013
AP EQ 200MG BASE/VIAL A202031 001 May 07, 2013
AP ONCO THERAPIES LTD EQ 1GM BASE/VIAL A200145 002 Jul 25, 2011
AP EQ 2GM BASE/VIAL A200145 003 Jul 25, 2011
AP EQ 200MG BASE/VIAL A200145 001 Jul 25, 2011
AP SAGENT PHARMS EQ 1GM BASE/VIAL A091597 002 May 07, 2013
AP EQ 200MG BASE/VIAL A091597 001 May 07, 2013
AP SUN PHARMA GLOBAL EQ 1GM BASE/VIAL A078433 002 Jul 25, 2011
AP EQ 200MG BASE/VIAL A078433 001 Jul 25, 2011
AP TEVA PHARMS EQ 1GM BASE/VIAL A077983 001 Jan 25, 2011
AP EQ 200MG BASE/VIAL A077983 002 Jan 25, 2011
GEMZAR
AP + LILLY EQ 1GM BASE/VIAL N020509 002 May 15, 1996
AP + EQ 200MG BASE/VIAL N020509 001 May 15, 1996
GEMCITABINE HYDROCHLORIDE
+ HOSPIRA INC 1GM/26.3ML (38MG/ML) N200795 002 Aug 04, 2011
+ 2GM/52.6ML (38MG/ML) N200795 003 Aug 04, 2011
+ 200MG/5.26ML (38MG/ML) N200795 001 Aug 04, 2011
GEMFIBROZIL
TABLET;ORAL
GEMFIBROZIL
AB APOTEX 600MG A075034 001 Jul 20, 1998
AB BLU CARIBE 600MG A078012 001 Mar 26, 2007
AB DAVA PHARMS INC 600MG A074270 001 Sep 27, 1993
AB HIKMA PHARMS 600MG A078599 001 Aug 16, 2010
AB IMPAX PHARMS 600MG A078207 001 Jun 01, 2007
AB INVAGEN PHARMS 600MG A077836 001 Jul 27, 2006
AB NORTHSTAR HLTHCARE 600MG A079072 001 Sep 13, 2010
AB SUN PHARM INDS INC 600MG A079239 001 Dec 29, 2008
AB TEVA 600MG A074256 001 Oct 31, 1993
LOPID
AB + PFIZER PHARMS 600MG N018422 003 Nov 20, 1986
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-170(of 371)
GEMIFLOXACIN MESYLATE
TABLET;ORAL
FACTIVE
+ LG LIFE SCIENCES EQ 320MG BASE N021158 001 Apr 04, 2003
GENTAMICIN SULFATE
CREAM;TOPICAL
GENTAMICIN SULFATE
AT + FOUGERA EQ 0.1% BASE A062531 001 Jul 05, 1984
AT PERRIGO NEW YORK EQ 0.1% BASE A062307 001
AT TARO EQ 0.1% BASE A062427 001 May 26, 1983
INJECTABLE;INJECTION
GENTAMICIN SULFATE
AP FRESENIUS KABI USA EQ 10MG BASE/ML A062366 002 Feb 06, 1986
AP + EQ 40MG BASE/ML A062366 001 Aug 04, 1983
AP HOSPIRA EQ 10MG BASE/ML A062420 001 Aug 15, 1983
AP EQ 10MG BASE/ML A062612 004 Feb 20, 1986
AP EQ 40MG BASE/ML A062420 002 Aug 15, 1983
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP + B BRAUN EQ 0.8MG BASE/ML A062814 001 Aug 28, 1987
AP + EQ 1.2MG BASE/ML A062814 002 Aug 28, 1987
AP + EQ 1.4MG BASE/ML A062814 003 Aug 28, 1987
AP + EQ 1.6MG BASE/ML A062814 004 Aug 28, 1987
AP + EQ 1.8MG BASE/ML A062814 005 Aug 28, 1987
AP + EQ 2MG BASE/ML A062814 006 Aug 28, 1987
AP + EQ 2.4MG BASE/ML A062814 007 Aug 28, 1987
AP + EQ 40MG BASE/100ML A062814 008 Aug 28, 1987
AP + EQ 60MG BASE/100ML A062814 009 Aug 28, 1987
AP + EQ 70MG BASE/100ML A062814 010 Aug 28, 1987
AP + EQ 80MG BASE/100ML A062814 011 Aug 28, 1987
AP + EQ 90MG BASE/100ML A062814 012 Aug 28, 1987
AP + EQ 100MG BASE/100ML A062814 013 Aug 28, 1987
AP + EQ 120MG BASE/100ML A062814 014 Aug 28, 1987
AP HOSPIRA EQ 1.2MG BASE/ML A062414 001 Aug 15, 1983
AP EQ 1.4MG BASE/ML A062414 002 Aug 15, 1983
AP EQ 1.6MG BASE/ML A062414 003 Aug 15, 1983
AP EQ 1.8MG BASE/ML A062414 004 Aug 15, 1983
AP EQ 2MG BASE/ML A062414 005 Aug 15, 1983
AP EQ 60MG BASE/100ML A062414 006 Aug 15, 1983
AP EQ 70MG BASE/100ML A062414 007 Aug 15, 1983
AP EQ 80MG BASE/100ML A062414 008 Aug 15, 1983
AP EQ 90MG BASE/100ML A062414 009 Aug 15, 1983
AP EQ 100MG BASE/100ML A062414 010 Aug 15, 1983
ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER
AP BAXTER HLTHCARE EQ 0.8MG BASE/ML A062373 001 Sep 07, 1982
AP EQ 1.2MG BASE/ML A062373 007 Sep 07, 1982
AP EQ 1.6MG BASE/ML A062373 008 Sep 07, 1982
AP EQ 2MG BASE/ML A062373 009 Sep 07, 1982
AP EQ 2.4MG BASE/ML A062373 010 Sep 07, 1982
AP EQ 40MG BASE/100ML A062373 003 Sep 07, 1982
AP EQ 60MG BASE/100ML A062373 004 Sep 07, 1982
AP EQ 80MG BASE/100ML A062373 002 Sep 07, 1982
AP EQ 100MG BASE/100ML A062373 005 Sep 07, 1982
AP EQ 120MG BASE/100ML A062373 006 Sep 07, 1982
OINTMENT;OPHTHALMIC
GENTAMICIN SULFATE
AT + AKORN EQ 0.3% BASE A064093 001 Aug 31, 1995
AT PERRIGO CO TENNESSEE EQ 0.3% BASE A065024 001 Jul 30, 2004
OINTMENT;TOPICAL
GENTAMICIN SULFATE
AT FOUGERA EQ 0.1% BASE A062533 001 Oct 05, 1984
AT + PERRIGO NEW YORK EQ 0.1% BASE A062351 001 Feb 18, 1982
AT TARO EQ 0.1% BASE A062477 001 Dec 23, 1983
SOLUTION/DROPS;OPHTHALMIC
GENOPTIC
AT ALLERGAN EQ 0.3% BASE A062452 001 Oct 10, 1984
GENTAK
AT AKORN EQ 0.3% BASE A064163 001 Oct 12, 2001
GENTAMICIN SULFATE
AT AKORN EQ 0.3% BASE A062635 001 Jan 08, 1987
AT ALCON RES LTD EQ 0.3% BASE A062196 001
AT + BAUSCH AND LOMB EQ 0.3% BASE A064048 001 May 11, 1994
AT PERRIGO CO TENNESSEE EQ 0.3% BASE A065121 001 Jan 30, 2004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-171(of 371)
GENTAMICIN SULFATE; PREDNISOLONE ACETATE
OINTMENT;OPHTHALMIC
PRED-G
+ ALLERGAN EQ 0.3% BASE;0.6% N050612 001 Dec 01, 1989
SUSPENSION/DROPS;OPHTHALMIC
PRED-G
+ ALLERGAN EQ 0.3% BASE;1% N050586 001 Jun 10, 1988
GLATIRAMER ACETATE
INJECTABLE;SUBCUTANEOUS
COPAXONE
+ TEVA PHARMS USA 20MG/ML N020622 002 Feb 12, 2002
+ 40MG/ML N020622 003 Jan 28, 2014
GLIMEPIRIDE
TABLET;ORAL
AMARYL
AB + SANOFI AVENTIS US 1MG N020496 001 Nov 30, 1995
AB 2MG N020496 002 Nov 30, 1995
AB 4MG N020496 003 Nov 30, 1995
GLIMEPIRIDE
AB ACCORD HLTHCARE 1MG A078181 001 Aug 23, 2007
AB 2MG A078181 002 Aug 23, 2007
AB 4MG A078181 003 Aug 23, 2007
AB ACTAVIS LABS FL INC 1MG A076995 001 Apr 27, 2010
AB 2MG A076995 002 Apr 27, 2010
AB 4MG A076995 003 Apr 27, 2010
AB AUROBINDO PHARMA LTD 1MG A202759 001 Jun 29, 2012
AB 2MG A202759 002 Jun 29, 2012
AB 4MG A202759 003 Jun 29, 2012
AB CARLSBAD 1MG A077911 001 Sep 22, 2009
AB 2MG A077911 002 Sep 22, 2009
AB 4MG A077911 003 Sep 22, 2009
AB DR REDDYS LABS LTD 1MG A077091 001 Oct 06, 2005
AB 2MG A077091 002 Oct 06, 2005
AB 4MG A077091 003 Oct 06, 2005
AB HIKMA PHARMS 1MG A078952 001 Aug 01, 2013
AB 2MG A078952 002 Aug 01, 2013
AB 4MG A078952 003 Aug 01, 2013
AB INDOCO REMEDIES 1MG A202112 001 Apr 17, 2013
AB 2MG A202112 002 Apr 17, 2013
AB 4MG A202112 003 Apr 17, 2013
AB INVAGEN PHARMS 1MG A077295 001 Oct 06, 2005
AB 2MG A077295 002 Oct 06, 2005
AB 4MG A077295 003 Oct 06, 2005
AB MICRO LABS LTD INDIA 1MG A091220 001 Jun 29, 2012
AB 2MG A091220 002 Jun 29, 2012
AB 4MG A091220 004 Jun 29, 2012
AB 8MG A091220 006 Jun 29, 2012
AB MYLAN 1MG A077624 001 Nov 28, 2005
AB 2MG A077624 002 Nov 28, 2005
AB 4MG A077624 003 Nov 28, 2005
AB TEVA 1MG A076802 001 Oct 06, 2005
AB 2MG A076802 002 Oct 06, 2005
AB 4MG A076802 003 Oct 06, 2005
AB VINTAGE 1MG A077370 001 Dec 23, 2005
AB 2MG A077370 002 Dec 23, 2005
AB 4MG A077370 003 Dec 23, 2005
AB 8MG A077370 004 Dec 23, 2005
MICRO LABS LTD INDIA 3MG A091220 003 Jun 29, 2012
6MG A091220 005 Jun 29, 2012
GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE
TABLET;ORAL
DUETACT
AB + TAKEDA PHARMS USA 2MG;30MG N021925 001 Jul 28, 2006
AB 4MG;30MG N021925 002 Jul 28, 2006
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE
AB SANDOZ 2MG;30MG A201049 001 Jan 04, 2013
AB 4MG;30MG A201049 002 Jan 04, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-172(of 371)
GLIMEPIRIDE; ROSIGLITAZONE MALEATE
TABLET;ORAL
AVANDARYL
+ SB PHARMCO 1MG;4MG N021700 001 Nov 23, 2005
2MG;4MG N021700 002 Nov 23, 2005
2MG;8MG N021700 004 Mar 30, 2007
4MG;4MG N021700 003 Nov 23, 2005
4MG;8MG N021700 005 Mar 30, 2007
GLIPIZIDE
TABLET;ORAL
GLIPIZIDE
AB ACCORD HLTHCARE 5MG A074550 001 Sep 11, 1997
AB 10MG A074550 002 Sep 11, 1997
AB APOTEX 5MG A075795 001 Jun 13, 2001
AB 10MG A075795 002 Jun 13, 2001
AB IVAX SUB TEVA PHARMS 5MG A074497 001 Aug 31, 1995
AB 10MG A074497 002 Aug 31, 1995
AB MYLAN 5MG A074226 001 May 10, 1994
AB 5MG A074438 001 Jun 20, 1995
AB 10MG A074226 002 May 10, 1994
AB 10MG A074438 002 Jun 20, 1995
AB SANDOZ 5MG A074305 001 Apr 07, 1995
AB 10MG A074305 002 Apr 07, 1995
AB SUN PHARM INDS INC 5MG A077820 001 Jul 11, 2006
AB 10MG A077820 002 Jul 11, 2006
AB WATSON LABS 5MG A074223 001 Feb 27, 1995
AB 10MG A074223 002 Feb 27, 1995
GLUCOTROL
AB PFIZER 5MG N017783 001 May 08, 1984
AB + 10MG N017783 002 May 08, 1984
TABLET, EXTENDED RELEASE;ORAL
GLIPIZIDE
AB PAR PHARM 5MG A076159 002 Sep 20, 2013
AB 10MG A076159 001 Sep 20, 2013
AB WATSON LABS 2.5MG A076467 003 Mar 27, 2006
AB 5MG A076467 001 Sep 08, 2003
AB 10MG A076467 002 Nov 07, 2003
GLUCOTROL XL
AB PFIZER 2.5MG N020329 003 Aug 10, 1999
AB 5MG N020329 001 Apr 26, 1994
AB + 10MG N020329 002 Apr 26, 1994
GLIPIZIDE; METFORMIN HYDROCHLORIDE
TABLET;ORAL
GLIPIZIDE AND METFORMIN HYDROCHLORIDE
AB COREPHARMA 2.5MG;250MG A077507 001 Oct 27, 2005
AB 2.5MG;500MG A077507 002 Oct 27, 2005
AB 5MG;500MG A077507 003 Oct 27, 2005
AB HERITAGE PHARMS INC 2.5MG;250MG A078728 001 Jun 23, 2010
AB 2.5MG;500MG A078728 002 Jun 23, 2010
AB 5MG;500MG A078728 003 Jun 23, 2010
AB MYLAN 2.5MG;250MG A078083 001 Apr 12, 2007
AB 2.5MG;500MG A078083 002 Apr 12, 2007
AB 5MG;500MG A078083 003 Apr 12, 2007
AB SUN PHARM INDS INC 2.5MG;250MG A077620 001 Jan 11, 2008
AB 2.5MG;500MG A077620 002 Jan 11, 2008
AB 5MG;500MG A077620 003 Jan 11, 2008
AB TEVA PHARMS 2.5MG;250MG A077270 001 Oct 28, 2005
AB 2.5MG;500MG A077270 002 Oct 28, 2005
AB + 5MG;500MG A077270 003 Oct 28, 2005
AB ZYDUS PHARMS USA INC 2.5MG;250MG A078905 001 Jan 31, 2011
AB 2.5MG;500MG A078905 002 Jan 31, 2011
AB 5MG;500MG A078905 003 Jan 31, 2011
GLUCAGON HYDROCHLORIDE RECOMBINANT
INJECTABLE;INJECTION
GLUCAGEN
+ NOVO NORDISK EQ 1MG BASE/VIAL N020918 001 Jun 22, 1998
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-173(of 371)
GLUCAGON RECOMBINANT
INJECTABLE;INJECTION
GLUCAGON
+ LILLY 1MG/VIAL N020928 001 Sep 11, 1998
GLUTAMINE
FOR SOLUTION;ORAL
NUTRESTORE
+ EMMAUS MEDCL 5GM/PACKET N021667 001 Jun 10, 2004
GLYBURIDE
TABLET;ORAL
GLYBURIDE
AB AUROBINDO PHARMA 1.25MG A077537 001 Oct 18, 2007
AB 2.5MG A077537 002 Oct 18, 2007
AB 5MG A077537 003 Oct 18, 2007
AB COREPHARMA 1.25MG A076257 001 Jun 27, 2002
AB 2.5MG A076257 002 Jun 27, 2002
AB 5MG A076257 003 Jun 27, 2002
AB HERITAGE PHARMS INC 1.25MG A090937 001 Feb 28, 2011
AB 2.5MG A090937 002 Feb 28, 2011
AB 5MG A090937 003 Feb 28, 2011
AB TEVA 1.25MG A074388 001 Aug 29, 1995
AB 2.5MG A074388 002 Aug 29, 1995
AB + 5MG A074388 003 Aug 29, 1995
GLYBURIDE (MICRONIZED)
AB DAVA PHARMS INC 1.5MG A074591 001 Dec 22, 1997
AB 3MG A074591 002 Dec 22, 1997
AB 4.5MG A074591 003 Dec 22, 1997
AB 6MG A074591 004 Dec 22, 1997
AB HIKMA 1.5MG A075890 001 Jul 31, 2003
AB 3MG A075890 002 Jul 31, 2003
AB 6MG A075890 003 Jul 31, 2003
AB MYLAN 1.5MG A074792 001 Jun 26, 1998
AB 3MG A074792 002 Jun 26, 1998
AB 6MG A074792 003 Aug 17, 1999
AB TEVA 1.5MG A074686 001 Apr 20, 1999
AB 3MG A074686 002 Apr 20, 1999
AB 4.5MG A074686 003 Apr 20, 1999
AB 6MG A074686 004 Apr 20, 1999
GLYNASE
AB PHARMACIA AND UPJOHN 1.5MG N020051 001 Mar 04, 1992
AB 3MG N020051 002 Mar 04, 1992
AB + 6MG N020051 004 Sep 24, 1993
DIABETA
BX SANOFI AVENTIS US 1.25MG N017532 001 May 01, 1984
BX 2.5MG N017532 002 May 01, 1984
BX + 5MG N017532 003 May 01, 1984
GLYBURIDE; METFORMIN HYDROCHLORIDE
TABLET;ORAL
GLUCOVANCE
AB BRISTOL MYERS SQUIBB 1.25MG;250MG N021178 001 Jul 31, 2000
AB + 2.5MG;500MG N021178 002 Jul 31, 2000
AB 5MG;500MG N021178 003 Jul 31, 2000
GLYBURIDE AND METFORMIN HYDROCHLORIDE
AB ACTAVIS ELIZABETH 1.25MG;250MG A076716 001 Jun 28, 2005
AB 2.5MG;500MG A076716 002 Jun 28, 2005
AB 5MG;500MG A076716 003 Jun 28, 2005
AB AUROBINDO PHARMA 1.25MG;250MG A077870 001 Nov 14, 2007
AB 2.5MG;500MG A077870 002 Nov 14, 2007
AB 5MG;500MG A077870 003 Nov 14, 2007
AB COREPHARMA 1.25MG;250MG A076731 001 Nov 19, 2004
AB 2.5MG;500MG A076731 002 Nov 19, 2004
AB 5MG;500MG A076731 003 Nov 19, 2004
AB HERITAGE PHARMS INC 1.25MG;250MG A079009 001 Jun 03, 2009
AB 2.5MG;500MG A079009 002 Jun 03, 2009
AB 5MG;500MG A079009 003 Jun 03, 2009
AB IVAX SUB TEVA PHARMS 1.25MG;250MG A076345 001 Feb 18, 2004
AB 2.5MG;500MG A076345 002 Feb 18, 2004
AB 5MG;500MG A076345 003 Feb 18, 2004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-174(of 371)
GLYCEROL PHENYLBUTYRATE
LIQUID;ORAL
RAVICTI
+ HYPERION THERAP INC 1.1GM/ML N203284 001 Feb 01, 2013
GLYCINE
SOLUTION;IRRIGATION
AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 1.5GM/100ML N017865 001
GLYCINE 1.5% IN PLASTIC CONTAINER
AT B BRAUN 1.5GM/100ML N016784 001
AT HOSPIRA 1.5GM/100ML N018315 001
GLYCOPYRROLATE
INJECTABLE;INJECTION
GLYCOPYRROLATE
AP HIKMA FARMACEUTICA 0.2MG/ML A090963 001 Sep 21, 2011
AP LUITPOLD 0.2MG/ML A089335 001 Jul 23, 1986
ROBINUL
AP + HIKMA MAPLE 0.2MG/ML N017558 001
SOLUTION;ORAL
CUVPOSA
+ MERZ PHARMS 1MG/5ML N022571 001 Jul 28, 2010
TABLET;ORAL
GLYCOPYRROLATE
AA AUROLIFE PHARMA LLC 1MG A202675 001 Apr 15, 2013
AA DR REDDYS LABS LTD 1MG A040847 001 Mar 21, 2008
AA 2MG A040847 002 Mar 21, 2008
AA EXCELLIUM 1MG A090195 001 Sep 21, 2012
AA 2MG A090195 002 Sep 21, 2012
AA NEXGEN PHARMA 1.5MG A091522 001 Mar 12, 2012
AA PAR PHARM 1MG A040653 001 Aug 31, 2006
AA 2MG A040653 002 Aug 31, 2006
AA RANBAXY 1MG A040844 001 Aug 18, 2009
AA 2MG A040844 002 Aug 18, 2009
AA STASON PHARMS 1MG A091182 001 Feb 03, 2014
AA 2MG A091182 002 Feb 03, 2014
AA VINTAGE 1MG A040821 001 Dec 29, 2008
AA 2MG A040821 002 Dec 29, 2008
AA VINTAGE PHARMS 1MG A090020 001 Oct 19, 2011
AA 2MG A090020 002 Oct 19, 2011
ROBINUL
AA + SHIONOGI INC 1MG N012827 001
ROBINUL FORTE
AA + SHIONOGI INC 2MG N012827 002
GONADOTROPIN, CHORIONIC
INJECTABLE;INJECTION
CHORIONIC GONADOTROPIN
AP + FERRING 10,000 UNITS/VIAL N017016 007
AP + FRESENIUS KABI USA 10,000 UNITS/VIAL N017067 002
PREGNYL
AP + ORGANON USA INC 10,000 UNITS/VIAL N017692 001
GOSERELIN ACETATE
IMPLANT;IMPLANTATION
ZOLADEX
+ ASTRAZENECA EQ 3.6MG BASE N019726 001 Dec 29, 1989
+ EQ 10.8MG BASE N020578 001 Jan 11, 1996
GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
SOLUTION/DROPS;OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
AT + BAUSCH AND LOMB 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A064047 001 Jan 31, 1996
UNITS/ML
AT LUITPOLD 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A065187 001 Oct 28, 2005
UNITS/ML
NEOSPORIN
AT + MONARCH PHARMS 0.025MG/ML;EQ 1.75MG BASE/ML;10,000 A060582 001
UNITS/ML
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-175(of 371)
GRANISETRON
FILM, EXTENDED RELEASE;TRANSDERMAL
SANCUSO
+ PROSTRAKAN INC
3.1MG/24HR
N022198 001 Sep 12, 2008
GRANISETRON HYDROCHLORIDE
INJECTABLE;INJECTION
GRANISETRON HYDROCHLORIDE
AP AKORN INC
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
A079119 001 Sep 10, 2009
AP
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
A079078 001 Sep 14, 2009
AP
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
A079078 002 Sep 14, 2009
AP BANNER PHARMACAPS
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
A078863 001 Jun 30, 2008
AP
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
A078880 001 Jun 30, 2008
AP BEDFORD LABS
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
A077913 001 Jun 26, 2008
AP
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
A077186 001 Jun 30, 2008
AP
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
A077187 001 Jun 30, 2008
AP CIPLA LTD
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
A078262 001 Dec 31, 2007
AP
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
A078258 001 Jun 30, 2008
AP
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
A078258 002 Jun 30, 2008
AP FRESENIUS KABI USA
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
A078522 001 Dec 31, 2007
AP
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
A078090 001 Jun 30, 2008
AP HIKMA MAPLE
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
A077177 001 Dec 31, 2007
AP LUITPOLD
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
A091274 001 Sep 22, 2010
AP SAGENT AGILA
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
A091137 002 Apr 09, 2010
AP SAGENT STRIDES
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
A091136 001 Apr 09, 2010
AP
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
A091136 002 Apr 09, 2010
AP SANDOZ
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
A078534 001 Apr 30, 2009
AP
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
A078531 001 Apr 30, 2009
AP
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
A078531 002 Apr 30, 2009
AP SANDOZ INC
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
A078835 001 Jun 30, 2008
AP
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
A078835 002 Jun 30, 2008
AP + TEVA PHARMS USA
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
A078392 001 Dec 31, 2007
AP +
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
A077963 001 Jan 03, 2008
AP +
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
A077297 001 Jun 30, 2008
AP WOCKHARDT USA
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
A078566 001 Feb 29, 2008
AP
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
A078564 001 Jun 30, 2008
AP
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
A078565 001 Jun 30, 2008
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
AP BANNER PHARMACAPS
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
A078863 002 Jun 30, 2008
AP + FRESENIUS KABI USA
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
A078096 001 Jun 30, 2008
GRANISTERON HYDROCHLORIDE
AP HIKMA FARMACEUTICA
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
A078629 001 Dec 23, 2009
AP
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
A078629 002 Dec 23, 2009
TABLET;ORAL
GRANISETRON HYDROCHLORIDE
AB APOTEX INC
EQ 1MG BASE
A078843 001 Feb 27, 2008
AB CIPLA LTD
EQ 1MG BASE
A078037 001 Feb 27, 2008
AB COREPHARMA
EQ 1MG BASE
A078260 001 Dec 31, 2007
AB DR REDDYS LABS LTD
EQ 1MG BASE
A078846 001 Feb 27, 2009
AB MYLAN
EQ 1MG BASE
A078725 001 Jan 30, 2008
AB NATCO PHARMA
EQ 1MG BASE
A078969 001 Jun 22, 2009
AB ORCHID HLTHCARE
EQ 1MG BASE
A078678 001 Feb 13, 2008
AB ROXANE
EQ 1MG BASE
A077842 001 Dec 31, 2007
AB TARO
EQ 1MG BASE
A090817 001 May 28, 2010
AB + TEVA PHARMS
EQ 1MG BASE
A078080 001 Dec 31, 2007
GRISEOFULVIN, MICROSIZE
SUSPENSION;ORAL
GRISEOFULVIN
AB + ACTAVIS MID ATLANTIC
125MG/5ML
A065394 001 Jul 06, 2007
AB IVAX SUB TEVA PHARMS
125MG/5ML
A065354 001 Sep 10, 2007
AB PERRIGO CO TENNESSEE
125MG/5ML
A065200 001 Mar 02, 2005
AB VINTAGE PHARMS
125MG/5ML
A065438 001 Oct 08, 2010
TABLET;ORAL
GRIFULVIN V
AB + VALEANT LUXEMBOURG
500MG
A062279 003
GRISEOFULVIN
AB SANDOZ
500MG
A091592 002 Aug 07, 2013
AB SIGMAPHARM LABS LLC
500MG
A202482 001 Oct 22, 2012
SANDOZ
250MG
A091592 001 Aug 07, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-176(of 371)
GRISEOFULVIN, ULTRAMICROSIZE
TABLET;ORAL
GRIS-PEG
AB VALEANT PHARMS INC 125MG N050475 001
AB + 250MG N050475 002
GRISEOFULVIN, ULTRAMICROSIZE
AB RICONPHARMA LLC 125MG A204371 001 Jan 09, 2014
AB 250MG A204371 002 Jan 09, 2014
GRISEOFULVIN,ULTRAMICROSIZE
AB SIGMAPHARM LABS LLC 125MG A202545 001 Oct 22, 2012
AB 250MG A202545 002 Oct 22, 2012
GUAIFENESIN; HYDROCODONE BITARTRATE
SOLUTION;ORAL
OBREDON
+ SOVEREIGN PHARMS
200MG/5ML;2.5MG/5ML
N205474 001 Nov 14, 2014
GUANABENZ ACETATE
TABLET;ORAL
GUANABENZ ACETATE
ANI PHARMS INC
EQ 4MG BASE
A074149 001 Apr 07, 1995
+
EQ 8MG BASE
A074149 002 Apr 07, 1995
GUANFACINE HYDROCHLORIDE
TABLET;ORAL
GUANFACINE HYDROCHLORIDE
AB AMNEAL PHARM EQ 1MG BASE
A075109 001 Nov 25, 1998
AB EQ 2MG BASE
A075109 002 Nov 25, 1998
AB EPIC PHARMA LLC EQ 1MG BASE
A074673 001 Feb 28, 1997
AB EQ 2MG BASE
A074673 002 Feb 28, 1997
AB MYLAN EQ 1MG BASE
A074796 001 Jan 27, 1997
AB EQ 2MG BASE
A074796 002 Jan 27, 1997
AB WATSON LABS EQ 1MG BASE
A074145 001 Oct 17, 1995
AB EQ 2MG BASE
A074145 002 Oct 17, 1995
TENEX
AB PROMIUS PHARMA EQ 1MG BASE
N019032 001 Oct 27, 1986
AB + EQ 2MG BASE
N019032 002 Nov 07, 1988
TABLET, EXTENDED RELEASE;ORAL
GUANFACINE HYDROCHLORIDE
AB ACTAVIS ELIZABETH
EQ 1MG BASE
A200881 001 Oct 05, 2012
AB
EQ 2MG BASE
A200881 002 Oct 05, 2012
AB
EQ 3MG BASE
A200881 003 Oct 05, 2012
AB
EQ 4MG BASE
A200881 004 Oct 05, 2012
INTUNIV
AB SHIRE
EQ 1MG BASE
N022037 001 Sep 02, 2009
AB
EQ 2MG BASE
N022037 002 Sep 02, 2009
AB
EQ 3MG BASE
N022037 003 Sep 02, 2009
AB +
EQ 4MG BASE
N022037 004 Sep 02, 2009
GUANIDINE HYDROCHLORIDE
TABLET;ORAL
GUANIDINE HYDROCHLORIDE
MERCK SHARP DOHME
125MG
N001546 001
HALCINONIDE
CREAM;TOPICAL
HALOG
+ RANBAXY
0.1%
N017556 001
OINTMENT;TOPICAL
HALOG
+ RANBAXY
0.1%
N017824 001
HALOBETASOL PROPIONATE
CREAM;TOPICAL
HALOBETASOL PROPIONATE
AB FOUGERA PHARMS
0.05%
A077001 001 Dec 16, 2004
AB G AND W LABS
0.05%
A078162 001 Apr 24, 2007
AB PERRIGO ISRAEL
0.05%
A077123 001 Dec 16, 2004
AB TARO
0.05%
A077227 001 Aug 04, 2005
ULTRAVATE
AB + RANBAXY
0.05%
N019967 001 Dec 27, 1990
OINTMENT;TOPICAL
HALOBETASOL PROPIONATE
AB G AND W LABS
0.05%
A077721 001 Sep 07, 2006
AB PERRIGO
0.05%
A076872 001 Dec 16, 2004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-177(of 371)
HALOBETASOL PROPIONATE
OINTMENT;TOPICAL
HALOBETASOL PROPIONATE
AB TARO 0.05% A076994 001 Dec 16, 2004
ULTRAVATE
AB + RANBAXY 0.05% N019968 001 Dec 17, 1990
HALOPERIDOL
TABLET;ORAL
HALOPERIDOL
AB MYLAN 0.5MG A070278 006 Jun 10, 1986
AB 1MG A070278 004 Jun 10, 1986
AB 2MG A070278 001 Jun 10, 1986
AB 5MG A070278 005 Jun 10, 1986
AB 10MG A070278 002 Jul 16, 2009
AB 20MG A070278 003 Jul 16, 2009
AB SANDOZ 0.5MG A071206 001 Nov 17, 1986
AB 1MG A071207 001 Nov 17, 1986
AB + 2MG A071208 001 Nov 17, 1986
AB 5MG A071209 001 Nov 17, 1986
AB 10MG A071210 001 Mar 11, 1988
AB 20MG A071211 001 Mar 11, 1988
AB ZYDUS PHARMS USA 5MG A077580 003 Nov 29, 2007
AB 10MG A077580 004 Nov 29, 2007
AB 20MG A077580 005 Nov 29, 2007
HALOPERIDOL DECANOATE
INJECTABLE;INJECTION
HALDOL
AO + JANSSEN PHARMS EQ 50MG BASE/ML N018701 001 Jan 14, 1986
AO + EQ 100MG BASE/ML N018701 002 Jan 31, 1997
HALOPERIDOL DECANOATE
AO AGILA SPECLTS EQ 50MG BASE/ML A075440 001 Feb 28, 2000
AO EQ 100MG BASE/ML A075440 002 Feb 28, 2000
AO EUROHLTH INTL EQ 50MG BASE/ML A074811 001 Jan 30, 1998
AO EQ 100MG BASE/ML A075305 001 Sep 28, 1998
AO FRESENIUS KABI USA EQ 50MG BASE/ML A074893 001 Dec 19, 1997
AO EQ 100MG BASE/ML A074893 002 Dec 19, 1997
AO TEVA PHARMS USA EQ 50MG BASE/ML A075393 001 May 11, 1999
AO EQ 100MG BASE/ML A075393 002 May 11, 1999
HALOPERIDOL LACTATE
CONCENTRATE;ORAL
HALOPERIDOL
AA PHARM ASSOC EQ 2MG BASE/ML A073037 001 Feb 26, 1993
AA SILARX EQ 2MG BASE/ML A073364 001 Sep 28, 1993
AA + TEVA PHARMS EQ 2MG BASE/ML A071617 001 Dec 01, 1988
INJECTABLE;INJECTION
HALDOL
AP + JANSSEN PHARMS EQ 5MG BASE/ML N015923 001
HALOPERIDOL
AP AGILA SPECLTS EQ 5MG BASE/ML A078347 001 Sep 14, 2009
AP EUROHLTH INTL EQ 5MG BASE/ML A075858 001 Jun 18, 2001
AP FRESENIUS KABI USA EQ 5MG BASE/ML A075689 001 Mar 09, 2001
AP GLAND PHARMA LTD EQ 5MG BASE/ML A076774 001 Aug 25, 2004
AP SAGENT PHARMS EQ 5MG BASE/ML A091637 001 Sep 02, 2011
AP EQ 5MG BASE/ML A200742 001 Sep 02, 2011
AP TEVA PHARMS USA EQ 5MG BASE/ML A076035 001 Aug 29, 2001
HEPARIN SODIUM
INJECTABLE;INJECTION
HEPARIN SODIUM
AP + FRESENIUS KABI USA 1,000 UNITS/ML N017029 001
AP + 5,000 UNITS/ML N017651 006
AP + 10,000 UNITS/ML N017029 003
AP + 20,000 UNITS/ML N017029 004
AP + HIKMA MAPLE 1,000 UNITS/ML N017037 001
AP + 5,000 UNITS/ML N017037 002
AP + 10,000 UNITS/ML N017037 003
AP HOSPIRA INC 1,000 UNITS/ML A090571 001 Aug 31, 2009
AP 5,000 UNITS/ML A090571 002 Aug 31, 2009
AP 10,000 UNITS/ML A090571 003 Aug 31, 2009
AP SAGENT PHARMS 1,000 UNITS/ML A090808 001 Jun 30, 2010
AP 5,000 UNITS/ML A090808 002 Jun 30, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-178(of 371)
HEPARIN SODIUM
INJECTABLE;INJECTION
HEPARIN SODIUM
AP 10,000 UNITS/ML A090808 003 Jun 30, 2010
AP 20,000 UNITS/ML A090809 001 Jun 30, 2010
AP SANDOZ 1,000 UNITS/ML A091682 001 Jun 08, 2011
AP 5,000 UNITS/ML A091659 001 Jun 08, 2011
AP 5,000 UNITS/ML A091682 002 Jun 08, 2011
AP 10,000 UNITS/ML A201002 001 Jun 08, 2011
AP SHENZHEN TECHDOW 1,000 UNITS/ML A202957 001 Jun 12, 2014
AP 5,000 UNITS/ML A202733 001 Jun 12, 2014
AP 5,000 UNITS/ML A202957 002 Jun 12, 2014
AP 10,000 UNITS/ML A203198 001 Jun 12, 2014
AP 20,000 UNITS/ML A203198 002 Jun 12, 2014
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 200 UNITS/100ML N018609 001 Apr 28, 1982
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP + B BRAUN 200 UNITS/100ML N019953 001 Jul 20, 1992
AP HOSPIRA 200 UNITS/100ML N018916 010 Jun 23, 1989
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
AP HOSPIRA 10,000 UNITS/100ML N019339 003 Mar 27, 1985
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 200 UNITS/100ML N018609 002 Apr 28, 1982
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP HOSPIRA 200 UNITS/100ML N018916 011 Jun 23, 1989
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 4,000 UNITS/100ML N019952 001 Jul 20, 1992
AP HOSPIRA 4,000 UNITS/100ML N019805 001 Jan 25, 1989
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 5,000 UNITS/100ML N019952 004 Jul 20, 1992
AP + 10,000 UNITS/100ML N019952 005 Jul 20, 1992
AP HOSPIRA 5,000 UNITS/100ML N019339 004 Mar 27, 1985
AP 5,000 UNITS/100ML N019805 002 Jan 25, 1989
AP 10,000 UNITS/100ML N019339 002 Mar 27, 1985
HEPARIN SODIUM IN PLASTIC CONTAINER
AP + FRESENIUS KABI USA 1,000 UNITS/ML N017029 013 Dec 05, 1985
AP + 5,000 UNITS/ML N017029 014 Dec 05, 1985
AP + 10,000 UNITS/ML N017029 015 Dec 05, 1985
AP + 20,000 UNITS/ML N017029 016 Dec 05, 1985
HEPARIN SODIUM PRESERVATIVE FREE
AP + FRESENIUS KABI USA 1,000 UNITS/ML N017029 010 Apr 28, 1986
AP SAGENT PHARMS 1,000 UNITS/ML A090810 001 Jun 30, 2010
AP SHENZHEN TECHDOW 1,000 UNITS/ML A202732 001 Jun 12, 2014
HEPARIN SODIUM
+ FRESENIUS KABI USA 10,000 UNITS/ML N017029 020 Mar 31, 2011
+ HOSPIRA 5,000 UNITS/ML A088100 001 Apr 28, 1983
+ PFIZER 1,000 UNITS/ML N201370 001 Jul 21, 2011
+ 5,000 UNITS/ML N201370 002 Jul 21, 2011
+ 10,000 UNITS/ML N201370 003 Jul 21, 2011
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 5,000 UNITS/100ML N019339 001 Mar 27, 1985
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
HOSPIRA 5,000 UNITS/100ML N018916 006 Jan 31, 1984
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
HOSPIRA 5,000 UNITS/100ML N018916 007 Jan 31, 1984
10,000 UNITS/100ML N018916 008 Jan 31, 1984
HEPARIN SODIUM PRESERVATIVE FREE
+ FRESENIUS KABI USA 10,000 UNITS/ML N017029 019 Nov 22, 2010
+ HOSPIRA 10,000 UNITS/ML A089522 001 May 04, 1987
+ PFIZER 1,000 UNITS/ML N201370 004 Jul 21, 2011
HEXACHLOROPHENE
EMULSION;TOPICAL
PHISOHEX
+ SANOFI AVENTIS US 3% N006882 001
SPONGE;TOPICAL
PRE-OP
AT + DAVIS AND GECK 480MG N017433 001
PRE-OP II
AT DAVIS AND GECK 480MG N017433 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-179(of 371)
HEXAMINOLEVULINATE HYDROCHLORIDE
FOR SOLUTION;INTRAVESICAL
CYSVIEW KIT
+ PHOTOCURE ASA
100MG/VIAL
N022555 001 May 28, 2010
HISTRELIN ACETATE
IMPLANT;SUBCUTANEOUS
SUPPRELIN LA
+ ENDO PHARM
50MG
N022058 001 May 03, 2007
VANTAS
+ ENDO PHARM
50MG
N021732 001 Oct 12, 2004
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
SYRUP;ORAL
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
AA ACTAVIS MID ATLANTIC 1.5MG/5ML;5MG/5ML
A088017 001 Jul 05, 1983
AA + HI TECH PHARMA 1.5MG/5ML;5MG/5ML
A040613 001 Feb 08, 2008
AA WOCKHARDT 1.5MG/5ML;5MG/5ML
A088008 001 Mar 03, 1983
TABLET;ORAL
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
AA NOVEL LABS INC
1.5MG;5MG
A091528 001 Apr 20, 2011
TUSSIGON
AA + KING PHARMS
1.5MG;5MG
A088508 001 Jul 30, 1985
HYALURONIDASE
INJECTABLE;INJECTION
AMPHADASE
+ AMPHASTAR PHARM
150 UNITS/ML
N021665 001 Oct 26, 2004
VITRASE
+ BAUSCH AND LOMB
200 UNITS/VIAL
N021640 002 Dec 02, 2004
HYALURONIDASE RECOMBINANT HUMAN
INJECTABLE;INJECTION
HYLENEX RECOMBINANT
+ HALOZYME THERAP
150 UNITS/ML
N021859 001 Dec 02, 2005
HYDRALAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
HYDRALAZINE HYDROCHLORIDE
AP AKORN 20MG/ML
A040730 001 Apr 21, 2009
AP FRESENIUS KABI USA 20MG/ML
A040388 001 Mar 13, 2001
AP + LUITPOLD 20MG/ML
A040136 001 Jun 30, 1997
AP NAVINTA LLC 20MG/ML
A202938 001 Mar 28, 2013
TABLET;ORAL
HYDRALAZINE HYDROCHLORIDE
AA ACTAVIS GRP PTC
10MG
A091679 001 Mar 04, 2013
AA
25MG
A091679 002 Mar 04, 2013
AA
50MG
A091679 003 Mar 04, 2013
AA
100MG
A091679 004 Mar 04, 2013
AA ALKEM LABS LTD
10MG
A200737 001 Dec 07, 2012
AA
25MG
A200737 002 Dec 07, 2012
AA
50MG
A200737 003 Dec 07, 2012
AA
100MG
A200737 004 Dec 07, 2012
AA CADILA PHARMS LTD
25MG
A203845 001 Sep 18, 2014
AA
50MG
A203845 002 Sep 18, 2014
AA
100MG
A203845 003 Sep 18, 2014
AA GLENMARK PHARMS LTD
10MG
A090527 001 May 27, 2009
AA
25MG
A090527 002 May 27, 2009
AA
50MG
A090527 003 May 27, 2009
AA
100MG
A090527 004 May 27, 2009
AA HERITAGE PHARMS INC
10MG
A086242 001 Feb 04, 2010
AA
25MG
A086242 003
AA
50MG
A086242 002
AA
100MG
A086242 004 Feb 04, 2010
AA HETERO LABS LTD III
10MG
A040901 001 Sep 12, 2008
AA
25MG
A040901 002 Sep 12, 2008
AA
50MG
A040901 003 Sep 12, 2008
AA
100MG
A040901 004 Sep 12, 2008
AA INVAGEN PHARMS
10MG
A090255 001 Dec 15, 2008
AA
25MG
A090255 002 Dec 15, 2008
AA
50MG
A090255 003 Dec 15, 2008
AA
100MG
A090255 004 Dec 15, 2008
AA MYLAN
10MG
A090413 001 Dec 08, 2010
AA
25MG
A090413 002 Dec 08, 2010
AA
50MG
A090413 003 Dec 08, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-180(of 371)
HYDRALAZINE HYDROCHLORIDE
TABLET;ORAL
HYDRALAZINE HYDROCHLORIDE
AA 100MG A090413 004 Dec 08, 2010
AA PAR PHARM 10MG A087836 001 Oct 05, 1982
AA 25MG A086961 002
AA 50MG A086962 001
AA 100MG A088391 001 Sep 27, 1983
AA + PLIVA 10MG A089097 001 Dec 18, 1985
AA + 25MG A088467 001 May 01, 1984
AA + 50MG A088468 001 May 01, 1984
AA + 100MG A089098 001 Dec 18, 1985
AA STRIDES PHARMA 25MG A200770 001 May 03, 2013
AA 50MG A200770 002 May 03, 2013
AA 100MG A200770 003 May 03, 2013
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
CAPSULE;ORAL
HYDRA-ZIDE
PAR PHARM 25MG;25MG A088957 001 Oct 21, 1985
+ 50MG;50MG A088946 001 Oct 21, 1985
HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE
TABLET;ORAL
BIDIL
+ ARBOR PHARMS LLC 37.5MG;20MG N020727 001 Jun 23, 2005
HYDROCHLOROTHIAZIDE
CAPSULE;ORAL
HYDROCHLOROTHIAZIDE
AB ALEMBIC PHARMS LTD 12.5MG A200645 001 Nov 30, 2010
AB APOTEX 12.5MG A078389 001 May 16, 2008
AB AUROBINDO PHARMA 12.5MG A078164 001 Sep 18, 2007
AB IPCA LABS LTD 12.5MG A079237 001 Apr 02, 2009
AB IVAX SUB TEVA PHARMS 12.5MG A077005 001 Jul 13, 2005
AB JUBILANT CADISTA 12.5MG A078391 001 Feb 11, 2008
AB LANNETT HOLDINGS INC 12.5MG A091662 001 Jan 27, 2012
AB MYLAN 12.5MG A075640 001 Jan 28, 2000
AB SUN PHARM INDS INC 12.5MG A090651 001 Apr 07, 2014
AB UNICHEM 12.5MG A090510 001 Jan 19, 2010
AB VINTAGE PHARMS 12.5MG A075907 001 Sep 17, 2002
MICROZIDE
AB + WATSON LABS 12.5MG N020504 001 Dec 27, 1996
TABLET;ORAL
HYDROCHLOROTHIAZIDE
AB ACCORD HLTHCARE 12.5MG A202556 001 Sep 24, 2012
AB 25MG A202556 002 Sep 24, 2012
AB 50MG A202556 003 Sep 24, 2012
AB ACTAVIS ELIZABETH 12.5MG A040707 001 Feb 27, 2007
AB APOTEX 25MG A040774 001 Oct 03, 2007
AB 50MG A040774 002 Oct 03, 2007
AB AUROBINDO PHARMA 25MG A040780 001 Jul 20, 2007
AB 50MG A040780 002 Jul 20, 2007
AB DAVA PHARMS INC 25MG A087059 001
AB 50MG A087068 001
AB EXCELLIUM 25MG A040702 001 Mar 16, 2007
AB 50MG A040702 002 Mar 16, 2007
AB HERITAGE PHARMS INC 25MG A085182 002
AB 50MG A085182 001
AB HIKMA PHARMS LLC 50MG A084878 001
AB IPCA LABS LTD 12.5MG A040807 001 Jul 20, 2007
AB 25MG A040807 002 Jul 20, 2007
AB 50MG A040807 003 Jul 20, 2007
AB IVAX SUB TEVA PHARMS 25MG A083177 001
AB + 50MG A083177 002
AB JUBILANT CADISTA 25MG A040809 001 Sep 04, 2007
AB 50MG A040809 002 Sep 04, 2007
AB LANNETT 25MG A084325 001
AB 50MG A084324 001
AB MYLAN PHARMS INC 12.5MG A040770 001 Jan 23, 2007
AB 25MG A040735 002 Jan 23, 2007
AB 50MG A040735 003 Jan 23, 2007
AB SCIEGEN PHARMS INC 25MG A203018 001 Jul 23, 2014
AB 50MG A203018 002 Jul 23, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-181(of 371)
HYDROCHLOROTHIAZIDE
TABLET;ORAL
HYDROCHLOROTHIAZIDE
AB SUN PHARM INDS INC 12.5MG
A040857 001 May 30, 2008
AB 25MG
A040810 001 Mar 27, 2007
AB 50MG
A040810 002 Mar 27, 2007
AB UNICHEM 25MG
A040907 001 Aug 15, 2008
AB 50MG
A040907 002 Aug 15, 2008
AB VINTAGE PHARMS 25MG
A040412 001 Mar 29, 2002
AB 50MG
A040412 002 Mar 29, 2002
ORETIC
AB ABBVIE 50MG
N011971 002
HYDROCHLOROTHIAZIDE; IRBESARTAN
TABLET;ORAL
AVALIDE
AB + SANOFI AVENTIS US 12.5MG;150MG N020758 002 Sep 30, 1997
AB + 12.5MG;300MG N020758 003 Aug 31, 1998
IRBESARTAN AND HYDROCHLOROTHIAZIDE
AB ALEMBIC LTD 12.5MG;150MG
A091370 001 Oct 15, 2012
AB 12.5MG;300MG
A091370 002 Oct 15, 2012
AB APOTEX INC 12.5MG;150MG
A201505 001 Oct 15, 2012
AB 12.5MG;300MG
A201505 002 Oct 15, 2012
AB AUROBINDO PHARMA LTD 12.5MG;150MG
A203630 001 Feb 22, 2013
AB 12.5MG;300MG
A203630 002 Feb 22, 2013
AB DR REDDYS LABS LTD 12.5MG;150MG
A203500 001 Sep 27, 2012
AB 12.5MG;300MG
A203500 002 Sep 27, 2012
AB LUPIN LTD 12.5MG;150MG
A201524 001 Feb 27, 2013
AB 12.5MG;300MG
A201524 002 Feb 27, 2013
AB MACLEODS PHARMS LTD 12.5MG;150MG
A202414 001 Sep 27, 2012
AB 12.5MG;300MG
A202414 002 Sep 27, 2012
AB MYLAN PHARMS INC 12.5MG;150MG
A077969 001 Sep 27, 2012
AB 12.5MG;300MG
A077969 002 Sep 27, 2012
AB PRINSTON INC 12.5MG;150MG
A203072 001 May 09, 2014
AB 12.5MG;300MG
A203072 002 May 09, 2014
AB ROXANE 12.5MG;150MG
A090351 001 Oct 15, 2012
AB 12.5MG;300MG
A090351 002 Oct 15, 2012
AB SANDOZ 12.5MG;150MG
A077446 001 Sep 27, 2012
AB 12.5MG;300MG
A077446 002 Sep 27, 2012
AB TEVA 12.5MG;150MG
A077369 001 Mar 30, 2012
AB 12.5MG;300MG
A077369 002 Mar 30, 2012
AB WATSON LABS INC 12.5MG;150MG
A091539 001 Oct 22, 2012
AB
12.5MG;300MG
A091539 002 Oct 22, 2012
HYDROCHLOROTHIAZIDE; LISINOPRIL
TABLET;ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDE
AB APOTEX INC 12.5MG;10MG
A076674 001 Oct 05, 2004
AB 12.5MG;20MG
A076674 002 Oct 05, 2004
AB 25MG;20MG
A076674 003 Oct 05, 2004
AB AUROBINDO 12.5MG;10MG
A077606 001 Mar 14, 2006
AB 12.5MG;20MG
A077606 002 Mar 14, 2006
AB 25MG;20MG
A077606 003 Mar 14, 2006
AB HIKMA INTL PHARMS 12.5MG;10MG
A076265 001 Jul 08, 2002
AB 12.5MG;20MG
A076265 002 Jul 08, 2002
AB 25MG;20MG
A076265 003 Jul 08, 2002
AB IVAX SUB TEVA PHARMS 12.5MG;10MG
A075776 001 Jul 01, 2002
AB 12.5MG;20MG
A075776 002 Jul 01, 2002
AB 25MG;20MG
A075776 003 Jul 01, 2002
AB LUPIN 12.5MG;10MG
A077912 001 Sep 27, 2006
AB 12.5MG;20MG
A077912 002 Sep 27, 2006
AB 25MG;20MG
A077912 003 Sep 27, 2006
AB MYLAN 12.5MG;10MG
A076113 001 Jul 01, 2002
AB 12.5MG;20MG
A076113 002 Jul 01, 2002
AB 25MG;20MG
A076113 003 Jul 01, 2002
AB PRINSTON INC 12.5MG;10MG
A076230 001 Jul 01, 2002
AB 12.5MG;20MG
A076230 002 Jul 01, 2002
AB 25MG;20MG
A076230 003 Jul 01, 2002
AB RANBAXY 12.5MG;10MG
A076007 001 Jul 01, 2002
AB 12.5MG;20MG
A076007 002 Jul 01, 2002
AB 25MG;20MG
A076007 003 Jul 01, 2002
AB SANDOZ 12.5MG;10MG
A076262 001 Jul 01, 2002
AB 12.5MG;20MG
A076262 002 Jul 01, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-182(of 371)
HYDROCHLOROTHIAZIDE; LISINOPRIL
TABLET;ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDE
AB 25MG;20MG A076262 003 Jul 01, 2002
AB WATSON LABS 12.5MG;10MG A076194 003 Jul 01, 2002
AB 12.5MG;20MG A076194 001 Jul 01, 2002
AB 25MG;20MG A076194 002 Jul 01, 2002
PRINZIDE
AB MERCK 12.5MG;10MG N019778 003 Nov 18, 1993
AB 12.5MG;20MG N019778 001 Feb 16, 1989
ZESTORETIC
AB ASTRAZENECA 12.5MG;10MG N019888 003 Nov 18, 1993
AB + 12.5MG;20MG N019888 001 Sep 20, 1990
AB + 25MG;20MG N019888 002 Jul 20, 1989
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
TABLET;ORAL
HYZAAR
AB MERCK SHARP DOHME 12.5MG;50MG N020387 001 Apr 28, 1995
AB 12.5MG;100MG N020387 003 Oct 20, 2005
AB + 25MG;100MG N020387 002 Nov 10, 1998
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
AB ALEMBIC PHARMS LTD 12.5MG;50MG A091617 001 Feb 17, 2012
AB 12.5MG;100MG A091617 002 Feb 17, 2012
AB 25MG;100MG A091617 003 Feb 17, 2012
AB APOTEX 12.5MG;50MG A090150 001 Oct 06, 2010
AB 12.5MG;100MG A090150 002 Aug 11, 2010
AB 25MG;100MG A090150 003 Oct 06, 2010
AB AUROBINDO PHARMA 12.5MG;50MG A091629 001 Oct 06, 2010
AB 12.5MG;100MG A091629 002 Oct 06, 2010
AB 25MG;100MG A091629 003 Jan 06, 2010
AB CADISTA PHARMS 12.5MG;50MG A201845 001 Sep 18, 2012
AB 12.5MG;100MG A201845 002 Sep 18, 2012
AB 25MG;100MG A201845 003 Sep 18, 2012
AB IPCA LABS LTD 12.5MG;50MG A201682 001 Mar 01, 2013
AB 12.5MG;100MG A201682 002 Mar 01, 2013
AB 25MG;100MG A201682 003 Mar 01, 2013
AB LUPIN LTD 12.5MG;50MG A078245 001 Oct 06, 2010
AB 12.5MG;100MG A078245 002 May 21, 2010
AB 25MG;100MG A078245 003 Oct 06, 2010
AB MACLEODS PHARMS LTD 12.5MG;50MG A202289 001 Aug 09, 2012
AB 12.5MG;100MG A202289 002 Aug 09, 2012
AB 25MG;100MG A202289 003 Aug 09, 2012
AB MYLAN 12.5MG;50MG A091652 001 Oct 06, 2010
AB 12.5MG;100MG A091652 002 Apr 06, 2010
AB 25MG;100MG A091652 003 Oct 06, 2010
AB ROXANE 12.5MG;50MG A077732 002 Oct 06, 2010
AB 12.5MG;100MG A077732 001 Apr 06, 2010
AB 25MG;100MG A077732 003 Oct 06, 2010
AB SANDOZ 12.5MG;50MG A077948 001 Oct 06, 2010
AB 12.5MG;100MG A077948 003 Aug 19, 2010
AB 25MG;100MG A077948 002 Oct 06, 2010
AB TEVA PHARMS 12.5MG;50MG A077157 001 Apr 06, 2010
AB 12.5MG;100MG A077157 002 Apr 06, 2010
AB 25MG;100MG A077157 003 Apr 06, 2010
AB TORRENT PHARMS 12.5MG;50MG A090528 001 Oct 06, 2010
AB 12.5MG;100MG A090528 003 Apr 06, 2010
AB 25MG;100MG A090528 002 Oct 06, 2010
AB ZYDUS PHARMS USA INC 12.5MG;50MG A078385 001 Oct 06, 2010
AB 25MG;100MG A078385 002 Oct 06, 2010
HYDROCHLOROTHIAZIDE; METHYLDOPA
TABLET;ORAL
METHYLDOPA AND HYDROCHLOROTHIAZIDE
MYLAN 15MG;250MG A070265 002 Jan 23, 1986
+ 25MG;250MG A070265 001 Jan 23, 1986
HYDROCHLOROTHIAZIDE; METOPROLOL SUCCINATE
TABLET, EXTENDED RELEASE;ORAL
DUTOPROL
COVIS PHARMA SARL 12.5MG;EQ 25MG TARTRATE N021956 001 Aug 28, 2006
12.5MG;EQ 50MG TARTRATE N021956 002 Aug 28, 2006
+ 12.5MG;EQ 100MG TARTRATE N021956 003 Aug 28, 2006
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-183(of 371)
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
TABLET;ORAL
LOPRESSOR HCT
AB US PHARMS HOLDINGS I 25MG;50MG N018303 001 Dec 31, 1984
AB + 25MG;100MG N018303 002 Dec 31, 1984
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE
AB ALEMBIC PHARMS LTD 25MG;50MG A202870 001 Nov 06, 2013
AB 25MG;100MG A202870 002 Nov 06, 2013
AB 50MG;100MG A202870 003 Nov 06, 2013
AB MYLAN 25MG;50MG A076792 001 Aug 20, 2004
AB 25MG;100MG A076792 002 Aug 20, 2004
AB 50MG;100MG A076792 003 Aug 20, 2004
AB SUN PHARM INDS 25MG;50MG A090654 001 Jan 19, 2012
AB 25MG;100MG A090654 002 Jan 19, 2012
AB 50MG;100MG A090654 003 Jan 19, 2012
HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE
TABLET;ORAL
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
AB GLENMARK PHARMS 12.5MG;7.5MG A090718 001 Mar 17, 2010
AB 12.5MG;15MG A090718 002 Mar 17, 2010
AB 25MG;15MG A090718 003 Mar 17, 2010
AB TEVA 12.5MG;7.5MG A076980 001 Mar 07, 2007
AB 12.5MG;15MG A076980 003 Mar 07, 2007
AB 25MG;15MG A076980 002 Mar 07, 2007
MOEXIPRIL HYDROCHLORIDE AND HYDROCHOLROTHIAZIDE
AB HERITAGE PHARMS INC 12.5MG;7.5MG A202150 001 Mar 07, 2014
AB 12.5MG;15MG A202150 002 Mar 07, 2014
AB 25MG;15MG A202150 003 Mar 07, 2014
UNIRETIC
AB UCB INC 12.5MG;7.5MG N020729 001 Jun 27, 1997
AB 12.5MG;15MG N020729 003 Feb 14, 2002
AB + 25MG;15MG N020729 002 Jun 27, 1997
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL
TABLET;ORAL
BENICAR HCT
DAIICHI SANKYO 12.5MG;20MG N021532 002 Jun 05, 2003
12.5MG;40MG N021532 003 Jun 05, 2003
+ 25MG;40MG N021532 005 Jun 05, 2003
HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE
TABLET;ORAL
INDERIDE-40/25
AB + WYETH PHARMS INC 25MG;40MG N018031 001
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
AB MYLAN 25MG;40MG A070947 002 Mar 04, 1987
AB + 25MG;80MG A070947 001 Apr 01, 1987
AB PLIVA 25MG;40MG A072042 001 Mar 14, 1988
AB 25MG;80MG A072043 001 Mar 14, 1988
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
TABLET;ORAL
ACCURETIC
AB PFIZER PHARMS 12.5MG;EQ 10MG BASE N020125 001 Dec 28, 1999
AB 12.5MG;EQ 20MG BASE N020125 002 Dec 28, 1999
AB + 25MG;EQ 20MG BASE N020125 003 Dec 28, 1999
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
AB APOTEX CORP 12.5MG;EQ 10MG BASE A091524 001 Mar 12, 2013
AB 12.5MG;EQ 20MG BASE A091524 002 Mar 12, 2013
AB 25MG;EQ 20MG BASE A091524 003 Mar 12, 2013
AB AUROBINDO PHARMA 12.5MG;EQ 10MG BASE A078450 001 Aug 24, 2007
AB 12.5MG;EQ 20MG BASE A078450 002 Aug 24, 2007
AB 25MG;EQ 20MG BASE A078450 003 Aug 24, 2007
AB INVAGEN PHARMS 12.5MG;10MG A201356 001 Apr 20, 2011
AB 12.5MG;20MG A201356 002 Apr 20, 2011
AB 25MG;20MG A201356 003 Apr 20, 2011
AB MYLAN 12.5MG;EQ 10MG BASE A077093 001 Mar 28, 2005
AB 12.5MG;EQ 20MG BASE A077093 002 Mar 28, 2005
AB 25MG;EQ 20MG BASE A077093 003 Mar 28, 2005
AB RANBAXY 12.5MG;EQ 10MG BASE A078211 001 Mar 04, 2009
AB 12.5MG;EQ 20MG BASE A078211 002 Mar 04, 2009
AB 25MG;EQ 20MG BASE A078211 003 Mar 04, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-184(of 371)
HYDROCHLOROTHIAZIDE; QUINAPRIL HYDROCHLORIDE
TABLET;ORAL
QUINARETIC
AB GAVIS PHARMS 12.5MG;EQ 10MG BASE A076374 001 Mar 31, 2004
AB 12.5MG;EQ 20MG BASE A076374 002 Mar 31, 2004
AB 25MG;EQ 20MG BASE A076374 003 Mar 31, 2004
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
TABLET;ORAL
ALDACTAZIDE
AB GD SEARLE LLC 25MG;25MG N012616 004 Dec 30, 1982
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
AB MUTUAL PHARM 25MG;25MG A089534 001 Jul 02, 1987
AB MYLAN 25MG;25MG A086513 001
ALDACTAZIDE
+ GD SEARLE LLC 50MG;50MG N012616 005 Dec 30, 1982
HYDROCHLOROTHIAZIDE; TELMISARTAN
TABLET;ORAL
MICARDIS HCT
AB BOEHRINGER INGELHEIM 12.5MG;40MG N021162 001 Nov 17, 2000
AB 12.5MG;80MG N021162 002 Nov 17, 2000
AB + 25MG;80MG N021162 003 Apr 19, 2004
TELMISARTAN AND HYDROCHLOROTHIAZIDE
AB ALEMBIC PHARMS LTD 12.5MG;40MG A203010 001 Feb 25, 2014
AB 12.5MG;80MG A203010 002 Feb 25, 2014
AB 25MG;80MG A203010 003 Feb 25, 2014
AB LUPIN LTD 12.5MG;40MG A091351 001 Aug 07, 2014
AB 12.5MG;80MG A091351 002 Aug 07, 2014
AB 25MG;80MG A091351 003 Aug 07, 2014
AB MYLAN PHARMS INC 12.5MG;40MG A091648 001 Feb 25, 2014
AB 12.5MG;80MG A091648 002 Feb 25, 2014
AB 25MG;80MG A091648 003 Feb 25, 2014
AB TORRENT PHARMS LTD 12.5MG;40MG A201192 001 Feb 25, 2014
AB 12.5MG;80MG A201192 002 Feb 25, 2014
AB 25MG;80MG A201192 003 Feb 25, 2014
HYDROCHLOROTHIAZIDE; TRIAMTERENE
CAPSULE;ORAL
DYAZIDE
AB + GLAXOSMITHKLINE LLC 25MG;37.5MG N016042 003 Mar 03, 1994
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
AB DURAMED PHARMS BARR 25MG;37.5MG A075052 001 Jun 18, 1999
AB IVAX SUB TEVA PHARMS 25MG;50MG A074259 001 Mar 30, 1995
AB LANNETT HOLDINGS INC 25MG;37.5MG A201407 001 Dec 09, 2011
AB MYLAN 25MG;37.5MG A074701 001 Jun 07, 1996
AB SANDOZ 25MG;37.5MG A074821 001 Jun 05, 1997
AB + 25MG;50MG A073191 001 Jul 31, 1991
TABLET;ORAL
MAXZIDE
AB + MYLAN PHARMS INC 50MG;75MG N019129 001 Oct 22, 1984
MAXZIDE-25
AB MYLAN PHARMS INC 25MG;37.5MG N019129 003 May 13, 1988
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
AB APOTEX INC 25MG;37.5MG A071251 002 May 05, 1998
AB 50MG;75MG A071251 001 Apr 17, 1988
AB PLIVA 25MG;37.5MG A074026 001 Apr 26, 1996
AB 50MG;75MG A073467 001 Jan 31, 1996
AB SANDOZ 25MG;37.5MG A073281 001 Apr 30, 1992
AB 50MG;75MG A072011 001 Jun 17, 1988
AB WATSON LABS 25MG;37.5MG A073449 001 Sep 23, 1993
AB 50MG;75MG A071851 001 Nov 30, 1988
HYDROCHLOROTHIAZIDE; VALSARTAN
TABLET;ORAL
DIOVAN HCT
AB NOVARTIS 12.5MG;80MG N020818 001 Mar 06, 1998
AB 12.5MG;160MG N020818 002 Mar 06, 1998
AB 12.5MG;320MG N020818 004 Apr 28, 2006
AB 25MG;160MG N020818 003 Jan 17, 2002
AB + 25MG;320MG N020818 005 Apr 28, 2006
VALSARTAN AND HYDROCHLOROTHIAZIDE
AB ALEMBIC LTD 12.5MG;80MG A201662 001 Mar 21, 2013
AB 12.5MG;160MG A201662 002 Mar 21, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-185(of 371)
HYDROCHLOROTHIAZIDE; VALSARTAN
TABLET;ORAL
VALSARTAN AND HYDROCHLOROTHIAZIDE
AB 12.5MG;320MG A201662 003 Mar 21, 2013
AB 25MG;160MG A201662 004 Mar 21, 2013
AB 25MG;320MG A201662 005 Mar 21, 2013
AB APOTEX INC 12.5MG;80MG A203026 001 Mar 21, 2013
AB 12.5MG;160MG A203026 002 Mar 21, 2013
AB 12.5MG;320MG A203026 003 Mar 21, 2013
AB 25MG;160MG A203026 004 Mar 21, 2013
AB 25MG;320MG A203026 005 Mar 21, 2013
AB AUROBINDO PHARMA LTD 12.5MG;80MG A202519 001 Mar 21, 2013
AB 12.5MG;160MG A202519 002 Mar 21, 2013
AB 12.5MG;320MG A202519 003 Mar 21, 2013
AB 25MG;160MG A202519 004 Mar 21, 2013
AB 25MG;320MG A202519 005 Mar 21, 2013
AB LUPIN LTD 12.5MG;80MG A078946 003 Mar 21, 2013
AB 12.5MG;160MG A078946 004 Mar 21, 2013
AB 12.5MG;320MG A078946 001 Mar 21, 2013
AB 25MG;160MG A078946 005 Mar 21, 2013
AB 25MG;320MG A078946 002 Mar 21, 2013
AB MACLEODS PHARMS LTD 12.5MG;80MG A203145 001 Apr 19, 2013
AB 12.5MG;160MG A203145 002 Apr 19, 2013
AB 12.5MG;320MG A203145 003 Apr 19, 2013
AB 25MG;160MG A203145 004 Apr 19, 2013
AB 25MG;320MG A203145 005 Apr 19, 2013
AB MYLAN PHARMS INC 12.5MG;80MG A078020 001 Sep 21, 2012
AB 12.5MG;160MG A078020 002 Sep 21, 2012
AB 12.5MG;320MG A078020 004 Sep 21, 2012
AB 25MG;160MG A078020 003 Sep 21, 2012
AB 25MG;320MG A078020 005 Sep 21, 2012
AB WATSON LABS INC 12.5MG;80MG A091519 001 Mar 21, 2013
AB 12.5MG;160MG A091519 002 Mar 21, 2013
AB 12.5MG;320MG A091519 003 Mar 21, 2013
AB 25MG;160MG A091519 004 Mar 21, 2013
AB 25MG;320MG A091519 005 Mar 21, 2013
HYDROCODONE BITARTRATE
CAPSULE, EXTENDED RELEASE;ORAL
ZOHYDRO ER
+ ZOGENIX INC 10MG N202880 001 Oct 25, 2013
15MG N202880 002 Oct 25, 2013
20MG N202880 003 Oct 25, 2013
30MG N202880 004 Oct 25, 2013
40MG N202880 005 Oct 25, 2013
50MG N202880 006 Oct 25, 2013
TABLET, EXTENDED RELEASE;ORAL
HYSINGLA
PURDUE PHARMA LP 20MG N206627 001 Nov 20, 2014
30MG N206627 002 Nov 20, 2014
40MG N206627 003 Nov 20, 2014
60MG N206627 004 Nov 20, 2014
80MG N206627 005 Nov 20, 2014
100MG N206627 006 Nov 20, 2014
120MG N206627 007 Nov 20, 2014
HYDROCODONE BITARTRATE; IBUPROFEN
TABLET;ORAL
HYDROCODONE BITARTRATE AND IBUPROFEN
AB ACTAVIS LABS FL INC 5MG;200MG A077454 001 Jun 23, 2010
AB 7.5MG;200MG A076604 001 Dec 31, 2003
AB AMNEAL PHARMS NY 5MG;200MG A076642 002 Mar 18, 2004
AB 7.5MG;200MG A076642 001 Oct 12, 2004
AB SUN PHARM INDS INC 2.5MG;200MG A091633 001 May 28, 2013
AB 5MG;200MG A091633 002 May 28, 2013
AB 7.5MG;200MG A091633 003 May 28, 2013
AB 10MG;200MG A091633 004 May 28, 2013
AB TEVA 7.5MG;200MG A076023 001 Apr 11, 2003
AB VINTAGE PHARMS 5MG;200MG A077727 001 Nov 06, 2006
AB 7.5MG;200MG A077723 001 Nov 06, 2006
AB 10MG;200MG A077723 002 Nov 06, 2006
REPREXAIN
AB AMNEAL PHARMS NY 2.5MG;200MG A076642 003 Oct 19, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-186(of 371)
HYDROCODONE BITARTRATE; IBUPROFEN
TABLET;ORAL
REPREXAIN
AB 10MG;200MG A076642 004 Oct 19, 2007
VICOPROFEN
AB + ABBVIE 7.5MG;200MG N020716 001 Sep 23, 1997
HYDROCODONE BITARTRATE; PSEUDOEPHEDRINE HYDROCHLORIDE
SOLUTION;ORAL
HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE
AA PADDOCK LLC 5MG/5ML;60MG/5ML A204658 001 Apr 29, 2014
AA TRIS PHARMA INC 5MG/5ML;60MG/5ML A203839 001 Oct 28, 2014
REZIRA
AA + CYPRESS PHARM 5MG/5ML;60MG/5ML N022442 001 Jun 08, 2011
HYDROCORTISONE
CREAM;TOPICAL
ALA-CORT
AT CROWN LABS 1% A080706 006
ANUSOL HC
AT SALIX PHARMS 2.5% A088250 001 Jun 06, 1984
HYDROCORTISONE
AT ACTAVIS MID ATLANTIC 1% A087795 001 May 03, 1983
AT 2.5% A089682 001 Mar 10, 1988
AT + FOUGERA 1% A080693 003
AT + 2.5% A089414 001 Dec 16, 1986
AT LYNE 2.5% A040879 001 Aug 20, 2010
AT PERRIGO NEW YORK 2.5% A085025 001
AT TARO 2.5% A088799 001 Nov 09, 1984
AT VINTAGE PHARMS 2.5% A040503 001 Mar 12, 2004
SYNACORT
AT MEDICIS 1% A087458 001
AT 2.5% A087457 001
ENEMA;RECTAL
COLOCORT
AB PADDOCK LLC 100MG/60ML A075172 001 Dec 03, 1999
CORTENEMA
AB + ANI PHARMS 100MG/60ML N016199 001
HYDROCORTISONE
AB TEVA PHARMS 100MG/60ML A074171 001 May 27, 1994
LOTION;TOPICAL
HYDROCORTISONE
AT + FOUGERA PHARMS 2.5% A040351 001 Jul 25, 2000
AT TARO 2.5% A040247 001 Jul 23, 1999
AT VINTAGE PHARMS 2.5% A040417 001 Jul 30, 2003
NUTRACORT
AT DOW PHARM 2.5% A087644 001 Aug 24, 1982
STIE-CORT
AT PERRIGO 2.5% A089074 001 Nov 26, 1985
ALA-SCALP
CROWN LABS 2% A083231 001
OINTMENT;TOPICAL
HYDROCORTISONE
AT ACTAVIS MID ATLANTIC 1% A087796 001 Oct 13, 1982
AT + FOUGERA 2.5% A081203 001 May 28, 1993
AT + FOUGERA PHARMS 1% A080692 001
AT PERRIGO NEW YORK 2.5% A085027 001
AT TARO 1% A086257 001
HYDROCORTISONE IN ABSORBASE
AT CAROLINA MEDCL 1% A088138 001 Sep 06, 1985
POWDER;FOR RX COMPOUNDING
HYDRO-RX
+ X GEN PHARMS 100% A085982 001
SOLUTION;TOPICAL
TEXACORT
+ MISSION PHARMA 2.5% A081271 001 Apr 17, 1992
TABLET;ORAL
CORTEF
AB PHARMACIA AND UPJOHN 5MG N008697 003
AB 10MG N008697 001
AB + 20MG N008697 002
HYDROCORTISONE
AB AMEDRA PHARMS 5MG A040646 001 Mar 30, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-187(of 371)
HYDROCORTISONE
TABLET;ORAL
HYDROCORTISONE
AB 10MG
A040646 002 Mar 30, 2007
AB 20MG
A040646 003 Mar 30, 2007
AB VINTAGE 5MG
A040761 001 Jul 16, 2007
AB 10MG
A040761 002 Jul 16, 2007
AB 20MG
A040761 003 Jul 16, 2007
HYDROCORTISONE ACETATE
AEROSOL, METERED;RECTAL
CORTIFOAM
+ MEDA PHARMS
10%
N017351 001 Feb 10, 1982
CREAM;TOPICAL
HYDROCORTISONE ACETATE
+ FERNDALE LABS
2.5%
A040259 001 Jul 29, 1999
MICORT-HC
+ SEBELA IRELAND LTD
2%
A040398 001 Mar 29, 2002
2.5%
A040396 001 Feb 27, 2001
POWDER;FOR RX COMPOUNDING
HYDROCORTISONE ACETATE
X GEN PHARMS
100%
A085981 001
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
CREAM;TOPICAL
CORTISPORIN
+ MONARCH PHARMS 0.5%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
N050218 001 Aug 09, 1985
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
AEROSOL, METERED;TOPICAL
EPIFOAM
BX MEDA PHARMS
1%;1%
A086457 001
PROCTOFOAM HC
BX MEDA PHARMS
1%;1%
A086195 001
CREAM;TOPICAL
PRAMOSONE
SEBELA IRELAND LTD
0.5%;1%
A083778 001
1%;1%
A085368 001
LOTION;TOPICAL
PRAMOSONE
SEBELA IRELAND LTD
1%;1%
A085980 001
2.5%;1%
A085979 001
HYDROCORTISONE ACETATE; UREA
CREAM;TOPICAL
U-CORT
TARO
1%;10%
A089472 001 Jun 13, 1988
HYDROCORTISONE BUTYRATE
CREAM;TOPICAL
HYDROCORTISONE BUTYRATE
AB1 TARO PHARM INDS
0.1%
A076654 001 Aug 03, 2005
LOCOID
AB1 + PRECISION DERMAT
0.1%
N018514 001 Mar 31, 1982
HYDROCORTISONE BUTYRATE
AB2 GLENMARK GENERICS
0.1%
A202145 001 Sep 27, 2013
LOCOID LIPOCREAM
AB2 + PRECISION DERMAT
0.1%
N020769 001 Sep 08, 1997
LOTION;TOPICAL
LOCOID
+ PRECISION DERMAT
0.1%
N022076 001 May 18, 2007
OINTMENT;TOPICAL
HYDROCORTISONE BUTYRATE
AB TARO
0.1%
A076842 001 Dec 27, 2004
LOCOID
AB + PRECISION DERMAT
0.1%
N018652 001 Oct 29, 1982
SOLUTION;TOPICAL
HYDROCORTISONE BUTYRATE
AT TARO PHARM INDS
0.1%
A076364 001 Jan 14, 2004
LOCOID
AT + PRECISION DERMAT
0.1%
N019116 001 Feb 25, 1987
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-188(of 371)
HYDROCORTISONE PROBUTATE
CREAM;TOPICAL
PANDEL
+ FOUGERA PHARMS 0.1% N020453 001 Feb 28, 1997
HYDROCORTISONE SODIUM SUCCINATE
INJECTABLE;INJECTION
A-HYDROCORT
AP HOSPIRA EQ 100MG BASE/VIAL A040666 001 Apr 06, 2006
SOLU-CORTEF
AP + PHARMACIA AND UPJOHN EQ 1GM BASE/VIAL N009866 004
AP + EQ 100MG BASE/VIAL N009866 001
AP + EQ 250MG BASE/VIAL N009866 002
AP + EQ 500MG BASE/VIAL N009866 003
HYDROCORTISONE VALERATE
CREAM;TOPICAL
HYDROCORTISONE VALERATE
AB PERRIGO NEW YORK 0.2% A075666 001 May 24, 2000
AB + TARO 0.2% A075042 001 Aug 25, 1998
OINTMENT;TOPICAL
HYDROCORTISONE VALERATE
+ TARO 0.2% A075043 001 Aug 25, 1998
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
SOLUTION/DROPS;OTIC
CORTISPORIN
AT + MONARCH PHARMS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N050479 001
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
AT ALCON PHARMS LTD 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062423 001 Aug 25, 1983
AT BAUSCH AND LOMB 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A064053 001 Dec 29, 1995
AT LUITPOLD 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A065216 001 Oct 31, 2005
SUSPENSION/DROPS;OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
+ ALCON PHARMS LTD 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062874 001 May 11, 1988
SUSPENSION/DROPS;OTIC
CORTISPORIN
AT + CITRON PHARMA LLC 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A060613 001
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE
AT ALCON PHARMS LTD 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062488 001 Nov 06, 1985
AT LUITPOLD 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A065219 001 May 01, 2006
OTICAIR
AT BAUSCH AND LOMB 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A064065 001 Aug 28, 1996
PEDIOTIC
AT MONARCH PHARMS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062822 001 Sep 29, 1987
HYDROFLUMETHIAZIDE
TABLET;ORAL
SALURON
AB + SHIRE LLC 50MG N011949 001
HYDROMORPHONE HYDROCHLORIDE
INJECTABLE;INJECTION
DILAUDID
AP + PURDUE PHARM PRODS 1MG/ML N019034 003 Apr 30, 2009
AP + 2MG/ML N019034 004 Apr 30, 2009
AP + 4MG/ML N019034 005 Apr 30, 2009
DILAUDID-HP
AP + PURDUE PHARM PRODS 10MG/ML N019034 001 Jan 11, 1984
HYDROMORPHONE HYDROCHLORIDE
AP AKORN 10MG/ML A078228 001 Apr 14, 2010
AP 10MG/ML A078261 001 Apr 14, 2010
AP BARR 10MG/ML A076444 001 Apr 25, 2003
AP HOSPIRA 10MG/ML A074598 001 Jun 19, 1997
AP HOSPIRA INC 1MG/ML N200403 001 Dec 01, 2011
AP 2MG/ML N200403 002 Dec 01, 2011
AP 4MG/ML N200403 003 Dec 01, 2011
AP 10MG/ML A078591 001 Jun 17, 2008
DILAUDID-HP
+ PURDUE PHARM PRODS 250MG/VIAL N019034 002 Aug 04, 1994
SOLUTION;ORAL
DILAUDID
AA + PURDUE PHARM PRODS 5MG/5ML N019891 001 Dec 07, 1992
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-189(of 371)
HYDROMORPHONE HYDROCHLORIDE
SOLUTION;ORAL
HYDROMORPHONE HYDROCHLORIDE
AA ROXANE 5MG/5ML A074653 001 Jul 29, 1998
TABLET;ORAL
DILAUDID
AB PURDUE PHARM PRODS 2MG N019892 003 Nov 09, 2007
AB 4MG N019892 002 Nov 09, 2007
AB + 8MG N019892 001 Dec 07, 1992
HYDROMORPHONE HYDROCHLORIDE
AB ELITE LABS 8MG A076723 001 Oct 18, 2005
AB LANNETT 2MG A078439 001 Dec 09, 2009
AB 4MG A078439 002 Dec 09, 2009
AB 8MG A077471 001 Dec 09, 2009
AB MALLINCKRODT 8MG A076855 001 Dec 23, 2004
AB MALLINCKRODT INC 2MG A078273 001 Sep 19, 2007
AB 4MG A078273 002 Sep 19, 2007
AB ROXANE 4MG A074597 003 May 29, 2009
AB 8MG A074597 001 Jul 29, 1998
TABLET, EXTENDED RELEASE;ORAL
EXALGO
AB MALLINCKRODT INC 8MG N021217 001 Mar 01, 2010
AB 12MG N021217 002 Mar 01, 2010
AB 16MG N021217 003 Mar 01, 2010
HYDROMORPHONE HYDROCHLORIDE
AB ACTAVIS LABS FL INC 8MG A202144 001 May 12, 2014
AB 12MG A202144 002 May 12, 2014
AB 16MG A202144 003 May 12, 2014
EXALGO
+ MALLINCKRODT INC 32MG N021217 004 Aug 24, 2012
HYDROXOCOBALAMIN
INJECTABLE;INJECTION
CYANOKIT
+ MERCK SANTE SAS 5GM/VIAL (5GM/KIT) N022041 001 Apr 08, 2011
HYDROXOCOBALAMIN
+ WATSON LABS 1MG/ML A085998 001
HYDROXYAMPHETAMINE HYDROBROMIDE; TROPICAMIDE
SOLUTION/DROPS;OPHTHALMIC
PAREMYD
+ AKORN 1%;0.25% N019261 001 Jan 30, 1992
HYDROXYCHLOROQUINE SULFATE
TABLET;ORAL
HYDROXYCHLOROQUINE SULFATE
AB HIKMA PHARMS LLC 200MG A040760 001 Aug 15, 2007
AB IPCA LABS LTD 200MG A040766 001 Jun 14, 2007
AB MYLAN 200MG A040274 001 May 29, 1998
AB SANDOZ 200MG A040104 001 Nov 30, 1995
AB TEVA PHARMS 200MG A040081 001 Sep 30, 1994
AB ZYDUS PHARMS USA INC 200MG A040657 001 Sep 21, 2007
PLAQUENIL
AB + SANOFI AVENTIS US 200MG N009768 001
HYDROXYPROGESTERONE CAPROATE
SOLUTION;INTRAMUSCULAR
MAKENA
+ LUMARA HEALTH INC 1250MG/5ML (250MG/ML) N021945 001 Feb 03, 2011
HYDROXYPROPYL CELLULOSE
INSERT;OPHTHALMIC
LACRISERT
+ ATON 5MG N018771 001
HYDROXYUREA
CAPSULE;ORAL
HYDREA
AB + BRISTOL MYERS SQUIBB 500MG N016295 001
HYDROXYUREA
AB BARR 500MG A075143 001 Oct 16, 1998
AB PAR PHARM 500MG A075340 001 Feb 24, 1999
DROXIA
BRISTOL MYERS SQUIBB 200MG N016295 002 Feb 25, 1998
300MG N016295 003 Feb 25, 1998
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-190(of 371)
HYDROXYUREA
CAPSULE;ORAL
DROXIA
400MG N016295 004 Feb 25, 1998
HYDROXYZINE HYDROCHLORIDE
INJECTABLE;INJECTION
HYDROXYZINE HYDROCHLORIDE
AP + FRESENIUS KABI USA 25MG/ML A087329 001
AP + 50MG/ML A087329 002
AP LUITPOLD 25MG/ML A087408 001
AP 50MG/ML A087408 002
SYRUP;ORAL
HYDROXYZINE HYDROCHLORIDE
AA + HI TECH PHARMA 10MG/5ML A040010 001 Oct 28, 1994
AA SILARX PHARMS INC 10MG/5ML A201674 001 Aug 21, 2013
AA + VINTAGE PHARMS 10MG/5ML A040391 001 Apr 10, 2002
AA + WOCKHARDT 10MG/5ML A087294 001 Apr 12, 1982
TABLET;ORAL
HYDROXYZINE HYDROCHLORIDE
AB AMNEAL PHARM 10MG A040808 001 Sep 24, 2008
AB 25MG A040808 002 Sep 24, 2008
AB 50MG A040808 003 Sep 24, 2008
AB EMCURE PHARMS USA 10MG A204279 001 Aug 20, 2014
AB 25MG A204279 002 Aug 20, 2014
AB 50MG A204279 003 Aug 20, 2014
AB HERITAGE PHARMS INC 10MG A040804 001 Jun 30, 2008
AB 25MG A040804 002 Jun 30, 2008
AB 50MG A040804 003 Jun 30, 2008
AB HETERO LABS LTD III 10MG A040805 001 May 29, 2008
AB 25MG A040805 002 May 29, 2008
AB 50MG A040805 003 May 29, 2008
AB INVAGEN PHARMS 10MG A040812 001 Mar 12, 2008
AB 25MG A040812 002 Mar 12, 2008
AB 50MG A040812 003 Mar 12, 2008
AB KVK TECH 10MG A040786 001 Mar 20, 2007
AB 25MG A040787 001 Mar 20, 2007
AB 50MG A040788 001 Mar 20, 2007
AB MUTUAL PHARM 10MG A089381 001 May 19, 1986
AB 25MG A089382 001 May 19, 1986
AB 50MG A089383 001 May 19, 1986
AB MYLAN 10MG A091176 001 Jun 07, 2010
AB 25MG A091176 002 Jun 07, 2010
AB 50MG A091176 003 Jun 07, 2010
AB NORTHSTAR HLTHCARE 10MG A040841 001 Mar 31, 2008
AB 25MG A040842 001 Mar 31, 2008
AB 50MG A040840 001 Mar 31, 2008
AB + PLIVA 10MG A088617 001 Jan 10, 1986
AB + 25MG A088618 001 Jan 10, 1986
AB + 50MG A088619 001 Jan 10, 1986
AB SUN PHARM INDS INC 10MG A040899 001 Jun 10, 2008
AB 25MG A040899 002 Jun 10, 2008
AB 50MG A040899 003 Jun 10, 2008
AB VINTAGE PHARMS 10MG A040579 001 May 27, 2005
AB 25MG A040574 001 May 27, 2005
AB 50MG A040580 001 May 27, 2005
AB WATSON LABS 10MG A088348 001 Sep 15, 1983
AB 25MG A088349 001 Sep 15, 1983
AB 50MG A088350 001 Sep 15, 1983
HYDROXYZINE PAMOATE
CAPSULE;ORAL
HYDROXYZINE PAMOATE
AB BARR EQ 25MG HCL A088496 001 Jun 15, 1984
AB EQ 50MG HCL A088487 001 Jun 15, 1984
AB EMCURE PHARMS USA EQ 25MG HYDROCHLORIDE A201507 001 Jun 03, 2013
AB EQ 50MG HYDROCHLORIDE A201507 002 Jun 03, 2013
AB SANDOZ EQ 25MG HCL A087479 001
AB EQ 50MG HCL A086183 001
AB WATSON LABS EQ 25MG HCL A040156 001 Jul 15, 1996
AB EQ 50MG HCL A040156 002 Jul 15, 1996
VISTARIL
AB PFIZER EQ 25MG HCL N011459 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-191(of 371)
HYDROXYZINE PAMOATE
CAPSULE;ORAL
VISTARIL
AB + EQ 50MG HCL N011459 004
HYDROXYZINE PAMOATE
BARR EQ 100MG HCL A088488 001 Jun 15, 1984
IBANDRONATE SODIUM
INJECTABLE;INTRAVENOUS
BONIVA
AP + ROCHE EQ 3MG BASE/3ML N021858 001 Jan 06, 2006
IBANDRONATE SODIUM
AP AGILA SPECLTS EQ 3MG BASE/3ML A202671 001 Sep 02, 2014
AP EMCURE PHARMS LTD EQ 3MG BASE/3ML A203987 001 Sep 02, 2014
AP SAGENT PHARMS EQ 3MG BASE/3ML A202235 001 Sep 02, 2014
AP SUN PHARM INDS LTD EQ 3MG BASE/3ML A090853 001 Feb 14, 2014
TABLET;ORAL
BONIVA
AB + HOFFMANN LA ROCHE EQ 150MG BASE N021455 002 Mar 24, 2005
IBANDRONATE SODIUM
AB APOTEX INC EQ 150MG BASE A078948 001 Mar 19, 2012
AB DR REDDYS LABS LTD EQ 150MG BASE A078997 001 Apr 30, 2012
AB MUTUAL PHARM CO INC EQ 150MG BASE A078996 001 Aug 15, 2012
AB MYLAN PHARMS INC EQ 150MG BASE A078995 001 Mar 19, 2012
AB ORCHID HLTHCARE EQ 150MG BASE A078998 001 Mar 19, 2012
AB WATSON LABS INC EQ 150MG BASE A079003 001 Mar 20, 2012
IBRUTINIB
CAPSULE;ORAL
IMBRUVICA
+ PHARMACYCLICS INC 140MG N205552 001 Nov 13, 2013
IBUPROFEN
SOLUTION;INTRAVENOUS
CALDOLOR
+ CUMBERLAND PHARMS 800MG/8ML (100MG/ML) N022348 002 Jun 11, 2009
SUSPENSION;ORAL
IBUPROFEN
AB + ACTAVIS MID ATLANTIC 100MG/5ML A074978 001 Mar 25, 1998
AB PERRIGO R AND D 100MG/5ML A076925 001 Sep 23, 2004
TABLET;ORAL
IBU-TAB
AB ALRA 400MG A071058 001 Aug 11, 1988
AB 600MG A071059 001 Aug 11, 1988
IBUPROFEN
AB AMNEAL PHARMS NY 400MG A071334 001 Nov 25, 1986
AB 400MG A078558 001 Jun 18, 2007
AB 600MG A071335 001 Nov 25, 1986
AB 600MG A078558 002 Jun 18, 2007
AB 800MG A071935 001 Oct 13, 1987
AB 800MG A078558 003 Jun 18, 2007
AB CONTRACT PHARMACAL 400MG A071267 001 Oct 15, 1986
AB 600MG A071268 001 Oct 15, 1986
AB 800MG A072300 001 Jul 01, 1988
AB DR REDDYS LA 400MG A075682 001 Nov 14, 2001
AB 600MG A075682 002 Nov 14, 2001
AB + 800MG A075682 003 Nov 14, 2001
AB DR REDDYS LABS INC 400MG A076112 001 Oct 31, 2001
AB 600MG A076112 002 Oct 31, 2001
AB 800MG A076112 003 Oct 31, 2001
AB MARKSANS PHARMA 400MG A090796 001 Dec 21, 2010
AB 600MG A090796 002 Dec 21, 2010
AB 800MG A090796 003 Dec 21, 2010
AB PERRIGO R AND D 400MG A077114 001 Jul 18, 2005
AB 600MG A077114 002 Jul 18, 2005
AB 800MG A077114 003 Jul 18, 2005
AB SHASUN USA 400MG A078329 001 Feb 05, 2009
AB 600MG A078329 002 Feb 05, 2009
AB 800MG A078329 003 Feb 05, 2009
AB VINTAGE PHARMS 300MG A071230 001 Oct 22, 1986
AB 400MG A071231 001 Oct 22, 1986
AB 400MG A071644 001 Feb 01, 1988
AB 600MG A071232 001 Oct 22, 1986
AB 800MG A072004 001 Nov 18, 1987
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-192(of 371)
IBUPROFEN LYSINE
INJECTABLE;INTRAVENOUS
NEOPROFEN
+ RECORDATI RARE EQ 20MG BASE/2ML (EQ 10MG BASE/ML) N021903 001 Apr 13, 2006
IBUPROFEN; OXYCODONE HYDROCHLORIDE
TABLET;ORAL
OXYCODONE HYDROCHLORIDE AND IBUPROFEN
AB ACTAVIS ELIZABETH 400MG;5MG A078769 001 Jan 04, 2008
AB + BARR LABS INC 400MG;5MG A078316 001 Nov 29, 2007
AB WATSON LABS 400MG;5MG A078394 001 Nov 26, 2007
IBUTILIDE FUMARATE
INJECTABLE;INJECTION
CORVERT
AP + PHARMACIA AND UPJOHN 0.1MG/ML N020491 001 Dec 28, 1995
IBUTILIDE FUMARATE
AP LUITPOLD 0.1MG/ML A090240 001 Jan 11, 2010
AP MYLAN INSTITUTIONAL 0.1MG/ML A090643 001 Jan 11, 2010
AP 0.1MG/ML A090924 001 Jan 11, 2010
ICATIBANT ACETATE
INJECTABLE;SUBCUTANEOUS
FIRAZYR
+ SHIRE ORPHAN THERAP EQ 30MG BASE/3ML (EQ 10MG BASE/ML) N022150 001 Aug 25, 2011
ICODEXTRIN
SOLUTION;INTRAPERITONEAL
EXTRANEAL
+ BAXTER HLTHCARE 7.5GM/100ML N021321 001 Dec 20, 2002
ICOSAPENT ETHYL
CAPSULE;ORAL
VASCEPA
+ AMARIN PHARMS 1GM N202057 001 Jul 26, 2012
IDARUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
IDAMYCIN PFS
AP + PHARMACIA AND UPJOHN 1MG/ML N050734 001 Feb 17, 1997
IDARUBICIN HYDROCHLORIDE
AP EUROHLTH INTL 1MG/ML A065275 001 Dec 14, 2006
AP 1MG/ML A065288 001 May 15, 2007
AP FRESENIUS KABI USA 1MG/ML A065440 001 Aug 04, 2009
AP ONCO THERAPIES LTD 1MG/ML A200144 001 Oct 11, 2012
IDARUBICIN HYDROCHLORIDE PFS
AP TEVA PHARMS USA 1MG/ML A065036 001 May 01, 2002
IDELALISIB
TABLET;ORAL
ZYDELIG
GILEAD SCIENCES INC 100MG N205858 001 Jul 23, 2014
+ 150MG N205858 002 Jul 23, 2014
IDOXURIDINE
SOLUTION/DROPS;OPHTHALMIC
DENDRID
AT + ALCON 0.1% N014169 001
HERPLEX
AT + ALLERGAN 0.1% N013935 002
IFOSFAMIDE
INJECTABLE;INJECTION
IFEX
AP BAXTER HLTHCARE 1GM/VIAL N019763 001 Dec 30, 1988
AP 3GM/VIAL N019763 002 Dec 30, 1988
IFOSFAMIDE
AP EUROHLTH INTL 1GM/20ML(50MG/ML) A076619 001 Jun 29, 2011
AP 3GM/60ML(50MG/ML) A076619 002 Jun 29, 2011
AP + FRESENIUS KABI USA 1GM/VIAL A076078 001 May 28, 2002
AP 1GM/20ML (50MG/ML) A090181 001 Sep 22, 2009
AP + 3GM/VIAL A076078 002 May 28, 2002
AP 3GM/60ML (50MG/ML) A090181 002 Sep 22, 2009
AP ONCO THERAPIES LTD 1GM/20ML (50MG/ML) A201689 001 Nov 26, 2012
AP 3GM/60ML (50MG/ML) A201689 002 Nov 26, 2012
AP + TEVA PHARMS USA 1GM/20ML (50MG/ML) A076657 001 Apr 04, 2007
AP + 3GM/60ML (50MG/ML) A076657 002 Apr 04, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-193(of 371)
IFOSFAMIDE; MESNA
INJECTABLE;INTRAVENOUS
IFOSFAMIDE/MESNA KIT
+ TEVA PHARMS USA 1GM/20ML;1GM/10ML (50MG/ML;100MG/ML)
A075874 001 Feb 26, 2002
+ 3GM/60ML;1GM/10ML (50MG/ML;100MG/ML)
A075874 002 Feb 26, 2002
ILOPERIDONE
TABLET;ORAL
FANAPT
+ NOVARTIS 1MG
N022192 001 May 06, 2009
2MG
N022192 002 May 06, 2009
4MG
N022192 003 May 06, 2009
6MG
N022192 004 May 06, 2009
8MG
N022192 005 May 06, 2009
10MG
N022192 006 May 06, 2009
12MG
N022192 007 May 06, 2009
ILOPROST
SOLUTION;INHALATION
VENTAVIS
+ ACTELION PHARMS LTD 10MCG/ML (10MCG/ML)
N021779 002 Dec 08, 2005
+ 20MCG/ML (20MCG/ML)
N021779 003 Aug 07, 2009
IMATINIB MESYLATE
TABLET;ORAL
GLEEVEC
NOVARTIS EQ 100MG BASE
N021588 001 Apr 18, 2003
+ EQ 400MG BASE
N021588 002 Apr 18, 2003
IMIGLUCERASE
INJECTABLE;INJECTION
CEREZYME
GENZYME 200 UNITS/VIAL
N020367 001 May 23, 1994
+ 400 UNITS/VIAL
N020367 002 Sep 22, 1999
IMIPRAMINE HYDROCHLORIDE
TABLET;ORAL
IMIPRAMINE HYDROCHLORIDE
AB EXCELLIUM 10MG
A040903 001 Oct 24, 2012
AB 25MG
A040903 002 Oct 24, 2012
AB 50MG
A040903 003 Oct 24, 2012
AB LUPIN LTD 10MG
A090443 001 Mar 11, 2010
AB 25MG
A090442 001 Mar 11, 2010
AB 50MG
A090441 001 Mar 11, 2010
AB MUTUAL PHARM 10MG
A081048 001 Jun 05, 1990
AB 25MG
A081049 001 Jun 05, 1990
AB 50MG
A081050 001 Jun 05, 1990
AB PAR PHARM 10MG
A088292 001 Oct 21, 1983
AB 10MG
A089422 001 Jul 14, 1987
AB 25MG
A088262 001 Oct 21, 1983
AB 50MG
A088276 001 Oct 21, 1983
AB SANDOZ 10MG
A084936 002
AB 25MG
A083745 001
AB 50MG
A084937 001
TOFRANIL
AB MALLINCKRODT INC 10MG A087844 001 May 22, 1984
AB 25MG A087845 001 May 22, 1984
AB + 50MG A087846 001 May 22, 1984
IMIPRAMINE PAMOATE
CAPSULE;ORAL
IMIPRAMINE PAMOATE
AB LUPIN LTD EQ 75MG HCL
A090444 001 Apr 16, 2010
AB EQ 100MG HCL
A090444 002 Apr 16, 2010
AB EQ 125MG HCL
A090444 003 Apr 16, 2010
AB EQ 150MG HCL
A090444 004 Apr 16, 2010
AB MYLAN PHARMS INC EQ 75MG HCL
A202338 001 Jun 28, 2013
AB EQ 100MG HCL
A202338 002 Jun 28, 2013
AB EQ 125MG HCL
A202338 003 Jun 28, 2013
AB EQ 150MG HCL
A202338 004 Jun 28, 2013
AB ROXANE EQ 75MG HCL
A091099 001 Apr 16, 2010
AB EQ 100MG HCL
A091099 002 Apr 16, 2010
AB EQ 125MG HCL
A091099 003 Apr 16, 2010
AB EQ 150MG HCL
A091099 004 Apr 16, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-194(of 371)
IMIPRAMINE PAMOATE
CAPSULE;ORAL
TOFRANIL-PM
AB + MALLINCKRODT INC EQ 75MG HCL N017090 001
AB EQ 100MG HCL N017090 004
AB EQ 125MG HCL N017090 003
AB EQ 150MG HCL N017090 002
IMIQUIMOD
CREAM;TOPICAL
ALDARA
AB + MEDICIS 5% N020723 001 Feb 27, 1997
IMIQUIMOD
AB APOTEX INC 5% A091308 001 Apr 06, 2012
AB FOUGERA PHARMS 5% A078548 001 Feb 25, 2010
AB GLENMARK GENERICS 5% A201994 001 Mar 06, 2012
AB PERRIGO ISRAEL 5% A078837 001 Sep 07, 2010
AB STRIDES PHARMA 5% A202002 001 Jun 24, 2014
AB TARO 5% A200173 001 Apr 15, 2011
AB TEVA PHARMS USA 5% A200481 001 Apr 18, 2011
AB TOLMAR 5% A091044 001 Feb 28, 2011
ZYCLARA
+ MEDICIS 2.5% N022483 002 Jul 15, 2011
+ 3.75% N022483 001 Mar 25, 2010
INAMRINONE LACTATE
INJECTABLE;INJECTION
AMRINONE LACTATE
+ EUROHLTH INTL EQ 5MG BASE/ML A075513 001 May 09, 2000
INDACATEROL MALEATE
POWDER;INHALATION
ARCAPTA NEOHALER
+ NOVARTIS EQ 75MCG BASE N022383 001 Jul 01, 2011
INDAPAMIDE
TABLET;ORAL
INDAPAMIDE
AB ACTAVIS ELIZABETH 1.25MG A074722 001 Jun 17, 1996
AB 2.5MG A074722 002 Jun 17, 1996
AB IVAX SUB TEVA PHARMS 1.25MG A074299 002 Apr 29, 1996
AB 2.5MG A074299 001 Jul 27, 1995
AB MYLAN 1.25MG A074461 002 Mar 26, 1997
AB + 2.5MG A074461 001 Mar 27, 1996
AB MYLAN PHARMS INC 1.25MG A075105 001 Jul 23, 1998
AB 2.5MG A075105 002 Jul 23, 1998
INDINAVIR SULFATE
CAPSULE;ORAL
CRIXIVAN
MERCK SHARP DOHME EQ 200MG BASE N020685 003 Mar 13, 1996
+ EQ 400MG BASE N020685 001 Mar 13, 1996
INDIUM IN-111 CHLORIDE
INJECTABLE;INJECTION
INDICLOR
+ GE HEALTHCARE 2mCi/0.2ML N019862 001 Dec 29, 1992
INDIUM IN 111 CHLORIDE
+ MALLINCKRODT 5mCi/0.5ML N019841 001 Sep 27, 1994
INDIUM IN-111 OXYQUINOLINE
INJECTABLE;INJECTION
INDIUM IN-111 OXYQUINOLINE
+ GE HEALTHCARE 1mCi/ML N019044 001 Dec 24, 1985
INDIUM IN-111 PENTETATE DISODIUM
INJECTABLE;INTRATHECAL
MPI INDIUM DTPA IN 111
+ GE HEALTHCARE 1mCi/ML N017707 001 Feb 18, 1982
INDIUM IN-111 PENTETREOTIDE KIT
INJECTABLE;INJECTION
OCTREOSCAN
+ MALLINCKRODT 3mCi/ML N020314 001 Jun 02, 1994
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-195(of 371)
INDOCYANINE GREEN
INJECTABLE;INJECTION
IC-GREEN
AP + AKORN 25MG/VIAL N011525 001
INDOCYANINE GREEN
AP PULSION MEDCL 25MG/VIAL A040811 001 Nov 21, 2007
INDOMETHACIN
CAPSULE;ORAL
INDOMETHACIN
AB GLENMARK GENERICS 25MG A091276 001 Dec 22, 2010
AB 50MG A091276 002 Dec 22, 2010
AB HERITAGE PHARMS INC 25MG N018851 001 May 18, 1984
AB 50MG N018851 002 May 18, 1984
AB HETERO LABS LTD III 25MG A091240 001 Apr 12, 2011
AB 50MG A091240 002 Apr 12, 2011
AB IVAX SUB TEVA PHARMS 25MG A070719 001 Feb 12, 1986
AB 50MG A070756 001 Feb 12, 1986
AB MYLAN 25MG N018858 001 Apr 20, 1984
AB + 50MG A070624 001 Sep 04, 1985
AB SANDOZ 25MG A070673 001 Apr 29, 1987
AB 50MG A070674 001 Apr 29, 1987
AB SUN PHARM INDS INC 25MG A091401 001 Mar 28, 2013
AB 50MG A091401 002 Mar 28, 2013
AB ZYDUS PHARMS USA INC 25MG A090403 001 Nov 15, 2010
AB 50MG A090403 002 Nov 15, 2010
TIVORBEX
IROKO PHARMS LLC 20MG N204768 001 Feb 24, 2014
+ 40MG N204768 002 Feb 24, 2014
CAPSULE, EXTENDED RELEASE;ORAL
INDOMETHACIN
AB AMNEAL PHARMS 75MG A091549 001 Dec 01, 2010
AB AVANTHI INC 75MG A079175 001 Mar 06, 2009
AB HETERO LABS LTD III 75MG A201807 001 Sep 28, 2012
AB MYLAN PHARMS INC 75MG A202139 001 Mar 20, 2014
AB PADDOCK LLC 75MG A200529 001 Nov 30, 2010
AB + SANDOZ 75MG A074464 001 May 28, 1998
AB WATSON LABS INC 75MG A202572 001 Dec 09, 2013
INJECTABLE;INJECTION
INDOMETHACIN
+ FRESENIUS KABI USA EQ 1MG BASE/VIAL N022536 001 Mar 17, 2010
SUPPOSITORY;RECTAL
INDOMETHACIN
+ G AND W LABS 50MG A073314 001 Aug 31, 1992
SUSPENSION;ORAL
INDOCIN
+ IROKO PHARMS 25MG/5ML N018332 001 Oct 10, 1985
INDOMETHACIN SODIUM
INJECTABLE;INJECTION
INDOCIN
AP + RECORDATI RARE EQ 1MG BASE/VIAL N018878 001 Jan 30, 1985
INDOMETHACIN SODIUM
AP EUROHLTH INTL EQ 1MG BASE/VIAL A078713 001 Jul 16, 2008
INGENOL MEBUTATE
GEL;TOPICAL
PICATO
LEO PHARMA AS 0.015% N202833 001 Jan 23, 2012
+ 0.05% N202833 002 Jan 23, 2012
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT
INJECTABLE;SUBCUTANEOUS
NOVOLOG MIX 70/30
+ NOVO NORDISK INC 700 UNITS/10ML;300 UNITS/10ML (70 N021172 001 Nov 01, 2001
UNITS/ML; 30 UNITS/ML)
NOVOLOG MIX 70/30 FLEXPEN
+ NOVO NORDISK INC 210 UNITS/3ML;90 UNITS/3ML (70 N021172 004 May 03, 2002
UNITS/ML; 30 UNITS/ML)
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-196(of 371)
INSULIN ASPART RECOMBINANT
INJECTABLE;SUBCUTANEOUS
NOVOLOG
+ NOVO NORDISK INC
1000 UNITS/10ML (100 UNITS/ML)
N020986 001 Jun 07, 2000
NOVOLOG FLEXPEN
+ NOVO NORDISK INC
300 UNITS/3ML (100 UNITS/ML)
N020986 003 Jan 19, 2001
NOVOLOG FLEXTOUCH
+ NOVO NORDISK INC
300 UNITS/3ML (100 UNITS/ML)
N020986 005 Oct 31, 2013
NOVOLOG PENFILL
+ NOVO NORDISK INC
300 UNITS/3ML (100 UNITS/ML)
N020986 002 Jun 07, 2000
INSULIN DETEMIR RECOMBINANT
INJECTABLE;SUBCUTANEOUS
LEVEMIR
+ NOVO NORDISK INC
1000 UNITS/10ML (100 UNITS/ML)
N021536 001 Jun 16, 2005
LEVEMIR FLEXPEN
+ NOVO NORDISK INC
300 UNITS/3ML (100 UNITS/ML)
N021536 002 Jun 16, 2005
LEVEMIR FLEXTOUCH
+ NOVO NORDISK INC
300 UNITS/3ML (100 UNITS/ML)
N021536 005 Oct 31, 2013
INSULIN GLARGINE RECOMBINANT
INJECTABLE;INJECTION
LANTUS
+ SANOFI AVENTIS US
100 UNITS/ML
N021081 001 Apr 20, 2000
LANTUS SOLOSTAR
+ SANOFI AVENTIS US
300 UNITS/3ML (100 UNITS/ML)
N021081 002 Apr 27, 2007
INSULIN GLULISINE RECOMBINANT
INJECTABLE;IV (INFUSION), SUBCUTANEOUS
APIDRA
+ SANOFI AVENTIS US 1000 UNITS/10ML (100 UNITS/ML)
N021629 001 Apr 16, 2004
+ 300 UNITS/3ML (100 UNITS/ML)
N021629 002 Dec 20, 2005
INJECTABLE;SUBCUTANEOUS
APIDRA SOLOSTAR
SANOFI AVENTIS US 300 UNITS/3ML
N021629 003 Feb 24, 2009
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT
INJECTABLE;INJECTION
HUMALOG MIX 50/50
+ LILLY
50 UNITS/ML;50 UNITS/ML
N021018 001 Dec 22, 1999
HUMALOG MIX 50/50 KWIKPEN
+ LILLY
50 UNITS/ML;50 UNITS/ML
N021018 002 Sep 06, 2007
HUMALOG MIX 75/25
+ LILLY
75 UNITS/ML;25 UNITS/ML
N021017 001 Dec 22, 1999
HUMALOG MIX 75/25 KWIKPEN
+ LILLY
75 UNITS/ML;25 UNITS/ML
N021017 002 Sep 06, 2007
INSULIN LISPRO RECOMBINANT
INJECTABLE;INJECTION
HUMALOG
+ LILLY
100 UNITS/ML
N020563 001 Jun 14, 1996
HUMALOG KWIKPEN
+ LILLY
100 UNITS/ML
N020563 003 Sep 06, 2007
INSULIN RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN R
+ LILLY
500 UNITS/ML
N018780 004 Mar 31, 1994
POWDER;INHALATION
AFREZZA
SANOFI AVENTIS
4 UNITS/INH
N022472 001 Jun 27, 2014
+
8 UNITS/INH
N022472 002 Jun 27, 2014
IOBENGUANE SULFATE I-123
SOLUTION;INTRAVENOUS
ADREVIEW
+ GE HEALTHCARE
10mCi/5ML (2mCi/ML)
N022290 001 Sep 19, 2008
IODIPAMIDE MEGLUMINE
INJECTABLE;INJECTION
CHOLOGRAFIN MEGLUMINE
+ BRACCO
52%
N009321 003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-197(of 371)
IODIXANOL
INJECTABLE;INJECTION
VISIPAQUE 270
+ GE HEALTHCARE 55% N020351 001 Mar 22, 1996
55% N020808 001 Aug 29, 1997
VISIPAQUE 320
+ GE HEALTHCARE 65.2% N020351 002 Mar 22, 1996
65.2% N020808 002 Aug 29, 1997
IOFLUPANE I-123
SOLUTION;INTRAVENOUS
DATSCAN
+ GE HLTHCARE INC 5mCi/2.5ML (2mCi/ML) N022454 001 Jan 14, 2011
IOHEXOL
INJECTABLE;INJECTION
OMNIPAQUE 140
+ GE HEALTHCARE 30.2% N018956 005 Nov 30, 1988
SOLUTION;INJECTION, ORAL
OMNIPAQUE 350
+ GE HEALTHCARE 75.5% N018956 004 Dec 26, 1985
75.5% N020608 003 Oct 24, 1995
SOLUTION;INJECTION, ORAL, RECTAL
OMNIPAQUE 180
+ GE HEALTHCARE 38.8% N018956 001 Dec 26, 1985
OMNIPAQUE 240
+ GE HEALTHCARE 51.8% N018956 002 Dec 26, 1985
51.8% N020608 001 Oct 24, 1995
OMNIPAQUE 300
+ GE HEALTHCARE 64.7% N018956 003 Dec 26, 1985
64.7% N020608 002 Oct 24, 1995
IOPAMIDOL
INJECTABLE;INJECTION
IOPAMIDOL-250
AP FRESENIUS KABI USA 51% A074679 001 Apr 02, 1997
IOPAMIDOL-300
AP FRESENIUS KABI USA 61% A074679 002 Apr 02, 1997
IOPAMIDOL-370
AP FRESENIUS KABI USA 76% A074679 003 Apr 02, 1997
ISOVUE-200
AP + BRACCO 41% N018735 006 Jul 07, 1987
ISOVUE-250
AP + BRACCO 51% N018735 007 Jul 06, 1992
AP + 51% N020327 002 Oct 12, 1994
ISOVUE-300
AP + BRACCO 61% N018735 002 Dec 31, 1985
AP + 61% N020327 003 Oct 12, 1994
ISOVUE-370
AP + BRACCO 76% N018735 003 Dec 31, 1985
AP + 76% N020327 004 Oct 12, 1994
SCANLUX-300
AP SANOCHEMIA CORP USA 61% A090394 001 Jun 18, 2010
SCANLUX-370
AP SANOCHEMIA CORP USA 76% A090394 002 Jun 18, 2010
ISOVUE-M 200
+ BRACCO 41% N018735 001 Dec 31, 1985
ISOVUE-M 300
+ BRACCO 61% N018735 004 Dec 31, 1985
IOPROMIDE
INJECTABLE;INJECTION
ULTRAVIST (PHARMACY BULK)
+ BAYER HLTHCARE 49.9% N021425 003 Mar 12, 2004
+ 62.3% N021425 001 Sep 20, 2002
+ 76.9% N021425 002 Sep 20, 2002
ULTRAVIST 150
+ BAYER HLTHCARE 31.2% N020220 004 May 10, 1995
ULTRAVIST 240
+ BAYER HLTHCARE 49.9% N020220 003 May 10, 1995
ULTRAVIST 300
+ BAYER HLTHCARE 62.3% N020220 002 May 10, 1995
ULTRAVIST 300 IN PLASTIC CONTAINER
+ BAYER HLTHCARE 62.3% N020220 005 Nov 18, 2008
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-198(of 371)
IOPROMIDE
INJECTABLE;INJECTION
ULTRAVIST 370
+ BAYER HLTHCARE 76.9% N020220 001 May 10, 1995
IOTHALAMATE MEGLUMINE
INJECTABLE;INJECTION
CONRAY
+ MALLINCKRODT 60% N013295 001
CONRAY 30
+ MALLINCKRODT 30% N016983 001
CONRAY 43
+ MALLINCKRODT 43% N013295 002
SOLUTION;INTRAVESICAL
CYSTO-CONRAY II
MALLINCKRODT 17.2% N017057 002
IOTHALAMATE SODIUM I-125
INJECTABLE;INJECTION
GLOFIL-125
ISOTEX 250-300uCi/ML N017279 001
IOVERSOL
INJECTABLE;INJECTION
OPTIRAY 240
+ MALLINCKRODT 51% N019710 002 Dec 30, 1988
OPTIRAY 300
+ MALLINCKRODT 64% N019710 004 Jan 22, 1992
+ 64% N020923 004 May 13, 1999
OPTIRAY 320
+ MALLINCKRODT 68% N019710 001 Dec 30, 1988
OPTIRAY 350
+ MALLINCKRODT 74% N019710 005 Jan 22, 1992
+ 74% N020923 003 May 28, 1998
IOXAGLATE MEGLUMINE; IOXAGLATE SODIUM
INJECTABLE;INJECTION
HEXABRIX
+ GUERBET 39.3%;19.6% N018905 002 Jul 26, 1985
IOXILAN
INJECTABLE;INJECTION
OXILAN-300
GUERBET 62% N020316 001 Dec 21, 1995
OXILAN-350
GUERBET 73% N020316 002 Dec 21, 1995
IPRATROPIUM BROMIDE
AEROSOL, METERED;INHALATION
ATROVENT HFA
+ BOEHRINGER INGELHEIM 0.021MG/INH N021527 001 Nov 27, 2004
SOLUTION;INHALATION
IPRATROPIUM BROMIDE
AN BAUSCH AND LOMB 0.02% A075835 001 Oct 15, 2001
AN LANDELA PHARM 0.02% A077072 001 Jul 19, 2005
AN + MYLAN SPECLT 0.02% A074755 001 Jan 10, 1997
AN NEPHRON 0.02% A075562 001 Sep 27, 2001
AN RITEDOSE CORP 0.02% A075693 001 Jan 26, 2001
AN WATSON LABS 0.02% A076291 001 May 09, 2005
SPRAY, METERED;NASAL
ATROVENT
AB + BOEHRINGER INGELHEIM 0.021MG/SPRAY N020393 001 Oct 20, 1995
AB + 0.042MG/SPRAY N020394 001 Oct 20, 1995
IPRATROPIUM BROMIDE
AB BAUSCH AND LOMB 0.021MG/SPRAY A076025 001 Mar 31, 2003
AB 0.042MG/SPRAY A076103 001 Mar 31, 2003
AB MYLAN SPECLT 0.021MG/SPRAY A075552 001 Mar 31, 2003
AB 0.042MG/SPRAY A075553 001 Mar 31, 2003
AB ROXANE 0.021MG/SPRAY A076664 001 Nov 05, 2003
AB 0.042MG/SPRAY A076598 001 Nov 05, 2003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-199(of 371)
IRBESARTAN
TABLET;ORAL
AVAPRO
AB SANOFI AVENTIS US
75MG
N020757 001 Sep 30, 1997
AB
150MG
N020757 002 Sep 30, 1997
AB +
300MG
N020757 003 Sep 30, 1997
IRBESARTAN
AB ALEMBIC PHARMS LTD
75MG
A091236 001 Oct 15, 2012
AB
150MG
A091236 002 Oct 15, 2012
AB
300MG
A091236 003 Oct 15, 2012
AB APOTEX INC
75MG
A200832 001 Oct 15, 2012
AB
150MG
A200832 002 Oct 15, 2012
AB
300MG
A200832 003 Oct 15, 2012
AB AUROBINDO PHARMA LTD
75MG
A203081 001 Sep 27, 2012
AB
150MG
A203081 002 Sep 27, 2012
AB
300MG
A203081 003 Sep 27, 2012
AB CIPLA LTD
75MG
A077205 001 Nov 14, 2012
AB
150MG
A077205 002 Nov 14, 2012
AB
300MG
A077205 003 Nov 14, 2012
AB DR REDDYS LABS LTD
75MG
A203161 001 Sep 27, 2012
AB
150MG
A203161 002 Sep 27, 2012
AB
300MG
A203161 003 Sep 27, 2012
AB HETERO LABS LTD V
75MG
A202910 001 Sep 27, 2012
AB
150MG
A202910 002 Sep 27, 2012
AB
300MG
A202910 003 Sep 27, 2012
AB LUPIN LTD
75MG
A201531 001 Oct 15, 2012
AB
150MG
A201531 002 Oct 15, 2012
AB
300MG
A201531 003 Oct 15, 2012
AB MACLEODS PHARMS LTD
75MG
A202254 001 Oct 03, 2012
AB
150MG
A202254 002 Oct 03, 2012
AB
300MG
A202254 003 Oct 03, 2012
AB MYLAN PHARMS INC
75MG
A200461 001 Sep 27, 2012
AB
150MG
A200461 002 Sep 27, 2012
AB
300MG
A200461 003 Sep 27, 2012
AB PRINSTON INC
75MG
A203071 001 Sep 27, 2012
AB
150MG
A203071 002 Sep 27, 2012
AB
300MG
A203071 003 Sep 27, 2012
AB ROXANE
75MG
A090201 001 Oct 15, 2012
AB
150MG
A090201 002 Oct 15, 2012
AB
300MG
A090201 003 Oct 15, 2012
AB SANDOZ
75MG
A077466 001 Sep 27, 2012
AB
150MG
A077466 002 Sep 27, 2012
AB
300MG
A077466 003 Sep 27, 2012
AB TEVA PHARMS
75MG
A077159 001 Mar 30, 2012
AB
150MG
A077159 002 Mar 30, 2012
AB
300MG
A077159 003 Mar 30, 2012
AB WATSON LABS INC
75MG
A090720 001 Oct 12, 2012
AB
150MG
A090720 002 Oct 12, 2012
AB
300MG
A090720 003 Oct 12, 2012
AB ZYDUS PHARMS USA INC
75MG
A079213 001 Sep 27, 2012
AB
150MG
A079213 002 Sep 27, 2012
AB
300MG
A079213 003 Sep 27, 2012
IRINOTECAN HYDROCHLORIDE
INJECTABLE;INJECTION
CAMPTOSAR
AP + PFIZER INC
40MG/2ML (20MG/ML)
N020571 001 Jun 14, 1996
AP +
100MG/5ML (20MG/ML)
N020571 002 Jun 14, 1996
IRINOTECAN HYDROCHLORIDE
AP ACCORD HLTHCARE
40MG/2ML (20MG/ML)
A079068 001 Nov 21, 2008
AP
100MG/5ML (20MG/ML)
A079068 002 Nov 21, 2008
AP ACTAVIS TOTOWA
40MG/2ML (20MG/ML)
A078589 001 Feb 27, 2008
AP
100MG/5ML (20MG/ML)
A078589 002 Feb 27, 2008
AP AKORN
40MG/2ML (20MG/ML)
A090726 001 Sep 16, 2009
AP
100MG/5ML (20MG/ML)
A090726 002 Sep 16, 2009
AP BEDFORD LABS
40MG/2ML (20MG/ML)
A078753 001 Dec 24, 2008
AP
100MG/5ML (20MG/ML)
A078753 002 Dec 24, 2008
AP CIPLA LTD
40MG/2ML (20MG/ML)
A077219 001 Feb 20, 2008
AP
100MG/5ML (20MG/ML)
A077219 002 Feb 20, 2008
AP DR REDDYS LABS LTD
40MG/2ML (20MG/ML)
A078953 001 Apr 15, 2010
AP
100MG/5ML (20MG/ML)
A078953 002 Apr 15, 2010
AP EBEWE PHARMA
40MG/2ML (20MG/ML)
A090137 001 Nov 12, 2009
AP
100MG/5ML (20MG/ML)
A090137 002 Nov 12, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-200(of 371)
IRINOTECAN HYDROCHLORIDE
INJECTABLE;INJECTION
IRINOTECAN HYDROCHLORIDE
AP EMCURE PHARMS LTD 40MG/2ML (20MG/ML)
A200771 001 Feb 14, 2012
AP 100MG/5ML (20MG/ML)
A200771 002 Feb 14, 2012
AP FRESENIUS KABI ONCOL 40MG/2ML (20MG/ML)
A078188 001 Feb 27, 2008
AP 100MG/5ML (20MG/ML)
A078188 002 Feb 27, 2008
AP FRESENIUS KABI USA 40MG/2ML (20MG/ML)
A077776 001 Feb 27, 2008
AP 100MG/5ML (20MG/ML)
A077776 002 Feb 27, 2008
AP HIKMA FARMACEUTICA 40MG/2ML (20MG/ML)
A091032 001 Dec 20, 2010
AP 100MG/5ML (20MG/ML)
A091032 002 Dec 20, 2010
AP HISUN PHARM HANGZHOU 40MG/2ML (20MG/ML)
A090016 001 Jan 28, 2009
AP 100MG/5ML (20MG/ML)
A090016 002 Jan 28, 2009
AP HOSPIRA 40MG/2ML (20MG/ML)
A077915 001 Feb 27, 2008
AP 100MG/5ML (20MG/ML)
A077915 002 Feb 27, 2008
AP + 500MG/25ML (20MG/ML)
A078796 001 Feb 27, 2008
AP JIANGSU HENGRUI MED 40MG/2ML (20MG/ML)
A090675 002 Dec 16, 2011
AP 100MG/5ML (20MG/ML)
A090675 001 Dec 16, 2011
AP MUSTAFA NEVZAT ILAC 40MG/2ML (20MG/ML)
A090393 002 May 13, 2011
AP 100MG/5ML (20MG/ML)
A090393 003 May 13, 2011
AP PLIVA LACHEMA 40MG/2ML (20MG/ML)
A078122 001 Oct 31, 2008
AP 100MG/5ML (20MG/ML)
A078122 002 Oct 31, 2008
AP SUN PHARMA GLOBAL 40MG/2ML (20MG/ML)
A078805 001 Apr 21, 2008
AP 100MG/5ML (20MG/ML)
A078805 002 Apr 21, 2008
AP TEVA PHARMS USA 40MG/2ML (20MG/ML)
A090101 002 Feb 27, 2008
AP 100MG/5ML (20MG/ML)
A090101 003 Feb 27, 2008
AP 500MG/25ML (20MG/ML)
A090101 001 Nov 26, 2008
CAMPTOSAR
+ PFIZER INC
300MG/15ML (20MG/ML)
N020571 003 Aug 05, 2010
IRON DEXTRAN
INJECTABLE;INJECTION
DEXFERRUM
BP LUITPOLD
EQ 50MG IRON/ML
N040024 001 Feb 23, 1996
INFED
BP + WATSON LABS (UTAH)
EQ 50MG IRON/ML
N017441 001
PROFERDEX
BP NEW RIVER
EQ 50MG IRON/ML
N017807 001
IRON SUCROSE
INJECTABLE;INTRAVENOUS
VENOFER
LUITPOLD
EQ 50MG BASE/2.5ML (EQ 20MG BASE/ML)
N021135 002 Mar 20, 2005
+
EQ 100MG BASE/5ML (EQ 20MG BASE/ML)
N021135 001 Nov 06, 2000
EQ 200MG BASE/10ML (EQ 20MG BASE/ML)
N021135 004 Feb 09, 2007
ISOCARBOXAZID
TABLET;ORAL
MARPLAN
+ VALIDUS PHARMS INC
10MG
N011961 001
ISOFLURANE
LIQUID;INHALATION
FORANE
AN + BAXTER HLTHCARE
99.9%
N017624 001
ISOFLURANE
AN HALOCARBON PRODS
99.9%
A075225 001 Oct 20, 1999
AN HOSPIRA
99.9%
A074097 001 Jan 25, 1993
AN PIRAMAL CRITICAL
99.9%
A074416 001 Sep 30, 1994
AN PIRAMAL ENT
99.9%
A074502 001 Jun 27, 1995
ISONIAZID
INJECTABLE;INJECTION
ISONIAZID
+ SANDOZ
100MG/ML
A040648 001 Jul 05, 2005
SYRUP;ORAL
ISONIAZID
+ CAROLINA MEDCL
50MG/5ML
A088235 001 Nov 10, 1983
TABLET;ORAL
ISONIAZID
AA BARR
100MG
A080936 001
AA
300MG
A080937 002
AA + SANDOZ
100MG
N008678 002
AA +
300MG
N008678 003
AA THEPHARMANETWORK LLC
100MG
A202610 001 Oct 29, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-201(of 371)
ISONIAZID
TABLET;ORAL
ISONIAZID
AA 300MG A202610 002 Oct 29, 2014
LANIAZID
AA LANNETT 300MG A089776 001 Jun 13, 1988
ISONIAZID; PYRAZINAMIDE; RIFAMPIN
TABLET;ORAL
RIFATER
+ SANOFI AVENTIS US
50MG;300MG;120MG
N050705 001 May 31, 1994
ISONIAZID; RIFAMPIN
CAPSULE;ORAL
RIFAMATE
+ SANOFI AVENTIS US
150MG;300MG
A061884 001
ISOPROTERENOL HYDROCHLORIDE
INJECTABLE;INJECTION
ISUPREL
+ HOSPIRA
0.2MG/ML
N010515 001
ISOSORBIDE DINITRATE
CAPSULE, EXTENDED RELEASE;ORAL
DILATRATE-SR
+ AUXILIUM PHARMS LLC
40MG
N019790 001 Sep 02, 1988
TABLET;ORAL
ISORDIL
AB VALEANT BERMUDA
5MG
N012093 007 Jul 29, 1988
ISOSORBIDE DINITRATE
AB HIKMA INTL PHARMS 5MG
A086067 001 Oct 29, 1987
AB 10MG
A086066 001 Oct 29, 1987
AB 20MG
A088088 001 Nov 02, 1987
AB 30MG
A040591 001 Jan 10, 2007
AB PAR PHARM 5MG
A086923 001 Mar 12, 1987
AB 10MG
A086925 001 Mar 12, 1987
AB 20MG
A087537 001 Oct 02, 1987
AB + 30MG
A087946 001 Jan 12, 1988
AB SANDOZ 5MG
A086221 001 Jan 07, 1988
AB 10MG
A086223 001 Jan 07, 1988
AB 20MG
A089367 001 Apr 07, 1988
ISORDIL
+ VALEANT BERMUDA
40MG
N012093 001 Jul 29, 1988
TABLET, EXTENDED RELEASE;ORAL
ISOSORBIDE DINITRATE
AB COREPHARMA
40MG
A040723 001 Mar 17, 2008
AB + SUN PHARM INDS INC
40MG
A040009 001 Dec 30, 1998
ISOSORBIDE MONONITRATE
TABLET;ORAL
ISOSORBIDE MONONITRATE
AB ACTAVIS ELIZABETH
10MG
A075037 002 Oct 30, 1998
AB
20MG
A075037 001 Oct 30, 1998
AB ANI PHARMS INC
20MG
A075147 001 Nov 27, 1998
AB HIKMA PHARMS LLC
20MG
A075361 001 Oct 05, 2000
MONOKET
AB KREMERS URBAN PHARMS
10MG
N020215 002 Jun 30, 1993
AB +
20MG
N020215 001 Jun 30, 1993
TABLET, EXTENDED RELEASE;ORAL
ISOSORBIDE MONONITRATE
AB DEXCEL LTD
60MG
A075522 001 Apr 17, 2000
AB HIKMA PHARMS
30MG
A076813 002 Mar 30, 2006
AB
60MG
A076813 001 Jan 07, 2005
AB KREMERS URBAN PHARMS
30MG
A075155 002 Jan 13, 2000
AB
60MG
A075155 001 Oct 30, 1998
AB +
120MG
A075155 003 Aug 04, 2000
AB NESHER PHARMS
30MG
A075395 001 Mar 16, 2000
AB
60MG
A075395 002 Mar 16, 2000
AB
120MG
A075395 003 Mar 16, 2000
AB TORRENT PHARMS
30MG
A200270 001 Jun 03, 2011
AB
60MG
A200495 001 Jun 03, 2011
AB
120MG
A200495 002 Jun 03, 2011
AB VINTAGE PHARMS
30MG
A090598 001 Aug 11, 2010
AB
60MG
A090598 002 Aug 11, 2010
AB
120MG
A090598 003 Aug 11, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-202(of 371)
ISOSULFAN BLUE
INJECTABLE;INJECTION
ISOSULFAN BLUE
+ MYLAN INSTITUTIONAL
1%
A090874 001 Jul 20, 2010
ISOTRETINOIN
CAPSULE;ORAL
AMNESTEEM
AB MYLAN PHARMS INC
10MG
A075945 001 Nov 08, 2002
AB
20MG
A075945 002 Nov 08, 2002
AB
40MG
A075945 003 Nov 08, 2002
CLARAVIS
AB TEVA PHARMS USA
10MG
A076356 001 Apr 11, 2003
AB
20MG
A076135 002 Apr 11, 2003
AB
30MG
A076135 003 May 11, 2006
AB +
40MG
A076135 001 Apr 11, 2003
MYORISAN
AB DOUGLAS PHARMS
10MG
A076485 001 Jan 19, 2012
AB
20MG
A076485 002 Jan 19, 2012
AB
40MG
A076485 003 Jan 19, 2012
SOTRET
AB RANBAXY
10MG
A076041 001 Dec 24, 2002
AB
20MG
A076041 002 Dec 24, 2002
AB
30MG
A076503 001 Jun 20, 2003
AB
40MG
A076041 003 Dec 24, 2002
ZENATANE
AB DR REDDYS LABS LTD
10MG
A202099 001 Mar 25, 2013
AB
20MG
A202099 002 Mar 25, 2013
AB
40MG
A202099 003 Mar 25, 2013
ABSORICA
BX RANBAXY
10MG
N021951 001 May 25, 2012
BX
20MG
N021951 002 May 25, 2012
BX
30MG
N021951 003 May 25, 2012
BX +
40MG
N021951 004 May 25, 2012
ISRADIPINE
CAPSULE;ORAL
ISRADIPINE
AB MIKAH PHARMA
2.5MG
A077169 001 Apr 24, 2006
AB
5MG
A077169 002 Apr 24, 2006
AB WATSON LABS
2.5MG
A077317 001 Jan 05, 2006
AB +
5MG
A077317 002 Jan 05, 2006
ITRACONAZOLE
CAPSULE;ORAL
ITRACONAZOLE
AB MYLAN PHARMS INC
100MG
A200463 001 Jul 20, 2012
AB SANDOZ
100MG
A076104 001 May 28, 2004
SPORANOX
AB + JANSSEN PHARMS
100MG
N020083 001 Sep 11, 1992
SOLUTION;ORAL
SPORANOX
+ JANSSEN PHARMS
10MG/ML
N020657 001 Feb 21, 1997
TABLET;ORAL
ONMEL
+ MERZ PHARMS
200MG
N022484 001 Apr 29, 2010
IVACAFTOR
TABLET;ORAL
KALYDECO
+ VERTEX PHARMS
150MG
N203188 001 Jan 31, 2012
IVERMECTIN
CREAM;TOPICAL
SOOLANTRA
+ GALDERMA LABS LP
1%
N206255 001 Dec 19, 2014
LOTION;TOPICAL
SKLICE
+ SANOFI PASTEUR INC
0.5%
N202736 001 Feb 07, 2012
TABLET;ORAL
IVERMECTIN
AB EDENBRIDGE PHARMS
3MG
A204154 001 Oct 24, 2014
STROMECTOL
AB + MERCK SHARP DOHME
3MG
N050742 002 Oct 08, 1998
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-203(of 371)
IXABEPILONE
INJECTABLE;IV (INFUSION)
IXEMPRA KIT
+ BRISTOL MYERS SQUIBB 15MG/VIAL N022065 001 Oct 16, 2007
+ 45MG/VIAL N022065 002 Oct 16, 2007
KANAMYCIN SULFATE
INJECTABLE;INJECTION
KANAMYCIN SULFATE
+ FRESENIUS KABI USA EQ 1GM BASE/3ML A065111 002 Dec 17, 2002
EQ 500MG BASE/2ML A065111 001 Dec 17, 2002
KETAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
KETALAR
AP + PAR STERILE PRODUCTS EQ 10MG BASE/ML N016812 001
AP + EQ 50MG BASE/ML N016812 002
AP + EQ 100MG BASE/ML N016812 003
KETAMINE HYDROCHLORIDE
AP EUROHLTH INTL EQ 50MG BASE/ML A074524 001 Mar 22, 1996
AP EQ 100MG BASE/ML A074524 002 Mar 22, 1996
AP HOSPIRA EQ 50MG BASE/ML A074549 001 Jun 27, 1996
AP EQ 100MG BASE/ML A074549 002 Jun 27, 1996
AP MYLAN INSTITUTIONAL EQ 10MG BASE/ML A076092 001 Sep 30, 2008
AP EQ 50MG BASE/ML A076092 002 Dec 28, 2001
AP EQ 100MG BASE/ML A076092 003 Oct 25, 2002
KETOCONAZOLE
AEROSOL, FOAM;TOPICAL
EXTINA
AT + DELCOR ASSET CORP 2% N021738 001 Jun 12, 2007
KETOCONAZOLE
AT PERRIGO ISRAEL 2% A091550 001 Aug 25, 2011
CREAM;TOPICAL
KETOCONAZOLE
AB FOUGERA PHARMS 2% A076294 001 Apr 28, 2004
AB + TEVA 2% A075581 001 Apr 25, 2000
KETOZOLE
AB TARO 2% A075638 001 Dec 18, 2002
GEL;TOPICAL
XOLEGEL
+ AQUA PHARMS 2% N021946 001 Jul 28, 2006
SHAMPOO;TOPICAL
KETOCONAZOLE
AB PERRIGO NEW YORK 2% A076419 001 Jan 07, 2004
AB TOLMAR 2% A076942 001 Apr 11, 2005
NIZORAL
AB + JANSSEN PHARMS 2% N019927 001 Aug 31, 1990
TABLET;ORAL
KETOCONAZOLE
AB MYLAN 200MG A075597 001 Dec 23, 1999
AB TARO 200MG A075319 001 Jun 15, 1999
AB + TEVA 200MG A075273 001 Jun 15, 1999
KETOPROFEN
CAPSULE;ORAL
KETOPROFEN
AB DORADO PHARMA 50MG A074014 002 Jan 29, 1993
AB 75MG A074014 003 Jan 29, 1993
AB MYLAN 50MG A074035 002 Dec 31, 1996
AB 75MG A074035 003 Dec 31, 1996
AB TEVA 50MG A073516 001 Dec 22, 1992
AB + 75MG A073517 001 Dec 22, 1992
DORADO PHARMA 25MG A074014 001 Jan 29, 1993
CAPSULE, EXTENDED RELEASE;ORAL
KETOPROFEN
AB ACTAVIS LABS FL INC 100MG A075270 002 Mar 24, 1999
AB 150MG A075270 003 Mar 24, 1999
AB 200MG A075270 001 Mar 24, 1999
AB MYLAN 100MG A075679 003 Feb 20, 2002
AB 150MG A075679 002 Feb 20, 2002
AB + 200MG A075679 001 Feb 20, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-204(of 371)
KETOROLAC TROMETHAMINE
INJECTABLE;INJECTION
KETOROLAC TROMETHAMINE
AP AGILA SPECLTS 15MG/ML A078299 001 Jul 16, 2007
AP 15MG/ML A201155 001 Aug 04, 2014
AP 30MG/ML A078299 002 Jul 16, 2007
AP 30MG/ML A201155 002 Aug 04, 2014
AP FRESENIUS KABI USA 15MG/ML A075784 001 Jan 11, 2002
AP 30MG/ML A075784 002 Jan 11, 2002
AP + HOSPIRA 15MG/ML A074802 001 Jun 05, 1997
AP 15MG/ML A074993 001 Jan 27, 1999
AP + 30MG/ML A074802 002 Jun 05, 1997
AP 30MG/ML A074993 002 Jan 27, 1999
AP SAGENT PHARMS 15MG/ML A091065 001 Nov 27, 2013
AP 30MG/ML A091065 002 Nov 27, 2013
AP SANDOZ 30MG/ML A076271 002 Oct 06, 2004
AP WOCKHARDT 15MG/ML A077942 001 Mar 27, 2007
AP 30MG/ML A077942 002 Mar 27, 2007
SOLUTION/DROPS;OPHTHALMIC
ACULAR
AT + ALLERGAN 0.5% N019700 001 Nov 09, 1992
ACULAR LS
AT + ALLERGAN 0.4% N021528 001 May 30, 2003
ACUVAIL
AT + ALLERGAN 0.45% N022427 001 Jul 22, 2009
KETOROLAC TROMETHAMINE
AT AKORN 0.4% A078399 001 Nov 05, 2009
AT 0.5% A078434 001 Nov 05, 2009
AT ALCON PHARMS LTD 0.4% A078721 001 Nov 05, 2009
AT 0.5% A076583 001 Nov 05, 2009
AT APOTEX INC 0.4% A077308 001 Nov 05, 2009
AT 0.5% A076109 001 Nov 05, 2009
AT SUN PHARMA GLOBAL 0.5% A090017 001 Nov 05, 2009
SPRAY, METERED;NASAL
SPRIX
+ LUITPOLD 15.75MG/SPRAY N022382 001 May 14, 2010
TABLET;ORAL
KETOROLAC TROMETHAMINE
AB + MYLAN 10MG A074761 001 May 16, 1997
AB PLIVA 10MG A075284 001 Jun 23, 1999
AB TEVA 10MG A074754 001 May 16, 1997
KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE
SOLUTION;IRRIGATION
OMIDRIA
+ OMEROS EQ 2.88MG BASE/ML;EQ 10.16MG BASE/ML N205388 001 May 30, 2014
LABETALOL HYDROCHLORIDE
INJECTABLE;INJECTION
LABETALOL HYDROCHLORIDE
AP AKORN INC 5MG/ML A075431 001 Nov 29, 1999
AP 5MG/ML A075524 001 Nov 29, 1999
AP EUROHLTH INTL 5MG/ML A075303 001 May 28, 1999
AP GLAND PHARMA LTD 5MG/ML A090699 001 Apr 03, 2012
AP + HOSPIRA 5MG/ML A075239 001 Nov 29, 1999
AP + 5MG/ML A075240 001 Nov 29, 1999
LABETALOL HYDROCLORIDE
AP SAGENT STRIDES 5MG/ML A079134 001 Feb 03, 2010
TABLET;ORAL
LABETALOL HYDROCHLORIDE
AB IVAX SUB TEVA PHARMS 100MG A074787 001 Aug 03, 1998
AB 200MG A074787 002 Aug 03, 1998
AB 300MG A074787 003 Aug 03, 1998
AB PAR FORM 100MG A200908 001 Jul 10, 2012
AB 200MG A200908 002 Jul 10, 2012
AB 300MG A200908 003 Jul 10, 2012
AB SANDOZ 100MG A075113 001 Aug 04, 1998
AB + 200MG A075113 002 Aug 04, 1998
AB 300MG A075113 003 Aug 04, 1998
AB WATSON LABS 100MG A075133 001 Aug 03, 1998
AB 200MG A075133 002 Aug 03, 1998
AB 300MG A075133 003 Aug 03, 1998
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-205(of 371)
LABETALOL HYDROCHLORIDE
TABLET;ORAL
TRANDATE
AB CNTY LINE PHARMS 100MG N018716 001 May 24, 1985
AB 200MG N018716 002 Aug 01, 1984
AB 300MG N018716 003 Aug 01, 1984
LACOSAMIDE
SOLUTION;INTRAVENOUS
VIMPAT
+ UCB INC 200MG/20ML (10MG/ML) N022254 001 Oct 28, 2008
SOLUTION;ORAL
VIMPAT
+ UCB INC 10MG/ML N022255 001 Apr 20, 2010
TABLET;ORAL
VIMPAT
UCB INC 50MG N022253 001 Oct 28, 2008
100MG N022253 002 Oct 28, 2008
150MG N022253 003 Oct 28, 2008
+ 200MG N022253 004 Oct 28, 2008
LACTULOSE
FOR SOLUTION;ORAL
LACTULOSE
+ CUMBERLAND PHARMS 10GM/PACKET A074712 001 Dec 10, 1997
+ 20GM/PACKET A074712 002 Dec 10, 1997
SOLUTION;ORAL
CONSTILAC
AA ALRA 10GM/15ML A071054 001 Jul 26, 1988
CONSTULOSE
AA + ACTAVIS MID ATLANTIC 10GM/15ML A070288 001 Aug 15, 1988
LACTULOSE
AA ANI PHARMS 10GM/15ML A078430 001 Nov 28, 2007
AA FRESENIUS KABI 10GM/15ML A090503 001 Jan 25, 2012
AA HI TECH PHARMA 10GM/15ML A074076 001 Jul 03, 1995
AA MORTON GROVE 10GM/15ML A074602 001 Nov 14, 1996
AA PHARM ASSOC 10GM/15ML A074623 001 Jul 30, 1996
AA ROXANE 10GM/15ML A073591 001 May 29, 1992
AA VINTAGE PHARMS 10GM/15ML A075993 001 Jul 26, 2001
AA VISTAPHARM 10GM/15ML A074138 001 Sep 30, 1992
SOLUTION;ORAL, RECTAL
CHOLAC
AA ALRA 10GM/15ML A071331 001 Jul 26, 1988
ENULOSE
AA + ACTAVIS MID ATLANTIC 10GM/15ML A071548 001 Aug 15, 1988
GENERLAC
AA MORTON GROVE PHARMS 10GM/15ML A074603 001 Oct 31, 1996
LACTULOSE
AA ANI PHARMS 10GM/15ML A090426 001 Nov 21, 2008
AA FRESENIUS KABI 10GM/15ML A090502 001 Jan 25, 2012
AA HI TECH PHARMA 10GM/15ML A074077 001 Jul 03, 1995
LAMIVUDINE
SOLUTION;ORAL
EPIVIR
AA + VIIV HLTHCARE 10MG/ML N020596 001 Nov 17, 1995
LAMIVUDINE
AA SILARX PHARMS INC 10MG/ML A203564 001 Oct 31, 2014
EPIVIR-HBV
+ GLAXOSMITHKLINE 5MG/ML N021004 001 Dec 08, 1998
TABLET;ORAL
EPIVIR
AB VIIV HLTHCARE 150MG N020564 001 Nov 17, 1995
AB + 300MG N020564 003 Jun 24, 2002
EPIVIR-HBV
AB + GLAXOSMITHKLINE 100MG N021003 001 Dec 08, 1998
LAMIVUDINE
AB APOTEX 150MG A091606 001 Dec 02, 2011
AB 300MG A091606 002 Dec 02, 2011
AB APOTEX INC 100MG A202941 001 Jan 02, 2014
AB AUROBINDO PHARMA LTD 150MG A202032 001 Nov 17, 2011
AB 300MG A202032 002 Nov 17, 2011
AB HETERO LABS LTD V 100MG A203260 001 Jan 02, 2014
AB 150MG A203277 001 Jan 06, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-206(of 371)
LAMIVUDINE
TABLET;ORAL
LAMIVUDINE
AB
300MG
A203277 002 Jan 06, 2014
AB LUPIN LTD
150MG
A205217 001 Dec 18, 2014
AB
300MG
A205217 002 Dec 18, 2014
AB MYLAN PHARMS INC
100MG
A204002 001 Dec 31, 2014
LAMIVUDINE; ZIDOVUDINE
TABLET;ORAL
COMBIVIR
AB + VIIV HLTHCARE
150MG;300MG
N020857 001 Sep 26, 1997
LAMIVUDINE AND ZIDOVUDINE
AB AUROBINDO PHARMA LTD
150MG;300MG
A202418 001 May 15, 2012
AB HETERO LABS LTD V
150MG;300MG
A203259 001 Feb 03, 2014
AB LUPIN LTD
150MG;300MG
A090246 001 May 15, 2012
AB MYLAN PHARMS INC
150MG;300MG
A204005 001 Aug 28, 2014
AB TEVA PHARMS
150MG;300MG
A079081 001 May 25, 2011
LAMOTRIGINE
TABLET;ORAL
LAMICTAL
AB + GLAXOSMITHKLINE LLC
25MG
N020241 005 Dec 27, 1994
AB
100MG
N020241 001 Dec 27, 1994
AB
150MG
N020241 002 Dec 27, 1994
AB
200MG
N020241 003 Dec 27, 1994
LAMOTRIGINE
AB ALEMBIC PHARMS LTD
25MG
A090607 001 Jan 13, 2011
AB
100MG
A090607 002 Jan 13, 2011
AB
150MG
A090607 003 Jan 13, 2011
AB
200MG
A090607 004 Jan 13, 2011
AB ALKEM LABS LTD
25MG
A200694 001 Jun 14, 2013
AB
100MG
A200694 002 Jun 14, 2013
AB
150MG
A200694 003 Jun 14, 2013
AB
200MG
A200694 004 Jun 14, 2013
AB APOTEX INC
25MG
A078625 001 Jan 27, 2009
AB
100MG
A078625 002 Jan 27, 2009
AB
150MG
A078625 003 Jan 27, 2009
AB
200MG
A078625 004 Jan 27, 2009
AB AUROBINDO PHARMA
25MG
A078956 001 Jan 27, 2009
AB
100MG
A078956 002 Jan 27, 2009
AB
150MG
A078956 003 Jan 27, 2009
AB
200MG
A078956 004 Jan 27, 2009
AB CADISTA PHARMS
25MG
A079132 001 Jan 27, 2009
AB
100MG
A079132 002 Jan 27, 2009
AB
150MG
A079132 003 Jan 27, 2009
AB
200MG
A079132 004 Jan 27, 2009
AB CIPLA LTD
25MG
A077783 001 Nov 01, 2010
AB
100MG
A077783 002 Nov 01, 2010
AB
150MG
A077783 003 Nov 01, 2010
AB
200MG
A077783 004 Nov 01, 2010
AB DR REDDYS LABS LTD
25MG
A076708 001 Jan 27, 2009
AB
100MG
A076708 002 Jan 27, 2009
AB
150MG
A076708 003 Jan 27, 2009
AB
200MG
A076708 004 Jan 27, 2009
AB GLENMARK GENERICS
25MG
A090169 001 May 12, 2012
AB
100MG
A090169 002 May 12, 2012
AB
150MG
A090169 003 May 12, 2012
AB
200MG
A090169 004 May 12, 2012
AB HIKMA PHARMS
25MG
A078134 001 Apr 19, 2011
AB
100MG
A078134 002 Apr 19, 2011
AB
150MG
A078134 003 Apr 19, 2011
AB
200MG
A078134 004 Apr 19, 2011
AB LUPIN LTD
25MG
A078691 001 Jun 01, 2010
AB
100MG
A078691 002 Jun 01, 2010
AB
150MG
A078691 003 Jun 01, 2010
AB
200MG
A078691 004 Jun 01, 2010
AB MYLAN
25MG
A077420 001 Jan 27, 2009
AB
100MG
A077420 002 Jan 27, 2009
AB
150MG
A077420 003 Jan 27, 2009
AB
200MG
A077420 004 Jan 27, 2009
AB TARO PHARM INDS
25MG
A078525 001 Jan 27, 2009
AB
100MG
A078525 002 Jan 27, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-207(of 371)
LAMOTRIGINE
TABLET;ORAL
LAMOTRIGINE
AB 150MG
A078525 003 Jan 27, 2009
AB 200MG
A078525 004 Jan 27, 2009
AB TEVA 25MG
A076388 001 Aug 30, 2006
AB 100MG
A076388 002 Aug 30, 2006
AB 150MG
A076388 003 Aug 30, 2006
AB 200MG
A076388 004 Aug 30, 2006
AB TORRENT PHARMS 25MG
A078947 001 Jan 27, 2009
AB 100MG
A078947 002 Jan 27, 2009
AB 150MG
A078947 003 Jan 27, 2009
AB 200MG
A078947 004 Jan 27, 2009
AB UNICHEM LABS LTD 25MG
A090170 001 Oct 06, 2011
AB 100MG
A090170 002 Oct 06, 2011
AB 150MG
A090170 003 Oct 06, 2011
AB 200MG
A090170 004 Oct 06, 2011
AB ZYDUS PHARMS USA 25MG
A077633 001 Jan 27, 2009
AB 100MG
A077633 003 Jan 27, 2009
AB 150MG
A077633 004 Jan 27, 2009
AB
200MG
A077633 005 Jan 27, 2009
50MG
A077633 002 Jan 27, 2009
250MG
A077633 006 Jan 27, 2009
TABLET, CHEWABLE;ORAL
LAMICTAL CD
AB GLAXOSMITHKLINE LLC
2MG
N020764 004 Sep 08, 2000
AB
5MG
N020764 001 Aug 24, 1998
AB +
25MG
N020764 002 Aug 24, 1998
LAMOTRIGINE
AB ALEMBIC PHARMS LTD
5MG
A201168 001 Jun 12, 2014
AB
25MG
A201168 002 Jun 12, 2014
AB AUROBINDO PHARMA
5MG
A090401 002 Nov 04, 2009
AB
25MG
A090401 003 Nov 04, 2009
AB DR REDDYS LABS LTD
5MG
A076701 001 Jan 22, 2009
AB
25MG
A076701 002 Jan 22, 2009
AB GLENMARK GENERICS
5MG
A079099 001 Feb 19, 2009
AB
25MG
A079099 002 Feb 19, 2009
AB JUBILANT GENERICS
5MG
A200220 001 Feb 28, 2011
AB
25MG
A200220 002 Feb 28, 2011
AB MYLAN
5MG
A076630 001 Jan 22, 2009
AB
25MG
A076630 002 Jan 22, 2009
AB TARO
5MG
A079204 001 Feb 04, 2009
AB
25MG
A079204 002 Feb 04, 2009
AB TEVA
5MG
A076420 001 Jun 21, 2006
AB
25MG
A076420 002 Jun 21, 2006
AB WATSON LABS
2MG
A076928 001 Jan 22, 2009
AB
5MG
A076928 002 Jan 22, 2009
AB
25MG
A076928 003 Jan 22, 2009
AB ZYDUS PHARMS USA INC
5MG
A078009 002 Jan 22, 2009
AB
25MG
A078009 003 Jan 22, 2009
TABLET, EXTENDED RELEASE;ORAL
LAMICTAL XR
AB GLAXOSMITHKLINE LLC
25MG
N022115 001 May 29, 2009
AB +
50MG
N022115 002 May 29, 2009
AB
100MG
N022115 003 May 29, 2009
AB
200MG
N022115 004 May 29, 2009
AB
250MG
N022115 006 Jun 21, 2011
AB
300MG
N022115 005 Apr 14, 2010
LAMOTRIGINE
AB ACTAVIS ELIZABETH
100MG
A200672 003 Oct 17, 2013
AB
200MG
A200672 004 Oct 17, 2013
AB
25MG
A200672 001 Oct 17, 2013
AB
50MG
A200672 002 Oct 17, 2013
AB
250MG
A203733 001 Nov 13, 2013
AB
300MG
A200672 005 Oct 17, 2013
AB ANCHEN PHARMS
25MG
A201374 001 Dec 26, 2012
AB
50MG
A201374 002 Dec 26, 2012
AB
100MG
A201374 003 Dec 26, 2012
AB
200MG
A201374 004 Dec 26, 2012
AB
250MG
A201374 005 Dec 26, 2012
AB
300MG
A201374 006 Dec 26, 2012
AB DR REDDYS LABS LTD
25MG
A202383 001 Jun 19, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-208(of 371)
LAMOTRIGINE
TABLET, EXTENDED RELEASE;ORAL
LAMOTRIGINE
AB 50MG A202383 002 Jun 19, 2013
AB 100MG A202383 003 Jun 19, 2013
AB 200MG A202383 004 Jun 19, 2013
AB 300MG A202383 005 Jun 19, 2013
AB PAR PHARM 25MG A201791 001 Jan 18, 2013
AB 50MG A201791 002 Jan 18, 2013
AB 100MG A201791 003 Jan 18, 2013
AB 200MG A201791 004 Jan 18, 2013
AB 250MG A201791 005 Jan 18, 2013
AB 300MG A201791 006 Jan 18, 2013
AB TORRENT PHARMS LTD 25MG A203370 001 Dec 23, 2013
AB 50MG A203370 002 Dec 23, 2013
AB 100MG A203370 003 Dec 23, 2013
AB 200MG A203370 004 Dec 23, 2013
AB WILSHIRE PHARMS INC 25MG A202887 001 Jun 17, 2013
AB 50MG A202887 002 Jun 17, 2013
AB 100MG A202887 003 Jun 17, 2013
AB 200MG A202887 004 Jun 17, 2013
AB WOCKHARDT LTD 25MG A202498 001 Jan 04, 2013
AB 50MG A202498 002 Jan 04, 2013
AB 100MG A202498 003 Jan 04, 2013
AB 200MG A202498 004 Jan 04, 2013
AB 300MG A202498 005 Jan 04, 2013
TABLET, ORALLY DISINTEGRATING;ORAL
LAMICTAL ODT
AB GLAXOSMITHKLINE LLC 25MG N022251 001 May 08, 2009
AB + 50MG N022251 002 May 08, 2009
AB 100MG N022251 003 May 08, 2009
AB 200MG N022251 004 May 08, 2009
LAMOTRIGINE
AB IMPAX LABS INC 25MG A200828 001 Jul 15, 2013
AB 50MG A200828 002 Jul 15, 2013
AB 100MG A200828 003 Jul 15, 2013
AB 200MG A200828 004 Jul 15, 2013
LANREOTIDE ACETATE
SOLUTION;SUBCUTANEOUS
SOMATULINE DEPOT
+ IPSEN PHARMA EQ 60MG BASE/0.2ML (EQ 60MG BASE/0.2ML) N022074 001 Aug 30, 2007
+ EQ 90MG BASE/0.3ML (EQ 90MG BASE/0.3ML) N022074 002 Aug 30, 2007
+ EQ 120MG BASE/0.5ML (EQ 120MG N022074 003 Aug 30, 2007
BASE/0.5ML)
LANSOPRAZOLE
CAPSULE, DELAYED REL PELLETS;ORAL
LANSOPRAZOLE
AB DR REDDYS LABS LTD 15MG A091269 001 Oct 15, 2010
AB 30MG A091269 002 Oct 15, 2010
AB MYLAN PHARMS INC 15MG A090763 001 Nov 10, 2009
AB 30MG A090763 002 Nov 10, 2009
AB NATCO PHARMA LTD 15MG A201921 001 Dec 18, 2012
AB 30MG A201921 002 Dec 18, 2012
AB SANDOZ 15MG A090331 001 Apr 23, 2010
AB 30MG A090331 002 Apr 23, 2010
AB SUN PHARMA GLOBAL 15MG A202637 001 Sep 13, 2013
AB 30MG A091509 001 Sep 13, 2013
AB TEVA PHARMS 15MG A077255 001 Nov 10, 2009
AB 30MG A077255 002 Nov 10, 2009
AB WOCKHARDT USA 15MG A202176 001 Sep 14, 2012
AB 30MG A202176 002 Sep 14, 2012
AB ZYDUS HLTHCARE 15MG A202366 001 Aug 19, 2013
AB 30MG A202366 002 Aug 19, 2013
LANSOPRAZOLE
AB KRKA TOVARNA ZDRAVIL 15MG A091212 001 Sep 16, 2013
AB 30MG A091212 002 Sep 16, 2013
PREVACID
AB TAKEDA PHARMS USA 15MG N020406 001 May 10, 1995
AB + 30MG N020406 002 May 10, 1995
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-209(of 371)
LANSOPRAZOLE
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL
PREVACID
TAKEDA PHARMS USA 15MG N021428 001 Aug 30, 2002
+ 30MG N021428 002 Aug 30, 2002
LANTHANUM CARBONATE
POWDER;ORAL
FOSRENOL
+ SHIRE DEV LLC EQ 1GM BASE N204734 002 Sep 24, 2014
EQ 750MG BASE N204734 001 Sep 24, 2014
TABLET, CHEWABLE;ORAL
FOSRENOL
+ SHIRE LLC EQ 1GM BASE N021468 004 Nov 23, 2005
EQ 500MG BASE N021468 002 Oct 26, 2004
EQ 750MG BASE N021468 003 Nov 23, 2005
LAPATINIB DITOSYLATE
TABLET;ORAL
TYKERB
+ SMITHKLINE BEECHAM EQ 250MG BASE N022059 001 Mar 13, 2007
LATANOPROST
SOLUTION/DROPS;OPHTHALMIC
LATANOPROST
AT AKORN 0.005% A090887 001 Jul 19, 2011
AT ALCON RES 0.005% A091449 001 Mar 22, 2011
AT BAUSCH AND LOMB 0.005% A201006 001 Mar 22, 2011
AT DR REDDYS LABS LTD 0.005% A202077 001 Feb 11, 2013
AT LUITPOLD 0.005% A200925 001 Mar 22, 2011
AT MYLAN 0.005% A201786 001 Mar 22, 2011
XALATAN
AT + PHARMACIA AND UPJOHN 0.005% N020597 001 Jun 05, 1996
LEDIPASVIR; SOFOSBUVIR
TABLET;ORAL
HARVONI
+ GILEAD SCIENCES INC 90MG;400MG N205834 001 Oct 10, 2014
LEFLUNOMIDE
TABLET;ORAL
ARAVA
AB SANOFI AVENTIS US 10MG N020905 001 Sep 10, 1998
AB + 20MG N020905 002 Sep 10, 1998
LEFLUNOMIDE
AB ALEMBIC PHARMS LTD 10MG A091369 001 Nov 21, 2011
AB 20MG A091369 002 Nov 21, 2011
AB APOTEX INC 10MG A077090 001 Sep 13, 2005
AB 20MG A077090 002 Sep 13, 2005
AB BARR 10MG A077083 001 Sep 13, 2005
AB 20MG A077083 002 Sep 13, 2005
AB HERITAGE PHARMS INC 10MG A077086 001 Sep 13, 2005
AB 20MG A077086 002 Sep 13, 2005
AB TEVA PHARMS 10MG A077084 001 Sep 13, 2005
AB 20MG A077084 002 Sep 13, 2005
ARAVA
+ SANOFI AVENTIS US 100MG N020905 003 Sep 10, 1998
LENALIDOMIDE
CAPSULE;ORAL
REVLIMID
CELGENE 2.5MG N021880 005 Dec 21, 2011
5MG N021880 001 Dec 27, 2005
10MG N021880 002 Dec 27, 2005
15MG N021880 003 Jun 29, 2006
20MG N021880 006 Jun 05, 2013
+ 25MG N021880 004 Jun 29, 2006
LETROZOLE
TABLET;ORAL
FEMARA
AB + NOVARTIS PHARMS 2.5MG N020726 001 Jul 25, 1997
LETROZOLE
AB ACCORD HLTHCARE 2.5MG A090934 001 Jun 03, 2011
AB APOTEX INC 2.5MG A091303 001 Apr 19, 2012
AB DR REDDYS LABS LTD 2.5MG A091191 001 Jun 03, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-210(of 371)
LETROZOLE
TABLET;ORAL
LETROZOLE
AB FRESENIUS KABI ONCOL 2.5MG A090491 001 Jun 03, 2011
AB INDICUS PHARMA 2.5MG A201804 001 Jun 03, 2011
AB JIANGSU HENGRUI MED 2.5MG A202716 001 May 16, 2013
AB KUDCO IRELAND 2.5MG A091098 001 Jun 03, 2011
AB LANNETT HOLDINGS INC 2.5MG A202048 001 Oct 29, 2014
AB MYLAN 2.5MG A078190 001 Dec 24, 2008
AB NATCO PHARMA LTD 2.5MG A200161 001 Jun 03, 2011
AB ROXANE 2.5MG A090838 001 Jun 03, 2011
AB SUN PHARM INDS LTD 2.5MG A091466 001 Jun 03, 2011
AB TEVA PHARMS 2.5MG A090289 001 Jun 03, 2011
AB VINTAGE PHARMS LLC 2.5MG A090789 001 Jun 03, 2011
LEUCOVORIN CALCIUM
INJECTABLE;INJECTION
LEUCOVORIN CALCIUM
AP + EUROHLTH INTL EQ 50MG BASE/VIAL A089384 001 Sep 14, 1987
AP + EQ 100MG BASE/VIAL A089717 001 Mar 28, 1988
AP TEVA PHARMS USA EQ 100MG BASE/VIAL A081277 001 Sep 28, 1993
AP EQ 350MG BASE/VIAL A040174 001 Jun 12, 1997
LEUCOVORIN CALCIUM PRESERVATIVE FREE
AP + EUROHLTH INTL EQ 200MG BASE/VIAL A040056 001 May 23, 1995
AP + EQ 350MG BASE/VIAL A040335 001 Apr 20, 2000
AP FRESENIUS KABI USA EQ 200MG BASE/VIAL A040258 001 Feb 26, 1999
AP SAGENT PHARMS EQ 50MG BASE/VIAL A200753 001 Sep 06, 2012
AP EQ 100MG BASE/VIAL A200753 002 Sep 06, 2012
AP EQ 200MG BASE/VIAL A200753 003 Sep 06, 2012
AP EQ 350MG BASE/VIAL A200855 001 Sep 06, 2012
+ EUROHLTH INTL EQ 10MG BASE/ML A040347 001 Apr 25, 2000
+ FRESENIUS KABI USA EQ 500MG BASE/VIAL A040286 001 Feb 26, 1999
TABLET;ORAL
LEUCOVORIN CALCIUM
AB BARR EQ 5MG BASE A071198 001 Sep 24, 1987
AB EQ 25MG BASE A071199 001 Sep 24, 1987
AB ROXANE EQ 5MG BASE A072733 001 Feb 22, 1993
AB EQ 15MG BASE A072735 001 Feb 22, 1993
AB + EQ 25MG BASE A072736 001 Feb 22, 1993
EQ 10MG BASE A072734 001 Feb 22, 1993
LEUPROLIDE ACETATE
INJECTABLE;INJECTION
LEUPROLIDE ACETATE
AP + SANDOZ 1MG/0.2ML A074728 001 Aug 04, 1998
AP SUN PHARMA GLOBAL 1MG/0.2ML A078885 001 Mar 09, 2009
AP TEVA PHARMS USA 1MG/0.2ML A075471 001 Oct 25, 2000
LUPRON DEPOT
+ ABBVIE ENDOCRINE INC 3.75MG N020011 002 Oct 26, 1995
+ 7.5MG/VIAL N019732 001 Jan 26, 1989
+ 11.25MG/VIAL N020708 001 Mar 07, 1997
+ 22.5MG/VIAL N020517 001 Dec 22, 1995
+ 30MG/VIAL N020517 002 May 30, 1997
45MG/VIAL N020517 003 Jun 17, 2011
LUPRON DEPOT-PED
+ ABBVIE ENDOCRINE INC 7.5MG/VIAL N020263 002 Apr 16, 1993
+ 11.25MG/VIAL N020263 005 Jan 21, 1994
+ 11.25MG/VIAL N020263 007 Aug 15, 2011
+ 15MG/VIAL N020263 006 Jan 21, 1994
+ 30MG/VIAL N020263 008 Aug 15, 2011
INJECTABLE;SUBCUTANEOUS
ELIGARD
+ TOLMAR THERAP 7.5MG/VIAL N021343 001 Jan 23, 2002
+ 22.5MG/VIAL N021379 001 Jul 24, 2002
+ 30MG/VIAL N021488 001 Feb 13, 2003
+ 45MG/VIAL N021731 001 Dec 14, 2004
LEUPROLIDE ACETATE; NORETHINDRONE ACETATE
INJECTABLE, TABLET;INTRAMUSCULAR, ORAL
LUPANETA PACK
ABBVIE ENDOCRINE 3.75MG/VIAL,N/A;N/A,5MG N203696 001 Dec 14, 2012
+ 11.25MG/VIAL,N/A;N/A,5MG N203696 002 Dec 14, 2012
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-211(of 371)
LEVALBUTEROL HYDROCHLORIDE
SOLUTION;INHALATION
LEVALBUTEROL HYDROCHLORIDE
AN CIPLA LTD EQ 0.021% BASE A078171 002 Dec 13, 2013
AN EQ 0.042% BASE A078171 003 Dec 13, 2013
AN EQ 0.0103% BASE A078171 001 Dec 13, 2013
AN MYLAN SPECLT EQ 0.0103% BASE A077800 001 Mar 15, 2013
AN EQ 0.021% BASE A077800 002 Mar 15, 2013
AN EQ 0.042% BASE A077800 003 Mar 15, 2013
AN EQ 0.25% BASE A078309 001 Mar 20, 2009
AN TEVA PARENTERAL EQ 0.25% BASE A200875 001 Sep 11, 2014
AN TEVA PHARMS USA EQ 0.0103% BASE A090297 001 Apr 26, 2013
AN EQ 0.021% BASE A090297 002 Apr 26, 2013
AN EQ 0.042% BASE A090297 003 Apr 26, 2013
AN WATSON LABS INC EQ 0.0103% BASE A077756 003 Apr 09, 2008
AN EQ 0.021% BASE A077756 001 Apr 09, 2008
AN EQ 0.042% BASE A077756 002 Apr 09, 2008
XOPENEX
AN + OAK PHARMS INC EQ 0.0103% BASE N020837 003 Jan 30, 2002
AN + EQ 0.021% BASE N020837 001 Mar 25, 1999
AN + EQ 0.042% BASE N020837 002 Mar 25, 1999
AN + EQ 0.25% BASE N020837 004 Jul 18, 2003
LEVALBUTEROL TARTRATE
AEROSOL, METERED;INHALATION
XOPENEX HFA
+ SUNOVION EQ 0.045MG BASE/INH N021730 001 Mar 11, 2005
LEVETIRACETAM
INJECTABLE;IV (INFUSION)
KEPPRA
AP + UCB INC 500MG/5ML (100MG/ML) N021872 001 Jul 31, 2006
LEVETIRACETAM
AP FRESENIUS KABI USA 500MG/5ML (100MG/ML) A090813 001 May 26, 2010
AP HIKMA FARMACEUTICA 500MG/5ML(100MG/ML) A090981 001 Oct 13, 2011
AP HOSPIRA INC 500MG/ML (100MG/ML) A202869 001 Apr 06, 2012
AP LUITPOLD 500MG/5ML (100MG/ML) A202143 001 Jan 31, 2012
AP SAGENT PHARMS 500MG/5ML (100MG/ML) A091627 001 Jun 26, 2013
AP SUN PHARM INDS LTD 500MG/5ML (100MG/ML) A090754 001 Jun 16, 2010
AP X GEN PHARMS 500MG/5ML (100MG/ML) A091485 001 Aug 05, 2011
LEVETIRACETAM IN SODIUM CHLORIDE
+ HQ SPECIALITY PHARMA 500MG/100ML (5MG/ML) N202543 001 Nov 09, 2011
+ 1000MG/100ML (10MG/ML) N202543 002 Nov 09, 2011
+ 1500MG/100ML (15MG/ML) N202543 003 Nov 09, 2011
SOLUTION;ORAL
KEPPRA
AA + UCB INC 100MG/ML N021505 001 Jul 15, 2003
LEVETIRACETAM
AA ACTAVIS MID ATLANTIC 100MG/ML A078976 001 Jan 15, 2009
AA AMNEAL PHARMS 100MG/ML A090992 001 Oct 27, 2009
AA AUROBINDO PHARM 100MG/ML A079063 001 Jan 15, 2009
AA BRECKENRIDGE PHARM 100MG/ML A079120 001 Jan 16, 2009
AA HETERO LABS LTD III 100MG/ML A203052 001 Feb 28, 2013
AA HI-TECH PHARMACAL 100MG/ML A090601 001 Feb 28, 2012
AA LUPIN LTD 100MG/ML A090893 001 Oct 17, 2011
AA ORIT LABS LLC 100MG/ML A203067 001 May 09, 2013
AA ROXANE 100MG/ML A078582 001 Jan 15, 2009
AA SILARX 100MG/ML A090263 001 Apr 03, 2009
AA TARO 100MG/ML A078774 001 Feb 10, 2009
AA TOLMAR 100MG/ML A079107 001 Jan 15, 2009
AA TRIS PHARMA INC 100MG/ML A090461 001 Sep 30, 2010
AA VINTAGE PHARMS 100MG/ML A090079 001 Apr 11, 2012
AA WOCKHARDT 100MG/ML A090028 001 Mar 03, 2010
TABLET;ORAL
KEPPRA
AB + UCB INC 1GM N021035 004 Jan 06, 2006
AB 250MG N021035 001 Nov 30, 1999
AB 500MG N021035 002 Nov 30, 1999
AB 750MG N021035 003 Nov 30, 1999
LEVETIRACETAM
AB ACCORD HLTHCARE 1GM A090843 004 Feb 14, 2011
AB 250MG A090843 001 Feb 14, 2011
AB 500MG A090843 002 Feb 14, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-212(of 371)
LEVETIRACETAM
TABLET;ORAL
LEVETIRACETAM
AB 750MG A090843 003 Feb 14, 2011
AB AJANTA PHARMA 1GM A201293 004 Jun 14, 2011
AB 250MG A201293 001 Jun 14, 2011
AB 500MG A201293 002 Jun 14, 2011
AB 750MG A201293 003 Jun 14, 2011
AB APOTEX INC 1GM A078869 004 Mar 13, 2009
AB 250MG A078869 001 Mar 13, 2009
AB 500MG A078869 002 Mar 13, 2009
AB 750MG A078869 003 Mar 13, 2009
AB AUROBINDO PHARMA 1GM A078993 004 Jan 15, 2009
AB 250MG A078993 001 Jan 15, 2009
AB 500MG A078993 002 Jan 15, 2009
AB 750MG A078993 003 Jan 15, 2009
AB BRECKENRIDGE PHARM 1GM A090511 004 Aug 18, 2011
AB 250MG A090511 001 Aug 18, 2011
AB 500MG A090511 002 Aug 18, 2011
AB 750MG A090511 003 Aug 18, 2011
AB DR REDDYS LABS LTD 1GM A078904 001 Jan 15, 2009
AB 250MG A076920 001 Jan 15, 2009
AB 500MG A076920 002 Jan 15, 2009
AB 750MG A076920 003 Jan 15, 2009
AB HETERO LABS LTD III 1GM A090515 004 Oct 08, 2010
AB 250MG A090515 001 Oct 08, 2010
AB 500MG A090515 002 Oct 08, 2010
AB 750MG A090515 003 Oct 08, 2010
AB INVAGEN PHARMS 250MG A078234 001 Jan 15, 2009
AB 500MG A078234 002 Jan 15, 2009
AB 750MG A078234 003 Jan 15, 2009
AB LOTUS PHARM CO LTD 500MG A090906 001 Nov 05, 2010
AB LUPIN 1GM A090025 001 Jan 15, 2009
AB 250MG A078154 001 Jan 15, 2009
AB 500MG A078154 002 Jan 15, 2009
AB 750MG A078154 003 Jan 15, 2009
AB METHAPHARM 1GM A090767 004 Jul 28, 2010
AB 250MG A090767 001 Jul 28, 2010
AB 500MG A090767 002 Jul 28, 2010
AB 750MG A090767 003 Jul 28, 2010
AB MYLAN 1GM A090261 001 Dec 08, 2009
AB 250MG A076919 001 Nov 04, 2008
AB 500MG A076919 002 Nov 04, 2008
AB 750MG A076919 003 Nov 04, 2008
AB ORCHID HLTHCARE 1GM A090484 001 Aug 05, 2010
AB 250MG A078526 001 Jan 15, 2009
AB 500MG A078526 002 Jan 15, 2009
AB 750MG A078526 003 Jan 15, 2009
AB PRINSTON INC 1GM A078106 004 Feb 10, 2009
AB 250MG A078106 001 Feb 10, 2009
AB 500MG A078106 002 Feb 10, 2009
AB 750MG A078106 003 Feb 10, 2009
AB ROXANE 1GM A078042 004 Jan 15, 2009
AB 250MG A078042 001 Jan 15, 2009
AB 500MG A078042 002 Jan 15, 2009
AB 750MG A078042 003 Jan 15, 2009
AB TARO 1GM A078960 001 Feb 01, 2010
AB 250MG A078960 004 Feb 01, 2010
AB 500MG A078960 003 Feb 01, 2010
AB 750MG A078960 002 Feb 01, 2010
AB TEVA PHARMS 1GM A078101 004 Jan 15, 2009
AB 250MG A078101 001 Jan 15, 2009
AB 500MG A078101 002 Jan 15, 2009
AB 750MG A078101 003 Jan 15, 2009
AB TORRENT PHARMS 1GM A078858 004 Jan 15, 2009
AB 250MG A078858 001 Jan 15, 2009
AB 500MG A078858 002 Jan 15, 2009
AB 750MG A078858 003 Jan 15, 2009
AB VINTAGE PHARMS 1GM A091491 004 Dec 14, 2010
AB 250MG A077319 001 Mar 20, 2009
AB 250MG A091491 001 Dec 14, 2010
AB 500MG A077319 002 Mar 20, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-213(of 371)
LEVETIRACETAM
TABLET;ORAL
LEVETIRACETAM
AB 500MG
A091491 002 Dec 14, 2010
AB 750MG
A077319 003 Mar 20, 2009
AB 750MG
A091491 003 Dec 14, 2010
AB WOCKHARDT 1GM
A079042 004 Jan 15, 2009
AB 250MG
A079042 001 Jan 15, 2009
AB 500MG
A079042 002 Jan 15, 2009
AB 750MG
A079042 003 Jan 15, 2009
AB ZYDUS PHARMS USA INC 1GM
A078918 002 Apr 29, 2009
AB 250MG
A078918 001 Apr 29, 2009
TABLET, EXTENDED RELEASE;ORAL
KEPPRA XR
AB UCB INC
500MG
N022285 001 Sep 12, 2008
AB +
750MG
N022285 002 Feb 12, 2009
LEVETIRACETAM
AB ACTAVIS ELIZABETH
500MG
A091557 001 Sep 12, 2011
AB
750MG
A091557 002 Sep 12, 2011
AB ACTAVIS LABS FL INC
500MG
A091093 001 Sep 12, 2011
AB
750MG
A091093 002 Sep 12, 2011
AB ANCHEN PHARMS
500MG
A091360 001 Oct 04, 2011
AB
750MG
A091360 002 Oct 04, 2011
AB APOTEX INC
500MG
A091261 001 Sep 12, 2011
AB
750MG
A091261 002 Sep 12, 2011
AB LUPIN LTD
500MG
A091399 001 Sep 12, 2011
AB
750MG
A091399 002 Sep 12, 2011
AB MUTUAL PHARM CO INC
500MG
A091285 001 Sep 12, 2011
AB
750MG
A091285 002 Sep 12, 2011
AB MYLAN PHARMS INC
500MG
A200475 001 Dec 19, 2011
AB
750MG
A200475 002 Dec 19, 2011
AB PAR PHARM
500MG
A091291 001 Sep 12, 2011
AB
750MG
A091291 002 Sep 12, 2011
AB ROUSES POINT PHARMS
500MG
A202524 001 Aug 27, 2012
AB
750MG
A202524 002 Aug 27, 2012
AB SUN PHARMA GLOBAL
500MG
A203059 001 Sep 09, 2013
AB
750MG
A203059 002 Sep 09, 2013
AB TEVA PHARMS
500MG
A091430 001 Sep 12, 2011
AB
750MG
A091430 002 Sep 12, 2011
AB TORRENT PHARMS LTD
500MG
A091338 001 May 29, 2012
AB
750MG
A091338 002 May 29, 2012
AB VINTAGE PHARMS
500MG
A201464 001 May 25, 2012
AB
750MG
A201464 002 May 25, 2012
AB VINTAGE PHARMS LLC
500MG
A202533 001 Jul 20, 2012
AB
750MG
A202533 002 Jul 20, 2012
LEVOBUNOLOL HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
AKBETA
AT AKORN
0.25%
A074779 001 Oct 29, 1996
AT
0.5%
A074780 001 Oct 29, 1996
BETAGAN
AT + ALLERGAN
0.25%
N019814 001 Jun 28, 1989
AT +
0.5%
N019219 002 Dec 19, 1985
LEVOBUNOLOL HYDROCHLORIDE
AT ALCON RES LTD
0.5%
A074850 001 Oct 28, 1996
AT BAUSCH AND LOMB
0.25%
A074307 001 Mar 04, 1994
AT
0.5%
A074326 001 Mar 04, 1994
AT FALCON PHARMS
0.25%
A074851 001 Oct 28, 1996
LEVOCARNITINE
INJECTABLE;INJECTION
CARNITOR
AP + SIGMA TAU
200MG/ML
N020182 001 Dec 16, 1992
LEVOCARNITINE
AP EUROHLTH INTL
200MG/ML
A075567 001 Mar 29, 2001
AP LUITPOLD
200MG/ML
A075861 001 Jun 22, 2001
AP TEVA PHARMS USA
200MG/ML
A075881 001 Mar 29, 2001
SOLUTION;ORAL
CARNITOR
AA + SIGMA TAU
1GM/10ML
N019257 001 Apr 10, 1986
CARNITOR SF
AA SIGMA TAU
1GM/10ML
N019257 002 Mar 28, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-214(of 371)
LEVOCARNITINE
SOLUTION;ORAL
LEVOCARNITINE
AA HI TECH PHARMA 1GM/10ML A077399 001 Oct 25, 2007
AA LYNE 1GM/10ML A076851 001 Aug 10, 2004
TABLET;ORAL
CARNITOR
AB + SIGMA TAU 330MG N018948 001 Dec 27, 1985
LEVOCARNITINE
AB COREPHARMA 330MG A076858 001 Sep 20, 2004
LEVOCETIRIZINE DIHYDROCHLORIDE
SOLUTION;ORAL
LEVOCETIRIZINE DIHYDROCHLORIDE
AA APOTEX INC 2.5MG/5ML A202915 001 Aug 21, 2014
AA L PERRIGO CO 2.5MG/5ML A091263 001 Nov 07, 2011
AA TARO PHARM INDS 2.5MG/5ML A202673 001 Jul 26, 2013
XYZAL
AA + UCB INC 2.5MG/5ML N022157 001 Jan 28, 2008
TABLET;ORAL
LEVOCETIRIZINE DIHYDROCHLORIDE
AB DR REDDYS LABS LTD 5MG A090392 001 Feb 24, 2011
AB GLENMARK GENERICS 5MG A090385 001 Feb 24, 2011
AB HETERO LABS LTD III 5MG A091264 001 Jun 29, 2012
AB MICRO LABS LTD INDIA 5MG A202046 001 Sep 17, 2013
AB SCIEGEN PHARMS INC 5MG A203646 001 Sep 09, 2014
AB SUN PHARMA GLOBAL 5MG A090362 001 Jan 31, 2013
AB SYNTHON PHARMS 5MG A090229 001 Nov 26, 2010
AB TEVA PHARMS 5MG A090199 001 Aug 22, 2011
XYZAL
AB + UCB INC 5MG N022064 001 May 25, 2007
LEVOFLOXACIN
INJECTABLE;INJECTION
LEVAQUIN
AP + JANSSEN PHARMS EQ 500MG/20ML (EQ 25MG/ML) N020635 001 Dec 20, 1996
AP + EQ 750MG/30ML (EQ 25MG/ML) N020635 004 Dec 20, 1996
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + JANSSEN PHARMS EQ 250MG/50ML (EQ 5MG/ML) N020635 002 Dec 20, 1996
AP + EQ 500MG/100ML (EQ 5MG/ML) N020635 003 Dec 20, 1996
AP + EQ 750MG/150ML (EQ 5MG/ML) N020635 005 Dec 20, 1996
LEVOFLOXACIN
AP AUROBINDO PHARMA LTD EQ 500MG/20ML (EQ 25MG/ML) A202328 001 Jan 24, 2013
AP EQ 750MG/30ML (EQ 25MG/ML) A202328 002 Jan 24, 2013
AP CLARIS LIFESCIENCES EQ 500MG/20ML (EQ 25MG/ML) A091436 001 Jun 05, 2013
AP EMCURE PHARMS LTD EQ 500MG/20ML (EQ 25MG/ML) A202590 001 Jan 24, 2013
AP EQ 750MG/30ML (EQ 25MG/ML) A202590 002 Jan 24, 2013
AP SAGENT PHARMS EQ 500MG/20ML (EQ 25MG/ML) A200560 001 Jun 20, 2011
AP EQ 750MG/30ML (EQ 25MG/ML) A200560 002 Jun 20, 2011
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
AP ACS DOBFAR INFO SA EQ 250MG/50ML (EQ 5MG/ML) A090343 001 Jul 07, 2011
AP EQ 500MG/100ML (EQ 5MG/ML) A090343 002 Jul 07, 2011
AP EQ 750MG/150ML (EQ 5MG/ML) A090343 003 Jul 07, 2011
AP CLARIS LIFESCIENCES EQ 250MG/50ML (EQ 5MG/ML) A091397 001 Aug 08, 2013
AP EQ 500MG/100ML (EQ 5MG/ML) A091397 002 Aug 08, 2013
AP EQ 750MG/150ML (EQ 5MG/ML) A091397 003 Aug 08, 2013
AP FRESENIUS KABI USA EQ 250MG/50ML (EQ 5MG/ML) A200674 001 Jun 19, 2013
AP EQ 500MG/100ML (EQ 5MG/ML) A200674 002 Jun 19, 2013
AP EQ 750MG/150ML (EQ 5MG/ML) A200674 003 Jun 19, 2013
AP HIKMA FARMACEUTICA EQ 250MG/50ML (EQ 5MG/ML) A091375 001 Sep 16, 2011
AP EQ 500MG/100ML (EQ5MG/ML) A091375 002 Sep 16, 2011
AP EQ 750MG/150ML (EQ 5MG/ML) A091375 003 Sep 16, 2011
SOLUTION;ORAL
LEVAQUIN
AA + JANSSEN PHARMS 250MG/10ML N021721 001 Oct 21, 2004
LEVOFLOXACIN
AA HI TECH PHARMA 250MG/10ML A091678 001 Jun 20, 2011
SOLUTION/DROPS;OPHTHALMIC
LEVOFLOXACIN
AT AKORN 0.5% A090268 001 Dec 20, 2010
AT NEXUS PHARMS 0.5% A077700 001 Dec 20, 2010
AT WATSON LABS INC 0.5% A076826 001 Feb 10, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-215(of 371)
LEVOFLOXACIN
SOLUTION/DROPS;OPHTHALMIC
QUIXIN
AT + SANTEN
0.5%
N021199 001 Aug 18, 2000
TABLET;ORAL
LEVAQUIN
AB JANSSEN PHARMS
250MG
N020634 001 Dec 20, 1996
AB
500MG
N020634 002 Dec 20, 1996
AB +
750MG
N020634 003 Sep 08, 2000
LEVOFLOXACIN
AB APOTEX INC
250MG
A090787 001 Sep 29, 2011
AB
500MG
A090787 002 Sep 29, 2011
AB
750MG
A090787 003 Sep 29, 2011
AB AUROBINDO PHARMA LTD
250MG
A201043 001 Jun 20, 2011
AB
500MG
A201043 002 Jun 20, 2011
AB
750MG
A201043 003 Jun 20, 2011
AB CIPLA LTD
250MG
A076890 001 Mar 30, 2012
AB
500MG
A076890 002 Mar 30, 2012
AB
750MG
A076890 003 Mar 30, 2012
AB DR REDDYS LABS INC
250MG
A076710 001 Jun 20, 2011
AB
500MG
A076710 002 Jun 20, 2011
AB
750MG
A076710 003 Jun 20, 2011
AB GLENMARK GENERICS
250MG
A200250 001 Jun 20, 2011
AB
500MG
A200250 002 Jun 20, 2011
AB
750MG
A200250 003 Jun 20, 2011
AB HETERO LABS LTD V
250MG
A202801 001 Jan 08, 2015
AB
500MG
A202801 002 Jan 08, 2015
AB
750MG
A202801 003 Jan 08, 2015
AB LUPIN
250MG
A078424 001 Jun 20, 2011
AB
500MG
A078424 002 Jun 20, 2011
AB
750MG
A078424 003 Jun 20, 2011
AB MACLEODS PHARMS LTD
250MG
A200839 001 Mar 22, 2012
AB
500MG
A200839 002 Mar 22, 2012
AB
750MG
A200839 003 Mar 22, 2012
AB MYLAN
250MG
A076276 001 Jun 20, 2011
AB
500MG
A076276 002 Jun 20, 2011
AB
750MG
A077097 001 Jun 20, 2011
AB ORCHID HLTHCARE
250MG
A202200 001 Jan 30, 2012
AB
500MG
A202200 002 Jan 30, 2012
AB
750MG
A202200 003 Jan 30, 2012
AB SANDOZ
250MG
A077438 001 Jun 20, 2011
AB
500MG
A077438 002 Jun 20, 2011
AB
750MG
A077438 003 Jun 20, 2011
AB TEVA
250MG
A076361 001 Jun 20, 2011
AB
500MG
A076361 002 Jun 20, 2011
AB
750MG
A076361 003 Jun 20, 2011
AB TORRENT PHARMS
250MG
A090722 001 Jun 20, 2011
AB
500MG
A090722 002 Jun 20, 2011
AB
750MG
A090722 003 Jun 20, 2011
AB WOCKHARDT
250MG
A090367 001 Jun 20, 2011
AB
500MG
A090367 002 Jun 20, 2011
AB
750MG
A090367 003 Jun 20, 2011
AB ZYDUS PHARMS USA INC
250MG
A077652 001 Sep 07, 2012
AB
500MG
A077652 002 Sep 07, 2012
AB
750MG
A077652 003 Sep 07, 2012
LEVOLEUCOVORIN CALCIUM
POWDER;IV (INFUSION)
FUSILEV
+ SPECTRUM PHARMS
EQ 50MG BASE/VIAL
N020140 001 Mar 07, 2008
LEVOMILNACIPRAN HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
FETZIMA
FOREST LABS INC EQ 20MG BASE
N204168 001 Jul 25, 2013
EQ 40MG BASE
N204168 002 Jul 25, 2013
EQ 80MG BASE
N204168 003 Jul 25, 2013
+ EQ 120MG BASE
N204168 004 Jul 25, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-216(of 371)
LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION
SCANDONEST L
+ DEPROCO 0.05MG/ML;2% A088388 001 Oct 10, 1984
LEVONORGESTREL
INTRAUTERINE DEVICE;INTRAUTERINE
MIRENA
+ BAYER HLTHCARE 52MG N021225 001 Dec 06, 2000
SKYLA
+ BAYER HLTHCARE 13.5MG N203159 001 Jan 09, 2013
TABLET;ORAL
LEVONORGESTREL
AB NOVEL LABS INC 1.5MG A202508 001 Feb 22, 2013
AB PERRIGO R AND D 0.75MG A090740 001 Dec 30, 2010
AB + WATSON LABS 0.75MG A078665 001 Aug 28, 2009
AB WATSON LABS INC 1.5MG A200670 001 Jul 12, 2012
PLAN B
AB + TEVA BRANDED PHARM 0.75MG N021045 002 Aug 24, 2006
LEVORPHANOL TARTRATE
TABLET;ORAL
LEVORPHANOL TARTRATE
+ ROXANE 2MG A074278 001 Mar 31, 2000
LEVOTHYROXINE SODIUM
CAPSULE;ORAL
TIROSINT
INST BIOCHIMIQUE 0.013MG N022121 001 Aug 01, 2007
INSTITUT BIOCHIMIQUE 0.025MG N021924 002 Oct 13, 2006
0.05MG N021924 003 Oct 13, 2006
0.075MG N021924 004 Oct 13, 2006
0.088MG N021924 010 Oct 02, 2009
0.1MG N021924 005 Oct 13, 2006
0.112MG N021924 008 Oct 02, 2009
0.125MG N021924 006 Oct 13, 2006
0.137MG N021924 009 Oct 02, 2009
+ 0.15MG N021924 007 Oct 13, 2006
POWDER;INTRAVENOUS
LEVOTHYROXINE SODIUM
+ FRESENIUS KABI USA 100MCG/VIAL N202231 001 Jun 24, 2011
+ 200MCG/VIAL N202231 002 Jun 24, 2011
+ 500MCG/VIAL N202231 003 Jun 24, 2011
LEVOTHYROXINE SODIUM **
**See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL
SYNTHROID
--> ABBVIE --> AB1,AB2 0.025MG N021402 001 Jul 24, 2002
--> --> AB1,AB2 0.05MG N021402 002 Jul 24, 2002
--> --> AB1,AB2 0.075MG N021402 003 Jul 24, 2002
--> --> AB1,AB2 0.088MG N021402 004 Jul 24, 2002
--> --> AB1,AB2 0.1MG N021402 005 Jul 24, 2002
--> --> AB1,AB2 0.112MG N021402 006 Jul 24, 2002
--> --> AB1,AB2 0.125MG N021402 007 Jul 24, 2002
--> --> AB1,AB2 0.137MG N021402 008 Jul 24, 2002
--> --> AB1,AB2 0.15MG N021402 009 Jul 24, 2002
--> --> AB1,AB2 0.175MG N021402 010 Jul 24, 2002
--> --> AB1,AB2 0.2MG N021402 012 Jul 24, 2002
--> + --> AB1,AB2 0.3MG N021402 011 Jul 24, 2002
LEVO-T
--> ALARA PHARM --> AB1,AB2,AB3 0.025MG N021342 001 Mar 01, 2002
--> --> AB1,AB2,AB3 0.05MG N021342 002 Mar 01, 2002
--> --> AB1,AB2,AB3 0.075MG N021342 003 Mar 01, 2002
--> --> AB1,AB2,AB3 0.088MG N021342 004 Mar 01, 2002
--> --> AB1,AB2,AB3 0.1MG N021342 005 Mar 01, 2002
--> --> AB1,AB2,AB3 0.112MG N021342 006 Mar 01, 2002
--> --> AB1,AB2,AB3 0.125MG N021342 007 Mar 01, 2002
--> --> AB1,AB2, 0.137MG N021342 012 Dec 08, 2003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-217(of 371)
LEVOTHYROXINE SODIUM **
**See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL
LEVO-T
AB3 0.137MG
--> --> AB1,AB2,AB3 0.15MG N021342 008 Mar 01, 2002
--> --> AB1,AB2,AB3 0.175MG N021342 009 Mar 01, 2002
--> --> AB1,AB2,AB3 0.2MG N021342 010 Mar 01, 2002
--> + --> AB1,AB2,AB3 0.3MG N021342 011 Mar 01, 2002
UNITHROID
--> STEVENS J --> AB1,AB2,AB3 0.025MG N021210 001 Aug 21, 2000
--> --> AB1,AB2,AB3 0.05MG N021210 002 Aug 21, 2000
--> --> AB1,AB2,AB3 0.075MG N021210 003 Aug 21, 2000
--> --> AB1,AB2,AB3 0.088MG N021210 004 Aug 21, 2000
--> --> AB1,AB2,AB3 0.1MG N021210 005 Aug 21, 2000
--> --> AB1,AB2,AB3 0.112MG N021210 006 Aug 21, 2000
--> --> AB1,AB2,AB3 0.125MG N021210 007 Aug 21, 2000
--> --> AB1,AB2,AB3 0.137MG N021210 012 Feb 08, 2008
--> --> AB1,AB2,AB3 0.15MG N021210 008 Aug 21, 2000
--> --> AB1,AB2,AB3 0.175MG N021210 009 Aug 21, 2000
--> --> AB1,AB2,AB3 0.2MG N021210 010 Aug 21, 2000
--> + --> AB1,AB2,AB3 0.3MG N021210 011 Aug 21, 2000
LEVOTHYROXINE SODIUM
--> MYLAN --> 0.025MG A076187 001 Jun 05, 2002
AB1,AB2,AB3,AB4
--> --> 0.05MG A076187 002 Jun 05, 2002
AB1,AB2,AB3,AB4
--> --> 0.075MG A076187 003 Jun 05, 2002
AB1,AB2,AB3,AB4
--> --> 0.088MG A076187 004 Jun 05, 2002
AB1,AB2,AB3,AB4
--> --> 0.1MG A076187 005 Jun 05, 2002
AB1,AB2,AB3,AB4
--> --> 0.112MG A076187 006 Jun 05, 2002
AB1,AB2,AB3,AB4
--> --> 0.125MG A076187 007 Jun 05, 2002
AB1,AB2,AB3,AB4
--> --> 0.137MG A076187 012 Dec 13, 2006
AB1,AB2,AB3,AB4
--> --> 0.15MG A076187 008 Jun 05, 2002
AB1,AB2,AB3,AB4
--> --> 0.175MG A076187 009 Jun 05, 2002
AB1,AB2,AB3,AB4
--> --> 0.2MG A076187 010 Jun 05, 2002
AB1,AB2,AB3,AB4
--> --> 0.3MG A076187 011 Jun 05, 2002
AB1,AB2,AB3,AB4
LEVOXYL
--> KING PHARMS R AND D --> AB1,AB3 0.025MG N021301 001 May 25, 2001
--> --> AB1,AB3 0.05MG N021301 002 May 25, 2001
--> --> AB1,AB3 0.075MG N021301 003 May 25, 2001
--> --> AB1,AB3 0.088MG N021301 004 May 25, 2001
--> --> AB1,AB3 0.1MG N021301 005 May 25, 2001
--> --> AB1,AB3 0.112MG N021301 006 May 25, 2001
--> --> AB1,AB3 0.125MG N021301 007 May 25, 2001
--> --> AB1,AB3 0.137MG N021301 008 May 25, 2001
--> --> AB1,AB3 0.15MG N021301 009 May 25, 2001
--> --> AB1,AB3 0.175MG N021301 010 May 25, 2001
--> + --> AB1,AB3 0.2MG N021301 011 May 25, 2001
LEVOTHROID
AB4 LLOYD 0.025MG N021116 001 Oct 24, 2002
AB4 0.05MG N021116 002 Oct 24, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-218(of 371)
LEVOTHYROXINE SODIUM **
**See current Annual Edition, 1.8 Description of Special Situations, Levothyroxine Sodium
TABLET;ORAL
LEVOTHROID
AB4 0.075MG N021116 003 Oct 24, 2002
AB4 0.088MG N021116 010 Oct 24, 2002
AB4 0.1MG N021116 004 Oct 24, 2002
AB4 0.112MG N021116 011 Oct 24, 2002
AB4 0.125MG N021116 005 Oct 24, 2002
AB4 0.137MG N021116 012 Dec 07, 2004
AB4 0.15MG N021116 006 Oct 24, 2002
AB4 0.175MG N021116 007 Oct 24, 2002
AB4 0.2MG N021116 008 Oct 24, 2002
AB4 + 0.3MG N021116 009 Oct 24, 2002
LIDOCAINE
OINTMENT;TOPICAL
LIDOCAINE
AT + FOUGERA 5% A080198 001
AT NOVOCOL INC 5% A040911 001 May 23, 2011
AT TARO 5% A086724 001
PATCH;TOPICAL
LIDOCAINE
AB WATSON LABS INC 5% A200675 001 Aug 23, 2012
LIDODERM
AB + TEIKOKU PHARMA USA 5% N020612 001 Mar 19, 1999
LIDOCAINE HYDROCHLORIDE
GEL;OPHTHALMIC
AKTEN
+ AKORN 3.5% N022221 001 Oct 07, 2008
INJECTABLE;INJECTION
LIDOCAINE HYDROCHLORIDE
AP AGILA SPECLTS 0.5% A091056 001 Dec 08, 2010
AP 0.5% A091058 001 Sep 30, 2010
AP 1% A091056 002 Dec 08, 2010
AP 1% A091058 002 Sep 30, 2010
AP 2% A202242 001 Apr 11, 2014
AP HOSPIRA 0.5% A088328 001 May 17, 1984
AP 1% A083158 001
AP 1% A088329 001 May 17, 1984
AP 2% A040078 001 Jun 23, 1995
AP 2% A083158 002
AP 2% A088294 001 May 17, 1984
AP 20% A083158 003
AP INTL MEDICATION 1% A083173 001
AP 2% A083173 002
AP LUITPOLD 1% A080850 001
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 200MG/100ML N019830 002 Apr 08, 1992
AP BAXTER HLTHCARE 200MG/100ML N018461 002
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 400MG/100ML N019830 003 Apr 08, 1992
AP BAXTER HLTHCARE 400MG/100ML N018461 003
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER
AP HOSPIRA 400MG/100ML N018388 002
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN 800MG/100ML N019830 004 Apr 08, 1992
AP BAXTER HLTHCARE 800MG/100ML N018461 004 Feb 22, 1982
LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER
AP HOSPIRA 800MG/100ML N018388 003 Nov 05, 1982
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
AP FRESENIUS KABI USA 1% A088586 001 Jul 24, 1985
AP HOSPIRA 0.5% A088325 001 Jul 31, 1984
AP 1% A088299 001 Jul 31, 1984
AP 2% A088327 001 Jul 31, 1984
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
AP AGILA SPECLTS 2% A090665 001 Sep 27, 2010
AP AUROBINDO PHARMA LTD 1% A203040 001 Mar 14, 2013
AP 1% A203082 001 Mar 14, 2013
AP 2% A203040 002 Mar 14, 2013
AP 2% A203082 002 Mar 14, 2013
AP FRESENIUS KABI USA 1% A080404 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-219(of 371)
LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
AP 2% A080404 003
AP 2% N017584 001
AP 4% N017584 002
AP HOSPIRA 1% A080408 001
AP 1.5% A080408 002
AP 4% A088295 001 May 17, 1984
AP INTL MEDICATION 20% N017702 001
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER
AP HOSPIRA 1% A040302 001 Sep 28, 1998
AP 2% A040302 002 Sep 28, 1998
XYLOCAINE
AP + FRESENIUS KABI USA 0.5% N006488 008
AP + 1% N006488 007
AP + 1.5% N006488 010
AP + 2% N006488 002
XYLOCAINE 4% PRESERVATIVE FREE
AP + FRESENIUS KABI USA 4% N010417 001
XYLOCAINE PRESERVATIVE FREE
AP + FRESENIUS KABI USA 1% N016801 005 Jan 19, 1988
AP + 2% N016801 001
AP + 4% N016801 002
AP + 20% N016801 004
INJECTABLE;SPINAL
LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%
+ HOSPIRA 5% A083914 001
JELLY;TOPICAL
GLYDO
AT SAGENT PHARMS 2% A201094 001 Apr 28, 2014
LIDOCAINE HYDROCHLORIDE
AT AKORN 2% A040433 001 Feb 12, 2003
AT INTL MEDICATION 2% A086283 001
AT WATSON LABS INC 2% A040837 001 Mar 23, 2011
XYLOCAINE
AT + OAK PHARMS 2% N008816 001
SOLUTION;ORAL
LIDOCAINE HYDROCHLORIDE
AT HI TECH PHARMA 2% A040014 001 Jul 10, 1995
AT WOCKHARDT 2% A087872 001 Nov 18, 1982
LIDOCAINE HYDROCHLORIDE VISCOUS
AT VINTAGE 2% A040708 001 Feb 27, 2007
LIDOCAINE VISCOUS
AT ROXANE 2% A088802 001 Apr 26, 1985
XYLOCAINE VISCOUS
AT + FRESENIUS KABI USA 2% N009470 001
SOLUTION;TOPICAL
LARYNG-O-JET KIT
AT INTL MEDICATION 4% A086364 001
LIDOCAINE HYDROCHLORIDE
AT IGI LABS INC 4% A204494 001 Mar 12, 2014
AT ROXANE 4% A088803 001 Apr 03, 1985
AT VINTAGE 4% A040710 001 Feb 27, 2007
AT WOCKHARDT 4% A087881 001 Nov 18, 1982
LTA II KIT
AT HOSPIRA 4% A080409 001
XYLOCAINE 4% PRESERVATIVE FREE
AT + FRESENIUS KABI USA 4% N010417 002
SYSTEM;INTRADERMAL
ZINGO
POWDER PHARMS 0.5MG N022114 001 Aug 16, 2007
LIDOCAINE; PRILOCAINE
CREAM;TOPICAL
EMLA
AB + WATSON LABS INC 2.5%;2.5% N019941 001 Dec 30, 1992
LIDOCAINE AND PRILOCAINE
AB FOUGERA PHARMS 2.5%;2.5% A076453 001 Aug 18, 2003
AB HI TECH PHARMA 2.5%;2.5% A076290 001 Sep 25, 2003
AB TOLMAR 2.5%;2.5% A076320 001 Aug 27, 2003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-220(of 371)
LIDOCAINE; PRILOCAINE
GEL;PERIODONTAL
ORAQIX
+ DENTSPLY PHARM 2.5%;2.5% N021451 001 Dec 19, 2003
LIDOCAINE; TETRACAINE
CREAM;TOPICAL
PLIAGLIS
+ GALDERMA LABS LP 7%;7% N021717 001 Jun 29, 2006
PATCH;TOPICAL
SYNERA
+ GALEN SPECIALTY 70MG;70MG N021623 001 Jun 23, 2005
LINACLOTIDE
CAPSULE;ORAL
LINZESS
FOREST LABS INC 145MCG N202811 001 Aug 30, 2012
+ 290MCG N202811 002 Aug 30, 2012
LINAGLIPTIN
TABLET;ORAL
TRADJENTA
+ BOEHRINGER INGELHEIM 5MG N201280 001 May 02, 2011
LINAGLIPTIN; METFORMIN HYDROCHLORIDE
TABLET;ORAL
JENTADUETO
+ BOEHRINGER INGELHEIM 2.5MG;1GM N201281 003 Jan 30, 2012
2.5MG;500MG N201281 001 Jan 30, 2012
2.5MG;850MG N201281 002 Jan 30, 2012
LINCOMYCIN HYDROCHLORIDE
INJECTABLE;INJECTION
LINCOCIN
+ PHARMACIA AND UPJOHN EQ 300MG BASE/ML N050317 001
LINDANE
LOTION;TOPICAL
LINDANE
AT OLTA PHARMS 1% A087313 001
AT + WOCKHARDT 1% A088190 001 Aug 16, 1984
SHAMPOO;TOPICAL
LINDANE
AT OLTA PHARMS 1% A087266 001
AT + WOCKHARDT 1% A088191 001 Sep 18, 1984
LINEZOLID
FOR SUSPENSION;ORAL
ZYVOX
+ PHARMACIA AND UPJOHN 100MG/5ML N021132 001 Apr 18, 2000
INJECTABLE;INJECTION
LINEZOLID
AP TEVA PHARMS 200MG/100ML A200222 001 Jun 27, 2012
ZYVOX
AP + PHARMACIA AND UPJOHN 200MG/100ML N021131 001 Apr 18, 2000
TABLET;ORAL
ZYVOX
+ PHARMACIA AND UPJOHN 600MG N021130 002 Apr 18, 2000
LIOTHYRONINE SODIUM
INJECTABLE;INJECTION
LIOTHYRONINE SODIUM
AP X GEN PHARMS EQ 0.01MG BASE/ML A076923 001 Aug 17, 2005
TRIOSTAT
AP + PAR STERILE PRODUCTS EQ 0.01MG BASE/ML N020105 001 Dec 31, 1991
TABLET;ORAL
CYTOMEL
AB KING PHARMS R AND D EQ 0.005MG BASE N010379 001
AB EQ 0.025MG BASE N010379 002
AB + EQ 0.05MG BASE N010379 003
LIOTHYRONINE SODIUM
AB COASTAL PHARMS EQ 0.005MG BASE A090097 001 Mar 20, 2009
AB EQ 0.025MG BASE A090097 002 Mar 20, 2009
AB EQ 0.05MG BASE A090097 003 Mar 20, 2009
AB MYLAN EQ 0.005MG BASE A090326 001 Jul 14, 2009
AB EQ 0.025MG BASE A090326 002 Jul 14, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-221(of 371)
LIOTHYRONINE SODIUM
TABLET;ORAL
LIOTHYRONINE SODIUM
AB EQ 0.05MG BASE
A090326 003 Jul 14, 2009
AB SIGMAPHARM LABS LLC EQ 0.005MG BASE
A200295 001 Nov 29, 2012
AB EQ 0.025MG BASE
A200295 002 Nov 29, 2012
AB EQ 0.05MG BASE
A200295 003 Nov 29, 2012
LIOTRIX (T4;T3)
TABLET;ORAL
THYROLAR-0.25
FOREST LABS
0.0031MG;0.0125MG
N016807 001
THYROLAR-0.5
FOREST LABS
0.0063MG;0.025MG
N016807 005
THYROLAR-1
FOREST LABS
0.0125MG;0.05MG
N016807 004
THYROLAR-2
FOREST LABS
0.025MG;0.1MG
N016807 002
THYROLAR-3
+ FOREST LABS
0.0375MG;0.15MG
N016807 003
LIRAGLUTIDE RECOMBINANT
SOLUTION;SUBCUTANEOUS
SAXENDA
+ NOVO NORDISK INC
18MG/3ML (6MG/ML)
N206321 001 Dec 23, 2014
VICTOZA
+ NOVO NORDISK INC
18MG/3ML (6MG/ML)
N022341 001 Jan 25, 2010
LISDEXAMFETAMINE DIMESYLATE
CAPSULE;ORAL
VYVANSE
SHIRE DEVELOPMENT
10MG
N021977 007 Oct 30, 2014
20MG
N021977 004 Dec 10, 2007
30MG
N021977 001 Feb 23, 2007
40MG
N021977 005 Dec 10, 2007
50MG
N021977 002 Feb 23, 2007
60MG
N021977 006 Dec 10, 2007
+
70MG
N021977 003 Feb 23, 2007
LISINOPRIL
TABLET;ORAL
LISINOPRIL
AB ACCORD HLTHCARE
2.5MG
A202554 001 Jul 30, 2013
AB
5MG
A202554 002 Jul 30, 2013
AB
10MG
A202554 003 Jul 30, 2013
AB
20MG
A202554 004 Jul 30, 2013
AB
30MG
A202554 005 Jul 30, 2013
AB
40MG
A202554 006 Jul 30, 2013
AB APOTEX INC
2.5MG
A076102 001 Sep 30, 2002
AB
5MG
A076102 002 Sep 30, 2002
AB
10MG
A076102 003 Sep 30, 2002
AB
20MG
A076102 004 Sep 30, 2002
AB
30MG
A076102 005 Sep 30, 2002
AB
40MG
A076102 006 Sep 30, 2002
AB AUROBINDO
2.5MG
A077622 001 Feb 22, 2006
AB
5MG
A077622 002 Feb 22, 2006
AB
10MG
A077622 003 Feb 22, 2006
AB
20MG
A077622 004 Feb 22, 2006
AB
30MG
A077622 005 Feb 22, 2006
AB
40MG
A077622 006 Feb 22, 2006
AB HIKMA INTL PHARMS
2.5MG
A076063 001 Jul 01, 2002
AB
5MG
A076063 002 Jul 01, 2002
AB
10MG
A076063 003 Jul 01, 2002
AB
20MG
A076063 004 Jul 01, 2002
AB
30MG
A076063 006 Jun 27, 2003
AB
40MG
A076063 005 Jul 01, 2002
AB INVAGEN PHARMS
2.5MG
A203508 001 Oct 29, 2013
AB
5MG
A203508 002 Oct 29, 2013
AB
10MG
A203508 003 Oct 29, 2013
AB
20MG
A203508 004 Oct 29, 2013
AB
30MG
A203508 005 Oct 29, 2013
AB
40MG
A203508 006 Oct 29, 2013
AB IVAX SUB TEVA PHARMS
2.5MG
A075752 001 Jul 01, 2002
AB
5MG
A075752 002 Jul 01, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-222(of 371)
LISINOPRIL
TABLET;ORAL
LISINOPRIL
AB 10MG A075752 003 Jul 01, 2002
AB 20MG A075752 004 Jul 01, 2002
AB 30MG A075752 005 Jul 01, 2002
AB 40MG A075752 006 Jul 01, 2002
AB LUPIN 2.5MG A077321 001 Sep 09, 2005
AB 5MG A077321 002 Sep 09, 2005
AB 10MG A077321 003 Sep 09, 2005
AB 20MG A077321 004 Sep 09, 2005
AB 30MG A077321 005 Sep 09, 2005
AB 40MG A077321 006 Sep 09, 2005
AB MYLAN 2.5MG A076071 001 Jul 01, 2002
AB 5MG A076071 002 Jul 01, 2002
AB 10MG A076071 003 Jul 01, 2002
AB 20MG A076071 004 Jul 01, 2002
AB 30MG A076071 005 Jul 01, 2002
AB 40MG A076071 006 Jul 01, 2002
AB PRINSTON INC 2.5MG A076180 001 Jul 01, 2002
AB 5MG A076180 002 Jul 01, 2002
AB 10MG A076180 003 Jul 01, 2002
AB 20MG A076164 001 Jul 01, 2002
AB 30MG A076164 002 Jul 01, 2002
AB 40MG A076164 003 Jul 01, 2002
AB RANBAXY 2.5MG A075944 001 Jul 01, 2002
AB 5MG A075944 002 Jul 01, 2002
AB 10MG A075944 003 Jul 01, 2002
AB 20MG A075944 004 Jul 01, 2002
AB 30MG A075944 006 Feb 11, 2003
AB 40MG A075944 005 Jul 01, 2002
AB SANDOZ 2.5MG A075994 001 Jul 01, 2002
AB 5MG A075994 002 Jul 01, 2002
AB 10MG A075994 003 Jul 01, 2002
AB 20MG A075994 004 Jul 01, 2002
AB 30MG A075994 005 Jul 01, 2002
AB 40MG A075994 006 Jul 01, 2002
AB VINTAGE 2.5MG A075743 001 Jul 01, 2002
AB 5MG A075743 002 Jul 01, 2002
AB 10MG A075743 003 Jul 01, 2002
AB 20MG A075743 004 Jul 01, 2002
AB 30MG A075743 005 Jul 01, 2002
AB 40MG A075743 006 Jul 01, 2002
AB WATSON LABS 2.5MG A076059 001 Jul 01, 2002
AB 5MG A076059 002 Jul 01, 2002
AB 10MG A076059 003 Jul 01, 2002
AB 20MG A076059 004 Jul 01, 2002
AB 30MG A076059 005 Jul 01, 2002
AB 40MG A076059 006 Jul 01, 2002
AB WOCKHARDT 2.5MG A078402 001 Apr 19, 2007
AB 5MG A078402 002 Apr 19, 2007
AB 10MG A078402 003 Apr 19, 2007
AB 20MG A078402 004 Apr 19, 2007
AB 30MG A078402 005 Apr 19, 2007
AB 40MG A078402 006 Apr 19, 2007
PRINIVIL
AB MERCK 5MG N019558 001 Dec 29, 1987
AB 10MG N019558 002 Dec 29, 1987
AB 20MG N019558 003 Dec 29, 1987
AB 40MG N019558 004 Oct 25, 1988
ZESTRIL
AB ASTRAZENECA 2.5MG N019777 005 Apr 29, 1993
AB 5MG N019777 001 May 19, 1988
AB 10MG N019777 002 May 19, 1988
AB 20MG N019777 003 May 19, 1988
AB 30MG N019777 006 Jan 20, 1999
AB + 40MG N019777 004 May 19, 1988
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-223(of 371)
LITHIUM CARBONATE
CAPSULE;ORAL
LITHIUM CARBONATE
AB ALEMBIC LTD 150MG A079159 001 Jan 12, 2009
AB 300MG A079159 002 Jan 12, 2009
AB 600MG A079159 003 Jan 12, 2009
AB GLENMARK GENERICS 150MG A079139 001 Feb 03, 2009
AB 300MG A079139 002 Feb 03, 2009
AB 600MG A079139 003 Feb 03, 2009
AB HETERO LABS LTD III 150MG A090702 001 Sep 25, 2009
AB 300MG A090702 002 Sep 25, 2009
AB 600MG A090702 003 Sep 25, 2009
AB HIKMA INTL PHARMS 150MG A076243 002 Feb 24, 2003
AB 300MG A076243 001 Jun 27, 2002
AB ROXANE 150MG N017812 002 Jan 28, 1987
AB 300MG N017812 001
AB + 600MG N017812 003 Jan 28, 1987
TABLET;ORAL
LITHIUM CARBONATE
AB + ROXANE 300MG N018558 001 Jan 29, 1982
AB SUN PHARM INDS INC 300MG A091027 001 Jun 24, 2010
TABLET, EXTENDED RELEASE;ORAL
LITHIUM CARBONATE
AB GLENMARK GENERICS 300MG A091544 001 Dec 27, 2010
AB 450MG A091616 001 Feb 14, 2011
AB HIKMA INTL PHARMS 450MG A076490 001 Jun 17, 2003
AB MYLAN PHARMS INC 300MG A202288 001 Jun 29, 2012
AB 450MG A202219 001 Aug 08, 2012
AB ROXANE 300MG A076832 001 Oct 28, 2004
AB + 450MG A076691 001 Jan 05, 2004
LITHOBID
AB + ANI PHARMS INC 300MG N018027 001
LITHIUM CITRATE
SYRUP;ORAL
LITHIUM CITRATE
AA + ROXANE EQ 300MG CARBONATE/5ML N018421 001
AA WOCKHARDT EQ 300MG CARBONATE/5ML A070755 001 May 21, 1986
LODOXAMIDE TROMETHAMINE
SOLUTION/DROPS;OPHTHALMIC
ALOMIDE
+ ALCON EQ 0.1% BASE N020191 001 Sep 23, 1993
LOMITAPIDE MESYLATE
CAPSULE;ORAL
JUXTAPID
AEGERION EQ 5MG BASE N203858 001 Dec 21, 2012
EQ 10MG BASE N203858 002 Dec 21, 2012
+ EQ 20MG BASE N203858 003 Dec 21, 2012
LOMUSTINE
CAPSULE;ORAL
GLEOSTINE
CORDEN PHARMA 10MG N017588 001
40MG N017588 002
+ 100MG N017588 003
LOPERAMIDE HYDROCHLORIDE
CAPSULE;ORAL
IMODIUM
AB + MCNEIL CONS 2MG N017694 001
LOPERAMIDE HYDROCHLORIDE
AB MYLAN 2MG A072741 001 Sep 18, 1991
AB TEVA 2MG A073192 001 Apr 30, 1992
LOPINAVIR; RITONAVIR
CAPSULE;ORAL
KALETRA
+ ABBVIE 133.3MG;33.3MG N021226 001 Sep 15, 2000
SOLUTION;ORAL
KALETRA
+ ABBVIE 80MG/ML;20MG/ML N021251 001 Sep 15, 2000
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-224(of 371)
LOPINAVIR; RITONAVIR
TABLET;ORAL
KALETRA
ABBVIE 100MG;25MG N021906 002 Nov 09, 2007
+ 200MG;50MG N021906 001 Oct 28, 2005
LORAZEPAM
CONCENTRATE;ORAL
LORAZEPAM
AA AMNEAL PHARMS 2MG/ML A091383 001 Dec 23, 2009
AA HI-TECH PHARMA CO 2MG/ML A200169 001 Jan 30, 2012
AA LUPIN LTD 2MG/ML A091407 001 Feb 19, 2013
AA PADDOCK LLC 2MG/ML A079244 001 Apr 28, 2009
AA PHARM ASSOC 2MG/ML A090260 001 Jun 15, 2010
LORAZEPAM INTENSOL
AA + ROXANE 2MG/ML A072755 001 Jun 28, 1991
INJECTABLE;INJECTION
ATIVAN
AP + HIKMA MAPLE 2MG/ML N018140 001
AP + 4MG/ML N018140 002
LORAZEPAM
AP AKORN 2MG/ML A075025 001 Jul 23, 1998
AP HOSPIRA 2MG/ML A074243 001 Apr 12, 1994
AP 2MG/ML A074282 001 May 27, 1994
AP 4MG/ML A074243 002 Apr 12, 1994
AP 4MG/ML A074282 002 May 27, 1994
AP INTL MEDICATION SYS 2MG/ML A076150 001 Nov 15, 2004
LORAZEPAM PRESERVATIVE FREE
AP BEDFORD LABS 2MG/ML A077074 001 Jul 13, 2005
AP 4MG/ML A077074 002 Jul 13, 2005
TABLET;ORAL
ATIVAN
AB VALEANT INTL 0.5MG N017794 001
AB 1MG N017794 002
AB + 2MG N017794 003
LORAZEPAM
AB AMNEAL PHARMS 0.5MG A078826 001 Jun 23, 2010
AB 1MG A078826 002 Jun 23, 2010
AB 2MG A078826 003 Jun 23, 2010
AB EXCELLIUM 0.5MG A078203 001 Jul 30, 2007
AB 1MG A078203 002 Jul 30, 2007
AB 2MG A078203 003 Jul 30, 2007
AB IVAX SUB TEVA PHARMS 0.5MG A077396 001 Dec 13, 2006
AB 1MG A077396 002 Dec 13, 2006
AB 2MG A077396 003 Dec 13, 2006
AB MYLAN 0.5MG A071589 001 Oct 13, 1987
AB 0.5MG A077657 001 Mar 16, 2006
AB 1MG A071590 001 Oct 13, 1987
AB 1MG A077657 002 Mar 16, 2006
AB 2MG A071591 001 Oct 13, 1987
AB 2MG A077657 003 Mar 16, 2006
AB RANBAXY 0.5MG A076045 001 Aug 29, 2001
AB 1MG A076045 002 Aug 29, 2001
AB 2MG A076045 003 Aug 29, 2001
AB SANDOZ 0.5MG A071403 001 Apr 21, 1987
AB 1MG A071404 001 Apr 21, 1987
AB 2MG A071141 001 Apr 21, 1987
AB VINTAGE PHARMS 0.5MG A077754 001 May 10, 2006
AB 1MG A077754 002 May 10, 2006
AB 2MG A077754 003 May 10, 2006
AB WATSON LABS 0.5MG A072926 001 Oct 31, 1991
AB 1MG A072927 001 Oct 31, 1991
AB 2MG A072928 001 Oct 31, 1991
LORCASERIN HYDROCHLORIDE
TABLET;ORAL
BELVIQ
+ EISAI INC 10MG N022529 001 Jun 27, 2012
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-225(of 371)
LOSARTAN POTASSIUM
TABLET;ORAL
COZAAR
AB MERCK SHARP DOHME 25MG N020386 001 Apr 14, 1995
AB 50MG N020386 002 Apr 14, 1995
AB + 100MG N020386 003 Oct 13, 1998
LOSARTAN POTASSIUM
AB ALEMBIC PHARMS LTD 25MG A090428 001 Oct 06, 2010
AB 50MG A090428 002 Oct 06, 2010
AB 100MG A090428 003 Oct 06, 2010
AB APOTEX CORP 25MG A090790 001 Oct 06, 2010
AB 50MG A090790 002 Oct 06, 2010
AB 100MG A090790 003 Oct 06, 2010
AB AUROBINDO PHARMA 25MG A090083 001 Oct 06, 2010
AB 50MG A090083 002 Oct 06, 2010
AB 100MG A090083 003 Oct 06, 2010
AB CADISTA PHARMS 25MG A201170 001 Sep 18, 2012
AB 50MG A201170 002 Sep 18, 2012
AB 100MG A201170 003 Sep 18, 2012
AB IPCA LABS LTD 25MG A200290 001 Aug 30, 2013
AB 50MG A200290 002 Aug 30, 2013
AB 100MG A200290 003 Aug 30, 2013
AB LUPIN LTD 25MG A078232 001 Oct 06, 2010
AB 50MG A078232 002 Oct 06, 2010
AB 100MG A078232 003 Oct 06, 2010
AB MACLEODS PHARMS LTD 25MG A202230 001 May 30, 2012
AB 50MG A202230 002 May 30, 2012
AB 100MG A202230 003 May 30, 2012
AB MICRO LABS LTD INDIA 25MG A091541 001 Sep 24, 2012
AB 50MG A091541 002 Sep 24, 2012
AB 100MG A091541 003 Sep 24, 2012
AB MYLAN 25MG A091590 001 Oct 06, 2010
AB 50MG A091590 002 Oct 06, 2010
AB 100MG A091590 003 Oct 06, 2010
AB PRINSTON INC 25MG A091497 001 Jun 06, 2011
AB 50MG A091497 002 Jun 06, 2011
AB 100MG A091497 003 Jun 06, 2011
AB ROXANE 25MG A077459 001 Oct 06, 2010
AB 50MG A077459 002 Oct 06, 2010
AB 100MG A077459 003 Oct 06, 2010
AB SANDOZ 25MG A077424 001 Oct 06, 2010
AB 50MG A077424 002 Oct 06, 2010
AB 100MG A077424 003 Oct 06, 2010
AB TEVA 25MG A076958 001 Apr 06, 2010
AB 50MG A076958 002 Apr 06, 2010
AB 100MG A076958 003 Apr 06, 2010
AB TORRENT PHARMS 25MG A090467 001 Oct 06, 2010
AB 50MG A090467 002 Oct 06, 2010
AB 100MG A090467 003 Oct 06, 2010
AB UPSHER SMITH 25MG A090544 001 Oct 06, 2010
AB 50MG A090544 002 Oct 06, 2010
AB 100MG A090544 003 Oct 06, 2010
AB VIVIMED LABS 25MG A090382 001 Oct 06, 2010
AB 50MG A090382 002 Oct 06, 2010
AB 100MG A090382 003 Oct 06, 2010
AB ZYDUS PHARMS USA INC 25MG A078243 001 Oct 06, 2010
AB 50MG A078243 002 Oct 06, 2010
AB 100MG A078243 003 Oct 06, 2010
LOTEPREDNOL ETABONATE
GEL;OPHTHALMIC
LOTEMAX
+ BAUSCH AND LOMB INC 0.5% N202872 001 Sep 28, 2012
OINTMENT;OPHTHALMIC
LOTEMAX
+ BAUSCH AND LOMB 0.5% N200738 001 Apr 15, 2011
SUSPENSION/DROPS;OPHTHALMIC
ALREX
+ BAUSCH AND LOMB 0.2% N020803 001 Mar 09, 1998
LOTEMAX
+ BAUSCH AND LOMB 0.5% N020583 001 Mar 09, 1998
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-226(of 371)
LOTEPREDNOL ETABONATE; TOBRAMYCIN
SUSPENSION/DROPS;OPHTHALMIC
ZYLET
+ BAUSCH AND LOMB 0.5%;0.3% N050804 001 Dec 14, 2004
LOVASTATIN
TABLET;ORAL
LOVASTATIN
AB ACTAVIS ELIZABETH 10MG A075828 001 Dec 17, 2001
AB 20MG A075828 002 Dec 17, 2001
AB 40MG A075828 003 Dec 17, 2001
AB APOTEX INC 10MG A077748 001 Feb 28, 2007
AB 20MG A077748 002 Feb 28, 2007
AB 40MG A077748 003 Feb 28, 2007
AB CARLSBAD 10MG A075991 001 Jun 05, 2002
AB 20MG A075991 002 Jun 05, 2002
AB + 40MG A075991 003 Jun 05, 2002
AB LUPIN 10MG A078296 001 Mar 14, 2008
AB 20MG A078296 002 Nov 01, 2007
AB 40MG A078296 003 Nov 01, 2007
AB MUTUAL PHARM 10MG A077520 001 Apr 14, 2006
AB 20MG A077520 002 Apr 14, 2006
AB 40MG A077520 003 Apr 14, 2006
AB MYLAN 10MG A075451 001 Dec 17, 2001
AB 10MG A075935 001 Dec 17, 2001
AB 20MG A075451 002 Dec 17, 2001
AB 20MG A075935 002 Dec 17, 2001
AB 40MG A075451 003 Dec 17, 2001
AB 40MG A075935 003 Dec 17, 2001
AB SANDOZ 10MG A075300 001 Dec 17, 2001
AB 10MG A075636 001 Dec 17, 2001
AB 20MG A075300 002 Dec 17, 2001
AB 20MG A075636 002 Dec 17, 2001
AB 40MG A075300 003 Dec 17, 2001
AB 40MG A075636 003 Dec 17, 2001
AB TEVA 10MG A075551 003 Dec 17, 2001
AB 20MG A075551 002 Dec 17, 2001
AB 40MG A075551 001 Dec 17, 2001
TABLET, EXTENDED RELEASE;ORAL
ALTOPREV
ANDRX LABS LLC 20MG N021316 002 Jun 26, 2002
40MG N021316 003 Jun 26, 2002
+ 60MG N021316 004 Jun 26, 2002
LOVASTATIN; NIACIN
TABLET, EXTENDED RELEASE;ORAL
ADVICOR
+ ABBVIE 20MG;1GM N021249 003 Dec 17, 2001
+ 20MG;500MG N021249 001 Dec 17, 2001
+ 20MG;750MG N021249 002 Dec 17, 2001
+ 40MG;1GM N021249 004 Apr 27, 2006
LOXAPINE
POWDER;INHALATION
ADASUVE
+ TEVA PHARMS USA INC 10MG N022549 001 Dec 21, 2012
LOXAPINE SUCCINATE
CAPSULE;ORAL
LOXAPINE SUCCINATE
AB LANNETT HOLDINGS INC EQ 5MG BASE A090695 001 Sep 26, 2011
AB EQ 10MG BASE A090695 002 Sep 26, 2011
AB EQ 25MG BASE A090695 003 Sep 26, 2011
AB EQ 50MG BASE A090695 004 Sep 26, 2011
AB MIKAH PHARMA EQ 5MG BASE A076868 001 Aug 04, 2005
AB EQ 10MG BASE A076868 002 Aug 04, 2005
AB EQ 25MG BASE A076868 003 Aug 04, 2005
AB EQ 50MG BASE A076868 004 Aug 04, 2005
AB MYLAN EQ 5MG BASE A076762 001 Nov 01, 2004
AB EQ 10MG BASE A076762 002 Nov 01, 2004
AB EQ 25MG BASE A076762 003 Nov 01, 2004
AB EQ 50MG BASE A076762 004 Nov 01, 2004
AB WATSON LABS EQ 5MG BASE A072204 001 Jun 15, 1988
AB EQ 10MG BASE A072205 001 Jun 15, 1988
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-227(of 371)
LOXAPINE SUCCINATE
CAPSULE;ORAL
LOXAPINE SUCCINATE
AB + EQ 25MG BASE A072206 001 Jun 15, 1988
AB EQ 50MG BASE A072062 001 Jun 15, 1988
LUBIPROSTONE
CAPSULE;ORAL
AMITIZA
SUCAMPO PHARMA LLC 8MCG N021908 002 Apr 29, 2008
+ 24MCG N021908 001 Jan 31, 2006
LUCINACTANT
SUSPENSION;INTRATRACHEAL
SURFAXIN
+ DISCOVERY LABS 8.5ML N021746 001 Mar 06, 2012
LULICONAZOLE
CREAM;TOPICAL
LUZU
+ MEDICIS 1% N204153 001 Nov 14, 2013
LURASIDONE HYDROCHLORIDE
TABLET;ORAL
LATUDA
SUNOVION PHARMS INC 20MG N200603 003 Dec 07, 2011
+ 40MG N200603 001 Oct 28, 2010
60MG N200603 005 Jul 12, 2013
80MG N200603 002 Oct 28, 2010
120MG N200603 004 Apr 26, 2012
MACITENTAN
TABLET;ORAL
OPSUMIT
+ ACTELION PHARMS LTD 10MG N204410 001 Oct 18, 2013
MAFENIDE ACETATE
CREAM;TOPICAL
SULFAMYLON
+ MYLAN INSTITUTIONAL EQ 85MG BASE/GM N016763 001
FOR SOLUTION;TOPICAL
MAFENIDE ACETATE
AT PAR FORM 5% A201511 001 Feb 12, 2013
SULFAMYLON
AT + MYLAN INSTITUTIONAL 5% N019832 003 Jun 05, 1998
MAGNESIUM ACETATE TETRAHYDRATE; POTASSIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
PLASMA-LYTE 56 IN PLASTIC CONTAINER
BAXTER HLTHCARE 32MG/100ML;128MG/100ML;234MG/100ML N019047 001 Jun 15, 1984
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM
CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE;INJECTION
ISOLYTE S PH 7.4 IN PLASTIC CONTAINER
+ B BRAUN 30MG/100ML;37MG/100ML;0.82MG/100ML;370M N019696 001 Sep 29, 1989
G/100ML;530MG/100ML;500MG/100ML;12MG/10
0ML
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
INJECTABLE;INJECTION
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 30MG/100ML;37MG/100ML;368MG/100ML;526MG N017378 001
/100ML;502MG/100ML
PLASMA-LYTE A IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 30MG/100ML;37MG/100ML;368MG/100ML;526MG N017378 002 Nov 22, 1982
/100ML;502MG/100ML
ISOLYTE S IN PLASTIC CONTAINER
B BRAUN 30MG/100ML;37MG/100ML;370MG/100ML;530MG N019711 001 Sep 29, 1989
/100ML;500MG/100ML
NORMOSOL-R IN PLASTIC CONTAINER
HOSPIRA 30MG/100ML;37MG/100ML;222MG/100ML;526MG N017586 001
/100ML;502MG/100ML
SOLUTION;IRRIGATION
PHYSIOLYTE IN PLASTIC CONTAINER
B BRAUN 30MG/100ML;37MG/100ML;370MG/100ML;530MG N019024 001 Jun 08, 1984
/100ML;500MG/100ML
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-228(of 371)
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
SOLUTION;IRRIGATION
PHYSIOSOL IN PLASTIC CONTAINER
HOSPIRA 30MG/100ML;37MG/100ML;222MG/100ML;526MG N017637 002 Jul 08, 1982
/100ML;502MG/100ML
MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
SOLUTION;INJECTION
NORMOCARB HF 25
+ DIALYSIS SUPS 0.21GM/100ML;2.8GM/100ML;9.07GM/100ML N021910 001 Jul 26, 2006
NORMOCARB HF 35
+ DIALYSIS SUPS 0.21GM/100ML;3.97GM/100ML;8.3GM/100ML N021910 002 Jul 26, 2006
MAGNESIUM SULFATE
INJECTABLE;INJECTION
MAGNESIUM SULFATE
AP EXELA PHARMA SCS LLC 500MG/ML A206039 001 Dec 18, 2014
AP + FRESENIUS KABI USA 500MG/ML N019316 001 Sep 08, 1986
AP + HOSPIRA 500MG/ML A075151 001 Apr 25, 2000
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER
+ HOSPIRA 1GM/100ML N020488 001 Jul 11, 1995
+ 2GM/100ML N020488 002 Jul 11, 1995
MAGNESIUM SULFATE IN PLASTIC CONTAINER
HOSPIRA 2GM/50ML (40MG/ML) N020309 003 Jan 26, 2007
+ 4GM/100ML (40MG/ML) N020309 001 Jun 24, 1994
+ 4GM/50ML (80MG/ML) N020309 002 Jun 24, 1994
20GM/500ML (40MG/ML) N020309 004 Jan 18, 1995
40GM/1000ML(40MG/ML) N020309 005 Jan 18, 1995
MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE
SOLUTION;ORAL
SUPREP BOWEL PREP KIT
+ BRAINTREE LABS 1.6GM/BOT;3.13GM/BOT;17.5GM/BOT N022372 001 Aug 05, 2010
MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM
BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE
SOLUTION;ORAL
SUCLEAR
+ BRAINTREE LABS 1.6GM;210GM;0.74GM;3.13GM;2.86GM;5.6GM; N203595 001 Jan 18, 2013
17.5GM
MAGNESIUM SULFATE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM CHLORIDE; SODIUM
PHOSPHATE
SOLUTION;IRRIGATION
TIS-U-SOL
AT BAXTER HLTHCARE 20MG/100ML;40MG/100ML;6.25MG/100ML;800M N018508 001 Feb 19, 1982
G/100ML;8.75MG/100ML
TIS-U-SOL IN PLASTIC CONTAINER
AT BAXTER HLTHCARE 20MG/100ML;40MG/100ML;6.25MG/100ML;800M N018336 001
G/100ML;8.75MG/100ML
MALATHION
LOTION;TOPICAL
MALATHION
AT SUVEN LIFE 0.5% A091559 001 May 23, 2012
OVIDE
AT + TARO PHARMS NORTH 0.5% N018613 001 Aug 02, 1982
MANGANESE CHLORIDE
INJECTABLE;INJECTION
MANGANESE CHLORIDE IN PLASTIC CONTAINER
HOSPIRA EQ 0.1MG MANGANESE/ML N018962 001 Jun 26, 1986
MANNITOL
INJECTABLE;INJECTION
MANNITOL 10%
AP B BRAUN 10GM/100ML N016080 002
MANNITOL 10% IN PLASTIC CONTAINER
AP B BRAUN 10GM/100ML N020006 002 Jul 26, 1993
AP HOSPIRA 10GM/100ML N019603 002 Jan 08, 1987
MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER
AP B BRAUN 10GM/100ML N016080 006
MANNITOL 15%
AP B BRAUN 15GM/100ML N016080 003
MANNITOL 15% IN PLASTIC CONTAINER
AP B BRAUN 15GM/100ML N020006 003 Jul 26, 1993
AP HOSPIRA 15GM/100ML N019603 003 Jan 08, 1990
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-229(of 371)
MANNITOL
INJECTABLE;INJECTION
MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%
AP B BRAUN 15GM/100ML N016080 005
MANNITOL 20%
AP B BRAUN 20GM/100ML N016080 004
MANNITOL 20% IN PLASTIC CONTAINER
AP B BRAUN 20GM/100ML N020006 004 Jul 26, 1993
AP HOSPIRA 20GM/100ML N019603 004 Jan 08, 1990
MANNITOL 25%
AP FRESENIUS KABI USA 12.5GM/50ML A080677 001
AP HOSPIRA 12.5GM/50ML N016269 006 Aug 25, 1994
AP INTL MEDICATION 12.5GM/50ML A083051 001
AP LUITPOLD 12.5GM/50ML A087409 001 Jan 21, 1982
MANNITOL 5%
AP B BRAUN 5GM/100ML N016080 001
MANNITOL 5% IN PLASTIC CONTAINER
AP B BRAUN 5GM/100ML N020006 001 Jul 26, 1993
AP HOSPIRA 5GM/100ML N019603 001 Jan 08, 1987
MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%
AP B BRAUN 5GM/100ML N016080 007
OSMITROL 10% IN WATER
AP BAXTER HLTHCARE 10GM/100ML N013684 002
OSMITROL 10% IN WATER IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 10GM/100ML N013684 006
OSMITROL 15% IN WATER
AP BAXTER HLTHCARE 15GM/100ML N013684 004
OSMITROL 15% IN WATER IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 15GM/100ML N013684 008
OSMITROL 20% IN WATER
AP BAXTER HLTHCARE 20GM/100ML N013684 003
OSMITROL 20% IN WATER IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 20GM/100ML N013684 007
OSMITROL 5% IN WATER
AP BAXTER HLTHCARE 5GM/100ML N013684 001
OSMITROL 5% IN WATER IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 5GM/100ML N013684 005
SOLUTION;IRRIGATION
RESECTISOL IN PLASTIC CONTAINER
B BRAUN 5GM/100ML N016772 002
MANNITOL; SORBITOL
SOLUTION;IRRIGATION
SORBITOL-MANNITOL IN PLASTIC CONTAINER
HOSPIRA 540MG/100ML;2.7GM/100ML N018316 001
MAPROTILINE HYDROCHLORIDE
TABLET;ORAL
MAPROTILINE HYDROCHLORIDE
MYLAN 25MG A072285 002 Oct 03, 1988
+ 50MG A072285 001 Oct 03, 1988
75MG A072285 003 Oct 03, 1988
MARAVIROC
TABLET;ORAL
SELZENTRY
VIIV HLTHCARE 150MG N022128 001 Aug 06, 2007
+ 300MG N022128 002 Aug 06, 2007
MEBENDAZOLE
TABLET, CHEWABLE;ORAL
MEBENDAZOLE
+ AMEDRA PHARMS LLC 100MG A073580 001 Jan 04, 1995
MECAMYLAMINE HYDROCHLORIDE
TABLET;ORAL
MECAMYLAMINE HYDROCHLORIDE
NEXGEN PHARMA 2.5MG A204054 001 Mar 19, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-230(of 371)
MECASERMIN RECOMBINANT
INJECTABLE;SUBCUTANEOUS
INCRELEX
+ IPSEN INC 40MG/4ML (10MG/ML) N021839 001 Aug 30, 2005
MECHLORETHAMINE HYDROCHLORIDE
GEL;TOPICAL
VALCHLOR
+ ACTELION PHARMS LTD EQ 0.016% BASE N202317 001 Aug 23, 2013
INJECTABLE;INJECTION
MUSTARGEN
+ RECORDATI RARE 10MG/VIAL N006695 001
MECLIZINE HYDROCHLORIDE
TABLET;ORAL
MECLIZINE HYDROCHLORIDE
AA AMNEAL PHARMS 12.5MG A201451 001 Feb 23, 2011
AA 25MG A201451 002 Feb 23, 2011
AA EPIC PHARMA LLC 12.5MG A200294 001 Apr 13, 2012
AA 25MG A200294 002 Apr 13, 2012
AA JUBILANT CADISTA 12.5MG A040659 001 Jun 04, 2010
AA 25MG A040659 002 Jun 04, 2010
AA MYLAN PHARMS INC 12.5MG A202640 001 Sep 17, 2012
AA 25MG A202640 002 Sep 17, 2012
AA PAR PHARM 12.5MG A087127 001
AA 25MG A087128 001
AA SANDOZ 12.5MG A084843 002 May 22, 1989
AA 25MG A084092 003 May 22, 1989
AA VINTAGE PHARMS 12.5MG A040179 001 Jan 30, 1997
AA 25MG A040179 002 Jan 30, 1997
MECLOFENAMATE SODIUM
CAPSULE;ORAL
MECLOFENAMATE SODIUM
MYLAN EQ 50MG BASE A071081 002 Sep 03, 1986
+ EQ 100MG BASE A071081 001 Sep 03, 1986
MEDROXYPROGESTERONE ACETATE
INJECTABLE;INJECTION
DEPO-PROVERA
AB + PHARMACIA AND UPJOHN 150MG/ML N020246 001 Oct 29, 1992
MEDROXYPROGESTERONE ACETATE
AB SANDOZ 150MG/ML A078711 001 May 20, 2009
AB TEVA PHARMS USA 150MG/ML A076553 001 Jul 28, 2004
DEPO-PROVERA
+ PHARMACIA AND UPJOHN 400MG/ML N012541 003
INJECTABLE;SUBCUTANEOUS
DEPO-SUBQ PROVERA 104
+ PHARMACIA AND UPJOHN 104MG/0.65ML N021583 001 Dec 17, 2004
TABLET;ORAL
MEDROXYPROGESTERONE ACETATE
AB BARR 2.5MG A040159 001 Aug 09, 1996
AB 5MG A040159 002 Aug 09, 1996
AB 10MG A040159 003 Aug 09, 1996
PROVERA
AB PHARMACIA AND UPJOHN 2.5MG N011839 001
AB 5MG N011839 003
AB + 10MG N011839 004
MEFENAMIC ACID
CAPSULE;ORAL
MEFENAMIC ACID
AB BRECKENRIDGE PHARM 250MG A090359 001 Feb 05, 2013
AB LUPIN LTD 250MG A091322 001 Jul 22, 2011
AB MICRO LABS LTD 250MG A090562 001 Nov 19, 2010
AB VINTAGE PHARMS LLC 250MG A091608 001 Jun 02, 2014
PONSTEL
AB + SHIONOGI INC 250MG N015034 003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-231(of 371)
MEFLOQUINE HYDROCHLORIDE
TABLET;ORAL
MEFLOQUINE HYDROCHLORIDE
AB BARR 250MG
A076392 001 Dec 29, 2003
AB ROXANE 250MG
A076523 001 Oct 01, 2004
AB + SANDOZ 250MG
A076175 001 Feb 20, 2002
MEGESTROL ACETATE
SUSPENSION;ORAL
MEGACE
AB + BRISTOL MYERS SQUIBB
40MG/ML
N020264 001 Sep 10, 1993
MEGACE ES
AB + PAR PHARM
125MG/ML
N021778 001 Jul 05, 2005
MEGESTROL ACETATE
AB PAR PHARM
40MG/ML
A075671 001 Jul 25, 2001
AB ROXANE
40MG/ML
A075997 001 Feb 15, 2002
AB TEVA PHARMS
40MG/ML
A075681 001 May 05, 2003
AB TWI PHARMS INC
125MG/ML
A203139 001 Aug 27, 2014
AB WOCKHARDT
40MG/ML
A076721 001 Nov 01, 2004
TABLET;ORAL
MEGESTROL ACETATE
AB BARR
20MG
A074621 002 Aug 16, 1996
AB
40MG
A074621 001 Nov 30, 1995
AB PAR PHARM
20MG
A072422 001 Aug 08, 1988
AB +
40MG
A072423 001 Aug 08, 1988
AB ROXANE
20MG
A074458 001 Sep 29, 1995
AB
40MG
A074458 002 Sep 29, 1995
MELOXICAM
SUSPENSION;ORAL
MOBIC
+ BOEHRINGER INGELHEIM
7.5MG/5ML
N021530 001 Jun 01, 2004
TABLET;ORAL
MELOXICAM
AB APOTEX INC
7.5MG
A077882 001 Jul 20, 2006
AB
15MG
A077882 002 Jul 20, 2006
AB AUROBINDO PHARMA
7.5MG
A078008 001 Oct 02, 2006
AB
15MG
A078008 002 Oct 02, 2006
AB BRECKENRIDGE PHARM
7.5MG
A077920 001 Jul 19, 2006
AB
15MG
A077920 002 Jul 19, 2006
AB CARLSBAD
7.5MG
A077918 001 Dec 07, 2006
AB
15MG
A077918 002 Dec 07, 2006
AB CIPLA LTD
7.5MG
A077929 001 Jul 19, 2006
AB
15MG
A077929 002 Jul 19, 2006
AB DR REDDYS LABS INC
7.5MG
A077931 001 Jul 25, 2006
AB
15MG
A077931 002 Jul 25, 2006
AB GLENMARK GENERICS
7.5MG
A077932 001 Jul 19, 2006
AB
15MG
A077932 002 Jul 19, 2006
AB LUPIN PHARMS
7.5MG
A077944 001 Jul 19, 2006
AB
15MG
A077944 002 Jul 19, 2006
AB MYLAN
7.5MG
A077923 001 Jul 19, 2006
AB
15MG
A077923 002 Jul 19, 2006
AB PURACAP PHARM
7.5MG
A077938 001 Jul 19, 2006
AB
15MG
A077938 002 Jul 19, 2006
AB STRIDES PHARMA
7.5MG
A077928 001 May 13, 2009
AB
15MG
A077928 002 May 13, 2009
AB SUN PHARM INDS INC
7.5MG
A077937 001 Jul 19, 2006
AB
15MG
A077937 002 Jul 19, 2006
AB TARO
7.5MG
A078102 001 Nov 07, 2006
AB
15MG
A078102 002 Nov 07, 2006
AB TEVA PHARMS
7.5MG
A077936 001 Jul 19, 2006
AB
15MG
A077936 002 Jul 19, 2006
AB UNICHEM
7.5MG
A077927 001 Dec 20, 2006
AB
15MG
A077927 002 Dec 20, 2006
AB ZYDUS PHARMS USA
7.5MG
A077921 001 Jul 19, 2006
AB
15MG
A077921 002 Jul 19, 2006
MOBIC
AB BOEHRINGER INGELHEIM
7.5MG
N020938 001 Apr 13, 2000
AB +
15MG
N020938 002 Aug 23, 2000
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-232(of 371)
MELPHALAN
TABLET;ORAL
ALKERAN
+ GLAXOSMITHKLINE 2MG N014691 002
MELPHALAN HYDROCHLORIDE
INJECTABLE;INJECTION
ALKERAN
AP + GLAXOSMITHKLINE EQ 50MG BASE/VIAL N020207 001 Nov 18, 1992
MELPHALAN HYDROCHLORIDE
AP EUROHLTH INTL EQ 50MG BASE/VIAL A090303 001 Oct 28, 2010
AP MYLAN INSTITUTIONAL EQ 50MG BASE/VIAL A090270 001 Jun 09, 2009
MEMANTINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
NAMENDA XR
FOREST LABS 7MG N022525 001 Jun 21, 2010
14MG N022525 002 Jun 21, 2010
21MG N022525 003 Jun 21, 2010
+ 28MG N022525 004 Jun 21, 2010
SOLUTION;ORAL
NAMENDA
+ FOREST LABS 2MG/ML N021627 001 Apr 18, 2005
TABLET;ORAL
NAMENDA
AB FOREST LABS 5MG N021487 001 Oct 16, 2003
AB + 10MG N021487 002 Oct 16, 2003
MENOTROPINS (FSH;LH)
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS
REPRONEX
+ FERRING 75 IU/VIAL;75 IU/VIAL N021047 001 Aug 27, 1999
INJECTABLE;SUBCUTANEOUS
MENOPUR
+ FERRING 75 IU/VIAL;75 IU/VIAL N021663 001 Oct 29, 2004
MEPENZOLATE BROMIDE
TABLET;ORAL
CANTIL
+ SANOFI AVENTIS US 25MG N010679 003
MEPERIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
DEMEROL
AP + HOSPIRA 25MG/ML N021171 001
AP + 50MG/ML N021171 002
AP + 75MG/ML N021171 003
AP + 100MG/ML N021171 004
MEPERIDINE HYDROCHLORIDE
AP HIKMA MAPLE 25MG/ML A080445 001
AP 25MG/ML A080455 007
AP 50MG/ML A080445 002
AP 50MG/ML A080455 008
AP 75MG/ML A080445 003
AP 75MG/ML A080455 009
AP 100MG/ML A080445 004
AP 100MG/ML A080455 010
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
AP HIKMA MAPLE 10MG/ML A081002 001 Jul 30, 1993
AP + HOSPIRA 10MG/ML A088432 001 Aug 16, 1984
SYRUP;ORAL
MEPERIDINE HYDROCHLORIDE
+ ROXANE 50MG/5ML A088744 001 Jan 30, 1985
TABLET;ORAL
DEMEROL
AA + SANOFI AVENTIS US 50MG N005010 001
AA + 100MG N005010 004
MEPERIDINE HYDROCHLORIDE
AA BARR 50MG A088639 001 Jul 02, 1984
AA 100MG A088640 001 Sep 19, 1984
AA EPIC PHARMA 50MG A040331 001 May 28, 1999
AA 100MG A040331 002 May 28, 1999
AA MALLINCKRODT 50MG A040352 001 Jun 13, 2000
AA 100MG A040352 002 Jun 13, 2000
AA MIKART 50MG A040893 001 Jun 24, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-233(of 371)
MEPERIDINE HYDROCHLORIDE
TABLET;ORAL
MEPERIDINE HYDROCHLORIDE
AA 100MG A040893 003 Jun 24, 2009
AA ROXANE 50MG A040110 001 Mar 12, 1997
AA 100MG A040110 002 Mar 12, 1997
AA SUN PHARM INDS INC 50MG A040446 001 Aug 08, 2002
AA 100MG A040446 002 Aug 08, 2002
AA VINTAGE PHARMS 50MG A040191 001 Dec 17, 1998
AA 100MG A040191 002 Dec 17, 1998
MIKART 75MG A040893 002 Jun 24, 2009
150MG A040893 004 Jun 24, 2009
MEPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION
CARBOCAINE
AP + HOSPIRA 1% N012250 001
AP + 1.5% N012250 005
AP + 2% N012250 002
ISOCAINE HYDROCHLORIDE
AP + NOVOCOL 3% A080925 001
MEPIVACAINE HYDROCHLORIDE
AP HOSPIRA INC 3% A040806 001 Apr 28, 2008
POLOCAINE
AP FRESENIUS KABI USA 1% A089407 001 Dec 01, 1986
AP 2% A089410 001 Dec 01, 1986
POLOCAINE-MPF
AP FRESENIUS KABI USA 1% A089406 001 Dec 01, 1986
AP 1.5% A089408 001 Dec 01, 1986
AP 2% A089409 001 Dec 01, 1986
SCANDONEST PLAIN
AP + DEPROCO 3% A088387 001 Oct 10, 1984
MEPROBAMATE
TABLET;ORAL
MEPROBAMATE
AA ALEMBIC PHARMS LTD 200MG A090122 001 Feb 18, 2009
AA 400MG A090122 002 Feb 18, 2009
AA INVAGEN PHARMS 200MG A040797 001 Feb 27, 2008
AA 400MG A040797 002 Feb 27, 2008
AA + WATSON LABS 200MG A083304 001
AA + 400MG A083308 001
MERCAPTOPURINE
SUSPENSION;ORAL
PURIXAN
+ NOVA LABS LTD 20MG/ML N205919 001 Apr 28, 2014
TABLET;ORAL
MERCAPTOPURINE
AB MYLAN 50MG A040594 001 Jul 01, 2005
AB PROMETHEUS LABS 50MG A040461 001 Feb 11, 2004
AB + ROXANE 50MG A040528 001 Feb 13, 2004
MEROPENEM
INJECTABLE;INJECTION
MEROPENEM
AP ACS DOBFAR 1GM/VIAL A091404 002 Oct 26, 2011
AP 500MG/VIAL A091404 001 Oct 26, 2011
AP HOSPIRA INC 1GM/VIAL A090940 002 Jun 22, 2010
AP 500MG/VIAL A090940 001 Jun 22, 2010
AP SANDOZ 1GM/VIAL A091201 002 Mar 29, 2011
AP 500MG/VIAL A091201 001 Mar 29, 2011
MERREM
AP + ASTRAZENECA 1GM/VIAL N050706 001 Jun 21, 1996
AP + 500MG/VIAL N050706 003 Jun 21, 1996
MESALAMINE
CAPSULE, DELAYED RELEASE;ORAL
DELZICOL
+ WARNER CHILCOTT LLC 400MG N204412 001 Feb 01, 2013
CAPSULE, EXTENDED RELEASE;ORAL
APRISO
+ SALIX PHARMS 375MG N022301 001 Oct 31, 2008
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-234(of 371)
MESALAMINE
CAPSULE, EXTENDED RELEASE;ORAL
PENTASA
SHIRE 250MG N020049 001 May 10, 1993
+ 500MG N020049 002 Jul 08, 2004
ENEMA;RECTAL
MESALAMINE
AB PERRIGO ISRAEL 4GM/60ML A076751 001 Sep 17, 2004
AB TEVA 4GM/60ML A076841 001 Sep 30, 2004
ROWASA
AB + MEDA PHARMS 4GM/60ML N019618 001 Dec 24, 1987
SFROWASA
AB MEDA PHARMS 4GM/60ML N019618 002 Jun 20, 2008
SUPPOSITORY;RECTAL
CANASA
+ FOREST LABS INC 1GM N021252 002 Nov 05, 2004
TABLET, DELAYED RELEASE;ORAL
ASACOL
+ WARNER CHILCOTT LLC 400MG N019651 001 Jan 31, 1992
ASACOL HD
+ WARNER CHILCOTT LLC 800MG N021830 001 May 29, 2008
LIALDA
+ SHIRE 1.2GM N022000 001 Jan 16, 2007
MESNA
INJECTABLE;INTRAVENOUS
MESNA
AP AGILA SPECLTS 100MG/ML A203364 001 Jul 18, 2014
AP EUROHLTH INTL 100MG/ML A075739 001 Jan 09, 2004
AP FRESENIUS KABI USA 100MG/ML A075811 001 Apr 26, 2001
AP MYLAN INSTITUTIONAL 100MG/ML A076488 001 Mar 08, 2012
AP SAGENT PHARMS 100MG/ML A090913 001 Apr 13, 2010
AP TEVA PHARMS USA 100MG/ML A075764 001 Apr 27, 2001
MESNEX
AP + BAXTER HLTHCARE 100MG/ML N019884 001 Dec 30, 1988
TABLET;ORAL
MESNEX
+ BAXTER HLTHCARE 400MG N020855 001 Mar 21, 2002
MESTRANOL; NORETHINDRONE
TABLET;ORAL-28
NORINYL 1+50 28-DAY
+ WATSON LABS 0.05MG;1MG N016659 001
METAPROTERENOL SULFATE
SOLUTION;INHALATION
METAPROTERENOL SULFATE
AN + MYLAN SPECLT 0.4% A071786 001 Aug 05, 1988
AN + 0.6% A070804 001 Aug 17, 1987
AN WOCKHARDT 0.4% A075586 001 May 30, 2002
AN 0.6% A075586 002 May 30, 2002
SYRUP;ORAL
METAPROTERENOL SULFATE
+ SILARX 10MG/5ML A073632 001 Jul 22, 1992
TABLET;ORAL
METAPROTERENOL SULFATE
PAR PHARM 10MG A072024 001 Jun 28, 1988
+ 20MG A072025 001 Jun 28, 1988
METARAMINOL BITARTRATE
INJECTABLE;INJECTION
METARAMINOL BITARTRATE
+ FRESENIUS KABI USA EQ 10MG BASE/ML A080722 001
METAXALONE
TABLET;ORAL
METAXALONE
AB AMNEAL PHARMS 800MG A203399 001 Jun 21, 2013
AB SANDOZ 800MG A040445 001 Mar 31, 2010
SKELAXIN
AB + KING PHARMS 800MG N013217 003 Aug 30, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-235(of 371)
METFORMIN HYDROCHLORIDE
SOLUTION;ORAL
RIOMET
+ RANBAXY
500MG/5ML
N021591 001 Sep 11, 2003
TABLET;ORAL
GLUCOPHAGE
AB + BRISTOL MYERS SQUIBB 1GM
N020357 005 Nov 05, 1998
AB 500MG
N020357 001 Mar 03, 1995
AB 850MG
N020357 002 Mar 03, 1995
METFORMIN HYDROCHLORIDE
AB ALKEM 1GM
A091184 003 Nov 01, 2010
AB 500MG
A091184 001 Nov 01, 2010
AB 850MG
A091184 002 Nov 01, 2010
AB AMNEAL PHARMS NY 1GM
A077880 003 Jun 05, 2006
AB 500MG
A077880 001 Jun 05, 2006
AB 850MG
A077880 002 Jun 05, 2006
AB APOTEX 1GM
A075984 003 Apr 23, 2002
AB 1GM
A090666 003 Dec 07, 2011
AB 500MG
A075984 001 Apr 23, 2002
AB 500MG
A090666 001 Dec 07, 2011
AB 850MG
A075984 002 Apr 23, 2002
AB 850MG
A090666 002 Dec 07, 2011
AB ATLAS PHARMS LLC 1GM
A076033 003 Jan 24, 2002
AB 500MG
A076033 001 Jan 24, 2002
AB 850MG
A076033 002 Jan 24, 2002
AB AUROBINDO 1GM
A077095 003 Jan 14, 2005
AB 500MG
A077095 001 Jan 14, 2005
AB 850MG
A077095 002 Jan 14, 2005
AB CHARTWELL LIFE SCI 1GM
A075972 003 Jan 24, 2002
AB 500MG
A075972 001 Jan 24, 2002
AB 850MG
A075972 002 Jan 24, 2002
AB DR REDDYS LABS INC 1GM
A077787 003 Aug 23, 2006
AB 500MG
A077787 001 Aug 23, 2006
AB 850MG
A077787 002 Aug 23, 2006
AB GLENMARK GENERICS 1GM
A078170 003 May 23, 2008
AB 500MG
A078170 001 May 23, 2008
AB 850MG
A078170 002 May 23, 2008
AB GRANULES INDIA 1GM
A090564 003 Apr 22, 2010
AB 500MG
A090564 001 Apr 22, 2010
AB 850MG
A090564 002 Apr 22, 2010
AB INDICUS PHARMA 1GM
A079148 003 Nov 25, 2008
AB 500MG
A079148 001 Nov 25, 2008
AB 850MG
A079148 002 Nov 25, 2008
AB MARKSANS PHARMA 1GM
A090888 003 Mar 12, 2012
AB 500MG
A090888 001 Mar 12, 2012
AB 850MG
A090888 002 Mar 12, 2012
AB MUTUAL PHARMA 1GM
A076038 003 Feb 21, 2002
AB 500MG
A076038 001 Feb 21, 2002
AB 850MG
A076038 002 Feb 21, 2002
AB MYLAN 1GM
A075973 003 Jan 25, 2002
AB 1GM
A075976 003 Jan 24, 2002
AB 500MG
A075973 001 Jan 25, 2002
AB 500MG
A075976 001 Jan 24, 2002
AB 850MG
A075973 002 Jan 25, 2002
AB 850MG
A075976 002 Jan 24, 2002
AB MYLAN PHARMS INC 1GM
A075969 003 Jan 29, 2002
AB 500MG
A075969 001 Jan 29, 2002
AB 850MG
A075969 002 Jan 29, 2002
AB PROVIDENT PHARM 1GM
A077853 003 Jul 28, 2006
AB 500MG
A077853 001 Jul 28, 2006
AB 850MG
A077853 002 Jul 28, 2006
AB SANDOZ 1GM
A075965 003 Jan 25, 2002
AB 1GM
A075985 003 Jan 25, 2002
AB 500MG
A075965 001 Jan 25, 2002
AB 500MG
A075985 001 Jan 25, 2002
AB 850MG
A075965 002 Jan 25, 2002
AB 850MG
A075985 002 Jan 25, 2002
AB SCIEGEN PHARMS INC 500MG
A203769 001 Sep 11, 2013
AB 850MG
A203769 002 Sep 11, 2013
AB 1GM
A203769 003 Sep 11, 2013
AB SUN PHARM INDS INC 1GM
A075967 003 Jan 29, 2002
AB 500MG
A075967 001 Jan 29, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-236(of 371)
METFORMIN HYDROCHLORIDE
TABLET;ORAL
METFORMIN HYDROCHLORIDE
AB 850MG
A075967 002 Jan 29, 2002
AB TEVA 1GM
A075978 003 Nov 05, 2002
AB 500MG
A075978 001 Jan 25, 2002
AB 850MG
A075978 002 Jan 25, 2002
AB TORRENT PHARMS 1GM
A077711 003 Jan 24, 2007
AB 500MG
A077711 001 Jan 24, 2007
AB 850MG
A077711 002 Jan 24, 2007
AB WATSON LABS FLORIDA 1GM
A075961 003 Jan 25, 2002
AB 500MG
A075961 001 Jan 25, 2002
AB 850MG
A075961 002 Jan 25, 2002
AB ZYDUS HLTHCARE 1GM
A203686 003 Aug 28, 2014
AB 500MG
A203686 001 Aug 28, 2014
AB 850MG
A203686 002 Aug 28, 2014
AB ZYDUS PHARMS USA 1GM
A077064 003 Apr 18, 2005
AB 500MG
A077064 001 Apr 18, 2005
AB 850MG
A077064 002 Apr 18, 2005
CHARTWELL LIFE SCI 625MG
A075972 005 Jan 24, 2002
750MG
A075972 004 Jan 24, 2002
TABLET, EXTENDED RELEASE;ORAL
GLUCOPHAGE XR
AB + BRISTOL MYERS SQUIBB
750MG
N021202 004 Apr 11, 2003
METFORMIN HYDROCHLORIDE
AB ACTAVIS LABS FL INC
750MG
A076869 001 Apr 12, 2005
AB AMNEAL PHARMS NY
750MG
A078596 002 Jan 03, 2008
AB APOTEX
750MG
A076706 002 Dec 29, 2005
AB AUROBINDO PHARMA LTD
750MG
A079118 002 Jul 20, 2012
AB BARR
750MG
A076863 001 Oct 14, 2004
AB CSPC OUYI PHARM CO
750MG
A078321 002 Apr 17, 2008
AB IMPAX LABS
750MG
A076985 001 Sep 13, 2005
AB MYLAN
750MG
A077113 001 Sep 08, 2005
AB NOSTRUM PHARMS LLC
750MG
A076756 002 Dec 12, 2011
AB SUN PHARM INDS (IN)
750MG
A077336 002 Feb 09, 2006
AB TEVA
750MG
A076864 001 Apr 12, 2005
AB ZYDUS PHARMS USA
750MG
A077078 001 Apr 21, 2005
GLUCOPHAGE XR
AB1 BRISTOL MYERS SQUIBB
500MG
N021202 001 Oct 13, 2000
METFORMIN HYDROCHLORIDE
AB1 ACTAVIS LABS FL INC
500MG
A076172 001 Jun 16, 2004
AB1 AMNEAL PHARMS NY
500MG
A078596 001 Jan 03, 2008
AB1 APOTEX
500MG
A076706 001 Dec 14, 2004
AB1 AUROBINDO PHARMA LTD
500MG
A079118 001 Jul 20, 2012
AB1 CSPC OUYI PHARM CO
500MG
A078321 001 Apr 17, 2008
AB1 IMPAX LABS
500MG
A076249 001 Jul 30, 2004
AB1 INVENTIA HLTHCARE
500MG
A201991 001 Jan 18, 2012
AB1 MYLAN
500MG
A076650 001 Sep 13, 2005
AB1 NOSTRUM PHARMS LLC
500MG
A076756 001 Jul 26, 2006
AB1 SANDOZ
500MG
A076873 001 Dec 14, 2004
AB1 SUN PHARM INDS (IN)
500MG
A077336 001 Feb 09, 2006
AB1 TEVA
500MG
A076269 001 Jun 18, 2004
AB1 TORRENT PHARM
500MG
A090014 001 Dec 30, 2009
AB1 ZYDUS PHARMS USA
500MG
A077060 001 Apr 20, 2005
FORTAMET
AB2 + ANDRX LABS LLC
1GM
N021574 002 Apr 27, 2004
AB2
500MG
N021574 001 Apr 27, 2004
METFORMIN HYDROCHLORIDE
AB2 LUPIN LTD
1GM
A090692 002 Jun 29, 2011
AB2
500MG
A090692 001 Jun 29, 2011
AB2 MYLAN PHARMS INC
1GM
A200690 002 Aug 01, 2012
AB2
500MG
A200690 001 Aug 01, 2012
AB3 LUPIN LTD
1GM
A091664 002 Jul 19, 2013
AB3
500MG
A091664 001 Jul 19, 2013
GLUMETZA
+ SANTARUS INC
1GM
N021748 002 Jun 03, 2005
500MG
N021748 001 Jun 03, 2005
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-237(of 371)
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE
TABLET;ORAL
ACTOPLUS MET
AB TAKEDA PHARMS USA 500MG;EQ 15MG BASE N021842 001 Aug 29, 2005
AB + 850MG;EQ 15MG BASE N021842 002 Aug 29, 2005
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE
AB AUROBINDO PHARMA LTD 500MG;EQ 15MG BASE
A200823 001 Feb 13, 2013
AB 850MG;EQ 15MG BASE
A200823 002 Feb 13, 2013
AB MYLAN 500MG;EQ 15MG BASE
A090406 001 Feb 25, 2011
AB 850MG;EQ 15MG BASE
A090406 002 Feb 25, 2011
AB SANDOZ 500MG;EQ 15MG BASE
A091273 001 Apr 16, 2013
AB 850MG;EQ 15MG BASE
A091273 002 Apr 16, 2013
AB TEVA PHARMS USA 500MG;EQ 15MG BASE
A091155 001 Mar 10, 2014
AB 850MG;EQ 15MG BASE
A091155 002 Mar 10, 2014
AB TORRENT PHARMS LTD 500MG;EQ 15MG BASE
A202001 001 Feb 13, 2013
AB 850MG;EQ 15MG BASE
A202001 002 Feb 13, 2013
TABLET, EXTENDED RELEASE;ORAL
ACTOPLUS MET XR
TAKEDA PHARMS USA
1GM;EQ 15MG BASE
N022024 001 May 12, 2009
+
1GM;EQ 30MG BASE
N022024 002 May 12, 2009
METFORMIN HYDROCHLORIDE; REPAGLINIDE
TABLET;ORAL
PRANDIMET
NOVO NORDISK INC 500MG;1MG
N022386 001 Jun 23, 2008
+ 500MG;2MG
N022386 002 Jun 23, 2008
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
TABLET;ORAL
AVANDAMET
AB SB PHARMCO 1GM;EQ 2MG BASE
N021410 004 Aug 25, 2003
AB + 1GM;EQ 4MG BASE
N021410 005 Aug 25, 2003
AB 500MG;EQ 2MG BASE
N021410 002 Oct 10, 2002
AB 500MG;EQ 4MG BASE
N021410 003 Oct 10, 2002
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE
AB TEVA 1GM;EQ 4MG BASE
A077337 004 May 07, 2014
AB 1GM;EQ 2MG BASE
A077337 003 May 07, 2014
AB 500MG;EQ 2MG BASE
A077337 001 May 07, 2014
AB 500MG;EQ 4MG BASE
A077337 002 May 07, 2014
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
KOMBIGLYZE XR
ASTRAZENECA AB 1GM;EQ 2.5MG BASE
N200678 003 Nov 05, 2010
+ 1GM;EQ 5MG BASE
N200678 002 Nov 05, 2010
500MG;EQ 5MG BASE
N200678 001 Nov 05, 2010
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE
TABLET;ORAL
JANUMET
+ MERCK SHARP DOHME
1GM;EQ 50MG BASE
N022044 002 Mar 30, 2007
500MG;EQ 50MG BASE
N022044 001 Mar 30, 2007
TABLET, EXTENDED RELEASE;ORAL
JANUMET XR
MERCK SHARP DOHME
1GM;EQ 50MG BASE
N202270 002 Feb 02, 2012
+
1GM;EQ 100MG BASE
N202270 003 Feb 02, 2012
500MG;EQ 50MG BASE
N202270 001 Feb 02, 2012
METHACHOLINE CHLORIDE
FOR SOLUTION;INHALATION
PROVOCHOLINE
+ METHAPHARM
100MG/VIAL
N019193 001 Oct 31, 1986
METHADONE HYDROCHLORIDE
CONCENTRATE;ORAL
METHADONE HYDROCHLORIDE
AA ROXANE
10MG/ML
A040180 001 Apr 30, 1998
AA VISTAPHARM
10MG/ML
A040088 001 Nov 30, 1994
METHADONE HYDROCHLORIDE INTENSOL
AA ROXANE 10MG/ML
A089897 001 Sep 06, 1988
METHADOSE
AA + MALLINCKRODT 10MG/ML
N017116 002
INJECTABLE;INJECTION
DOLOPHINE HYDROCHLORIDE
+ MYLAN INSTITUTIONAL 10MG/ML
N021624 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-238(of 371)
METHADONE HYDROCHLORIDE
POWDER;FOR RX COMPOUNDING
METHADONE HYDROCHLORIDE
MALLINCKRODT 50GM/BOT N006383 002
100GM/BOT N006383 003
500GM/BOT N006383 004
SOLUTION;ORAL
METHADONE HYDROCHLORIDE
AA + ROXANE 5MG/5ML A087393 001
AA + 10MG/5ML A087997 001 Aug 30, 1982
AA VISTAPHARM 5MG/5ML A090707 001 Jun 30, 2010
AA 10MG/5ML A090707 002 Jun 30, 2010
TABLET;ORAL
DOLOPHINE HYDROCHLORIDE
AA + ROXANE 5MG N006134 002
AA + 10MG N006134 010
METHADONE HYDROCHLORIDE
AA MALLINCKRODT 5MG A040517 001 Apr 27, 2004
AA 10MG A040517 002 Apr 27, 2004
AA SANDOZ 10MG A040241 002 May 29, 1998
AA THE PHARMANETWORK 10MG A090635 001 Nov 25, 2009
METHADOSE
AA MALLINCKRODT 5MG A040050 001 Apr 15, 1993
AA 10MG A040050 002 Apr 15, 1993
TABLET, FOR SUSPENSION;ORAL
METHADONE HYDROCHLORIDE
AA MALLINCKRODT INC 40MG A077142 001 Jul 12, 2005
AA + ROXANE 40MG N017058 001
AA SANDOZ 40MG A075082 001 Mar 25, 1998
METHADOSE
AA MALLINCKRODT 40MG A074184 001 Apr 29, 1993
METHAMPHETAMINE HYDROCHLORIDE
TABLET;ORAL
DESOXYN
AA + RECORDATI RARE 5MG N005378 002
METHAMPHETAMINE HYDROCHLORIDE
AA COASTAL PHARMS 5MG A091189 001 Apr 21, 2010
METHAZOLAMIDE
TABLET;ORAL
METHAZOLAMIDE
AB ANI PHARMS INC 25MG A040001 001 Jun 30, 1993
AB 50MG A040001 002 Jun 30, 1993
AB MIKART 25MG A040062 001 Jan 27, 1994
AB + 50MG A040062 002 Jan 27, 1994
AB SANDOZ 25MG A040036 001 Jun 30, 1993
AB 50MG A040036 002 Jun 30, 1993
METHENAMINE HIPPURATE
TABLET;ORAL
HIPREX
AB + SANOFI AVENTIS US 1GM N017681 001
METHENAMINE HIPPURATE
AB COREPHARMA 1GM A076411 001 Jun 20, 2003
UREX
AB CNTY LINE PHARMS 1GM N016151 001
METHIMAZOLE
TABLET;ORAL
METHIMAZOLE
AB CEDAR PHARMS 5MG A040547 001 Feb 18, 2005
AB 10MG A040547 002 Feb 18, 2005
AB EMCURE PHARMS USA 5MG A040734 001 Dec 14, 2007
AB 10MG A040734 002 Dec 14, 2007
AB MYLAN 5MG A040350 001 Mar 29, 2000
AB + 10MG A040350 002 Mar 29, 2000
AB SANDOZ 5MG A040411 001 Mar 27, 2001
AB 10MG A040411 002 Mar 27, 2001
AB SUN PHARM INDS INC 5MG A040870 001 Sep 25, 2007
AB 10MG A040870 002 Sep 25, 2007
AB VINTAGE PHARMS 5MG A202068 001 Mar 07, 2012
AB 10MG A202068 002 Mar 07, 2012
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-239(of 371)
METHIMAZOLE
TABLET;ORAL
TAPAZOLE
AB KING PHARMS 5MG A040320 001 Mar 31, 2000
AB 10MG A040320 002 Mar 31, 2000
METHOCARBAMOL
SOLUTION;IM-IV
METHOCARBAMOL
AP MYLAN INSTITUTIONAL 1GM/10ML (100MG/ML) A204404 001 Dec 05, 2014
ROBAXIN
AP + HIKMA MAPLE 1GM/10ML (100MG/ML) N011790 001
TABLET;ORAL
METHOCARBAMOL
AA AUSTARPHARMA LLC 500MG A200958 001 Oct 21, 2011
AA 750MG A200958 002 Oct 21, 2011
AA HETERO LABS LTD III 500MG A090200 001 Nov 06, 2009
AA 750MG A090200 002 Nov 06, 2009
AA HIKMA INTL PHARMS 500MG A085159 001
AA 750MG A085123 001
AA LANNETT HOLDINGS INC 500MG A084756 002 Mar 31, 2003
AA 750MG A084756 001
AA PRINSTON INC 500MG A086989 001
AA 750MG A086988 001
AA SANDOZ 500MG A084616 001
AA 750MG A084615 001
AA VINTAGE PHARMS 500MG A040489 001 Jan 29, 2003
AA 750MG A040489 002 Jan 29, 2003
AA WATSON LABS 500MG A084277 001
AA 750MG A084276 002
ROBAXIN
AA + AUXILIUM PHARMS LLC 500MG N011011 004
ROBAXIN-750
AA + AUXILIUM PHARMS LLC 750MG N011011 006
METHOHEXITAL SODIUM
INJECTABLE;INJECTION
BREVITAL SODIUM
+ PAR STERILE PRODUCTS 2.5GM/VIAL N011559 002
+ 200MG/VIAL N011559 004 Dec 21, 2012
+ 500MG/VIAL N011559 001
METHOTREXATE
SOLUTION;SUBCUTANEOUS
OTREXUP
ANTARES PHARMA INC 7.5MG/0.4ML (7.5MG/0.4ML) N204824 005 Nov 07, 2014
10MG/0.4ML (10MG/0.4ML) N204824 001 Oct 11, 2013
15MG/0.4ML (15MG/0.4ML) N204824 002 Oct 11, 2013
20MG/0.4ML (20MG/0.4ML) N204824 003 Oct 11, 2013
+ 25MG/0.4ML (25MG/0.4ML) N204824 004 Oct 11, 2013
RASUVO
MEDAC PHARMA INC 7.5MG/0.15ML (7.5MG/0.15ML) N205776 001 Jul 10, 2014
10MG/0.20ML (10MG/0.20ML) N205776 002 Jul 10, 2014
12.5MG/0.25ML (12.5MG/0.25ML) N205776 003 Jul 10, 2014
15MG/0.30ML (15MG/0.30ML) N205776 004 Jul 10, 2014
17.5MG/0.35ML (17.5MG/0.35ML) N205776 005 Jul 10, 2014
20MG/0.4ML (20MG/0.4ML) N205776 006 Jul 10, 2014
22.5MG/0.45ML (22.5MG/0.45ML) N205776 007 Jul 10, 2014
25MG/0.5ML (25MG/0.5ML) N205776 008 Jul 10, 2014
27.5MG/0.55ML (27.5MG/0.55ML) N205776 009 Jul 10, 2014
30MG/0.6ML (30MG/0.6ML) N205776 010 Jul 10, 2014
METHOTREXATE SODIUM
INJECTABLE;INJECTION
METHOTREXATE PRESERVATIVE FREE
AP FRESENIUS KABI USA EQ 1GM BASE/VIAL A040266 001 Feb 26, 1999
AP PHARMACHEMIE BV EQ 100MG BASE/4ML (EQ 25MG BASE/ML) A200171 001 Feb 27, 2012
METHOTREXATE SODIUM
AP + EUROHLTH INTL EQ 100MG BASE/4ML (EQ 25MG BASE/ML) A089341 001 Sep 16, 1986
AP + FRESENIUS KABI USA EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A040263 001 Feb 26, 1999
AP + EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A040263 002 Feb 26, 1999
AP + HOSPIRA EQ 50MG BASE/2ML (EQ 25MG BASE/ML) N011719 010 Dec 15, 2004
METHOTREXATE SODIUM PRESERVATIVE FREE
AP + ACCORD HLTHCARE EQ 1GM BASE/40ML (EQ 25MG BASE/ML) A040716 001 Apr 30, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-240(of 371)
METHOTREXATE SODIUM
INJECTABLE;INJECTION
METHOTREXATE SODIUM PRESERVATIVE FREE
AP + EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A040767 001 Apr 30, 2007
AP + EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A040768 001 Apr 30, 2007
AP EBEWE PHARMA EQ 1GM BASE/40ML (EQ 25MG BASE/ML) A090029 001 Mar 31, 2009
AP EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A090039 001 Mar 31, 2009
AP EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A090039 002 Mar 31, 2009
AP + EUROHLTH INTL EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A089340 001 Sep 16, 1986
AP + EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A089343 001 Sep 16, 1986
AP + HOSPIRA EQ 1GM BASE/40ML (EQ 25MG BASE/ML) N011719 012 Apr 13, 2005
AP ONCO THERAPIES LTD EQ 1GM BASE/40ML (EQ 25MG BASE/ML) A201530 001 Mar 29, 2012
AP EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A201529 001 Mar 29, 2012
AP EQ 100MG BASE/4ML (EQ 25MG BASE/ML) A201529 002 Mar 29, 2012
AP EQ 200MG BASE/8ML (EQ 25MG BASE/ML) A201529 003 Mar 29, 2012
AP EQ 250MG BASE/10ML (EQ 25MG BASE/ML) A201529 004 Mar 29, 2012
AP PHARMACHEMIE BV EQ 1GM BASE/40ML (EQ 25MG BASE/ML) A040843 001 Jan 11, 2010
AP EQ 50MG BASE/2ML (EQ 25MG BASE/ML) A040850 001 Jan 11, 2010
AP EQ 250MG/10ML (EQ 25MG BASE/ML) A040853 001 Jan 11, 2010
METHOTREXATE SODIUM
+ EUROHLTH INTL EQ 200MG BASE/8ML (EQ 25MG BASE/ML) A089342 001 Sep 16, 1986
METHOTREXATE SODIUM PRESERVATIVE FREE
+ EUROHLTH INTL EQ 1GM BASE/VIAL A040632 001 Aug 12, 2005
TABLET;ORAL
METHOTREXATE SODIUM
AB BARR EQ 2.5MG BASE A081099 001 Oct 15, 1990
AB + DAVA PHARMS INC EQ 2.5MG BASE N008085 002
AB MYLAN EQ 2.5MG BASE A081235 001 May 15, 1992
AB ROXANE EQ 2.5MG BASE A040054 001 Aug 01, 1994
TREXALL
BARR EQ 5MG BASE A040385 001 Mar 21, 2001
EQ 7.5MG BASE A040385 002 Mar 21, 2001
EQ 10MG BASE A040385 003 Mar 21, 2001
+ EQ 15MG BASE A040385 004 Mar 21, 2001
METHOXSALEN
CAPSULE;ORAL
METHOXSALEN
AB STRIDES PHARMA 10MG A202687 001 Jun 05, 2014
OXSORALEN-ULTRA
AB + DOW PHARM 10MG N019600 001 Oct 30, 1986
8-MOP
+ VALEANT PHARM INTL 10MG N009048 001
INJECTABLE;INJECTION
UVADEX
+ THERAKOS 0.02MG/ML N020969 001 Feb 25, 1999
LOTION;TOPICAL
OXSORALEN
+ VALEANT PHARM INTL 1% N009048 002
METHSCOPOLAMINE BROMIDE
TABLET;ORAL
METHSCOPOLAMINE BROMIDE
AA BAYSHORE PHARMS LLC 2.5MG A200602 001 Sep 24, 2012
AA 5MG A200602 002 Sep 24, 2012
AA BRECKENRIDGE PHARM 2.5MG A040642 001 Dec 06, 2011
AA 5MG A040642 002 Dec 06, 2011
AA VINTAGE PHARMS 2.5MG A040624 001 Dec 28, 2006
AA 5MG A040624 002 Dec 28, 2006
PAMINE
AA + FOUGERA PHARMS 2.5MG N008848 001
PAMINE FORTE
AA + FOUGERA PHARMS 5MG N008848 002 Mar 25, 2003
METHSUXIMIDE
CAPSULE;ORAL
CELONTIN
PARKE DAVIS 150MG N010596 007
+ 300MG N010596 008
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-241(of 371)
METHYCLOTHIAZIDE
TABLET;ORAL
METHYCLOTHIAZIDE
+ MYLAN PHARMS INC
5MG
A087672 001 Aug 17, 1982
METHYLDOPA
TABLET;ORAL
METHYLDOPA
AB ACCORD HLTHCARE 250MG
A070084 001 Oct 15, 1985
AB 500MG
A070085 001 Oct 15, 1985
AB IVAX SUB TEVA PHARMS 250MG
A070098 001 Feb 20, 1986
AB 500MG
A070343 001 Feb 20, 1986
AB MYLAN 250MG
A070076 002 Apr 18, 1985
AB + 500MG
A070076 001 Apr 18, 1985
AB WATSON LABS 500MG
A070625 001 Jun 06, 1986
METHYLDOPATE HYDROCHLORIDE
INJECTABLE;INJECTION
METHYLDOPATE HYDROCHLORIDE
AP + LUITPOLD
50MG/ML
A071279 001 Oct 02, 1987
METHYLERGONOVINE MALEATE
INJECTABLE;INJECTION
METHERGINE
AP + EDISON THERAPS LLC
0.2MG/ML
N006035 004
METHYLERGONOVINE MALEATE
AP ERGOJECT
0.2MG/ML
A040889 001 Sep 13, 2010
AP LUITPOLD
0.2MG/ML
A090193 001 Nov 24, 2008
TABLET;ORAL
METHERGINE
AB + EDISON THERAPS LLC
0.2MG
N006035 003
METHYLERGONOVINE MALEATE
AB NOVEL LABS INC
0.2MG
A091577 001 May 02, 2011
METHYLNALTREXONE BROMIDE
INJECTABLE;SUBCUTANEOUS
RELISTOR
SALIX PHARMS
8MG/0.4ML (8MG/0.4ML)
N021964 002 Sep 27, 2010
+
12MG/0.6ML (12MG/0.6ML)
N021964 003 Apr 24, 2008
SOLUTION;SUBCUTANEOUS
RELISTOR
+ SALIX PHARMS
12MG/0.6ML (12MG/0.6ML)
N021964 001 Apr 24, 2008
METHYLPHENIDATE
FILM, EXTENDED RELEASE;TRANSDERMAL
DAYTRANA
NOVEN PHARMS INC 10MG/9HR (1.1MG/HR)
N021514 001 Apr 06, 2006
15MG/9HR (1.6MG/HR)
N021514 002 Apr 06, 2006
20MG/9HR (2.2MG/HR)
N021514 003 Apr 06, 2006
+ 30MG/9HR (3.3MG/HR)
N021514 004 Apr 06, 2006
METHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
METHYLPHENIDATE HYDROCHLORIDE
AB1 BARR LABS INC 10MG A079031 004 Oct 15, 2014
AB1 20MG A079031 001 Jul 13, 2012
AB1 30MG A079031 002 Jul 13, 2012
AB1 40MG A079031 003 Jul 13, 2012
AB1 WATSON LABS INC 20MG A078458 001 Dec 01, 2011
AB1 30MG A078458 002 Dec 01, 2011
AB1 40MG A078458 003 Dec 01, 2011
RITALIN LA
AB1 NOVARTIS 10MG N021284 004 Apr 10, 2004
AB1 20MG N021284 001 Jun 05, 2002
AB1 30MG N021284 002 Jun 05, 2002
AB1 + 40MG N021284 003 Jun 05, 2002
METADATE CD
AB2 UCB INC 10MG N021259 003 May 27, 2003
AB2 20MG N021259 001 Apr 03, 2001
AB2 30MG N021259 002 Jun 19, 2003
AB2 40MG N021259 004 Feb 19, 2006
AB2 50MG N021259 005 Feb 19, 2006
AB2 + 60MG N021259 006 Feb 19, 2006
METHYLPHENIDATE HYDROCHLORIDE
AB2 TEVA PHARMS 10MG
A077707 001 Jul 19, 2012
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-242(of 371)
METHYLPHENIDATE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
METHYLPHENIDATE HYDROCHLORIDE
AB2 20MG A077707 002 Jul 19, 2012
AB2 30MG A077707 003 Jul 19, 2012
AB2 40MG A078873 001 Jul 19, 2012
AB2 50MG A078873 002 Jul 19, 2012
AB2 60MG A078873 003 Jul 19, 2012
RITALIN LA
NOVARTIS 60MG N021284 005 Oct 27, 2014
FOR SUSPENSION, EXTENDED RELEASE;ORAL
QUILLIVANT XR
+ NEXTWAVE PHARMS 5MG/ML N202100 001 Sep 27, 2012
SOLUTION;ORAL
METHYLIN
AA + MALLINCKRODT 5MG/5ML N021419 001 Dec 19, 2002
AA + 10MG/5ML N021419 002 Dec 19, 2002
METHYLPHENIDATE HYDROCHLORIDE
AA SUN PHARM INDS INC 5MG/5ML A201466 001 Nov 12, 2013
AA 10MG/5ML A201466 002 Nov 12, 2013
AA TRIS PHARMA INC 5MG/5ML A091601 001 Jul 23, 2010
AA 10MG/5ML A091601 002 Jul 23, 2010
TABLET;ORAL
METHYLPHENIDATE HYDROCHLORIDE
AB ACTAVIS LABS FL INC 5MG A040220 001 Aug 29, 1997
AB 10MG A040220 002 Aug 29, 1997
AB 20MG A040220 003 Aug 29, 1997
AB COREPHARMA 5MG A091159 001 Mar 12, 2014
AB 10MG A091159 002 Mar 12, 2014
AB 20MG A091159 003 Mar 12, 2014
AB MALLINCKRODT 5MG A040300 001 Nov 27, 1998
AB 10MG A040300 002 Nov 27, 1998
AB 20MG A040300 003 Nov 27, 1998
AB SUN PHARM INDS INC 5MG A090710 001 Mar 15, 2012
AB 10MG A090710 002 Mar 15, 2012
AB 20MG A090710 003 Mar 15, 2012
AB UCB INC 5MG A086429 001
AB 10MG A085799 001
AB 20MG A086428 001
AB VINTAGE PHARMS 5MG A202892 001 Sep 23, 2014
AB 10MG A202892 002 Sep 23, 2014
AB 20MG A202892 003 Sep 23, 2014
RITALIN
AB NOVARTIS 5MG N010187 003
AB 10MG N010187 006
AB + 20MG N010187 010
TABLET, CHEWABLE;ORAL
METHYLIN
MALLINCKRODT 2.5MG N021475 001 Apr 15, 2003
5MG N021475 002 Apr 15, 2003
+ 10MG N021475 003 Apr 15, 2003
TABLET, EXTENDED RELEASE;ORAL
METADATE ER
AB + UCB INC 20MG A089601 001 Jun 01, 1988
METHYLIN ER
AB MALLINCKRODT INC 20MG A075629 002 May 09, 2000
RITALIN-SR
AB NOVARTIS 20MG N018029 001 Mar 30, 1982
METHYLPHENIDATE HYDROCHLORIDE
BX KUDCO IRELAND 18MG A091695 001 Jul 09, 2013
BX 27MG A091695 002 Jul 09, 2013
BX 36MG A091695 003 Sep 23, 2013
BX 54MG A091695 004 Sep 23, 2013
BX MALLINCKRODT INC 27MG A202608 001 Dec 28, 2012
BX 36MG A202608 002 Dec 28, 2012
BX 54MG A202608 003 Dec 28, 2012
CONCERTA
JANSSEN PHARMS 18MG N021121 001 Aug 01, 2000
27MG N021121 004 Apr 01, 2002
36MG N021121 002 Aug 01, 2000
+ 54MG N021121 003 Dec 08, 2000
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-243(of 371)
METHYLPHENIDATE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
METHYLIN ER
MALLINCKRODT INC 10MG A075629 001 May 09, 2000
METHYLPREDNISOLONE
TABLET;ORAL
MEDROL
AB PHARMACIA AND UPJOHN 2MG N011153 002
AB 4MG N011153 001
AB 8MG N011153 004
AB 16MG N011153 003
AB + 32MG N011153 006
METHYLPREDNISOLONE
AB DURAMED PHARMS BARR 4MG A088497 001 Feb 21, 1984
AB JUBILANT CADISTA 4MG A040189 001 Oct 31, 1997
AB 8MG A040189 002 Oct 31, 1997
AB 16MG A040189 003 Jul 20, 2007
AB 32MG A040189 004 Jul 20, 2007
AB SANDOZ 4MG A040194 001 Oct 31, 1997
AB VINTAGE PHARMS 4MG A040183 001 Dec 22, 1998
AB WATSON LABS 4MG A040232 001 Oct 16, 1997
METHYLPREDNISOLONE ACETATE
INJECTABLE;INJECTION
DEPO-MEDROL
AB + PHARMACIA AND UPJOHN 40MG/ML N011757 001
AB + 80MG/ML N011757 004
METHYLPREDNISOLONE ACETATE
AB SANDOZ 40MG/ML A040719 001 Jan 29, 2009
AB 40MG/ML A040794 001 Mar 05, 2009
AB 80MG/ML A040719 002 Jan 29, 2009
AB 80MG/ML A040794 002 Mar 05, 2009
AB TEVA PHARMS USA 40MG/ML A040557 001 Feb 23, 2005
AB 40MG/ML A040620 001 Oct 27, 2006
AB 80MG/ML A040557 002 Feb 23, 2005
AB 80MG/ML A040620 002 Oct 27, 2006
DEPO-MEDROL
+ PHARMACIA AND UPJOHN 20MG/ML N011757 002
METHYLPREDNISOLONE SODIUM SUCCINATE
INJECTABLE;INJECTION
A-METHAPRED
AP HOSPIRA EQ 40MG BASE/VIAL A040664 001 Dec 20, 2005
AP EQ 125MG BASE/VIAL A040665 001 Dec 20, 2005
AP HOSPIRA INC EQ 40MG BASE/VIAL A040793 001 Nov 25, 2008
AP EQ 125MG BASE/VIAL A040827 001 Nov 25, 2008
METHYLPREDNISOLONE SODIUM SUCCINATE
AP FRESENIUS KABI USA EQ 1GM BASE/VIAL A040612 001 Aug 12, 2004
AP EQ 40MG BASE/VIAL A040583 001 Jul 30, 2004
AP EQ 125MG BASE/VIAL A040583 002 Jul 30, 2004
AP MUSTAFA NEVSAT EQ 1GM BASE/VIAL A040888 004 Jul 18, 2011
AP EQ 2GM BASE/VIAL A040888 005 Jul 18, 2011
AP EQ 40MG BASE/VIAL A040888 001 Jul 18, 2011
AP EQ 125MG BASE/VIAL A040888 002 Jul 18, 2011
AP EQ 500MG BASE/VIAL A040888 003 Jul 18, 2011
SOLU-MEDROL
AP + PHARMACIA AND UPJOHN EQ 1GM BASE/VIAL N011856 006
AP + EQ 2GM BASE/VIAL N011856 007 Feb 27, 1985
AP + EQ 40MG BASE/VIAL N011856 003
AP + EQ 125MG BASE/VIAL N011856 004
AP + EQ 500MG BASE/VIAL N011856 005
METHYLTESTOSTERONE
CAPSULE;ORAL
TESTRED
+ VALEANT PHARM INTL 10MG A083976 001
TABLET;ORAL
ANDROID 10
BP VALEANT PHARM INTL 10MG A086450 001
ANDROID 25
BP VALEANT PHARM INTL 25MG A087147 001
METHYLTESTOSTERONE
BP IMPAX LABS 10MG A080767 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-244(of 371)
METHYLTESTOSTERONE
TABLET;ORAL
METHYLTESTOSTERONE
BP 25MG A084310 001
METIPRANOLOL HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
METIPRANOLOL
AT ALCON RES LTD 0.3% A075720 001 Aug 06, 2001
OPTIPRANOLOL
AT + BAUSCH AND LOMB 0.3% N019907 001 Dec 29, 1989
METOCLOPRAMIDE HYDROCHLORIDE
INJECTABLE;INJECTION
METOCLOPRAMIDE
AP EMCURE PHARMS LTD EQ 5MG BASE/ML A204756 001 Dec 20, 2013
METOCLOPRAMIDE HYDROCHLORIDE
AP BD RX EQ 5MG BASE/ML A091392 001 Apr 19, 2013
AP HOSPIRA EQ 5MG BASE/ML A073118 001 Jan 17, 1991
AP TEVA PHARMS USA EQ 5MG BASE/ML A073135 001 Nov 27, 1991
REGLAN
AP + BAXTER HLTHCARE CORP EQ 5MG BASE/ML N017862 001
SOLUTION;ORAL
METOCLOPRAMIDE HYDROCHLORIDE
AA ANI PHARMS EQ 5MG BASE/5ML A071402 001 Jun 25, 1993
AA PHARM ASSOC EQ 5MG BASE/5ML A072744 001 May 28, 1991
AA SILARX EQ 5MG BASE/5ML A073680 001 Oct 27, 1992
AA VISTAPHARM EQ 5MG BASE/5ML A075051 001 Jan 26, 2001
AA + WOCKHARDT EQ 5MG BASE/5ML A074703 001 Oct 31, 1997
TABLET;ORAL
METOCLOPRAMIDE HYDROCHLORIDE
AB IPCA LABS LTD EQ 5MG BASE A078807 001 Jun 12, 2008
AB EQ 10MG BASE A078807 002 Jun 12, 2008
AB MUTUAL PHARM EQ 5MG BASE A071536 002 Jan 16, 1997
AB NORTHSTAR HLTHCARE EQ 5MG BASE A078374 001 Nov 30, 2007
AB EQ 10MG BASE A078374 002 Nov 30, 2007
AB PAR PHARM INC EQ 10MG BASE A070581 001 Oct 17, 1985
AB TEVA EQ 5MG BASE A072801 001 Jun 15, 1993
AB EQ 10MG BASE A070184 001 Jul 29, 1985
AB VINTAGE PHARMS EQ 5MG BASE A077878 001 Aug 28, 2006
AB EQ 10MG BASE A077878 002 Aug 28, 2006
AB WATSON LABS EQ 5MG BASE A072750 001 Dec 28, 1995
AB EQ 10MG BASE A071250 001 Feb 03, 1988
REGLAN
AB ANI PHARMS EQ 5MG BASE N017854 002 May 05, 1987
AB + EQ 10MG BASE N017854 001
TABLET, ORALLY DISINTEGRATING;ORAL
METOCLOPRAMIDE HYDROCHLORIDE
AB NOVEL LABS INC EQ 5MG BASE A202191 001 Aug 15, 2014
METOZOLV ODT
AB + SALIX PHARMS EQ 5MG BASE N022246 001 Sep 04, 2009
METOCLOPRAMIDE HYDROCHLORIDE
NOVEL LABS INC EQ 10MG BASE A202191 002 Aug 15, 2014
METOLAZONE
TABLET;ORAL
METOLAZONE
AB MYLAN 2.5MG A076698 001 Dec 23, 2003
AB 5MG A076698 002 Oct 19, 2004
AB 10MG A076698 003 Oct 19, 2004
AB SANDOZ 2.5MG A076732 001 Dec 19, 2003
AB 5MG A076466 001 Dec 19, 2003
AB 10MG A076466 002 Dec 19, 2003
ZAROXOLYN
AB UCB INC 2.5MG N017386 001
AB + 5MG N017386 002
AB + 10MG N017386 003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-245(of 371)
METOPROLOL SUCCINATE
TABLET, EXTENDED RELEASE;ORAL
METOPROLOL SUCCINATE
AB ACTAVIS LABS FL INC
EQ 25MG TARTRATE
A077118 001 Aug 03, 2009
AB
EQ 50MG TARTRATE
A076862 001 Aug 03, 2009
AB
EQ 100MG TARTRATE
A077298 001 Apr 15, 2010
AB
EQ 200MG TARTRATE
A077298 002 Apr 15, 2010
AB DR REDDYS LABS LTD
EQ 25MG TARTRATE
A090617 001 Aug 01, 2012
AB
EQ 50MG TARTRATE
A090617 002 Aug 01, 2012
AB MYLAN PHARMS INC
EQ 25MG TARTRATE
A202033 001 Dec 15, 2011
AB
EQ 50MG TARTRATE
A202033 002 Dec 15, 2011
AB
EQ 100MG TARTRATE
A202033 003 Dec 15, 2011
AB
EQ 200MG TARTRATE
A202033 004 Dec 15, 2011
AB REDDYS
EQ 100MG TARTRATE
A078889 001 Aug 15, 2012
AB
EQ 200MG TARTRATE
A078889 002 Aug 15, 2012
AB WOCKHARDT
EQ 25MG TARTRATE
A090615 001 Jul 22, 2010
AB
EQ 50MG TARTRATE
A090615 002 Jul 22, 2010
AB
EQ 100MG TARTRATE
A090615 003 Jul 22, 2010
AB
EQ 200MG TARTRATE
A090615 004 Jul 22, 2010
TOPROL-XL
AB ASTRAZENECA PHARMS EQ 25MG TARTRATE
N019962 004 Feb 05, 2001
AB + EQ 50MG TARTRATE
N019962 001 Jan 10, 1992
AB EQ 100MG TARTRATE
N019962 002 Jan 10, 1992
AB + EQ 200MG TARTRATE
N019962 003 Jan 10, 1992
METOPROLOL TARTRATE
INJECTABLE;INJECTION
LOPRESSOR
AP + NOVARTIS
1MG/ML
N018704 001 Mar 30, 1984
METOPROLOL TARTRATE
AP BEDFORD LABS
1MG/ML
A076495 001 Jul 07, 2003
AP CLARIS LIFESCIENCES
1MG/ML
A078950 001 Apr 29, 2013
AP FRESENIUS KABI USA
1MG/ML
A091045 001 Oct 25, 2010
AP GLAND PHARMA LTD
1MG/ML
A204205 001 Aug 27, 2014
AP HIKMA FARMACEUTICA
1MG/ML
A077761 001 May 30, 2007
AP HOSPIRA
1MG/ML
A074133 001 Dec 21, 1993
AP
1MG/ML
A075160 001 Jul 06, 1998
AP
1MG/ML
A078085 001 Apr 29, 2008
AP LUITPOLD
1MG/ML
A090386 001 Sep 30, 2009
AP
1MG/ML
A091307 001 Dec 29, 2010
AP SAGENT STRIDES
1MG/ML
A090317 001 Apr 19, 2010
AP SANDOZ
1MG/ML
A077360 001 Oct 02, 2007
TABLET;ORAL
LOPRESSOR
AB US PHARMS HOLDINGS I
50MG
N017963 001
AB
100MG
N017963 002
METOPROLOL TARTRATE
AB ALEMBIC PHARMS LTD
25MG
A202871 001 May 28, 2013
AB
50MG
A202871 002 May 28, 2013
AB
100MG
A202871 003 May 28, 2013
AB AUROBINDO PHARMA
25MG
A077739 001 Sep 11, 2007
AB
50MG
A077739 002 Sep 11, 2007
AB
100MG
A077739 003 Sep 11, 2007
AB IPCA LABS LTD
25MG
A078459 001 Jun 17, 2008
AB
50MG
A078459 002 Jun 17, 2008
AB
100MG
A078459 003 Jun 17, 2008
AB MUTUAL PHARM
25MG
A073654 002 Jul 15, 2009
AB
50MG
A073653 001 Dec 21, 1993
AB
100MG
A073654 001 Dec 21, 1993
AB MYLAN
25MG
A076704 001 Jan 16, 2004
AB
50MG
A076704 002 Jan 16, 2004
AB +
100MG
A076704 003 Jan 16, 2004
AB RUBICON RES PVT LTD
25MG
A200981 001 Oct 28, 2014
AB
50MG
A200981 002 Oct 28, 2014
AB
100MG
A200981 003 Oct 28, 2014
AB SANDOZ
50MG
A073288 001 Mar 25, 1994
AB
100MG
A073289 001 Mar 25, 1994
AB SUN PHARM INDS INC
25MG
A076670 001 Jan 15, 2004
AB
50MG
A074644 001 Dec 10, 1996
AB
100MG
A074644 002 Dec 10, 1996
AB TEVA
50MG
A074141 001 Jan 31, 1995
AB
100MG
A074141 002 Jan 31, 1995
AB WATSON LABS
50MG
A074217 001 May 27, 1994
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-246(of 371)
METOPROLOL TARTRATE
TABLET;ORAL
METOPROLOL TARTRATE
AB 100MG A074217 002 May 27, 1994
METRONIDAZOLE
CAPSULE;ORAL
FLAGYL
AB + GD SEARLE LLC 375MG N020334 001 May 03, 1995
METRONIDAZOLE
AB ALEMBIC LTD 375MG A079065 001 Jun 23, 2009
AB PAR PHARM 375MG A076522 001 Jan 29, 2004
CREAM;TOPICAL
METROCREAM
AB + GALDERMA LABS LP 0.75% N020531 001 Sep 20, 1995
METRONIDAZOLE
AB FOUGERA PHARMS 0.75% A076408 001 May 28, 2004
AB G AND W LABS 0.75% A077549 001 Dec 19, 2007
NORITATE
+ VALEANT BERMUDA 1% N020743 001 Sep 26, 1997
GEL;TOPICAL
METROGEL
AB + GALDERMA LABS LP 0.75% N019737 001 Nov 22, 1988
AB + 1% N021789 001 Jun 30, 2005
METRONIDAZOLE
AB FOUGERA PHARMS 0.75% A077018 001 Jun 06, 2006
AB G AND W LABS INC 0.75% A078178 001 Jan 19, 2011
AB TARO 0.75% A077819 001 Jul 18, 2006
AB TOLMAR 0.75% A077547 001 Jul 13, 2006
AB 1% A090903 001 Jul 22, 2011
GEL;VAGINAL
METROGEL-VAGINAL
AB + MEDICIS 0.75% N020208 001 Aug 17, 1992
METRONIDAZOLE
AB TOLMAR 0.75% A077264 001 Oct 31, 2006
VANDAZOLE
BX TEVA PHARMS 0.75% N021806 001 May 20, 2005
METRONIDAZOLE
+ WATSON LABS INC 1.3% N205223 001 Mar 24, 2014
INJECTABLE;INJECTION
FLAGYL I.V. RTU IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 500MG/100ML N018657 001
AP + PFIZER 500MG/100ML N018353 002
METRO I.V. IN PLASTIC CONTAINER
AP + B BRAUN 500MG/100ML N018900 001 Sep 29, 1983
METRONIDAZOLE IN PLASTIC CONTAINER
AP CLARIS LIFESCIENCES 500MG/100ML A078084 001 Mar 31, 2008
AP + HOSPIRA 500MG/100ML N018890 002 Nov 18, 1983
LOTION;TOPICAL
METROLOTION
AB + GALDERMA LABS LP 0.75% N020901 001 Nov 24, 1998
METRONIDAZOLE
AB FOUGERA PHARMS 0.75% A077197 001 May 24, 2006
TABLET;ORAL
FLAGYL
AB GD SEARLE LLC 250MG N012623 001
AB + 500MG N012623 003
METRONIDAZOLE
AB ALEMBIC PHARMS LTD 250MG A079067 001 Mar 13, 2009
AB 500MG A079067 002 Mar 13, 2009
AB MUTUAL PHARM 250MG A070772 001 Jul 16, 1986
AB 500MG A070773 001 Jul 16, 1986
AB PLIVA 500MG A070033 001 Dec 06, 1984
AB TEVA PHARMS USA 250MG A070027 001 Nov 06, 1984
AB UNICHEM LABS LTD 250MG A203458 001 Jan 22, 2014
AB 500MG A203458 002 Jan 22, 2014
AB WATSON LABS 250MG A070035 001 Dec 20, 1984
AB WATSON LABS INC 500MG A070044 001 Feb 08, 1985
TABLET, EXTENDED RELEASE;ORAL
FLAGYL ER
AB + GD SEARLE LLC 750MG N020868 001 Nov 26, 1997
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-247(of 371)
METRONIDAZOLE
TABLET, EXTENDED RELEASE;ORAL
METRONIDAZOLE
AB ALEMBIC LTD
750MG
A090222 001 May 05, 2010
METYRAPONE
CAPSULE;ORAL
METOPIRONE
+ HRA PHARMA
250MG
N012911 002 Aug 09, 1996
METYROSINE
CAPSULE;ORAL
DEMSER
+ ATON PHARMA VPNA
250MG
N017871 001
MEXILETINE HYDROCHLORIDE
CAPSULE;ORAL
MEXILETINE HYDROCHLORIDE
TEVA
150MG
A074377 001 May 16, 1995
200MG
A074377 002 May 16, 1995
+
250MG
A074377 003 May 16, 1995
MICAFUNGIN SODIUM
INJECTABLE;IV (INFUSION)
MYCAMINE
+ ASTELLAS
50MG/VIAL
N021506 002 Mar 16, 2005
+
100MG/VIAL
N021506 003 Jun 27, 2006
MICONAZOLE
TABLET;BUCCAL
ORAVIG
+ BIOALLIANCE PHARMA
50MG
N022404 001 Apr 16, 2010
MICONAZOLE NITRATE
SUPPOSITORY;VAGINAL
MICONAZOLE NITRATE
AB ACTAVIS MID ATLANTIC 200MG
A073508 001 Nov 19, 1993
MONISTAT 3
AB + MEDTECH PRODUCTS 200MG
N018888 001 Aug 15, 1984
MICONAZOLE NITRATE; PETROLATUM, WHITE; ZINC OXIDE
OINTMENT;TOPICAL
VUSION
+ DELCOR ASSET
0.25%;81.35%;15%
N021026 001 Feb 16, 2006
MIDAZOLAM HYDROCHLORIDE
INJECTABLE;INJECTION
MIDAZOLAM HYDROCHLORIDE
AP AKORN INC EQ 1MG BASE/ML
A075494 001 Jun 30, 2000
AP EQ 5MG BASE/ML
A075481 001 Jun 30, 2000
AP EQ 5MG BASE/ML
A075494 002 Jun 30, 2000
AP BEDFORD EQ 1MG BASE/ML
A075247 002 Jun 23, 2000
AP EQ 5MG BASE/ML
A075247 001 Jun 23, 2000
AP BEDFORD LABS EQ 1MG BASE/ML
A075421 002 Jun 20, 2000
AP EQ 5MG BASE/ML
A075421 001 Jun 20, 2000
AP FRESENIUS KABI USA EQ 1MG BASE/ML
A075154 002 Jun 20, 2000
AP EQ 5MG BASE/ML
A075154 001 Jun 20, 2000
AP GLAND PHARMA LTD EQ 1MG BASE/ML
A090696 001 Feb 29, 2012
AP EQ 5MG BASE/ML
A090850 001 Jan 25, 2012
AP HIKMA MAPLE EQ 1MG BASE/ML
A075243 001 Jun 20, 2000
AP EQ 1MG BASE/ML
A075324 001 Jun 20, 2000
AP EQ 5MG BASE/ML
A075243 002 Jun 20, 2000
AP EQ 5MG BASE/ML
A075324 002 Jun 20, 2000
AP + HOSPIRA EQ 1MG BASE/ML
A075293 001 Jun 20, 2000
AP EQ 1MG BASE/ML
A075856 001 Jun 13, 2002
AP + EQ 5MG BASE/ML
A075293 002 Jun 20, 2000
AP EQ 5MG BASE/ML
A075856 002 Jun 13, 2002
AP WOCKHARDT EQ 1MG BASE/ML
A078141 001 May 30, 2008
AP EQ 1MG BASE/ML
A078511 001 Nov 10, 2008
AP EQ 5MG BASE/ML
A078141 002 May 30, 2008
AP EQ 5MG BASE/ML
A078511 002 Nov 10, 2008
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
AP BD RX EQ 1MG BASE/ML
A203460 001 Aug 22, 2014
AP EQ 5MG BASE/ML
A203460 002 Aug 22, 2014
AP + HOSPIRA EQ 1MG BASE/ML
A075857 001 Jul 22, 2002
AP + EQ 5MG BASE/ML
A075857 002 Jul 22, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-248(of 371)
MIDAZOLAM HYDROCHLORIDE
INJECTABLE;INJECTION
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE
AP SAGENT STRIDES
EQ 1MG BASE/ML
A090315 001 Nov 29, 2010
AP
EQ 5MG BASE/ML
A090315 002 Nov 29, 2010
MIDOZALAM HYDROCHLORIDE
AP SAGENT STRIDES
EQ 1MG BASE/ML
A090316 001 May 04, 2011
AP
EQ 5MG BASE/ML
A090316 002 May 04, 2011
SYRUP;ORAL
MIDAZOLAM HYDROCHLORIDE
AA HI TECH PHARMA EQ 2MG BASE/ML
A075958 001 Sep 04, 2003
AA PADDOCK LLC EQ 2MG BASE/ML
A076379 001 May 02, 2005
AA RANBAXY EQ 2MG BASE/ML
A076058 001 Mar 15, 2002
AA + ROXANE EQ 2MG BASE/ML
A075873 001 Apr 30, 2002
MIDODRINE HYDROCHLORIDE
TABLET;ORAL
MIDODRINE HYDROCHLORIDE
AB APOTEX INC
2.5MG
A077746 001 Sep 12, 2006
AB
5MG
A077746 002 Sep 12, 2006
AB
10MG
A077746 003 Sep 12, 2006
AB IMPAX PHARMS
2.5MG
A076449 001 May 27, 2004
AB
5MG
A076449 002 May 27, 2004
AB
10MG
A076449 003 Dec 16, 2005
AB MYLAN PHARMS INC
2.5MG
A076577 001 Sep 10, 2003
AB +
5MG
A076577 002 Sep 10, 2003
AB
10MG
A076577 003 Sep 10, 2003
AB SANDOZ
2.5MG
A076514 001 Sep 11, 2003
AB
5MG
A076514 002 Sep 11, 2003
AB
10MG
A076514 003 Jul 02, 2004
ORVATEN
AB UPSHER SMITH
2.5MG
A076725 001 Nov 03, 2004
AB
5MG
A076725 002 Nov 03, 2004
AB
10MG
A076725 003 Nov 03, 2004
MIFEPRISTONE
TABLET;ORAL
KORLYM
+ CORCEPT THERAP
300MG
N202107 001 Feb 17, 2012
MIFEPREX
+ DANCO LABS LLC
200MG
N020687 001 Sep 28, 2000
MIGLITOL
TABLET;ORAL
GLYSET
PHARMACIA AND UPJOHN
25MG
N020682 001 Dec 18, 1996
50MG
N020682 002 Dec 18, 1996
+
100MG
N020682 003 Dec 18, 1996
MIGLUSTAT
CAPSULE;ORAL
ZAVESCA
+ ACTELION PHARMS LTD
100MG
N021348 001 Jul 31, 2003
MILNACIPRAN HYDROCHLORIDE
TABLET;ORAL
SAVELLA
CYPRESS BIOSCIENCE
12.5MG
N022256 001 Jan 14, 2009
25MG
N022256 002 Jan 14, 2009
+
50MG
N022256 003 Jan 14, 2009
100MG
N022256 004 Jan 14, 2009
MILRINONE LACTATE
INJECTABLE;INJECTION
MILRINONE LACTATE
AP + BEDFORD
EQ 1MG BASE/ML
A075660 001 May 28, 2002
AP FRESENIUS KABI USA
EQ 1MG BASE/ML
A075936 001 May 28, 2002
AP GLAND PHARMA LTD
EQ 1MG BASE/ML
A077190 001 Oct 31, 2006
AP HIKMA FARMACEUTICA
EQ 1MG BASE/ML
A077966 001 Dec 03, 2010
AP HIKMA MAPLE
EQ 1MG BASE/ML
A075530 001 May 28, 2002
AP HOSPIRA INC
EQ 1MG BASE/ML
A203280 001 Sep 03, 2014
AP INTL MEDICATED
EQ 1MG BASE/ML
A076013 001 Aug 02, 2002
MILRINONE LACTATE IN DEXTROSE 5%
AP APOTEX INC EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) A077151 002 Jul 20, 2005
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-249(of 371)
MILRINONE LACTATE
INJECTABLE;INJECTION
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
AP B BRAUN EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A076414 001 Aug 18, 2004
AP + BAXTER HLTHCARE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A075834 001 May 28, 2002
AP + EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) A075834 002 May 28, 2002
AP BEDFORD LABS EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A078113 001 May 21, 2008
AP EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) A078113 002 May 21, 2008
AP HOSPIRA EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A075885 001 May 28, 2002
AP EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) A075885 002 May 28, 2002
MILRINONE LACTATE IN PLASTIC CONTAINER
AP HIKMA FARMACEUTICA EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A090038 001 Jan 21, 2010
AP EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) A090038 002 Jan 21, 2010
MILTEFOSINE
CAPSULE;ORAL
IMPAVIDO
+ KNIGHT THERAPS 50MG N204684 001 Mar 19, 2014
MINOCYCLINE HYDROCHLORIDE
CAPSULE;ORAL
DYNACIN
AB CNTY LINE PHARMS EQ 75MG BASE A063067 002 Sep 15, 1999
AB EQ 100MG BASE A063067 001 Jul 31, 1990
MINOCIN
AB PRECISION DERMAT EQ 50MG BASE N050649 001 May 31, 1990
AB EQ 100MG BASE N050649 002 May 31, 1990
MINOCYCLINE HYDROCHLORIDE
AB AUROBINDO PHARMA EQ 50MG BASE A065470 001 Mar 11, 2008
AB EQ 75MG BASE A065470 002 Mar 11, 2008
AB EQ 100MG BASE A065470 003 Mar 11, 2008
AB IMPAX LABS EQ 50MG BASE A065005 001 Mar 23, 1999
AB EQ 75MG BASE A065005 003 Apr 18, 2001
AB EQ 100MG BASE A065005 002 Mar 23, 1999
AB RANBAXY EQ 50MG BASE A065062 001 Nov 30, 2000
AB EQ 75MG BASE A065062 002 Nov 30, 2000
AB EQ 100MG BASE A065062 003 Nov 30, 2000
AB SUN PHARM INDS INC EQ 50MG BASE A090867 001 May 13, 2013
AB EQ 75MG BASE A090867 002 May 13, 2013
AB EQ 100MG BASE A090867 003 May 13, 2013
AB TEVA EQ 50MG BASE A063011 001 Mar 02, 1992
AB EQ 75MG BASE A063009 002 Aug 12, 2003
AB + EQ 100MG BASE A063009 001 Mar 02, 1992
AB WATSON LABS EQ 50MG BASE A063181 001 Dec 30, 1991
AB EQ 75MG BASE A063065 002 Jun 10, 1999
AB EQ 100MG BASE A063065 001 Dec 30, 1991
INJECTABLE;INJECTION
MINOCIN
+ REMPEX PHARMS INC EQ 100MG BASE/VIAL N050444 001
POWDER, EXTENDED RELEASE;DENTAL
ARESTIN
+ ORAPHARMA EQ 1MG BASE N050781 001 Feb 16, 2001
TABLET;ORAL
MINOCYCLINE HYDROCHLORIDE
AB DR REDDYS LABS LTD EQ 50MG BASE A065436 001 Dec 26, 2007
AB EQ 75MG BASE A065436 002 Dec 26, 2007
AB EQ 100MG BASE A065436 003 Dec 26, 2007
AB PAR PHARM EQ 50MG BASE A065131 001 Apr 16, 2003
AB EQ 75MG BASE A065131 002 Apr 16, 2003
AB + EQ 100MG BASE A065131 003 Apr 16, 2003
AB RANBAXY EQ 50MG BASE A065156 001 Jan 06, 2004
AB EQ 75MG BASE A065156 002 Jan 06, 2004
AB EQ 100MG BASE A065156 003 Jan 06, 2004
TABLET, EXTENDED RELEASE;ORAL
MINOCYCLINE HYDROCHLORIDE
AB AUROBINDO PHARMA LTD EQ 45MG BASE A202261 001 Nov 19, 2012
AB EQ 90MG BASE A202261 003 Nov 19, 2012
AB EQ 135MG BASE A202261 005 Nov 19, 2012
AB BARR LABS INC EQ 45MG BASE A065485 001 Mar 17, 2009
AB EQ 65MG BASE A065485 004 May 18, 2012
AB EQ 90MG BASE A065485 002 Mar 17, 2009
AB EQ 115MG BASE A065485 005 May 18, 2012
AB EQ 135MG BASE A065485 003 Mar 17, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-250(of 371)
MINOCYCLINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
MINOCYCLINE HYDROCHLORIDE
AB IMPAX LABS INC EQ 45MG BASE A090024 001 Feb 03, 2009
AB EQ 90MG BASE A090024 002 Feb 03, 2009
AB EQ 135MG BASE A090024 003 Feb 03, 2009
AB LUPIN LTD EQ 45MG BASE A091424 001 Nov 30, 2011
AB EQ 90MG BASE A091424 003 Nov 30, 2011
AB EQ 135MG BASE A091424 004 Nov 30, 2011
AB MYLAN PHARMS INC EQ 45MG BASE A090911 001 Jul 20, 2010
AB EQ 80MG BASE A203443 002 Aug 22, 2014
AB EQ 90MG BASE A090911 002 Jul 20, 2010
AB EQ 105MG BASE A203443 003 Aug 22, 2014
AB EQ 135MG BASE A090911 003 Jul 20, 2010
AB RANBAXY LABS LTD EQ 45MG BASE A091118 001 Sep 25, 2014
AB EQ 80MG BASE A091118 004 Sep 25, 2014
AB EQ 90MG BASE A091118 005 Sep 25, 2014
AB EQ 105MG BASE A091118 006 Sep 25, 2014
AB EQ 135MG BASE A091118 008 Sep 25, 2014
AB SANDOZ EQ 45MG BASE A090422 001 Aug 13, 2009
AB EQ 90MG BASE A090422 002 Aug 13, 2009
AB EQ 135MG BASE A090422 003 Aug 13, 2009
SOLODYN
AB MEDICIS EQ 65MG BASE N050808 004 Jul 23, 2009
AB + EQ 80MG BASE N050808 007 Aug 27, 2010
AB EQ 105MG BASE N050808 006 Aug 27, 2010
AB EQ 115MG BASE N050808 005 Jul 23, 2009
+ EQ 55MG BASE N050808 008 Aug 27, 2010
MINOXIDIL
TABLET;ORAL
MINOXIDIL
AB MUTUAL PHARM 2.5MG A072708 001 Dec 14, 1995
AB 10MG A072709 001 Dec 14, 1995
AB PAR PHARM 2.5MG A071826 001 Nov 14, 1988
AB 10MG A071839 001 Nov 14, 1988
AB WATSON LABS 2.5MG A071344 001 Mar 03, 1987
AB + 10MG A071345 001 Mar 03, 1987
MIPOMERSEN SODIUM
SOLUTION;SUBCUTANEOUS
KYNAMRO
+ GENZYME CORP 200MG/ML (200MG/ML) N203568 001 Jan 29, 2013
MIRABEGRON
TABLET, EXTENDED RELEASE;ORAL
MYRBETRIQ
APGDI 25MG N202611 001 Jun 28, 2012
+ 50MG N202611 002 Jun 28, 2012
MIRTAZAPINE
TABLET;ORAL
MIRTAZAPINE
AB ACTAVIS LABS FL INC 15MG A076336 001 Jun 20, 2003
AB 30MG A076336 002 Jun 20, 2003
AB 45MG A076336 003 Jun 20, 2003
AB APOTEX INC 15MG A077666 001 Aug 22, 2007
AB 30MG A077666 002 Aug 22, 2007
AB 45MG A077666 003 Aug 22, 2007
AB AUROBINDO 7.5MG A076921 001 Oct 22, 2004
AB 15MG A076921 002 Oct 22, 2004
AB 30MG A076921 003 Oct 22, 2004
AB 45MG A076921 004 Oct 22, 2004
AB MYLAN 15MG A076122 001 Jun 19, 2003
AB 30MG A076122 002 Jun 19, 2003
AB 45MG A076122 003 Jun 19, 2003
AB MYLAN PHARMS INC 15MG A076176 001 Jun 19, 2003
AB 30MG A076176 002 Jun 19, 2003
AB 45MG A076176 003 Jun 19, 2003
AB SANDOZ 15MG A076219 001 Jun 19, 2003
AB 30MG A076219 002 Jun 19, 2003
AB 45MG A076219 003 Jun 19, 2003
AB SUN PHARM INDS INC 7.5MG A076541 004 Apr 22, 2004
AB 15MG A076541 001 Apr 22, 2004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-251(of 371)
MIRTAZAPINE
TABLET;ORAL
MIRTAZAPINE
AB 30MG A076541 002 Apr 22, 2004
AB 45MG A076541 003 Apr 22, 2004
AB TEVA 15MG A076119 001 Jan 24, 2003
AB 30MG A076119 002 Jan 24, 2003
AB 45MG A076119 003 Jun 19, 2003
AB WATSON LABS 15MG A076312 001 Jun 19, 2003
AB 30MG A076312 002 Jun 19, 2003
AB 45MG A076312 003 Jun 19, 2003
REMERON
AB + ORGANON USA INC 15MG N020415 001 Jun 14, 1996
AB 30MG N020415 002 Jun 14, 1996
AB 45MG N020415 003 Mar 17, 1997
TABLET, ORALLY DISINTEGRATING;ORAL
MIRTAZAPINE
AB ACTAVIS LABS FL INC 15MG A076307 001 Dec 17, 2003
AB 30MG A076307 002 Dec 17, 2003
AB 45MG A076307 003 Feb 28, 2006
AB AUROBINDO PHARMA LTD 15MG A077376 002 Dec 08, 2005
AB 30MG A077376 003 Dec 08, 2005
AB 45MG A077376 004 Feb 28, 2006
AB TEVA 15MG A076901 001 Jun 28, 2005
AB 30MG A076901 002 Jun 28, 2005
AB 45MG A076901 003 Jun 28, 2005
REMERON SOLTAB
AB + ORGANON USA INC 15MG N021208 001 Jan 12, 2001
AB 30MG N021208 002 Jan 12, 2001
AB 45MG N021208 003 Jan 12, 2001
MISOPROSTOL
TABLET;ORAL
CYTOTEC
AB GD SEARLE LLC 0.1MG N019268 003 Sep 21, 1990
AB + 0.2MG N019268 001 Dec 27, 1988
MISOPROSTOL
AB IVAX SUB TEVA PHARMS 0.1MG A076095 001 Jul 10, 2002
AB 0.2MG A076095 002 Jul 10, 2002
AB NOVEL LABS INC 0.1MG A091667 001 Jul 25, 2012
AB 0.2MG A091667 002 Jul 25, 2012
MITOMYCIN
FOR SOLUTION;TOPICAL
MITOSOL
+ MOBIUS THERAP 0.2MG/VIAL N022572 001 Feb 07, 2012
INJECTABLE;INJECTION
MITOMYCIN
AP + ACCORD HLTHCARE 5MG/VIAL A064144 001 Apr 30, 1998
AP + 20MG/VIAL A064144 002 Apr 30, 1998
AP + 40MG/VIAL A064144 003 Aug 11, 2009
AP BEDFORD 5MG/VIAL A064117 001 Apr 19, 1995
AP 20MG/VIAL A064117 002 Apr 19, 1995
AP HIKMA MAPLE 5MG/VIAL A064180 001 Dec 23, 1999
AP 20MG/VIAL A064180 002 Dec 23, 1999
MITOTANE
TABLET;ORAL
LYSODREN
+ BRISTOL MYERS SQUIBB 500MG N016885 001
MITOXANTRONE HYDROCHLORIDE
INJECTABLE;INJECTION
MITOXANTRONE HYDROCHLORIDE
AP EUROHLTH INTL EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A076611 001 Apr 11, 2006
AP EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) A076611 002 Apr 11, 2006
AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A076611 003 Apr 11, 2006
AP FRESENIUS KABI USA EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A077496 001 Apr 11, 2006
AP EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) A077496 002 Apr 11, 2006
AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A077496 003 Apr 11, 2006
AP + HOSPIRA EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A076871 001 Apr 11, 2006
AP + EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) A076871 002 Apr 11, 2006
AP + EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A076871 003 Apr 11, 2006
AP MYLAN INSTITUTIONAL EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A078980 001 Apr 13, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-252(of 371)
MITOXANTRONE HYDROCHLORIDE
INJECTABLE;INJECTION
MITOXANTRONE HYDROCHLORIDE
AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A078980 002 Apr 13, 2009
AP ONCO THERAPIES LTD EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A201014 001 Dec 11, 2012
AP TEVA PHARMS USA EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A077356 001 Apr 11, 2006
AP EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) A077356 002 Apr 11, 2006
AP EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A077356 003 Apr 11, 2006
MODAFINIL
TABLET;ORAL
MODAFINIL
AB ALEMBIC LTD 100MG A202700 001 Oct 18, 2012
AB 200MG A202700 002 Oct 18, 2012
AB APOTEX INC 100MG A077667 001 Feb 03, 2014
AB 200MG A077667 002 Feb 03, 2014
AB AUROBINDO PHARMA LTD 100MG A202566 001 Sep 27, 2012
AB 200MG A202566 002 Sep 27, 2012
AB CARLSBAD 100MG A076715 001 Nov 01, 2012
AB 200MG A076715 002 Nov 01, 2012
AB HIKMA PHARMS 100MG A090543 001 Sep 26, 2012
AB 200MG A090543 002 Sep 26, 2012
AB MYLAN PHARMS INC 100MG A076594 001 Jul 16, 2012
AB 200MG A076594 002 Jul 16, 2012
AB ORCHID HLTHCARE 100MG A078963 001 Sep 26, 2012
AB 200MG A078963 002 Sep 26, 2012
PROVIGIL
AB CEPHALON 100MG N020717 001 Dec 24, 1998
AB + 200MG N020717 002 Dec 24, 1998
MOEXIPRIL HYDROCHLORIDE
TABLET;ORAL
MOEXIPRIL HYDROCHLORIDE
AB APOTEX INC 7.5MG A078454 001 Jun 02, 2008
AB 15MG A078454 002 Jun 02, 2008
AB GLENMARK GENERICS 7.5MG A090416 001 Mar 30, 2010
AB 15MG A090416 002 Mar 30, 2010
AB PADDOCK LLC 7.5MG A077536 001 Nov 30, 2006
AB 15MG A077536 002 Nov 30, 2006
AB TEVA 7.5MG A076204 001 May 08, 2003
AB 15MG A076204 002 May 08, 2003
UNIVASC
AB UCB INC 7.5MG N020312 001 Apr 19, 1995
AB + 15MG N020312 002 Apr 19, 1995
MOMETASONE FUROATE
AEROSOL, METERED;INHALATION
ASMANEX HFA
MERCK SHARP DOHME 0.10MG/INH N205641 001 Apr 25, 2014
+ 0.20MG/INH N205641 002 Apr 25, 2014
CREAM;TOPICAL
ELOCON
AB + MERCK SHARP DOHME 0.1% N019625 001 May 06, 1987
AB 0.1% N019625 002 Apr 19, 2013
MOMETASONE FUROATE
AB FOUGERA PHARMS 0.1% A076171 001 Apr 08, 2005
AB G AND W LABS 0.1% A077447 001 May 22, 2006
AB GLENMARK GENERICS 0.1% A078541 001 May 28, 2008
AB TARO 0.1% A076679 001 Dec 21, 2004
AB TOLMAR 0.1% A076591 001 Apr 18, 2007
LOTION;TOPICAL
ELOCON
AB + MERCK SHARP DOHME 0.1% N019796 001 Mar 30, 1989
MOMETASONE FUROATE
AB FOUGERA PHARMS 0.1% A075919 001 Nov 29, 2007
AB G AND W LABS 0.1% A077678 001 Nov 21, 2007
AB GLENMARK GENERICS 0.1% A090506 001 Aug 09, 2010
AB PERRIGO 0.1% A077180 001 Apr 06, 2005
AB TARO 0.1% A076788 001 Mar 15, 2006
AB TOLMAR 0.1% A076499 001 Nov 21, 2007
OINTMENT;TOPICAL
ELOCON
AB + MERCK SHARP DOHME 0.1% N019543 001 Apr 30, 1987
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-253(of 371)
MOMETASONE FUROATE
OINTMENT;TOPICAL
MOMETASONE FUROATE
AB FOUGERA PHARMS 0.1%
A077061 001 Mar 28, 2005
AB G AND W LABS 0.1%
A077401 001 Jun 20, 2006
AB GLENMARK GENERICS 0.1%
A078571 001 May 28, 2008
AB PERRIGO NEW YORK 0.1%
A076067 001 Mar 18, 2002
AB TOLMAR 0.1%
A076481 001 Nov 14, 2003
POWDER;INHALATION
ASMANEX TWISTHALER
MERCK SHARP DOHME
0.11MG/INH
N021067 002 Feb 01, 2008
+
0.22MG/INH
N021067 001 Mar 30, 2005
MOMETASONE FUROATE MONOHYDRATE
SPRAY, METERED;NASAL
NASONEX
+ MERCK SHARP DOHME
EQ 0.05MG BASE/SPRAY
N020762 001 Oct 01, 1997
MONTELUKAST SODIUM
GRANULE;ORAL
MONTELUKAST SODIUM
AB DR REDDYS LABS LTD
EQ 4MG BASE/PACKET
A202906 001 Sep 17, 2012
AB MYLAN PHARMS INC
EQ 4MG BASE/PACKET
A202776 001 Dec 18, 2012
AB TEVA PHARMS
EQ 4MG BASE/PACKET
A090955 001 Aug 03, 2012
SINGULAIR
AB + MERCK
EQ 4MG BASE/PACKET
N021409 001 Jul 26, 2002
TABLET;ORAL
MONTELUKAST SODIUM
AB ACCORD HLTHCARE
EQ 10MG BASE
A202717 001 Sep 21, 2012
AB APOTEX CORP
EQ 10MG BASE
A201294 001 Aug 03, 2012
AB AUROBINDO PHARMA LTD
EQ 10MG BASE
A202468 001 Aug 03, 2012
AB DR REDDYS LABS LTD
EQ 10MG BASE
A201582 001 Aug 06, 2012
AB GLENMARK GENERICS
EQ 10MG BASE
A090926 001 Aug 03, 2012
AB HETERO LABS LTD V
EQ 10MG BASE
A202843 001 Sep 10, 2014
AB KUDCO IRELAND
EQ 10MG BASE
A201522 001 Aug 03, 2012
AB MACLEODS PHARMS LTD
EQ 10MG BASE
A203366 001 Sep 11, 2014
AB MYLAN PHARMS INC
EQ 10MG BASE
A079103 001 Aug 03, 2012
AB ROXANE
EQ 10MG BASE
A090655 001 Aug 03, 2012
AB SANDOZ INC
EQ 10MG BASE
A200889 001 Aug 03, 2012
AB TEVA PHARMS
EQ 10MG BASE
A078605 001 Aug 03, 2012
AB TORRENT PHARMS LTD
EQ 10MG BASE
A201515 001 Aug 03, 2012
AB UNIMARK REMEDIES LTD
EQ 10MG BASE
A202859 001 Oct 30, 2014
AB VINTAGE PHARMS LLC
EQ 10MG BASE
A091576 001 Aug 03, 2012
SINGULAIR
AB + MERCK
EQ 10MG BASE
N020829 002 Feb 20, 1998
TABLET, CHEWABLE;ORAL
MONTELUKAST SODIUM
AB APOTEX INC
EQ 4MG BASE
A201508 001 Aug 03, 2012
AB
EQ 5MG BASE
A201508 002 Aug 03, 2012
AB AUROBINDO PHARMA LTD
EQ 4MG BASE
A202096 001 Aug 03, 2012
AB
EQ 5MG BASE
A202096 002 Aug 03, 2012
AB DR REDDYS LABS LTD
EQ 4MG BASE
A201581 001 Aug 06, 2012
AB
EQ 5MG BASE
A201581 002 Aug 06, 2012
AB KUDCO IRELAND
EQ 4MG BASE
A200405 001 Aug 03, 2012
AB
EQ 5MG BASE
A200405 002 Aug 03, 2012
AB MYLAN PHARMS INC
EQ 4MG BASE
A079142 001 Aug 03, 2012
AB
EQ 5MG BASE
A079142 002 Aug 03, 2012
AB ROXANE
EQ 4MG BASE
A091128 001 Aug 03, 2012
AB
EQ 5MG BASE
A091128 002 Aug 03, 2012
AB SANDOZ INC
EQ 4MG BASE
A091414 001 Aug 03, 2012
AB
EQ 5MG BASE
A091414 002 Aug 03, 2012
AB TEVA PHARMS
EQ 4MG BASE
A078723 001 Aug 03, 2012
AB
EQ 5MG BASE
A078723 002 Aug 03, 2012
AB TORRENT PHARMS LTD
EQ 4MG BASE
A090984 001 Aug 03, 2012
AB
EQ 5MG BASE
A090984 002 Aug 03, 2012
AB UNIMARK REMEDIES LTD
EQ 4MG BASE
A203037 001 Oct 30, 2014
AB
EQ 5MG BASE
A203037 002 Oct 30, 2014
AB VINTAGE PHARMS LLC
EQ 4MG BASE
A091588 001 Aug 03, 2012
AB
EQ 5MG BASE
A091588 002 Aug 03, 2012
SINGULAIR
AB MERCK
EQ 4MG BASE
N020830 002 Mar 03, 2000
AB +
EQ 5MG BASE
N020830 001 Feb 20, 1998
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-254(of 371)
MORPHINE SULFATE
CAPSULE, EXTENDED RELEASE;ORAL
KADIAN
AB1 + WATSON LABS INC 10MG N020616 008 Apr 20, 2007
AB1 20MG N020616 001 Jul 03, 1996
AB1 30MG N020616 004 Mar 09, 2001
AB1 50MG N020616 002 Jul 03, 1996
AB1 60MG N020616 005 Mar 09, 2001
AB1 80MG N020616 006 Oct 27, 2006
AB1 + 100MG N020616 003 Jul 03, 1996
AB1 + 200MG N020616 007 Feb 27, 2007
MORPHINE SULFATE
AB1 PAR PHARM INC 20MG A200812 001 Nov 10, 2011
AB1 30MG A200812 002 Nov 10, 2011
AB1 50MG A200812 003 Nov 10, 2011
AB1 60MG A200812 004 Nov 10, 2011
AB1 80MG A200812 005 Nov 10, 2011
AB1 100MG A200812 006 Nov 10, 2011
AB1 TEVA PHARMS USA 20MG A202718 001 Dec 29, 2014
AB1 30MG A202718 002 Dec 29, 2014
AB1 50MG A202718 003 Dec 29, 2014
AB1 60MG A202718 004 Dec 29, 2014
AB1 80MG A202718 005 Dec 29, 2014
AB1 100MG A202718 006 Dec 29, 2014
AB1 UPSHER SMITH 10MG A202104 001 Jun 03, 2013
AB1 20MG A202104 002 Jun 03, 2013
AB1 30MG A202104 003 Jun 03, 2013
AB1 50MG A202104 004 Jun 03, 2013
AB1 60MG A202104 005 Jun 03, 2013
AB1 80MG A202104 006 Jun 03, 2013
AB1 100MG A202104 007 Jun 03, 2013
AVINZA
AB2 KING PHARMS LLC 30MG N021260 001 Mar 20, 2002
AB2 45MG N021260 005 Dec 18, 2008
AB2 60MG N021260 002 Mar 20, 2002
AB2 75MG N021260 006 Dec 18, 2008
AB2 90MG N021260 003 Mar 20, 2002
AB2 + 120MG N021260 004 Mar 20, 2002
MORPHINE SULFATE
AB2 ACTAVIS ELIZABETH 30MG A079040 001 Jan 16, 2013
AB2 45MG A079040 002 Jan 16, 2013
AB2 60MG A079040 003 Jan 16, 2013
AB2 75MG A079040 004 Jan 16, 2013
AB2 90MG A079040 005 Jan 16, 2013
AB2 120MG A079040 006 Jan 16, 2013
KADIAN
WATSON LABS INC 40MG N020616 009 Jul 09, 2012
70MG N020616 010 Jul 09, 2012
130MG N020616 011 Jul 09, 2012
150MG N020616 012 Jul 09, 2012
INJECTABLE;INJECTION
ASTRAMORPH PF
AP FRESENIUS KABI USA 0.5MG/ML A071050 001 Oct 07, 1986
AP 0.5MG/ML A071051 001 Oct 07, 1986
AP 1MG/ML A071052 001 Oct 07, 1986
AP 1MG/ML A071053 001 Oct 07, 1986
DURAMORPH PF
AP + HIKMA MAPLE 0.5MG/ML N018565 001 Sep 18, 1984
AP + 1MG/ML N018565 002 Sep 18, 1984
MORPHINE SULFATE
AP HOSPIRA 0.5MG/ML A071849 001 May 11, 1988
AP 0.5MG/ML A073509 001 Sep 30, 1992
AP 1MG/ML A071850 001 May 11, 1988
AP 1MG/ML A073510 001 Sep 30, 1992
AP + 1MG/ML N019916 001 Oct 30, 1992
INFUMORPH
+ HIKMA MAPLE 10MG/ML N018565 003 Jul 19, 1991
+ 25MG/ML N018565 004 Jul 19, 1991
MORPHINE SULFATE
+ HOSPIRA 5MG/ML N019916 002 Oct 27, 2006
+ HOSPIRA INC 2MG/ML N202515 001 Nov 14, 2011
+ 4MG/ML N202515 002 Nov 14, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-255(of 371)
MORPHINE SULFATE
INJECTABLE;INJECTION
MORPHINE SULFATE
+ 8MG/ML N202515 003 Nov 14, 2011
+ 10MG/ML N202515 004 Nov 14, 2011
+ 15MG/ML N202515 005 Nov 14, 2011
+ MERIDIAN MEDCL TECHN 15MG/ML N019999 001 Jul 12, 1990
SOLUTION;INTRAMUSCULAR, INTRAVENOUS
MORPHINE SULFATE
+ BD RX 2MG/ML (2MG/ML) N204223 001 Oct 30, 2013
+ 4MG/ML (4MG/ML) N204223 002 Oct 30, 2013
+ 5MG/ML (5MG/ML) N204223 003 Oct 30, 2013
+ 8MG/ML (8MG/ML) N204223 004 Oct 30, 2013
+ 10MG/ML (10MG/ML) N204223 005 Oct 30, 2013
SOLUTION;ORAL
MORPHINE SULFATE
AA MALLINCKRODT INC 100MG/5ML A202348 001 Jul 15, 2011
AA PADDOCK LLC 100MG/5ML A201574 001 Aug 06, 2012
AA ROXANE 10MG/5ML N022195 001 Mar 17, 2008
AA 20MG/5ML N022195 002 Mar 17, 2008
AA + 100MG/5ML N022195 003 Jan 25, 2010
AA SUN PHARM INDS INC 10MG/5ML A201011 001 Feb 05, 2014
AA 20MG/5ML A201011 002 Feb 05, 2014
AA VISTAPHARM 10MG/5ML A201947 001 Jan 05, 2012
AA 20MG/5ML A201947 002 Jan 05, 2012
LANNETT HOLDINGS INC 100MG/5ML N201517 001 Jun 23, 2011
TABLET;ORAL
MORPHINE SULFATE
ROXANE 15MG N022207 001 Mar 17, 2008
+ 30MG N022207 002 Mar 17, 2008
TABLET, EXTENDED RELEASE;ORAL
MORPHINE SULFATE
AB DAVA PHARMS INC 15MG A075407 001 Jan 28, 2000
AB MALLINCKRODT 15MG A076412 001 Jul 31, 2003
AB 30MG A076412 002 Jul 31, 2003
AB 60MG A076412 003 Jul 31, 2003
AB 100MG A076438 001 Jul 03, 2003
AB 200MG A076438 002 Jul 03, 2003
AB MYLAN PHARMS INC 15MG A200824 001 Oct 18, 2011
AB 30MG A200824 002 Oct 18, 2011
AB 60MG A200824 003 Oct 18, 2011
AB 100MG A200824 004 Oct 18, 2011
AB 200MG A200824 005 Oct 18, 2011
AB NESHER PHARMS 15MG A076733 001 May 19, 2004
AB 30MG A076720 002 Dec 23, 2005
AB 60MG A076720 001 May 19, 2004
AB 100MG A077855 001 Sep 27, 2007
AB 200MG A077855 002 Sep 27, 2007
AB RANBAXY LABS LTD 15MG A078761 001 May 11, 2012
AB 30MG A078761 002 May 11, 2012
AB 60MG A078761 003 May 11, 2012
AB 100MG A078761 004 May 11, 2012
AB 200MG A078761 005 May 11, 2012
AB RHODES PHARMS 15MG A074862 001 Jul 07, 1998
AB 30MG A074862 002 Jul 07, 1998
AB 60MG A074862 003 Jul 07, 1998
AB 100MG A074769 001 Jul 02, 1998
AB 200MG A074769 002 Jul 02, 1998
AB VINTAGE PHARMS LLC 15MG A075295 001 Oct 28, 1998
AB 30MG A075295 002 Oct 28, 1998
AB 60MG A075295 003 Oct 28, 1998
AB 100MG A075295 004 Sep 15, 2000
AB 200MG A075295 005 Sep 15, 2000
MS CONTIN
AB PURDUE PHARMA LP 15MG N019516 003 Sep 12, 1989
AB 30MG N019516 001 May 29, 1987
AB 60MG N019516 002 Apr 08, 1988
AB + 100MG N019516 004 Jan 16, 1990
AB 200MG N019516 005 Nov 08, 1993
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-256(of 371)
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
EMBEDA
ALPHARMA PHARMS 20MG;0.8MG N022321 001 Aug 13, 2009
30MG;1.2MG N022321 002 Aug 13, 2009
50MG;2MG N022321 003 Aug 13, 2009
+ 60MG;2.4MG N022321 004 Aug 13, 2009
80MG;3.2MG N022321 005 Aug 13, 2009
100MG;4MG N022321 006 Aug 13, 2009
MOXIFLOXACIN HYDROCHLORIDE
INJECTABLE;IV (INFUSION)
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
+ BAYER HLTHCARE 160MG/100ML N021277 001 Nov 30, 2001
SOLUTION/DROPS;OPHTHALMIC
MOXIFLOXACIN HYDROCHLORIDE
AT LUPIN LTD EQ 0.5% BASE A202867 001 Sep 04, 2014
VIGAMOX
AT + ALCON PHARMS LTD EQ 0.5% BASE N021598 001 Apr 15, 2003
MOXEZA
+ ALCON PHARMS LTD EQ 0.5% BASE N022428 001 Nov 19, 2010
TABLET;ORAL
AVELOX
AB + BAYER HLTHCARE EQ 400MG BASE N021085 001 Dec 10, 1999
MOXIFLOXACIN HYDROCHLORIDE
AB AUROBINDO PHARMA LTD EQ 400MG BASE A202632 001 Mar 04, 2014
AB DR REDDYS LABS LTD EQ 400MG BASE A076938 001 Mar 04, 2014
AB TEVA PHARMS USA EQ 400MG BASE A077437 001 Feb 18, 2014
AB TORRENT PHARMS LTD EQ 400MG BASE A200160 001 Apr 03, 2014
MUPIROCIN
OINTMENT;TOPICAL
BACTROBAN
AB + GLAXOSMITHKLINE 2% N050591 001 Dec 31, 1987
MUPIROCIN
AB FOUGERA PHARMS 2% A065192 001 Nov 30, 2005
AB GLENMARK PHARMS 2% A090480 001 Jun 08, 2011
AB PERRIGO NEW YORK 2% A065123 001 Nov 07, 2003
AB TARO 2% A065170 001 Sep 23, 2005
AB TEVA 2% A065085 001 Nov 07, 2003
CENTANY
BX PERRIGO NEW YORK 2% N050788 001 Dec 04, 2002
MUPIROCIN CALCIUM
CREAM;TOPICAL
BACTROBAN
AB + GLAXOSMITHKLINE EQ 2% BASE N050746 001 Dec 11, 1997
MUPIROCIN
AB GLENMARK GENERICS EQ 2% BASE A201587 001 Jan 24, 2013
OINTMENT;NASAL
BACTROBAN
+ GLAXOSMITHKLINE EQ 2% BASE N050703 001 Sep 18, 1995
MYCOPHENOLATE MOFETIL
CAPSULE;ORAL
CELLCEPT
AB + ROCHE PALO 250MG N050722 001 May 03, 1995
MYCOPHENOLATE MOFETIL
AB ACCORD HLTHCARE 250MG A090253 001 May 04, 2009
AB ALKEM LABS LTD 250MG A200197 001 Jun 13, 2013
AB APOTEX CORP 250MG A090419 001 Apr 22, 2009
AB CADISTA PHARMS 250MG A090762 001 Dec 15, 2014
AB DR REDDYS LABS LTD 250MG A091315 001 Oct 27, 2011
AB MYLAN 250MG A065520 001 May 04, 2009
AB ROXANE 250MG A065410 001 Jul 29, 2008
AB SANDOZ 250MG A065379 001 Oct 15, 2008
AB STRIDES PHARMA 250MG A090055 001 Jun 10, 2010
AB TEVA PHARMS 250MG A065491 001 May 06, 2009
AB VINTAGE PHARMS LLC 250MG A090111 001 Dec 22, 2009
SUSPENSION;ORAL
CELLCEPT
AB + ROCHE PALO 200MG/ML N050759 001 Oct 01, 1998
MYCOPHENOLATE MOFETIL
AB ALKEM LABS LTD 200MG/ML A203005 001 Nov 14, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-257(of 371)
MYCOPHENOLATE MOFETIL
TABLET;ORAL
CELLCEPT
AB + ROCHE PALO 500MG N050723 001 Jun 19, 1997
MYCOPHENOLATE MOFETIL
AB ACCORD HLTHCARE 500MG A065416 001 May 04, 2009
AB ALKEM LABS LTD 500MG A091249 001 Nov 04, 2011
AB APOTEX 500MG A090499 001 Apr 22, 2009
AB CADISTA PHARMS 500MG A090661 001 Dec 15, 2014
AB MYLAN 500MG A065521 001 May 04, 2009
AB ROXANE 500MG A065413 001 Jul 29, 2008
AB SANDOZ 500MG A065451 001 Oct 15, 2008
AB STRIDES PHARMA 500MG A090456 001 Jun 10, 2010
AB TEVA PHARMS 500MG A065457 001 May 04, 2009
AB VINTAGE PHARMS LLC 500MG A090606 001 Jul 16, 2010
MYCOPHENOLATE MOFETIL HYDROCHLORIDE
INJECTABLE;INJECTION
CELLCEPT
+ ROCHE PALO 500MG/VIAL N050758 001 Aug 12, 1998
MYCOPHENOLIC ACID
TABLET, DELAYED RELEASE;ORAL
MYCOPHENOLIC ACID
AB APOTEX INC 180MG A091558 001 Aug 21, 2012
AB 360MG A091558 002 Aug 19, 2014
AB MYLAN PHARMS INC 180MG A091248 002 Jan 08, 2014
AB 360MG A091248 001 Jan 08, 2014
AB TEVA PHARMS USA 180MG A202720 001 Oct 30, 2014
AB 360MG A202720 002 Oct 30, 2014
MYFORTIC
AB NOVARTIS 180MG N050791 001 Feb 27, 2004
AB + 360MG N050791 002 Feb 27, 2004
NABILONE
CAPSULE;ORAL
CESAMET
+ MEDA PHARMS 1MG N018677 001 Dec 26, 1985
NABUMETONE
TABLET;ORAL
NABUMETONE
AB APOTEX INC 500MG A090427 001 Dec 30, 2011
AB 750MG A090427 002 Dec 30, 2011
AB INVAGEN PHARMS 500MG A078671 001 Mar 07, 2008
AB 750MG A078671 002 Mar 07, 2008
AB LUPIN LTD 500MG A090445 001 Jan 12, 2011
AB 750MG A090445 002 Jan 12, 2011
AB MYLAN PHARMS INC 500MG A090516 001 Jul 12, 2010
AB 750MG A090516 002 Jul 12, 2010
AB PAR PHARM 500MG A076009 001 Jan 24, 2003
AB 750MG A076009 002 Jan 24, 2003
AB SANDOZ 500MG A075280 001 Feb 25, 2002
AB 750MG A075280 002 Feb 25, 2002
AB TEVA 500MG A075189 001 May 26, 2000
AB + 750MG A075189 002 Sep 24, 2001
AB WATSON LABS 500MG A091083 001 Jun 13, 2011
AB 750MG A091083 002 Jun 13, 2011
NADOLOL
TABLET;ORAL
CORGARD
AB KING PHARMS 20MG N018063 005 Oct 28, 1986
AB 40MG N018063 001
AB + 80MG N018063 002
NADOLOL
AB IVAX SUB TEVA PHARMS 20MG A074229 001 Aug 30, 1996
AB 40MG A074229 002 Aug 30, 1996
AB 80MG A074255 001 Jan 24, 1996
AB MYLAN 20MG A074172 001 Oct 31, 1993
AB 40MG A074172 002 Oct 31, 1993
AB 80MG A074172 003 Oct 31, 1993
AB SANDOZ 20MG A074501 001 Nov 09, 1995
AB 40MG A074501 002 Nov 09, 1995
AB 80MG A074501 003 Nov 09, 1995
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-258(of 371)
NAFARELIN ACETATE
SPRAY, METERED;NASAL
SYNAREL
+ GD SEARLE LLC EQ 0.2MG BASE/SPRAY N019886 001 Feb 13, 1990
NAFCILLIN SODIUM
INJECTABLE;INJECTION
NAFCILLIN SODIUM
AP AGILA SPECLTS EQ 1GM BASE/VIAL A200002 001 Apr 07, 2014
AP EQ 2GM BASE/VIAL A200002 002 Apr 07, 2014
AP ANTIBIOTICE EQ 1GM BASE/VIAL A090560 001 Oct 03, 2011
AP EQ 2GM BASE/VIAL A090560 002 Oct 03, 2011
AP AUROBINDO PHARMA LTD EQ 1GM BASE/VIAL A091613 001 Dec 26, 2012
AP EQ 2GM BASE/VIAL A091613 002 Dec 26, 2012
AP EQ 10GM BASE/VIAL A091614 001 Dec 26, 2012
AP ISTITUTO BIO ITA SPA EQ 1GM BASE/VIAL A090002 001 Jun 30, 2011
AP EQ 2GM BASE/VIAL A090002 002 Jun 30, 2011
AP EQ 10GM BASE/VIAL A090005 001 Apr 20, 2011
AP SAGENT PHARMS EQ 1GM BASE/VIAL A090582 001 Aug 24, 2012
AP EQ 2GM BASE/VIAL A090582 002 Aug 24, 2012
AP EQ 10GM BASE/VIAL A090580 001 Aug 24, 2012
AP + SANDOZ EQ 1GM BASE/VIAL A062527 002 Aug 02, 1984
AP + EQ 1GM BASE/VIAL A062732 001 Dec 23, 1986
AP + EQ 2GM BASE/VIAL A062527 003 Aug 02, 1984
AP + EQ 2GM BASE/VIAL A062732 002 Dec 23, 1986
AP + EQ 10GM BASE/VIAL A062527 004 Aug 02, 1984
NALLPEN IN PLASTIC CONTAINER
+ BAXTER HLTHCARE EQ 2GM BASE/100ML N050655 002 Oct 31, 1989
+ EQ 20MG BASE/ML N050655 001 Oct 31, 1989
NAFTIFINE HYDROCHLORIDE
CREAM;TOPICAL
NAFTIN
+ MERZ PHARMS 1% N019599 001 Feb 29, 1988
+ 2% N019599 002 Jan 13, 2012
GEL;TOPICAL
NAFTIN
+ MERZ PHARMS 1% N019356 001 Jun 18, 1990
+ 2% N204286 001 Jun 27, 2013
NALBUPHINE HYDROCHLORIDE
INJECTABLE;INJECTION
NALBUPHINE HYDROCHLORIDE
AP + HOSPIRA 10MG/ML A070914 001 Feb 03, 1989
AP + 10MG/ML A070915 001 Feb 03, 1989
AP + 20MG/ML A070916 001 Feb 03, 1989
AP + 20MG/ML A070918 001 Feb 03, 1989
NALOXEGOL OXALATE
TABLET;ORAL
MOVANTIK
ASTRAZENECA PHARMS EQ 12.5MG BASE N204760 001 Sep 16, 2014
+ EQ 25MG BASE N204760 002 Sep 16, 2014
NALOXONE HYDROCHLORIDE
INJECTABLE;INJECTION
NALOXONE HYDROCHLORIDE
AP + HOSPIRA 0.4MG/ML A070172 001 Sep 24, 1986
AP + 0.4MG/ML A070254 001 Jan 07, 1987
AP + 0.4MG/ML A070256 001 Jan 07, 1987
AP + 0.4MG/ML A070257 001 Jan 07, 1987
AP INTL MEDICATION 0.4MG/ML A070639 001 Sep 24, 1986
AP + 1MG/ML A072076 001 Mar 24, 1988
AP MYLAN INSTITUTIONAL 0.4MG/ML A204997 001 Mar 06, 2014
SOLUTION;INTRAMUSCULAR, SUBCUTANEOUS
EVZIO
+ KALEO INC 0.4MG/0.4ML N205787 001 Apr 03, 2014
NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE
TABLET;ORAL
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE
AB GAVIS PHARMS EQ 0.5MG BASE;EQ 50MG BASE A075735 001 Jul 11, 2001
AB RANBAXY EQ 0.5MG BASE;EQ 50MG BASE A075523 001 Mar 17, 2000
AB + WATSON LABS EQ 0.5MG BASE;EQ 50MG BASE A074736 001 Jan 21, 1997
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-259(of 371)
NALTREXONE
FOR SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
VIVITROL
+ ALKERMES 380MG/VIAL N021897 001 Apr 13, 2006
NALTREXONE HYDROCHLORIDE
TABLET;ORAL
NALTREXONE HYDROCHLORIDE
AB ACCORD HLTHCARE 50MG A091205 001 Aug 17, 2011
AB BARR 50MG A074918 001 May 08, 1998
AB ELITE LABS 50MG A075274 001 May 26, 1999
AB MALLINCKRODT 50MG A076264 002 Mar 22, 2002
AB SUN PHARMA GLOBAL 50MG A090356 001 Feb 24, 2012
REVIA
AB + TEVA WOMENS 50MG N018932 001 Nov 20, 1984
NALTREXONE HYDROCHLORIDE
MALLINCKRODT 25MG A076264 001 Mar 22, 2002
100MG A076264 003 Mar 22, 2002
NANDROLONE DECANOATE
INJECTABLE;INJECTION
NANDROLONE DECANOATE
+ PHARMAFORCE 200MG/ML A091252 001 Aug 30, 2010
NAPHAZOLINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
NAPHAZOLINE HYDROCHLORIDE
+ AKORN INC 0.1% A083590 001
NAPROXEN
SUSPENSION;ORAL
NAPROSYN
AB + ROCHE PALO 25MG/ML N018965 001 Mar 23, 1987
NAPROXEN
AB ROXANE 25MG/ML A074190 001 Mar 30, 1994
TABLET;ORAL
NAPROSYN
AB ROCHE PALO 250MG N017581 002
AB 375MG N017581 003
AB + 500MG N017581 004 Apr 15, 1982
NAPROXEN
AB AMNEAL PHARMS NY 250MG A075927 001 Dec 18, 2001
AB 375MG A075927 002 Dec 18, 2001
AB 500MG A075927 003 Dec 18, 2001
AB AUROBINDO PHARMA USA 250MG A200429 001 Nov 08, 2011
AB 375MG A200429 002 Nov 08, 2011
AB 500MG A200429 003 Nov 08, 2011
AB GLENMARK GENERICS 250MG A078250 001 Mar 28, 2007
AB 375MG A078250 002 Mar 28, 2007
AB 500MG A078250 003 Mar 28, 2007
AB HIKMA INTL PHARMS 250MG A076494 001 Jan 14, 2004
AB 375MG A076494 002 Jan 14, 2004
AB 500MG A076494 003 Jan 14, 2004
AB INVAGEN PHARMS 250MG A091305 001 Aug 24, 2011
AB 375MG A091305 002 Aug 24, 2011
AB 500MG A091305 003 Aug 24, 2011
AB MARKSANS PHARMA 250MG A091416 001 Feb 14, 2011
AB 375MG A091416 002 Feb 14, 2011
AB 500MG A091416 003 Feb 14, 2011
AB MYLAN 250MG A074121 001 Dec 21, 1993
AB 375MG A074121 002 Dec 21, 1993
AB 500MG A074121 003 Dec 21, 1993
AB PERRIGO R AND D 250MG A077339 001 Apr 27, 2005
AB 375MG A077339 002 Apr 27, 2005
AB 500MG A077339 003 Apr 27, 2005
AB SANDOZ 250MG A074140 001 Dec 21, 1993
AB 375MG A074140 002 Dec 21, 1993
AB 500MG A074140 003 Dec 21, 1993
AB TEVA 250MG A074201 001 Dec 21, 1993
AB 375MG A074201 002 Dec 21, 1993
AB 500MG A074201 003 Dec 21, 1993
AB ZYDUS PHARMS USA 250MG A078620 001 Jun 07, 2007
AB 375MG A078620 002 Jun 07, 2007
AB 500MG A078620 003 Jun 07, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-260(of 371)
NAPROXEN
TABLET, DELAYED RELEASE;ORAL
EC-NAPROSYN
AB + ROCHE PALO 375MG N020067 002 Oct 14, 1994
AB + 500MG N020067 003 Oct 14, 1994
NAPROXEN
AB INVAGEN PHARMS 375MG A091432 001 Sep 19, 2011
AB 500MG A091432 002 Sep 19, 2011
AB MYLAN PHARMS INC 375MG A075390 001 Apr 19, 2001
AB 500MG A075390 002 Apr 19, 2001
AB PLIVA 375MG A075337 001 May 26, 1999
AB 500MG A075337 002 May 26, 1999
AB SANDOZ 375MG A075061 001 Feb 18, 1998
AB 500MG A075061 002 Feb 18, 1998
AB TEVA 375MG A075227 001 Jun 30, 1998
AB 500MG A075227 002 Jun 30, 1998
NAPROXEN SODIUM
TABLET;ORAL
ANAPROX
AB HOFFMANN LA ROCHE EQ 250MG BASE N018164 001
ANAPROX DS
AB + HOFFMANN LA ROCHE EQ 500MG BASE N018164 003 Sep 30, 1987
NAPROXEN SODIUM
AB AMNEAL PHARMS NY EQ 250MG BASE A078432 001 Apr 25, 2007
AB EQ 500MG BASE A078432 002 Apr 25, 2007
AB AUROBINDO PHARMA LTD EQ 250MG BASE A200629 001 Oct 31, 2011
AB EQ 500MG BASE A200629 002 Oct 31, 2011
AB DR REDDYS LABS LTD EQ 250MG BASE A078486 001 Jul 26, 2007
AB EQ 500MG BASE A078486 002 Jul 26, 2007
AB GLENMARK GENERICS EQ 250MG BASE A078314 001 Apr 27, 2007
AB EQ 500MG BASE A078314 002 Apr 27, 2007
AB HIKMA EQ 250MG BASE A074480 002 Feb 18, 1998
AB EQ 500MG BASE A074480 001 May 14, 1996
AB TEVA EQ 250MG BASE A074198 001 Dec 21, 1993
AB EQ 500MG BASE A074198 002 Dec 21, 1993
TABLET, EXTENDED RELEASE;ORAL
NAPRELAN
AB ALMATICA PHARMA INC EQ 375MG BASE N020353 001 Jan 05, 1996
AB EQ 500MG BASE N020353 002 Jan 05, 1996
NAPROXEN SODIUM
AB ACTAVIS LABS FL INC EQ 375MG BASE A075416 002 Apr 23, 2003
AB EQ 500MG BASE A075416 001 Aug 27, 2002
NAPRELAN
+ ALMATICA PHARMA INC EQ 750MG BASE N020353 003 Jan 05, 1996
NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE
TABLET;ORAL
TREXIMET
+ PERNIX IRELAND LTD 500MG;EQ 85MG BASE N021926 001 Apr 15, 2008
NARATRIPTAN HYDROCHLORIDE
TABLET;ORAL
AMERGE
AB GLAXOSMITHKLINE LLC EQ 1MG BASE N020763 002 Feb 10, 1998
AB + EQ 2.5MG BASE N020763 001 Feb 10, 1998
NARATRIPTAN
AB APOTEX CORP EQ 1MG BASE A091373 001 Apr 22, 2011
AB EQ 2.5MG BASE A091373 002 Apr 22, 2011
AB HERITAGE PHARMS INC EQ 1MG BASE A200502 001 Feb 28, 2011
AB EQ 2.5MG BASE A200502 002 Feb 28, 2011
AB MYLAN PHARMS INC EQ 1MG BASE A202431 001 May 31, 2012
AB EQ 2.5MG BASE A202431 002 May 31, 2012
AB ORCHID HLTHCARE EQ 1MG BASE A091441 001 Apr 30, 2012
AB EQ 2.5MG BASE A091441 002 Apr 30, 2012
AB PADDOCK LLC EQ 1MG BASE A091326 001 Jul 08, 2010
AB EQ 2.5MG BASE A091326 002 Jul 08, 2010
AB ROXANE EQ 1MG BASE A090381 001 Jul 07, 2010
AB EQ 2.5MG BASE A090381 002 Jul 07, 2010
AB SANDOZ EQ 1MG BASE A090288 001 Jul 07, 2010
AB EQ 2.5MG BASE A090288 002 Jul 07, 2010
AB SUN PHARM INDS LTD EQ 2.5MG BASE A091552 001 Feb 14, 2011
AB TEVA PHARMS EQ 1MG BASE A078751 001 Jul 07, 2010
AB EQ 2.5MG BASE A078751 002 Jul 07, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-261(of 371)
NATAMYCIN
SUSPENSION;OPHTHALMIC
NATACYN
+ ALCON
5%
N050514 001
NATEGLINIDE
TABLET;ORAL
NATEGLINIDE
AB DR REDDYS LABS LTD
60MG
A077461 001 Sep 09, 2009
AB
120MG
A077461 002 Sep 09, 2009
AB PAR PHARM
60MG
A077463 001 Sep 09, 2009
AB
120MG
A077463 002 Sep 09, 2009
AB WATSON LABS
60MG
A077462 001 Mar 30, 2011
AB
120MG
A077462 002 Mar 30, 2011
STARLIX
AB NOVARTIS
60MG
N021204 001 Dec 22, 2000
AB +
120MG
N021204 002 Dec 22, 2000
NEBIVOLOL HYDROCHLORIDE
TABLET;ORAL
BYSTOLIC
FOREST LABS
EQ 2.5MG BASE
N021742 002 Dec 17, 2007
EQ 5MG BASE
N021742 003 Dec 17, 2007
EQ 10MG BASE
N021742 004 Dec 17, 2007
+
EQ 20MG BASE
N021742 005 Oct 08, 2008
NEDOCROMIL SODIUM
SOLUTION/DROPS;OPHTHALMIC
ALOCRIL
AT + ALLERGAN
2%
N021009 001 Dec 08, 1999
NEDOCROMIL SODIUM
AT AKORN
2%
A090638 001 Aug 22, 2012
NEFAZODONE HYDROCHLORIDE
TABLET;ORAL
NEFAZODONE HYDROCHLORIDE
AB RANBAXY 50MG
A076409 001 Sep 16, 2003
AB 100MG
A076409 002 Sep 16, 2003
AB 150MG
A076409 003 Sep 16, 2003
AB 200MG
A076409 004 Sep 16, 2003
AB 250MG
A076409 005 Sep 16, 2003
AB TEVA 50MG
A076037 001 Sep 16, 2003
AB 100MG
A076037 002 Sep 16, 2003
AB 150MG
A076037 003 Sep 16, 2003
AB 200MG
A076037 004 Sep 16, 2003
AB + 250MG
A076037 005 Sep 16, 2003
BX DR REDDYS LABS INC 50MG
A076309 001 Sep 16, 2003
BX 100MG
A076309 002 Sep 16, 2003
BX 150MG
A076309 003 Sep 16, 2003
BX 200MG
A076309 004 Sep 16, 2003
BX 250MG
A076309 005 Sep 16, 2003
NELARABINE
INJECTABLE;IV (INFUSION)
ARRANON
+ SMITHKLINE BEECHAM
250MG/50ML (5MG/ML)
N021877 001 Oct 28, 2005
NELFINAVIR MESYLATE
TABLET;ORAL
VIRACEPT
+ AGOURON
EQ 250MG BASE
N020779 001 Mar 14, 1997
+
EQ 625MG BASE
N021503 001 Apr 30, 2003
NEOMYCIN SULFATE
SOLUTION;ORAL
NEO-FRADIN
+ X GEN PHARMS
EQ 87.5MG BASE/5ML
A065010 001 May 23, 2002
TABLET;ORAL
NEOMYCIN SULFATE
AA OMAN PHARM PRODUCTS
500MG
A065468 001 Mar 29, 2010
AA + TEVA
500MG
A060304 001
AA X GEN PHARMS
500MG
A065220 001 Jul 28, 2006
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-262(of 371)
NEOMYCIN SULFATE; POLYMYXIN B SULFATE
SOLUTION;IRRIGATION
NEOMYCIN AND POLYMYXIN B SULFATE
AT WATSON LABS EQ 40MG BASE/ML;200,000 UNITS/ML A062664 001 Apr 08, 1986
AT X GEN PHARMS EQ 40MG BASE/ML;200,000 UNITS/ML A065106 001 Jan 31, 2006
AT EQ 40MG BASE/ML;200,000 UNITS/ML A065108 001 Jan 31, 2006
NEOSPORIN G.U. IRRIGANT
AT + MONARCH PHARMS EQ 40MG BASE/ML;200,000 UNITS/ML A060707 001
NEOSTIGMINE METHYLSULFATE
SOLUTION;INTRAVENOUS
BLOXIVERZ
+ ECLAT PHARMS LLC 5MG/10ML (0.5MG/ML) N204078 001 May 31, 2013
+ 10MG/10ML (1MG/ML) N204078 002 May 31, 2013
NEPAFENAC
SUSPENSION/DROPS;OPHTHALMIC
ILEVRO
+ ALCON RES LTD 0.3% N203491 001 Oct 16, 2012
NEVANAC
+ ALCON PHARMS LTD 0.1% N021862 001 Aug 19, 2005
NESIRITIDE RECOMBINANT
FOR SOLUTION;INTRAVENOUS
NATRECOR
+ SCIOS LLC 1.5MG/VIAL N020920 001 Aug 10, 2001
NETUPITANT; PALONOSETRON HYDROCHLORIDE
CAPSULE;ORAL
AKYNZEO
+ HELSINN HLTHCARE 300MG;EQ 0.5MG BASE N205718 001 Oct 10, 2014
NEVIRAPINE
SUSPENSION;ORAL
NEVIRAPINE
AA AUROBINDO 50MG/5ML A077702 001 May 22, 2012
VIRAMUNE
AA + BOEHRINGER INGELHEIM 50MG/5ML N020933 001 Sep 11, 1998
TABLET;ORAL
NEVIRAPINE
AB APOTEX INC 200MG A203021 001 May 22, 2012
AB AUROBINDO 200MG A077521 001 May 22, 2012
AB CIPLA 200MG A077956 001 May 22, 2012
AB HETERO LABS LTD III 200MG A078584 001 May 22, 2012
AB MICRO LABS LTD 200MG A203080 001 May 22, 2012
AB MYLAN LABS 200MG A078864 001 May 22, 2012
AB MYLAN PHARMS INC 200MG A202523 001 May 22, 2012
AB PRINSTON INC 200MG A078644 001 May 22, 2012
AB SCIEGEN PHARMS INC 200MG A203176 001 May 22, 2012
AB STRIDES PHARMA 200MG A078195 001 May 22, 2012
VIRAMUNE
AB + BOEHRINGER INGELHEIM 200MG N020636 001 Jun 21, 1996
TABLET, EXTENDED RELEASE;ORAL
NEVIRAPINE
AB APOTEX INC 400MG A205258 001 Apr 03, 2014
AB MYLAN PHARMS INC 400MG A205651 001 Oct 27, 2014
AB SANDOZ 400MG A203411 001 Apr 03, 2014
VIRAMUNE XR
AB + BOEHRINGER INGELHEIM 400MG N201152 001 Mar 25, 2011
100MG N201152 002 Nov 08, 2012
NIACIN
TABLET;ORAL
NIACIN
AA WOCKHARDT 500MG A081134 001 Apr 28, 1992
NIACOR
AA + UPSHER SMITH 500MG A040378 001 May 03, 2000
TABLET, EXTENDED RELEASE;ORAL
NIACIN
AB BARR 1GM A076250 001 Apr 14, 2005
AB 500MG A076378 001 Apr 26, 2005
AB 750MG A076378 002 Apr 26, 2005
AB LUPIN LTD 1GM A090446 001 Mar 20, 2014
AB 500MG A090860 001 Mar 20, 2014
AB 750MG A090892 001 Mar 20, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-263(of 371)
NIACIN
TABLET, EXTENDED RELEASE;ORAL
NIACIN
AB SUN PHARMA GLOBAL 1GM A200484 002 Apr 23, 2014
AB 500MG A200484 001 Apr 23, 2014
AB 750MG A201273 001 Apr 23, 2014
NIASPAN
AB + ABBVIE 1GM N020381 004 Jul 28, 1997
AB 500MG N020381 002 Jul 28, 1997
AB + 750MG N020381 003 Jul 28, 1997
NIACIN; SIMVASTATIN
TABLET, EXTENDED RELEASE;ORAL
SIMCOR
+ ABBVIE 1GM;20MG N022078 003 Feb 15, 2008
+ 1GM;40MG N022078 005 Jul 28, 2010
+ 500MG;20MG N022078 001 Feb 15, 2008
+ 500MG;40MG N022078 004 Jul 28, 2010
+ 750MG;20MG N022078 002 Feb 15, 2008
NICARDIPINE HYDROCHLORIDE
CAPSULE;ORAL
CARDENE
AB CHIESI USA INC 20MG N019488 001 Dec 21, 1988
AB + 30MG N019488 002 Dec 21, 1988
NICARDIPINE HYDROCHLORIDE
AB ANI PHARMS INC 20MG A074439 001 Dec 10, 1996
AB 20MG A074540 001 Oct 28, 1996
AB 30MG A074439 002 Dec 10, 1996
AB 30MG A074540 002 Oct 28, 1996
AB EPIC PHARMA 20MG A074928 001 Mar 19, 1998
AB 30MG A074928 002 Mar 19, 1998
AB MYLAN 20MG A074642 001 Jul 18, 1996
AB 30MG A074642 002 Jul 18, 1996
INJECTABLE;INJECTION
CARDENE
AP + CHIESI USA INC 25MG/10ML (2.5MG/ML) N019734 001 Jan 30, 1992
NICARDIPINE HYDROCHLORIDE
AP BEDFORD 25MG/10ML (2.5MG/ML) A078714 001 Dec 28, 2009
AP EXELA PHARMA SCIENCE 25MG/10ML (2.5MG/ML) N022276 001 Jul 24, 2008
AP LUITPOLD 25MG/10ML (2.5MG/ML) A090534 001 Nov 17, 2009
AP MYLAN INSTITUTIONAL 25MG/10ML (2.5MG/ML) A090664 001 Nov 17, 2009
AP NAVINTA LLC 25MG/10ML (2.5MG/ML) A090125 001 Nov 17, 2009
AP SUN PHARMA GLOBAL 25MG/10ML (2.5MG/ML) N078405 001 Nov 17, 2009
AP WOCKHARDT 25MG/10ML (2.5MG/ML) A090671 001 Nov 17, 2009
INJECTABLE;INTRAVENOUS
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
+ CHIESI USA INC 40MG/200ML (0.2MG/ML) N019734 004 Nov 07, 2008
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
+ CHIESI USA INC 20MG/200ML (0.1MG/ML) N019734 003 Jul 31, 2008
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
+ CHIESI USA INC 20MG/200ML (0.1MG/ML) N019734 002 Jul 31, 2008
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
+ CHIESI USA INC 40MG/200ML (0.2MG/ML) N019734 005 Nov 07, 2008
NICOTINE
INHALANT;ORAL
NICOTROL
+ PHARMACIA AND UPJOHN 4MG/CARTRIDGE N020714 001 May 02, 1997
SPRAY, METERED;NASAL
NICOTROL
+ PFIZER INC 0.5MG/SPRAY N020385 001 Mar 22, 1996
NIFEDIPINE
CAPSULE;ORAL
NIFEDIPINE
AB ACTAVIS ELIZABETH 10MG A072579 001 Jan 08, 1991
AB 20MG A072556 001 Sep 20, 1990
AB EMCURE PHARMS USA 10MG A202644 001 Apr 25, 2013
AB 20MG A202644 002 Apr 25, 2013
AB INTERGEL PHARM 10MG A072781 001 Jul 30, 1993
PROCARDIA
AB + PFIZER 10MG N018482 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-264(of 371)
NIFEDIPINE
TABLET, EXTENDED RELEASE;ORAL
ADALAT CC
AB1 BAYER HLTHCARE 30MG N020198 001 Apr 21, 1993
AB1 + 60MG N020198 002 Apr 21, 1993
AB1 + 90MG N020198 003 Apr 21, 1993
AFEDITAB CR
AB1 WATSON LABS 30MG A075128 001 Mar 10, 2000
AB1 60MG A075659 001 Oct 26, 2001
NIFEDIPINE
AB1 MYLAN 30MG A201071 001 Dec 03, 2010
AB1 60MG A201071 002 Dec 03, 2010
AB1 90MG A201071 003 Dec 03, 2010
AB1 PAR PHARM 30MG A077899 001 Dec 13, 2006
AB1 60MG A077899 002 Dec 13, 2006
AB1 90MG A077899 003 May 25, 2012
AB1 VALEANT INTL 30MG A075269 001 Dec 04, 2000
AB1 60MG A075269 002 Dec 04, 2000
AB1 90MG A076070 001 Aug 16, 2002
AB2 MATRIX LABS LTD 30MG A090602 001 Sep 13, 2010
AB2 60MG A090602 002 Sep 13, 2010
AB2 90MG A090602 003 Sep 13, 2010
AB2 MYLAN 30MG A090649 001 Jun 21, 2010
AB2 60MG A090649 002 Jun 21, 2010
AB2 90MG A090649 003 Jun 21, 2010
AB2 OSMOTICA PHARM 30MG A077127 001 Nov 21, 2005
AB2 60MG A077127 002 Nov 21, 2005
AB2 90MG A077410 001 Oct 03, 2007
AB2 TWI PHARMS INC 30MG A203126 001 Apr 03, 2014
AB2 60MG A203126 002 Apr 03, 2014
AB2 90MG A203126 003 Apr 03, 2014
AB2 VALEANT INTL 30MG A075289 002 Feb 06, 2001
AB2 60MG A075289 001 Sep 27, 2000
PROCARDIA XL
AB2 PFIZER 30MG N019684 001 Sep 06, 1989
AB2 60MG N019684 002 Sep 06, 1989
AB2 + 90MG N019684 003 Sep 06, 1989
NILOTINIB HYDROCHLORIDE MONOHYDRATE
CAPSULE;ORAL
TASIGNA
NOVARTIS EQ 150MG BASE N022068 002 Jun 17, 2010
+ EQ 200MG BASE N022068 001 Oct 29, 2007
NILUTAMIDE
TABLET;ORAL
NILANDRON
+ COVIS PHARMA SARL 150MG N020169 002 Apr 30, 1999
NIMODIPINE
CAPSULE;ORAL
NIMODIPINE
AB + BANNER PHARMACAPS 30MG A076740 001 Jan 17, 2008
AB BARR LABS INC 30MG A077811 001 May 02, 2007
AB SUN PHARM INDS INC 30MG A077067 001 Apr 17, 2007
AB THEPHARMANETWORK LLC 30MG A090103 001 Apr 07, 2014
SOLUTION;ORAL
NYMALIZE
+ ARBOR PHARMS LLC 60MG/20ML N203340 001 May 10, 2013
NINTEDANIB
CAPSULE;ORAL
OFEV
BOEHRINGER INGELHEIM 100MG N205832 001 Oct 15, 2014
+ 150MG N205832 002 Oct 15, 2014
NISOLDIPINE
TABLET, EXTENDED RELEASE;ORAL
NISOLDIPINE
AB MYLAN 8.5MG A091001 001 Jan 26, 2011
AB 17MG A091001 002 Jan 26, 2011
AB 34MG A091001 004 Jan 26, 2011
SULAR
AB + SHIONOGI INC 8.5MG N020356 008 Jan 02, 2008
AB + 17MG N020356 007 Jan 02, 2008
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-265(of 371)
NISOLDIPINE
TABLET, EXTENDED RELEASE;ORAL
SULAR
AB + 34MG N020356 005 Jan 02, 2008
NISOLDIPINE
MYLAN 20MG A079051 001 Jul 25, 2008
25.5MG A091001 003 Jan 26, 2011
+ 30MG A079051 002 Jul 25, 2008
+ 40MG A079051 003 Jul 25, 2008
NITAZOXANIDE
FOR SUSPENSION;ORAL
ALINIA
+ ROMARK 100MG/5ML N021498 001 Nov 22, 2002
TABLET;ORAL
ALINIA
+ ROMARK 500MG N021497 001 Jul 21, 2004
NITISINONE
CAPSULE;ORAL
ORFADIN
SWEDISH ORPHAN 2MG N021232 001 Jan 18, 2002
5MG N021232 002 Jan 18, 2002
+ 10MG N021232 003 Jan 18, 2002
NITRIC OXIDE
GAS;INHALATION
INOMAX
INO 100PPM N020845 002 Dec 23, 1999
+ 800PPM N020845 003 Dec 23, 1999
NITROFURANTOIN
SUSPENSION;ORAL
FURADANTIN
AB + SHIONOGI INC 25MG/5ML N009175 001
NITROFURANTOIN
AB AMNEAL PHARMS 25MG/5ML A201679 001 May 11, 2011
AB NOVEL LABS INC 25MG/5ML A201693 001 Sep 08, 2014
AB SUN PHARM INDS INC 25MG/5ML A201355 001 Aug 14, 2013
NITROFURANTOIN, MACROCRYSTALLINE
CAPSULE;ORAL
MACRODANTIN
AB ALVOGEN INC 50MG N016620 001
AB + 100MG N016620 002
NITROFURANTOIN
AB IVAX SUB TEVA PHARMS 50MG A073671 001 Jan 28, 1993
AB 100MG A073652 001 Jan 28, 1993
AB MYLAN 50MG A074967 001 Jul 09, 1997
AB 100MG A077025 001 Aug 18, 2004
MACRODANTIN
ALVOGEN INC 25MG N016620 003
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
CAPSULE;ORAL
MACROBID
AB + ALVOGEN INC 75MG;25MG N020064 001 Dec 24, 1991
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
AB MYLAN 75MG;25MG A076648 001 Mar 22, 2004
AB SANDOZ 75MG;25MG A077066 001 Apr 05, 2005
NITROGLYCERIN
AEROSOL, METERED;SUBLINGUAL
NITROMIST
+ MIST PHARMS LLC 0.4MG/SPRAY N021780 001 Nov 02, 2006
FILM, EXTENDED RELEASE;TRANSDERMAL
MINITRAN
AB1 MEDICIS 0.2MG/HR A089772 001 Aug 30, 1996
AB1 0.4MG/HR A089773 001 Aug 30, 1996
AB1 VALEANT PHARM NORTH 0.1MG/HR A089771 001 Aug 30, 1996
AB1 0.6MG/HR A089774 001 Aug 30, 1996
NITRO-DUR
AB1 + MERCK SHARP DOHME 0.1MG/HR N020145 001 Apr 04, 1995
AB1 + 0.2MG/HR N020145 002 Apr 04, 1995
AB1 + 0.4MG/HR N020145 004 Apr 04, 1995
AB1 + 0.6MG/HR N020145 005 Apr 04, 1995
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-266(of 371)
NITROGLYCERIN
FILM, EXTENDED RELEASE;TRANSDERMAL
NITROGLYCERIN
AB2 HERCON PHARM 0.2MG/HR A089884 001 Oct 30, 1998
AB2 0.4MG/HR A089885 001 Oct 30, 1998
AB2 0.6MG/HR A089886 001 Oct 30, 1998
AB2 + MYLAN TECHNOLOGIES 0.2MG/HR A074559 003 Aug 30, 1996
AB2 + 0.4MG/HR A074559 002 Aug 30, 1996
AB2 + 0.6MG/HR A074559 001 Aug 30, 1996
NITRO-DUR
+ MERCK SHARP DOHME 0.3MG/HR N020145 003 Apr 04, 1995
+ 0.8MG/HR N020145 006 Apr 04, 1995
NITROGLYCERIN
+ MYLAN TECHNOLOGIES 0.1MG/HR A074559 004 Feb 06, 1998
INJECTABLE;INJECTION
NITROGLYCERIN IN DEXTROSE 5%
AP + BAXTER HLTHCARE 10MG/100ML N019970 001 Dec 29, 1989
AP + 20MG/100ML N019970 002 Dec 29, 1989
AP + 40MG/100ML N019970 003 Dec 29, 1989
AP HOSPIRA 10MG/100ML A071846 001 Aug 31, 1990
AP 20MG/100ML A071847 001 Aug 31, 1990
AP 40MG/100ML A071848 001 Aug 31, 1990
NITROGLYCERIN
+ LUITPOLD 5MG/ML A072034 001 May 24, 1988
OINTMENT;INTRA-ANAL
RECTIV
+ FOREST LABS INC 0.4% N021359 001 Jun 21, 2011
OINTMENT;TRANSDERMAL
NITROGLYCERIN
+ FOUGERA 2% A087355 001 Jul 08, 1988
SPRAY, METERED;SUBLINGUAL
NITROGLYCERIN
AB PERRIGO ISRAEL 0.4MG/SPRAY A091496 001 Sep 20, 2013
NITROLINGUAL PUMPSPRAY
AB + POHL BOSKAMP 0.4MG/SPRAY N018705 002 Jan 10, 1997
TABLET;SUBLINGUAL
NITROSTAT
PFIZER PHARMS 0.3MG N021134 001 May 01, 2000
0.4MG N021134 002 May 01, 2000
+ 0.6MG N021134 003 May 01, 2000
NIZATIDINE
CAPSULE;ORAL
NIZATIDINE
AB ANI PHARMS INC 150MG A075668 001 Sep 12, 2002
AB 300MG A075668 002 Sep 12, 2002
AB DR REDDYS LABS LTD 150MG A077314 001 Sep 15, 2005
AB 300MG A077314 002 Sep 15, 2005
AB GLENMARK GENERICS 150MG A090618 001 Jul 15, 2011
AB 300MG A090618 002 Jul 15, 2011
AB MYLAN PHARMS INC 150MG A075806 001 Jul 05, 2002
AB + 300MG A075806 002 Jul 05, 2002
AB SANDOZ 150MG A076178 001 Jul 05, 2002
AB 300MG A076178 002 Jul 05, 2002
AB WATSON LABS 150MG A075616 001 Jul 09, 2002
AB 300MG A075616 002 Jul 09, 2002
SOLUTION;ORAL
AXID
AA + BRAINTREE 15MG/ML N021494 001 May 25, 2004
NIZATIDINE
AA AMNEAL PHARMS 15MG/ML A090576 001 Nov 18, 2009
NOREPINEPHRINE BITARTRATE
INJECTABLE;INJECTION
LEVOPHED
AP + HOSPIRA EQ 1MG BASE/ML N007513 001
NOREPINEPHRINE BITARTRATE
AP BEDFORD EQ 1MG BASE/ML A040462 001 Oct 31, 2003
AP CLARIS LIFESCIENCES EQ 1MG BASE/ML A040859 001 Mar 27, 2012
AP TEVA PHARMS USA EQ 1MG BASE/ML A040455 001 Mar 03, 2003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-267(of 371)
NORETHINDRONE
TABLET;ORAL-28
CAMILA
AB1 BARR 0.35MG A076177 001 Oct 21, 2002
HEATHER
AB1 GLENMARK GENERICS 0.35MG A090454 001 Apr 23, 2010
NOR-QD
AB1 + WATSON LABS (UTAH) 0.35MG N017060 001
NORETHINDRONE
AB1 FAMY CARE LTD 0.35MG A201483 001 Jun 24, 2013
AB1 HAUPT PHARMA 0.35MG A202260 001 Aug 01, 2013
AB1 LUPIN LTD 0.35MG A091325 001 Sep 19, 2011
AB1 NOVAST LABS LTD 0.35MG A202014 001 Sep 13, 2013
ERRIN
AB2 BARR 0.35MG A076225 001 Oct 21, 2002
JENCYCLA
AB2 LUPIN LTD 0.35MG A091323 001 Mar 28, 2013
MICRONOR
AB2 + JANSSEN PHARMS 0.35MG N016954 001
NORETHINDRONE
AB2 FAMY CARE LTD 0.35MG A200980 001 Jun 12, 2013
AB2 GLENMARK GENERICS 0.35MG A091209 001 Jul 21, 2010
AB2 NOVAST LABS 0.35MG A200961 001 Sep 13, 2013
NORETHINDRONE ACETATE
TABLET;ORAL
AYGESTIN
AB + DURAMED RES 5MG N018405 001 Apr 21, 1982
NORETHINDRONE ACETATE
AB AMNEAL PHARMS 5MG A200275 001 Jul 30, 2012
AB BARR 5MG A075951 001 May 25, 2001
AB GLENMARK GENERICS 5MG A091090 001 Jul 21, 2010
NORTRIPTYLINE HYDROCHLORIDE
CAPSULE;ORAL
NORTRIPTYLINE HYDROCHLORIDE
AB MYLAN EQ 10MG BASE A074234 001 Jul 26, 1993
AB EQ 25MG BASE A074234 002 Jul 26, 1993
AB EQ 50MG BASE A074234 003 Jul 26, 1993
AB EQ 75MG BASE A074234 004 Jul 26, 1993
AB TARO EQ 10MG BASE A075520 004 May 08, 2000
AB EQ 25MG BASE A075520 003 May 08, 2000
AB EQ 50MG BASE A075520 001 May 08, 2000
AB EQ 75MG BASE A075520 002 May 08, 2000
AB TEVA EQ 10MG BASE A074132 001 Mar 27, 1995
AB EQ 25MG BASE A074132 002 Mar 27, 1995
AB EQ 50MG BASE A074132 003 Mar 27, 1995
AB EQ 75MG BASE A074132 004 Mar 27, 1995
AB WATSON LABS EQ 10MG BASE A073553 001 Mar 30, 1992
AB EQ 25MG BASE A073554 001 Mar 30, 1992
AB EQ 50MG BASE A073555 001 Mar 30, 1992
AB EQ 75MG BASE A073556 001 Mar 30, 1992
PAMELOR
AB MALLINCKRODT LLC EQ 10MG BASE N018013 001
AB EQ 25MG BASE N018013 002
AB EQ 50MG BASE N018013 004
AB + EQ 75MG BASE N018013 003
SOLUTION;ORAL
NORTRIPTYLINE HYDROCHLORIDE
AA + PHARM ASSOC EQ 10MG BASE/5ML A075606 001 Aug 28, 2000
AA TARO EQ 10MG BASE/5ML A077965 001 Jun 20, 2006
NYSTATIN
CREAM;TOPICAL
NYSTATIN
AT ACTAVIS MID ATLANTIC 100,000 UNITS/GM A062949 001 Jun 13, 1988
AT FOUGERA PHARMS 100,000 UNITS/GM A062129 001
AT PERRIGO NEW YORK 100,000 UNITS/GM A062225 001
AT + TARO 100,000 UNITS/GM A064022 001 Jan 29, 1993
AT VINTAGE 100,000 UNITS/GM A065315 001 May 31, 2006
OINTMENT;TOPICAL
NYSTATIN
AT ACTAVIS MID ATLANTIC 100,000 UNITS/GM A062840 001 Nov 13, 1987
AT + FOUGERA PHARMS 100,000 UNITS/GM A062124 002 Sep 23, 1982
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-268(of 371)
NYSTATIN
OINTMENT;TOPICAL
NYSTATIN
AT PERRIGO NEW YORK 100,000 UNITS/GM A062472 001 Feb 13, 1984
POWDER;TOPICAL
NYSTATIN
AT + COASTAL PHARMS 100,000 UNITS/GM A065203 001 Jul 15, 2004
AT GAVIS PHARMS 100,000 UNITS/GM A065138 001 Jul 23, 2004
AT UPSHER SMITH 100,000 UNITS/GM A065183 001 May 03, 2005
AT X GEN PHARMS 100,000 UNITS/GM A065175 001 Dec 17, 2004
NYSTOP
AT PADDOCK LLC 100,000 UNITS/GM A064118 001 Aug 16, 1996
SUSPENSION;ORAL
NYSTATIN
AA ACTAVIS MID ATLANTIC 100,000 UNITS/ML A062349 001 Jul 14, 1982
AA FOUGERA 100,000 UNITS/ML A062517 001 Jun 07, 1984
AA HI TECH PHARMA 100,000 UNITS/ML A064042 001 Feb 28, 1994
AA TARO 100,000 UNITS/ML A062876 001 Feb 29, 1988
AA VINTAGE PHARMS 100,000 UNITS/ML A065148 001 Jun 28, 2005
AA VISTAPHARM 100,000 UNITS/ML A064142 001 Jun 25, 1998
AA 100,000 UNITS/ML A065422 001 Mar 07, 2011
AA + WOCKHARDT 100,000 UNITS/ML A062512 001 Oct 29, 1984
TABLET;ORAL
NYSTATIN
AA HERITAGE PHARMS INC 500,000 UNITS A062474 001 Dec 22, 1983
AA MUTUAL PHARM 500,000 UNITS A062838 001 Dec 22, 1988
AA + TEVA 500,000 UNITS A062506 001 Jan 16, 1984
TABLET;VAGINAL
NYSTATIN
+ ODYSSEY PHARMS 100,000 UNITS A062615 001 Oct 17, 1985
NYSTATIN; TRIAMCINOLONE ACETONIDE
CREAM;TOPICAL
NYSTATIN AND TRIAMCINOLONE ACETONIDE
AT FOUGERA 100,000 UNITS/GM;0.1% A062599 001 Oct 08, 1985
AT + TARO 100,000 UNITS/GM;0.1% A062364 001 Dec 22, 1987
OINTMENT;TOPICAL
NYSTATIN AND TRIAMCINOLONE ACETONIDE
AT FOUGERA 100,000 UNITS/GM;0.1% A062602 001 Oct 09, 1985
AT + TARO 100,000 UNITS/GM;0.1% A063305 001 Mar 29, 1993
OCTREOTIDE ACETATE
INJECTABLE;INJECTION
OCTREOTIDE ACETATE
AP + EUROHLTH INTL EQ 0.2MG BASE/ML A076330 001 Apr 08, 2005
AP + EQ 1MG BASE/ML A076330 002 Apr 08, 2005
AP FRESENIUS KABI USA EQ 0.2MG BASE/ML A077450 001 Feb 10, 2006
AP EQ 1MG BASE/ML A077450 002 Feb 10, 2006
AP SAGENT PHARMS EQ 0.2MG BASE/ML A091041 001 Nov 12, 2013
AP EQ 1MG BASE/ML A091041 002 Nov 12, 2013
AP SUN PHARM INDS EQ 0.05MG BASE/ML A077329 001 Mar 04, 2008
AP EQ 0.05MG BASE/ML A077372 001 Aug 14, 2007
AP EQ 0.1MG BASE/ML A077329 002 Mar 04, 2008
AP EQ 0.1MG BASE/ML A077372 002 Aug 14, 2007
AP EQ 0.2MG BASE/ML A077330 001 Mar 04, 2008
AP EQ 0.2MG BASE/ML A077373 001 Aug 14, 2007
AP EQ 0.5MG BASE/ML A077329 003 Mar 04, 2008
AP EQ 0.5MG BASE/ML A077372 003 Aug 14, 2007
AP EQ 1MG BASE/ML A077331 001 Mar 04, 2008
AP EQ 1MG BASE/ML A077373 002 Aug 14, 2007
AP TEVA PHARMS USA EQ 0.05MG BASE/ML A075957 001 Oct 03, 2005
AP EQ 0.1MG BASE/ML A075957 002 Oct 03, 2005
AP EQ 0.2MG BASE/ML A075959 001 Nov 21, 2005
AP EQ 0.5MG BASE/ML A075957 003 Oct 03, 2005
AP EQ 1MG BASE/ML A075959 002 Nov 21, 2005
AP WOCKHARDT USA EQ 0.2MG BASE/ML A090986 001 May 11, 2011
AP EQ 1MG BASE/ML A090986 002 May 11, 2011
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
AP + EUROHLTH INTL EQ 0.05MG BASE/ML A076313 001 Mar 28, 2005
AP + EQ 0.1MG BASE/ML A076313 003 Mar 28, 2005
AP + EQ 0.5MG BASE/ML A076313 002 Mar 28, 2005
AP FRESENIUS KABI USA EQ 0.05MG BASE/ML A077457 001 Feb 10, 2006
AP EQ 0.1MG BASE/ML A077457 002 Feb 10, 2006
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-269(of 371)
OCTREOTIDE ACETATE
INJECTABLE;INJECTION
OCTREOTIDE ACETATE (PRESERVATIVE FREE)
AP EQ 0.5MG BASE/ML A077457 003 Feb 10, 2006
AP MYLAN INSTITUTIONAL EQ 0.05MG BASE/ML A079198 001 Feb 10, 2011
AP EQ 0.1MG BASE/ML A079198 002 Feb 10, 2011
AP EQ 0.5MG BASE/ML A079198 003 Feb 10, 2011
AP SAGENT PHARMS EQ 0.05MG BASE/ML A090834 001 Nov 12, 2013
AP EQ 0.1MG BASE/ML A090834 002 Nov 12, 2013
AP EQ 0.5MG BASE/ML A090834 003 Nov 12, 2013
AP WOCKHARDT USA EQ 0.05MG BASE/ML A090985 001 May 11, 2011
AP EQ 0.1MG BASE/ML A090985 002 May 11, 2011
AP EQ 0.5MG BASE/ML A090985 003 May 11, 2011
SANDOSTATIN
AP + NOVARTIS EQ 0.05MG BASE/ML N019667 001 Oct 21, 1988
AP + EQ 0.1MG BASE/ML N019667 002 Oct 21, 1988
AP + EQ 0.2MG BASE/ML N019667 004 Jun 12, 1991
AP + EQ 0.5MG BASE/ML N019667 003 Oct 21, 1988
AP + EQ 1MG BASE/ML N019667 005 Jun 12, 1991
SANDOSTATIN LAR
NOVARTIS EQ 10MG BASE/VIAL N021008 001 Nov 25, 1998
EQ 20MG BASE/VIAL N021008 002 Nov 25, 1998
+ EQ 30MG BASE/VIAL N021008 003 Nov 25, 1998
OFLOXACIN
SOLUTION/DROPS;OPHTHALMIC
OCUFLOX
AT + ALLERGAN 0.3% N019921 001 Jul 30, 1993
OFLOXACIN
AT AKORN 0.3% A076407 001 Apr 15, 2008
AT ALCON PHARMS LTD 0.3% A076231 001 May 14, 2004
AT ALTAIRE PHARMS INC 0.3% A202692 001 Apr 29, 2013
AT BAUSCH AND LOMB 0.3% A076622 001 May 14, 2004
AT FDC LTD 0.3% A078559 001 Feb 25, 2009
AT FERA PHARMS 0.3% A076830 001 Aug 31, 2004
AT HI TECH PHARMA 0.3% A076615 001 May 14, 2004
SOLUTION/DROPS;OTIC
FLOXIN OTIC
AT + DAIICHI 0.3% N020799 001 Dec 16, 1997
OFLOXACIN
AT ALCON PHARMS LTD 0.3% A078222 001 Mar 17, 2008
AT APOTEX INC 0.3% A076527 001 Sep 28, 2007
AT BAUSCH AND LOMB 0.3% A076128 001 Mar 17, 2008
AT FERA PHARMS 0.3% A090395 001 Aug 11, 2009
AT HI TECH PHARMA 0.3% A076616 001 Mar 17, 2008
TABLET;ORAL
OFLOXACIN
AB CADILA PHARMS LTD 200MG A091656 001 Sep 18, 2014
AB 300MG A091656 002 Sep 18, 2014
AB 400MG A091656 003 Sep 18, 2014
AB DR REDDYS LABS LTD 200MG A077098 001 Feb 10, 2006
AB 300MG A077098 002 Feb 10, 2006
AB 400MG A077098 003 Feb 10, 2006
AB TEVA 200MG A076182 001 Sep 02, 2003
AB 300MG A076182 002 Sep 02, 2003
AB + 400MG A076182 003 Sep 02, 2003
OLANZAPINE
INJECTABLE;INTRAMUSCULAR
OLANZAPINE
AP LUITPOLD 10MG/VIAL A201741 001 Mar 20, 2012
AP SANDOZ INC 10MG/VIAL A201588 001 Oct 24, 2011
ZYPREXA
AP + LILLY 10MG/VIAL N021253 001 Mar 29, 2004
TABLET;ORAL
OLANZAPINE
AB APOTEX INC 2.5MG A090798 001 Apr 23, 2012
AB 5MG A090798 002 Apr 23, 2012
AB 7.5MG A090798 003 Apr 23, 2012
AB 10MG A090798 004 Apr 23, 2012
AB 15MG A090798 005 Apr 23, 2012
AB 20MG A090798 006 Apr 23, 2012
AB AUROBINDO PHARMA LTD 2.5MG A202050 001 Apr 23, 2012
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-270(of 371)
OLANZAPINE
TABLET;ORAL
OLANZAPINE
AB 5MG A202050 002 Apr 23, 2012
AB 7.5MG A202050 003 Apr 23, 2012
AB 10MG A202050 004 Apr 23, 2012
AB 15MG A202050 005 Apr 23, 2012
AB 20MG A202050 006 Apr 23, 2012
AB DR REDDYS LABS LTD 2.5MG A076255 001 Apr 23, 2012
AB 5MG A076255 002 Apr 23, 2012
AB 7.5MG A076255 003 Apr 23, 2012
AB 10MG A076255 004 Apr 23, 2012
AB 15MG A076133 001 Apr 23, 2012
AB 20MG A076133 002 Oct 24, 2011
AB MACLEODS PHARMS LTD 2.5MG A202862 001 Aug 15, 2014
AB 5MG A202862 002 Aug 15, 2014
AB 7.5MG A202862 003 Aug 15, 2014
AB 10MG A202862 004 Aug 15, 2014
AB 15MG A202862 005 Aug 15, 2014
AB 20MG A202862 006 Aug 15, 2014
AB MYLAN 2.5MG A076866 001 Apr 23, 2012
AB 5MG A076866 002 Apr 23, 2012
AB 7.5MG A076866 003 Apr 23, 2012
AB 10MG A076866 004 Apr 23, 2012
AB 15MG A076866 005 Apr 23, 2012
AB 20MG A076866 006 Apr 23, 2012
AB ORCHID HLTHCARE 2.5MG A202287 001 Apr 23, 2012
AB 5MG A202287 002 Apr 23, 2012
AB 7.5MG A202287 003 Apr 23, 2012
AB 10MG A202287 004 Apr 23, 2012
AB 15MG A202287 005 Apr 23, 2012
AB 20MG A202287 006 Apr 23, 2012
AB SUN PHARM INDS 2.5MG A091038 001 Apr 23, 2012
AB 5MG A091038 002 Apr 23, 2012
AB 7.5MG A091038 003 Apr 23, 2012
AB 10MG A091038 004 Apr 23, 2012
AB 15MG A091038 005 Apr 23, 2012
AB 20MG A091038 006 Apr 23, 2012
AB TEVA PHARMS 2.5MG A076000 001 Oct 24, 2011
AB 5MG A076000 002 Oct 24, 2011
AB 7.5MG A076000 003 Oct 24, 2011
AB 10MG A076000 004 Oct 24, 2011
AB 15MG A076000 005 Oct 24, 2011
AB TORRENT PHARMS LTD 2.5MG A091434 001 Apr 23, 2012
AB 5MG A091434 002 Apr 23, 2012
AB 7.5MG A091434 003 Apr 23, 2012
AB 10MG A091434 004 Apr 23, 2012
AB 15MG A091434 005 Apr 23, 2012
AB 20MG A091434 006 Apr 23, 2012
ZYPREXA
AB LILLY 2.5MG N020592 001 Sep 30, 1996
AB + 5MG N020592 002 Sep 30, 1996
AB 7.5MG N020592 003 Sep 30, 1996
AB 10MG N020592 004 Sep 30, 1996
AB 15MG N020592 005 Sep 09, 1997
AB 20MG N020592 006 Sep 09, 1997
TABLET, ORALLY DISINTEGRATING;ORAL
OLANZAPINE
AB APOTEX INC 5MG A091265 001 Oct 24, 2011
AB 10MG A091265 002 Oct 24, 2011
AB 15MG A091265 003 Oct 24, 2011
AB 20MG A091265 004 Oct 24, 2011
AB AUROBINDO PHARMA LTD 5MG A203708 001 May 15, 2014
AB 10MG A203708 002 May 15, 2014
AB 15MG A203708 003 May 15, 2014
AB 20MG A203708 004 May 15, 2014
AB BARR LABS INC 5MG A077243 001 Jan 30, 2012
AB 10MG A077243 002 Jan 30, 2012
AB 15MG A077243 003 Jan 30, 2012
AB 20MG A077243 004 Jan 30, 2012
AB DR REDDYS LABS LTD 5MG A076534 001 Oct 24, 2011
AB 10MG A076534 002 Oct 24, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-271(of 371)
OLANZAPINE
TABLET, ORALLY DISINTEGRATING;ORAL
OLANZAPINE
AB 15MG
A076534 003 Oct 24, 2011
AB 20MG
A076534 004 Oct 24, 2011
AB JUBILANT GENERICS 5MG
A200221 001 Sep 12, 2012
AB 10MG
A200221 002 Sep 12, 2012
AB 15MG
A200221 003 Sep 12, 2012
AB 20MG
A200221 004 Sep 12, 2012
AB MYLAN PHARMS INC 5MG
A202285 001 May 12, 2014
AB 10MG
A202285 002 May 12, 2014
AB 15MG
A202285 003 May 12, 2014
AB 20MG
A202285 004 May 12, 2014
AB PAR PHARM 5MG
A078109 001 Oct 24, 2011
AB 10MG
A078109 002 Oct 24, 2011
AB 15MG
A078109 003 Oct 24, 2011
AB 20MG
A078109 004 Oct 24, 2011
AB SUN PHARM INDS 5MG
A090881 001 Feb 28, 2012
AB 10MG
A090881 002 Feb 28, 2012
AB 15MG
A090881 003 Feb 28, 2012
AB 20MG
A090881 004 Feb 28, 2012
AB TORRENT PHARMS LLC 5MG
A091415 001 Oct 25, 2011
AB 10MG
A091415 002 Oct 25, 2011
AB 15MG
A091415 003 Oct 25, 2011
AB 20MG
A091415 004 Oct 25, 2011
ZYPREXA ZYDIS
AB + LILLY 5MG N021086 001 Apr 06, 2000
AB 10MG N021086 002 Apr 06, 2000
AB 15MG N021086 003 Apr 06, 2000
AB 20MG N021086 004 Apr 06, 2000
OLANZAPINE PAMOATE
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
ZYPREXA RELPREVV
ELI LILLY CO
EQ 210MG BASE/VIAL
N022173 001 Dec 11, 2009
EQ 300MG BASE/VIAL
N022173 002 Dec 11, 2009
+
EQ 405MG BASE/VIAL
N022173 003 Dec 11, 2009
OLAPARIB
CAPSULE;ORAL
OLAPARIB
ASTRAZENECA PHARMS
50MG
N206162 001 Dec 19, 2014
OLIVE OIL; SOYBEAN OIL
INJECTABLE;INJECTION
CLINOLIPID 20%
+ BAXTER HLTHCARE
16%(160GM/1000ML);4% (40GM/1000ML)
N204508 001 Oct 03, 2013
OLMESARTAN MEDOXOMIL
TABLET;ORAL
BENICAR
DAIICHI SANKYO
5MG
N021286 001 Apr 25, 2002
20MG
N021286 003 Apr 25, 2002
+
40MG
N021286 004 Apr 25, 2002
OLODATEROL HYDROCHLORIDE
SPRAY, METERED;INHALATION
STRIVERDI RESPIMAT
+ BOEHRINGER INGELHEIM
EQ 0.0025MG BASE/INH
N203108 001 Jul 31, 2014
OLOPATADINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
PATADAY
+ ALCON PHARMS LTD
EQ 0.2% BASE
N021545 001 Dec 22, 2004
PATANOL
+ ALCON
EQ 0.1% BASE
N020688 001 Dec 18, 1996
SPRAY, METERED;NASAL
OLOPATADINE HYDROCHLORIDE
AB APOTEX INC 0.665MG/SPRAY
A091572 001 Oct 08, 2014
PATANASE
AB + ALCON PHARMS LTD 0.665MG/SPRAY
N021861 001 Apr 15, 2008
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-272(of 371)
OLSALAZINE SODIUM
CAPSULE;ORAL
DIPENTUM
+ MEDA PHARMS 250MG N019715 001 Jul 31, 1990
OMACETAXINE MEPESUCCINATE
POWDER;SUBCUTANEOUS
SYNRIBO
+ IVAX INTL 3.5MG/VIAL N203585 001 Oct 26, 2012
OMEGA-3-ACID ETHYL ESTERS
CAPSULE;ORAL
LOVAZA
AB + SMITHKLINE BEECHAM 1GM CONTAINS AT LEAST 900MG OF THE N021654 001 Nov 10, 2004
ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
OMEGA-3-ACID ETHYL ESTERS
AB APOTEX INC 1GM CONTAINS AT LEAST 900MG OF THE A090973 001 Sep 30, 2014
ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
AB PAR PHARM INC 1GM CONTAINS AT LEAST 900MG OF THE A091018 001 Jun 24, 2014
ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
AB TEVA PHARMS USA 1GM CONTAINS AT LEAST 900MG OF THE A091028 001 Apr 07, 2014
ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
OMTRYG
+ TRYGG 1.2GM CONTAINS AT LEAST 900MG OF THE N204977 001 Apr 23, 2014
ETHYL ESTERS OF OMEGA-3 FATTY ACIDS
OMEGA-3-CARBOXYLIC ACIDS
CAPSULE;ORAL
EPANOVA
+ ASTRAZENECA PHARMS 1GM CONTAINS AT LEAST 850MG OF N205060 001 May 05, 2014
POLYUNSATURATED FATTY ACIDS
OMEPRAZOLE
CAPSULE, DELAYED REL PELLETS;ORAL
OMEPRAZOLE
AB ACTAVIS LABS FL INC 10MG A075347 001 May 30, 2008
AB 20MG A075347 002 May 30, 2008
AB 40MG A075347 003 May 30, 2008
AB APOTEX 10MG A076048 001 Oct 22, 2007
AB 20MG A076048 002 Oct 22, 2007
AB 40MG A076048 003 Jan 21, 2009
AB DR REDDYS LABS LTD 10MG A075576 003 Oct 22, 2007
AB 10MG A078490 002 Mar 16, 2009
AB 20MG A075576 002 Oct 22, 2007
AB 20MG A078490 003 Mar 16, 2009
AB 40MG A075576 001 Jan 21, 2009
AB 40MG A078490 001 Apr 17, 2009
AB GLENMARK GENERICS 10MG A091672 001 Oct 31, 2014
AB 20MG A091672 002 Oct 31, 2014
AB 40MG A091672 003 Oct 31, 2014
AB IMPAX LABS 10MG A075785 001 Oct 22, 2007
AB 20MG A075785 002 Oct 22, 2007
AB 40MG A075785 003 Jan 21, 2009
AB KREMERS URBAN PHARMS 10MG A075410 001 Nov 01, 2002
AB 20MG A075410 002 Nov 01, 2002
AB 40MG A075410 003 Jan 23, 2009
AB MYLAN 10MG A075876 001 May 29, 2003
AB 20MG A075876 002 May 29, 2003
AB 40MG A075876 003 Jan 21, 2009
AB SANDOZ 10MG A075757 001 Jan 28, 2003
AB 20MG A075757 002 Jan 28, 2003
AB 40MG A076515 001 Jan 21, 2009
AB ZYDUS PHARMS USA INC 10MG A091352 001 Nov 19, 2012
AB 20MG A091352 002 Nov 19, 2012
AB 40MG A091352 003 Nov 19, 2012
PRILOSEC
AB ASTRAZENECA PHARMS 10MG N019810 003 Oct 05, 1995
AB + 20MG N019810 001 Sep 14, 1989
AB + 40MG N019810 002 Jan 15, 1998
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-273(of 371)
OMEPRAZOLE MAGNESIUM
FOR SUSPENSION, DELAYED RELEASE;ORAL
PRILOSEC
ASTRAZENECA PHARMS EQ 2.5MG BASE/PACKET N022056 001 Mar 20, 2008
+ EQ 10MG BASE/PACKET N022056 002 Mar 20, 2008
OMEPRAZOLE; SODIUM BICARBONATE
CAPSULE;ORAL
OMEPRAZOLE AND SODIUM BICARBONATE
AB PAR PHARM 20MG;1.1GM
A078966 001 May 25, 2010
AB 40MG;1.1GM
A078966 002 May 25, 2010
ZEGERID
AB SANTARUS INC 20MG;1.1GM
N021849 001 Feb 27, 2006
AB + 40MG;1.1GM
N021849 002 Feb 27, 2006
FOR SUSPENSION;ORAL
ZEGERID
SANTARUS INC
20MG/PACKET;1.68GM/PACKET
N021636 001 Jun 15, 2004
+
40MG/PACKET;1.68GM/PACKET
N021636 002 Dec 21, 2004
ONDANSETRON
FILM;ORAL
ZUPLENZ
GALENA BIOPHARMA INC 4MG
N022524 001 Jul 02, 2010
+ 8MG
N022524 002 Jul 02, 2010
TABLET, ORALLY DISINTEGRATING;ORAL
ONDANSETRON
AB AUROBINDO PHARMA 4MG
A090469 001 Apr 12, 2010
AB 8MG
A090469 002 Apr 12, 2010
AB BARR 4MG
A076693 001 Jun 25, 2007
AB 8MG
A076693 002 Jun 25, 2007
AB GLENMARK GENERICS 4MG
A078152 001 Jun 27, 2007
AB 8MG
A078152 002 Jun 27, 2007
AB MYLAN 4MG
A078139 001 Jun 25, 2007
AB 8MG
A078139 002 Jun 25, 2007
AB RANBAXY 4MG
A078602 001 Feb 24, 2011
AB 8MG
A078602 002 Feb 24, 2011
AB SANDOZ 4MG
A078050 001 Aug 13, 2007
AB 8MG
A078050 002 Aug 13, 2007
AB SUN PHARM INDS 4MG
A077557 001 Aug 02, 2007
AB 8MG
A077557 002 Aug 02, 2007
AB TEVA 4MG
A076810 001 Jun 25, 2007
AB 8MG
A076810 002 Jun 25, 2007
ZOFRAN ODT
AB GLAXOSMITHKLINE 4MG
N020781 001 Jan 27, 1999
AB + 8MG
N020781 002 Jan 27, 1999
ONDANSETRON HYDROCHLORIDE
INJECTABLE;INJECTION
ONDANSETRON HYDROCHLORIDE
AP AGILA SPECLTS
EQ 2MG BASE/ML
A078257 001 Apr 23, 2008
AP AUROBINDO PHARMA LTD
EQ 2MG BASE/ML
A202599 001 Dec 21, 2012
AP BEDFORD
EQ 2MG BASE/ML
A076967 001 Dec 26, 2006
AP CLARIS LIFESCIENCES
EQ 2MG BASE/ML
A078288 001 Feb 22, 2013
AP EMCURE PHARMS
EQ 2MG BASE/ML
A090424 001 Apr 16, 2010
AP FRESENIUS KABI USA
EQ 2MG BASE/ML
A076974 001 Dec 26, 2006
AP GLAND PHARMA LTD
EQ 2MG BASE/ML
A079224 001 Sep 25, 2009
AP
EQ 2MG BASE/ML
A090648 001 Jun 15, 2012
AP HIKMA FARMACEUTICA
EQ 2MG BASE/ML
A076781 001 Dec 26, 2006
AP HIKMA MAPLE
EQ 2MG BASE/ML
A077365 001 Dec 26, 2006
AP HOSPIRA
EQ 2MG BASE/ML
A077473 001 Dec 26, 2006
AP
EQ 2MG BASE/ML
A077840 001 Jan 19, 2007
AP LANNETT
EQ 2MG BASE/ML
A090883 001 Aug 05, 2010
AP LUITPOLD
EQ 2MG BASE/ML
A079039 001 Nov 18, 2008
AP QILU PHARM CO LTD
EQ 2MG BASE/ML
A203711 001 Sep 08, 2014
AP SANDOZ
EQ 2MG BASE/ML
A077430 001 Jun 27, 2007
AP SUN PHARM INDS (IN)
EQ 2MG BASE/ML
A077172 001 Dec 26, 2006
AP TEVA
EQ 2MG BASE/ML
A076876 001 Nov 22, 2006
AP WOCKHARDT
EQ 2MG BASE/ML
A077577 001 Dec 26, 2006
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
AP AGILA SPECLTS EQ 2MG BASE/ML
A078244 001 Apr 23, 2008
AP AUROBINDO PHARMA LTD EQ 2MG BASE/ML
A202600 001 Dec 21, 2012
AP BD RX EQ 2MG BASE/ML
A202253 001 Jul 19, 2013
AP BEDFORD LABS EQ 2MG BASE/ML
A077011 001 Dec 26, 2006
AP CLARIS LIFESCIENCES EQ 2MG BASE/ML
A078287 001 Feb 22, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-274(of 371)
ONDANSETRON HYDROCHLORIDE
INJECTABLE;INJECTION
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
AP EMCURE PHARMS LTD
EQ 2MG BASE/ML
A078945 001 Jan 03, 2013
AP FRESENIUS KABI USA
EQ 2MG BASE/ML
A076972 001 Dec 26, 2006
AP HIKMA FARMACEUTICA
EQ 2MG BASE/ML
A076780 001 Dec 26, 2006
AP HIKMA MAPLE
EQ 2MG BASE/ML
A077541 001 Dec 26, 2006
AP HOSPIRA
EQ 2MG BASE/ML
A077548 001 Dec 26, 2006
AP LUITPOLD
EQ 2MG BASE/ML
A079032 001 Nov 18, 2008
AP SANDOZ
EQ 2MG BASE/ML
A077551 001 Jun 27, 2007
AP SUN PHARM INDS LTD
EQ 2MG BASE/ML
A077173 001 Dec 26, 2006
AP TARO PHARMS IRELAND
EQ 2MG BASE/ML
A078014 001 Mar 21, 2008
AP TEVA
EQ 2MG BASE/ML
A076759 001 Nov 22, 2006
AP WOCKHARDT
EQ 2MG BASE/ML
A077716 001 Dec 26, 2006
ZOFRAN
AP + GLAXOSMITHKLINE
EQ 2MG BASE/ML
N020007 001 Jan 04, 1991
ZOFRAN PRESERVATIVE FREE
AP + GLAXOSMITHKLINE
EQ 2MG BASE/ML
N020007 003 Dec 10, 1993
SOLUTION;ORAL
ONDANSETRON HYDROCHLORIDE
AA AMNEAL PHARMS
EQ 4MG BASE/5ML
A091483 001 Jan 31, 2011
AA APOTEX
EQ 4MG BASE/5ML
A078127 001 Jun 25, 2007
AA AUROBINDO PHARMA
EQ 4MG BASE/5ML
A078776 001 Nov 28, 2007
AA ROXANE
EQ 4MG BASE/5ML
A076960 001 Dec 26, 2006
AA SILARX
EQ 4MG BASE/5ML
A091342 001 Jan 27, 2011
AA TARO
EQ 4MG BASE/5ML
A077009 001 Nov 30, 2007
ZOFRAN
AA + GLAXOSMITHKLINE
EQ 4MG BASE/5ML
N020605 001 Jan 24, 1997
TABLET;ORAL
ONDANSETRON HYDROCHLORIDE
AB APOTEX
EQ 4MG BASE
A077306 001 Jun 25, 2007
AB
EQ 8MG BASE
A077306 002 Jun 25, 2007
AB AUROBINDO PHARMA
EQ 4MG BASE
A078539 001 Jul 31, 2007
AB
EQ 8MG BASE
A078539 002 Jul 31, 2007
AB
EQ 24MG BASE
A078539 003 Jul 31, 2007
AB DR REDDYS LABS LTD
EQ 4MG BASE
A076183 003 Dec 26, 2006
AB
EQ 8MG BASE
A076183 002 Dec 26, 2006
AB
EQ 24MG BASE
A076183 001 Dec 26, 2006
AB GLENMARK GENERICS
EQ 4MG BASE
A077535 001 Jun 25, 2007
AB
EQ 8MG BASE
A077535 002 Jun 25, 2007
AB
EQ 24MG BASE
A077535 003 Jun 25, 2007
AB IPCA LABS LTD
EQ 4MG BASE
A203761 001 Jan 23, 2014
AB
EQ 8MG BASE
A203761 002 Jan 23, 2014
AB MYLAN
EQ 4MG BASE
A076930 001 Jun 25, 2007
AB
EQ 8MG BASE
A076930 002 Jun 25, 2007
AB
EQ 24MG BASE
A076930 004 Jun 25, 2007
AB NATCO PHARMA LTD
EQ 4MG BASE
A077851 001 Jun 25, 2007
AB
EQ 8MG BASE
A077851 002 Jun 25, 2007
AB PLIVA HRVATSKA DOO
EQ 4MG BASE
A077112 001 Jun 25, 2007
AB
EQ 8MG BASE
A077112 002 Jun 25, 2007
AB
EQ 24MG BASE
A077112 003 Jun 25, 2007
AB SANDOZ
EQ 4MG BASE
A077517 001 Jun 25, 2007
AB
EQ 8MG BASE
A077517 002 Jun 25, 2007
AB
EQ 24MG BASE
A077517 003 Jun 25, 2007
AB SUN PHARM INDS (IN)
EQ 4MG BASE
A077050 001 Jun 25, 2007
AB
EQ 8MG BASE
A077050 002 Jun 25, 2007
AB TEVA
EQ 4MG BASE
A076252 001 Jun 25, 2007
AB
EQ 8MG BASE
A076252 002 Jun 25, 2007
AB
EQ 24MG BASE
A076252 003 Jun 25, 2007
ZOFRAN
AB GLAXOSMITHKLINE
EQ 4MG BASE
N020103 001 Dec 31, 1992
AB
EQ 8MG BASE
N020103 002 Dec 31, 1992
AB +
EQ 24MG BASE
N020103 003 Aug 27, 1999
ONDANSETRON HYDROCHLORIDE
DR REDDYS LABS LTD
EQ 16MG BASE
A076183 004 Dec 26, 2006
ORITAVANCIN DIPHOSPHATE
POWDER;IV (INFUSION)
ORBACTIV
+ MEDICINES CO EQ 400MG BASE/VIAL N206334 001 Aug 06, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-275(of 371)
ORLISTAT
CAPSULE;ORAL
XENICAL
+ HOFFMANN LA ROCHE 120MG N020766 001 Apr 23, 1999
ORPHENADRINE CITRATE
INJECTABLE;INJECTION
NORFLEX
AP + MEDICIS 30MG/ML N013055 001
ORPHENADRINE CITRATE
AP AKORN 30MG/ML A040484 001 May 24, 2006
AP EUROHLTH INTL 30MG/ML A040463 001 Mar 04, 2003
AP SAGENT PHARMS 30MG/ML A090585 001 Aug 30, 2011
AP WATSON LABS 30MG/ML A084779 001 Mar 15, 1982
TABLET, EXTENDED RELEASE;ORAL
ORPHENADRINE CITRATE
AB GAVIS PHARMS 100MG A040284 001 Jun 19, 1998
AB IMPAX PHARMS 100MG A040368 001 Jun 23, 2000
AB INVAGEN PHARMS 100MG A091158 001 Jul 27, 2012
AB + SANDOZ 100MG A040327 001 Feb 15, 2000
AB TEDOR PHARMA INC 100MG A040249 001 Jan 29, 1999
OSELTAMIVIR PHOSPHATE
CAPSULE;ORAL
TAMIFLU
ROCHE EQ 30MG BASE N021087 003 Jul 02, 2007
EQ 45MG BASE N021087 002 Jul 02, 2007
+ EQ 75MG BASE N021087 001 Oct 27, 1999
FOR SUSPENSION;ORAL
TAMIFLU
+ ROCHE EQ 6MG BASE/ML N021246 002 Mar 21, 2011
OSPEMIFENE
TABLET;ORAL
OSPHENA
+ SHIONOGI INC 60MG N203505 001 Feb 26, 2013
OXACILLIN SODIUM
INJECTABLE;INJECTION
OXACILLIN SODIUM
AP AGILA SPECLTS EQ 1GM BASE/VIAL A091486 001 Aug 25, 2014
AP EQ 2GM BASE/VIAL A091486 002 Aug 25, 2014
AP AUROBINDO PHARMA LTD EQ 1GM BASE/VIAL A201539 001 Jan 18, 2013
AP EQ 2GM BASE/VIAL A201539 002 Jan 18, 2013
AP EQ 10GM BASE/VIAL A201538 001 Jan 18, 2013
AP SAGENT PHARMS EQ 1GM BASE/VIAL A091246 001 Mar 30, 2012
AP EQ 2GM BASE/VIAL A091246 002 Mar 30, 2012
AP EQ 10GM BASE/VIAL A091245 001 Mar 30, 2012
AP + SANDOZ EQ 1GM BASE/VIAL A061490 003
AP + EQ 2GM BASE/VIAL A061490 004
AP + EQ 10GM BASE/VIAL A061490 006 May 09, 1991
BACTOCILL IN PLASTIC CONTAINER
+ BAXTER HLTHCARE EQ 20MG BASE/ML N050640 001 Oct 26, 1989
+ EQ 40MG BASE/ML N050640 002 Oct 26, 1989
POWDER;INTRAVENOUS
OXACILLIN SODIUM
AP + SANDOZ EQ 1GM BASE/VIAL A062737 001 Dec 23, 1986
AP + EQ 2GM BASE/VIAL A062737 002 Dec 23, 1986
OXALIPLATIN
INJECTABLE;IV (INFUSION)
ELOXATIN
AP + SANOFI AVENTIS US 50MG/10ML (5MG/ML) N021759 001 Jan 31, 2005
AP + 100MG/20ML (5MG/ML) N021759 002 Jan 31, 2005
OXALIPLATIN
AP ACTAVIS TOTOWA 50MG/VIAL A078803 001 Aug 08, 2012
AP 100MG/VIAL A078803 002 Aug 08, 2012
AP EBEWE PHARMA 50MG/10ML (5MG/ML) A078812 001 Aug 07, 2009
AP 100MG/20ML (5MG/ML) A078812 002 Aug 07, 2009
AP FRESENIUS KABI ONCOL 50MG/10ML (5MG/ML) A078811 001 Jun 10, 2010
AP 100MG/20ML (5MG/ML) A078811 002 Jun 10, 2010
AP 50MG/VIAL A078810 001 Aug 07, 2009
AP 100MG/VIAL A078810 002 Aug 07, 2009
AP FRESENIUS KABI USA 50MG/VIAL A078819 001 Jun 02, 2010
AP 100MG/VIAL A078819 002 Jun 02, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-276(of 371)
OXALIPLATIN
INJECTABLE;IV (INFUSION)
OXALIPLATIN
AP HOSPIRA INC 50MG/VIAL A078815 001 Sep 30, 2009
AP 100MG/VIAL A078815 002 Sep 30, 2009
AP HOSPIRA WORLDWIDE 50MG/10ML (5MG/ML) A078813 001 Aug 07, 2009
AP 100MG/20ML (5MG/ML) A078813 002 Aug 07, 2009
AP JIANGSU HENGRUI MED 50MG/10ML (5MG/ML) A203869 001 Jun 18, 2014
AP 100MG/20ML (5MG/ML) A203869 002 Jun 18, 2014
AP ONCO THERAPIES LTD 50MG/10ML (5MG/ML) A091358 001 Aug 07, 2012
AP 50MG/VIAL A200979 001 Aug 08, 2012
AP 100MG/20ML (5MG/ML) A091358 002 Aug 07, 2012
AP 100MG/VIAL A200979 002 Aug 08, 2012
AP SANDOZ 50MG/10ML (5MG/ML) A078817 001 Jan 24, 2011
AP 100MG/20ML (5MG/ML) A078817 002 Jan 24, 2011
AP + SUN PHARMA GLOBAL 50MG/VIAL A078818 001 Aug 07, 2009
AP 50MG/10ML (5MG/ML) A202922 001 Apr 08, 2014
AP + 100MG/VIAL A078818 002 Aug 07, 2009
AP 100MG/20ML (5MG/ML) A202922 002 Apr 08, 2014
AP + TEVA PHARMS 50MG/10ML (5MG/ML) N022160 001 Aug 07, 2009
AP + 100MG/20ML (5MG/ML) N022160 002 Aug 07, 2009
ELOXATIN
+ SANOFI AVENTIS US 200MG/40ML (5MG/ML) N021759 003 Nov 17, 2006
OXANDROLONE
TABLET;ORAL
OXANDRIN
AB CREALTA PHARMS LLC 2.5MG N013718 001
AB + 10MG N013718 002 Nov 05, 2001
OXANDROLONE
AB PAR PHARM 2.5MG A077827 001 Jun 22, 2007
AB 10MG A077827 002 Jun 22, 2007
AB UPSHER SMITH 2.5MG A076761 001 Dec 01, 2006
AB 10MG A078033 001 Mar 22, 2007
OXAPROZIN
TABLET;ORAL
DAYPRO
AB + GD SEARLE 600MG N018841 004 Oct 29, 1992
OXAPROZIN
AB APOTEX INC 600MG A075987 001 Sep 02, 2004
AB DR REDDYS LABS LTD 600MG A075855 001 Jan 31, 2001
AB IVAX SUB TEVA PHARMS 600MG A075846 001 May 13, 2002
AB SANDOZ 600MG A075845 001 Jan 31, 2001
AB SUN PHARM INDS INC 600MG A075844 001 Jan 03, 2002
AB TEVA 600MG A075849 001 Jul 03, 2002
OXAZEPAM
CAPSULE;ORAL
OXAZEPAM
AB ACTAVIS ELIZABETH 10MG A072251 001 Apr 14, 1988
AB 15MG A072252 001 Apr 14, 1988
AB + 30MG A072253 001 Apr 14, 1988
AB SANDOZ 10MG A071813 001 Apr 19, 1988
AB 15MG A071756 001 Apr 19, 1988
AB 30MG A071814 001 Apr 19, 1988
OXCARBAZEPINE
SUSPENSION;ORAL
OXCARBAZEPINE
AB AMNEAL PHARMS 300MG/5ML A202961 001 Sep 17, 2012
AB RANBAXY 300MG/5ML A078734 001 Jun 26, 2009
AB ROXANE 300MG/5ML A201193 001 Oct 03, 2012
TRILEPTAL
AB + NOVARTIS 300MG/5ML N021285 001 May 25, 2001
TABLET;ORAL
OXCARBAZEPINE
AB APOTEX INC 150MG A077747 001 Apr 09, 2008
AB 300MG A077747 002 Apr 09, 2008
AB 600MG A077747 003 Apr 09, 2008
AB BRECKENRIDGE PHARM 150MG A078069 001 Jan 11, 2008
AB 300MG A078069 002 Jan 11, 2008
AB 600MG A078069 003 Jan 11, 2008
AB CADISTA PHARMS 150MG A090239 001 Jan 25, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-277(of 371)
OXCARBAZEPINE
TABLET;ORAL
OXCARBAZEPINE
AB 300MG A090239 002 Jan 25, 2010
AB 600MG A090239 003 Jan 25, 2010
AB GLENMARK GENERICS 150MG A077802 001 Oct 09, 2007
AB 300MG A077802 002 Oct 09, 2007
AB 600MG A077802 003 Oct 09, 2007
AB ROXANE 150MG A077795 001 Oct 09, 2007
AB 300MG A077795 002 Oct 09, 2007
AB 600MG A077795 003 Oct 09, 2007
AB SUN PHARM INDS 150MG A077794 001 Oct 09, 2007
AB 300MG A077794 002 Oct 09, 2007
AB 600MG A077794 003 Oct 09, 2007
AB TARO 150MG A077801 001 Nov 15, 2007
AB 300MG A077801 002 Nov 15, 2007
AB 600MG A077801 003 Nov 15, 2007
TRILEPTAL
AB NOVARTIS 150MG N021014 001 Jan 14, 2000
AB 300MG N021014 002 Jan 14, 2000
AB + 600MG N021014 003 Jan 14, 2000
TABLET, EXTENDED RELEASE;ORAL
OXTELLAR XR
SUPERNUS PHARMS 150MG N202810 001 Oct 19, 2012
300MG N202810 002 Oct 19, 2012
+ 600MG N202810 003 Oct 19, 2012
OXICONAZOLE NITRATE
CREAM;TOPICAL
OXISTAT
+ FOUGERA PHARMS EQ 1% BASE N019828 001 Dec 30, 1988
LOTION;TOPICAL
OXISTAT
+ FOUGERA PHARMS EQ 1% BASE N020209 001 Sep 30, 1992
OXTRIPHYLLINE
TABLET, EXTENDED RELEASE;ORAL
CHOLEDYL SA
+ WARNER CHILCOTT LLC 400MG A087863 001 May 24, 1983
+ 600MG A086742 001
OXYBUTYNIN
FILM, EXTENDED RELEASE;TRANSDERMAL
OXYBUTYNIN
AB BARR LABS DIV TEVA 3.9MG/24HR A090526 001 Mar 04, 2014
OXYTROL
AB + WATSON LABS (UTAH) 3.9MG/24HR N021351 002 Feb 26, 2003
GEL, METERED;TRANSDERMAL
GELNIQUE 3%
+ WATSON LABS INC 3% N202513 001 Dec 07, 2011
OXYBUTYNIN CHLORIDE
GEL;TRANSDERMAL
GELNIQUE
+ WATSON LABS 10%(100MG/PACKET) N022204 001 Jan 27, 2009
SYRUP;ORAL
OXYBUTYNIN CHLORIDE
AA PHARM ASSOC 5MG/5ML A075137 001 Dec 18, 1998
AA SILARX 5MG/5ML A074520 001 Mar 29, 1996
AA VINTAGE PHARMS 5MG/5ML A076682 001 Dec 28, 2004
AA + WOCKHARDT 5MG/5ML A074868 001 Feb 12, 1997
TABLET;ORAL
OXYBUTYNIN CHLORIDE
AB TEVA PHARMS USA 5MG A071655 001 Nov 14, 1988
AB USL PHARMA 5MG A074625 001 Jul 31, 1996
AB + VINTAGE PHARMS 5MG A075079 001 Oct 31, 1997
TABLET, EXTENDED RELEASE;ORAL
DITROPAN XL
AB JANSSEN PHARMS 5MG N020897 001 Dec 16, 1998
AB 10MG N020897 002 Dec 16, 1998
AB + 15MG N020897 003 Jun 22, 1999
OXYBUTYNIN CHLORIDE
AB IMPAX PHARMS 5MG A076745 002 May 09, 2007
AB 10MG A076745 003 May 09, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-278(of 371)
OXYBUTYNIN CHLORIDE
TABLET, EXTENDED RELEASE;ORAL
OXYBUTYNIN CHLORIDE
AB
15MG
A076745 001 Nov 09, 2006
AB MYLAN
5MG
A076702 001 Nov 09, 2006
AB MYLAN PHARMS INC
10MG
A076644 001 Nov 09, 2006
AB
15MG
A076644 002 May 10, 2007
AB OSMOTICA PHARM
5MG
A078503 001 Feb 04, 2009
AB
10MG
A078503 002 Feb 04, 2009
AB
15MG
A078503 003 Feb 04, 2009
OXYCODONE HYDROCHLORIDE
CAPSULE;ORAL
OXYCODONE HYDROCHLORIDE
AB COASTAL PHARMS 5MG
A203107 001 Jul 26, 2012
AB LANNETT HOLDINGS INC 5MG
A203823 001 Aug 01, 2014
AB + LEHIGH VALLEY 5MG
N200534 001 Oct 20, 2010
SOLUTION;ORAL
OXYCODONE HYDROCHLORIDE
AA COASTAL PHARMS
100MG/5ML
A204092 001 Jun 05, 2014
AA LANNETT HOLDINGS INC
100MG/5ML
A204085 001 Sep 09, 2014
AA LEHIGH VALLEY
5MG/5ML
N200535 002 Aug 22, 2013
AA +
100MG/5ML
N200535 001 Oct 20, 2010
AA ROXANE
5MG/5ML
A204037 001 Jul 15, 2013
AA
100MG/5ML
A203208 001 Jul 12, 2013
AA + VISTAPHARM
5MG/5ML
N201194 001 Jan 12, 2012
AA
100MG/5ML
A202537 001 Jul 30, 2012
TABLET;ORAL
OXYCODONE HYDROCHLORIDE
AB ACTAVIS ELIZABETH
15MG
A076636 001 Feb 06, 2004
AB
30MG
A076636 002 Feb 06, 2004
AB ALVOGEN INC
5MG
A202116 001 Dec 30, 2011
AB
15MG
A202116 002 Dec 30, 2011
AB
30MG
A202116 003 Dec 30, 2011
AB AMNEAL PHARMS
5MG
A203638 001 Jun 03, 2014
AB
10MG
A203638 002 Jun 03, 2014
AB
15MG
A203638 003 Jun 03, 2014
AB
20MG
A203638 004 Jun 03, 2014
AB
30MG
A203638 005 Jun 03, 2014
AB AUROLIFE PHARMA LLC
5MG
A202160 001 Nov 19, 2012
AB
15MG
A202160 002 Nov 19, 2012
AB
30MG
A202160 003 Nov 19, 2012
AB AVANTHI INC
5MG
A091393 001 Aug 31, 2009
AB
10MG
A091393 002 Aug 31, 2009
AB
15MG
A091393 003 Aug 31, 2009
AB
20MG
A091393 004 Aug 31, 2009
AB
30MG
A091393 005 Aug 31, 2009
AB COASTAL PHARMS
5MG
A091313 001 Feb 18, 2011
AB
15MG
A091313 002 Feb 18, 2011
AB
30MG
A091313 003 Feb 18, 2011
AB COREPHARMA
5MG
A090895 001 Aug 24, 2009
AB
15MG
A090895 002 Aug 24, 2009
AB
30MG
A090895 003 Aug 24, 2009
AB MALLINCKRODT INC
5MG
A076758 003 Mar 19, 2007
AB
15MG
A076758 001 Jun 30, 2004
AB
30MG
A076758 002 Jun 30, 2004
AB NESHER PHARMS
5MG
A077290 001 Dec 08, 2005
AB
10MG
A077290 002 Dec 08, 2005
AB
15MG
A077290 003 Dec 08, 2005
AB
20MG
A077290 004 Dec 08, 2005
AB
30MG
A077290 005 Dec 08, 2005
AB RHODES PHARMS
5MG
A091490 001 Mar 09, 2011
AB
10MG
A091490 002 Mar 09, 2011
AB
15MG
A091490 003 Mar 09, 2011
AB
20MG
A091490 004 Mar 09, 2011
AB
30MG
A091490 005 Mar 09, 2011
AB SUN PHARM INDS INC
5MG
A090659 001 Apr 10, 2009
AB
10MG
A090659 005 Nov 06, 2012
AB
15MG
A090659 002 Apr 10, 2009
AB
20MG
A090659 004 Nov 06, 2012
AB
30MG
A090659 003 Apr 10, 2009
AB VINTAGE PHARMS
5MG
A077712 003 Mar 02, 2009
AB
15MG
A077712 001 Jan 31, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-279(of 371)
OXYCODONE HYDROCHLORIDE
TABLET;ORAL
OXYCODONE HYDROCHLORIDE
AB
30MG
A077712 002 Jan 31, 2007
ROXICODONE
AB MALLINCKRODT INC
5MG
N021011 003 May 15, 2009
AB +
15MG
N021011 001 Aug 31, 2000
AB
30MG
N021011 002 Aug 31, 2000
OXECTA
ACURA PHARMS INC
5MG
N202080 001 Jun 17, 2011
7.5MG
N202080 002 Jun 17, 2011
TABLET, EXTENDED RELEASE;ORAL
OXYCONTIN
PURDUE PHARMA LP
10MG
N022272 001 Apr 05, 2010
15MG
N022272 002 Apr 05, 2010
20MG
N022272 003 Apr 05, 2010
30MG
N022272 004 Apr 05, 2010
+
40MG
N022272 005 Apr 05, 2010
60MG
N022272 006 Apr 05, 2010
80MG
N022272 007 Apr 05, 2010
OXYMETHOLONE
TABLET;ORAL
ANADROL-50
+ MEDA PHARMS
50MG
N016848 001
OXYMORPHONE HYDROCHLORIDE
INJECTABLE;INJECTION
OPANA
+ ENDO PHARMS
1MG/ML
N011707 002
TABLET;ORAL
OPANA
AB ENDO PHARMS
5MG
N021611 001 Jun 22, 2006
AB +
10MG
N021611 002 Jun 22, 2006
OXYMORPHONE HYDROCHLORIDE
AB AVANTHI INC
5MG
A203601 001 Jan 30, 2013
AB
10MG
A203601 002 Jan 30, 2013
AB COREPHARMA
5MG
A201187 001 Dec 15, 2014
AB
10MG
A201187 002 Dec 15, 2014
AB MALLINCKRODT INC
5MG
A202321 001 Apr 25, 2013
AB
10MG
A202321 002 Apr 25, 2013
AB ROXANE
5MG
A090964 001 Sep 27, 2010
AB
10MG
A090964 002 Sep 27, 2010
AB TEVA
5MG
A091443 002 Feb 15, 2011
AB
10MG
A091443 001 Feb 15, 2011
TABLET, EXTENDED RELEASE;ORAL
OXYMORPHONE HYDROCHLORIDE
AB ACTAVIS ELIZABETH
5MG
A079046 003 Jul 11, 2013
AB
7.5MG
A079046 001 Dec 13, 2010
AB
10MG
A079046 004 Jul 11, 2013
AB
15MG
A079046 002 Dec 13, 2010
AB
20MG
A079046 005 Jul 11, 2013
AB
30MG
A079046 006 Jul 11, 2013
AB
40MG
A079046 007 Jul 11, 2013
AB IMPAX LABS
5MG
A079087 001 Jun 14, 2010
AB
7.5MG
A079087 002 Dec 21, 2010
AB
10MG
A079087 003 Jun 14, 2010
AB
15MG
A079087 004 Dec 21, 2010
AB
20MG
A079087 005 Jun 14, 2010
AB
30MG
A079087 006 Jul 22, 2010
AB
40MG
A079087 007 Jun 14, 2010
AB MALLINCKRODT INC
5MG
A202946 001 Jun 27, 2014
AB
7.5MG
A202946 002 Jun 27, 2014
AB
10MG
A202946 003 Jun 27, 2014
AB
15MG
A202946 004 Jun 27, 2014
AB
20MG
A202946 005 Jun 27, 2014
AB
30MG
A202946 006 Jun 27, 2014
AB
40MG
A202946 007 Jun 27, 2014
AB PAR PHARM
5MG
A200792 001 Oct 24, 2014
AB
7.5MG
A200792 002 Oct 24, 2014
AB
10MG
A200792 003 Oct 24, 2014
AB
15MG
A200792 004 Oct 24, 2014
AB
20MG
A200792 005 Oct 24, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-280(of 371)
OXYMORPHONE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
OXYMORPHONE HYDROCHLORIDE
AB 30MG A200792 006 Oct 24, 2014
AB 40MG A200792 007 Oct 24, 2014
AB ROXANE 5MG A200822 002 Jul 15, 2013
AB 7.5MG A200822 003 Jul 15, 2013
AB 10MG A200822 004 Jul 15, 2013
AB 15MG A200822 005 Jul 15, 2013
AB 20MG A200822 006 Jul 15, 2013
AB 30MG A200822 007 Jul 15, 2013
AB 40MG A200822 001 Jul 15, 2013
OPANA ER
ENDO PHARMS 5MG N201655 001 Dec 09, 2011
7.5MG N201655 002 Dec 09, 2011
10MG N201655 003 Dec 09, 2011
15MG N201655 004 Dec 09, 2011
20MG N201655 005 Dec 09, 2011
30MG N201655 006 Dec 09, 2011
+ 40MG N201655 007 Dec 09, 2011
OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
TERRAMYCIN W/ POLYMYXIN B SULFATE
+ PFIZER EQ 5MG BASE/GM;10,000 UNITS/GM A061015 001
OXYTOCIN
INJECTABLE;INJECTION
OXYTOCIN
AP + FRESENIUS KABI USA 10USP UNITS/ML (10USP UNITS/ML) N018248 001
AP + 100USP UNITS/10ML (10USP UNITS/ML) N018248 002
AP HIKMA FARMACEUTICA 10USP UNITS/ML (10USP UNITS/ML) A200219 001 Feb 13, 2013
AP + HIKMA MAPLE 10USP UNITS/ML (10USP UNITS/ML) N018243 001
AP + 100USP UNITS/10ML (10USP UNITS/ML) N018243 002 Jan 10, 2007
AP SAGENT PHARMS 10USP UNITS/ML (10USP UNITS/ML) A091676 001 Oct 29, 2014
AP 100USP UNITS/10ML (10USP UNITS/ML) A091676 002 Oct 29, 2014
PITOCIN
AP + PAR STERILE PRODUCTS 10USP UNITS/ML (10USP UNITS/ML) N018261 001
AP 100USP UNITS/10ML (10USP UNITS/ML) N018261 002 Jul 27, 2007
OXYTOCIN
+ FRESENIUS KABI USA 300USP UNITS/30ML (10USP UNITS/ML) N018248 003 Jul 27, 2007
PITOCIN
PAR STERILE PRODUCTS 500USP UNITS/50ML (10USP UNITS/ML) N018261 003 Sep 05, 2012
PACLITAXEL
FOR SUSPENSION;IV (INFUSION)
ABRAXANE
+ ABRAXIS BIOSCIENCE 100MG/VIAL N021660 001 Jan 07, 2005
INJECTABLE;INJECTION
PACLITAXEL
AP ACTAVIS TOTOWA 6MG/ML A090130 001 Dec 09, 2009
AP EBEWE PHARMA 6MG/ML A078167 001 Dec 26, 2007
AP EUROHLTH INTL 6MG/ML A075190 001 Jan 28, 2002
AP FRESENIUS KABI ONCOL 6MG/ML A077574 001 Nov 27, 2006
AP + HOSPIRA 6MG/ML A076131 001 May 08, 2002
AP ONCO THERAPIES LTD 6MG/ML A091540 001 Sep 29, 2011
AP TEVA PHARMS 6MG/ML A075184 001 Jan 25, 2002
TAXOL
AP HQ SPCLT PHARMA 6MG/ML N020262 001 Dec 29, 1992
PALIPERIDONE
TABLET, EXTENDED RELEASE;ORAL
INVEGA
JANSSEN PHARMS 1.5MG N021999 006 Aug 26, 2008
3MG N021999 001 Dec 19, 2006
+ 6MG N021999 002 Dec 19, 2006
9MG N021999 003 Dec 19, 2006
PALIPERIDONE PALMITATE
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
INVEGA SUSTENNA
JANSSEN PHARMS 39MG/0.25ML (39MG/0.25ML) N022264 001 Jul 31, 2009
78MG/0.5ML (78MG/0.5ML) N022264 002 Jul 31, 2009
+ 117MG/0.75ML (117MG/0.75ML) N022264 003 Jul 31, 2009
156MG/ML (156MG/ML) N022264 004 Jul 31, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-281(of 371)
PALIPERIDONE PALMITATE
SUSPENSION, EXTENDED RELEASE;INTRAMUSCULAR
INVEGA SUSTENNA
234MG/1.5ML (156MG/ML) N022264 005 Jul 31, 2009
PALONOSETRON HYDROCHLORIDE
INJECTABLE;INTRAVENOUS
ALOXI
+ HELSINN HLTHCARE EQ 0.075MG BASE/1.5ML (EQ 0.05MG N021372 002 Feb 29, 2008
BASE/ML)
+ EQ 0.25MG BASE/5ML (EQ 0.05MG BASE/ML) N021372 001 Jul 25, 2003
PAMIDRONATE DISODIUM
INJECTABLE;INJECTION
PAMIDRONATE DISODIUM
AP AGILA SPECLTS 30MG/10ML (3MG/ML) A078520 001 Oct 31, 2008
AP 90MG/10ML (9MG/ML) A078520 002 Oct 31, 2008
AP AREVA PHARMS 30MG/VIAL A077433 001 Nov 26, 2008
AP 60MG/VIAL A077433 002 Nov 26, 2008
AP 90MG/VIAL A077433 003 Nov 26, 2008
AP EUROHLTH INTL 30MG/VIAL A075290 001 Apr 30, 2001
AP + 30MG/10ML (3MG/ML) N021113 001 Mar 04, 2002
AP 90MG/VIAL A075290 003 Apr 30, 2001
AP + 90MG/10ML (9MG/ML) N021113 002 Mar 04, 2002
AP FRESENIUS KABI USA 30MG/VIAL A075773 001 May 06, 2002
AP 30MG/10ML (3MG/ML) A076207 001 May 17, 2002
AP 90MG/VIAL A075773 002 May 06, 2002
AP 90MG/10ML (9MG/ML) A076207 002 May 17, 2002
AP + HOSPIRA 30MG/10ML (3MG/ML) A075841 001 Jun 27, 2002
AP + 60MG/10ML (6MG/ML) A075841 002 Jun 27, 2002
AP + 90MG/10ML (9MG/ML) A075841 003 Jun 27, 2002
AP LUITPOLD 30MG/10ML (3MG/ML) A078942 001 Jul 25, 2008
AP 90MG/10ML (9MG/ML) A078942 002 Jul 25, 2008
AP MUSTAFA NEVZAT 30MG/10ML (3MG/ML) A078373 001 Dec 23, 2008
AP 90MG/10ML (9MG/ML) A078373 002 Dec 23, 2008
AP PLIVA LACHEMA 30MG/10ML (3MG/ML) A078156 001 Aug 19, 2008
AP 60MG/10ML (6MG/ML) A078156 002 Aug 19, 2008
AP 90MG/10ML (9MG/ML) A078156 003 Aug 19, 2008
AP SUN PHARMA GLOBAL 30MG/VIAL A077703 001 Dec 24, 2008
AP 90MG/VIAL A077703 002 Dec 24, 2008
AP TEVA PHARMS USA 30MG/10ML (3MG/ML) A076153 001 Mar 27, 2002
AP 90MG/10ML (9MG/ML) A076153 002 Mar 27, 2002
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
CAPSULE, DELAYED RELEASE;ORAL
CREON
ABBVIE 12,000USP UNITS\;38,000USP N020725 002 Apr 30, 2009
UNITS\;60,000USP UNITS\
15,000USP UNITS\;3,000USP N020725 004 Jul 12, 2011
UNITS\;9,500USP UNITS\
19,000USP UNITS\;30,000USP N020725 001 Apr 30, 2009
UNITS\;6,000USP UNITS\
114,000USP UNITS;180,000USP N020725 005 Mar 14, 2013
UNITS;36,000USP UNITS
+ 120,000USP UNITS\;24,000USP N020725 003 Apr 30, 2009
UNITS\;76,000USP UNITS\
PANCREAZE
JANSSEN PHARMS 10,850USP UNITS;2,600USP UNITS;6,200USP N022523 005 Mar 07, 2014
UNITS
17,500USP UNITS;4,200USP N022523 001 Apr 12, 2010
UNITS;10,000USP UNITS
43,750USP UNITS;10,500USP N022523 002 Apr 12, 2010
UNITS;25,000USP UNITS
+ 61,000USP UNITS;21,000USP N022523 003 Apr 12, 2010
UNITS;37,000USP UNITS
70,000USP UNITS;16,800USP N022523 004 Apr 12, 2010
UNITS;40,000USP UNITS
PERTZYE
DIGESTIVE CARE INC 30,250USP UNITS;8,000USP N022175 001 May 17, 2012
UNITS;28,750USP UNITS
+ 60,500USP UNITS;16,000USP N022175 002 May 17, 2012
UNITS;57,500USP UNITS
ULTRESA
FOREST LABS INC 13,800USP UNITS;27,600USP N022222 001 Mar 01, 2012
UNITS;27,600USP UNITS
20,700USP UNITS;41,400USP N022222 002 Mar 01, 2012
UNITS;41,400USP UNITS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-282(of 371)
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
CAPSULE, DELAYED RELEASE;ORAL
ULTRESA
+ 23,000USP UNITS;46,000USP N022222 003 Mar 01, 2012
UNITS;46,000USP UNITS
ZENPEP
FOREST LABS INC 218,000USP UNITS; 40,00USP UNITS; N022210 007 Mar 25, 2014
136,000 USP UNITS
10,000USP UNITS;16,000USP N022210 005 Jun 15, 2011
UNITS;3,000USP UNITS
10,000USP UNITS;34,000USP N022210 002 Aug 27, 2009
UNITS;55,000USP UNITS
15,000USP UNITS;51,000USP N022210 003 Aug 27, 2009
UNITS;82,000USP UNITS
17,000USP UNITS;27,000USP N022210 001 Aug 27, 2009
UNITS;5,000USP UNITS
109,000USP UNITS;20,000USP N022210 004 Aug 27, 2009
UNITS;68,000USP UNITS
+ 136,000USP UNITS;25,000USP N022210 006 Jul 13, 2011
UNITS;85,000USP UNITS
TABLET;ORAL
VIOKACE
FOREST LABS INC 10440USPU;39150USPU;39150USPU N022542 001 Mar 01, 2012
+ 20880USPU;78300USPU;78300USPU N022542 002 Mar 01, 2012
PANCURONIUM BROMIDE
INJECTABLE;INJECTION
PANCURONIUM BROMIDE
AP HOSPIRA 1MG/ML A072320 001 Jan 19, 1989
AP + TEVA PHARMS USA 1MG/ML A072759 001 Jul 31, 1990
AP + 2MG/ML A072760 001 Jul 31, 1990
PANTOPRAZOLE SODIUM
FOR SUSPENSION, DELAYED RELEASE;ORAL
PROTONIX
+ WYETH PHARMS INC EQ 40MG BASE N022020 001 Nov 14, 2007
INJECTABLE;IV (INFUSION)
PANTOPRAZOLE SODIUM
AP AKORN INC EQ 40MG BASE/VIAL A079197 001 Nov 08, 2012
PROTONIX IV
AP + WYETH PHARMS INC EQ 40MG BASE/VIAL N020988 001 Mar 22, 2001
TABLET, DELAYED RELEASE;ORAL
PANTOPRAZOLE SODIUM
AB ACTAVIS TOTOWA EQ 20MG BASE A090797 001 Feb 07, 2011
AB EQ 40MG BASE A090797 002 Feb 07, 2011
AB APOTEX INC EQ 20MG BASE A090807 001 May 02, 2012
AB EQ 40MG BASE A090807 002 May 02, 2012
AB AUROBINDO PHARMA LTD EQ 20MG BASE A202038 001 Sep 28, 2012
AB EQ 40MG BASE A202038 002 Sep 28, 2012
AB DR REDDYS LABS LTD EQ 20MG BASE A077619 001 Jan 19, 2011
AB EQ 40MG BASE A077619 002 Jan 19, 2011
AB HETERO LABS LTD V EQ 20MG BASE A202882 001 Sep 10, 2014
AB EQ 40MG BASE A202882 002 Sep 10, 2014
AB JUBILANT GENERICS EQ 20MG BASE A090901 001 Aug 30, 2011
AB EQ 40MG BASE A090901 002 Aug 30, 2011
AB KUDCO IRELAND EQ 20MG BASE A078281 001 Jan 20, 2011
AB EQ 40MG BASE A078281 002 Jan 20, 2011
AB MACLEODS PHARMS LTD EQ 20MG BASE A200821 001 Feb 16, 2012
AB EQ 40MG BASE A200821 002 Feb 16, 2012
AB MYLAN PHARMS INC EQ 20MG BASE A090970 001 Jan 19, 2011
AB EQ 40MG BASE A090970 002 Jan 19, 2011
AB ORCHID HLTHCARE EQ 20MG BASE A202052 001 Dec 02, 2014
AB EQ 40MG BASE A202052 002 Dec 02, 2014
AB PERRIGO R AND D EQ 20MG BASE A203024 001 May 07, 2014
AB RANBAXY LABS LTD EQ 20MG BASE A200794 001 May 02, 2012
AB EQ 40MG BASE A200794 002 May 02, 2012
AB SUN PHARMA GLOBAL EQ 20MG BASE A077058 001 Sep 10, 2007
AB EQ 40MG BASE A077058 002 Sep 10, 2007
AB TEVA EQ 20MG BASE A077056 001 Aug 02, 2007
AB EQ 40MG BASE A077056 002 Aug 02, 2007
AB TORRENT PHARMS EQ 20MG BASE A090074 001 Jan 19, 2011
AB EQ 40MG BASE A090074 002 Jan 19, 2011
AB WOCKHARDT EQ 20MG BASE A091231 001 Jan 19, 2011
AB EQ 40MG BASE A091231 002 Jan 19, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-283(of 371)
PANTOPRAZOLE SODIUM
TABLET, DELAYED RELEASE;ORAL
PROTONIX
AB WYETH PHARMS INC EQ 20MG BASE N020987 002 Jun 12, 2001
AB + EQ 40MG BASE N020987 001 Feb 02, 2000
PARICALCITOL
CAPSULE;ORAL
PARICALCITOL
AB BANNER PHARMACAPS 1MCG A202539 001 Mar 27, 2014
AB 2MCG A202539 002 Mar 27, 2014
AB 4MCG A202539 003 Mar 27, 2014
AB DR REDDYS LABS LTD 1MCG A091412 001 Jun 24, 2014
AB 2MCG A091412 002 Jun 24, 2014
AB 4MCG A091412 003 Jun 24, 2014
AB RISING PHARMS INC 1MCG A202124 001 Jun 24, 2014
AB 2MCG A202124 002 Jun 24, 2014
AB 4MCG A202124 003 Jun 24, 2014
AB TEVA PHARMS USA 1MCG A090829 001 Sep 27, 2013
AB 2MCG A090829 002 Sep 27, 2013
AB 4MCG A090829 003 Sep 27, 2013
ZEMPLAR
AB ABBVIE 1MCG N021606 001 May 26, 2005
AB 2MCG N021606 002 May 26, 2005
AB + 4MCG N021606 003 May 26, 2005
SOLUTION;INTRAVENOUS
PARICALCITOL
AP HIKMA PHARMS 0.002MG/ML (0.002MG/ML) N205917 001 Nov 18, 2014
AP 0.005MG/ML (0.005MG/ML) N205917 002 Nov 18, 2014
AP 0.01MG/2ML (0.005MG/ML) N205917 003 Nov 18, 2014
AP HOSPIRA INC 0.002MG/ML (0.002MG/ML) N201657 001 Oct 21, 2014
AP 0.005MG/ML (0.005MG/ML) N201657 002 Oct 21, 2014
AP 0.01MG/2ML (0.005MG/ML) N201657 003 Oct 21, 2014
AP SANDOZ CANADA INC 0.002MG/ML (0.002MG/ML) A091108 001 Jul 27, 2011
AP 0.005MG/ML (0.005MG/ML) A091108 002 Jul 27, 2011
AP 0.01MG/2ML (0.005MG/ML) A091108 003 Jul 27, 2011
ZEMPLAR
AP + ABBVIE 0.002MG/ML (0.002MG/ML) N020819 002 Feb 01, 2000
AP + 0.005MG/ML (0.005MG/ML) N020819 001 Apr 17, 1998
AP + 0.01MG/2ML (0.005MG/ML) N020819 003 Feb 01, 2000
PAROMOMYCIN SULFATE
CAPSULE;ORAL
PAROMOMYCIN SULFATE
AA HERITAGE PHARMS INC EQ 250MG BASE A065173 001 Dec 14, 2007
AA + SUN PHARM INDS INC EQ 250MG BASE A064171 001 Jun 30, 1997
PAROXETINE HYDROCHLORIDE
SUSPENSION;ORAL
PAXIL
AB + APOTEX TECHNOLOGIES EQ 10MG BASE/5ML N020710 001 Jun 25, 1997
TABLET;ORAL
PAROXETINE
AB PRINSTON INC EQ 10MG BASE A203854 001 Oct 31, 2014
AB EQ 20MG BASE A203854 002 Oct 31, 2014
AB EQ 30MG BASE A203854 003 Oct 31, 2014
AB EQ 40MG BASE A203854 004 Oct 31, 2014
PAROXETINE HYDROCHLORIDE
AB APOTEX EQ 10MG BASE A075356 001 Jul 30, 2003
AB EQ 20MG BASE A075356 002 Jul 30, 2003
AB EQ 30MG BASE A075356 003 Jul 30, 2003
AB EQ 40MG BASE A075356 004 Jul 30, 2003
AB AUROBINDO PHARMA EQ 10MG BASE A078406 001 Jul 25, 2007
AB EQ 20MG BASE A078406 002 Jul 25, 2007
AB EQ 30MG BASE A078406 003 Jul 25, 2007
AB EQ 40MG BASE A078406 004 Jul 25, 2007
AB MYLAN EQ 10MG BASE A078902 001 Mar 13, 2008
AB EQ 20MG BASE A078902 002 Mar 13, 2008
AB EQ 30MG BASE A078902 003 Mar 13, 2008
AB EQ 40MG BASE A078902 004 Mar 13, 2008
AB MYLAN PHARMS INC EQ 10MG BASE A075716 001 Mar 08, 2004
AB EQ 20MG BASE A075716 002 Mar 08, 2004
AB EQ 30MG BASE A075716 003 Mar 08, 2004
AB EQ 40MG BASE A075716 004 Mar 08, 2004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-284(of 371)
PAROXETINE HYDROCHLORIDE
TABLET;ORAL
PAROXETINE HYDROCHLORIDE
AB PROSAM LABS
EQ 10MG BASE
A076968 001 Jun 21, 2010
AB
EQ 20MG BASE
A076968 002 Jun 21, 2010
AB
EQ 30MG BASE
A076968 003 Jun 21, 2010
AB
EQ 40MG BASE
A076968 004 Jun 21, 2010
AB SUN PHARM INDS INC
EQ 10MG BASE
A078194 001 Jun 29, 2007
AB
EQ 20MG BASE
A078194 002 Jun 29, 2007
AB
EQ 30MG BASE
A078194 003 Jun 29, 2007
AB
EQ 40MG BASE
A078194 004 Jun 29, 2007
AB TEVA
EQ 10MG BASE
A076618 001 Aug 15, 2005
AB
EQ 20MG BASE
A076618 002 Aug 15, 2005
AB
EQ 30MG BASE
A076618 003 Aug 15, 2005
AB
EQ 40MG BASE
A076618 004 Aug 15, 2005
AB ZYDUS PHARMS USA
EQ 10MG BASE
A077584 001 Mar 07, 2007
AB
EQ 20MG BASE
A077584 002 Mar 07, 2007
AB
EQ 30MG BASE
A077584 003 Mar 07, 2007
AB
EQ 40MG BASE
A077584 004 Mar 07, 2007
PAXIL
AB APOTEX TECHNOLOGIES
EQ 10MG BASE
N020031 001 Dec 29, 1992
AB
EQ 20MG BASE
N020031 002 Dec 29, 1992
AB
EQ 30MG BASE
N020031 003 Dec 29, 1992
AB +
EQ 40MG BASE
N020031 005 Dec 29, 1992
TABLET, EXTENDED RELEASE;ORAL
PAROXETINE HYDROCHLORIDE
AB MYLAN
EQ 12.5MG BASE
A077873 001 Jun 29, 2007
AB
EQ 25MG BASE
A077873 002 Jun 29, 2007
AB
EQ 37.5MG BASE
A091427 001 Apr 14, 2011
PAXIL CR
AB APOTEX TECHNOLOGIES
EQ 12.5MG BASE
N020936 001 Feb 16, 1999
AB
EQ 25MG BASE
N020936 002 Feb 16, 1999
AB +
EQ 37.5MG BASE
N020936 003 Dec 06, 2000
PAROXETINE MESYLATE
CAPSULE;ORAL
BRISDELLE
+ NOVEN THERAP
EQ 7.5MG BASE
N204516 001 Jun 28, 2013
TABLET;ORAL
PEXEVA
NOVEN THERAP
EQ 10MG BASE
N021299 001 Jul 03, 2003
EQ 20MG BASE
N021299 002 Jul 03, 2003
EQ 30MG BASE
N021299 003 Jul 03, 2003
+
EQ 40MG BASE
N021299 004 Jul 03, 2003
PASIREOTIDE DIASPARTATE
SOLUTION;SUBCUTANEOUS
SIGNIFOR
NOVARTIS
EQ 0.3MG BASE/ML (EQ 0.3MG BASE/ML)
N200677 001 Dec 14, 2012
EQ 0.6MG BASE/ML (EQ 0.6MG BASE/ML)
N200677 002 Dec 14, 2012
+
EQ 0.9MG BASE/ML (EQ 0.9MG BASE/ML)
N200677 003 Dec 14, 2012
PASIREOTIDE PAMOATE
POWDER;INTRAMUSCULAR
SIGNIFOR LAR
NOVARTIS PHARMS CORP
EQ 20MG BASE/VIAL
N203255 001 Dec 15, 2014
EQ 40MG BASE/VIAL
N203255 002 Dec 15, 2014
+
EQ 60MG BASE/VIAL
N203255 003 Dec 15, 2014
PAZOPANIB HYDROCHLORIDE
TABLET;ORAL
VOTRIENT
+ GLAXOSMITHKLINE
EQ 200MG BASE
N022465 001 Oct 19, 2009
EQ 400MG BASE
N022465 002 Oct 19, 2009
PEGADEMASE BOVINE
INJECTABLE;INJECTION
ADAGEN
+ SIGMA TAU
250 UNITS/ML
N019818 001 Mar 21, 1990
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-285(of 371)
PEGAPTANIB SODIUM
INJECTABLE;INTRAVITREAL
MACUGEN
+ VALEANT PHARMS LLC EQ 0.3MG ACID/0.09ML N021756 001 Dec 17, 2004
PEGVISOMANT
INJECTABLE;SUBCUTANEOUS
SOMAVERT
+ PHARMACIA AND UPJOHN 10MG/VIAL N021106 001 Mar 25, 2003
+ 15MG/VIAL N021106 002 Mar 25, 2003
+ 20MG/VIAL N021106 003 Mar 25, 2003
+ 25MG/VIAL N021106 004 Jul 31, 2014
+ 30MG/VIAL N021106 005 Jul 31, 2014
PEMETREXED DISODIUM
INJECTABLE;IV (INFUSION)
ALIMTA
+ LILLY EQ 100MG BASE/VIAL N021462 002 Sep 07, 2007
+ EQ 500MG BASE/VIAL N021462 001 Feb 04, 2004
PENCICLOVIR SODIUM
CREAM;TOPICAL
DENAVIR
+ DENCO ASSET 1% N020629 001 Sep 24, 1996
PENICILLAMINE
CAPSULE;ORAL
CUPRIMINE
+ ATON 250MG N019853 001
TABLET;ORAL
DEPEN
+ MEDA PHARMS 250MG N019854 001
PENICILLIN G BENZATHINE
INJECTABLE;INJECTION
BICILLIN L-A
BC + KING PHARMS 600,000 UNITS/ML N050141 001
PERMAPEN
BC PFIZER 600,000 UNITS/ML A060014 001
BICILLIN L-A
+ KING PHARMS 300,000 UNITS/ML N050141 003
PENICILLIN G BENZATHINE; PENICILLIN G PROCAINE
INJECTABLE;INJECTION
BICILLIN C-R
+ KING PHARMS 150,000 UNITS/ML;150,000 UNITS/ML N050138 002
+ 300,000 UNITS/ML;300,000 UNITS/ML N050138 001
BICILLIN C-R 900/300
+ KING PHARMS 900,000 UNITS/2ML;300,000 UNITS/2ML N050138 003
PENICILLIN G POTASSIUM
INJECTABLE;INJECTION
PENICILLIN G POTASSIUM
AP HANFORD GC 5,000,000 UNITS/VIAL A065149 002 Jul 23, 2009
AP 20,000,000 UNITS/VIAL A065149 003 Jul 23, 2009
AP ISTITUTO BIO ITA SPA 5,000,000 UNITS/VIAL A065448 001 Aug 18, 2009
AP 20,000,000 UNITS/VIAL A065448 002 Aug 18, 2009
AP SANDOZ 5,000,000 UNITS/VIAL A065079 002 Aug 30, 2002
AP 20,000,000 UNITS/VIAL A065079 003 Aug 30, 2002
PFIZERPEN
AP + PFIZER 5,000,000 UNITS/VIAL A060657 002
AP + 20,000,000 UNITS/VIAL A060657 003
PENICILLIN G POTASSIUM
HANFORD GC 1,000,000 UNITS/VIAL A065149 001 Jul 23, 2009
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER
+ BAXTER HLTHCARE 20,000 UNITS/ML N050638 001 Jun 25, 1990
+ 40,000 UNITS/ML N050638 002 Jun 25, 1990
+ 60,000 UNITS/ML N050638 003 Jun 25, 1990
PENICILLIN G PROCAINE
INJECTABLE;INJECTION
PENICILLIN G PROCAINE
+ KING PHARMS 300,000 UNITS/ML A060101 002
+ 600,000 UNITS/ML A060101 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-286(of 371)
PENICILLIN G SODIUM
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
PENICILLIN G SODIUM
+ SANDOZ
5,000,000 UNITS/VIAL
A065068 001 Feb 26, 2001
PENICILLIN V POTASSIUM
FOR SOLUTION;ORAL
PENICILLIN V POTASSIUM
AA DAVA PHARMS INC EQ 125MG BASE/5ML
A062981 001 Feb 10, 1989
AA EQ 250MG BASE/5ML
A062981 002 Feb 10, 1989
PENICILLIN-VK
AA TEVA EQ 125MG BASE/5ML
A060456 001
AA + EQ 250MG BASE/5ML
A060456 002
TABLET;ORAL
PENICILLIN V POTASSIUM
AB AUROBINDO PHARMA
EQ 250MG BASE
A065435 001 Apr 29, 2008
AB
EQ 500MG BASE
A065435 002 Apr 29, 2008
AB DAVA PHARMS INC
EQ 250MG BASE
A062936 001 Nov 25, 1988
AB
EQ 500MG BASE
A062935 001 Nov 23, 1988
AB HIKMA PHARMS
EQ 250MG BASE
A090549 001 Oct 11, 2013
AB
EQ 500MG BASE
A090549 002 Oct 11, 2013
AB SANDOZ
EQ 250MG BASE
A064071 001 Nov 30, 1995
AB +
EQ 500MG BASE
A064071 002 Nov 30, 1995
PENICILLIN-VK
AB TEVA
EQ 250MG BASE
A060711 002
AB
EQ 500MG BASE
A060711 003
PENTAMIDINE ISETHIONATE
FOR SOLUTION;INHALATION
NEBUPENT
+ FRESENIUS KABI USA
300MG/VIAL
N019887 001 Jun 15, 1989
INJECTABLE;INJECTION
PENTAM
+ FRESENIUS KABI USA
300MG/VIAL
N019264 001 Oct 16, 1984
PENTAZOCINE LACTATE
INJECTABLE;INJECTION
TALWIN
+ HOSPIRA
EQ 30MG BASE/ML
N016194 001
PENTOBARBITAL SODIUM
INJECTABLE;INJECTION
NEMBUTAL SODIUM
+ OAK PHARMS
50MG/ML
A083246 001
PENTOSAN POLYSULFATE SODIUM
CAPSULE;ORAL
ELMIRON
+ JANSSEN PHARMS
100MG
N020193 001 Sep 26, 1996
PENTOSTATIN
INJECTABLE;INJECTION
NIPENT
AP + HOSPIRA INC
10MG/VIAL
N020122 001 Oct 11, 1991
PENTOSTATIN
AP EUROHLTH INTL
10MG/VIAL
A077841 001 Aug 07, 2007
AP MYLAN INSTITUTIONAL
10MG/VIAL
A203554 001 Sep 19, 2014
PENTOXIFYLLINE
TABLET, EXTENDED RELEASE;ORAL
PENTOXIFYLLINE
AB APOTEX
400MG
A075191 001 Jun 09, 1999
AB IMPAX LABS
400MG
A075093 001 Aug 10, 1999
AB MYLAN
400MG
A074425 001 Jul 08, 1997
AB PLIVA
400MG
A074874 001 May 25, 1999
AB VALEANT BERMUDA
400MG
A075028 001 Jul 20, 1998
PENTOXIL
AB UPSHER SMITH
400MG
A074962 001 Mar 31, 1999
PERAMIVIR
SOLUTION;IV (INFUSION)
RAPIVAB
+ BIOCRYST
200MG/20ML (10MG/ML)
N206426 001 Dec 19, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-287(of 371)
PERAMPANEL
TABLET;ORAL
FYCOMPA
EISAI INC
2MG
N202834 001 Oct 22, 2012
4MG
N202834 002 Oct 22, 2012
6MG
N202834 003 Oct 22, 2012
8MG
N202834 004 Oct 22, 2012
10MG
N202834 005 Oct 22, 2012
+
12MG
N202834 006 Oct 22, 2012
PERFLUTREN
INJECTABLE;INTRAVENOUS
DEFINITY
+ LANTHEUS MEDCL
6.52MG/ML
N021064 001 Jul 31, 2001
PERINDOPRIL ERBUMINE
TABLET;ORAL
ACEON
AB SYMPLMED PHARMS LLC
2MG
N020184 001 Dec 30, 1993
AB
4MG
N020184 002 Dec 30, 1993
AB +
8MG
N020184 003 Dec 30, 1993
PERINDOPRIL ERBUMINE
AB ANI PHARMS INC
2MG
A078138 001 Nov 10, 2009
AB
4MG
A078138 002 Nov 10, 2009
AB
8MG
A078138 003 Nov 10, 2009
AB APOTEX
2MG
A090463 001 Aug 30, 2010
AB
4MG
A090463 002 Aug 30, 2010
AB
8MG
A090463 003 Aug 30, 2010
AB AUROBINDO PHARMA
2MG
A079070 001 Nov 10, 2009
AB
4MG
A079070 002 Nov 10, 2009
AB
8MG
A079070 003 Nov 10, 2009
AB LUPIN LTD
2MG
A078263 001 Jan 27, 2010
AB
4MG
A078263 002 Jan 27, 2010
AB
8MG
A078263 003 Jan 27, 2010
AB ROXANE
2MG
A090072 001 Nov 10, 2009
AB
4MG
A090072 002 Nov 10, 2009
AB
8MG
A090072 003 Nov 10, 2009
PERMETHRIN
CREAM;TOPICAL
ELIMITE
AB + RENAISSANCE PHARMA
5%
N019855 001 Aug 25, 1989
PERMETHRIN
AB ACTAVIS MID ATLANTIC
5%
A074806 001 Jan 23, 1998
AB PERRIGO NEW YORK
5%
A076369 001 Apr 21, 2003
PERPHENAZINE
TABLET;ORAL
PERPHENAZINE
AB SANDOZ
2MG
A089683 001 Dec 08, 1988
AB
4MG
A089684 001 Dec 08, 1988
AB
8MG
A089685 001 Dec 08, 1988
AB +
16MG
A089686 001 Dec 08, 1988
AB VINTAGE PHARMS
2MG
A040226 001 Dec 31, 1998
AB
4MG
A040226 002 Dec 31, 1998
AB
8MG
A040226 003 Dec 31, 1998
AB
16MG
A040226 004 Dec 31, 1998
PHENDIMETRAZINE TARTRATE
CAPSULE, EXTENDED RELEASE;ORAL
BONTRIL
BC VALEANT 105MG A088021 001 Sep 21, 1982
PHENDIMETRAZINE TARTRATE
BC + SANDOZ 105MG N018074 001
TABLET;ORAL
BONTRIL PDM
AA + VALEANT 35MG A085272 001
PHENDIMETRAZINE TARTRATE
AA ELITE LABS INC 35MG A040762 001 Jan 28, 2008
AA KVK TECH 35MG A091042 001 Aug 31, 2010
AA MIKART 35MG A089452 001 Oct 30, 1991
AA SANDOZ 35MG A085588 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-288(of 371)
PHENELZINE SULFATE
TABLET;ORAL
NARDIL
AB + PARKE DAVIS EQ 15MG BASE N011909 002
PHENELZINE SULFATE
AB NOVEL LABS INC EQ 15MG BASE A200181 001 Dec 08, 2010
PHENOXYBENZAMINE HYDROCHLORIDE
CAPSULE;ORAL
DIBENZYLINE
AB + COVIS PHARMA SARL 10MG N008708 001
PHENOXYBENZAMINE HYDROCHLORIDE
AB ROXANE 10MG A201050 001 Jul 16, 2012
PHENTERMINE HYDROCHLORIDE
CAPSULE;ORAL
ADIPEX-P
AA + TEVA 37.5MG A088023 001 Aug 02, 1983
PHENTERMINE HYDROCHLORIDE
AA BARR 15MG A090591 001 Mar 18, 2010
AA 30MG A090591 002 Mar 18, 2010
AA ELITE LABS 15MG A202248 001 Sep 28, 2012
AA 30MG A202248 002 Sep 28, 2012
AA INVAGEN PHARMS 15MG A202858 001 Feb 14, 2014
AA 30MG A202858 002 Feb 14, 2014
AA 30MG A204414 001 May 05, 2014
AA 37.5MG A202846 001 Feb 05, 2014
AA KEN LIFESCIENCE 15MG A205019 001 Dec 05, 2014
AA 30MG A205019 002 Dec 05, 2014
AA 37.5MG A205017 001 Sep 25, 2014
AA KVK TECH 15MG A040886 002 Mar 31, 2008
AA 30MG A040875 001 Mar 21, 2008
AA 30MG A040886 001 Mar 31, 2008
AA 37.5MG A040887 001 Apr 24, 2008
AA LANNETT 15MG A087022 002 Jan 20, 2012
AA 30MG A087022 001 Feb 03, 1983
AA 30MG A091359 001 Jul 16, 2010
AA LANNETT HOLDINGS INC 37.5MG A201961 001 Jul 20, 2011
AA MUTUAL PHARM 30MG A040525 001 Oct 23, 2003
AA + SANDOZ 15MG A087190 002
AA + 30MG A086945 001 Jul 20, 1983
AA + 30MG A087190 001
TABLET;ORAL
ADIPEX-P
AA + TEVA 37.5MG A085128 001
PHENTERMINE HYDROCHLORIDE
AA AUROLIFE PHARMA LLC 37.5MG A203068 001 Aug 06, 2014
AA BARR 37.5MG A090470 001 Aug 31, 2009
AA ELITE LABS 37.5MG A200272 001 Jan 31, 2011
AA INVAGEN PHARMS 37.5MG A202942 001 Feb 05, 2014
AA KEN LIFESCIENCE 37.5MG A205008 001 Sep 25, 2014
AA KVK TECH 37.5MG A040876 001 Mar 31, 2008
AA LANNETT 37.5MG A040555 001 Apr 15, 2005
AA MIKAH PHARMA 37.5MG A040190 001 May 30, 1997
AA MIRROR PHARMS 37.5MG A091451 001 Sep 21, 2012
AA MUTUAL PHARM 37.5MG A040526 001 Oct 23, 2003
AA SUN PHARM INDS INC 37.5MG A040790 001 Aug 21, 2007
AA VINTAGE PHARMS 37.5MG A040377 001 Jan 04, 2002
TABLET, ORALLY DISINTEGRATING;ORAL
SUPRENZA
CITIUS PHARMS 15MG N202088 001 Jun 13, 2011
30MG N202088 002 Jun 13, 2011
+ 37.5MG N202088 003 Mar 27, 2012
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE
CAPSULE, EXTENDED RELEASE;ORAL
QSYMIA
VIVUS EQ 3.75MG BASE;23MG N022580 001 Jul 17, 2012
EQ 7.5MG BASE;46MG N022580 002 Jul 17, 2012
EQ 11.25MG BASE;69MG N022580 003 Jul 17, 2012
+ EQ 15MG BASE;92MG N022580 004 Jul 17, 2012
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-289(of 371)
PHENTERMINE RESIN COMPLEX
CAPSULE, EXTENDED RELEASE;ORAL
PHENTERMINE RESIN COMPLEX
+ LANNETT HOLDINGS INC EQ 15MG BASE A040872 001 Jul 28, 2011
+ EQ 30MG BASE A040872 002 Jul 28, 2011
PHENTOLAMINE MESYLATE
INJECTABLE;INJECTION
PHENTOLAMINE MESYLATE
AP EUROHLTH INTL 5MG/VIAL A040235 001 Mar 11, 1998
REGITINE
AP + NOVARTIS 5MG/VIAL N008278 003
ORAVERSE
+ SEPTODONT HOLDING 0.4MG/1.7ML N022159 001 May 09, 2008
PHENYLEPHRINE HYDROCHLORIDE
SOLUTION;IV (INFUSION)
PHENYLEPHRINE HYDROCHLORIDE
+ WEST WARD PHARM CORP 10MG/ML (10MG/ML) N203826 001 Dec 20, 2012
VAZCULEP
ECLAT PHARMS LLC 10MG/ML (10MG/ML) N204300 001 Jun 27, 2014
50MG/5ML (10MG/ML) N204300 002 Jun 27, 2014
+ 100MG/10ML (10MG/ML) N204300 003 Jun 27, 2014
SOLUTION/DROPS;OPHTHALMIC
PHENYLEPHRINE HYDROCHLORIDE
PARAGON BIOTECK 2.5% N203510 001 Mar 21, 2013
+ 10% N203510 002 Mar 21, 2013
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
SYRUP;ORAL
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE
AA HI-TECH PHARMACAL 5MG/5ML;6.25MG/5ML A040675 001 Dec 23, 2014
AA VINTAGE 5MG/5ML;6.25MG/5ML A040654 001 Dec 07, 2006
PROMETH VC PLAIN
AA + ACTAVIS MID ATLANTIC 5MG/5ML;6.25MG/5ML A088761 001 Nov 08, 1984
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE
AA AMNEAL PHARMS 5MG/5ML;6.25MG/5ML A040902 001 Aug 25, 2009
PHENYTOIN
SUSPENSION;ORAL
DILANTIN-125
AB + PARKE DAVIS 125MG/5ML N008762 001
PHENYTOIN
AB TARO 125MG/5ML A040521 001 Mar 08, 2004
AB VISTAPHARM 125MG/5ML A040342 001 Jan 31, 2001
AB 125MG/5ML A040610 001 Aug 18, 2005
AB WOCKHARDT 125MG/5ML A040420 001 Apr 19, 2002
TABLET, CHEWABLE;ORAL
DILANTIN
AB + PFIZER PHARMS 50MG A084427 001
PHENYTOIN
AB COREPHARMA 50MG A040884 001 Nov 28, 2014
AB MYLAN PHARMS INC 50MG A200691 001 Dec 26, 2012
AB TARO 50MG A200565 001 Apr 17, 2014
PHENYTOIN SODIUM
CAPSULE;ORAL
DILANTIN
AB + PARKE DAVIS 30MG EXTENDED A084349 001
AB + 100MG EXTENDED A084349 002
EXTENDED PHENYTOIN SODIUM
AB AMNEAL PHARMS NY 100MG EXTENDED A040765 001 Nov 12, 2008
AB MYLAN 100MG EXTENDED A040298 001 Dec 28, 1998
AB SUN PHARM INDS 200MG EXTENDED A040731 001 Jun 30, 2008
AB 300MG EXTENDED A040731 002 Jun 30, 2008
AB SUN PHARM INDS (IN) 100MG EXTENDED A040621 001 Dec 11, 2006
AB TARO 100MG EXTENDED A040684 001 Sep 05, 2006
AB WOCKHARDT 30MG EXTENDED A040759 001 Dec 18, 2007
AB WOCKHARDT USA 100MG EXTENDED A040732 001 Jan 30, 2008
PHENYTEK
AB MYLAN 200MG EXTENDED A040298 002 Dec 06, 2001
AB + 300MG EXTENDED A040298 003 Dec 06, 2001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-290(of 371)
PHENYTOIN SODIUM
INJECTABLE;INJECTION
PHENYTOIN SODIUM
AP + HIKMA MAPLE 50MG/ML A084307 001
AP HOSPIRA 50MG/ML A089521 001 Mar 17, 1987
AP LUITPOLD 50MG/ML A040781 001 Dec 04, 2007
AP X-GEN PHARMS 50MG/ML A040573 001 Sep 13, 2006
PHYTONADIONE
INJECTABLE;INJECTION
PHYTONADIONE
BP + INTL MEDICATION 1MG/0.5ML A083722 001
VITAMIN K1
BP + HOSPIRA 1MG/0.5ML A087954 001 Jul 25, 1983
+ 10MG/ML A087955 001 Jul 25, 1983
TABLET;ORAL
MEPHYTON
+ VALEANT PHARMS 5MG N010104 003
PILOCARPINE HYDROCHLORIDE
GEL;OPHTHALMIC
PILOPINE HS
+ ALCON 4% N018796 001 Oct 01, 1984
SOLUTION;OPHTHALMIC
ISOPTO CARPINE
ALCON RES 1% N200890 001 Jun 22, 2010
2% N200890 002 Jun 22, 2010
+ 4% N200890 003 Jun 22, 2010
TABLET;ORAL
PILOCARPINE HYDROCHLORIDE
AB COREPHARMA 5MG A076746 001 Nov 16, 2004
AB IMPAX LABS 5MG A077248 001 Mar 31, 2006
AB 7.5MG A077248 002 Mar 31, 2006
AB LANNETT 5MG A077220 001 Oct 14, 2005
AB 7.5MG A077220 002 May 06, 2009
AB ROXANE 5MG A076963 001 Dec 22, 2004
AB 7.5MG A076963 002 Feb 27, 2007
SALAGEN
AB EISAI INC 5MG N020237 001 Mar 22, 1994
AB + 7.5MG N020237 002 Apr 18, 2003
PIMECROLIMUS
CREAM;TOPICAL
ELIDEL
+ VALEANT BERMUDA 1% N021302 001 Dec 13, 2001
PIMOZIDE
TABLET;ORAL
ORAP
TEVA 1MG N017473 003 Aug 27, 1997
+ 2MG N017473 001 Jul 31, 1984
PINDOLOL
TABLET;ORAL
PINDOLOL
AB MUTUAL PHARM 5MG A074063 001 Jan 27, 1994
AB 10MG A074063 002 Jan 27, 1994
AB MYLAN PHARMS INC 5MG A074019 001 Sep 03, 1992
AB + 10MG A074019 002 Sep 03, 1992
PIOGLITAZONE HYDROCHLORIDE
TABLET;ORAL
ACTOS
AB TAKEDA PHARMS USA EQ 15MG BASE N021073 001 Jul 15, 1999
AB EQ 30MG BASE N021073 002 Jul 15, 1999
AB + EQ 45MG BASE N021073 003 Jul 15, 1999
PIOGLITAZONE HYDROCHLORIDE
AB ACCORD HLTHCARE EQ 15MG BASE A200044 001 Feb 13, 2013
AB EQ 30MG BASE A200044 002 Feb 13, 2013
AB EQ 45MG BASE A200044 003 Feb 13, 2013
AB AUROBINDO PHARMA LTD EQ 15MG BASE A200268 001 Feb 13, 2013
AB EQ 30MG BASE A200268 002 Feb 13, 2013
AB EQ 45MG BASE A200268 003 Feb 13, 2013
AB BRECKENRIDGE PHARM EQ 15MG BASE A078472 001 Feb 13, 2013
AB EQ 30MG BASE A078472 002 Feb 13, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-291(of 371)
PIOGLITAZONE HYDROCHLORIDE
TABLET;ORAL
PIOGLITAZONE HYDROCHLORIDE
AB EQ 45MG BASE A078472 003 Feb 13, 2013
AB DR REDDYS LABS LTD EQ 15MG BASE A078383 001 Mar 12, 2013
AB EQ 30MG BASE A078383 002 Mar 12, 2013
AB EQ 45MG BASE A078383 003 Mar 12, 2013
AB LUPIN LTD EQ 15MG BASE A204133 001 Apr 07, 2014
AB EQ 30MG BASE A204133 002 Apr 07, 2014
AB EQ 45MG BASE A204133 003 Apr 07, 2014
AB MACLEODS PHARMS LTD EQ 15MG BASE A202467 001 Feb 06, 2013
AB EQ 30MG BASE A202467 002 Feb 06, 2013
AB EQ 45MG BASE A202467 003 Feb 06, 2013
AB MYLAN PHARMS INC EQ 15MG BASE A076801 001 Aug 17, 2012
AB EQ 30MG BASE A076801 002 Aug 17, 2012
AB EQ 45MG BASE A076801 003 Aug 17, 2012
AB SANDOZ EQ 15MG BASE A078670 001 Feb 13, 2013
AB EQ 30MG BASE A078670 002 Feb 13, 2013
AB EQ 45MG BASE A078670 003 Feb 13, 2013
AB TEVA PHARMS USA EQ 15MG BASE A077210 001 Jan 10, 2014
AB EQ 30MG BASE A077210 002 Jan 10, 2014
AB EQ 45MG BASE A077210 003 Jan 10, 2014
AB TORRENT PHARMS LTD EQ 15MG BASE A091298 001 Feb 13, 2013
AB EQ 30MG BASE A091298 002 Feb 13, 2013
AB EQ 45MG BASE A091298 003 Feb 13, 2013
AB WATSON LABS EQ 15MG BASE A076798 001 Oct 26, 2012
AB EQ 30MG BASE A076798 002 Oct 26, 2012
AB EQ 45MG BASE A076798 003 Oct 26, 2012
AB ZYDUS PHARMS USA INC EQ 15MG BASE A202456 001 Feb 13, 2013
AB EQ 30MG BASE A202456 002 Feb 13, 2013
AB EQ 45MG BASE A202456 003 Feb 13, 2013
PIPERACILLIN SODIUM
INJECTABLE;INJECTION
PIPERACILLIN
+ ISTITUTO BIO ITA SPA EQ 2GM BASE/VIAL A065114 001 Nov 14, 2003
+ EQ 3GM BASE/VIAL A065114 002 Nov 14, 2003
+ EQ 4GM BASE/VIAL A065114 003 Nov 14, 2003
+ EQ 40GM BASE/VIAL A065157 001 Jul 12, 2004
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
INJECTABLE;INJECTION
PIPERACILLIN AND TAZOBACTAM
AP AGILA SPECLTS EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A065458 001 Aug 15, 2014
AP EQ 3MG BASE/VIAL;EQ 375MG BASE/VIAL A065458 002 Aug 15, 2014
AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A065458 003 Aug 15, 2014
AP AUROBINDO PHARMA LTD EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A065498 001 May 23, 2011
AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A065498 002 May 23, 2011
AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A065498 003 May 23, 2011
AP HOSPIRA INC EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A065386 001 Sep 15, 2009
AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A065386 002 Sep 15, 2009
AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A065386 003 Sep 15, 2009
AP EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL A065446 001 Sep 15, 2009
AP ISTITUTO BIO ITA SPA EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A065523 001 May 31, 2011
AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A065523 002 May 31, 2011
AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A065523 003 May 31, 2011
AP EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL A090498 001 May 31, 2011
AP SANDOZ EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A065362 001 Oct 21, 2010
AP EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL A065363 001 Oct 21, 2010
AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A065362 002 Oct 21, 2010
AP EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL A065363 002 Oct 21, 2010
AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A065362 003 Oct 21, 2010
AP EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL A065363 003 Oct 21, 2010
ZOSYN
AP + WYETH PHARMS INC EQ 2GM BASE/VIAL;EQ 250MG BASE/VIAL N050684 001 Oct 22, 1993
AP + EQ 3GM BASE/VIAL;EQ 375MG BASE/VIAL N050684 002 Oct 22, 1993
AP + EQ 4GM BASE/VIAL;EQ 500MG BASE/VIAL N050684 003 Oct 22, 1993
AP + EQ 36GM BASE/VIAL;EQ 4.5GM BASE/VIAL N050684 004 Oct 22, 1993
ZOSYN IN PLASTIC CONTAINER
+ WYETH PHARMS INC EQ 4GM BASE/100ML;EQ 500MG BASE/100ML N050750 003 Feb 24, 1998
+ EQ 40MG BASE/ML;EQ 5MG BASE/ML N050750 001 Feb 24, 1998
+ EQ 60MG BASE/ML;EQ 7.5MG BASE/ML N050750 002 Feb 24, 1998
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-292(of 371)
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM
INJECTABLE;IV (INFUSION)
PIPERACILLIN AND TAZOBACTAM
SANDOZ
EQ 12GM BASE/VIAL;EQ 1.5GM BASE/VIAL
A203557 001 Oct 29, 2014
PIRBUTEROL ACETATE
AEROSOL, METERED;INHALATION
MAXAIR
+ MEDICIS
EQ 0.2MG BASE/INH
N020014 001 Nov 30, 1992
PIRFENIDONE
CAPSULE;ORAL
ESBRIET
+ INTERMUNE INC
267MG
N022535 001 Oct 15, 2014
PIROXICAM
CAPSULE;ORAL
FELDENE
AB PFIZER 10MG
N018147 002 Apr 06, 1982
AB + 20MG
N018147 003 Apr 06, 1982
PIROXICAM
AB MUTUAL PHARM 10MG
A073535 001 Mar 12, 1993
AB MYLAN 10MG
A074102 001 Jul 31, 1992
AB 20MG
A074102 002 Jul 31, 1992
AB NOSTRUM LABS 10MG
A074116 001 Jun 15, 1993
AB 20MG
A074118 001 Jun 15, 1993
AB TEVA 10MG
A074131 001 Dec 11, 1992
AB 20MG
A074131 002 Dec 11, 1992
PITAVASTATIN CALCIUM
TABLET;ORAL
LIVALO
KOWA CO
EQ 1MG BASE
N022363 001 Aug 03, 2009
EQ 2MG BASE
N022363 002 Aug 03, 2009
+
EQ 4MG BASE
N022363 003 Aug 03, 2009
PLERIXAFOR
SOLUTION;SUBCUTANEOUS
MOZOBIL
+ GENZYME
24MG/1.2ML (20MG/ML)
N022311 001 Dec 15, 2008
PODOFILOX
GEL;TOPICAL
CONDYLOX
+ WATSON PHARMS
0.5%
N020529 001 Mar 13, 1997
SOLUTION;TOPICAL
CONDYLOX
AT + WATSON PHARMS
0.5%
N019795 001 Dec 13, 1990
PODOFILOX
AT PADDOCK LLC
0.5%
A075600 001 Jan 29, 2002
AT PRECISION DERMAT
0.5%
A090184 001 Jul 21, 2010
POLIDOCANOL
SOLUTION;INTRAVENOUS
ASCLERA
CHEMISCH FBRK KRSSLR
10MG/2ML (5MG/ML)
N021201 001 Mar 30, 2010
+
20MG/2ML (10MG/ML)
N021201 002 Mar 30, 2010
VARITHENA
+ PROVENSIS
180MG/18ML (10MG/ML)
N205098 001 Nov 25, 2013
POLYETHYLENE GLYCOL 3350
FOR SOLUTION;ORAL
GLYCOLAX
AA KREMERS URBAN PHARMS
17GM/SCOOPFUL
A076652 001 Jul 02, 2004
POLYETHYLENE GLYCOL 3350
AA BRECKENRIDGE PHARM
17GM/SCOOPFUL
A077736 001 May 26, 2006
AA NEXGEN PHARMA INC
17GM/SCOOPFUL
A077706 001 Sep 27, 2006
AA PADDOCK LLC
17GM/SCOOPFUL
A077893 001 May 26, 2006
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
FOR SOLUTION;ORAL
LAX-LYTE WITH FLAVOR PACKS
AA PADDOCK LLC 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ A079232 001 Feb 25, 2010
BOT
NULYTELY
AA + BRAINTREE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ N019797 001 Apr 22, 1991
BOT
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-293(of 371)
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
FOR SOLUTION;ORAL
NULYTELY-FLAVORED
AA + BRAINTREE 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ N019797 002 Nov 18, 1994
BOT
PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE
AA MYLAN 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ A090409 001 Apr 02, 2010
BOT
AA NOVEL LABS INC 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ A090019 001 May 27, 2009
BOT
TRILYTE
AA MEDA PHARMS 420GM/BOT;1.48GM/BOT;5.72GM/BOT;11.2GM/ A076491 001 Feb 05, 2004
BOT
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE
ANHYDROUS
FOR SOLUTION;ORAL
GOLYTELY
AA + BRAINTREE 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ N019011 001 Jul 13, 1984
BOT;22.74GM/BOT
PEG 3350 AND ELECTROLYTES
AA MYLAN 236GM;2.97GM;6.74GM;5.86GM;22.74GM A090928 001 Jan 28, 2010
AA NOVEL LABS INC 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A090231 001 Jun 01, 2009
BOT;22.74GM/BOT
AA 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ A090186 001 Jun 01, 2009
BOT;22.72GM/BOT
COLYTE
MEDA PHARMS 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53G N018983 010 Jan 31, 1989
M/BOT;21.5GM/BOT
COLYTE WITH FLAVOR PACKS
MEDA PHARMS 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ N018983 012 Oct 08, 1998
BOT;22.72GM/BOT
GOLYTELY
+ BRAINTREE 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC N019011 002 Jun 02, 1992
KET;5.53GM/PACKET;21.5GM/PACKET
POLYMYXIN B SULFATE
INJECTABLE;INJECTION
POLYMYCIN B SULFATE
AP SAGENT STRIDES EQ 500,000 UNITS BASE/VIAL A090110 001 Jun 29, 2011
POLYMYXIN B SULFATE
AP + EUROHLTH INTL EQ 500,000 UNITS BASE/VIAL A060716 001
AP FRESENIUS KABI USA EQ 500,000 UNITS BASE/VIAL A065372 001 Jan 10, 2008
AP X GEN PHARMS EQ 500,000 UNITS BASE/VIAL A063000 001 Sep 30, 1994
AP XELLIA PHARMS APS EQ 500,000 UNITS BASE/VIAL A202766 001 Jan 15, 2014
POLYMYXIN B SULFATE; TRIMETHOPRIM SULFATE
SOLUTION/DROPS;OPHTHALMIC
POLYTRIM
AT + ALLERGAN 10,000 UNITS/ML;EQ 1MG BASE/ML N050567 001 Oct 20, 1988
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE
AT AKORN INC 10,000 UNITS/ML;EQ 1MG BASE/ML A065006 001 Dec 17, 1998
AT BAUSCH AND LOMB 10,000 UNITS/ML;EQ 1MG BASE/ML A064120 001 Feb 14, 1997
AT FALCON PHARMS 10,000 UNITS/ML;EQ 1MG BASE/ML A064211 001 Apr 13, 1998
POMALIDOMIDE
CAPSULE;ORAL
POMALYST
CELGENE 1MG N204026 001 Feb 08, 2013
2MG N204026 002 Feb 08, 2013
3MG N204026 003 Feb 08, 2013
+ 4MG N204026 004 Feb 08, 2013
PONATINIB HYDROCHLORIDE
TABLET;ORAL
ICLUSIG
ARIAD EQ 15MG BASE N203469 001 Dec 14, 2012
+ EQ 45MG BASE N203469 002 Dec 14, 2012
PORACTANT ALFA
SUSPENSION;INTRATRACHEAL
CUROSURF
+ CHIESI USA INC 80MG/ML N020744 001 Nov 18, 1999
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-294(of 371)
PORFIMER SODIUM
INJECTABLE;INJECTION
PHOTOFRIN
CONCORDIA LABS INC 75MG/VIAL N020451 001 Dec 27, 1995
POSACONAZOLE
SOLUTION;IV (INFUSION)
NOXAFIL
+ MERCK SHARP DOHME 300MG/16.7ML (18MG/ML) N205596 001 Mar 13, 2014
SUSPENSION;ORAL
NOXAFIL
+ SCHERING 40MG/ML N022003 001 Sep 15, 2006
TABLET, DELAYED RELEASE;ORAL
NOXAFIL
+ MERCK SHARP DOHME 100MG N205053 001 Nov 25, 2013
POTASSIUM ACETATE
INJECTABLE;INJECTION
POTASSIUM ACETATE IN PLASTIC CONTAINER
+ HOSPIRA 2MEQ/ML N018896 001 Jul 20, 1984
POTASSIUM CHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
MICRO-K
AB NESHER PHARMS 8MEQ N018238 001
MICRO-K 10
AB NESHER PHARMS 10MEQ N018238 002 May 14, 1984
POTASSIUM CHLORIDE
AB ACTAVIS LABS FL INC 8MEQ A077419 001 Jun 02, 2008
AB + 10MEQ A077419 002 Jun 02, 2008
AB AMNEAL PHARMS 10MEQ A202128 001 Feb 22, 2013
AB ANCHEN PHARMS 8MEQ A202886 001 Dec 26, 2013
AB 10MEQ A202886 002 Dec 26, 2013
AB PADDOCK LLC 8MEQ A200185 001 May 18, 2011
AB 10MEQ A200185 002 May 18, 2011
INJECTABLE;INJECTION
POTASSIUM CHLORIDE
AP B BRAUN 2MEQ/ML A085870 001
AP BAXTER HLTHCARE 2MEQ/ML A085499 001
AP FRESENIUS KABI USA 2MEQ/ML A080225 001
AP + HOSPIRA 2MEQ/ML A080205 001
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 14.9MG/ML N019904 001 Dec 26, 1989
AP + 746MG/100ML N019904 005 Dec 17, 1990
AP HOSPIRA 14.9MG/ML N020161 005 Nov 30, 1992
AP 745MG/100ML N020161 001 Nov 30, 1992
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 1.49GM/100ML N019904 006 Dec 17, 1990
AP + 29.8MG/ML N019904 002 Dec 26, 1989
AP HOSPIRA 1.49GM/100ML N020161 002 Nov 30, 1992
AP + 29.8MG/ML N020161 006 Aug 11, 1998
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 2.24GM/100ML N019904 003 Dec 26, 1989
AP + HOSPIRA 2.24GM/100ML N020161 003 Aug 11, 1998
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 2.98GM/100ML N019904 004 Dec 26, 1989
AP + HOSPIRA 2.98GM/100ML N020161 004 Aug 11, 1998
POTASSIUM CHLORIDE IN PLASTIC CONTAINER
AP FRESENIUS KABI USA 2MEQ/ML A088901 001 Jan 25, 1985
AP 2MEQ/ML A088908 001 Jan 25, 1985
POTASSIUM CHLORIDE
+ FRESENIUS KABI USA 3MEQ/ML A080225 003
SOLUTION;ORAL
POTASSIUM CHLORIDE
PHARMA-MED INC 20MEQ/15ML N206814 001 Dec 22, 2014
+ 40MEQ/15ML N206814 002 Dec 22, 2014
TABLET, EXTENDED RELEASE;ORAL
KLOR-CON M10
AB1 UPSHER SMITH LABS 10MEQ A074726 002 Aug 09, 2000
KLOR-CON M20
AB1 + UPSHER SMITH LABS 20MEQ A074726 001 Nov 20, 1998
POTASSIUM CHLORIDE
AB1 ACTAVIS LABS FL INC 10MEQ A075604 001 Apr 10, 2002
AB1 20MEQ A075604 002 Apr 10, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-295(of 371)
POTASSIUM CHLORIDE
TABLET, EXTENDED RELEASE;ORAL
POTASSIUM CHLORIDE
AB1 EURAND 20MEQ A076368 001 Aug 18, 2004
KLOR-CON
AB2 UPSHER-SMITH LABS 8MEQ N019123 001 Apr 17, 1986
AB2 + 10MEQ N019123 002 Apr 17, 1986
POTASSIUM CHLORIDE
AB2 MYLAN PHARMS INC 8.0MEQ A204662 001 Aug 21, 2014
AB2 10.0MEQ A204662 002 Aug 21, 2014
K-TAB
BC ABBVIE 8MEQ N018279 002 Aug 01, 1988
BC 10MEQ N018279 001
BC + 20MEQ N018279 003 Nov 25, 2013
KLOR-CON M15
UPSHER SMITH LABS 15MEQ A074726 003 Jun 06, 2003
POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP HOSPIRA 149MG/100ML;450MG/100ML A078446 001 Sep 10, 2008
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP + BAXTER HLTHCARE 150MG/100ML;450MG/100ML N017648 005 Nov 26, 2002
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP B BRAUN 150MG/100ML;900MG/100ML N019708 004 Sep 29, 1989
AP BAXTER HLTHCARE 150MG/100ML;900MG/100ML N017648 001
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 300MG/100ML;900MG/100ML N017648 002
POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP HOSPIRA 149MG/100ML;900MG/100ML N019686 001 Oct 17, 1988
POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP HOSPIRA 298MG/100ML;900MG/100ML N019686 002 Oct 17, 1988
POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%
BAXTER HLTHCARE 224MG/100ML;900MG/100ML N017648 003
POTASSIUM CITRATE
TABLET, EXTENDED RELEASE;ORAL
POTASSIUM CITRATE
AB COREPHARMA 5MEQ A077440 001 Jun 09, 2006
AB 10MEQ A077440 002 Jun 09, 2006
AB ZYDUS PHARMS USA INC 5MEQ A203546 001 Aug 06, 2014
AB 10MEQ A203546 002 Aug 06, 2014
AB 15MEQ A203546 003 Aug 06, 2014
UROCIT-K
AB MISSION PHARMA 5MEQ N019071 001 Aug 30, 1985
AB 10MEQ N019071 002 Aug 31, 1992
AB + 15MEQ N019071 003 Dec 30, 2009
POVIDONE-IODINE
SOLUTION/DROPS;OPHTHALMIC
BETADINE
+ ALCON PHARMS LTD 5% N018634 001 Dec 17, 1986
PRALATREXATE
SOLUTION;INTRAVENOUS
FOLOTYN
ALLOS 20MG/ML (20MG/ML) N022468 001 Sep 24, 2009
+ 40MG/2ML (20MG/ML) N022468 002 Sep 24, 2009
PRALIDOXIME CHLORIDE
INJECTABLE;INJECTION
PRALIDOXIME CHLORIDE
+ MERIDIAN MEDCL TECHN 300MG/ML N018986 001 Apr 26, 1983
PROTOPAM CHLORIDE
+ BAXTER HLTHCARE CORP 1GM/VIAL N014134 001
PRAMIPEXOLE DIHYDROCHLORIDE
TABLET;ORAL
MIRAPEX
AB BOEHRINGER INGELHEIM 0.125MG N020667 001 Jul 01, 1997
AB + 0.25MG N020667 002 Jul 01, 1997
AB 0.5MG N020667 006 Feb 12, 1998
AB 0.75MG N020667 007 Jul 30, 2007
AB 1MG N020667 003 Jul 01, 1997
AB 1.5MG N020667 005 Jul 01, 1997
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-296(of 371)
PRAMIPEXOLE DIHYDROCHLORIDE
TABLET;ORAL
PRAMIPEXOLE DIHYDROCHLORIDE
AB ACTAVIS GRP PTC 0.125MG A091254 001 Nov 30, 2010
AB 0.25MG A091254 002 Nov 30, 2010
AB 0.5MG A091254 003 Nov 30, 2010
AB 0.75MG A091254 004 Nov 30, 2010
AB 1MG A091254 005 Nov 30, 2010
AB 1.5MG A091254 006 Nov 30, 2010
AB ALEMBIC LTD 0.125MG A078894 001 Oct 08, 2010
AB 0.25MG A078894 002 Oct 08, 2010
AB 0.5MG A078894 003 Oct 08, 2010
AB 1MG A078894 004 Oct 08, 2010
AB 1.5MG A078894 005 Oct 08, 2010
AB APOTEX INC 0.125MG A090151 001 Apr 30, 2012
AB 0.25MG A090151 002 Apr 30, 2012
AB 0.5MG A090151 003 Apr 30, 2012
AB 0.75MG A090151 006 Apr 30, 2012
AB 1MG A090151 004 Apr 30, 2012
AB 1.5MG A090151 005 Apr 30, 2012
AB AUROBINDO PHARMA LTD 0.125MG A202633 001 Oct 26, 2012
AB 0.25MG A202633 002 Oct 26, 2012
AB 0.5MG A202633 003 Oct 26, 2012
AB 0.75MG A202633 004 Oct 26, 2012
AB 1MG A202633 005 Oct 26, 2012
AB 1.5MG A202633 006 Oct 26, 2012
AB BARR 0.125MG A077724 001 Feb 19, 2008
AB 0.25MG A077724 002 Feb 19, 2008
AB 0.5MG A077724 003 Feb 19, 2008
AB 1MG A077724 004 Feb 19, 2008
AB 1.5MG A077724 005 Feb 19, 2008
AB BRECKENRIDGE PHARM 0.125MG A091450 001 Oct 08, 2010
AB 0.25MG A091450 002 Oct 08, 2010
AB 0.5MG A091450 003 Oct 08, 2010
AB 1MG A091450 004 Oct 08, 2010
AB 1.5MG A091450 005 Oct 08, 2010
AB GLENMARK GENERICS 0.125MG A090781 001 Oct 08, 2010
AB 0.25MG A090781 002 Oct 08, 2010
AB 0.5MG A090781 003 Oct 08, 2010
AB 1MG A090781 004 Oct 08, 2010
AB 1.5MG A090781 005 Oct 08, 2010
AB MACLEODS PHARMS LTD 0.125MG A202164 001 Sep 20, 2012
AB 0.25MG A202164 002 Sep 20, 2012
AB 0.5MG A202164 003 Sep 20, 2012
AB 1MG A202164 004 Sep 20, 2012
AB 1.5MG A202164 005 Sep 20, 2012
AB MYLAN 0.125MG A077854 001 Oct 08, 2010
AB 0.25MG A077854 002 Oct 08, 2010
AB 0.5MG A077854 003 Oct 08, 2010
AB 0.75MG A090764 001 Apr 09, 2010
AB 1MG A077854 004 Oct 08, 2010
AB 1.5MG A077854 005 Oct 08, 2010
AB SANDOZ 0.125MG A090190 001 Jul 06, 2010
AB 0.25MG A090190 002 Jul 06, 2010
AB 0.5MG A090190 003 Jul 06, 2010
AB 0.75MG A090190 006 Oct 08, 2010
AB 1MG A090190 004 Jul 06, 2010
AB 1.5MG A090190 005 Jul 06, 2010
AB SCIEGEN PHARMS INC 0.125MG A203855 001 Oct 28, 2014
AB 0.25MG A203855 002 Oct 28, 2014
AB 0.5MG A203855 003 Oct 28, 2014
AB 0.75MG A203855 004 Oct 28, 2014
AB 1MG A203855 005 Oct 28, 2014
AB 1.5MG A203855 006 Oct 28, 2014
AB STRIDES PHARMA 0.125MG A202702 001 Jun 03, 2014
AB 0.25MG A202702 002 Jun 03, 2014
AB 0.5MG A202702 003 Jun 03, 2014
AB 0.75MG A202702 004 Jun 03, 2014
AB 1MG A202702 005 Jun 03, 2014
AB 1.5MG A202702 006 Jun 03, 2014
AB SUN PHARM INDS INC 0.125MG A091683 001 Mar 27, 2013
AB 0.25MG A091683 002 Mar 27, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-297(of 371)
PRAMIPEXOLE DIHYDROCHLORIDE
TABLET;ORAL
PRAMIPEXOLE DIHYDROCHLORIDE
AB
0.5MG
A091683 003 Mar 27, 2013
AB
0.75MG
A091683 004 Mar 27, 2013
AB
1MG
A091683 005 Mar 27, 2013
AB
1.5MG
A091683 006 Mar 27, 2013
AB TEVA PHARMS
0.125MG
A090241 001 Oct 08, 2010
AB
0.25MG
A090241 002 Oct 08, 2010
AB
0.5MG
A090241 003 Oct 08, 2010
AB
0.75MG
A090241 004 Oct 08, 2010
AB
1MG
A090241 005 Oct 08, 2010
AB
1.5MG
A090241 006 Oct 08, 2010
AB TORRENT PHARMS
0.125MG
A090865 001 Oct 08, 2010
AB
0.25MG
A090865 002 Oct 08, 2010
AB
0.5MG
A090865 003 Oct 08, 2010
AB
0.75MG
A090865 004 Oct 08, 2010
AB
1MG
A090865 005 Oct 08, 2010
AB
1.5MG
A090865 006 Oct 08, 2010
AB ZYDUS PHARMS USA INC
0.125MG
A078920 001 Jul 06, 2010
AB
0.25MG
A078920 002 Jul 06, 2010
AB
0.5MG
A078920 003 Jul 06, 2010
AB
1MG
A078920 004 Jul 06, 2010
AB
1.5MG
A078920 005 Jul 06, 2010
TABLET, DELAYED RELEASE;ORAL
PRAMIPEXOLE DIHYDROCHLORIDE
AB SANDOZ
0.375MG
A202353 001 Dec 04, 2014
AB
0.75MG
A202353 002 Dec 04, 2014
AB
1.5MG
A202353 003 Dec 04, 2014
AB
3MG
A202353 004 Dec 04, 2014
AB
4.5MG
A202353 005 Dec 04, 2014
TABLET, EXTENDED RELEASE;ORAL
MIRAPEX ER
AB + BOEHRINGER INGELHEIM
0.375MG
N022421 001 Feb 19, 2010
AB
0.75MG
N022421 002 Feb 19, 2010
AB
1.5MG
N022421 003 Feb 19, 2010
AB
2.25MG
N022421 006 Jun 17, 2011
AB
3MG
N022421 004 Feb 19, 2010
AB
3.75MG
N022421 007 Jun 17, 2011
AB
4.5MG
N022421 005 Feb 19, 2010
PRAMIPEXOLE DIHYDROCHLORIDE
AB ANCHEN PHARMS
0.375MG
A202206 001 Feb 06, 2014
AB
0.75MG
A202206 002 Feb 06, 2014
AB
1.5MG
A202206 003 Feb 06, 2014
AB
2.25MG
A202206 004 Feb 06, 2014
AB
3MG
A202206 005 Feb 06, 2014
AB
3.75MG
A202206 006 Feb 06, 2014
AB
4.5MG
A202206 007 Feb 06, 2014
PRAMLINTIDE ACETATE
INJECTABLE;SUBCUTANEOUS
SYMLIN
ASTRAZENECA AB
EQ 1.5MG BASE/1.5ML (EQ 1MG BASE/ML)
N021332 002 Sep 25, 2007
+
EQ 2.7MG BASE/2.7ML (EQ 1MG BASE/ML)
N021332 003 Sep 25, 2007
PRASUGREL HYDROCHLORIDE
TABLET;ORAL
EFFIENT
ELI LILLY AND CO
EQ 5MG BASE
N022307 001 Jul 10, 2009
+
EQ 10MG BASE
N022307 002 Jul 10, 2009
PRAVASTATIN SODIUM
TABLET;ORAL
PRAVACHOL
AB BRISTOL MYERS SQUIBB
20MG
N019898 003 Oct 31, 1991
AB
40MG
N019898 004 Mar 22, 1993
AB +
80MG
N019898 008 Dec 18, 2001
PRAVASTATIN SODIUM
AB APOTEX
10MG
A076341 001 Oct 23, 2006
AB
20MG
A076341 002 Oct 23, 2006
AB
40MG
A076341 003 Oct 23, 2006
AB
80MG
A076341 004 Dec 28, 2007
AB CIPLA LTD
10MG
A077904 001 Oct 23, 2006
AB
20MG
A077904 002 Oct 23, 2006
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-298(of 371)
PRAVASTATIN SODIUM
TABLET;ORAL
PRAVASTATIN SODIUM
AB 40MG
A077904 003 Oct 23, 2006
AB DR REDDYS LABS INC 10MG
A076714 001 Oct 23, 2006
AB 20MG
A076714 002 Oct 23, 2006
AB 40MG
A076714 003 Oct 23, 2006
AB 80MG
A076714 004 Dec 28, 2007
AB GLENMARK GENERICS 10MG
A077987 001 May 11, 2007
AB 20MG
A077987 002 May 11, 2007
AB 40MG
A077987 003 May 11, 2007
AB 80MG
A077987 004 Dec 28, 2007
AB LUPIN PHARMS 10MG
A077917 001 Jan 08, 2008
AB 20MG
A077917 002 Jan 08, 2008
AB 40MG
A077917 003 Jan 08, 2008
AB 80MG
A077917 004 Jan 08, 2008
AB MYLAN 10MG
A077013 001 Oct 23, 2006
AB 20MG
A077013 002 Oct 23, 2006
AB 40MG
A077013 003 Oct 23, 2006
AB 80MG
A077013 004 Dec 28, 2007
AB MYLAN PHARMS INC 10MG
A079187 001 May 27, 2010
AB 20MG
A079187 002 May 27, 2010
AB 40MG
A079187 003 May 27, 2010
AB 80MG
A079187 004 May 27, 2010
AB SANDOZ 10MG
A076397 003 Oct 23, 2006
AB 20MG
A076397 002 Oct 23, 2006
AB 40MG
A076397 001 Oct 23, 2006
AB 80MG
A077491 001 Feb 11, 2008
AB TEVA 10MG
A076056 001 Apr 24, 2006
AB 20MG
A076056 002 Apr 24, 2006
AB 40MG
A076056 003 Apr 24, 2006
AB TEVA PHARMS 80MG
A077793 001 Jan 15, 2008
AB WATSON LABS 10MG
A076939 004 Oct 23, 2006
AB 20MG
A076939 003 Oct 23, 2006
AB 40MG
A076939 002 Oct 23, 2006
AB 80MG
A076939 001 Dec 28, 2007
AB ZYDUS PHARMS USA 10MG
A077751 001 Apr 30, 2008
AB 20MG
A077751 002 Apr 30, 2008
AB 40MG
A077751 003 Apr 30, 2008
AB 80MG
A077751 004 Apr 30, 2008
PRAZIQUANTEL
TABLET;ORAL
BILTRICIDE
+ BAYER HLTHCARE 600MG
N018714 001 Dec 29, 1982
PRAZOSIN HYDROCHLORIDE
CAPSULE;ORAL
MINIPRESS
AB PFIZER EQ 1MG BASE
N017442 002
AB + EQ 2MG BASE
N017442 003
AB EQ 5MG BASE
N017442 001
PRAZOSIN HYDROCHLORIDE
AB IVAX SUB TEVA PHARMS EQ 1MG BASE
A071994 001 Sep 12, 1988
AB MYLAN EQ 1MG BASE
A072575 003 May 16, 1989
AB EQ 2MG BASE
A072575 002 May 16, 1989
AB EQ 5MG BASE
A072575 001 May 16, 1989
AB TEVA PHARMS EQ 2MG BASE
A071995 001 Sep 12, 1988
AB EQ 5MG BASE
A071745 001 Sep 12, 1988
PREDNICARBATE
CREAM;TOPICAL
DERMATOP E EMOLLIENT
AB + VALEANT BERMUDA 0.1%
N020279 001 Oct 29, 1993
PREDNICARBATE
AB FOUGERA PHARMS 0.1%
A077287 001 Sep 19, 2006
OINTMENT;TOPICAL
DERMATOP
AB + VALEANT BERMUDA 0.1%
N019568 001 Sep 23, 1991
PREDNICARBATE
AB FOUGERA PHARMS 0.1%
A077236 001 Mar 09, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-299(of 371)
PREDNISOLONE
SYRUP;ORAL
PREDNISOLONE
AA ALPHARMA 15MG/5ML A040323 001 May 13, 1999
AA + HI TECH PHARMA CO 15MG/5ML A040401 001 Feb 27, 2003
AA PHARM ASSOC 15MG/5ML A040399 001 Mar 05, 2003
AA VINTAGE 15MG/5ML A040775 001 Sep 21, 2007
AA WOCKHARDT 15MG/5ML A040313 001 Sep 10, 2003
PRELONE
AA TEVA 15MG/5ML A089081 001 Feb 04, 1986
TABLET;ORAL
PREDNISOLONE
+ WATSON LABS 5MG A080354 001
PREDNISOLONE ACETATE
SUSPENSION;ORAL
FLO-PRED
+ TARO EQ 15MG BASE/5ML N022067 002 Jan 17, 2008
SUSPENSION/DROPS;OPHTHALMIC
OMNIPRED
AB ALCON 1% N017469 001
PRED FORTE
AB + ALLERGAN 1% N017011 001
PRED MILD
+ ALLERGAN 0.12% N017100 001
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM
OINTMENT;OPHTHALMIC
BLEPHAMIDE S.O.P.
+ ALLERGAN 0.2%;10% A087748 001 Dec 03, 1986
SUSPENSION;OPHTHALMIC
BLEPHAMIDE
+ ALLERGAN 0.2%;10% N012813 002
PREDNISOLONE SODIUM PHOSPHATE
SOLUTION;ORAL
ORAPRED
AA + CONCORDIA PHARMS INC EQ 15MG BASE/5ML A075117 001 Dec 14, 2000
PEDIAPRED
AA + SETON PHARM EQ 5MG BASE/5ML N019157 001 May 28, 1986
PREDNISOLONE SODIUM PHOSPHATE
AA AMNEAL PHARMS EQ 15MG BASE/5ML A078345 001 Mar 10, 2009
AA HI TECH PHARMA EQ 5MG BASE/5ML A075183 001 Mar 26, 2003
AA PADDOCK LLC EQ 5MG BASE/5ML A075988 001 May 25, 2004
AA PHARM ASSOC EQ 15MG BASE/5ML A076913 001 Apr 25, 2005
AA VINTAGE EQ 15MG BASE/5ML A079010 001 May 26, 2009
AA WOCKHARDT EQ 5MG BASE/5ML A075099 001 Jun 28, 2002
AA EQ 15MG BASE/5ML A076895 001 Oct 04, 2004
+ MISSION PHARMA EQ 25MG BASE/5ML A091396 001 Sep 13, 2010
+ PHARM ASSOC EQ 10MG BASE/5ML A078465 001 Mar 07, 2008
+ EQ 20MG BASE/5ML A078988 001 Jun 09, 2008
SOLUTION/DROPS;OPHTHALMIC
PREDNISOLONE SODIUM PHOSPHATE
+ BAUSCH AND LOMB EQ 0.9% PHOSPHATE A040070 001 Jul 29, 1994
TABLET, ORALLY DISINTEGRATING;ORAL
ORAPRED ODT
AB CONCORDIA PHARMS INC EQ 10MG BASE N021959 001 Jun 01, 2006
AB EQ 15MG BASE N021959 002 Jun 01, 2006
AB + EQ 30MG BASE N021959 003 Jun 01, 2006
PREDNISOLONE SODIUM PHOSPHATE
AB MYLAN PHARMS INC EQ 10MG BASE A202179 001 Apr 10, 2013
AB EQ 15MG BASE A202179 002 Apr 10, 2013
AB EQ 30MG BASE A202179 003 Apr 10, 2013
PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM
SOLUTION/DROPS;OPHTHALMIC
SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE
AT ALCON PHARMS LTD EQ 0.23% PHOSPHATE;10% A073630 001 May 27, 1993
AT + BAUSCH AND LOMB EQ 0.23% PHOSPHATE;10% A074449 001 Dec 29, 1995
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-300(of 371)
PREDNISONE
SOLUTION;ORAL
PREDNISONE
+ ROXANE 5MG/5ML A088703 001 Nov 08, 1984
PREDNISONE INTENSOL
+ ROXANE 5MG/ML A088810 001 Feb 20, 1985
TABLET;ORAL
PREDNISONE
AB CONTRACT PHARMACAL 5MG A080209 001
AB HIKMA PHARMS 1MG A040890 001 Nov 01, 2010
AB 2.5MG A040538 001 Jan 08, 2004
AB 5MG A080292 001
AB 10MG A088832 001 Dec 04, 1985
AB 20MG A083677 001
AB 50MG A088465 001 Jun 01, 1984
AB JUBILANT CADISTA 1MG A040611 001 Jun 06, 2005
AB 5MG A040362 002 Aug 29, 2001
AB 10MG A040362 001 Aug 29, 2001
AB 20MG A040362 003 Jun 29, 2005
AB MUTUAL PHARM 5MG A089245 001 Dec 04, 1985
AB 10MG A089246 001 Dec 04, 1985
AB 20MG A089247 001 Dec 04, 1985
AB + ROXANE 1MG A087800 001 Apr 22, 1982
AB + 2.5MG A087801 001 Apr 22, 1982
AB + 5MG A080352 001
AB + 10MG A084122 001
AB + 20MG A087342 001
AB + 50MG A084283 001
AB VINTAGE PHARMS 1MG A040584 001 Dec 21, 2004
AB 2.5MG A040581 001 Dec 21, 2004
AB 5MG A040256 001 Jul 12, 2002
AB 10MG A040256 002 Jul 12, 2002
AB 20MG A040392 001 Feb 12, 2003
AB WATSON LABS 5MG A080356 001
AB 10MG A085162 001
AB 20MG A085161 001
TABLET, DELAYED RELEASE;ORAL
RAYOS
HORIZON PHARMA 1MG N202020 001 Jul 26, 2012
2MG N202020 002 Jul 26, 2012
+ 5MG N202020 003 Jul 26, 2012
PREGABALIN
CAPSULE;ORAL
LYRICA
AB PF PRISM CV 25MG N021446 001 Dec 30, 2004
AB 50MG N021446 002 Dec 30, 2004
AB 75MG N021446 003 Dec 30, 2004
AB 100MG N021446 004 Dec 30, 2004
AB 150MG N021446 005 Dec 30, 2004
AB 200MG N021446 006 Dec 30, 2004
AB 225MG N021446 007 Dec 30, 2004
AB + 300MG N021446 008 Dec 30, 2004
PREGABALIN
AB LUPIN LTD 25MG A091040 001 Jul 03, 2012
AB 50MG A091040 002 Jul 03, 2012
AB 75MG A091040 003 Jul 03, 2012
AB 100MG A091040 004 Jul 03, 2012
AB 150MG A091040 005 Jul 03, 2012
AB 200MG A091040 006 Jul 03, 2012
AB 225MG A091040 007 Jul 03, 2012
AB 300MG A091040 008 Jul 03, 2012
AB TEVA PHARMS 25MG A091219 001 Jul 03, 2012
AB 50MG A091219 002 Jul 03, 2012
AB 75MG A091224 001 Jul 03, 2012
AB 100MG A091224 002 Jul 03, 2012
AB 150MG A091224 003 Jul 03, 2012
AB 200MG A091224 004 Jul 03, 2012
AB 225MG A091224 005 Jul 03, 2012
AB 300MG A091224 006 Jul 03, 2012
AB WATSON LABS INC 25MG A091221 001 Jul 03, 2012
AB 50MG A091221 002 Jul 03, 2012
AB 75MG A091221 003 Jul 03, 2012
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-301(of 371)
PREGABALIN
CAPSULE;ORAL
PREGABALIN
AB
100MG
A091221 004 Jul 03, 2012
AB
150MG
A091221 005 Jul 03, 2012
AB
200MG
A091221 006 Jul 03, 2012
AB
225MG
A091221 007 Jul 03, 2012
AB
300MG
A091221 008 Jul 03, 2012
SOLUTION;ORAL
LYRICA
+ PF PRISM CV
20MG/ML
N022488 001 Jan 04, 2010
PRILOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
PRILOCAINE HYDROCHLORIDE
+ SEPTODONT INC
4%
A079235 001 Sep 29, 2010
PRIMAQUINE PHOSPHATE
TABLET;ORAL
PRIMAQUINE
AB + SANOFI AVENTIS US EQ 15MG BASE
N008316 001
PRIMAQUINE PHOSPHATE
AB ALVOGEN INC EQ 15MG BASE
A203924 001 Feb 03, 2014
AB BAYSHORE PHARMS LLC EQ 15MG BASE
A204476 001 Feb 25, 2014
PRIMIDONE
TABLET;ORAL
MYSOLINE
AB + VALEANT
50MG
N009170 003
AB
250MG
N009170 002
PRIMIDONE
AB AMNEAL PHARM
50MG
A040866 001 Apr 23, 2008
AB
250MG
A040866 002 Apr 23, 2008
AB HIKMA PHARMS LLC
250MG
A040667 002 Jul 27, 2006
AB IMPAX LABS
50MG
A040717 001 Feb 12, 2008
AB
250MG
A040717 002 Feb 12, 2008
AB LANNETT
50MG
A084903 002 May 24, 2001
AB
250MG
A084903 001
AB MUTUAL PHARM
50MG
A040626 001 Sep 29, 2005
AB
250MG
A040626 002 Sep 29, 2005
AB VINTAGE PHARMS
50MG
A040586 001 Feb 24, 2005
AB
250MG
A040586 002 Feb 24, 2005
AB WATSON LABS
250MG
A083551 001
PROBENECID
TABLET;ORAL
PROBALAN
AB LANNETT
500MG
A080966 001
PROBENECID
AB + MYLAN
500MG
A084211 002
AB WATSON LABS
500MG
A084442 004 Mar 29, 1983
PROCAINAMIDE HYDROCHLORIDE
INJECTABLE;INJECTION
PROCAINAMIDE HYDROCHLORIDE
+ HOSPIRA
100MG/ML
A089069 001 Feb 12, 1986
+
500MG/ML
A089070 001 Feb 12, 1986
PROCARBAZINE HYDROCHLORIDE
CAPSULE;ORAL
MATULANE
+ SIGMA TAU
EQ 50MG BASE
N016785 001
PROCHLORPERAZINE
SUPPOSITORY;RECTAL
COMPRO
AB PADDOCK LLC
25MG
A040246 001 Jun 28, 2000
PROCHLORPERAZINE
AB + G AND W LABS
25MG
A040058 001 Nov 24, 1993
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-302(of 371)
PROCHLORPERAZINE EDISYLATE
INJECTABLE;INJECTION
PROCHLORPERAZINE EDISYLATE
AP BEDFORD
EQ 5MG BASE/ML
A040540 001 May 28, 2004
AP EMCURE PHARMS LTD
EQ 5MG BASE/ML
A204147 001 Oct 15, 2013
AP + HIKMA MAPLE
EQ 5MG BASE/ML
A089903 001 Aug 29, 1989
PROCHLORPERAZINE MALEATE
TABLET;ORAL
PROCHLORPERAZINE MALEATE
AB MYLAN
EQ 5MG BASE
A040185 002 Oct 28, 1996
AB
EQ 10MG BASE
A040185 001 Oct 28, 1996
AB SANDOZ
EQ 5MG BASE
A040101 001 Jul 19, 1996
AB +
EQ 10MG BASE
A040101 002 Jul 19, 1996
AB TEVA PHARMS
EQ 5MG BASE
A040120 001 Jul 11, 1996
AB
EQ 10MG BASE
A040120 002 Jul 11, 1996
PROCOMP
AB JUBILANT CADISTA
EQ 5MG BASE
A040268 001 Feb 27, 1998
AB
EQ 10MG BASE
A040268 002 Feb 27, 1998
PROGESTERONE
CAPSULE;ORAL
PROGESTERONE
AB BANNER PHARMACAPS
100MG
A200900 001 Aug 16, 2013
AB
200MG
A200900 002 Aug 16, 2013
AB SOFGEN PHARMS
100MG
A200456 001 Sep 28, 2012
AB
200MG
A200456 002 Sep 28, 2012
AB TEVA PHARMS
100MG
A202121 001 Feb 29, 2012
AB
200MG
A202121 002 Feb 29, 2012
PROMETRIUM
AB ABBVIE INC
100MG
N019781 001 May 14, 1998
AB +
200MG
N019781 002 Oct 15, 1999
GEL;VAGINAL
CRINONE
WATSON LABS
4%
N020701 001 Jul 31, 1997
+
8%
N020701 002 Jul 31, 1997
INJECTABLE;INJECTION
PROGESTERONE
AO FRESENIUS KABI USA
50MG/ML
A075906 001 Apr 25, 2001
AO HIKMA FARMACEUTICA
50MG/ML
A091033 001 Oct 28, 2010
AO LUITPOLD
50MG/ML
A090845 001 Jun 22, 2009
AO + WATSON LABS (UTAH)
50MG/ML
N017362 002
INSERT;VAGINAL
ENDOMETRIN
+ FERRING
100MG
N022057 001 Jun 21, 2007
PROMETHAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
PROMETHAZINE HYDROCHLORIDE
AP + HIKMA MAPLE
25MG/ML
A083312 001
AP +
50MG/ML
A083312 002
AP X-GEN PHARMS
25MG/ML
A040737 001 Apr 24, 2008
AP
50MG/ML
A040737 002 Apr 24, 2008
SUPPOSITORY;RECTAL
PROMETHAZINE HYDROCHLORIDE
AB G AND W LABS
12.5MG
A040428 002 Mar 31, 2003
AB +
25MG
A040428 001 Feb 05, 2002
AB PERRIGO NEW YORK
12.5MG
A040500 001 Jun 30, 2003
AB
25MG
A040500 002 Jun 30, 2003
AB TARO
12.5MG
A040603 001 Oct 26, 2006
AB
25MG
A040603 002 Oct 26, 2006
AB WATSON LABS INC
12.5MG
A040479 001 Jun 24, 2003
AB
25MG
A040479 002 Jun 24, 2003
PROMETHEGAN
+ G AND W LABS
50MG
A087165 001 Aug 14, 1987
SYRUP;ORAL
PROMETHAZINE HYDROCHLORIDE
AA AMNEAL PHARMS
6.25MG/5ML
A040882 001 Dec 30, 2009
AA HI TECH PHARMA
6.25MG/5ML
A040026 001 Sep 25, 1998
AA SUN PHARM INDS INC
6.25MG/5ML
A040891 001 Mar 13, 2009
AA TARO
6.25MG/5ML
A040718 001 Apr 04, 2007
AA TRIS PHARMA INC
6.25MG/5ML
A091675 001 Jun 28, 2012
AA VINTAGE
6.25MG/5ML
A040643 001 Apr 26, 2006
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-303(of 371)
PROMETHAZINE HYDROCHLORIDE
SYRUP;ORAL
PROMETHAZINE PLAIN
AA + WOCKHARDT 6.25MG/5ML A087953 001 Nov 15, 1982
TABLET;ORAL
PROMETHAZINE HYDROCHLORIDE
AB AMNEAL PHARMS NY 12.5MG A091179 001 Dec 13, 2010
AB 25MG A091179 002 Dec 13, 2010
AB 50MG A091179 003 Dec 13, 2010
AB EMCURE PHARMS USA 12.5MG A040673 001 Mar 05, 2008
AB 25MG A040673 002 Mar 05, 2008
AB 50MG A040673 003 Mar 05, 2008
AB IMPAX LABS 12.5MG A040724 001 Feb 12, 2008
AB 25MG A040724 002 Feb 12, 2008
AB 50MG A040791 001 May 20, 2008
AB KVK TECH 12.5MG A040712 002 May 04, 2007
AB 25MG A040712 001 Jul 31, 2006
AB 50MG A040713 001 Jul 31, 2006
AB MYLAN 12.5MG A091054 001 Aug 30, 2011
AB 25MG A091054 002 Aug 30, 2011
AB 50MG A091054 003 Aug 30, 2011
AB SANDOZ 25MG A084176 003
AB + 50MG A084176 001
AB SUN PHARM INDS INC 12.5MG A040863 001 Dec 30, 2008
AB 25MG A040863 002 Dec 30, 2008
AB 50MG A040863 003 Dec 30, 2008
AB VINTAGE PHARMS 12.5MG A040622 001 Jul 18, 2006
AB 25MG A040622 002 Jul 18, 2006
AB 50MG A040622 003 Jul 18, 2006
AB WATSON LABS 25MG A083426 001
AB 50MG A083711 001
AB ZYDUS PHARMS USA 12.5MG A040596 001 Nov 18, 2005
AB 25MG A040596 002 Nov 18, 2005
AB 50MG A040596 003 Nov 18, 2005
PROPAFENONE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
PROPAFENONE HYDROCHLORIDE
AB PAR PHARM 225MG A078540 001 Oct 18, 2010
AB 325MG A078540 002 Oct 18, 2010
AB 425MG A078540 003 Oct 18, 2010
RYTHMOL SR
AB GLAXOSMITHKLINE LLC 225MG N021416 001 Sep 04, 2003
AB 325MG N021416 002 Sep 04, 2003
AB + 425MG N021416 003 Sep 04, 2003
TABLET;ORAL
PROPAFENONE HYDROCHLORIDE
AB ANI PHARMS INC 150MG A076550 001 Apr 23, 2004
AB 225MG A076550 002 Apr 23, 2004
AB 300MG A076550 003 Apr 23, 2004
AB MUTUAL PHARM 150MG A075998 001 Nov 29, 2001
AB 225MG A075998 002 Nov 29, 2001
AB 300MG A075998 003 Nov 29, 2001
AB VINTAGE PHARMS 150MG A075938 001 Oct 17, 2002
AB 225MG A075938 002 Oct 17, 2002
AB 300MG A075938 003 Oct 17, 2002
AB WATSON LABS 150MG A075203 001 Oct 24, 2000
AB 225MG A075203 002 Oct 24, 2000
RYTHMOL
AB GLAXOSMITHKLINE LLC 150MG N019151 001 Nov 27, 1989
AB 225MG N019151 003 Nov 20, 1992
AB + 300MG N019151 002 Nov 27, 1989
PROPANTHELINE BROMIDE
TABLET;ORAL
PROPANTHELINE BROMIDE
+ ROXANE 15MG A080927 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-304(of 371)
PROPARACAINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
ALCAINE
AT + ALCON 0.5% A080027 001
PROPARACAINE HYDROCHLORIDE
AT AKORN INC 0.5% A040277 001 Mar 16, 2000
AT BAUSCH AND LOMB 0.5% A040074 001 Sep 29, 1995
PROPOFOL
INJECTABLE;INJECTION
DIPRIVAN
AB + FRESENIUS KABI USA 10MG/ML N019627 002 Jun 11, 1996
PROPOFOL
AB HOSPIRA 10MG/ML A077908 001 Mar 17, 2006
AB TEVA PHARMS USA 10MG/ML A075102 001 Jan 04, 1999
PROPOXYPHENE HYDROCHLORIDE
CAPSULE;ORAL
PROPOXYPHENE HYDROCHLORIDE
PVT FORM 32MG A083464 001
PROPRANOLOL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
INDERAL LA
AB CRANFORD PHARMS LLC 60MG N018553 004 Mar 18, 1987
AB 80MG N018553 002 Apr 19, 1983
AB 120MG N018553 003 Apr 19, 1983
AB + 160MG N018553 001 Apr 19, 1983
PROPRANOLOL HYDROCHLORIDE
AB ACTAVIS ELIZABETH 60MG A078494 001 Aug 10, 2007
AB 80MG A078494 002 Aug 10, 2007
AB 120MG A078494 003 Aug 10, 2007
AB 160MG A078494 004 Aug 10, 2007
AB APTALIS PHARMATECH 60MG A078703 001 Jul 15, 2011
AB 80MG A078703 002 Jul 15, 2011
AB 120MG A078703 003 Jul 15, 2011
AB 160MG A078703 004 Jul 15, 2011
AB MYLAN 60MG A078022 001 Feb 15, 2007
AB 80MG A078022 002 Feb 15, 2007
AB 120MG A078022 003 Feb 15, 2007
AB 160MG A078022 004 Feb 15, 2007
AB NORTEC DEV ASSOC 60MG A078065 001 Jan 26, 2007
AB 80MG A078065 002 Jan 26, 2007
AB 120MG A078065 003 Jan 26, 2007
AB 160MG A078065 004 Jan 26, 2007
AB UPSHER SMITH 60MG A078311 001 Mar 06, 2009
AB 80MG A078311 002 Mar 06, 2009
AB 120MG A078311 003 Mar 06, 2009
AB 160MG A078311 004 Mar 06, 2009
AB ZYDUS PHARMS USA INC 60MG A090321 001 Mar 25, 2011
AB 80MG A090321 002 Mar 25, 2011
AB 120MG A090321 003 Mar 25, 2011
AB 160MG A090321 004 Mar 25, 2011
INNOPRAN XL
BX GLAXOSMITHKLINE LLC 80MG N021438 001 Mar 12, 2003
BX 120MG N021438 002 Mar 12, 2003
INJECTABLE;INJECTION
PROPRANOLOL HYDROCHLORIDE
AP + BAXTER HLTHCARE CORP 1MG/ML N016419 001
AP BEDFORD 1MG/ML A075792 001 Aug 29, 2000
AP FRESENIUS KABI USA 1MG/ML A075826 001 Aug 31, 2001
AP HIKMA FARMACEUTICA 1MG/ML A077760 001 Jan 31, 2008
AP SANDOZ 1MG/ML A076400 001 Feb 26, 2003
SOLUTION;ORAL
HEMANGEOL
+ PIERRE FABRE DERMA 4.28MG/ML N205410 001 Mar 14, 2014
PROPRANOLOL HYDROCHLORIDE
+ ROXANE 20MG/5ML A070979 001 May 15, 1987
+ 40MG/5ML A070690 001 May 15, 1987
TABLET;ORAL
PROPRANOLOL HYDROCHLORIDE
AB IPCA LABS LTD 10MG A078955 001 Jun 02, 2008
AB 20MG A078955 002 Jun 02, 2008
AB 40MG A078955 003 Jun 02, 2008
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-305(of 371)
PROPRANOLOL HYDROCHLORIDE
TABLET;ORAL
PROPRANOLOL HYDROCHLORIDE
AB 60MG
A078955 004 Jun 02, 2008
AB 80MG
A078955 005 Jun 02, 2008
AB MYLAN 10MG
A070213 002 Nov 19, 1985
AB 20MG
A070213 003 Nov 19, 1985
AB 40MG
A070213 001 Nov 19, 1985
AB 60MG
A070213 005 Apr 08, 2011
AB 80MG
A070213 004 Nov 19, 1985
AB NORTHSTAR HLTHCARE 10MG
A078213 001 Jan 10, 2008
AB 20MG
A078213 002 Jan 10, 2008
AB 40MG
A078213 003 Jan 10, 2008
AB 60MG
A078213 004 Jan 10, 2008
AB 80MG
A078213 005 Jan 10, 2008
AB PLIVA 10MG
A071972 001 Apr 06, 1988
AB 20MG
A071973 001 Apr 06, 1988
AB 40MG
A071974 001 Apr 06, 1988
AB 60MG
A071975 001 Apr 06, 1988
AB + 80MG
A071976 001 Apr 06, 1988
AB VINTAGE PHARMS 10MG
A070217 001 Aug 01, 1986
AB 20MG
A070218 001 Aug 01, 1986
AB 40MG
A070219 001 Aug 01, 1986
AB 60MG
A070220 001 Sep 24, 1986
AB 80MG
A070221 001 Apr 14, 1986
AB WATSON LABS 10MG
A070175 001 May 13, 1986
AB 20MG
A070176 001 May 13, 1986
AB 40MG
A070177 001 May 13, 1986
AB 80MG
A070178 001 May 13, 1986
PROPYLTHIOURACIL
TABLET;ORAL
PROPYLTHIOURACIL
BD ACTAVIS ELIZABETH
50MG
A080172 001
BD + DAVA PHARMS INC
50MG
N006188 001
PROTAMINE SULFATE
INJECTABLE;INJECTION
PROTAMINE SULFATE
+ FRESENIUS KABI USA
10MG/ML
A089454 001 Apr 07, 1987
PROTRIPTYLINE HYDROCHLORIDE
TABLET;ORAL
PROTRIPTYLINE HYDROCHLORIDE
AB EPIC PHARMA LLC
5MG
A202220 001 Nov 19, 2012
AB
10MG
A202220 002 Nov 19, 2012
AB ROXANE
5MG
A078913 001 Sep 16, 2008
AB
10MG
A078913 002 Sep 16, 2008
AB SIGMAPHARM LABS LLC
5MG
A090462 001 May 03, 2010
AB
10MG
A090462 002 May 03, 2010
VIVACTIL
AB ODYSSEY PHARMS
5MG
A073644 001 Aug 24, 1995
AB +
10MG
A073645 001 Aug 24, 1995
PYRAZINAMIDE
TABLET;ORAL
PYRAZINAMIDE
AB + DAVA PHARMS INC
500MG
A080157 001
AB MIKART
500MG
A081319 001 Jun 30, 1992
PYRIDOSTIGMINE BROMIDE
INJECTABLE;INJECTION
MESTINON
AP + VALEANT PHARM INTL
5MG/ML
N009830 001
REGONOL
AP SANDOZ
5MG/ML
N017398 001
SYRUP;ORAL
MESTINON
+ VALEANT PHARM NORTH
60MG/5ML
N015193 001
TABLET;ORAL
MESTINON
AB + VALEANT PHARMS LLC
60MG
N009829 002
PYRIDOSTIGMINE BROMIDE
AB IMPAX LABS
60MG
A040502 001 Apr 24, 2003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-306(of 371)
PYRIDOSTIGMINE BROMIDE
TABLET, EXTENDED RELEASE;ORAL
MESTINON
+ VALEANT PHARMS LLC
180MG
N011665 001
PYRIDOXINE HYDROCHLORIDE
INJECTABLE;INJECTION
PYRIDOXINE HYDROCHLORIDE
+ FRESENIUS KABI USA
100MG/ML
A080618 001
PYRIMETHAMINE
TABLET;ORAL
DARAPRIM
+ AMEDRA PHARMS
25MG
N008578 001
QUAZEPAM
TABLET;ORAL
DORAL
+ SCIECURE PHARMA INC
15MG
N018708 001 Dec 27, 1985
QUETIAPINE FUMARATE
TABLET;ORAL
QUETIAPINE FUMARATE
AB ACCORD HLTHCARE EQ 25MG BASE
A202152 001 Mar 27, 2012
AB EQ 50MG BASE
A202152 002 Mar 27, 2012
AB EQ 100MG BASE
A202152 003 Mar 27, 2012
AB EQ 200MG BASE
A202152 004 Mar 27, 2012
AB EQ 300MG BASE
A202152 005 Mar 27, 2012
AB EQ 400MG BASE
A202152 006 Mar 27, 2012
AB ACTAVIS GRP PTC EQ 25MG BASE
A201762 001 Feb 27, 2013
AB EQ 50MG BASE
A201762 002 Feb 27, 2013
AB EQ 100MG BASE
A201762 003 Feb 27, 2013
AB EQ 150MG BASE
A201762 004 Feb 27, 2013
AB EQ 200MG BASE
A201762 005 Feb 27, 2013
AB EQ 300MG BASE
A201762 006 Feb 27, 2013
AB EQ 400MG BASE
A201762 007 Feb 27, 2013
AB ALEMBIC PHARMS LTD EQ 25MG BASE
A203390 001 Oct 28, 2014
AB EQ 50MG BASE
A203390 002 Oct 28, 2014
AB EQ 100MG BASE
A203390 003 Oct 28, 2014
AB EQ 200MG BASE
A203390 004 Oct 28, 2014
AB EQ 300MG BASE
A203390 005 Oct 28, 2014
AB EQ 400MG BASE
A203390 006 Oct 28, 2014
AB ALKEM LABS LTD EQ 25MG BASE
A201504 001 Feb 12, 2013
AB EQ 50MG BASE
A201504 002 Feb 12, 2013
AB EQ 100MG BASE
A201504 003 Feb 12, 2013
AB EQ 150MG BASE
A201504 004 Feb 12, 2013
AB EQ 200MG BASE
A201504 005 Feb 12, 2013
AB EQ 300MG BASE
A201504 006 Feb 12, 2013
AB EQ 400MG BASE
A201504 007 Feb 12, 2013
AB APOTEX INC EQ 25MG BASE
A090960 001 Mar 27, 2012
AB EQ 50MG BASE
A090960 002 Mar 27, 2012
AB EQ 100MG BASE
A090960 003 Mar 27, 2012
AB EQ 200MG BASE
A090960 004 Mar 27, 2012
AB EQ 300MG BASE
A090960 005 Mar 27, 2012
AB EQ 400MG BASE
A090960 006 Mar 27, 2012
AB AUROBINDO PHARMA LTD EQ 25MG BASE
A091388 001 Mar 27, 2012
AB EQ 50MG BASE
A091388 002 Mar 27, 2012
AB EQ 100MG BASE
A091388 003 Mar 27, 2012
AB EQ 150MG BASE
A091388 004 Mar 27, 2012
AB EQ 200MG BASE
A091388 005 Mar 27, 2012
AB EQ 300MG BASE
A091388 006 Mar 27, 2012
AB EQ 400MG BASE
A091388 007 Mar 27, 2012
AB DR REDDYS LABS LTD EQ 25MG BASE
A077380 001 Mar 27, 2012
AB EQ 50MG BASE
A077380 002 Mar 27, 2012
AB EQ 100MG BASE
A077380 003 Mar 27, 2012
AB EQ 150MG BASE
A077380 004 Mar 27, 2012
AB EQ 200MG BASE
A077380 005 Mar 27, 2012
AB EQ 300MG BASE
A077380 006 Mar 27, 2012
AB EQ 400MG BASE
A077380 007 Mar 27, 2012
AB JUBILANT GENERICS EQ 25MG BASE
A203150 001 Nov 26, 2013
AB LUPIN LTD EQ 25MG BASE
A201109 001 Mar 27, 2012
AB EQ 50MG BASE
A201109 002 Mar 27, 2012
AB EQ 100MG BASE
A201109 003 Mar 27, 2012
AB EQ 200MG BASE
A201109 004 Mar 27, 2012
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-307(of 371)
QUETIAPINE FUMARATE
TABLET;ORAL
QUETIAPINE FUMARATE
AB EQ 300MG BASE
A201109 005 Mar 27, 2012
AB EQ 400MG BASE
A201109 006 Mar 27, 2012
AB MYLAN PHARMS INC EQ 25MG BASE
A090323 001 Mar 27, 2012
AB ROXANE EQ 25MG BASE
A090120 001 Mar 27, 2012
AB EQ 50MG BASE
A090749 001 Mar 27, 2012
AB EQ 100MG BASE
A090749 002 Mar 27, 2012
AB EQ 200MG BASE
A090749 003 Mar 27, 2012
AB EQ 300MG BASE
A090749 004 Mar 27, 2012
AB EQ 400MG BASE
A090749 005 Mar 27, 2012
AB SANDOZ EQ 25MG BASE
A078679 001 Dec 14, 2012
AB EQ 50MG BASE
A078679 002 Dec 14, 2012
AB EQ 100MG BASE
A078679 003 Dec 14, 2012
AB EQ 150MG BASE
A078679 004 Dec 14, 2012
AB EQ 200MG BASE
A078679 005 Dec 14, 2012
AB EQ 300MG BASE
A078679 006 Dec 14, 2012
AB EQ 400MG BASE
A078679 007 Dec 14, 2012
AB SUN PHARMA GLOBAL
EQ 25MG BASE
A201190 001 Mar 27, 2012
AB
EQ 50MG BASE
A201190 002 Mar 27, 2012
AB
EQ 100MG BASE
A201190 003 Mar 27, 2012
AB
EQ 200MG BASE
A201190 004 Mar 27, 2012
AB
EQ 300MG BASE
A201190 005 Mar 27, 2012
AB
EQ 400MG BASE
A201190 006 Mar 27, 2012
AB TEVA PHARMS
EQ 25MG BASE
A077745 001 Mar 27, 2012
AB
EQ 50MG BASE
A077745 002 Mar 27, 2012
AB
EQ 100MG BASE
A077745 003 Mar 27, 2012
AB
EQ 150MG BASE
A077745 004 Mar 27, 2012
AB
EQ 200MG BASE
A077745 005 Mar 27, 2012
AB
EQ 300MG BASE
A077745 006 Mar 27, 2012
AB
EQ 400MG BASE
A077745 007 Mar 27, 2012
AB TORRENT PHARMS LTD
EQ 25MG BASE
A200363 001 Mar 27, 2012
AB
EQ 50MG BASE
A200363 002 Mar 27, 2012
AB
EQ 100MG BASE
A200363 003 Mar 27, 2012
AB
EQ 200MG BASE
A200363 004 Mar 27, 2012
AB
EQ 300MG BASE
A200363 005 Mar 27, 2012
AB
EQ 400MG BASE
A200363 006 Mar 27, 2012
SEROQUEL
AB + ASTRAZENECA EQ 25MG BASE
N020639 001 Sep 26, 1997
AB EQ 50MG BASE
N020639 007 Oct 04, 2005
AB EQ 100MG BASE
N020639 002 Sep 26, 1997
AB EQ 200MG BASE
N020639 003 Sep 26, 1997
AB + EQ 300MG BASE
N020639 005 Jul 26, 2000
AB EQ 400MG BASE
N020639 006 Oct 04, 2005
TABLET, EXTENDED RELEASE;ORAL
SEROQUEL XR
ASTRAZENECA
EQ 50MG BASE
N022047 001 May 17, 2007
EQ 150MG BASE
N022047 005 Aug 11, 2008
+
EQ 200MG BASE
N022047 002 May 17, 2007
EQ 300MG BASE
N022047 003 May 17, 2007
EQ 400MG BASE
N022047 004 May 17, 2007
QUINAPRIL HYDROCHLORIDE
TABLET;ORAL
ACCUPRIL
AB PFIZER PHARMS
EQ 5MG BASE
N019885 001 Nov 19, 1991
AB
EQ 10MG BASE
N019885 002 Nov 19, 1991
AB
EQ 20MG BASE
N019885 003 Nov 19, 1991
AB +
EQ 40MG BASE
N019885 004 Nov 19, 1991
QUINAPRIL HYDROCHLORIDE
AB ACTAVIS LABS FL INC
EQ 5MG BASE
A076049 001 Jan 14, 2005
AB
EQ 10MG BASE
A076049 002 Jan 14, 2005
AB
EQ 20MG BASE
A076049 003 Jan 14, 2005
AB
EQ 40MG BASE
A076049 004 Jan 14, 2005
AB AUROBINDO PHARMA LTD
EQ 5MG BASE
A202725 001 Apr 29, 2013
AB
EQ 10MG BASE
A202725 002 Apr 29, 2013
AB
EQ 20MG BASE
A202725 003 Apr 29, 2013
AB
EQ 40MG BASE
A202725 004 Apr 29, 2013
AB INVAGEN PHARMS
EQ 5MG BASE
A078457 001 Aug 24, 2007
AB
EQ 10MG BASE
A078457 002 Aug 24, 2007
AB
EQ 20MG BASE
A078457 003 Aug 24, 2007
AB
EQ 40MG BASE
A078457 004 Aug 24, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-308(of 371)
QUINAPRIL HYDROCHLORIDE
TABLET;ORAL
QUINAPRIL HYDROCHLORIDE
AB LUPIN
EQ 5MG BASE
A077690 001 Jun 20, 2006
AB
EQ 10MG BASE
A077690 002 Jun 20, 2006
AB
EQ 20MG BASE
A077690 003 Jun 20, 2006
AB
EQ 40MG BASE
A077690 004 Jun 20, 2006
AB MYLAN
EQ 5MG BASE
A076694 001 Dec 23, 2004
AB
EQ 10MG BASE
A076694 002 Dec 23, 2004
AB
EQ 20MG BASE
A076694 003 Dec 23, 2004
AB
EQ 40MG BASE
A076694 004 Dec 23, 2004
AB RANBAXY
EQ 5MG BASE
A076607 001 Dec 15, 2004
AB
EQ 10MG BASE
A076607 002 Dec 15, 2004
AB
EQ 20MG BASE
A076607 003 Dec 15, 2004
AB
EQ 40MG BASE
A076607 004 Dec 15, 2004
AB SUN PHARM INDS LTD
EQ 5MG BASE
A090800 001 Jun 18, 2009
AB
EQ 10MG BASE
A090800 002 Jun 18, 2009
AB
EQ 20MG BASE
A090800 003 Jun 18, 2009
AB
EQ 40MG BASE
A090800 004 Jun 18, 2009
AB TEVA
EQ 5MG BASE
A075504 001 Aug 24, 2007
AB
EQ 10MG BASE
A075504 002 Aug 24, 2007
AB
EQ 20MG BASE
A075504 003 Aug 24, 2007
AB
EQ 40MG BASE
A075504 004 Aug 24, 2007
QUINIDINE GLUCONATE
INJECTABLE;INJECTION
QUINIDINE GLUCONATE
+ LILLY
80MG/ML
N007529 002 Feb 10, 1989
TABLET, EXTENDED RELEASE;ORAL
QUINIDINE GLUCONATE
BX + MUTUAL PHARM
324MG
A089338 001 Feb 11, 1987
QUINIDINE SULFATE
TABLET;ORAL
QUINIDINE SULFATE
AB MUTUAL PHARM 200MG
A081030 001 Apr 14, 1989
AB 300MG
A081031 001 Apr 14, 1989
AB SANDOZ 200MG
A088072 002
AB 300MG
A088072 001 Sep 26, 1983
AB + WATSON LABS 200MG
A083288 001
AB + 300MG
A085583 001
TABLET, EXTENDED RELEASE;ORAL
QUINIDINE SULFATE
+ TEVA PHARMS
300MG
A040045 001 Jun 30, 1994
QUININE SULFATE
CAPSULE;ORAL
QUALAQUIN
AB + MUTUAL PHARM CO INC
324MG
N021799 001 Aug 12, 2005
QUININE SULFATE
AB MYLAN PHARMS INC
324MG
A202581 001 Dec 14, 2012
AB TEVA PHARMS
324MG
A091661 001 Sep 28, 2012
RABEPRAZOLE SODIUM
CAPSULE, DELAYED RELEASE;ORAL
ACIPHEX SPRINKLE
EISAI INC
5MG
N204736 001 Mar 26, 2013
+
10MG
N204736 002 Mar 26, 2013
TABLET, DELAYED RELEASE;ORAL
ACIPHEX
AB + EISAI INC
20MG
N020973 002 Aug 19, 1999
RABEPRAZOLE SODIUM
AB DR REDDYS LABS LTD
20MG
A076824 001 Nov 08, 2013
AB KREMERS URBAN DEV
20MG
A090678 001 Nov 08, 2013
AB LUPIN LTD
20MG
A078964 001 Nov 08, 2013
AB MYLAN PHARMS INC
20MG
A076885 001 Nov 08, 2013
AB TEVA PHARMS USA
20MG
A076822 001 Nov 08, 2013
AB TORRENT PHARMS LTD
20MG
A202376 001 Nov 08, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-309(of 371)
RADIUM RA-223 DICHLORIDE
SOLUTION;INTRAVENOUS
XOFIGO
+ BAYER HLTHCARE 162mCi/6ML (27mCi/ML) N203971 001 May 15, 2013
RALOXIFENE HYDROCHLORIDE
TABLET;ORAL
EVISTA
AB + LILLY 60MG N020815 001 Dec 09, 1997
RALOXIFENE HYDROCHLORIDE
AB INVAGEN PHARMS 60MG A090842 001 Sep 24, 2014
AB TEVA PHARMS USA 60MG A078193 001 Mar 04, 2014
RALTEGRAVIR POTASSIUM
POWDER;ORAL
ISENTRESS
+ MERCK SHARP DOHME EQ 100MG BASE/PACKET N205786 001 Dec 20, 2013
TABLET;ORAL
ISENTRESS
+ MERCK SHARP DOHME EQ 400MG BASE N022145 001 Oct 12, 2007
TABLET, CHEWABLE;ORAL
ISENTRESS
MERCK SHARP DOHME EQ 25MG BASE N203045 001 Dec 21, 2011
+ EQ 100MG BASE N203045 002 Dec 21, 2011
RAMELTEON
TABLET;ORAL
RAMELTEON
AB TEVA PHARMS USA 8MG A091693 001 Jul 26, 2013
ROZEREM
AB + TAKEDA PHARMS USA 8MG N021782 001 Jul 22, 2005
RAMIPRIL
CAPSULE;ORAL
ALTACE
AB KING PHARMS 1.25MG N019901 001 Jan 28, 1991
AB 2.5MG N019901 002 Jan 28, 1991
AB 5MG N019901 003 Jan 28, 1991
AB + 10MG N019901 004 Jan 28, 1991
RAMIPRIL
AB ACCORD HLTHCARE INC 1.25MG A202392 001 Apr 15, 2014
AB 2.5MG A202392 002 Apr 15, 2014
AB 5MG A202392 003 Apr 15, 2014
AB 10MG A202392 004 Apr 15, 2014
AB APOTEX 1.25MG A079116 001 Jun 20, 2008
AB 2.5MG A079116 002 Jun 20, 2008
AB 5MG A079116 003 Jun 20, 2008
AB 10MG A079116 004 Jun 20, 2008
AB AUROBINDO PHARMA LTD 1.25MG A091604 001 Jun 08, 2011
AB 2.5MG A091604 002 Jun 08, 2011
AB 5MG A091604 003 Jun 08, 2011
AB 10MG A091604 004 Jun 08, 2011
AB DR REDDYS LABS LTD 1.25MG A078191 001 Jun 18, 2008
AB 2.5MG A078191 002 Jun 18, 2008
AB 5MG A078191 003 Jun 18, 2008
AB 10MG A078191 004 Jun 18, 2008
AB INVAGEN PHARMS 1.25MG A078745 001 Jun 18, 2008
AB 2.5MG A078745 002 Jun 18, 2008
AB 5MG A078745 003 Jun 18, 2008
AB 10MG A078745 004 Jun 18, 2008
AB LUPIN 1.25MG A077626 001 Jun 09, 2008
AB 2.5MG A077626 002 Jun 09, 2008
AB 5MG A077626 003 Jun 09, 2008
AB 10MG A077626 004 Jun 09, 2008
AB ROXANE 1.25MG A077900 001 Jun 18, 2008
AB 2.5MG A077900 002 Jun 18, 2008
AB 5MG A077900 003 Jun 18, 2008
AB 10MG A077900 004 Jun 18, 2008
AB SANDOZ 1.25MG A077514 001 Jun 18, 2008
AB 2.5MG A077514 002 Jun 18, 2008
AB 5MG A077514 003 Jun 18, 2008
AB 10MG A077514 004 Jun 18, 2008
AB TEVA PHARMS 1.25MG A077470 001 Jun 18, 2008
AB 2.5MG A077470 002 Jun 18, 2008
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-310(of 371)
RAMIPRIL
CAPSULE;ORAL
RAMIPRIL
AB 5MG
A077470 003 Jun 18, 2008
AB 10MG
A077470 004 Jun 18, 2008
AB WATSON LABS 1.25MG
A076549 001 Oct 24, 2005
AB 2.5MG
A076549 002 Oct 24, 2005
AB 5MG
A076549 003 Oct 24, 2005
AB 10MG
A076549 004 Oct 24, 2005
AB ZYDUS PHARMS USA 1.25MG
A078832 001 Sep 02, 2008
AB 2.5MG
A078832 002 Sep 02, 2008
AB 5MG
A078832 003 Sep 02, 2008
AB 10MG
A078832 004 Sep 02, 2008
TABLET;ORAL
RAMIPRIL
AB MYLAN PHARMS INC
1.25MG
A090650 001 Jun 30, 2011
AB
2.5MG
A090650 002 Jun 30, 2011
AB
5MG
A090650 003 Jun 30, 2011
AB
10MG
A090650 004 Jun 30, 2011
AB ZYDUS PHARMS USA INC
1.25MG
A090697 001 Sep 24, 2009
AB
2.5MG
A090697 002 Sep 24, 2009
AB
5MG
A090697 003 Sep 24, 2009
AB
10MG
A090697 004 Sep 24, 2009
RANITIDINE HYDROCHLORIDE
CAPSULE;ORAL
RANITIDINE HYDROCHLORIDE
AB DR REDDYS LABS LTD
EQ 150MG BASE
A075742 001 Nov 29, 2000
AB
EQ 300MG BASE
A075742 002 Nov 29, 2000
AB SANDOZ
EQ 150MG BASE
A074655 001 Oct 22, 1997
AB +
EQ 300MG BASE
A074655 002 Oct 22, 1997
INJECTABLE;INJECTION
RANITIDINE HYDROCHLORIDE
AP EUROHLTH INTL
EQ 25MG BASE/ML
A074777 001 Mar 02, 2005
AP
EQ 25MG BASE/ML
A077458 001 Feb 16, 2006
AP ZYDUS PHARMS USA INC
25MG/ML
A091534 001 Feb 22, 2013
ZANTAC
AP + COVIS INJECTABLES
EQ 25MG BASE/ML
N019090 001 Oct 19, 1984
SYRUP;ORAL
RANITIDINE HYDROCHLORIDE
AA ACTAVIS MID ATLANTIC
EQ 15MG BASE/ML
A076124 001 Feb 21, 2007
AA AMNEAL PHARMS
EQ 15MG BASE/ML
A078312 001 Sep 02, 2008
AA AUROBINDO PHARM
EQ 15MG BASE/ML
A090623 001 Jul 28, 2010
AA BIO PHARM INC
EQ 15MG BASE/ML
A090102 001 May 26, 2009
AA BRECKENRIDGE PHARM
EQ 15MG BASE/ML
A078684 001 Aug 27, 2009
AA CARACO
EQ 15MG BASE/ML
A091091 001 Sep 20, 2011
AA HI TECH PHARMA
EQ 15MG BASE/ML
A091078 001 Mar 22, 2011
AA PHARM ASSOC
EQ 15MG BASE/ML
A077405 001 Sep 21, 2007
AA SILARX
EQ 15MG BASE/ML
A091288 001 Dec 09, 2010
AA TARO
EQ 15MG BASE/ML
A077476 001 Jun 13, 2011
AA TOLMAR
EQ 15MG BASE/ML
A090054 001 Nov 15, 2010
AA VINTAGE PHARMS
EQ 15MG BASE/ML
A078890 001 Jul 01, 2010
AA WOCKHARDT
EQ 15MG BASE/ML
A079211 001 May 26, 2009
AA
EQ 15MG BASE/ML
A079212 001 Feb 23, 2009
ZANTAC
AA + GLAXO GRP LTD
EQ 15MG BASE/ML
N019675 001 Dec 30, 1988
TABLET;ORAL
RANITIDINE HYDROCHLORIDE
AB AMNEAL PHARMS NY
EQ 150MG BASE
A077824 001 Oct 13, 2006
AB
EQ 300MG BASE
A077824 002 Oct 13, 2006
AB APOTEX
EQ 150MG BASE
A074680 001 Sep 12, 1997
AB
EQ 300MG BASE
A074680 002 Sep 12, 1997
AB DR REDDYS LABS INC
EQ 150MG BASE
A076705 001 Jul 27, 2005
AB
EQ 300MG BASE
A076705 002 Jul 27, 2005
AB GLENMARK GENERICS
EQ 150MG BASE
A078542 001 Nov 19, 2008
AB
EQ 300MG BASE
A078542 002 Nov 19, 2008
AB IVAX SUB TEVA PHARMS
EQ 150MG BASE
A075165 001 Sep 30, 1998
AB
EQ 300MG BASE
A075165 002 Sep 30, 1998
AB MYLAN
EQ 150MG BASE
A074023 001 Aug 22, 1997
AB
EQ 300MG BASE
A074023 002 Aug 22, 1997
AB PAR PHARM
EQ 150MG BASE
A075180 001 Jan 28, 1999
AB
EQ 300MG BASE
A075180 002 Jan 28, 1999
AB SANDOZ
EQ 150MG BASE
A074467 001 Aug 29, 1997
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-311(of 371)
RANITIDINE HYDROCHLORIDE
TABLET;ORAL
RANITIDINE HYDROCHLORIDE
AB
EQ 300MG BASE
A074467 002 Aug 29, 1997
AB TEVA
EQ 150MG BASE
A074488 001 Jul 31, 1997
AB
EQ 300MG BASE
A074488 002 Jul 31, 1997
AB WOCKHARDT
EQ 150MG BASE
A075208 001 Dec 17, 1998
AB
EQ 300MG BASE
A075208 002 Dec 17, 1998
ZANTAC 150
AB GLAXO GRP LTD
EQ 150MG BASE
N018703 001 Jun 09, 1983
ZANTAC 300
AB + GLAXO GRP LTD
EQ 300MG BASE
N018703 002 Dec 09, 1985
RANOLAZINE
TABLET, EXTENDED RELEASE;ORAL
RANEXA
AB + GILEAD
1GM
N021526 001 Feb 12, 2007
AB
500MG
N021526 002 Jan 27, 2006
RANOLAZINE
AB LUPIN LTD
500MG
A201046 001 Jul 29, 2013
AB
1GM
A201046 002 Jul 29, 2013
RASAGILINE MESYLATE
TABLET;ORAL
AZILECT
AB TEVA
EQ 0.5MG BASE
N021641 001 May 16, 2006
AB +
EQ 1MG BASE
N021641 002 May 16, 2006
RASAGILINE MESYLATE
AB APOTEX INC
EQ 0.5MG BASE
A201950 001 Sep 12, 2013
AB
EQ 1MG BASE
A201950 002 Sep 12, 2013
REGADENOSON
SOLUTION;INTRAVENOUS
LEXISCAN
+ ASTELLAS
0.4MG/5ML (0.08MG/ML)
N022161 001 Apr 10, 2008
REGORAFENIB
TABLET;ORAL
STIVARGA
+ BAYER HLTHCARE
40MG
N203085 001 Sep 27, 2012
REMIFENTANIL HYDROCHLORIDE
INJECTABLE;INJECTION
ULTIVA
MYLAN INSTITUTIONAL
EQ 1MG BASE/VIAL
N020630 001 Jul 12, 1996
EQ 2MG BASE/VIAL
N020630 002 Jul 12, 1996
+
EQ 5MG BASE/VIAL
N020630 003 Jul 12, 1996
REPAGLINIDE
TABLET;ORAL
PRANDIN
AB NOVO NORDISK INC
0.5MG
N020741 001 Dec 22, 1997
AB
1MG
N020741 002 Dec 22, 1997
AB +
2MG
N020741 003 Dec 22, 1997
REPAGLINIDE
AB ACTAVIS TOTOWA
0.5MG
A090008 001 Jan 22, 2014
AB
1MG
A090008 002 Jan 22, 2014
AB
2MG
A090008 003 Jan 22, 2014
AB AUROBINDO PHARMA LTD
0.5MG
A203820 001 Jan 22, 2014
AB
1MG
A203820 002 Jan 22, 2014
AB
2MG
A203820 003 Jan 22, 2014
AB MYLAN PHARMS INC
0.5MG
A090252 001 Aug 23, 2013
AB
1MG
A090252 002 Jan 22, 2014
AB
2MG
A090252 003 Jan 22, 2014
AB PADDOCK LLC
0.5MG
A201189 001 Jul 17, 2013
AB
1MG
A201189 002 Jan 22, 2014
AB
2MG
A201189 003 Jan 22, 2014
AB SANDOZ
0.5MG
A078555 001 Nov 22, 2013
AB
1MG
A078555 002 Jan 22, 2014
AB
2MG
A078555 003 Jan 22, 2014
AB SUN PHARM INDS INC
1MG
A077571 002 Jul 11, 2013
AB
2MG
A077571 003 Jul 11, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-312(of 371)
RESERPINE
TABLET;ORAL
RESERPINE
BP SANDOZ 0.1MG N009838 001
BP + 0.25MG N009838 002
RETAPAMULIN
OINTMENT;TOPICAL
ALTABAX
+ GLAXO GRP LTD 1% N022055 001 Apr 12, 2007
RIBAVIRIN
CAPSULE;ORAL
REBETOL
AB + MERCK SHARP DOHME 200MG N020903 002 Jul 25, 2001
RIBASPHERE
AB THREE RIVERS PHARMS 200MG A076203 001 Apr 06, 2004
RIBAVARIN
AB AUROBINDO PHARMA 200MG A079117 001 Sep 17, 2009
RIBAVIRIN
AB SANDOZ 200MG A076192 001 Apr 06, 2004
AB TEVA 200MG A076277 001 Oct 04, 2004
AB ZYDUS PHARMS USA 200MG A077224 001 Oct 28, 2005
REBETOL
+ MERCK SHARP DOHME 200MG**Indicated for use and comarketed N020903 001 Jun 03, 1998
with Interferon ALFA-2B, Recombinant
(INTRON A), as Rebetron Combination
Therapy**
FOR SOLUTION;INHALATION
VIRAZOLE
+ VALEANT PHARM INTL 6GM/VIAL N018859 001 Dec 31, 1985
SOLUTION;ORAL
REBETOL
+ SCHERING 40MG/ML N021546 001 Jul 29, 2003
TABLET;ORAL
COPEGUS
AB ROCHE 200MG N021511 001 Dec 03, 2002
RIBAVIRIN
AB AUROBINDO PHARMA 200MG A079111 001 Sep 17, 2009
AB SANDOZ 200MG A077743 001 Oct 03, 2006
AB 200MG A202546 001 Aug 12, 2014
AB 400MG A202546 002 Aug 12, 2014
AB 500MG A202546 003 Aug 12, 2014
AB 600MG A202546 004 Aug 12, 2014
AB TEVA 200MG A077053 001 Dec 05, 2005
AB THREE RIVERS PHARMS 200MG A077456 001 Dec 05, 2005
AB 400MG A077456 002 Dec 05, 2005
AB + 600MG A077456 003 Dec 05, 2005
AB ZYDUS PHARMS USA 200MG A077094 001 Dec 05, 2005
AB 400MG A077094 002 Mar 16, 2007
AB 500MG A077094 004 Apr 18, 2008
AB 600MG A077094 003 Mar 16, 2007
RIFABUTIN
CAPSULE;ORAL
MYCOBUTIN
AB + PHARMACIA AND UPJOHN 150MG N050689 001 Dec 23, 1992
RIFABUTIN
AB LUPIN LTD 150MG A090033 001 Feb 24, 2014
RIFAMPIN
CAPSULE;ORAL
RIFADIN
AB SANOFI AVENTIS US 150MG A062303 001
AB + 300MG N050420 001
RIFAMPIN
AB LANNETT 150MG A065390 001 Mar 28, 2008
AB 300MG A065390 002 Mar 28, 2008
AB LUPIN PHARMS 150MG A090034 001 Aug 21, 2013
AB 300MG A090034 002 Aug 21, 2013
AB SANDOZ 150MG A064150 002 Jan 02, 1998
AB 300MG A064150 001 May 28, 1997
AB VERSAPHARM 150MG A065028 001 Mar 14, 2001
AB 300MG A065028 002 Mar 14, 2001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-313(of 371)
RIFAMPIN
CAPSULE;ORAL
RIMACTANE
AB PROSAM LABS 300MG N050429 001
INJECTABLE;INJECTION
RIFADIN
AP + SANOFI AVENTIS US 600MG/VIAL N050627 001 May 25, 1989
RIFAMPIN
AP AGILA SPECLTS 600MG/VIAL A065421 001 May 22, 2008
AP BEDFORD 600MG/VIAL A064217 001 Oct 29, 1999
AP EMCURE PHARMS LTD 600MG/VIAL A204101 001 Aug 18, 2014
AP FRESENIUS KABI USA 600MG/VIAL A091181 001 Aug 21, 2014
AP VERSAPHARM INC 600MG/VIAL A065502 001 Sep 21, 2010
RIFAPENTINE
TABLET;ORAL
PRIFTIN
+ SANOFI AVENTIS US 150MG N021024 001 Jun 22, 1998
RIFAXIMIN
TABLET;ORAL
XIFAXAN
+ SALIX PHARMS 200MG N021361 001 May 25, 2004
+ 550MG N022554 001 Mar 24, 2010
RILPIVIRINE HYDROCHLORIDE
TABLET;ORAL
EDURANT
+ JANSSEN PRODS EQ 25MG BASE N202022 001 May 20, 2011
RILUZOLE
TABLET;ORAL
RILUTEK
AB + COVIS PHARMA SARL 50MG N020599 001 Dec 12, 1995
RILUZOLE
AB APOTEX CORP 50MG A091300 001 Jun 18, 2013
AB GLENMARK GENERICS 50MG A091394 001 Jun 18, 2013
AB IMPAX LABS 50MG A076173 001 Jan 29, 2003
AB MYLAN PHARMS INC 50MG A203042 001 Jul 01, 2013
AB SUN PHARM INDS LTD 50MG A091417 001 Jun 18, 2013
RIMANTADINE HYDROCHLORIDE
TABLET;ORAL
FLUMADINE
AB + CARACO 100MG N019649 001 Sep 17, 1993
RIMANTADINE HYDROCHLORIDE
AB IMPAX LABS 100MG A076132 001 Aug 30, 2002
RIMEXOLONE
SUSPENSION/DROPS;OPHTHALMIC
VEXOL
+ ALCON 1% N020474 001 Dec 30, 1994
RIOCIGUAT
TABLET;ORAL
ADEMPAS
BAYER HLTHCARE 0.5MG N204819 001 Oct 08, 2013
1MG N204819 002 Oct 08, 2013
1.5MG N204819 003 Oct 08, 2013
2MG N204819 004 Oct 08, 2013
+ 2.5MG N204819 005 Oct 08, 2013
RISEDRONATE SODIUM
TABLET;ORAL
ACTONEL
AB WARNER CHILCOTT LLC 5MG N020835 002 Apr 14, 2000
AB 30MG N020835 001 Mar 27, 1998
AB + 35MG N020835 003 May 25, 2002
AB + 150MG N020835 005 Apr 22, 2008
RISEDRONATE SODIUM
AB APOTEX INC 75MG A090877 002 Jun 10, 2014
AB 150MG A090877 003 Jun 10, 2014
AB MYLAN PHARMS INC 75MG A200477 004 Jun 10, 2014
AB 150MG A200477 005 Jun 10, 2014
AB SUN PHARMA GLOBAL 75MG A090886 004 Jun 10, 2014
AB 150MG A090886 005 Jun 10, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-314(of 371)
RISEDRONATE SODIUM
TABLET;ORAL
RISEDRONATE SODIUM
AB TEVA PHARMS
5MG
A077132 001 Oct 05, 2007
AB
30MG
A077132 002 Oct 05, 2007
AB
35MG
A077132 003 Oct 05, 2007
AB TEVA PHARMS USA
150MG
A079215 001 Jun 13, 2014
TABLET, DELAYED RELEASE;ORAL
ATELVIA
+ WARNER CHILCOTT LLC
35MG
N022560 001 Oct 08, 2010
RISPERIDONE
INJECTABLE;INTRAMUSCULAR
RISPERDAL CONSTA
JANSSEN PHARMS
12.5MG/VIAL
N021346 004 Apr 12, 2007
+
25MG/VIAL
N021346 001 Oct 29, 2003
37.5MG/VIAL
N021346 002 Oct 29, 2003
50MG/VIAL
N021346 003 Oct 29, 2003
SOLUTION;ORAL
RISPERDAL
AA + JANSSEN PHARMS
1MG/ML
N020588 001 Jun 10, 1996
RISPERIDONE
AA AMNEAL PHARMS
1MG/ML
A091384 001 May 25, 2011
AA ANI PHARMS INC
1MG/ML
A076440 001 Jan 30, 2009
AA APOTEX INC
1MG/ML
A077719 001 Jul 29, 2009
AA AUROBINDO PHARMA
1MG/ML
A078452 001 Sep 04, 2009
AA BIO PHARM INC
1MG/ML
A078909 001 Jul 29, 2009
AA PRECISION DOSE
1MG/ML
A076797 001 Jun 28, 2010
AA ROXANE
1MG/ML
A076904 001 Jul 29, 2009
AA SILARX PHARMS INC
1MG/ML
A202386 001 Jan 12, 2015
AA TARO
1MG/ML
A090347 001 Feb 07, 2011
AA TRIS PHARMA INC
1MG/ML
A079059 001 Dec 12, 2012
AA VINTAGE
1MG/ML
A079158 001 Dec 03, 2010
AA WOCKHARDT
1MG/ML
A078744 001 Oct 08, 2009
TABLET;ORAL
RISPERDAL
AB JANSSEN PHARMS
0.25MG
N020272 008 May 10, 1999
AB
0.5MG
N020272 007 Jan 27, 1999
AB +
1MG
N020272 001 Dec 29, 1993
AB
2MG
N020272 002 Dec 29, 1993
AB
3MG
N020272 003 Dec 29, 1993
AB
4MG
N020272 004 Dec 29, 1993
RISPERIDONE
AB AJANTA PHARMA LTD
0.25MG
A201003 001 Aug 24, 2011
AB
0.5MG
A201003 002 Aug 24, 2011
AB
1MG
A201003 003 Aug 24, 2011
AB
2MG
A201003 004 Aug 24, 2011
AB
3MG
A201003 005 Aug 24, 2011
AB
4MG
A201003 006 Aug 24, 2011
AB APOTEX INC
0.25MG
A077953 001 Sep 15, 2008
AB
0.5MG
A077953 002 Sep 15, 2008
AB
1MG
A077953 003 Sep 15, 2008
AB
2MG
A077953 004 Sep 15, 2008
AB
3MG
A077953 005 Sep 15, 2008
AB
4MG
A077953 006 Sep 15, 2008
AB AUROBINDO PHARMA
0.25MG
A078269 001 Oct 08, 2008
AB
0.5MG
A078269 002 Oct 08, 2008
AB
1MG
A078269 003 Oct 08, 2008
AB
2MG
A078269 004 Oct 08, 2008
AB
3MG
A078269 005 Oct 08, 2008
AB
4MG
A078269 006 Oct 08, 2008
AB CIPLA
0.25MG
A077543 001 May 18, 2011
AB
0.5MG
A077543 002 May 18, 2011
AB
1MG
A077543 003 May 18, 2011
AB
2MG
A077543 004 May 18, 2011
AB
3MG
A077543 005 May 18, 2011
AB
4MG
A077543 006 May 18, 2011
AB DR REDDYS LABS LTD
0.25MG
A076879 001 Oct 24, 2008
AB
0.5MG
A076879 002 Oct 24, 2008
AB
1MG
A076879 003 Oct 24, 2008
AB
2MG
A076879 004 Oct 24, 2008
AB
3MG
A076879 005 Oct 24, 2008
AB
4MG
A076879 006 Oct 24, 2008
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-315(of 371)
RISPERIDONE
TABLET;ORAL
RISPERIDONE
AB MYLAN 0.25MG A076288 001 Sep 15, 2008
AB 0.5MG A076288 002 Sep 15, 2008
AB 1MG A076288 003 Sep 15, 2008
AB 2MG A076288 004 Sep 15, 2008
AB 3MG A076288 005 Sep 15, 2008
AB 4MG A076288 006 Sep 15, 2008
AB PLIVA HRVATSKA DOO 0.25MG A077769 001 Oct 16, 2008
AB 0.5MG A077769 002 Oct 16, 2008
AB 1MG A077769 003 Oct 16, 2008
AB 2MG A077769 004 Oct 16, 2008
AB 3MG A077769 005 Oct 16, 2008
AB 4MG A077769 006 Oct 16, 2008
AB PRINSTON INC 0.25MG A077493 001 Nov 29, 2011
AB 0.5MG A077493 002 Nov 29, 2011
AB 1MG A077493 003 Nov 29, 2011
AB 2MG A077493 004 Nov 29, 2011
AB 3MG A077493 005 Nov 29, 2011
AB 4MG A077493 006 Nov 29, 2011
AB PROSAM LABS 0.25MG A078071 001 Jun 17, 2009
AB 0.5MG A078071 002 Jun 17, 2009
AB 1MG A078071 003 Jun 17, 2009
AB 2MG A078071 004 Jun 17, 2009
AB 3MG A078071 005 Jun 17, 2009
AB 4MG A078071 006 Jun 17, 2009
AB SANDOZ 0.25MG A078528 001 Oct 16, 2009
AB 0.5MG A078528 002 Oct 16, 2009
AB 1MG A078528 003 Oct 16, 2009
AB 2MG A078528 004 Oct 16, 2009
AB 3MG A078528 005 Oct 16, 2009
AB 4MG A078528 006 Oct 16, 2009
AB SUN PHARM INDS INC 0.25MG A078036 001 Mar 10, 2014
AB 0.5MG A078036 002 Mar 10, 2014
AB 1MG A078036 003 Mar 10, 2014
AB 2MG A078036 004 Mar 10, 2014
AB 3MG A078036 005 Mar 10, 2014
AB 4MG A078036 006 Mar 10, 2014
AB TEVA 0.25MG A076228 001 Jun 30, 2008
AB 0.5MG A076228 002 Jun 30, 2008
AB 1MG A076228 003 Jun 30, 2008
AB 2MG A076228 004 Jun 30, 2008
AB 3MG A076228 005 Jun 30, 2008
AB 4MG A076228 006 Jun 30, 2008
AB TORRENT PHARMS 0.25MG A079088 001 Oct 30, 2008
AB 0.5MG A079088 002 Oct 30, 2008
AB 1MG A079088 003 Oct 30, 2008
AB 2MG A079088 004 Oct 30, 2008
AB 3MG A079088 005 Oct 30, 2008
AB 4MG A079088 006 Oct 30, 2008
AB VINTAGE 0.25MG A078707 001 Dec 29, 2008
AB 0.5MG A078707 002 Dec 29, 2008
AB 1MG A078707 003 Dec 29, 2008
AB 2MG A078707 004 Dec 29, 2008
AB 3MG A078707 005 Dec 29, 2008
AB 4MG A078707 006 Dec 29, 2008
AB WOCKHARDT 0.25MG A078871 001 Oct 09, 2008
AB 0.5MG A078871 002 Oct 09, 2008
AB 1MG A078871 003 Oct 09, 2008
AB 2MG A078871 004 Oct 09, 2008
AB 3MG A078871 005 Oct 09, 2008
AB 4MG A078871 006 Oct 09, 2008
AB ZYDUS PHARMS USA INC 0.25MG A078040 001 Oct 16, 2008
AB 0.5MG A078040 002 Oct 16, 2008
AB 1MG A078040 003 Oct 16, 2008
AB 2MG A078040 004 Oct 16, 2008
AB 3MG A078040 005 Oct 16, 2008
AB 4MG A078040 006 Oct 16, 2008
TABLET, ORALLY DISINTEGRATING;ORAL
RISPERDAL
AB JANSSEN PHARMS 0.5MG N021444 001 Apr 02, 2003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-316(of 371)
RISPERIDONE
TABLET, ORALLY DISINTEGRATING;ORAL
RISPERDAL
AB + 1MG
N021444 002 Apr 02, 2003
AB 2MG
N021444 003 Apr 02, 2003
AB 3MG
N021444 004 Dec 23, 2004
AB 4MG
N021444 005 Dec 23, 2004
RISPERIDONE
AB ACTAVIS LABS FL INC 0.5MG
A076996 001 Apr 19, 2011
AB 1MG
A076996 002 Apr 19, 2011
AB 2MG
A076996 003 Apr 19, 2011
AB 3MG
A076996 004 Apr 19, 2011
AB 4MG
A076996 005 Apr 19, 2011
AB DR REDDYS LABS LTD 0.5MG
A077328 001 Feb 24, 2009
AB 1MG
A077328 002 Oct 05, 2009
AB 2MG
A077328 003 Feb 24, 2009
AB JUBILANT GENERICS 0.5MG
A090839 001 Nov 04, 2011
AB 1MG
A090839 002 Nov 04, 2011
AB 2MG
A090839 003 Nov 04, 2011
AB 3MG
A090839 004 Nov 04, 2011
AB 4MG
A090839 005 Nov 04, 2011
AB MYLAN PHARMS INC 0.25MG
A091537 006 Feb 12, 2013
AB 0.5MG
A091537 001 Mar 30, 2011
AB 1MG
A091537 002 Mar 30, 2011
AB 2MG
A091537 003 Mar 30, 2011
AB 3MG
A091537 004 Mar 30, 2011
AB 4MG
A091537 005 Mar 30, 2011
AB PAR PHARM 0.25MG
A077494 001 Apr 30, 2009
AB 0.5MG
A077494 002 Apr 30, 2009
AB 1MG
A077494 003 Oct 26, 2009
AB 2MG
A077494 004 Apr 30, 2009
AB 3MG
A077494 005 Apr 30, 2009
AB 4MG
A077494 006 Apr 30, 2009
AB RANBAXY 0.5MG
A077542 001 Aug 06, 2010
AB 1MG
A077542 002 Aug 06, 2010
AB 2MG
A077542 003 Aug 06, 2010
AB 3MG
A078474 001 Aug 06, 2010
AB 4MG
A078474 002 Aug 06, 2010
AB SANDOZ 0.5MG
A078116 001 Dec 22, 2009
AB 1MG
A078116 002 Dec 22, 2009
AB 2MG
A078116 003 Dec 22, 2009
AB 3MG
A078116 004 Dec 22, 2009
AB 4MG
A078116 005 Dec 22, 2009
AB SUN PHARM INDS LTD 0.5MG
A078464 001 Apr 08, 2013
AB 1MG
A078464 002 Apr 08, 2013
AB 2MG
A078464 003 Apr 08, 2013
AB 3MG
A078464 004 Apr 08, 2013
AB 4MG
A078464 005 Apr 08, 2013
AB TEVA 0.5MG
A076908 001 Mar 12, 2012
AB 1MG
A076908 002 Mar 12, 2012
AB 2MG
A076908 003 Mar 12, 2012
AB ZYDUS PHARMS USA 0.5MG
A078516 001 May 01, 2009
AB 2MG
A078516 003 May 01, 2009
RITONAVIR
CAPSULE;ORAL
NORVIR
+ ABBVIE
100MG
N020945 001 Jun 29, 1999
SOLUTION;ORAL
NORVIR
+ ABBVIE
80MG/ML
N020659 001 Mar 01, 1996
TABLET;ORAL
NORVIR
AB + ABBVIE
100MG
N022417 001 Feb 10, 2010
RITONAVIR
AB ROXANE
100MG
A202573 001 Jan 15, 2015
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-317(of 371)
RIVAROXABAN
TABLET;ORAL
XARELTO
+ JANSSEN PHARMS 10MG N022406 001 Jul 01, 2011
15MG N022406 002 Nov 04, 2011
+ 20MG N022406 003 Nov 04, 2011
RIVASTIGMINE
FILM, EXTENDED RELEASE;TRANSDERMAL
EXELON
NOVARTIS 4.6MG/24HR N022083 001 Jul 06, 2007
+ 9.5MG/24HR N022083 002 Jul 06, 2007
13.3MG/24HR N022083 005 Aug 31, 2012
RIVASTIGMINE TARTRATE
CAPSULE;ORAL
EXELON
AB + NOVARTIS EQ 1.5MG BASE N020823 003 Apr 21, 2000
AB EQ 3MG BASE N020823 004 Apr 21, 2000
AB EQ 4.5MG BASE N020823 005 Apr 21, 2000
AB EQ 6MG BASE N020823 006 Apr 21, 2000
RIVASTIGMINE TARTRATE
AB ALEMBIC PHARMS LTD EQ 1.5MG BASE A091689 001 Jun 12, 2012
AB EQ 3MG BASE A091689 002 Jun 12, 2012
AB EQ 4.5MG BASE A091689 003 Jun 12, 2012
AB EQ 6MG BASE A091689 004 Jun 12, 2012
AB APOTEX INC EQ 1.5MG BASE A091072 001 May 16, 2013
AB EQ 3MG BASE A091072 002 May 16, 2013
AB EQ 4.5MG BASE A091072 003 May 16, 2013
AB EQ 6MG BASE A091072 004 May 16, 2013
AB DR REDDYS LABS INC EQ 1.5MG BASE A077130 001 Oct 31, 2007
AB EQ 3MG BASE A077130 002 Oct 31, 2007
AB EQ 4.5MG BASE A077130 003 Oct 31, 2007
AB EQ 6MG BASE A077130 004 Oct 31, 2007
AB MACLEODS PHARMS LTD EQ 1.5MG BASE A203148 001 Aug 22, 2014
AB EQ 3MG BASE A203148 002 Aug 22, 2014
AB EQ 4.5MG BASE A203148 003 Aug 22, 2014
AB EQ 6MG BASE A203148 004 Aug 22, 2014
AB SUN PHARM INDS EQ 1.5MG BASE A077131 001 Oct 22, 2007
AB EQ 3MG BASE A077131 002 Oct 22, 2007
AB EQ 4.5MG BASE A077131 003 Oct 22, 2007
AB EQ 6MG BASE A077131 004 Oct 22, 2007
AB WATSON LABS EQ 1.5MG BASE A077129 001 Jan 08, 2008
AB EQ 3MG BASE A077129 002 Jan 08, 2008
AB EQ 4.5MG BASE A077129 003 Jan 08, 2008
AB EQ 6MG BASE A077129 004 Jan 08, 2008
RIZATRIPTAN BENZOATE
TABLET;ORAL
MAXALT
AB MERCK EQ 5MG BASE N020864 001 Jun 29, 1998
AB + EQ 10MG BASE N020864 002 Jun 29, 1998
RIZATRIPTAN BENZOATE
AB APOTEX INC EQ 5MG BASE A202244 001 Dec 31, 2012
AB EQ 10MG BASE A202244 002 Dec 31, 2012
AB AUROBINDO PHARMA LTD EQ 5MG BASE A202490 001 Dec 31, 2012
AB EQ 10MG BASE A202490 002 Dec 31, 2012
AB CIPLA LTD EQ 5MG BASE A077526 001 Mar 26, 2013
AB EQ 10MG BASE A077526 002 Mar 26, 2013
AB EMCURE PHARMS LTD EQ 5MG BASE A204090 001 Nov 26, 2013
AB EQ 10MG BASE A204090 002 Nov 26, 2013
AB GLENMARK GENERICS EQ 5MG BASE A201967 001 Dec 31, 2012
AB EQ 10MG BASE A201967 002 Dec 31, 2012
AB INVAGEN PHARMS EQ 5MG BASE A204339 001 Jul 01, 2013
AB EQ 10MG BASE A204339 002 Jul 01, 2013
AB JUBILANT GENERICS EQ 5MG BASE A203252 001 Dec 31, 2014
AB EQ 10MG BASE A203252 002 Dec 31, 2014
AB MACLEODS PHARMS LTD EQ 5MG BASE A203147 001 Feb 11, 2014
AB EQ 10MG BASE A203147 002 Feb 11, 2014
AB MYLAN PHARMS INC EQ 5MG BASE A201993 001 Dec 31, 2012
AB EQ 10MG BASE A201993 002 Dec 31, 2012
AB NATCO PHARMA LTD EQ 5MG BASE A200482 001 Dec 31, 2012
AB EQ 10MG BASE A200482 002 Dec 31, 2012
AB SANDOZ EQ 5MG BASE A079230 001 Dec 31, 2012
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-318(of 371)
RIZATRIPTAN BENZOATE
TABLET;ORAL
RIZATRIPTAN BENZOATE
AB EQ 10MG BASE A079230 002 Dec 31, 2012
AB SUN PHARMA GLOBAL EQ 5MG BASE A202047 001 Dec 31, 2012
AB EQ 10MG BASE A202047 002 Dec 31, 2012
AB TEVA PHARMS EQ 5MG BASE A077263 001 Dec 31, 2012
AB EQ 10MG BASE A077263 002 Dec 31, 2012
TABLET, ORALLY DISINTEGRATING;ORAL
MAXALT-MLT
AB MERCK EQ 5MG BASE N020865 001 Jun 29, 1998
AB + EQ 10MG BASE N020865 002 Jun 29, 1998
RIZATRIPTAN BENZOATE
AB APOTEX INC EQ 5MG BASE A202477 001 Jul 01, 2013
AB EQ 10MG BASE A202477 002 Jul 01, 2013
AB AUROBINDO PHARMA LTD EQ 5MG BASE A203062 001 Jul 01, 2013
AB EQ 10MG BASE A203062 002 Jul 01, 2013
AB GLENMARK GENERICS EQ 5MG BASE A201914 001 Jul 01, 2013
AB EQ 10MG BASE A201914 002 Jul 01, 2013
AB MACLEODS PHARMS LTD EQ 5MG BASE A203146 001 Sep 19, 2014
AB EQ 10MG BASE A203146 002 Sep 19, 2014
AB MYLAN PHARMS INC EQ 5MG BASE A078173 001 Dec 31, 2012
AB EQ 10MG BASE A078173 002 Dec 31, 2012
AB NATCO PHARMA LTD EQ 5MG BASE A203478 001 Jul 01, 2013
AB EQ 10MG BASE A203478 002 Jul 01, 2013
AB SANDOZ EQ 5MG BASE A078739 001 Jul 01, 2013
AB EQ 10MG BASE A078739 002 Jul 01, 2013
ROCURONIUM BROMIDE
INJECTABLE;INJECTION
ROCURONIUM BROMIDE
AP FRESENIUS KABI USA 50MG/5ML (10MG/ML) A078651 001 Dec 29, 2008
AP 100MG/10ML (10MG/ML) A078651 002 Dec 29, 2008
AP HOSPIRA 50MG/5ML (10MG/ML) A078519 001 Nov 26, 2008
AP 100MG/10ML (10MG/ML) A078519 002 Nov 26, 2008
AP MYLAN INSTITUTIONAL 50MG/5ML (10MG/ML) A079199 001 Nov 26, 2008
AP 100MG/10ML (10MG/ML) A079199 002 Nov 26, 2008
AP SAGENT STRIDES 50MG/5ML (10MG/ML) A091458 001 Jul 28, 2010
AP 100MG/10ML (10MG/ML) A091458 002 Jul 28, 2010
AP + SANDOZ 50MG/5ML (10MG/ML) A079195 001 Dec 05, 2008
AP + 100MG/10ML (10MG/ML) A079195 002 Dec 05, 2008
AP TAMARANG 50MG/5ML (10MG/ML) A091115 001 Aug 27, 2012
AP 100MG/10ML (10MG/ML) A091115 002 Aug 27, 2012
AP TEVA PHARMS 50MG/5ML (10MG/ML) A078717 001 Nov 26, 2008
AP 100MG/10ML (10MG/ML) A078717 002 Nov 26, 2008
ROFLUMILAST
TABLET;ORAL
DALIRESP
+ FOREST RES INST INC 500MCG N022522 001 Feb 28, 2011
ROMIDEPSIN
POWDER;IV (INFUSION)
ISTODAX
+ CELGENE 10MG/VIAL N022393 001 Nov 05, 2009
ROPINIROLE HYDROCHLORIDE
TABLET;ORAL
REQUIP
AB + GLAXOSMITHKLINE LLC EQ 0.25MG BASE N020658 001 Sep 19, 1997
AB EQ 0.5MG BASE N020658 002 Sep 19, 1997
AB EQ 1MG BASE N020658 003 Sep 19, 1997
AB EQ 2MG BASE N020658 004 Sep 19, 1997
AB EQ 3MG BASE N020658 006 Jan 27, 1999
AB EQ 4MG BASE N020658 007 Jan 27, 1999
AB EQ 5MG BASE N020658 005 Sep 19, 1997
ROPINIROLE HYDROCHLORIDE
AB ALEMBIC LTD EQ 0.25MG BASE A090429 001 Mar 24, 2010
AB EQ 0.5MG BASE A090429 002 Mar 24, 2010
AB EQ 1MG BASE A090429 003 Mar 24, 2010
AB EQ 2MG BASE A090429 004 Mar 24, 2010
AB EQ 3MG BASE A090429 005 Mar 24, 2010
AB EQ 4MG BASE A090429 006 Mar 24, 2010
AB EQ 5MG BASE A090429 007 Mar 24, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-319(of 371)
ROPINIROLE HYDROCHLORIDE
TABLET;ORAL
ROPINIROLE HYDROCHLORIDE
AB APOTEX EQ 0.25MG BASE A079165 001 Feb 07, 2012
AB EQ 0.5MG BASE A079165 002 Feb 07, 2012
AB EQ 1MG BASE A079165 003 Feb 07, 2012
AB EQ 2MG BASE A079165 004 Feb 07, 2012
AB EQ 3MG BASE A079165 005 Feb 07, 2012
AB EQ 4MG BASE A079165 006 Feb 07, 2012
AB EQ 5MG BASE A079165 007 Feb 07, 2012
AB GLENMARK GENERICS EQ 0.25MG BASE A090135 001 Feb 25, 2010
AB EQ 0.5MG BASE A090135 002 Feb 25, 2010
AB EQ 1MG BASE A090135 003 Feb 25, 2010
AB EQ 2MG BASE A090135 004 Feb 25, 2010
AB EQ 3MG BASE A090135 005 Feb 25, 2010
AB EQ 4MG BASE A090135 006 Feb 25, 2010
AB EQ 5MG BASE A090135 007 Feb 25, 2010
AB MYLAN EQ 0.25MG BASE A078881 001 May 05, 2008
AB EQ 0.5MG BASE A078881 002 May 05, 2008
AB EQ 1MG BASE A078881 003 May 05, 2008
AB EQ 2MG BASE A078881 004 May 05, 2008
AB EQ 3MG BASE A078881 005 May 05, 2008
AB EQ 4MG BASE A078881 006 May 05, 2008
AB EQ 5MG BASE A078881 007 May 19, 2008
AB ORCHID HLTHCARE EQ 0.25MG BASE A079229 001 Nov 28, 2012
AB EQ 0.5MG BASE A079229 002 Nov 28, 2012
AB EQ 1MG BASE A079229 003 Nov 28, 2012
AB EQ 2MG BASE A079229 004 Nov 28, 2012
AB EQ 3MG BASE A079229 005 Nov 28, 2012
AB EQ 4MG BASE A079229 006 Nov 28, 2012
AB EQ 5MG BASE A079229 007 Nov 28, 2012
AB PRINSTON INC EQ 0.25MG BASE A078110 001 May 05, 2008
AB EQ 0.5MG BASE A078110 002 May 05, 2008
AB EQ 1MG BASE A078110 003 May 05, 2008
AB EQ 2MG BASE A078110 004 May 05, 2008
AB EQ 3MG BASE A078110 005 May 05, 2008
AB EQ 4MG BASE A078110 006 May 05, 2008
AB EQ 5MG BASE A078110 007 Jul 11, 2008
AB ROXANE EQ 0.25MG BASE A077852 001 May 05, 2008
AB EQ 0.5MG BASE A077852 002 May 05, 2008
AB EQ 1MG BASE A077852 003 May 05, 2008
AB EQ 2MG BASE A077852 004 May 05, 2008
AB EQ 3MG BASE A077852 005 May 05, 2008
AB EQ 4MG BASE A077852 006 May 05, 2008
AB EQ 5MG BASE A077852 007 May 19, 2008
AB TEVA EQ 0.25MG BASE A077460 001 May 05, 2008
AB EQ 0.5MG BASE A077460 002 May 05, 2008
AB EQ 1MG BASE A077460 003 May 05, 2008
AB EQ 2MG BASE A077460 004 May 05, 2008
AB EQ 3MG BASE A077460 005 May 05, 2008
AB EQ 4MG BASE A077460 006 May 05, 2008
AB EQ 5MG BASE A077460 007 May 19, 2008
AB WOCKHARDT EQ 0.25MG BASE A079050 001 May 29, 2008
AB EQ 0.5MG BASE A079050 002 May 29, 2008
AB EQ 1MG BASE A079050 003 May 29, 2008
AB EQ 2MG BASE A079050 004 May 29, 2008
AB EQ 3MG BASE A079050 005 May 29, 2008
AB EQ 4MG BASE A079050 006 May 29, 2008
AB EQ 5MG BASE A079050 007 May 29, 2008
AB ZYDUS PHARMS USA INC EQ 0.25MG BASE A090411 001 Jun 01, 2009
AB EQ 0.5MG BASE A090411 002 Jun 01, 2009
AB EQ 1MG BASE A090411 003 Jun 01, 2009
AB EQ 2MG BASE A090411 004 Jun 01, 2009
AB EQ 3MG BASE A090411 005 Jun 01, 2009
AB EQ 4MG BASE A090411 006 Jun 01, 2009
AB EQ 5MG BASE A090411 007 Jun 01, 2009
TABLET, EXTENDED RELEASE;ORAL
REQUIP XL
AB + GLAXOSMITHKLINE LLC EQ 2MG BASE N022008 001 Jun 13, 2008
AB EQ 4MG BASE N022008 003 Jun 13, 2008
AB EQ 6MG BASE N022008 006 Apr 10, 2009
AB EQ 8MG BASE N022008 004 Jun 13, 2008
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-320(of 371)
ROPINIROLE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
REQUIP XL
AB
EQ 12MG BASE
N022008 005 Oct 31, 2008
ROPINIROLE HYDROCHLORIDE
AB ACTAVIS ELIZABETH
EQ 2MG BASE
A090869 001 May 17, 2012
AB
EQ 4MG BASE
A090869 002 May 17, 2012
AB
EQ 6MG BASE
A090869 003 May 17, 2012
AB
EQ 8MG BASE
A090869 004 May 17, 2012
AB
EQ 12MG BASE
A090869 005 May 17, 2012
AB ALEMBIC LTD
EQ 2MG BASE
A202786 001 Apr 22, 2013
AB
EQ 4MG BASE
A202786 002 Apr 22, 2013
AB
EQ 6MG BASE
A202786 003 Apr 22, 2013
AB
EQ 8MG BASE
A202786 004 Apr 22, 2013
AB
EQ 12MG BASE
A202786 005 Apr 22, 2013
AB DR REDDYS LABS LTD
EQ 2MG BASE
A201576 001 Jun 06, 2012
AB
EQ 4MG BASE
A201576 002 Jun 06, 2012
AB
EQ 6MG BASE
A201576 003 Jun 06, 2012
AB
EQ 8MG BASE
A201576 004 Jun 06, 2012
AB
EQ 12MG BASE
A201576 005 Jun 06, 2012
AB MYLAN PHARMS INC
EQ 2MG BASE
A200462 001 Oct 15, 2012
AB
EQ 4MG BASE
A200462 003 Oct 15, 2012
AB
EQ 6MG BASE
A200462 004 Oct 15, 2012
AB
EQ 8MG BASE
A200462 005 Oct 15, 2012
AB
EQ 12MG BASE
A200462 006 Oct 15, 2012
AB SANDOZ INC
EQ 2MG BASE
A201047 001 Jun 06, 2012
AB
EQ 4MG BASE
A201047 003 Jun 06, 2012
AB
EQ 6MG BASE
A201047 004 Jun 06, 2012
AB
EQ 8MG BASE
A201047 005 Jun 06, 2012
AB
EQ 12MG BASE
A201047 006 Jun 06, 2012
AB WATSON LABS INC
EQ 2MG BASE
A200431 001 Jun 06, 2012
AB
EQ 4MG BASE
A200431 002 Jun 06, 2012
AB
EQ 6MG BASE
A200431 003 Jun 06, 2012
AB
EQ 8MG BASE
A200431 004 Jun 06, 2012
AB
EQ 12MG BASE
A200431 005 Jun 06, 2012
AB WOCKHARDT LTD
EQ 2MG BASE
A091395 001 Aug 27, 2012
AB
EQ 4MG BASE
A091395 002 Aug 27, 2012
AB
EQ 6MG BASE
A091395 003 Aug 27, 2012
AB
EQ 8MG BASE
A091395 004 Aug 27, 2012
AB
EQ 12MG BASE
A091395 005 Aug 27, 2012
MYLAN PHARMS INC
EQ 3MG BASE
A200462 002 Oct 15, 2012
ROPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION
NAROPIN
AP FRESENIUS KABI USA
2MG/ML
N020533 001 Sep 24, 1996
AP
5MG/ML
N020533 003 Sep 24, 1996
AP
7.5MG/ML
N020533 004 Sep 24, 1996
AP +
10MG/ML
N020533 005 Sep 24, 1996
ROPIVACAINE HYDROCHLORIDE
AP HOSPIRA
2MG/ML
A090194 001 Sep 23, 2014
AP
5MG/ML
A090194 002 Sep 23, 2014
AP
7.5MG/ML
A090194 003 Sep 23, 2014
AP
10MG/ML
A090194 004 Sep 23, 2014
AP NAVINTA LLC
5MG/ML
A078601 002 Jul 17, 2014
AP
10MG/ML
A078601 003 Jul 17, 2014
AP SAGENT STRIDES
2MG/ML
A090318 001 Sep 23, 2014
AP
5MG/ML
A090318 002 Sep 23, 2014
AP
7.5MG/ML
A090318 003 Sep 23, 2014
AP
10MG/ML
A090318 004 Sep 23, 2014
ROSIGLITAZONE MALEATE
TABLET;ORAL
AVANDIA
AB SB PHARMCO
EQ 2MG BASE
N021071 002 May 25, 1999
AB
EQ 4MG BASE
N021071 003 May 25, 1999
AB +
EQ 8MG BASE
N021071 004 May 25, 1999
ROSIGLITAZONE MALEATE
AB TEVA
EQ 2MG BASE
A076747 001 Jan 25, 2013
AB
EQ 4MG BASE
A076747 002 Jan 25, 2013
AB
EQ 8MG BASE
A076747 003 Jan 25, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-321(of 371)
ROSUVASTATIN CALCIUM
TABLET;ORAL
CRESTOR
IPR 5MG
N021366 002 Aug 12, 2003
10MG
N021366 003 Aug 12, 2003
20MG
N021366 004 Aug 12, 2003
+ 40MG
N021366 005 Aug 12, 2003
ROTIGOTINE
FILM, EXTENDED RELEASE;TRANSDERMAL
NEUPRO
UCB INC 1MG/24HR
N021829 004 Apr 02, 2012
+ 2MG/24HR
N021829 001 May 09, 2007
3MG/24HR
N021829 005 Apr 02, 2012
4MG/24HR
N021829 002 May 09, 2007
6MG/24HR
N021829 003 May 09, 2007
8MG/24HR
N021829 006 Apr 02, 2012
RUBIDIUM CHLORIDE RB-82
INJECTABLE;INJECTION
CARDIOGEN-82
BRACCO N/A
N019414 001 Dec 29, 1989
RUFINAMIDE
SUSPENSION;ORAL
BANZEL
+ EISAI INC 40MG/ML
N201367 001 Mar 03, 2011
TABLET;ORAL
BANZEL
EISAI INC 200MG
N021911 002 Nov 14, 2008
+ 400MG
N021911 003 Nov 14, 2008
RUXOLITINIB PHOSPHATE
TABLET;ORAL
JAKAFI
INCYTE CORP EQ 5MG BASE
N202192 001 Nov 16, 2011
EQ 10MG BASE
N202192 002 Nov 16, 2011
EQ 15MG BASE
N202192 003 Nov 16, 2011
EQ 20MG BASE
N202192 004 Nov 16, 2011
+ EQ 25MG BASE
N202192 005 Nov 16, 2011
SACROSIDASE
SOLUTION;ORAL
SUCRAID
+ QOL MEDCL 8,500 IU/ML
N020772 001 Apr 09, 1998
SALMETEROL XINAFOATE
POWDER;INHALATION
SEREVENT
+ GLAXOSMITHKLINE EQ 0.05MG BASE/INH
N020692 001 Sep 19, 1997
SAMARIUM SM-153 LEXIDRONAM PENTASODIUM
INJECTABLE;INJECTION
QUADRAMET
+ LANTHEUS MEDICAL 50mCi/ML
N020570 001 Mar 28, 1997
SAPROPTERIN DIHYDROCHLORIDE
POWDER;ORAL
KUVAN
+ BIOMARIN PHARM 100MG/PACKET
N205065 001 Dec 19, 2013
TABLET;ORAL
KUVAN
+ BIOMARIN PHARM 100MG
N022181 001 Dec 13, 2007
SAQUINAVIR MESYLATE
CAPSULE;ORAL
INVIRASE
+ HOFFMANN LA ROCHE EQ 200MG BASE
N020628 001 Dec 06, 1995
TABLET;ORAL
INVIRASE
+ HOFFMAN LA ROCHE EQ 500MG BASE
N021785 001 Dec 17, 2004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-322(of 371)
SAXAGLIPTIN HYDROCHLORIDE
TABLET;ORAL
ONGLYZA
ASTRAZENECA AB EQ 2.5MG BASE
N022350 001 Jul 31, 2009
+ EQ 5MG BASE
N022350 002 Jul 31, 2009
SCOPOLAMINE
FILM, EXTENDED RELEASE;TRANSDERMAL
TRANSDERM SCOP
+ NOVARTIS
1MG/72HR
N017874 001
SECOBARBITAL SODIUM
CAPSULE;ORAL
SECONAL SODIUM
+ MARATHON PHARMS
50MG
A086101 001 Oct 03, 1983
+
100MG
A086101 002 Oct 03, 1983
SECRETIN SYNTHETIC HUMAN
FOR SOLUTION;INTRAVENOUS
CHIRHOSTIM
+ CHIRHOCLIN
16MCG/VIAL
N021256 001 Apr 09, 2004
40MCG/VIAL
N021256 002 Jun 21, 2007
SELEGILINE
FILM, EXTENDED RELEASE;TRANSDERMAL
EMSAM
+ SOMERSET 6MG/24HR
N021336 001 Feb 27, 2006
9MG/24HR
N021336 002 Feb 27, 2006
12MG/24HR
N021336 003 Feb 27, 2006
SELEGILINE HYDROCHLORIDE
CAPSULE;ORAL
ELDEPRYL
AB + SOMERSET 5MG
N020647 001 May 15, 1996
SELEGILINE HYDROCHLORIDE
AB APOTEX 5MG
A075321 001 Dec 04, 1998
AB DAVA PHARMS INC 5MG
A075352 001 Nov 30, 1998
TABLET;ORAL
SELEGILINE HYDROCHLORIDE
AB + APOTEX INC 5MG A074871 001 Jun 06, 1997
AB MYLAN 5MG A074866 001 Nov 26, 1997
AB STASON 5MG A074912 001 Apr 30, 1998
TABLET, ORALLY DISINTEGRATING;ORAL
ZELAPAR
+ VALEANT PHARM INTL
1.25MG
N021479 001 Jun 14, 2006
SELENIUM SULFIDE
LOTION/SHAMPOO;TOPICAL
SELENIUM SULFIDE
AT PERRIGO NEW YORK 2.5%
A089996 001 Jan 10, 1991
AT WOCKHARDT 2.5%
A088228 001 Sep 01, 1983
SELSUN
AT + CHATTEM 2.5%
N007936 001
SERTACONAZOLE NITRATE
CREAM;TOPICAL
ERTACZO
+ VALEANT LUXEMBOURG
2%
N021385 001 Dec 10, 2003
SERTRALINE HYDROCHLORIDE
CONCENTRATE;ORAL
SERTRALINE HYDROCHLORIDE
AA AUROBINDO PHARMA
EQ 20MG BASE/ML
A078861 001 Oct 31, 2008
ZOLOFT
AA + PFIZER
EQ 20MG BASE/ML
N020990 001 Dec 07, 1999
TABLET;ORAL
SERTRALINE HYDROCHLORIDE
AB ACCORD HLTHCARE
EQ 25MG BASE
A202825 001 Nov 07, 2014
AB
EQ 50MG BASE
A202825 002 Nov 07, 2014
AB
EQ 100MG BASE
A202825 003 Nov 07, 2014
AB APOTEX INC
EQ 25MG BASE
A076882 001 Feb 06, 2007
AB
EQ 50MG BASE
A076882 002 Feb 06, 2007
AB
EQ 100MG BASE
A076882 003 Feb 06, 2007
AB AUROBINDO PHARMA
EQ 25MG BASE
A077206 001 Feb 06, 2007
AB
EQ 50MG BASE
A077206 002 Feb 06, 2007
AB
EQ 100MG BASE
A077206 003 Feb 06, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-323(of 371)
SERTRALINE HYDROCHLORIDE
TABLET;ORAL
SERTRALINE HYDROCHLORIDE
AB AUSTARPHARMA LLC EQ 25MG BASE A078677 001 Mar 04, 2009
AB EQ 50MG BASE A078677 002 Mar 04, 2009
AB EQ 100MG BASE A078677 003 Mar 04, 2009
AB HIKMA PHARMS EQ 25MG BASE A077864 001 Aug 10, 2009
AB EQ 50MG BASE A077864 002 Aug 10, 2009
AB EQ 100MG BASE A077864 003 Aug 10, 2009
AB INVAGEN PHARMS EQ 25MG BASE A077397 001 Feb 06, 2007
AB EQ 50MG BASE A077397 002 Feb 06, 2007
AB EQ 100MG BASE A077397 003 Feb 06, 2007
AB LUPIN EQ 25MG BASE A077670 001 Feb 06, 2007
AB EQ 50MG BASE A077670 002 Feb 06, 2007
AB EQ 100MG BASE A077670 003 Feb 06, 2007
AB MYLAN EQ 25MG BASE A076671 001 Feb 06, 2007
AB EQ 50MG BASE A076671 002 Feb 06, 2007
AB EQ 100MG BASE A076671 003 Feb 06, 2007
AB MYLAN PHARMS INC EQ 25MG BASE A078626 001 Jan 31, 2008
AB EQ 50MG BASE A078626 002 Jan 31, 2008
AB EQ 100MG BASE A078626 003 Jan 31, 2008
AB PROSAM LABS EQ 25MG BASE A078175 001 Jul 21, 2010
AB EQ 50MG BASE A078175 002 Jul 21, 2010
AB EQ 100MG BASE A078175 003 Jul 21, 2010
AB RANBAXY EQ 25MG BASE A077977 001 Feb 06, 2007
AB EQ 50MG BASE A077977 002 Feb 06, 2007
AB EQ 100MG BASE A077977 003 Feb 06, 2007
AB SUN PHARM INDS (IN) EQ 25MG BASE A078108 001 Feb 06, 2007
AB EQ 50MG BASE A078108 002 Feb 06, 2007
AB EQ 100MG BASE A078108 003 Feb 06, 2007
AB TEVA EQ 25MG BASE A076465 001 Aug 11, 2006
AB EQ 50MG BASE A076465 002 Aug 11, 2006
AB EQ 100MG BASE A076465 003 Aug 11, 2006
AB TORRENT PHARMS EQ 25MG BASE A077765 001 Feb 06, 2007
AB EQ 50MG BASE A077765 002 Feb 06, 2007
AB EQ 100MG BASE A077765 003 Feb 06, 2007
AB WOCKHARDT EQ 25MG BASE A078403 001 Jan 08, 2008
AB EQ 50MG BASE A078403 002 Jan 08, 2008
AB EQ 100MG BASE A078403 003 Jan 08, 2008
AB ZYDUS PHARMS USA EQ 25MG BASE A077106 001 Feb 06, 2007
AB EQ 50MG BASE A077106 002 Feb 06, 2007
AB EQ 100MG BASE A077106 003 Feb 06, 2007
ZOLOFT
AB PFIZER EQ 25MG BASE N019839 005 Mar 06, 1996
AB EQ 50MG BASE N019839 001 Dec 30, 1991
AB + EQ 100MG BASE N019839 002 Dec 30, 1991
SERTRALINE HYDROCHLORIDE
RANBAXY EQ 150MG BASE A077977 004 Feb 06, 2007
EQ 200MG BASE A077977 005 Feb 06, 2007
SEVELAMER CARBONATE
FOR SUSPENSION;ORAL
RENVELA
+ GENZYME 2.4GM/PACKET N022318 002 Feb 18, 2009
800MG/PACKET N022318 001 Aug 12, 2009
TABLET;ORAL
RENVELA
+ GENZYME 800MG N022127 001 Oct 19, 2007
SEVELAMER HYDROCHLORIDE
TABLET;ORAL
RENAGEL
GENZYME 400MG N021179 001 Jul 12, 2000
+ 800MG N021179 002 Jul 12, 2000
SEVOFLURANE
LIQUID;INHALATION
SEVOFLURANE
AN BAXTER HLTHCARE 100% A075895 001 Jul 02, 2002
AN HALOCARBON PRODS 100% A078650 001 Nov 19, 2007
SOJOURN
AN PIRAMAL CRITICAL 100% A077867 001 May 02, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-324(of 371)
SEVOFLURANE
LIQUID;INHALATION
ULTANE
AN + ABBVIE
100%
N020478 001 Jun 07, 1995
SILDENAFIL CITRATE
FOR SUSPENSION;ORAL
REVATIO
+ PFIZER
EQ 10MG BASE/ML
N203109 001 Aug 30, 2012
SOLUTION;INTRAVENOUS
REVATIO
+ PFIZER
EQ 10MG BASE/12.5ML (EQ 0.8MG BASE/ML)
N022473 001 Nov 18, 2009
TABLET;ORAL
REVATIO
AB + PFIZER
EQ 20MG BASE
N021845 001 Jun 03, 2005
SILDENAFIL CITRATE
AB ACTAVIS GRP PTC
EQ 20MG BASE
A200149 001 Feb 25, 2013
AB AMNEAL PHARMS
EQ 20MG BASE
A202025 001 Feb 28, 2013
AB APOTEX CORP
EQ 20MG BASE
A091379 001 Nov 06, 2012
AB DR REDDYS LABS LTD
EQ 20MG BASE
A202598 001 Nov 06, 2012
AB HETERO LABS LTD V
EQ 20MG BASE
A203623 001 Nov 26, 2014
AB MACLEODS PHARMS LTD
EQ 20MG BASE
A203814 001 Dec 17, 2013
AB MYLAN PHARMS INC
EQ 20MG BASE
A201150 001 Nov 09, 2012
AB TEVA PHARMS
EQ 20MG BASE
A078380 001 Jan 07, 2013
AB TORRENT PHARMS LTD
EQ 20MG BASE
A091479 001 Nov 06, 2012
AB WATSON LABS INC
EQ 20MG BASE
A202503 001 Nov 06, 2012
VIAGRA
PFIZER IRELAND
EQ 25MG BASE
N020895 001 Mar 27, 1998
EQ 50MG BASE
N020895 002 Mar 27, 1998
+
EQ 100MG BASE
N020895 003 Mar 27, 1998
SILODOSIN
CAPSULE;ORAL
RAPAFLO
+ WATSON LABS
4MG
N022206 001 Oct 08, 2008
8MG
N022206 002 Oct 08, 2008
SILVER SULFADIAZINE
CREAM;TOPICAL
SILVADENE
AB + KING PHARMS 1%
N017381 001
SSD
AB DR REDDYS LA 1%
N018578 001 Feb 25, 1982
THERMAZENE
AB THEPHARMANETWORK LLC
1%
N018810 001 Dec 23, 1985
SSD AF
BX DR REDDYS LA
1%
N018578 003 Jul 11, 1990
SIMEPREVIR SODIUM
CAPSULE;ORAL
OLYSIO
+ JANSSEN PRODS
EQ 150MG BASE
N205123 001 Nov 22, 2013
SIMVASTATIN
TABLET;ORAL
SIMVASTATIN
AB ACCORD HLTHCARE
5MG
A078155 005 Apr 05, 2013
AB
10MG
A078155 002 Feb 26, 2008
AB
20MG
A078155 003 Feb 26, 2008
AB
40MG
A078155 004 Feb 26, 2008
AB
80MG
A078155 001 Feb 26, 2008
AB AUROBINDO PHARMA
5MG
A077691 001 Dec 20, 2006
AB
10MG
A077691 002 Dec 20, 2006
AB
20MG
A077691 003 Dec 20, 2006
AB
40MG
A077691 004 Dec 20, 2006
AB
80MG
A077691 005 Dec 20, 2006
AB BLU CARIBE
5MG
A078034 001 Dec 20, 2006
AB
10MG
A078034 002 Dec 20, 2006
AB
20MG
A078034 003 Dec 20, 2006
AB
40MG
A078034 004 Dec 20, 2006
AB
80MG
A078034 005 Dec 20, 2006
AB DR REDDYS LABS INC
5MG
A077752 005 Jan 23, 2008
AB
10MG
A077752 001 Dec 20, 2006
AB
20MG
A077752 002 Dec 20, 2006
AB
40MG
A077752 003 Dec 20, 2006
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-325(of 371)
SIMVASTATIN
TABLET;ORAL
SIMVASTATIN
AB 80MG
A077752 004 Dec 20, 2006
AB HETERO LABS LTD III 5MG
A200895 001 Nov 25, 2014
AB 10MG
A200895 002 Nov 25, 2014
AB 20MG
A200895 003 Nov 25, 2014
AB 40MG
A200895 004 Nov 25, 2014
AB 80MG
A200895 005 Nov 25, 2014
AB IVAX SUB TEVA PHARMS 5MG
A076052 001 Jun 23, 2006
AB 10MG
A076052 002 Jun 23, 2006
AB 20MG
A076052 003 Jun 23, 2006
AB 40MG
A076052 004 Jun 23, 2006
AB 80MG
A076052 005 Dec 20, 2006
AB LUPIN 5MG
A078103 005 Apr 14, 2009
AB 10MG
A078103 001 May 11, 2007
AB 20MG
A078103 002 May 11, 2007
AB 40MG
A078103 003 May 11, 2007
AB 80MG
A078103 004 May 11, 2007
AB MICRO LABS LTD 5MG
A090383 001 Sep 16, 2011
AB 10MG
A090383 002 Sep 16, 2011
AB 20MG
A090383 003 Sep 16, 2011
AB 40MG
A090383 004 Sep 16, 2011
AB 80MG
A090383 005 Sep 16, 2011
AB MYLAN PHARMS INC 5MG
A090868 001 Jun 08, 2010
AB 10MG
A090868 002 Jun 08, 2010
AB 20MG
A090868 003 Jun 08, 2010
AB 40MG
A090868 004 Jun 08, 2010
AB 80MG
A090868 005 Jun 08, 2010
AB PROSAM LABS 5MG
A078735 001 Aug 30, 2010
AB 10MG
A078735 002 Aug 30, 2010
AB 20MG
A078735 003 Aug 30, 2010
AB 40MG
A078735 004 Aug 30, 2010
AB 80MG
A078735 005 Aug 30, 2010
AB RANBAXY 5MG
A076285 001 Dec 20, 2006
AB 10MG
A076285 002 Dec 20, 2006
AB 20MG
A076285 003 Dec 20, 2006
AB 40MG
A076285 004 Dec 20, 2006
AB 80MG
A076285 005 Jun 23, 2006
AB WATSON LABS 5MG
A076685 001 Dec 20, 2006
AB 10MG
A076685 002 Dec 20, 2006
AB 20MG
A076685 003 Dec 20, 2006
AB 40MG
A076685 004 Dec 20, 2006
AB 80MG
A076685 005 Dec 20, 2006
AB ZYDUS PHARMS USA 5MG
A077837 001 Dec 20, 2006
AB 10MG
A077837 002 Dec 20, 2006
AB 20MG
A077837 003 Dec 20, 2006
AB 40MG
A077837 004 Dec 20, 2006
AB 80MG
A077837 005 Dec 20, 2006
ZOCOR
AB MERCK 5MG
N019766 001 Dec 23, 1991
AB 10MG
N019766 002 Dec 23, 1991
AB 20MG
N019766 003 Dec 23, 1991
AB 40MG
N019766 004 Dec 23, 1991
AB + 80MG
N019766 005 Jul 10, 1998
SINCALIDE
INJECTABLE;INJECTION
KINEVAC
+ BRACCO 0.005MG/VIAL
N017697 001
SINECATECHINS
OINTMENT;TOPICAL
VEREGEN
+ MEDIGENE AG 15%
N021902 001 Oct 31, 2006
SIROLIMUS
SOLUTION;ORAL
RAPAMUNE
+ PF PRISM CV 1MG/ML
N021083 001 Sep 15, 1999
TABLET;ORAL
RAPAMUNE
AB PF PRISM CV 0.5MG
N021110 004 Jan 25, 2010
AB 1MG
N021110 001 Aug 25, 2000
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-326(of 371)
SIROLIMUS
TABLET;ORAL
RAPAMUNE
AB + 2MG N021110 002 Aug 22, 2002
SIROLIMUS
AB DR REDDYS LABS LTD 1MG A201578 001 Oct 27, 2014
AB 2MG A201578 002 Oct 27, 2014
AB ZYDUS PHARMS USA INC 0.5MG A201676 003 Jan 08, 2014
SITAGLIPTIN PHOSPHATE
TABLET;ORAL
JANUVIA
MERCK SHARP DOHME EQ 25MG BASE N021995 001 Oct 16, 2006
EQ 50MG BASE N021995 002 Oct 16, 2006
+ EQ 100MG BASE N021995 003 Oct 16, 2006
SODIUM ACETATE ANHYDROUS
INJECTABLE;INJECTION
SODIUM ACETATE IN PLASTIC CONTAINER
+ HOSPIRA 2MEQ/ML N018893 001 May 04, 1983
SODIUM BENZOATE; SODIUM PHENYLACETATE
SOLUTION;IV (INFUSION)
AMMONUL
+ MEDICIS 10%;10% (5GM/50ML;5GM/50ML) N020645 001 Feb 17, 2005
SODIUM BICARBONATE
INJECTABLE;INJECTION
SODIUM BICARBONATE
+ HOSPIRA 0.9MEQ/ML A077394 001 Nov 09, 2005
+ 1MEQ/ML A077394 002 Nov 09, 2005
SODIUM CHLORIDE
INJECTABLE;INJECTION
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP FRESENIUS KABI USA 9MG/ML A088911 001 Feb 07, 1985
AP + HOSPIRA 9MG/ML N018800 001 Oct 29, 1982
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
AP B BRAUN 450MG/100ML N019635 001 Mar 09, 1988
AP BAXTER HLTHCARE 450MG/100ML N018016 001
AP HOSPIRA 450MG/100ML N018090 001
AP 450MG/100ML N019759 001 Jun 08, 1988
SODIUM CHLORIDE 0.9%
AP HIKMA (MAPLE) 9MG/ML A201850 001 Jan 20, 2012
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AP + B BRAUN 900MG/100ML N017464 001
AP + 900MG/100ML N019635 002 Mar 09, 1988
AP + BAXTER HLTHCARE 9MG/ML N016677 004 Oct 30, 1985
AP 9MG/ML N020178 002 Dec 07, 1992
AP + 900MG/100ML N016677 001
AP + 900MG/100ML N020178 001 Dec 07, 1992
AP + FRESENIUS KABI USA 9MG/ML A088912 001 Jan 10, 1985
AP FRESENIUS MEDCL 900MG/100ML A078177 001 Apr 12, 2007
AP HAEMONETICS 900MG/100ML A076316 001 Oct 27, 2004
AP + HOSPIRA 9MG/ML N018803 001 Oct 29, 1982
AP + 9MG/ML N019217 001 Jul 13, 1984
AP 9MG/ML N019465 002 Jul 15, 1985
AP + 900MG/100ML N016366 001
AP + 900MG/100ML N019465 001 Jul 15, 1985
AP + 900MG/100ML N019480 001 Sep 17, 1985
AP + TARO PHARMS IRELAND 9MG/ML A077407 001 Aug 11, 2006
SODIUM CHLORIDE 0.9%
MEDEFIL INC 90MG/10ML (9MG/ML) N202832 006 Jan 06, 2012
SODIUM CHLORIDE 0.9%
HIKMA MAPLE 9MG/ML A201833 001 Sep 24, 2013
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
+ MALLINCKRODT 45MG/50ML (9MG/ML) N021569 001 Jul 27, 2006
112.5MG/125ML (9MG/ML) N021569 002 Jul 27, 2006
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
BAXTER HLTHCARE 3GM/100ML N019022 001 Nov 01, 1983
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML N019022 002 Nov 01, 1983
SODIUM CHLORIDE IN PLASTIC CONTAINER
HOSPIRA 2.5MEQ/ML N018897 001 Jul 20, 1984
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-327(of 371)
SODIUM CHLORIDE
SOLUTION;IRRIGATION
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AT B BRAUN 900MG/100ML N016733 001
AT BAXTER HLTHCARE 900MG/100ML N017427 001
AT 900MG/100ML N017867 001
AT HOSPIRA 900MG/100ML N017514 001
AT 900MG/100ML N018314 001
SOLUTION FOR SLUSH;IRRIGATION
SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER
BAXTER HLTHCARE 900MG/100ML N019319 002 May 17, 1985
SODIUM FERRIC GLUCONATE COMPLEX
INJECTABLE;INJECTION
FERRLECIT
AB + SANOFI AVENTIS US 62.5MG/5ML N020955 001 Feb 18, 1999
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE
AB HIKMA PHARMS 62.5MG/5ML A078215 001 Mar 31, 2011
SODIUM FLUORIDE F-18
INJECTABLE;INTRAVENOUS
SODIUM FLUORIDE F-18
AP BIOMEDCL RES FDN 10-200mCi/ML A204351 001 Jan 09, 2015
AP ESSENTIAL ISOTOPES 10-200mCi/ML A204541 001 Oct 29, 2014
AP GLOBAL ISOTOPES LLC 10-200mCi/ML A204464 001 Oct 21, 2014
AP + HOUSTON CYCLOTRON 10-200mCi/ML A203544 001 Dec 26, 2012
AP NCM USA BRONX LLC 10-200mCi/ML A204513 001 Nov 28, 2014
AP SHERTECH LABS LLC 10-200mCi/ML A204315 001 Sep 22, 2014
AP UCSF RODIOPHARM 10-200mCi/ML A204437 001 Mar 13, 2014
AP UNIV TX MD ANDERSON 10-200mCi/ML A203247 001 Dec 23, 2013
+ MCPRF 10-91.5mCi/ML A203605 001 Jun 28, 2013
THE FEINSTEIN INST 20-600mCi/ML A204328 001 Nov 19, 2014
SODIUM IODIDE I-123
CAPSULE;ORAL
SODIUM IODIDE I 123
AA + CARDINAL HLTH 414 100uCi N018671 001 May 27, 1982
AA + 200uCi N018671 002 May 27, 1982
AA MALLINCKRODT 100uCi A071909 001 Feb 28, 1989
AA 200uCi A071910 001 Feb 28, 1989
SODIUM IODIDE I-131
CAPSULE;ORAL
SODIUM IODIDE I 131
+ MALLINCKRODT 0.8-100mCi N016517 001
SODIUM IODIDE I-131
JUBILANT DRAXIMAGE 0.009-0.1mCi N021305 006 May 19, 2005
SOLUTION;ORAL
HICON
+ JUBILANT DRAXIMAGE 250-1000mCi N021305 007 Dec 05, 2011
SODIUM IODIDE I 131
+ MALLINCKRODT 3.5-150mCi/VIAL N016515 001
SODIUM LACTATE
INJECTABLE;INJECTION
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER
AP BAXTER HLTHCARE 1.87GM/100ML N016692 001
SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER
AP B BRAUN 1.87GM/100ML N020004 001 Apr 21, 1992
SODIUM LACTATE IN PLASTIC CONTAINER
+ HOSPIRA 5MEQ/ML N018947 001 Sep 05, 1984
SODIUM NITRITE
SOLUTION;INTRAVENOUS
SODIUM NITRITE
+ HOPE PHARMS 300MG/10ML (30MG/ML) N203922 001 Feb 14, 2012
SODIUM NITRITE; SODIUM THIOSULFATE
SOLUTION, SOLUTION;INTRAVENOUS, INTRAVENOUS
NITHIODOTE
+ HOPE PHARMS 300MG/10ML(30MG/ML),N/A;N/A,12.5GM/50ML N201444 001 Jan 14, 2011
(250MG/ML)
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-328(of 371)
SODIUM NITROPRUSSIDE
INJECTABLE;INJECTION
NITROPRESS
+ HOSPIRA 25MG/ML A071961 001 Aug 01, 1988
SODIUM OXYBATE
SOLUTION;ORAL
XYREM
+ JAZZ PHARMS 500MG/ML N021196 001 Jul 17, 2002
SODIUM PHENYLBUTYRATE
POWDER;ORAL
BUPHENYL
AB + HYPERION THERAPS INC 3GM/TEASPOONFUL N020573 001 Apr 30, 1996
SODIUM PHENYLBUTYRATE
AB SIGMAPHARM LABS LLC 3GM/TEASPOONFUL A202819 001 Mar 22, 2013
TABLET;ORAL
BUPHENYL
AB + HYPERION THERAPS INC 500MG N020572 001 May 13, 1996
SODIUM PHENYLBUTYRATE
AB AMPOLGEN 500MG A090910 001 Nov 18, 2011
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
TABLET;ORAL
OSMOPREP
+ SALIX PHARMS 0.398GM;1.102GM N021892 001 Mar 16, 2006
SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE; SODIUM PHOSPHATE, MONOBASIC, ANHYDROUS
INJECTABLE;INJECTION
SODIUM PHOSPHATES IN PLASTIC CONTAINER
+ HOSPIRA 142MG/ML;276MG/ML N018892 001 May 10, 1983
SODIUM POLYSTYRENE SULFONATE
POWDER;ORAL, RECTAL
KALEXATE
AA KVK TECH 454GM/BOT A040905 001 Mar 30, 2009
KAYEXALATE
AA + COVIS PHARMA SARL 453.6GM/BOT N011287 001
KIONEX
AA PADDOCK LLC 454GM/BOT A040029 001 Feb 06, 1998
SODIUM POLYSTYRENE SULFONATE
AA CAROLINA MEDCL 454GM/BOT A089910 001 Jan 19, 1989
AA CEDAR PHARMS 453.6GM/BOT A090313 001 Dec 21, 2011
AA EPIC PHARMA LLC 453.6GM/BOT A202333 001 Mar 19, 2014
AA NUVO PHARM INC 454GM/BOT A204071 001 Nov 28, 2014
15GM/BOT A204071 002 Nov 28, 2014
SUSPENSION;ORAL, RECTAL
KIONEX
AA PADDOCK LLC 15GM/60ML A040028 001 Sep 17, 2007
SODIUM POLYSTYRENE SULFONATE
AA PADDOCK LLC 15GM/60ML A090590 001 May 13, 2011
AA ROXANE 15GM/60ML A089049 001 Nov 17, 1986
SPS
AA + CAROLINA MEDCL 15GM/60ML A087859 001 Dec 08, 1982
SODIUM TETRADECYL SULFATE
INJECTABLE;INJECTION
SOTRADECOL
MYLAN INSTITUTIONAL 20MG/2ML (10MG/ML) A040541 001 Nov 12, 2004
+ 60MG/2ML (30MG/ML) A040541 002 Nov 12, 2004
SODIUM THIOSULFATE
SOLUTION;INTRAVENOUS
SODIUM THIOSULFATE
+ HOPE PHARMS 12.5GM/50ML (250MG/ML) N203923 001 Feb 14, 2012
SOFOSBUVIR
TABLET;ORAL
SOVALDI
+ GILEAD SCIENCES INC 400MG N204671 001 Dec 06, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-329(of 371)
SOLIFENACIN SUCCINATE
TABLET;ORAL
SOLIFENACIN SUCCINATE
AB TEVA PHARMS USA 5MG A091464 001 Apr 02, 2014
AB 10MG A091464 002 Apr 02, 2014
VESICARE
AB ASTELLAS 5MG N021518 001 Nov 19, 2004
AB + 10MG N021518 002 Nov 19, 2004
SOMATROPIN RECOMBINANT
INJECTABLE;INJECTION
GENOTROPIN
BX + PHARMACIA AND UPJOHN 5.8MG/VIAL N020280 006 Aug 24, 1995
GENOTROPIN PRESERVATIVE FREE
BX PHARMACIA AND UPJOHN 1.5MG/VIAL N020280 004 Aug 24, 1995
HUMATROPE
BX + LILLY 5MG/VIAL N019640 004 Mar 08, 1987
BX 6MG/VIAL N019640 005 Feb 04, 1999
NORDITROPIN FLEXPRO
BX NOVO NORDISK INC 5MG/1.5ML N021148 008 Mar 01, 2010
BX 10MG/1.5ML N021148 009 Mar 01, 2010
NUTROPIN
BX GENENTECH 5MG/VIAL N020168 001 Nov 17, 1993
OMNITROPE
BX SANDOZ 1.5MG/VIAL N021426 002 May 30, 2006
BX 5MG/1.5ML N021426 003 Jan 16, 2008
BX 5.8MG/VIAL N021426 001 May 30, 2006
BX 10MG/1.5ML N021426 004 Aug 25, 2008
SAIZEN
BX EMD SERONO 5MG/VIAL N019764 002 Oct 08, 1996
SEROSTIM
BX EMD SERONO 4MG/VIAL N020604 003 Jul 25, 1997
BX 5MG/VIAL N020604 002 Aug 23, 1996
BX 6MG/VIAL N020604 001 Aug 23, 1996
TEV-TROPIN
BX + FERRING 5MG/VIAL N019774 002 Jan 04, 2002
VALTROPIN
BX LG LIFE 5MG/VIAL N021905 001 Apr 19, 2007
GENOTROPIN
+ PHARMACIA AND UPJOHN 13.8MG/VIAL N020280 007 Oct 23, 1996
GENOTROPIN PRESERVATIVE FREE
PHARMACIA AND UPJOHN 0.2MG/VIAL N020280 001 Jan 27, 1998
0.4MG/VIAL N020280 002 Jan 27, 1998
0.6MG/VIAL N020280 003 Jan 27, 1998
0.8MG/VIAL N020280 005 Jan 27, 1998
1MG/VIAL N020280 008 Jan 27, 1998
1.2MG/VIAL N020280 009 Jan 27, 1998
1.4MG/VIAL N020280 010 Jan 27, 1998
1.6MG/VIAL N020280 011 Jan 27, 1998
1.8MG/VIAL N020280 012 Jan 27, 1998
+ 2MG/VIAL N020280 013 Jan 27, 1998
HUMATROPE
+ LILLY 12MG/VIAL N019640 006 Feb 04, 1999
+ 24MG/VIAL N019640 007 Feb 04, 1999
NORDITROPIN FLEXPRO
NOVO NORDISK INC 15MG/1.5ML N021148 010 Mar 01, 2010
NORDITROPIN NORDIFLEX
NOVO NORDISK INC 30MG/3ML N021148 007 Mar 10, 2009
NUTROPIN
+ GENENTECH 10MG/VIAL N020168 002 Nov 17, 1993
NUTROPIN AQ
+ GENENTECH 5MG/2ML (2.5MG/ML) N020522 003 Jan 03, 2008
+ 10MG/2ML (5MG/ML) N020522 001 Dec 29, 1995
+ 20MG/2ML (10MG/ML) N020522 004 Jan 03, 2008
NUTROPIN AQ PEN
+ GENENTECH 10MG/2ML (5MG/ML) N020522 002 Apr 22, 2002
SAIZEN
+ EMD SERONO 8.8MG/VIAL N019764 003 Aug 29, 2000
ZORBTIVE
+ EMD SERONO 8.8MG/VIAL N021597 004 Dec 01, 2003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-330(of 371)
SORAFENIB TOSYLATE
TABLET;ORAL
NEXAVAR
+ BAYER HLTHCARE EQ 200MG BASE
N021923 001 Dec 20, 2005
SORBITOL
SOLUTION;IRRIGATION
SORBITOL 3% IN PLASTIC CONTAINER
BAXTER HLTHCARE 3GM/100ML
N017863 001
SORBITOL 3.3% IN PLASTIC CONTAINER
B BRAUN
3.3GM/100ML
N016741 001
SOTALOL HYDROCHLORIDE
SOLUTION;INTRAVENOUS
SOTALOL HYDROCHLORIDE
+ ACADEMIC PHARMS
150MG/10ML (15MG/ML)
N022306 001 Jul 02, 2009
SOLUTION;ORAL
SOTYLIZE
+ ARBOR PHARMS LLC
5MG/ML (5MG/ML)
N205108 001 Oct 22, 2014
TABLET;ORAL
BETAPACE
AB1 BAYER HLTHCARE
80MG
N019865 001 Oct 30, 1992
AB1
120MG
N019865 005 Apr 20, 1994
AB1 +
160MG
N019865 002 Oct 30, 1992
AB1
240MG
N019865 003 Oct 30, 1992
SORINE
AB1 UPSHER SMITH
80MG
A075500 001 Apr 27, 2001
AB1
120MG
A075500 004 Apr 27, 2001
AB1
160MG
A075500 002 Apr 27, 2001
AB1
240MG
A075500 003 Apr 27, 2001
SOTALOL HYDROCHLORIDE
AB1 APOTEX INC
80MG
A076140 001 Sep 26, 2002
AB1
120MG
A076140 002 Sep 26, 2002
AB1
160MG
A076140 003 Sep 26, 2002
AB1
240MG
A076140 004 Sep 26, 2002
AB1 IMPAX PHARMS
80MG
A075663 001 Nov 07, 2000
AB1
120MG
A075663 002 Nov 07, 2000
AB1
160MG
A075663 003 Nov 07, 2000
AB1
240MG
A075663 004 Nov 07, 2000
AB1 MYLAN
80MG
A075237 001 May 01, 2000
AB1
80MG
A075725 001 Dec 19, 2000
AB1
120MG
A075237 002 May 01, 2000
AB1
120MG
A075725 002 Dec 19, 2000
AB1
160MG
A075237 003 May 01, 2000
AB1
160MG
A075725 003 Dec 19, 2000
AB1
240MG
A075237 004 May 01, 2000
AB1
240MG
A075725 004 Dec 19, 2000
AB1 SANDOZ
80MG
A075366 001 May 01, 2000
AB1
120MG
A075366 002 May 01, 2000
AB1
160MG
A075366 003 May 01, 2000
AB1
240MG
A075366 004 May 01, 2000
AB1 TEVA
80MG
A075429 001 May 01, 2000
AB1
120MG
A075429 002 May 01, 2000
AB1
160MG
A075429 003 May 01, 2000
AB1
240MG
A075429 004 May 01, 2000
AB1 VINTAGE PHARMS
80MG
A075563 001 Nov 07, 2003
AB1
120MG
A075563 002 Nov 07, 2003
AB1
160MG
A075563 003 Nov 07, 2003
AB1
240MG
A075563 004 Nov 07, 2003
BETAPACE AF
AB2 COVIS PHARMA SARL
80MG
N021151 001 Feb 22, 2000
AB2
120MG
N021151 002 Feb 22, 2000
AB2 +
160MG
N021151 003 Feb 22, 2000
SOTALOL HYDROCHLORIDE
AB2 APOTEX
80MG
A076214 001 Aug 27, 2003
AB2
120MG
A076214 002 Aug 27, 2003
AB2
160MG
A076214 003 Aug 27, 2003
AB2 EPIC PHARMA INC
80MG
A077070 001 Nov 04, 2005
AB2
120MG
A077070 002 Nov 04, 2005
AB2
160MG
A077070 003 Nov 04, 2005
AB2 MYLAN
80MG
A077616 001 Feb 07, 2007
AB2
120MG
A077616 002 Feb 07, 2007
AB2
160MG
A077616 003 Feb 07, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-331(of 371)
SOTALOL HYDROCHLORIDE
TABLET;ORAL
SOTALOL HYDROCHLORIDE
AB2 TEVA
80MG
A076883 001 Jul 26, 2004
AB2
120MG
A076883 002 Jul 26, 2004
AB2
160MG
A076883 003 Jul 26, 2004
SOYBEAN OIL
INJECTABLE;INJECTION
INTRALIPID 10%
AP + FRESENIUS
10%
N017643 001
INTRALIPID 20%
AP + FRESENIUS
20%
N018449 001
AP +
20%
N020248 001 Aug 07, 1996
INTRALIPID 30%
AP + FRESENIUS
30%
N019942 001 Dec 30, 1993
NUTRILIPID 10%
AP + B BRAUN
10%
N019531 001 May 28, 1993
NUTRILIPID 20%
AP + B BRAUN
20%
N019531 002 May 28, 1993
SPINOSAD
SUSPENSION;TOPICAL
NATROBA
+ PARAPRO LLC
0.9%
N022408 001 Jan 18, 2011
SPIRONOLACTONE
TABLET;ORAL
ALDACTONE
AB GD SEARLE LLC
25MG
N012151 009 Dec 30, 1983
AB
50MG
N012151 008 Dec 30, 1982
AB +
100MG
N012151 010 Dec 30, 1983
SPIRONOLACTONE
AB ACTAVIS ELIZABETH
25MG
A040353 003 Mar 15, 2006
AB
50MG
A040353 001 Jul 29, 1999
AB
100MG
A040353 002 Jul 29, 1999
AB AMNEAL PHARMS
25MG
A091426 001 Jun 08, 2010
AB
50MG
A091426 002 Jun 08, 2010
AB
100MG
A091426 003 Jun 08, 2010
AB JUBILANT GENERICS
25MG
A203253 001 Apr 23, 2014
AB
50MG
A203253 002 Apr 23, 2014
AB
100MG
A203253 003 Apr 23, 2014
AB MUTUAL PHARM
25MG
A089424 001 Jul 23, 1986
AB
50MG
A089424 002 Aug 11, 1999
AB
100MG
A089424 003 Aug 11, 1999
AB MYLAN
25MG
A040424 001 Aug 20, 2001
AB
50MG
A040424 002 Aug 20, 2001
AB
100MG
A040424 003 Aug 20, 2001
AB ORION CORP ORION
25MG
A202187 001 Mar 06, 2014
AB
50MG
A202187 002 Mar 06, 2014
AB
100MG
A202187 003 Mar 06, 2014
AB SANDOZ
25MG
A086809 001
AB VINTAGE
25MG
A040750 001 Aug 29, 2006
AB
50MG
A040750 002 Aug 29, 2006
AB
100MG
A040750 003 Aug 29, 2006
STAVUDINE
CAPSULE;ORAL
STAVUDINE
AB AUROBINDO PHARMA
15MG
A077672 003 Dec 29, 2008
AB
20MG
A077672 004 Dec 29, 2008
AB
30MG
A077672 001 Dec 29, 2008
AB
40MG
A077672 002 Dec 29, 2008
AB HETERO LABS LTD III 15MG A078957 001 Dec 29, 2008
AB 20MG A078957 002 Dec 29, 2008
AB 30MG A078957 003 Dec 29, 2008
AB 40MG A078957 004 Dec 29, 2008
AB MATRIX LABS LTD 30MG A078775 001 Jan 05, 2009
AB 40MG A078775 002 Jan 05, 2009
AB MYLAN 15MG A079069 001 Dec 29, 2008
AB 20MG A079069 002 Dec 29, 2008
AB 30MG A079069 003 Dec 29, 2008
AB 40MG A079069 004 Dec 29, 2008
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-332(of 371)
STAVUDINE
CAPSULE;ORAL
ZERIT
AB BRISTOL MYERS SQUIBB 15MG N020412 002 Jun 24, 1994
AB 20MG N020412 003 Jun 24, 1994
AB 30MG N020412 004 Jun 24, 1994
AB + 40MG N020412 005 Jun 24, 1994
FOR SOLUTION;ORAL
STAVUDINE
AA AUROBINDO PHARMA 1MG/ML A077774 001 Dec 29, 2008
AA CIPLA LTD 1MG/ML A078030 001 Mar 20, 2009
ZERIT
AA + BRISTOL MYERS SQUIBB 1MG/ML N020413 001 Sep 06, 1996
STERILE WATER FOR INJECTION
LIQUID;N/A
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
AP + HOSPIRA 100% N018802 001 Oct 27, 1982
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
AP + B BRAUN 100% N019633 001 Feb 29, 1988
AP + BAXTER HLTHCARE 100% N018632 001 Jun 30, 1982
AP + 100% N018632 002 Apr 19, 1988
AP FRESENIUS KABI USA 100% A088400 001 Jan 16, 1984
AP + HOSPIRA 100% N018233 001
AP + 100% N018801 001 Oct 27, 1982
AP + 100% N019869 001 Dec 26, 1989
AP TARO PHARMS IRELAND 100% A077393 001 Aug 11, 2006
STERILE WATER FOR IRRIGATION
LIQUID;IRRIGATION
STERILE WATER
AT BAXTER HLTHCARE 100% N017428 001
STERILE WATER IN PLASTIC CONTAINER
AT B BRAUN 100% N016734 001
AT BAXTER HLTHCARE 100% N017866 001
AT HOSPIRA 100% N017513 001
AT 100% N018313 001
STREPTOMYCIN SULFATE
INJECTABLE;INJECTION
STREPTOMYCIN SULFATE
+ X GEN PHARMS EQ 1GM BASE/VIAL A064210 001 Jun 30, 1998
STREPTOZOCIN
INJECTABLE;INJECTION
ZANOSAR
+ TEVA PHARMS USA 1GM/VIAL N050577 001 May 07, 1982
STRONTIUM CHLORIDE SR-89
INJECTABLE;INJECTION
METASTRON
AP + GE HEALTHCARE 1mCi/ML N020134 001 Jun 18, 1993
STRONTIUM CHLORIDE SR-89
AP BIO NUCLEONICS 1mCi/ML A075941 001 Jan 06, 2003
SUCCIMER
CAPSULE;ORAL
CHEMET
+ RECORDATI RARE 100MG N019998 002 Jan 30, 1991
SUCCINYLCHOLINE CHLORIDE
INJECTABLE;INJECTION
ANECTINE
AP + SANDOZ 20MG/ML N008453 002
QUELICIN
AP + HOSPIRA 20MG/ML N008845 006
QUELICIN PRESERVATIVE FREE
AP + HOSPIRA 20MG/ML N008845 001
+ 100MG/ML N008845 004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-333(of 371)
SUCRALFATE
SUSPENSION;ORAL
CARAFATE
+ FOREST LABS INC 1GM/10ML N019183 001 Dec 16, 1993
TABLET;ORAL
CARAFATE
AB + FOREST LABS INC 1GM N018333 001
SUCRALFATE
AB NOSTRUM LABS 1GM A074415 001 Jun 08, 1998
AB TEVA 1GM A070848 001 Mar 29, 1996
SUCROFERRIC OXYHYDROXIDE
TABLET, CHEWABLE;ORAL
VELPHORO
+ VIFOR FRESENIUS 500MG N205109 001 Nov 27, 2013
SUFENTANIL CITRATE
INJECTABLE;INJECTION
SUFENTA PRESERVATIVE FREE
AP + AKORN EQ 0.05MG BASE/ML N019050 001 May 04, 1984
SUFENTANIL CITRATE
AP HIKMA MAPLE EQ 0.05MG BASE/ML A074413 001 Dec 15, 1995
AP HOSPIRA EQ 0.05MG BASE/ML A074534 001 Dec 11, 1996
SULCONAZOLE NITRATE
CREAM;TOPICAL
EXELDERM
+ RANBAXY 1% N018737 001 Feb 28, 1989
SOLUTION;TOPICAL
EXELDERM
+ RANBAXY 1% N018738 001 Aug 30, 1985
SULFACETAMIDE SODIUM
LOTION;TOPICAL
KLARON
AB + VALEANT BERMUDA 10% N019931 001 Dec 23, 1996
SULFACETAMIDE SODIUM
AB FOUGERA PHARMS 10% A077015 001 Nov 17, 2006
AB PERRIGO CO TENNESSEE 10% A078649 001 Mar 23, 2009
AB TARO 10% A078668 001 May 20, 2009
OINTMENT;OPHTHALMIC
CETAMIDE
AT + ALCON 10% A080021 001
SULFACETAMIDE SODIUM
AT PERRIGO CO TENNESSEE 10% A080029 001
SOLUTION/DROPS;OPHTHALMIC
BLEPH-10
AT + ALLERGAN 10% A080028 001
SULFACETAMIDE SODIUM
AT ALCON PHARMS LTD 10% A089560 001 Oct 18, 1988
AT BAUSCH AND LOMB 10% A040066 001 Dec 28, 1994
SULFADIAZINE
TABLET;ORAL
SULFADIAZINE
+ SANDOZ 500MG A040091 001 Jul 29, 1994
SULFAMETHOXAZOLE; TRIMETHOPRIM
INJECTABLE;INJECTION
SULFAMETHOXAZOLE AND TRIMETHOPRIM
+ TEVA PHARMS USA 80MG/ML;16MG/ML A073303 001 Oct 31, 1991
SUSPENSION;ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIM
AB AUROBINDO PHARMA 200MG/5ML;40MG/5ML A091348 001 Jun 08, 2010
AB + HI TECH PHARMA 200MG/5ML;40MG/5ML A074650 001 Dec 29, 1997
AB VINTAGE 200MG/5ML;40MG/5ML A077785 001 Jan 24, 2007
SULFATRIM PEDIATRIC
AB STI PHARMA LLC 200MG/5ML;40MG/5ML N018615 001 Jan 07, 1983
TABLET;ORAL
BACTRIM
AB MUTUAL PHARM 400MG;80MG N017377 001
BACTRIM DS
AB + MUTUAL PHARM 800MG;160MG N017377 002
SEPTRA
AB MONARCH PHARMS 400MG;80MG N017376 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-334(of 371)
SULFAMETHOXAZOLE; TRIMETHOPRIM
TABLET;ORAL
SEPTRA DS
AB MONARCH PHARMS 800MG;160MG N017376 002
SULFAMETHOXAZOLE AND TRIMETHOPRIM
AB AMNEAL PHARMS NY 400MG;80MG A076899 001 Jan 27, 2005
AB 800MG;160MG A076899 002 Jan 27, 2005
AB AUROBINDO PHARMA 400MG;80MG A090624 001 Feb 16, 2010
AB 800MG;160MG A090624 002 Feb 16, 2010
AB GLENMARK GENERICS 400MG;80MG A090828 002 Dec 22, 2010
AB 800MG;160MG A090828 001 Dec 22, 2010
AB MUTUAL PHARM 800MG;160MG A071017 001 Aug 25, 1986
AB VINTAGE 400MG;80MG A078060 002 Jan 25, 2007
AB 800MG;160MG A078060 001 Jan 25, 2007
AB VISTA PHARMS 400MG;80MG A076817 001 Oct 07, 2005
AB 800MG;160MG A076817 002 Oct 07, 2005
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
AB TEVA 800MG;160MG A070037 001 Jun 02, 1987
SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH
AB TEVA PHARMS 400MG;80MG A070030 001 Jun 02, 1987
SULFANILAMIDE
CREAM;VAGINAL
AVC
+ MEDA PHARMS 15% N006530 003 Jan 27, 1987
SULFASALAZINE
SUSPENSION;ORAL
AZULFIDINE
+ PHARMACIA AND UPJOHN 250MG/5ML A086983 001
TABLET;ORAL
AZULFIDINE
AB + PHARMACIA AND UPJOHN 500MG N007073 001
SULFASALAZINE
AB VINTAGE PHARMS 500MG A040349 001 Jan 11, 2002
AB WATSON LABS 500MG A085828 001
TABLET, DELAYED RELEASE;ORAL
AZULFIDINE EN-TABS
AB + PHARMACIA AND UPJOHN 500MG N007073 002 Apr 06, 1983
SULFASALAZINE
AB VINTAGE PHARMS 500MG A075339 001 Jan 11, 2002
SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES
FOR SUSPENSION;INTRAVENOUS
LUMASON
+ BRACCO 60.7MG/25MG N203684 001 Oct 15, 2014
SULINDAC
TABLET;ORAL
CLINORIL
AB + MERCK 200MG N017911 002
SULINDAC
AB EPIC PHARMA 150MG A072710 001 Mar 25, 1991
AB 200MG A072711 001 Mar 25, 1991
AB HERITAGE PHARMS INC 150MG A073262 002 Sep 06, 1991
AB 200MG A073262 001 Sep 06, 1991
AB MUTUAL PHARM 150MG A072050 001 Apr 17, 1991
AB 200MG A072051 001 Apr 17, 1991
AB MYLAN 150MG A073039 002 Jun 22, 1993
AB 200MG A073039 001 Jun 22, 1993
AB WATSON LABS 150MG A071891 001 Apr 03, 1990
AB 200MG A071795 001 Apr 03, 1990
SUMATRIPTAN
SPRAY;NASAL
IMITREX
+ GLAXOSMITHKLINE 5MG/SPRAY N020626 001 Aug 26, 1997
+ 20MG/SPRAY N020626 003 Aug 26, 1997
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-335(of 371)
SUMATRIPTAN SUCCINATE
INJECTABLE;SUBCUTANEOUS
IMITREX STATDOSE
AB + GLAXOSMITHKLINE
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
N020080 003 Dec 23, 1996
SUMATRIPTAN SUCCINATE
AB DR REDDYS LABS INC
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A090495 001 Jan 29, 2014
AB SUN PHARMA GLOBAL
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A090358 001 Jun 21, 2011
IMITREX
AP + GLAXOSMITHKLINE
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
N020080 001 Dec 28, 1992
SUMATRIPTAN SUCCINATE
AP AGILA SPECLTS
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A203322 001 Apr 14, 2014
AP AUROBINDO PHARMA LTD
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A202758 001 Apr 23, 2013
AP BEDFORD
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A079123 001 Feb 06, 2009
AP FRESENIUS KABI USA
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A079242 001 Mar 02, 2009
AP HIKMA FARMACEUTICA
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A200183 001 Sep 16, 2013
AP INJECTALIA
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A090310 001 Aug 11, 2010
AP PAR PHARM
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A077332 001 Oct 09, 2009
AP PAR STERILE PRODUCTS
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A077871 001 Jul 09, 2009
AP SAGENT AGILA
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A090641 001 Jul 28, 2010
AP SAGENT STRIDES
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A090314 001 Jun 10, 2010
AP TEVA PHARMS USA
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A077907 001 Feb 06, 2009
AP WOCKHARDT
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A078593 001 Feb 06, 2009
ALSUMA
BX MERIDIAN MEDCL
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
N022377 001 Jun 29, 2010
IMITREX STATDOSE
BX + GLAXOSMITHKLINE
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
N020080 002 Feb 01, 2006
SUMAVEL DOSEPRO
BX + ENDO VENTURES LTD
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
N022239 002 Nov 26, 2013
BX +
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
N022239 001 Jul 15, 2009
SYSTEM;IONTOPHORESIS
ZECUITY
+ TEVA BRANDED PHARM
EQ 6.5MG BASE/4HR
N202278 001 Jan 17, 2013
TABLET;ORAL
IMITREX
AB GLAXOSMITHKLINE
EQ 25MG BASE
N020132 002 Jun 01, 1995
AB
EQ 50MG BASE
N020132 003 Jun 01, 1995
AB +
EQ 100MG BASE
N020132 001 Jun 01, 1995
SUMATRIPTAN SUCCINATE
AB APOTEX INC
EQ 25MG BASE
A200263 001 Jun 19, 2012
AB
EQ 50MG BASE
A200263 002 Jun 19, 2012
AB
EQ 100MG BASE
A200263 003 Jun 19, 2012
AB AUROBINDO PHARMA
EQ 25MG BASE
A078327 001 Aug 10, 2009
AB
EQ 50MG BASE
A078327 002 Aug 10, 2009
AB
EQ 100MG BASE
A078327 003 Aug 10, 2009
AB DR REDDYS LABS INC
EQ 25MG BASE
A076847 001 Aug 10, 2009
AB
EQ 50MG BASE
A076847 002 Aug 10, 2009
AB
EQ 100MG BASE
A076847 003 Aug 10, 2009
AB HIKMA PHARMS
EQ 25MG BASE
A078298 001 May 21, 2013
AB
EQ 50MG BASE
A078298 002 May 21, 2013
AB
EQ 100MG BASE
A078298 003 May 21, 2013
AB MYLAN
EQ 25MG BASE
A077744 001 Aug 10, 2009
AB
EQ 50MG BASE
A077744 002 Aug 10, 2009
AB
EQ 100MG BASE
A077744 003 Aug 10, 2009
AB ORCHID HLTHCARE
EQ 25MG BASE
A078284 001 Aug 10, 2009
AB
EQ 50MG BASE
A078284 002 Aug 10, 2009
AB
EQ 100MG BASE
A078284 003 Aug 10, 2009
AB RANBAXY
EQ 25MG BASE
A076554 001 Aug 10, 2009
AB
EQ 50MG BASE
A076554 002 Aug 10, 2009
AB
EQ 100MG BASE
A076572 001 Feb 09, 2009
AB SANDOZ
EQ 25MG BASE
A076976 001 Aug 10, 2009
AB
EQ 50MG BASE
A076976 002 Aug 10, 2009
AB
EQ 100MG BASE
A076976 003 Aug 10, 2009
AB SUN PHARM INDS
EQ 25MG BASE
A078295 001 Aug 10, 2009
AB
EQ 50MG BASE
A078295 002 Aug 10, 2009
AB
EQ 100MG BASE
A078295 003 Aug 10, 2009
AB WATSON LABS
EQ 25MG BASE
A076933 001 Aug 10, 2009
AB
EQ 50MG BASE
A076933 002 Aug 10, 2009
AB
EQ 100MG BASE
A076933 003 Aug 10, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-336(of 371)
SUNITINIB MALATE
CAPSULE;ORAL
SUNITINIB MALATE
AB MYLAN PHARMS INC EQ 12.5MG BASE A201275 001 Jan 30, 2014
AB EQ 25MG BASE A201275 002 Jan 30, 2014
AB EQ 37.5MG BASE A201275 003 Jan 30, 2014
AB EQ 50MG BASE A201275 004 Jan 30, 2014
SUTENT
AB CPPI CV EQ 12.5MG BASE N021938 001 Jan 26, 2006
AB EQ 25MG BASE N021938 002 Jan 26, 2006
AB EQ 37.5MG BASE N021938 004 Mar 31, 2009
AB + EQ 50MG BASE N021938 003 Jan 26, 2006
SUVOREXANT
TABLET;ORAL
BELSOMRA
MERCK SHARP DOHME 5MG N204569 001 Aug 13, 2014
10MG N204569 002 Aug 13, 2014
15MG N204569 003 Aug 13, 2014
+ 20MG N204569 004 Aug 13, 2014
TACROLIMUS
CAPSULE;ORAL
PROGRAF
AB ASTELLAS EQ 0.5MG BASE N050708 003 Aug 24, 1998
AB EQ 1MG BASE N050708 001 Apr 08, 1994
AB + EQ 5MG BASE N050708 002 Apr 08, 1994
TACROLIMUS
AB ACCORD HLTHCARE EQ 0.5MG BASE A091195 001 Aug 31, 2011
AB EQ 1MG BASE A091195 002 Aug 31, 2011
AB EQ 5MG BASE A091195 003 Aug 31, 2011
AB DR REDDYS LABS LTD EQ 0.5MG BASE A090509 001 May 12, 2010
AB EQ 1MG BASE A090509 002 May 12, 2010
AB EQ 5MG BASE A090509 003 May 12, 2010
AB MYLAN EQ 0.5MG BASE A090596 001 Sep 17, 2010
AB EQ 1MG BASE A090596 002 Sep 17, 2010
AB EQ 5MG BASE A090596 003 Sep 17, 2010
AB PANACEA BIOTEC LTD EQ 0.5MG BASE A090802 001 Sep 28, 2012
AB EQ 1MG BASE A090802 002 Sep 28, 2012
AB EQ 5MG BASE A090802 003 Sep 28, 2012
AB SANDOZ EQ 0.5MG BASE A065461 001 Aug 10, 2009
AB EQ 1MG BASE A065461 002 Aug 10, 2009
AB EQ 5MG BASE A065461 003 Aug 10, 2009
AB STRIDES PHARMA EQ 0.5MG BASE A090687 001 Jul 22, 2014
AB EQ 1MG BASE A090687 002 Jul 22, 2014
AB EQ 5MG BASE A090687 003 Jul 22, 2014
CAPSULE, EXTENDED RELEASE;ORAL
ASTAGRAF XL
ASTELLAS EQ 0.5MG BASE N204096 001 Jul 19, 2013
EQ 1MG BASE N204096 002 Jul 19, 2013
+ EQ 5MG BASE N204096 003 Jul 19, 2013
INJECTABLE;INJECTION
PROGRAF
+ ASTELLAS EQ 5MG BASE/ML N050709 001 Apr 08, 1994
OINTMENT;TOPICAL
PROTOPIC
AB + ASTELLAS 0.03% N050777 001 Dec 08, 2000
AB + 0.1% N050777 002 Dec 08, 2000
TACROLIMUS
AB FOUGERA PHARMS INC 0.03% A200744 001 Sep 09, 2014
AB 0.1% A200744 002 Sep 09, 2014
TADALAFIL
TABLET;ORAL
ADCIRCA
+ ELI LILLY CO 20MG N022332 001 May 22, 2009
CIALIS
LILLY 2.5MG N021368 004 Jan 07, 2008
5MG N021368 001 Nov 21, 2003
10MG N021368 002 Nov 21, 2003
+ 20MG N021368 003 Nov 21, 2003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-337(of 371)
TAFLUPROST
SOLUTION/DROPS;OPHTHALMIC
ZIOPTAN
+ OAK PHARMS INC
0.0015%
N202514 001 Feb 10, 2012
TALC
AEROSOL, METERED;INTRAPLEURAL
SCLEROSOL
+ BRYAN
400MG/SPRAY
N020587 001 Dec 24, 1997
POWDER;INTRAPLEURAL
TALC
+ BRYAN
5GM/BOT
N021388 001 Dec 15, 2003
TALIGLUCERASE ALFA
POWDER;IV (INFUSION)
ELELYSO
+ PFIZER
200 UNITS/VIAL
N022458 001 May 01, 2012
TAMOXIFEN CITRATE
SOLUTION;ORAL
SOLTAMOX
DARA BIOSCIENCES
EQ 10MG BASE/5ML
N021807 001 Oct 29, 2005
TABLET;ORAL
TAMOXIFEN CITRATE
AB ACTAVIS LABS FL INC EQ 10MG BASE
A070929 001 Feb 20, 2003
AB EQ 10MG BASE
A076179 001 Feb 20, 2003
AB EQ 20MG BASE
A070929 002 Feb 20, 2003
AB EQ 20MG BASE
A076179 002 Feb 20, 2003
AB APOTEX EQ 10MG BASE
A090878 001 Sep 23, 2011
AB EQ 20MG BASE
A090878 002 Sep 23, 2011
AB MYLAN EQ 10MG BASE
A074732 002 Feb 20, 2003
AB EQ 20MG BASE
A074732 001 Feb 20, 2003
AB TEVA EQ 10MG BASE
A075797 001 Feb 20, 2003
AB + TEVA PHARMS EQ 20MG BASE
A074858 001 Feb 20, 2003
TAMSULOSIN HYDROCHLORIDE
CAPSULE;ORAL
FLOMAX
AB + BOEHRINGER INGELHEIM
0.4MG
N020579 001 Apr 15, 1997
TAMSULOSIN HYDROCHLORIDE
AB ANCHEN PHARMS
0.4MG
A202010 001 Jan 04, 2013
AB AUROBINDO PHARMA LTD
0.4MG
A202433 001 Apr 30, 2013
AB IMPAX LABS
0.4MG
A090377 001 Mar 02, 2010
AB MYLAN
0.4MG
A090408 001 Apr 27, 2010
AB SANDOZ
0.4MG
A078015 001 Apr 27, 2010
AB SUN PHARM INDS LTD
0.4MG
A090931 001 Jul 15, 2010
AB SYNTHON PHARMS
0.4MG
A078801 001 Apr 27, 2010
AB TEVA PHARMS
0.4MG
A077630 001 Apr 27, 2010
AB WOCKHARDT
0.4MG
A078938 001 Apr 27, 2010
AB ZYDUS PHARMS USA INC
0.4MG
A078225 001 Apr 27, 2010
TAPENTADOL HYDROCHLORIDE
SOLUTION;ORAL
NUCYNTA
+ JANSSEN PHARMS
EQ 20MG BASE/ML
N203794 001 Oct 15, 2012
TABLET;ORAL
NUCYNTA
JANSSEN PHARMS
EQ 50MG BASE
N022304 001 Nov 20, 2008
EQ 75MG BASE
N022304 002 Nov 20, 2008
+
EQ 100MG BASE
N022304 003 Nov 20, 2008
TABLET, EXTENDED RELEASE;ORAL
NUCYNTA ER
JANSSEN PHARMS
EQ 50MG BASE
N200533 001 Aug 25, 2011
EQ 100MG BASE
N200533 002 Aug 25, 2011
EQ 150MG BASE
N200533 003 Aug 25, 2011
EQ 200MG BASE
N200533 004 Aug 25, 2011
+
EQ 250MG BASE
N200533 005 Aug 25, 2011
TASIMELTEON
CAPSULE;ORAL
HETLIOZ
+ VANDA PHARMS INC
20MG
N205677 001 Jan 31, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-338(of 371)
TAVABOROLE
SOLUTION;TOPICAL
KERYDIN
+ ANACOR PHARMS INC 5% N204427 001 Jul 07, 2014
TAZAROTENE
AEROSOL, FOAM;TOPICAL
FABIOR
+ STIEFEL LABS INC 0.1% N202428 001 May 11, 2012
CREAM;TOPICAL
AVAGE
+ ALLERGAN 0.1% N021184 003 Sep 30, 2002
TAZORAC
+ ALLERGAN 0.05% N021184 001 Sep 29, 2000
+ 0.1% N021184 002 Sep 29, 2000
GEL;TOPICAL
TAZORAC
+ ALLERGAN 0.05% N020600 001 Jun 13, 1997
+ 0.1% N020600 002 Jun 13, 1997
TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT
INJECTABLE;INJECTION
PULMOLITE
BS JUBILANT DRAXIMAGE N/A N017776 001
TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT
BS DRAXIMAGE N/A N017881 001 Dec 30, 1987
TECHNETIUM TC-99M BICISATE KIT
INJECTABLE;INJECTION
NEUROLITE
LANTHEUS MEDCL N/A N020256 001 Nov 23, 1994
TECHNETIUM TC-99M DISOFENIN KIT
INJECTABLE;INJECTION
HEPATOLITE
PHARMALUCENCE N/A N018467 001 Mar 16, 1982
TECHNETIUM TC-99M EXAMETAZIME KIT
INJECTABLE;INJECTION
CERETEC
+ GE HEALTHCARE N/A N019829 001 Dec 30, 1988
TECHNETIUM TC-99M MEBROFENIN KIT
INJECTABLE;INJECTION
CHOLETEC
AP + BRACCO N/A N018963 001 Jan 21, 1987
TECHNETIUM TC-99M MEBROFENIN
AP PHARMALUCENCE N/A A078242 001 Jan 29, 2008
TECHNETIUM TC-99M MEDRONATE
INJECTABLE;INJECTION
DRAXIMAGE MDP-25
+ JUBILANT DRAXIMAGE N/A N018035 002 Feb 27, 2004
TECHNETIUM TC-99M MEDRONATE KIT
INJECTABLE;INJECTION
CIS-MDP
AP PHARMALUCENCE N/A N018124 001
MDP-BRACCO
AP BRACCO N/A N018107 001
TECHNETIUM TC-99M MERTIATIDE KIT
INJECTABLE;INJECTION
TECHNESCAN MAG3
+ MALLINCKRODT N/A N019882 001 Jun 15, 1990
TECHNETIUM TC-99M OXIDRONATE KIT
INJECTABLE;INJECTION
TECHNESCAN
+ MALLINCKRODT N/A N018321 001
TECHNETIUM TC-99M PENTETATE KIT
INJECTABLE;INJECTION
AN-DTPA
AP JUBILANT DRAXIMAGE N/A N017714 001
DTPA
AP DRAXIMAGE N/A N018511 001 Dec 29, 1989
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-339(of 371)
TECHNETIUM TC-99M PYROPHOSPHATE KIT
INJECTABLE;INJECTION
CIS-PYRO
AP PHARMALUCENCE N/A N019039 001 Jun 30, 1987
TECHNESCAN PYP KIT
AP MALLINCKRODT N/A N017538 001
TECHNETIUM TC-99M RED BLOOD CELL KIT
INJECTABLE;INJECTION
ULTRATAG
MALLINCKRODT N/A N019981 001 Jun 10, 1991
TECHNETIUM TC-99M SESTAMIBI KIT
INJECTABLE;INJECTION
CARDIOLITE
AP + LANTHEUS MEDCL N/A N019785 001 Dec 21, 1990
TECHNETIUM TC 99M SESTAMIBI
AP CARDINAL HEALTH 414 N/A A078809 001 Apr 28, 2009
AP DRAXIMAGE N/A A078806 001 Apr 29, 2009
AP PHARMALUCENCE 10-30mCi A079157 001 Jul 10, 2009
TECHNETIUM TC-99M SESTAMIBI
AP MALLINCKRODT N/A A078098 001 Sep 22, 2008
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
SOLUTION;INTRAVENOUS
TECHNELITE
+ LANTHEUS MEDCL 1-20 CI/GENERATOR N017771 002 Feb 12, 2014
ULTRA-TECHNEKOW FM
+ MALLINCKRODT 1-19 CI/GENERATOR N017243 003 Feb 18, 2014
SOLUTION;INTRAVENOUS, ORAL
TECHNETIUM TC 99M GENERATOR
+ GE HEALTHCARE 68-2703mCi/GENERATOR N017693 002 Dec 13, 2013
TECHNETIUM TC-99M SUCCIMER KIT
INJECTABLE;INJECTION
MPI DMSA KIDNEY REAGENT
GE HEALTHCARE N/A N017944 001 May 18, 1982
TECHNETIUM TC-99M SULFUR COLLOID KIT
SOLUTION;INJECTION, ORAL
AN-SULFUR COLLOID
+ PHARMALUCENCE N/A N017858 001
TECHNETIUM TC-99M TETROFOSMIN KIT
INJECTABLE;INJECTION
MYOVIEW
+ GE HEALTHCARE N/A N020372 001 Feb 09, 1996
MYOVIEW 30ML
+ GE HEALTHCARE N/A N020372 002 Jul 07, 2005
TECHNETIUM TC-99M TILMANOCEPT
INJECTABLE;INJECTION
LYMPHOSEEK KIT
+ NAVIDEA BIOPHARMS N/A N202207 001 Mar 13, 2013
TEDIZOLID PHOSPHATE
POWDER;IV (INFUSION)
SIVEXTRO
+ CUBIST PHARMS INC 200MG/VIAL N205436 001 Jun 20, 2014
TABLET;ORAL
SIVEXTRO
+ CUBIST PHARMS INC 200MG N205435 001 Jun 20, 2014
TEDUGLUTIDE RECOMBINANT
POWDER;SUBCUTANEOUS
GATTEX KIT
+ NPS PHARMS INC 5MG/VIAL N203441 001 Dec 21, 2012
TELAPREVIR
TABLET;ORAL
INCIVEK
+ VERTEX PHARMS 375MG N201917 001 May 23, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-340(of 371)
TELAVANCIN HYDROCHLORIDE
POWDER;IV (INFUSION)
VIBATIV
THERAVANCE BIOPHARMA EQ 250MG BASE/VIAL N022110 001 Sep 11, 2009
+ EQ 750MG BASE/VIAL N022110 002 Sep 11, 2009
TELBIVUDINE
TABLET;ORAL
TYZEKA
+ NOVARTIS 600MG N022011 001 Oct 25, 2006
TELITHROMYCIN
TABLET;ORAL
KETEK
SANOFI AVENTIS US 300MG N021144 002 Feb 09, 2005
+ 400MG N021144 001 Apr 01, 2004
TELMISARTAN
TABLET;ORAL
MICARDIS
AB BOEHRINGER INGELHEIM 20MG N020850 003 Apr 04, 2000
AB 40MG N020850 001 Nov 10, 1998
AB + 80MG N020850 002 Nov 10, 1998
TELMISARTAN
AB ALEMBIC PHARMS LTD 20MG A202130 001 Jul 07, 2014
AB 40MG A202130 002 Jul 07, 2014
AB 80MG A202130 003 Jul 07, 2014
AB GLENMARK GENERICS 20MG A090032 001 Jul 07, 2014
AB 40MG A090032 002 Jul 07, 2014
AB 80MG A090032 003 Jul 07, 2014
AB MYLAN PHARMS INC 20MG A202397 001 Jul 07, 2014
AB 40MG A202397 002 Jul 07, 2014
AB 80MG A202397 003 Jul 07, 2014
AB SANDOZ 20MG A203867 001 Nov 03, 2014
AB 40MG A203867 002 Nov 03, 2014
AB 80MG A203867 003 Nov 03, 2014
AB TORRENT PHARMS LTD 20MG A203171 001 Jul 07, 2014
AB 40MG A203171 002 Jul 07, 2014
AB 80MG A203171 003 Jul 07, 2014
AB WATSON LABS 20MG A078710 001 Jan 08, 2014
AB 40MG A078710 002 Jan 08, 2014
AB 80MG A078710 003 Jan 08, 2014
AB ZYDUS PHARMS USA INC 20MG A203325 001 Aug 26, 2014
AB 40MG A203325 002 Aug 26, 2014
AB 80MG A203325 003 Aug 26, 2014
TEMAZEPAM
CAPSULE;ORAL
RESTORIL
AB MALLINCKRODT INC 7.5MG N018163 003 Oct 25, 1991
AB 15MG N018163 001
AB 22.5MG N018163 004 Nov 02, 2004
AB + 30MG N018163 002
TEMAZEPAM
AB ACTAVIS ELIZABETH 15MG A071638 001 Aug 07, 1987
AB 30MG A071620 001 Aug 07, 1987
AB MUTUAL PHARM 7.5MG A078581 001 Sep 08, 2009
AB 22.5MG A071175 002 Sep 14, 2009
AB MYLAN 7.5MG A070920 002 May 21, 2010
AB 15MG A070920 004 Jul 07, 1986
AB 22.5MG A070920 003 Jun 12, 2009
AB 30MG A070920 001 Jul 10, 1986
AB NOVEL LABS INC 7.5MG A071457 002 Jun 22, 2012
AB 15MG A071456 001 Apr 21, 1987
AB 22.5MG A071457 003 Jun 22, 2012
AB 30MG A071457 001 Apr 21, 1987
AB SANDOZ 15MG A071427 001 Jan 12, 1988
AB 30MG A071428 001 Jan 12, 1988
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-341(of 371)
TEMOZOLOMIDE
CAPSULE;ORAL
TEMODAR
AB MERCK SHARP DOHME
5MG
N021029 001 Aug 11, 1999
AB
20MG
N021029 002 Aug 11, 1999
AB
100MG
N021029 003 Aug 11, 1999
AB
140MG
N021029 005 Oct 19, 2006
AB
180MG
N021029 006 Oct 19, 2006
AB +
250MG
N021029 004 Aug 11, 1999
TEMOZOLOMIDE
AB BARR
5MG
A078879 001 Mar 01, 2010
AB
20MG
A078879 002 Mar 01, 2010
AB
100MG
A078879 003 Mar 01, 2010
AB
140MG
A078879 005 Mar 01, 2010
AB
180MG
A078879 006 Mar 01, 2010
AB
250MG
A078879 004 Mar 01, 2010
AB SUN PHARMA GLOBAL
5MG
A201742 001 Feb 12, 2014
AB
20MG
A201742 002 Feb 12, 2014
AB
100MG
A201742 003 Feb 12, 2014
AB
140MG
A201742 004 Feb 12, 2014
AB
180MG
A201742 005 Feb 12, 2014
AB
250MG
A201742 006 Feb 12, 2014
POWDER;INTRAVENOUS
TEMODAR
+ MERCK SHARP DOHME
100MG/VIAL
N022277 001 Feb 27, 2009
TEMSIROLIMUS
SOLUTION;INTRAVENOUS
TORISEL
+ PF PRISM CV
25MG/ML (25MG/ML)
N022088 001 May 30, 2007
TENIPOSIDE
INJECTABLE;INJECTION
VUMON
+ HQ SPECLT PHARMA
10MG/ML
N020119 001 Jul 14, 1992
TENOFOVIR DISOPROXIL FUMARATE
POWDER;ORAL
VIREAD
+ GILEAD SCIENCES INC
40MG/SCOOPFUL
N022577 001 Jan 18, 2012
TABLET;ORAL
VIREAD
GILEAD SCIENCES INC
150MG
N021356 002 Jan 18, 2012
200MG
N021356 003 Jan 18, 2012
250MG
N021356 004 Jan 18, 2012
+
300MG
N021356 001 Oct 26, 2001
TERAZOSIN HYDROCHLORIDE
CAPSULE;ORAL
TERAZOSIN HYDROCHLORIDE
AB APOTEX EQ 1MG BASE
A075498 001 Apr 12, 2001
AB EQ 2MG BASE
A075498 002 Apr 12, 2001
AB EQ 5MG BASE
A075498 003 Apr 12, 2001
AB EQ 10MG BASE
A075498 004 Apr 12, 2001
AB IVAX SUB TEVA PHARMS EQ 1MG BASE
A075614 002 Jan 30, 2001
AB EQ 2MG BASE
A075614 001 Jan 30, 2001
AB EQ 5MG BASE
A075614 003 Jan 30, 2001
AB EQ 10MG BASE
A075614 004 Jan 30, 2001
AB JUBILANT CADISTA EQ 1MG BASE
A075317 001 Dec 20, 2004
AB EQ 2MG BASE
A075317 002 Dec 20, 2004
AB EQ 5MG BASE
A075317 003 Dec 20, 2004
AB EQ 10MG BASE
A075317 004 Dec 20, 2004
AB MYLAN EQ 1MG BASE
A075140 002 Feb 11, 2000
AB EQ 2MG BASE
A075140 003 Feb 11, 2000
AB EQ 5MG BASE
A075140 001 Feb 11, 2000
AB EQ 10MG BASE
A075140 004 Feb 11, 2000
AB SANDOZ EQ 1MG BASE
A074823 001 Mar 30, 1998
AB + EQ 2MG BASE
A074823 002 Mar 30, 1998
AB EQ 5MG BASE
A074823 003 Mar 30, 1998
AB EQ 10MG BASE
A074823 004 Mar 30, 1998
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-342(of 371)
TERBINAFINE HYDROCHLORIDE
GRANULE;ORAL
LAMISIL
NOVARTIS EQ 125MG BASE/PACKET N022071 001 Sep 28, 2007
+ EQ 187.5MG BASE/PACKET N022071 002 Sep 28, 2007
TABLET;ORAL
LAMISIL
AB + NOVARTIS EQ 250MG BASE N020539 001 May 10, 1996
TERBINAFINE HYDROCHLORIDE
AB APOTEX EQ 250MG BASE A078199 001 Jul 02, 2007
AB AUROBINDO PHARMA EQ 250MG BASE A078297 001 Jul 02, 2007
AB BRECKENRIDGE PHARM EQ 250MG BASE A077714 001 Jun 04, 2010
AB CIPLA LTD EQ 250MG BASE A077137 001 Jul 02, 2007
AB DR REDDYS LABS INC EQ 250MG BASE A076390 001 Jul 02, 2007
AB GLENMARK GENERICS EQ 250MG BASE A078157 001 Jul 02, 2007
AB HARRIS PHARM EQ 250MG BASE A077919 001 Jul 02, 2007
AB INVAGEN PHARMS EQ 250MG BASE A077533 001 Jul 02, 2007
AB MYLAN EQ 250MG BASE A077195 001 Jul 02, 2007
AB ORCHID HLTHCARE EQ 250MG BASE A078163 001 Jul 02, 2007
AB TEVA EQ 250MG BASE A076377 001 Jul 02, 2007
AB WOCKHARDT EQ 250MG BASE A078229 001 Jul 02, 2007
TERBUTALINE SULFATE
INJECTABLE;INJECTION
TERBUTALINE SULFATE
AP AKORN 1MG/ML A078151 001 Jan 07, 2008
AP + BEDFORD 1MG/ML A076770 001 Apr 23, 2004
AP FRESENIUS KABI USA 1MG/ML A076887 001 May 26, 2004
AP HIKMA FARMACEUTICA 1MG/ML A078630 001 May 20, 2009
AP UNITED BIOMEDCL 1MG/ML A200122 001 Nov 08, 2013
TABLET;ORAL
TERBUTALINE SULFATE
AB IMPAX LABS 2.5MG A075877 001 Jun 26, 2001
AB + 5MG A075877 002 Jun 26, 2001
AB LANNETT 2.5MG A077152 001 Mar 25, 2005
AB 5MG A077152 002 Mar 25, 2005
TERCONAZOLE
CREAM;VAGINAL
TERAZOL 3
AB + JANSSEN PHARMS 0.8% N019964 001 Feb 21, 1991
TERAZOL 7
AB + JANSSEN PHARMS 0.4% N019579 001 Dec 31, 1987
TERCONAZOLE
AB FOUGERA PHARMS 0.4% A076712 001 Feb 18, 2005
AB TARO 0.4% A076043 001 Jan 19, 2005
AB 0.8% A075953 001 Apr 06, 2004
BX + NYCOMED US 0.8% N021735 001 Oct 01, 2004
SUPPOSITORY;VAGINAL
TERAZOL 3
AB + JANSSEN PHARMS 80MG N019641 001 May 24, 1988
TERCONAZOLE
AB PERRIGO NEW YORK 80MG A077149 001 Mar 17, 2006
TERIFLUNOMIDE
TABLET;ORAL
AUBAGIO
SANOFI AVENTIS US 7MG N202992 001 Sep 12, 2012
+ 14MG N202992 002 Sep 12, 2012
TERIPARATIDE RECOMBINANT HUMAN
INJECTABLE;SUBCUTANEOUS
FORTEO
+ LILLY 0.6MG/2.4ML (0.25MG/ML) N021318 002 Jun 25, 2008
TESAMORELIN ACETATE
POWDER;SUBCUTANEOUS
EGRIFTA
+ THERATECHNOLOGIES EQ 1MG BASE/VIAL N022505 001 Nov 10, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-343(of 371)
TESTOSTERONE
FILM, EXTENDED RELEASE;TRANSDERMAL
ANDRODERM
+ ACTAVIS LABS UT INC 2MG/24HR N020489 003 Oct 20, 2011
+ 4MG/24HR N020489 004 Oct 20, 2011
GEL;TRANSDERMAL
ANDROGEL
AB ABBVIE 25MG/2.5GM PACKET N021015 001 Feb 28, 2000
AB + 50MG/5GM PACKET N021015 002 Feb 28, 2000
TESTOSTERONE
AB PERRIGO ISRAEL 25MG/2.5GM PACKET N203098 002 Jan 31, 2013
AB 50MG/5GM PACKET N203098 003 Jan 31, 2013
TESTIM
BX + AUXILIUM PHARMS 1% (50MG/5GM PACKET) N021454 001 Oct 31, 2002
TESTOSTERONE
BX TEVA PHARMS 25MG/2.5GM PACKET N202763 001 Feb 14, 2012
BX 50MG/5GM PACKET N202763 002 Feb 14, 2012
ANDROGEL
ABBVIE 1.62% (20.25MG/1.25GM PACKET) N022309 002 Sep 07, 2012
+ 1.62% (40.5MG/2.5GM PACKET) N022309 003 Sep 07, 2012
VOGELXO
UPSHER SMITH 50MG/5GM PACKET N204399 002 Jun 04, 2014
GEL, METERED;NASAL
NATESTO
ENDO VENTURES LTD 5.5MG/0.122GM ACTUATION N205488 001 May 28, 2014
GEL, METERED;TRANSDERMAL
ANDROGEL
AB + ABBVIE 12.5MG/1.25GM ACTUATION N021015 003 Sep 26, 2003
TESTOSTERONE
AB PERRIGO ISRAEL 12.5MG/1.25GM ACTUATION N203098 001 Jan 31, 2013
VOGELXO
BX UPSHER SMITH 12.5MG/1.25GM ACTUATION N204399 003 Jun 04, 2014
ANDROGEL
+ ABBVIE 1.62% (20.25MG/1.25GM ACTUATION) N022309 001 Apr 29, 2011
FORTESTA
+ ENDO PHARMS 10MG/0.5GM ACTUATION N021463 001 Dec 29, 2010
PELLET;IMPLANTATION
TESTOPEL
+ ACTIENT PHARMS 75MG A080911 001
SOLUTION, METERED;TRANSDERMAL
AXIRON
+ ELI LILLY AND CO 30MG/1.5ML ACTUATION N022504 001 Nov 23, 2010
TABLET, EXTENDED RELEASE;BUCCAL
STRIANT
+ AUXILIUM PHARMS LLC 30MG N021543 001 Jun 19, 2003
TESTOSTERONE CYPIONATE
INJECTABLE;INJECTION
DEPO-TESTOSTERONE
AO + PHARMACIA AND UPJOHN 100MG/ML A085635 002
AO + 200MG/ML A085635 003
TESTOSTERONE CYPIONATE
AO BEDFORD 100MG/ML A090387 001 Jul 15, 2010
AO 200MG/ML A090387 002 Jul 15, 2010
AO HIKMA FARMACEUTICA 200MG/ML A091244 001 May 01, 2012
AO MYLAN INSTITUTIONAL 200MG/ML A040652 001 Dec 11, 2006
AO PADDOCK LLC 200MG/ML A040530 001 Jan 31, 2005
AO SANDOZ 100MG/ML A040615 001 Aug 10, 2006
AO 200MG/ML A040615 002 Aug 10, 2006
AO SUN PHARM INDS LTD 100MG/ML A201720 001 Jun 03, 2013
AO 200MG/ML A201720 002 Jun 03, 2013
AO WATSON LABS 200MG/ML A086030 001
TESTOSTERONE ENANTHATE
INJECTABLE;INJECTION
DELATESTRYL
AO + ENDO PHARMS 200MG/ML N009165 003
TESTOSTERONE ENANTHATE
AO HIKMA FARMACEUTICA 200MG/ML A091120 001 Sep 18, 2012
AO MYLAN INSTITUTIONAL 200MG/ML A040647 001 Oct 05, 2009
AO PADDOCK LLC 200MG/ML A040575 001 Jun 14, 2006
AO WATSON LABS 200MG/ML A085598 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-344(of 371)
TESTOSTERONE UNDECANOATE
INJECTABLE;INTRAMUSCULAR
AVEED
+ ENDO PHARMS INC 750MG/3ML (250MG/ML) N022219 001 Mar 04, 2014
TETRABENAZINE
TABLET;ORAL
XENAZINE
VALEANT BERMUDA 12.5MG N021894 001 Aug 15, 2008
+ 25MG N021894 002 Aug 15, 2008
TETRACYCLINE HYDROCHLORIDE
CAPSULE;ORAL
ACHROMYCIN V
AB HERITAGE PHARMS INC 250MG N050278 003
AB 500MG N050278 001
TETRACYCLINE HYDROCHLORIDE
AB IMPAX LABS 250MG A060469 001
AB 500MG A060469 003
AB IVAX SUB TEVA PHARMS 250MG A060704 001
AB + 500MG A060704 002
AB WATSON LABS 250MG A061837 001
AB 500MG A061837 002
IMPAX LABS 100MG A060469 002
TETRAHYDROZOLINE HYDROCHLORIDE
SOLUTION;NASAL
TYZINE
+ FOUGERA PHARMS 0.05% A086576 002
0.1% A086576 001
SPRAY;NASAL
TYZINE
+ FOUGERA PHARMS 0.1% A086576 003
THALIDOMIDE
CAPSULE;ORAL
THALOMID
CELGENE 50MG N020785 001 Jul 16, 1998
100MG N020785 002 Jan 17, 2003
150MG N020785 004 Jan 10, 2007
+ 200MG N020785 003 Jan 17, 2003
THALLOUS CHLORIDE TL-201
INJECTABLE;INJECTION
THALLOUS CHLORIDE TL 201
AP + GE HEALTHCARE 1mCi/ML N018110 002 Feb 27, 1996
AP + LANTHEUS MEDCL 1mCi/ML N017806 001
AP + MALLINCKRODT 1mCi/ML N018150 001
INJECTABLE;INTRAVENOUS
THALLOUS CHLORIDE TL 201
AP + LANTHEUS MEDCL 2mCi/ML N017806 002 Oct 09, 1998
THEOPHYLLINE
CAPSULE, EXTENDED RELEASE;ORAL
THEO-24
ACTIENT PHARMS 100MG A087942 001 Aug 22, 1983
200MG A087943 001 Aug 22, 1983
300MG A087944 001 Aug 22, 1983
+ 400MG A081034 001 Feb 28, 1992
INJECTABLE;INJECTION
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 40MG/100ML N019826 001 Aug 14, 1992
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 80MG/100ML N019826 002 Aug 14, 1992
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 160MG/100ML N019826 003 Aug 14, 1992
THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER
AP + B BRAUN 320MG/100ML N019826 006 Aug 14, 1992
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER
AP + HOSPIRA INC 4MG/ML N019211 007 Dec 14, 1984
AP + 40MG/100ML N019211 001 Dec 14, 1984
AP + 160MG/100ML N019211 003 Dec 14, 1984
AP + 320MG/100ML N019211 006 Jan 20, 1988
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-345(of 371)
THEOPHYLLINE
SOLUTION;ORAL
THEOPHYLLINE
AA + SILARX 80MG/15ML A091156 001 Apr 13, 2011
AA TRIS PHARMA INC 80MG/15ML A091586 001 Jun 15, 2012
SOLUTION, ELIXIR;ORAL
ELIXOPHYLLIN
+ SUN PHARM INDS INC 80MG/15ML A085186 001
TABLET;ORAL
THEOLAIR
+ MEDICIS 125MG A086399 001
+ 250MG A086399 002
TABLET, EXTENDED RELEASE;ORAL
THEOCHRON
AB SUN PHARM INDS INC 100MG A088320 001 Feb 21, 1985
AB 200MG A088321 001 Feb 21, 1985
THEOPHYLLINE
AB ALEMBIC LTD 300MG A090430 001 Oct 27, 2010
AB 450MG A090430 002 Oct 27, 2010
AB GLENMARK GENERICS 400MG A090355 001 Jul 13, 2010
AB 600MG A090355 002 Jul 13, 2010
AB NOSTRUM 400MG A040595 001 Apr 21, 2006
AB + 600MG A040560 002 Apr 21, 2006
AB + PLIVA 100MG A089807 001 Apr 30, 1990
AB + 200MG A089808 001 Apr 30, 1990
AB 300MG A089763 001 Apr 30, 1990
AB RHODES PHARMS 600MG A040086 001 Apr 15, 1996
AB + TEVA PHARMS 450MG A081236 001 Nov 09, 1992
UNIPHYL
AB RHODES PHARMS 400MG A087571 001 Sep 01, 1982
THIAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
THIAMINE HYDROCHLORIDE
AP + FRESENIUS KABI USA 100MG/ML A080556 001
AP MYLAN INSTITUTIONAL 100MG/ML A091623 001 Jun 25, 2012
THIOGUANINE
TABLET;ORAL
THIOGUANINE
+ ASPEN GLOBAL INC 40MG N012429 001
THIORIDAZINE HYDROCHLORIDE
TABLET;ORAL
THIORIDAZINE HYDROCHLORIDE
AB MUTUAL PHARM 10MG A089953 004 Aug 01, 1986
AB 25MG A089953 003 Aug 01, 1986
AB 50MG A089953 002 Aug 01, 1986
AB 100MG A089953 001 Oct 07, 1988
AB MYLAN 10MG A088004 002 Mar 15, 1983
AB 25MG A088004 003 Mar 15, 1983
AB 50MG A088004 004 Mar 15, 1983
AB + 100MG A088004 001 Nov 18, 1983
THIOTEPA
INJECTABLE;INJECTION
THIOTEPA
EUROHLTH INTL 15MG/VIAL A075547 001 Apr 02, 2001
THIOTHIXENE
CAPSULE;ORAL
NAVANE
AB PFIZER 1MG N016584 001
AB 2MG N016584 002
AB + 5MG N016584 003
AB 10MG N016584 004
THIOTHIXENE
AB MYLAN 1MG A071093 002 Jun 23, 1987
AB 2MG A071093 003 Jun 23, 1987
AB 5MG A071093 004 Jun 23, 1987
AB 10MG A071093 001 Jun 23, 1987
AB SANDOZ 1MG A071610 001 Jun 24, 1987
AB 2MG A071570 001 Jun 24, 1987
AB 5MG A071529 001 Jun 24, 1987
AB 10MG A071530 001 Jun 24, 1987
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-346(of 371)
THYROTROPIN ALFA
INJECTABLE;INJECTION
THYROGEN
+ GENZYME 1.1MG/VIAL N020898 001 Nov 30, 1998
TIAGABINE HYDROCHLORIDE
TABLET;ORAL
GABITRIL
AB CEPHALON 2MG N020646 005 Apr 16, 1999
AB + 4MG N020646 001 Sep 30, 1997
TIAGABINE HYDROCHLORIDE
AB SUN PHARM INDS 2MG A077555 001 Nov 04, 2011
AB 4MG A077555 002 Nov 04, 2011
GABITRIL
CEPHALON 12MG N020646 002 Sep 30, 1997
16MG N020646 003 Sep 30, 1997
TICAGRELOR
TABLET;ORAL
BRILINTA
+ ASTRAZENECA LP 90MG N022433 001 Jul 20, 2011
TICLOPIDINE HYDROCHLORIDE
TABLET;ORAL
TICLOPIDINE HYDROCHLORIDE
AB APOTEX 250MG A075089 001 Jul 01, 1999
AB SUN PHARM INDS INC 250MG A075526 001 Sep 26, 2002
AB + TEVA 250MG A075149 001 Aug 20, 1999
TIGECYCLINE
INJECTABLE;IV (INFUSION)
TYGACIL
+ PF PRISM CV 50MG/VIAL N021821 001 Jun 15, 2005
TIMOLOL
SOLUTION/DROPS;OPHTHALMIC
BETIMOL
+ OAK PHARMS INC EQ 0.25% BASE N020439 001 Mar 31, 1995
+ EQ 0.5% BASE N020439 002 Mar 31, 1995
TIMOLOL MALEATE
SOLUTION, GEL FORMING/DROPS;OPHTHALMIC
TIMOLOL MALEATE
AB ALCON RES LTD EQ 0.25% BASE N020963 001 Oct 21, 1998
AB EQ 0.5% BASE N020963 002 Oct 21, 1998
TIMOPTIC-XE
AB + VALEANT PHARMS LLC EQ 0.25% BASE N020330 001 Nov 04, 1993
AB + EQ 0.5% BASE N020330 002 Nov 04, 1993
SOLUTION/DROPS;OPHTHALMIC
TIMOLOL MALEATE
AT AKORN EQ 0.5% BASE A074466 001 Mar 25, 1997
AT EQ 0.5% BASE A074516 001 Mar 25, 1997
AT ALCON RES LTD EQ 0.25% BASE A074261 001 Apr 28, 1995
AT EQ 0.5% BASE A074262 001 Apr 28, 1995
AT BAUSCH AND LOMB EQ 0.25% BASE A074778 001 Mar 25, 1997
AT EQ 0.5% BASE A074776 001 Mar 25, 1997
AT FDC LTD EQ 0.25% BASE A077259 001 Apr 30, 2008
AT EQ 0.5% BASE A077259 002 Apr 30, 2008
AT HI TECH PHARMA EQ 0.5% BASE A075163 001 Sep 10, 2002
AT PACIFIC PHARMA EQ 0.25% BASE A074746 001 Mar 25, 1997
AT EQ 0.5% BASE A074747 001 Mar 25, 1997
AT WOCKHARDT EQ 0.25% BASE A078771 001 Sep 28, 2009
AT EQ 0.5% BASE A078771 002 Sep 28, 2009
TIMOPTIC
AT + ATON EQ 0.25% BASE N018086 001
AT + EQ 0.5% BASE N018086 002
ISTALOL
BT + BAUSCH AND LOMB EQ 0.5% BASE N021516 001 Jun 04, 2004
TIMOPTIC IN OCUDOSE
+ ATON EQ 0.25% BASE N019463 001 Nov 05, 1986
+ EQ 0.5% BASE N019463 002 Nov 05, 1986
TABLET;ORAL
TIMOLOL MALEATE
MYLAN 5MG A072668 002 Jun 08, 1990
10MG A072668 003 Jun 08, 1990
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-347(of 371)
TIMOLOL MALEATE
TABLET;ORAL
TIMOLOL MALEATE
+
20MG
A072668 001 Jun 08, 1990
TINIDAZOLE
TABLET;ORAL
TINDAMAX
AB MISSION PHARMA
250MG
N021618 001 May 17, 2004
AB +
500MG
N021618 002 May 17, 2004
TINIDAZOLE
AB NOVEL LABS INC
250MG
A202044 001 Apr 30, 2012
AB
500MG
A202044 002 Apr 30, 2012
AB ROXANE
250MG
A201172 001 Apr 30, 2012
AB
500MG
A201172 002 Apr 30, 2012
AB UNIQUE PHARM LABS
250MG
A202489 001 Oct 09, 2013
AB
500MG
A202489 002 Oct 09, 2013
TIOPRONIN
TABLET;ORAL
THIOLA
+ MISSION PHARMA
100MG
N019569 001 Aug 11, 1988
TIOTROPIUM BROMIDE
POWDER;INHALATION
SPIRIVA
+ BOEHRINGER INGELHEIM
EQ 0.018MG BASE/INH
N021395 001 Jan 30, 2004
SPRAY, METERED;INHALATION
SPIRIVA RESPIMAT
+ BOEHRINGER INGELHEIM
EQ 0.0025MG BASE/INH
N021936 001 Sep 24, 2014
TIPRANAVIR
CAPSULE;ORAL
APTIVUS
+ BOEHRINGER INGELHEIM
250MG
N021814 001 Jun 22, 2005
SOLUTION;ORAL
APTIVUS
+ BOEHRINGER INGELHEIM
100MG/ML
N022292 001 Jun 23, 2008
TIROFIBAN HYDROCHLORIDE
INJECTABLE;INJECTION
AGGRASTAT
MEDICURE
EQ 5MG BASE/100ML (EQ 0.05MG BASE/ML)
N020913 002 May 17, 2002
+
EQ 12.5MG BASE/250ML (EQ 0.05MG
N020913 003 Apr 20, 2000
BASE/ML)
TIZANIDINE HYDROCHLORIDE
CAPSULE;ORAL
TIZANIDINE HYDROCHLORIDE
AB APOTEX INC
EQ 2MG BASE
A078868 001 Feb 03, 2012
AB
EQ 4MG BASE
A078868 002 Feb 03, 2012
AB
EQ 6MG BASE
A078868 003 Feb 03, 2012
AB MYLAN PHARMS INC
EQ 2MG BASE
A091502 001 Nov 09, 2012
AB
EQ 4MG BASE
A091502 002 Nov 09, 2012
AB
EQ 6MG BASE
A091502 003 Nov 09, 2012
ZANAFLEX
AB ACORDA
EQ 2MG BASE
N021447 001 Aug 29, 2002
AB
EQ 4MG BASE
N021447 002 Aug 29, 2002
AB +
EQ 6MG BASE
N021447 003 Aug 29, 2002
TABLET;ORAL
TIZANIDINE HYDROCHLORIDE
AB APOTEX
EQ 2MG BASE
A076533 001 Jan 16, 2004
AB
EQ 4MG BASE
A076533 002 Jan 16, 2004
AB COREPHARMA
EQ 2MG BASE
A076347 001 Oct 11, 2002
AB
EQ 4MG BASE
A076347 002 Oct 11, 2002
AB DR REDDYS LABS INC
EQ 2MG BASE
A076286 001 Jul 03, 2002
AB
EQ 4MG BASE
A076286 002 Jul 03, 2002
AB MYLAN
EQ 2MG BASE
A076354 001 Mar 28, 2003
AB
EQ 4MG BASE
A076354 002 Mar 28, 2003
AB PROSAM LABS
EQ 2MG BASE
A076281 001 Oct 20, 2003
AB
EQ 4MG BASE
A076281 002 Oct 20, 2003
AB SANDOZ INC
EQ 2MG BASE
A076280 001 Nov 26, 2002
AB
EQ 4MG BASE
A076280 002 Jun 27, 2002
AB SUN PHARM INDS INC
EQ 2MG BASE
A076416 001 Sep 29, 2003
AB
EQ 4MG BASE
A076416 002 Sep 29, 2003
AB TEVA
EQ 2MG BASE
A076284 001 Jul 03, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-348(of 371)
TIZANIDINE HYDROCHLORIDE
TABLET;ORAL
TIZANIDINE HYDROCHLORIDE
AB EQ 4MG BASE A076284 002 Jul 03, 2002
AB UNICHEM LABS LTD EQ 2MG BASE A091283 001 Nov 28, 2012
AB EQ 4MG BASE A091283 002 Nov 28, 2012
ZANAFLEX
AB + ACORDA EQ 4MG BASE N020397 001 Nov 27, 1996
TOBRAMYCIN
OINTMENT;OPHTHALMIC
TOBREX
+ ALCON 0.3% N050555 001
POWDER;INHALATION
TOBI PODHALER
+ NOVARTIS 28MG N201688 001 Mar 22, 2013
SOLUTION;INHALATION
TOBI
AN + NOVARTIS PHARMS 300MG/5ML N050753 001 Dec 22, 1997
TOBRAMYCIN
AN AKORN INC 300MG/5ML A201422 001 May 28, 2014
AN TEVA PHARMS USA 300MG/5ML A091589 001 Oct 10, 2013
BETHKIS
CHIESI USA INC 300MG/4ML N201820 001 Oct 12, 2012
KITABIS PAK
+ PULMOFLOW INC 300MG/5ML N205433 001 Dec 02, 2014
SOLUTION/DROPS;OPHTHALMIC
AKTOB
AT AKORN 0.3% A064096 001 Jan 31, 1996
TOBRAMYCIN
AT BAUSCH AND LOMB 0.3% A064052 001 Nov 29, 1993
AT FERA PHARMS 0.3% A065026 001 Sep 11, 2001
TOBREX
AT ALCON 0.3% A062535 001 Dec 13, 1984
AT + FALCON PHARMS 0.3% N050541 001
TOBRAMYCIN SULFATE
INJECTABLE;INJECTION
TOBRAMYCIN SULFATE
AP AGILA SPECLTS EQ 40MG BASE/ML A065407 001 Mar 11, 2008
AP AKORN EQ 40MG BASE/ML A205179 001 Sep 16, 2014
AP FRESENIUS KABI USA EQ 1.2GM BASE/VIAL N050789 001 Jul 13, 2004
AP EQ 10MG BASE/ML A065122 001 Nov 29, 2002
AP + EQ 40MG BASE/ML A065122 002 Nov 29, 2002
AP HIKMA MAPLE EQ 40MG BASE/ML A063117 001 Apr 26, 1991
AP + HOSPIRA EQ 10MG BASE/ML A063112 001 Apr 30, 1991
AP EQ 40MG BASE/ML A063111 001 Apr 30, 1991
AP + EQ 40MG BASE/ML A063116 001 May 18, 1992
AP TEVA PHARMS USA EQ 40MG BASE/ML A063100 001 Jan 30, 1992
AP + X GEN PHARMS EQ 1.2GM BASE/VIAL A065013 001 Aug 17, 2001
AP XELLIA PHARMS APS EQ 1.2GM BASE/VIAL A205685 001 Sep 16, 2014
TOBRAMYCIN SULFATE (PHARMACY BULK)
AP FRESENIUS KABI USA EQ 40MG BASE/ML A065120 001 Nov 29, 2002
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
+ HOSPIRA EQ 1.2MG BASE/ML A063081 003 Jul 31, 1990
+ EQ 1.6MG BASE/ML A063081 006 Jun 02, 1993
+ EQ 80MG BASE/100ML A063081 001 Jul 31, 1990
TOFACITINIB CITRATE
TABLET;ORAL
XELJANZ
+ PF PRISM CV EQ 5MG BASE N203214 001 Nov 06, 2012
TOLAZAMIDE
TABLET;ORAL
TOLAZAMIDE
MYLAN PHARMS INC 250MG A070259 001 Jan 02, 1986
+ 500MG A070259 003 Mar 17, 1986
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-349(of 371)
TOLBUTAMIDE
TABLET;ORAL
TOLBUTAMIDE
+ MYLAN PHARMS INC 500MG A086445 001
TOLCAPONE
TABLET;ORAL
TASMAR
+ VALEANT PHARMS LLC 100MG N020697 001 Jan 29, 1998
TOLMETIN SODIUM
CAPSULE;ORAL
TOLMETIN SODIUM
AB MYLAN EQ 400MG BASE A073393 001 May 27, 1993
AB + TEVA EQ 400MG BASE A073290 001 Nov 27, 1991
TABLET;ORAL
TOLMETIN SODIUM
AB MUTUAL PHARM EQ 200MG BASE A073310 001 Nov 27, 1991
AB + MYLAN EQ 600MG BASE A074473 001 Aug 30, 1994
TOLTERODINE TARTRATE
CAPSULE, EXTENDED RELEASE;ORAL
DETROL LA
AB PHARMACIA AND UPJOHN 2MG N021228 001 Dec 22, 2000
AB + 4MG N021228 002 Dec 22, 2000
TOLTERODINE TARTRATE
AB MYLAN PHARMS INC 2MG A201486 001 Oct 31, 2013
AB 4MG A201486 002 Oct 31, 2013
TABLET;ORAL
DETROL
AB PHARMACIA AND UPJOHN 1MG N020771 001 Mar 25, 1998
AB + 2MG N020771 002 Mar 25, 1998
TOLTERODINE TARTRATE
AB APOTEX CORP 1MG A200164 001 Sep 25, 2012
AB 2MG A200164 002 Sep 25, 2012
AB MYLAN PHARMS INC 1MG A202641 001 Nov 27, 2012
AB 2MG A202641 002 Nov 27, 2012
TOLVAPTAN
TABLET;ORAL
SAMSCA
OTSUKA AMERICA PHARM 15MG N022275 001 May 19, 2009
+ 30MG N022275 002 May 19, 2009
TOPIRAMATE
CAPSULE;ORAL
TOPAMAX
AB JANSSEN PHARMS 15MG N020844 001 Oct 26, 1998
AB + 25MG N020844 002 Oct 26, 1998
TOPIRAMATE
AB MYLAN 15MG A078418 001 Oct 14, 2009
AB 25MG A078418 002 Oct 14, 2009
AB TEVA 15MG A076575 001 Apr 17, 2009
AB 25MG A076575 002 Apr 17, 2009
AB WATSON LABS 15MG A077868 001 Apr 15, 2009
AB 25MG A077868 002 Apr 15, 2009
AB ZYDUS PHARMS USA INC 15MG A078877 001 Oct 14, 2009
AB 25MG A078877 002 Oct 14, 2009
CAPSULE, EXTENDED RELEASE;ORAL
QUDEXY XR
UPSHER SMITH 25MG N205122 001 Mar 11, 2014
50MG N205122 002 Mar 11, 2014
100MG N205122 003 Mar 11, 2014
150MG N205122 004 Mar 11, 2014
+ 200MG N205122 005 Mar 11, 2014
TROKENDI XR
SUPERNUS PHARMS 25MG N201635 001 Aug 16, 2013
50MG N201635 002 Aug 16, 2013
100MG N201635 003 Aug 16, 2013
+ 200MG N201635 004 Aug 16, 2013
TABLET;ORAL
TOPAMAX
AB JANSSEN PHARMS 25MG N020505 004 Dec 24, 1996
AB 50MG N020505 005 Dec 24, 1996
AB + 100MG N020505 001 Dec 24, 1996
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-350(of 371)
TOPIRAMATE
TABLET;ORAL
TOPAMAX
AB 200MG N020505 002 Dec 24, 1996
TOPIRAMATE
AB ACCORD HLTHCARE 25MG A076311 001 Mar 27, 2009
AB 50MG A076311 002 Mar 27, 2009
AB 100MG A076311 003 Mar 27, 2009
AB 200MG A076311 004 Mar 27, 2009
AB ACTIVIS TOTOWA LLC 25MG A078637 001 Feb 27, 2013
AB 50MG A078637 002 Feb 27, 2013
AB 100MG A078637 003 Feb 27, 2013
AB 200MG A078637 004 Feb 27, 2013
AB APOTEX INC 25MG A077733 001 Mar 27, 2009
AB 50MG A077733 002 Mar 27, 2009
AB 100MG A077733 003 Mar 27, 2009
AB 200MG A077733 004 Mar 27, 2009
AB AUROBINDO PHARMA 25MG A078462 001 Mar 27, 2009
AB 50MG A078462 002 Mar 27, 2009
AB 100MG A078462 003 Mar 27, 2009
AB 200MG A078462 004 Mar 27, 2009
AB CIPLA LTD 25MG A076343 001 Mar 27, 2009
AB 50MG A076343 002 Mar 27, 2009
AB 100MG A076343 003 Mar 27, 2009
AB 200MG A076343 004 Mar 27, 2009
AB GLENMARK GENERICS 25MG A077627 001 Mar 27, 2009
AB 50MG A077627 002 Mar 27, 2009
AB 100MG A077627 003 Mar 27, 2009
AB 200MG A077627 004 Mar 27, 2009
AB INVAGEN PHARMS 25MG A079162 001 Mar 27, 2009
AB 50MG A079162 002 Mar 27, 2009
AB 100MG A079162 003 Mar 27, 2009
AB 200MG A079162 004 Mar 27, 2009
AB LUPIN 25MG A078410 001 Sep 11, 2013
AB 50MG A078410 002 Sep 11, 2013
AB 100MG A078410 003 Sep 11, 2013
AB 200MG A078410 004 Sep 11, 2013
AB MYLAN 25MG A076314 001 Mar 27, 2009
AB 50MG A076314 002 Mar 27, 2009
AB 100MG A076314 003 Mar 27, 2009
AB 200MG A076314 004 Mar 27, 2009
AB RANBAXY 25MG A076327 001 Mar 27, 2009
AB 100MG A076327 002 Mar 27, 2009
AB 200MG A076327 003 Mar 27, 2009
AB SUN PHARMA GLOBAL 25MG A090278 001 Mar 27, 2009
AB 50MG A090278 002 Mar 27, 2009
AB 100MG A090278 003 Mar 27, 2009
AB 200MG A090278 004 Mar 27, 2009
AB TEVA 25MG A076317 001 Mar 27, 2009
AB 50MG A076317 002 Mar 27, 2009
AB 100MG A076317 003 Mar 27, 2009
AB 200MG A076317 004 Mar 27, 2009
AB TORRENT PHARMS 25MG A079153 001 Mar 27, 2009
AB 50MG A079153 002 Mar 27, 2009
AB 100MG A079153 003 Mar 27, 2009
AB 200MG A079153 004 Mar 27, 2009
AB UNICHEM LABS LTD 25MG A090162 001 Mar 27, 2009
AB 50MG A090162 002 Mar 27, 2009
AB 100MG A090162 003 Mar 27, 2009
AB 200MG A090162 004 Feb 19, 2013
AB UPSHER SMITH 25MG A078499 001 Jan 07, 2010
AB 50MG A078499 002 Jan 07, 2010
AB 100MG A078499 003 Jan 07, 2010
AB 200MG A078499 004 Jan 07, 2010
AB WOCKHARDT USA 25MG A090353 001 Sep 01, 2010
AB 50MG A090353 002 Sep 01, 2010
AB 100MG A090353 003 Sep 01, 2010
AB 200MG A090353 004 Sep 01, 2010
AB ZYDUS PHARMS USA INC 25MG A078235 001 Mar 27, 2009
AB 50MG A078235 002 Mar 27, 2009
AB 100MG A078235 003 Mar 27, 2009
AB 200MG A078235 004 Mar 27, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-351(of 371)
TOPIRAMATE
TABLET;ORAL
TOPIRAMATE
AB HIKMA PHARMS 25MG A091185 001 Nov 25, 2013
AB 50MG A091185 002 Nov 25, 2013
AB 100MG A091185 003 Nov 25, 2013
AB 200MG A091185 004 Nov 25, 2013
TOPOTECAN HYDROCHLORIDE
CAPSULE;ORAL
HYCAMTIN
GLAXO WELLCOME EQ 0.25MG BASE N020981 001 Oct 11, 2007
+ EQ 1MG BASE N020981 002 Oct 11, 2007
INJECTABLE;INJECTION
HYCAMTIN
AP + GLAXOSMITHKLINE EQ 4MG BASE/VIAL N020671 001 May 28, 1996
TOPOTECAN HYDROCHLORIDE
AP ACCORD HLTHCARE EQ 4MG BASE/VIAL A202351 001 Jun 26, 2013
AP ACTAVIS TOTOWA EQ 4MG BASE/VIAL A090620 001 Dec 02, 2010
AP CIPLA LTD EQ 4MG BASE/VIAL A091199 001 Dec 01, 2010
AP DR REDDYS LABS LTD EQ 4MG BASE/VIAL A201191 001 Mar 09, 2011
AP FRESENIUS KABI USA EQ 4MG BASE/VIAL A091089 001 Nov 29, 2010
AP INNOPHARMA LICENSING EQ 4MG BASE/VIAL A201166 001 Aug 08, 2012
AP ONCO THERAPIES LTD EQ 4MG BASE/VIAL A091542 001 Aug 28, 2012
AP SAGENT PHARMS EQ 4MG BASE/VIAL A091284 001 Jan 26, 2011
AP SUN PHARM INDS LTD EQ 4MG BASE/VIAL A202203 001 Aug 29, 2013
SOLUTION;INTRAVENOUS
TOPOTECAN HYDROCHLORIDE
AP + HOSPIRA INC EQ 4MG BASE/4ML (EQ 1MG BASE/ML) N200582 001 Feb 02, 2011
AP TEVA PHARMS USA EQ 4MG BASE/4ML (EQ 1MG BASE/ML) N022453 001 Dec 20, 2012
TOREMIFENE CITRATE
TABLET;ORAL
FARESTON
+ PROSTRAKAN INC EQ 60MG BASE N020497 001 May 29, 1997
TORSEMIDE
INJECTABLE;INJECTION
TORSEMIDE
AP + EUROHLTH INTL 20MG/2ML (10MG/ML) A078007 001 Jun 11, 2008
AP + 50MG/5ML (10MG/ML) A078007 002 Jun 11, 2008
AP LUITPOLD 20MG/2ML (10MG/ML) A090656 001 Apr 21, 2010
AP 50MG/5ML (10MG/ML) A090656 002 Apr 21, 2010
TABLET;ORAL
DEMADEX
AB MEDA PHARMS 5MG N020136 001 Aug 23, 1993
AB 10MG N020136 002 Aug 23, 1993
AB + 20MG N020136 003 Aug 23, 1993
AB 100MG N020136 004 Aug 23, 1993
TORSEMIDE
AB APOTEX INC 5MG A076894 001 May 31, 2005
AB 10MG A076894 002 May 31, 2005
AB 20MG A076894 003 May 31, 2005
AB 100MG A076894 004 May 31, 2005
AB AUROBINDO PHARMA 5MG A078249 001 Oct 17, 2007
AB 10MG A078249 002 Oct 17, 2007
AB 20MG A078249 003 Oct 17, 2007
AB 100MG A078249 004 Oct 17, 2007
AB HETERO LABS LTD III 5MG A079234 001 Jan 27, 2009
AB 10MG A079234 002 Jan 27, 2009
AB 20MG A079234 003 Jan 27, 2009
AB 100MG A079234 004 Jan 27, 2009
AB PAR PHARM 5MG A076226 001 May 27, 2003
AB 10MG A076226 002 May 27, 2003
AB 20MG A076226 003 May 27, 2003
AB 100MG A076226 004 May 27, 2003
AB PLIVA PHARM IND 5MG A076346 001 May 30, 2003
AB 10MG A076346 002 May 30, 2003
AB 20MG A076346 003 May 30, 2003
AB 100MG A076346 004 Oct 19, 2004
AB ROXANE 5MG A076943 001 Mar 01, 2005
AB 10MG A076943 002 Mar 01, 2005
AB 20MG A076943 003 Mar 01, 2005
AB SUN PHARM INDS 5MG A078478 001 Feb 26, 2008
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-352(of 371)
TORSEMIDE
TABLET;ORAL
TORSEMIDE
AB 10MG
A078478 002 Feb 26, 2008
AB 20MG
A078478 003 Feb 26, 2008
AB 100MG
A078478 004 Feb 26, 2008
AB TEVA 5MG
A076110 001 May 14, 2002
AB 10MG
A076110 002 May 14, 2002
AB 20MG
A076110 003 May 14, 2002
AB 100MG
A076110 004 May 14, 2002
AB VINTAGE PHARMS 5MG
A090613 001 Mar 22, 2011
AB 10MG
A090613 002 Mar 22, 2011
AB 20MG
A090613 003 Mar 22, 2011
AB
100MG
A090613 004 Mar 22, 2011
TRAMADOL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
CONZIP
+ CIPHER PHARMS INC
100MG
N022370 001 May 07, 2010
150MG
N022370 004 Aug 01, 2011
200MG
N022370 002 May 07, 2010
300MG
N022370 003 May 07, 2010
TABLET;ORAL
TRAMADOL HYDROCHLORIDE
AB ACCORD HLTHCARE INC
50MG
A202390 001 May 16, 2013
AB ALLIED PHARMA INC
50MG
A202075 001 Nov 28, 2011
AB AMNEAL PHARMS
50MG
A076003 001 Jun 20, 2002
AB APOTEX
50MG
A075981 001 Jul 10, 2002
AB AUROBINDO PHARMA LTD
50MG
A203494 001 Mar 31, 2014
AB CSPC OUYI PHARM CO
50MG
A091498 001 Mar 29, 2013
AB IPCA LABS LTD
50MG
A201973 001 Nov 16, 2012
AB MALLINCKRODT
50MG
A075983 001 Jun 25, 2002
AB MUTUAL PHARM
50MG
A076100 001 Jun 20, 2002
AB MYLAN
50MG
A075986 001 Jun 21, 2002
AB MYLAN PHARMS INC
50MG
A075980 001 Nov 21, 2002
AB NORTHSTAR HLTHCARE
50MG
A078935 001 May 26, 2010
AB PLIVA
50MG
A075982 001 Jul 01, 2002
AB SUN PHARM INDS INC
50MG
A075964 001 Jun 19, 2002
AB TEVA
50MG
A075977 001 Jun 19, 2002
AB ZYDUS PHARMS USA INC
50MG
A090404 001 Jan 31, 2011
ULTRAM
AB + JANSSEN PHARMS
50MG
N020281 002 Mar 03, 1995
TABLET, EXTENDED RELEASE;ORAL
TRAMADOL HYDROCHLORIDE
AB1 LUPIN LTD
100MG
A200503 001 Aug 29, 2011
AB1
200MG
A200503 002 Aug 29, 2011
AB1
300MG
A200503 003 Aug 29, 2011
AB1 PAR PHARM INC
100MG
A078783 001 Nov 13, 2009
AB1
200MG
A078783 002 Nov 13, 2009
AB1
300MG
A078783 003 Sep 20, 2011
AB1 SUN PHARMA GLOBAL
100MG
A201384 001 Dec 07, 2011
AB1
200MG
A201384 002 Dec 07, 2011
AB1
300MG
A201384 003 Dec 07, 2011
ULTRAM ER
AB1 + VALEANT INTL
100MG
N021692 001 Sep 08, 2005
AB1
200MG
N021692 002 Sep 08, 2005
AB1
300MG
N021692 003 Sep 08, 2005
TRAMADOL HYDROCHLORIDE
AB2 ACTAVIS ELIZABETH
100MG
A091609 001 Jun 27, 2012
AB2
200MG
A091609 002 Jun 27, 2012
AB2
300MG
A091609 003 Jun 27, 2012
AB2 ANCHEN PHARMS
100MG
A200491 001 Jun 27, 2012
AB2
200MG
A200491 002 Jun 27, 2012
AB2
300MG
A200491 003 Jun 27, 2012
AB2 + SUN PHARMA GLOBAL
100MG
A091607 001 Dec 30, 2011
AB2
200MG
A091607 002 Dec 30, 2011
AB2
300MG
A091607 003 Dec 30, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-353(of 371)
TRAMETINIB DIMETHYL SULFOXIDE
TABLET;ORAL
MEKINIST
GLAXOSMITHKLINE LLC EQ 0.5MG NON-SOLVATED PARENT N204114 001 May 29, 2013
EQ 1MG NON-SOLVATED PARENT N204114 002 May 29, 2013
+ EQ 2MG NON-SOLVATED PARENT N204114 003 May 29, 2013
TRANDOLAPRIL
TABLET;ORAL
MAVIK
AB ABBVIE 1MG N020528 001 Apr 26, 1996
AB 2MG N020528 002 Apr 26, 1996
AB + 4MG N020528 003 Apr 26, 1996
TRANDOLAPRIL
AB AUROBINDO PHARMA 1MG A078438 001 Jun 12, 2007
AB 2MG A078438 002 Jun 12, 2007
AB 4MG A078438 003 Jun 12, 2007
AB EPIC PHARMA 1MG A078508 003 Jun 18, 2008
AB 2MG A078508 001 Jun 18, 2008
AB 4MG A078508 002 Jun 18, 2008
AB INVAGEN PHARMS 1MG A078320 001 Jun 12, 2007
AB 2MG A078320 002 Jun 12, 2007
AB 4MG A078320 003 Jun 12, 2007
AB LUPIN 1MG A077522 001 Jun 12, 2007
AB 2MG A077522 002 Jun 12, 2007
AB 4MG A077522 003 Jun 12, 2007
AB MYLAN 1MG A078346 001 Apr 28, 2008
AB 2MG A078346 002 Apr 28, 2008
AB 4MG A078346 003 Apr 28, 2008
AB TEVA PHARMS 1MG A077489 001 Dec 12, 2006
AB 2MG A077489 002 Dec 12, 2006
AB 4MG A077489 003 Dec 12, 2006
AB WATSON LABS 1MG A077805 001 Jun 12, 2007
AB 2MG A077805 002 Jun 12, 2007
AB 4MG A077805 003 Jun 12, 2007
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
TARKA
AB ABBVIE 1MG;240MG N020591 003 Oct 22, 1996
AB 2MG;180MG N020591 001 Oct 22, 1996
AB 2MG;240MG N020591 004 Oct 22, 1996
AB + 4MG;240MG N020591 002 Oct 22, 1996
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE
AB GLENMARK GENERICS 1MG;240MG A079135 004 Aug 30, 2010
AB 2MG;180MG A079135 001 May 26, 2010
AB 2MG;240MG A079135 002 May 26, 2010
AB 4MG;240MG A079135 003 May 05, 2010
TRANEXAMIC ACID
INJECTABLE;INJECTION
CYKLOKAPRON
AP + PHARMACIA AND UPJOHN 100MG/ML N019281 001 Dec 30, 1986
TRANEXAMIC ACID
AP ACIC FINE CHEMS 100MG/ML A202436 001 Feb 11, 2014
AP EMCURE PHARMS LTD 100MG/ML A203521 001 Aug 12, 2014
AP LUITPOLD 100MG/ML A201885 001 Aug 10, 2011
AP MYLAN INSTITUTIONAL 100MG/ML A091657 001 Nov 03, 2011
AP VERSAPHARM INC 100MG/ML A202373 001 Nov 17, 2011
AP X-GEN PHARMS INC 100MG/ML A201580 001 Jun 14, 2013
TABLET;ORAL
LYSTEDA
AB + FERRING PHARMS AS 650MG N022430 001 Nov 13, 2009
TRANEXAMIC ACID
AB ACTAVIS LABS FL INC 650MG A202093 001 Dec 27, 2012
AB APOTEX INC 650MG A202286 001 Jan 27, 2014
TRANYLCYPROMINE SULFATE
TABLET;ORAL
PARNATE
AB + COVIS PHARMA EQ 10MG BASE N012342 003 Aug 16, 1985
TRANYLCYPROMINE SULFATE
AB PAR PHARM EQ 10MG BASE A040640 001 Jun 29, 2006
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-354(of 371)
TRAVOPROST
SOLUTION/DROPS;OPHTHALMIC
IZBA
+ ALCON LABS INC 0.003% N204822 001 May 15, 2014
TRAVATAN Z
+ ALCON PHARMS LTD 0.004% N021994 001 Sep 21, 2006
TRAVOPROST
+ PAR PHARM 0.004% A091340 001 Mar 01, 2013
TRAZODONE HYDROCHLORIDE
TABLET;ORAL
TRAZODONE HYDROCHLORIDE
AB ALVOGEN 50MG A071636 001 Apr 18, 1988
AB 100MG A071514 001 Apr 18, 1988
AB APOTEX 50MG A071258 001 Mar 25, 1987
AB + APOTEX INC 100MG A071196 001 Mar 25, 1987
AB 150MG A071196 002 Apr 26, 1999
AB 300MG A071196 003 Apr 26, 1999
AB MUTUAL PHARM 50MG A073137 002 Mar 24, 1993
AB 100MG A073137 001 Mar 24, 1993
AB 150MG A073137 003 Dec 22, 1995
AB MYLAN PHARMS INC 50MG A090514 001 Jun 02, 2009
AB 100MG A090514 002 Jun 02, 2009
AB 150MG A090514 003 Jun 02, 2009
AB 300MG A090514 004 Jun 02, 2009
AB PLIVA 150MG A071525 001 Mar 09, 1988
AB TEVA PHARMS USA 50MG A071523 001 Dec 11, 1987
AB 100MG A071524 001 Dec 11, 1987
AB TORRENT PHARMS LTD 50MG A202180 001 Nov 27, 2013
AB 100MG A202180 002 Nov 27, 2013
AB 150MG A202180 003 Nov 27, 2013
AB 300MG A202180 004 Nov 27, 2013
AB VINTAGE 50MG A072192 001 Feb 02, 1989
AB 100MG A072193 001 Feb 02, 1989
TABLET, EXTENDED RELEASE;ORAL
OLEPTRO
+ ANGELINI PHARMA 150MG N022411 001 Feb 02, 2010
300MG N022411 002 Feb 02, 2010
TREPROSTINIL
INJECTABLE;IV (INFUSION), SUBCUTANEOUS
REMODULIN
UNITED THERAP 1MG/ML N021272 001 May 21, 2002
2.5MG/ML N021272 002 May 21, 2002
5MG/ML N021272 003 May 21, 2002
+ 10MG/ML N021272 004 May 21, 2002
SOLUTION;INHALATION
TYVASO
+ UNITED THERAP 0.6MG/ML N022387 001 Jul 30, 2009
TREPROSTINIL DIOLAMINE
TABLET, EXTENDED RELEASE;ORAL
ORENITRAM
UNITED THERAP EQ 0.125MG BASE N203496 001 Dec 20, 2013
EQ 0.25MG BASE N203496 002 Dec 20, 2013
EQ 1MG BASE N203496 003 Dec 20, 2013
+ EQ 2.5MG BASE N203496 004 Dec 20, 2013
TRETINOIN
CAPSULE;ORAL
TRETINOIN
AB ANCHEN PHARMS 10MG A201687 001 Oct 24, 2012
AB + BARR LABS INC 10MG A077684 001 Jun 22, 2007
CREAM;TOPICAL
AVITA
AB MYLAN PHARMS INC 0.025% N020404 003 Jan 14, 1997
RETIN-A
AB + VALEANT BERMUDA 0.025% N019049 001 Sep 16, 1988
AB + 0.1% N017340 001
TRETINOIN
AB MATAWAN PHARMS 0.025% A075264 001 Dec 24, 1998
AB 0.1% A075213 001 Dec 24, 1998
RETIN-A
AB1 + VALEANT BERMUDA 0.05% N017522 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-355(of 371)
TRETINOIN
CREAM;TOPICAL
TRETINOIN
AB1 MATAWAN PHARMS 0.05% A075265 001 Dec 24, 1998
RENOVA
AB2 + VALEANT INTL 0.05% N019963 001 Dec 29, 1995
TRETINOIN
AB2 SUNEVA MEDCL 0.05% A076498 001 Sep 15, 2005
RENOVA
+ VALEANT INTL 0.02% N021108 001 Aug 31, 2000
TRETINOIN
+ WATSON LABS INC 0.0375% A090098 001 Mar 22, 2010
0.075% A202209 001 Oct 11, 2012
GEL;TOPICAL
RETIN-A
AB + VALEANT INTL 0.01% N017955 001
AB + 0.025% N017579 002
RETIN-A MICRO
AB + VALEANT INTL 0.04% N020475 002 May 10, 2002
AB + 0.1% N020475 001 Feb 07, 1997
TRETINOIN
AB MATAWAN PHARMS 0.01% A075589 001 Jun 11, 2002
AB 0.025% A075529 001 Feb 22, 2000
AB SPEAR PHARMS INC 0.04% A202567 001 Jul 17, 2013
AB 0.1% A202026 001 Jul 17, 2013
AVITA
BT MYLAN 0.025% N020400 001 Jan 29, 1998
ATRALIN
+ DOW PHARM 0.05% N022070 001 Jul 26, 2007
RETIN-A-MICRO
+ VALEANT INTL 0.08% N020475 003 Jan 28, 2014
SOLUTION;TOPICAL
RETIN-A
+ VALEANT INTL 0.05% N016921 001
TRIAMCINOLONE ACETONIDE
CREAM;TOPICAL
TRIAMCINOLONE ACETONIDE
AT + FOUGERA PHARMS 0.025% A085692 001
AT + 0.1% A085692 003
AT + 0.5% A085692 002
AT PERRIGO NEW YORK 0.025% A086415 001
AT 0.1% A086414 001
AT 0.5% A086413 001
AT TARO 0.1% A040039 001 Nov 26, 1997
AT VINTAGE 0.025% A040671 001 Jun 09, 2006
AT 0.1% A040671 002 Jun 09, 2006
TRIDERM
AT CROWN LABS 0.1% A088042 001 Mar 19, 1984
INJECTABLE;INJECTION
KENALOG-10
APOTHECON 10MG/ML N012041 001
KENALOG-40
+ APOTHECON 40MG/ML N014901 001
INJECTABLE;INTRAVITREAL
TRIESENCE
+ ALCON 40MG/ML (40MG/ML) N022048 001 Nov 29, 2007
LOTION;TOPICAL
TRIAMCINOLONE ACETONIDE
AT FOUGERA PHARMS 0.025% A040467 001 Apr 21, 2003
AT 0.1% A040467 002 Apr 21, 2003
AT VERSAPHARM INC 0.025% A202374 001 May 08, 2013
AT 0.1% A202374 002 May 08, 2013
AT VINTAGE 0.1% A040672 002 Dec 13, 2006
AT + WOCKHARDT 0.1% A088451 001 Apr 03, 1985
AT + WOCKHARDT EU OPERATN 0.025% A088450 001 Apr 01, 1985
OINTMENT;TOPICAL
TRIAMCINOLONE ACETONIDE
AT FOUGERA PHARMS 0.025% A085691 001
AT 0.1% A085691 003
AT 0.5% A085691 002
AT + PERRIGO NEW YORK 0.025% A087356 001
AT + 0.1% A087357 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-356(of 371)
TRIAMCINOLONE ACETONIDE
OINTMENT;TOPICAL
TRIAMCINOLONE ACETONIDE
AT + 0.5% A087385 001
AT TARO 0.1% A040037 001 Sep 30, 1994
TRIAMCINOLONE ACETONIDE IN ABSORBASE
+ CAROLINA MEDCL
0.05%
A089595 001 Mar 23, 1995
PASTE;DENTAL
TRIAMCINOLONE ACETONIDE
AT LYNE
0.1%
A040771 001 Jul 01, 2010
AT + TARO
0.1%
A070730 001 Oct 01, 1986
SPRAY;TOPICAL
KENALOG
+ RANBAXY
0.147MG/GM
N012104 001
SPRAY, METERED;NASAL
TRIAMCINOLONE ACETONIDE
TEVA PHARMS
0.055MG/SPRAY
A078104 001 Jul 30, 2009
TRIAMCINOLONE HEXACETONIDE
INJECTABLE;INJECTION
ARISTOSPAN
+ SANDOZ
5MG/ML
N016466 001
+
20MG/ML
N016466 002
TRIAMTERENE
CAPSULE;ORAL
DYRENIUM
COVIS PHARMA SARL
50MG
N013174 001
+
100MG
N013174 002
TRIAZOLAM
TABLET;ORAL
HALCION
AB PHARMACIA AND UPJOHN
0.125MG
N017892 003 Apr 26, 1985
AB +
0.25MG
N017892 001 Nov 15, 1982
TRIAZOLAM
AB MYLAN PHARMS INC
0.125MG
A074031 001 Mar 25, 1994
AB
0.25MG
A074031 002 Mar 25, 1994
AB ROXANE
0.125MG
A074224 001 Jun 01, 1994
AB
0.25MG
A074224 002 Jun 01, 1994
TRIENTINE HYDROCHLORIDE
CAPSULE;ORAL
SYPRINE
+ ATON
250MG
N019194 001 Nov 08, 1985
TRIFLUOPERAZINE HYDROCHLORIDE
TABLET;ORAL
TRIFLUOPERAZINE HYDROCHLORIDE
AB MYLAN EQ 1MG BASE
A040209 001 Jul 07, 1997
AB EQ 2MG BASE
A040209 002 Jul 07, 1997
AB EQ 5MG BASE
A040209 003 Jul 07, 1997
AB + EQ 10MG BASE
A040209 004 Jul 07, 1997
AB SANDOZ EQ 1MG BASE
A085785 001
AB EQ 2MG BASE
A085786 001
AB EQ 5MG BASE
A085789 001
AB EQ 10MG BASE
A085788 001
TRIFLURIDINE
SOLUTION/DROPS;OPHTHALMIC
TRIFLURIDINE
AT ALCON PHARMS LTD 1%
A074311 001 Oct 06, 1995
VIROPTIC
AT + MONARCH PHARMS 1%
N018299 001
TRIHEXYPHENIDYL HYDROCHLORIDE
ELIXIR;ORAL
TRIHEXYPHENIDYL HYDROCHLORIDE
AA MIKART 2MG/5ML
A040251 001 Sep 27, 1999
AA + PHARM ASSOC 2MG/5ML
A040177 001 Apr 17, 1997
TABLET;ORAL
TRIHEXYPHENIDYL HYDROCHLORIDE
AA NATCO PHARMA LTD 2MG
A091630 001 Nov 17, 2010
AA 5MG
A091630 002 Nov 17, 2010
AA VINTAGE PHARMS 2MG
A040254 001 Dec 24, 1998
AA 5MG
A040254 002 Dec 24, 1998
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-357(of 371)
TRIHEXYPHENIDYL HYDROCHLORIDE
TABLET;ORAL
TRIHEXYPHENIDYL HYDROCHLORIDE
AA + WATSON LABS 2MG
A084363 001
AA + 5MG
A084364 001
TRIMETHADIONE
TABLET;ORAL
TRIDIONE
+ ABBVIE 150MG
N005856 009
TRIMETHOBENZAMIDE HYDROCHLORIDE
CAPSULE;ORAL
TIGAN
AB + KING PHARMS 300MG
N017531 006 Dec 13, 2001
TRIMETHOBENZAMIDE HYDROCHLORIDE
AB GAVIS PHARMS 300MG
A076546 001 Aug 20, 2003
AB MUTUAL PHARMA 300MG
A076570 001 Aug 28, 2003
INJECTABLE;INJECTION
TIGAN
AP + PAR STERILE PRODUCTS 100MG/ML
N017530 001
TRIMETHOBENZAMIDE HYDROCHLORIDE
AP LUITPOLD 100MG/ML
A091330 001 Mar 08, 2011
TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE
AP LUITPOLD
100MG/ML
A091329 001 Mar 08, 2011
TRIMETHOPRIM
TABLET;ORAL
TRIMETHOPRIM
AB NOVEL LABS INC 100MG
A091437 001 Jun 15, 2011
AB + TEVA 100MG
N018679 001 Jul 30, 1982
AB WATSON LABS 100MG
A070049 001 Jun 06, 1985
TRIMETHOPRIM HYDROCHLORIDE
SOLUTION;ORAL
PRIMSOL
+ FSC
EQ 50MG BASE/5ML
N074973 001 Jan 24, 2000
TRIMIPRAMINE MALEATE
CAPSULE;ORAL
SURMONTIL
AB ODYSSEY PHARMS
EQ 25MG BASE
N016792 001
AB
EQ 50MG BASE
N016792 002
AB +
EQ 100MG BASE
N016792 003 Sep 15, 1982
TRIMIPRAMINE MALEATE
AB MIKAH PHARMA
EQ 25MG BASE
A077361 001 Aug 02, 2006
AB
EQ 50MG BASE
A077361 002 Aug 02, 2006
AB
EQ 100MG BASE
A077361 003 Aug 02, 2006
TRIPTORELIN PAMOATE
INJECTABLE;INTRAMUSCULAR
TRELSTAR
+ WATSON LABS
EQ 3.75MG BASE/VIAL
N020715 001 Jun 15, 2000
+
EQ 11.25MG BASE/VIAL
N021288 001 Jun 29, 2001
+
EQ 22.5MG BASE/VIAL
N022437 001 Mar 10, 2010
TROMETHAMINE
INJECTABLE;INJECTION
THAM
+ HOSPIRA
3.6GM/100ML
N013025 002
TROPICAMIDE
SOLUTION/DROPS;OPHTHALMIC
MYDRIACYL
AT + ALCON
0.5%
A084305 001
AT +
1%
A084306 001
TROPICACYL
AT AKORN
0.5%
A040314 001 Sep 29, 2000
AT
1%
A040315 001 Sep 29, 2000
TROPICAMIDE
AT BAUSCH AND LOMB
0.5%
A040067 001 Jul 27, 1994
AT
1%
A040064 001 Jul 27, 1994
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-358(of 371)
TROSPIUM CHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
SANCTURA XR
AB + ALLERGAN 60MG N022103 001 Aug 03, 2007
TROSPIUM CHLORIDE
AB ACTAVIS LABS FL INC 60MG A091289 001 Oct 12, 2012
AB PADDOCK LLC 60MG A201291 001 May 24, 2013
TABLET;ORAL
SANCTURA
AB + ALLERGAN 20MG N021595 001 May 28, 2004
TROSPIUM CHLORIDE
AB APOTEX 20MG A091513 001 Dec 06, 2011
AB GLENMARK GENERICS 20MG A091575 001 Aug 13, 2010
AB PADDOCK LLC 20MG A091573 001 Nov 17, 2010
TRYPAN BLUE
SOLUTION;OPHTHALMIC
MEMBRANEBLUE
+ DORC 0.15% N022278 001 Feb 20, 2009
VISIONBLUE
+ DORC 0.06% N021670 001 Dec 16, 2004
ULIPRISTAL ACETATE
TABLET;ORAL
ELLA
+ LAB HRA PHARMA 30MG N022474 001 Aug 13, 2010
UMECLIDINIUM BROMIDE
POWDER;INHALATION
INCRUSE ELLIPTA
+ GLAXO GRP ENGLAND EQ 62.5MCG BASE/INH N205382 001 Apr 30, 2014
UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE
POWDER;INHALATION
ANORO ELLIPTA
+ GLAXOSMITHKLINE EQ 0.0625MG BASE/INH;EQ 0.025MG N203975 001 Dec 18, 2013
BASE/INH
UNOPROSTONE ISOPROPYL
SOLUTION/DROPS;OPHTHALMIC
RESCULA
+ SUCAMPO PHARMS 0.15% N021214 001 Aug 03, 2000
UREA, C-14
CAPSULE;ORAL
PYTEST
+ AVENT 1uCi N020617 001 May 09, 1997
PYTEST KIT
+ AVENT 1uCi N020617 002 May 09, 1997
UROFOLLITROPIN
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS
BRAVELLE
+ FERRING 75 IU/VIAL N021289 001 May 06, 2002
URSODIOL
CAPSULE;ORAL
ACTIGALL
AB + WATSON PHARMS 300MG N019594 002 Dec 31, 1987
URSODIOL
AB COREPHARMA 300MG A077895 001 Jul 27, 2006
AB EPIC PHARMA 300MG A075517 001 Mar 14, 2000
AB LANNETT 300MG A079082 001 Dec 15, 2008
AB MYLAN 300MG A090530 001 Feb 17, 2010
AB TEVA PHARMS 300MG A075592 001 May 25, 2000
TABLET;ORAL
URSO 250
AB FOREST LABS INC 250MG N020675 001 Dec 10, 1997
URSO FORTE
AB + FOREST LABS INC 500MG N020675 002 Jul 21, 2004
URSODIOL
AB GLENMARK GENERICS 250MG A090801 001 Jul 12, 2011
AB 500MG A090801 002 Jul 12, 2011
AB IMPAX LABS INC 250MG A200826 001 Dec 23, 2011
AB 500MG A200826 002 Dec 23, 2011
AB PAR PHARM 250MG A202540 001 Feb 14, 2013
AB 500MG A202540 002 Feb 14, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-359(of 371)
VALACYCLOVIR HYDROCHLORIDE
TABLET;ORAL
VALACYCLOVIR HYDROCHLORIDE
AB APOTEX INC EQ 1GM BASE
A090500 002 Apr 04, 2014
AB EQ 500MG BASE
A090500 001 Apr 04, 2014
AB AUROBINDO PHARMA EQ 1GM BASE
A090682 002 May 24, 2010
AB EQ 500MG BASE
A090682 001 May 24, 2010
AB CIPLA LTD EQ 1GM BASE
A077135 002 May 24, 2010
AB EQ 500MG BASE
A077135 001 May 24, 2010
AB DR REDDYS LABS LTD EQ 1GM BASE
A079012 002 May 24, 2010
AB EQ 500MG BASE
A079012 001 May 24, 2010
AB JUBILANT GENERICS EQ 1GM BASE
A201506 002 Apr 03, 2012
AB EQ 500MG BASE
A201506 001 Apr 03, 2012
AB MYLAN EQ 1GM BASE
A078070 002 May 24, 2010
AB EQ 500MG BASE
A078070 001 May 24, 2010
AB MYLAN PHARMS INC EQ 1GM BASE
A078518 002 May 24, 2010
AB EQ 500MG BASE
A078518 001 May 24, 2010
AB RANBAXY EQ 1GM BASE
A076588 002 Jan 31, 2007
AB EQ 500MG BASE
A076588 001 Jan 31, 2007
AB ROXANE EQ 1GM BASE
A078656 002 May 24, 2010
AB EQ 500MG BASE
A078656 001 May 24, 2010
AB SANDOZ EQ 1GM BASE
A077478 002 May 24, 2010
AB EQ 500MG BASE
A077478 001 May 24, 2010
AB TEVA PHARMS EQ 1GM BASE
A077655 002 May 24, 2010
AB EQ 500MG BASE
A077655 001 May 24, 2010
AB WATSON LABS INC EQ 1GM BASE
A090370 002 Mar 16, 2011
AB EQ 500MG BASE
A090370 001 Mar 16, 2011
AB WOCKHARDT EQ 1GM BASE
A090216 002 May 24, 2010
AB EQ 500MG BASE
A090216 001 May 24, 2010
VALTREX
AB + GLAXOSMITHKLINE EQ 1GM BASE
N020487 002 Jun 23, 1995
AB EQ 500MG BASE
N020487 001 Jun 23, 1995
VALGANCICLOVIR HYDROCHLORIDE
FOR SOLUTION;ORAL
VALCYTE
+ HOFFMANN LA ROCHE
50MG/ML
N022257 001 Aug 28, 2009
TABLET;ORAL
VALCYTE
AB + HOFFMANN LA ROCHE
EQ 450MG BASE
N021304 001 Mar 29, 2001
VALGANCICLOVIR HYDROCHLORIDE
AB DR REDDYS LABS LTD
EQ 450MG BASE
A203511 001 Nov 04, 2014
AB ENDO PHARMS INC
EQ 450MG BASE
A200790 001 Nov 04, 2014
VALPROATE SODIUM
INJECTABLE;INJECTION
DEPACON
AP + ABBVIE EQ 100MG BASE/ML
N020593 001 Dec 30, 1996
VALPROATE SODIUM
AP BEDFORD EQ 100MG BASE/ML
A076295 001 Nov 14, 2002
AP FRESENIUS KABI USA EQ 100MG BASE/ML
A076539 001 Jun 26, 2003
AP HIKMA FARMACEUTICA EQ 100MG BASE/ML
A078523 001 Feb 17, 2010
VALPROIC ACID
CAPSULE;ORAL
DEPAKENE
AB + ABBVIE
250MG
N018081 001
VALPROIC ACID
AB BANNER PHARMACAPS
250MG
A073484 001 Jun 29, 1993
AB CATALENT
250MG
A073229 001 Oct 29, 1991
AB SUN PHARM INDS LTD
250MG
A091037 001 Feb 22, 2013
SYRUP;ORAL
DEPAKENE
AA + ABBVIE
250MG/5ML
N018082 001
VALPROIC ACID
AA ALPHARMA
250MG/5ML
A075782 001 Dec 22, 2000
AA ANI PHARMS INC
250MG/5ML
A073178 001 Aug 25, 1992
AA HIGH TECH PHARMA
250MG/5ML
A074060 001 Jan 13, 1995
AA PHARM ASSOC
250MG/5ML
A075379 001 Dec 15, 2000
AA SUN PHARM INDS INC
250MG/5ML
A090517 001 May 28, 2010
AA VINTAGE
250MG/5ML
A077960 001 Oct 13, 2006
AA WOCKHARDT
250MG/5ML
A070868 001 Jul 01, 1986
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-360(of 371)
VALRUBICIN
SOLUTION;INTRAVESICAL
VALSTAR PRESERVATIVE FREE
+ ENDO PHARM
40MG/ML
N020892 001 Sep 25, 1998
VALSARTAN
TABLET;ORAL
DIOVAN
AB NOVARTIS 40MG
N021283 004 Aug 14, 2002
AB 80MG
N021283 001 Jul 18, 2001
AB 160MG
N021283 002 Jul 18, 2001
AB + 320MG
N021283 003 Jul 18, 2001
VALSARTAN
AB ALEMBIC PHARMS LTD 40MG
A091367 001 Jan 05, 2015
AB 80MG
A091367 002 Jan 05, 2015
AB 160MG
A091367 003 Jan 05, 2015
AB 320MG
A091367 004 Jan 05, 2015
AB AUROBINDO PHARMA LTD 40MG
A202223 001 Jan 05, 2015
AB 80MG
A202223 002 Jan 05, 2015
AB 160MG
A202223 003 Jan 05, 2015
AB 320MG
A202223 004 Jan 05, 2015
AB HETERO LABS LTD V 40MG
A203311 001 Jan 05, 2015
AB 80MG
A203311 002 Jan 05, 2015
AB 160MG
A203311 003 Jan 05, 2015
AB 320MG
A203311 004 Jan 05, 2015
AB IVAX PHARMS 40MG
A077530 001 Jan 05, 2015
AB 80MG
A077530 002 Jan 05, 2015
AB 160MG
A077530 003 Jan 05, 2015
AB 320MG
A077530 004 Jan 05, 2015
AB JUBILANT GENERICS 40MG
A203536 001 Jan 05, 2015
AB 80MG
A203536 002 Jan 05, 2015
AB 160MG
A203536 003 Jan 05, 2015
AB 320MG
A203536 004 Jan 05, 2015
AB LUPIN LTD 40MG
A201677 001 Jan 05, 2015
AB 80MG
A201677 002 Jan 05, 2015
AB 160MG
A201677 003 Jan 05, 2015
AB 320MG
A201677 004 Jan 05, 2015
AB MYLAN LABS LTD 40MG
A090866 001 Jan 05, 2015
AB 80MG
A090866 002 Jan 05, 2015
AB 160MG
A090866 003 Jan 05, 2015
AB 320MG
A090866 004 Jan 05, 2015
AB OHM LABS INC 40MG
A077492 001 Jun 26, 2014
AB 80MG
A077492 002 Jun 26, 2014
AB 160MG
A077492 003 Jun 26, 2014
AB 320MG
A077492 004 Jun 26, 2014
AB TORRENT PHARMS LTD 40MG
A202728 001 Jan 05, 2015
AB 80MG
A202728 002 Jan 05, 2015
AB 160MG
A202728 003 Jan 05, 2015
AB 320MG
A202728 004 Jan 05, 2015
AB WATSON LABS INC 40MG
A090642 001 Jan 05, 2015
AB 80MG
A090642 002 Jan 05, 2015
AB 160MG
A090642 003 Jan 05, 2015
AB 320MG
A090642 004 Jan 05, 2015
VANCOMYCIN HYDROCHLORIDE
CAPSULE;ORAL
VANCOCIN HYDROCHLORIDE
AB ANI PHARMS INC
EQ 125MG BASE
N050606 001 Apr 15, 1986
AB +
EQ 250MG BASE
N050606 002 Apr 15, 1986
VANCOMYCIN HYDROCHLORIDE
AB AKORN
EQ 125MG BASE
A065478 001 Apr 09, 2012
AB
EQ 250MG BASE
A065478 002 Apr 09, 2012
AB FRESENIUS KABI USA
EQ 125MG BASE
A065453 001 Jun 18, 2012
AB
EQ 250MG BASE
A065453 002 Jun 18, 2012
AB STRIDES PHARMA
EQ 125MG BASE
A065490 001 Apr 09, 2012
AB
EQ 250MG BASE
A065490 002 Apr 09, 2012
AB WATSON LABS
EQ 125MG BASE
A065510 001 Apr 09, 2012
AB
EQ 250MG BASE
A065510 002 Apr 09, 2012
INJECTABLE;INJECTION
VANCOMYCIN HYDROCHLORIDE
AP AGILA SPECLTS
EQ 1GM BASE/VIAL
A065397 002 Dec 30, 2008
AP
EQ 5GM BASE/VIAL
A065432 001 Dec 30, 2008
AP
EQ 10GM BASE/VIAL
A091469 001 Jul 01, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-361(of 371)
VANCOMYCIN HYDROCHLORIDE
INJECTABLE;INJECTION
VANCOMYCIN HYDROCHLORIDE
AP EQ 10GM BASE/VIAL A091554 001 Sep 19, 2011
AP EQ 500MG BASE/VIAL A065397 001 Dec 30, 2008
AP EMCURE PHARMS LTD EQ 1GM BASE/VIAL A202275 002 Oct 31, 2013
AP EQ 10GM BASE/VIAL A202464 001 Oct 09, 2013
AP EQ 5GM BASE/VIAL A202274 001 Oct 31, 2013
AP EQ 500MG BASE/VIAL A202275 001 Oct 31, 2013
AP + FRESENIUS KABI USA EQ 1GM BASE/VIAL A062663 002 Jul 31, 1987
AP + EQ 5GM BASE/VIAL A062663 003 Jun 03, 1988
AP + EQ 10GM BASE/VIAL A062663 004 Nov 28, 1997
AP + EQ 500MG BASE/VIAL A062663 001 Mar 17, 1987
AP + HOSPIRA EQ 1GM BASE/VIAL A062912 001 Aug 04, 1988
AP + EQ 1GM BASE/VIAL A062933 001 Oct 29, 1992
AP + EQ 5GM BASE/VIAL A063076 001 Dec 21, 1990
AP + EQ 500MG BASE/VIAL A062911 001 Aug 04, 1988
AP + EQ 500MG BASE/VIAL A062931 001 Oct 29, 1992
AP + EQ 750MG BASE/VIAL A062912 002 Jan 07, 2009
AP + EQ 750MG BASE/VIAL A062933 002 May 27, 2009
AP HOSPIRA INC EQ 10GM BASE/VIAL A065455 001 Apr 29, 2009
AP MUSTAFA NEVZAT ILAC EQ 1GM BASE/VIAL A065401 002 Jun 30, 2008
AP EQ 500MG BASE/VIAL A065401 001 Jun 30, 2008
AP SAGENT PHARMS EQ 5GM BASE/VIAL A200837 001 Aug 10, 2012
AP EQ 10GM BASE/VIAL A200837 002 Sep 02, 2014
AP SANDOZ EQ 1GM BASE/VIAL A090250 002 Apr 27, 2010
AP EQ 500MG BASE/VIAL A090250 001 Apr 27, 2010
AP SANDOZ INC EQ 5GM BASE/VIAL A201048 001 Aug 10, 2012
AP EQ 10GM BASE/VIAL A201048 002 Aug 10, 2012
VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER
+ BAXTER HLTHCARE EQ 500MG BASE/100ML N050671 001 Apr 29, 1993
+ EQ 750MG BASE/150ML N050671 002 Dec 20, 2010
VANDETANIB
TABLET;ORAL
CAPRELSA
IPR PHARMS INC 100MG N022405 001 Apr 06, 2011
+ 300MG N022405 002 Apr 06, 2011
VARDENAFIL HYDROCHLORIDE
TABLET;ORAL
LEVITRA
AB BAYER HLTHCARE 2.5MG N021400 003 Aug 19, 2003
AB 5MG N021400 001 Aug 19, 2003
AB 10MG N021400 002 Aug 19, 2003
AB + 20MG N021400 004 Aug 19, 2003
VARDENAFIL HYDROCHLORIDE
AB TEVA PHARMS 2.5MG A091347 001 May 03, 2012
AB 5MG A091347 002 May 03, 2012
AB 10MG A091347 003 May 03, 2012
AB 20MG A091347 004 May 03, 2012
TABLET, ORALLY DISINTEGRATING;ORAL
STAXYN
+ BAYER HLTHCARE 10MG N200179 001 Jun 17, 2010
VARENICLINE TARTRATE
TABLET;ORAL
CHANTIX
PFIZER INC EQ 0.5MG BASE N021928 001 May 10, 2006
+ EQ 1MG BASE N021928 002 May 10, 2006
VASOPRESSIN
SOLUTION;IV (INFUSION)
VASOSTRICT
+ PAR STERILE PRODUCTS 20UNITS/ML (20UNITS/ML) N204485 001 Apr 17, 2014
VECURONIUM BROMIDE
INJECTABLE;INJECTION
VECURONIUM BROMIDE
AP AGILA SPECLTS 10MG/VIAL A090243 001 May 11, 2010
AP 20MG/VIAL A090243 002 May 11, 2010
AP BEDFORD 10MG/VIAL A075549 001 Jun 13, 2000
AP 20MG/VIAL A075549 002 Jun 13, 2000
AP HOSPIRA 10MG/VIAL A075164 001 Oct 21, 1999
AP 20MG/VIAL A075164 002 Oct 21, 1999
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-362(of 371)
VECURONIUM BROMIDE
INJECTABLE;INJECTION
VECURONIUM BROMIDE
AP MUSTAFA NEVZAT 10MG/VIAL
A078274 001 Dec 29, 2008
AP 20MG/VIAL
A078274 002 Dec 29, 2008
AP + SUN PHARMA GLOBAL 10MG/VIAL
A079001 001 Jun 17, 2009
AP + 20MG/VIAL
A079001 002 Jun 17, 2009
AP TEVA PHARMS USA 10MG/VIAL
A074688 001 Aug 25, 1999
AP 20MG/VIAL
A074688 002 Aug 25, 1999
VELAGLUCERASE ALFA
INJECTABLE;IV (INFUSION)
VPRIV
SHIRE HUMAN GENETIC
400 UNITS/VIAL
N022575 001 Feb 26, 2010
VEMURAFENIB
TABLET;ORAL
ZELBORAF
+ HOFFMANN LA ROCHE
240MG
N202429 001 Aug 17, 2011
VENLAFAXINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
EFFEXOR XR
AB WYETH PHARMS INC
EQ 37.5MG BASE
N020699 001 Oct 20, 1997
AB
EQ 75MG BASE
N020699 002 Oct 20, 1997
AB +
EQ 150MG BASE
N020699 004 Oct 20, 1997
VENLAFAXINE HYDROCHLORIDE
AB ANCHEN PHARMS
EQ 37.5MG BASE
A078087 001 Mar 16, 2012
AB
EQ 75MG BASE
A078087 002 Mar 16, 2012
AB
EQ 150MG BASE
A078087 003 Mar 16, 2012
AB AUROBINDO PHARMA LTD
EQ 37.5MG BASE
A200834 001 Apr 14, 2011
AB
EQ 75MG BASE
A200834 002 Apr 14, 2011
AB
EQ 150MG BASE
A200834 003 Apr 14, 2011
AB DR REDDYS LABS LTD
EQ 37.5MG BASE
A078421 001 May 06, 2011
AB
EQ 75MG BASE
A078421 002 May 06, 2011
AB
EQ 150MG BASE
A078421 003 May 06, 2011
AB MYLAN
EQ 37.5MG BASE
A078789 001 Jun 01, 2011
AB
EQ 75MG BASE
A078789 002 Jun 01, 2011
AB
EQ 150MG BASE
A078789 003 Jun 01, 2011
AB ORCHID HLTHCARE
EQ 37.5MG BASE
A091123 001 Jul 11, 2011
AB
EQ 75MG BASE
A091123 002 Jul 11, 2011
AB
EQ 150MG BASE
A091123 003 Jul 11, 2011
AB TEVA
EQ 37.5MG BASE
A076565 001 Jun 28, 2010
AB
EQ 75MG BASE
A076565 002 Jun 28, 2010
AB
EQ 150MG BASE
A076565 003 Jun 28, 2010
AB TORRENT PHARMS LLC
EQ 37.5MG BASE
A090899 001 Jun 01, 2011
AB
EQ 75MG BASE
A090899 002 Jun 01, 2011
AB
EQ 150MG BASE
A090899 003 Jun 01, 2011
AB VALEANT BERMUDA
EQ 37.5MG BASE
A090071 001 Apr 15, 2011
AB
EQ 75MG BASE
A090071 002 Apr 15, 2011
AB
EQ 150MG BASE
A090071 003 Apr 15, 2011
AB WOCKHARDT
EQ 37.5MG BASE
A078865 001 Apr 14, 2011
AB
EQ 75MG BASE
A078865 002 Apr 14, 2011
AB
EQ 150MG BASE
A078865 003 Apr 14, 2011
AB ZYDUS PHARMS USA INC
EQ 37.5MG BASE
A090174 001 Apr 14, 2011
AB
EQ 75MG BASE
A090174 002 Apr 14, 2011
AB
EQ 150MG BASE
A090174 003 Apr 14, 2011
TABLET;ORAL
VENLAFAXINE HYDROCHLORIDE
AB ALEMBIC PHARMS LTD
EQ 25MG BASE
A078932 001 Dec 14, 2010
AB
EQ 37.5MG BASE
A078932 002 Dec 14, 2010
AB
EQ 50MG BASE
A078932 003 Dec 14, 2010
AB
EQ 75MG BASE
A078932 004 Dec 14, 2010
AB
EQ 100MG BASE
A078932 005 Dec 14, 2010
AB AMNEAL PHARMS
EQ 25MG BASE
A079098 001 May 11, 2010
AB
EQ 37.5MG BASE
A079098 002 May 11, 2010
AB
EQ 50MG BASE
A079098 003 May 11, 2010
AB
EQ 75MG BASE
A079098 004 May 11, 2010
AB
EQ 100MG BASE
A079098 005 May 11, 2010
AB AUROBINDO PHARMA
EQ 25MG BASE
A090555 001 Apr 07, 2010
AB
EQ 37.5MG BASE
A090555 002 Apr 07, 2010
AB
EQ 50MG BASE
A090555 003 Apr 07, 2010
AB
EQ 75MG BASE
A090555 004 Apr 07, 2010
AB
EQ 100MG BASE
A090555 005 Apr 07, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-363(of 371)
VENLAFAXINE HYDROCHLORIDE
TABLET;ORAL
VENLAFAXINE HYDROCHLORIDE
AB DR REDDYS LABS LTD EQ 25MG BASE A078301 001 Jun 13, 2008
AB EQ 37.5MG BASE A078301 002 Jun 13, 2008
AB EQ 50MG BASE A078301 003 Jun 13, 2008
AB EQ 75MG BASE A078301 004 Jun 13, 2008
AB EQ 100MG BASE A078301 005 Jun 13, 2008
AB HERITAGE PHARMS INC EQ 25MG BASE A078554 001 Jan 09, 2009
AB EQ 37.5MG BASE A078554 002 Jan 09, 2009
AB EQ 50MG BASE A078554 003 Jan 09, 2009
AB EQ 75MG BASE A078554 004 Jan 09, 2009
AB EQ 100MG BASE A078554 005 Jan 09, 2009
AB MYLAN EQ 25MG BASE A077166 001 Jun 13, 2008
AB EQ 37.5MG BASE A077166 002 Jun 13, 2008
AB EQ 50MG BASE A077166 003 Jun 13, 2008
AB EQ 75MG BASE A077166 004 Jun 13, 2008
AB EQ 100MG BASE A077166 005 Jun 13, 2008
AB SUN PHARM INDS INC EQ 25MG BASE A078627 001 Jun 13, 2008
AB EQ 37.5MG BASE A078627 002 Jun 13, 2008
AB EQ 50MG BASE A078627 003 Jun 13, 2008
AB EQ 75MG BASE A078627 004 Jun 13, 2008
AB EQ 100MG BASE A078627 005 Jun 13, 2008
AB TEVA EQ 25MG BASE A076690 001 Aug 03, 2006
AB EQ 37.5MG BASE A076690 002 Aug 03, 2006
AB + EQ 50MG BASE A076690 003 Aug 03, 2006
AB EQ 75MG BASE A076690 004 Aug 03, 2006
AB EQ 100MG BASE A076690 005 Aug 03, 2006
AB VINTAGE EQ 25MG BASE A090027 001 Aug 04, 2010
AB EQ 37.5MG BASE A090027 002 Aug 04, 2010
AB EQ 50MG BASE A090027 003 Aug 04, 2010
AB EQ 75MG BASE A090027 004 Aug 04, 2010
AB EQ 100MG BASE A090027 005 Aug 04, 2010
AB ZYDUS PHARMS USA EQ 25MG BASE A077653 001 Jun 13, 2008
AB EQ 37.5MG BASE A077653 002 Jun 13, 2008
AB EQ 50MG BASE A077653 003 Jun 13, 2008
AB EQ 75MG BASE A077653 004 Jun 13, 2008
AB EQ 100MG BASE A077653 005 Jun 13, 2008
TABLET, EXTENDED RELEASE;ORAL
VENLAFAXINE HYDROCHLORIDE
AB OSMOTICA PHARM EQ 37.5MG BASE N022104 001 May 20, 2008
AB EQ 75MG BASE N022104 002 May 20, 2008
AB + EQ 150MG BASE N022104 003 May 20, 2008
AB SUN PHARMA GLOBAL EQ 37.5MG BASE A091272 001 Aug 18, 2010
AB EQ 75MG BASE A091272 002 Aug 18, 2010
AB EQ 150MG BASE A091272 003 Aug 18, 2010
OSMOTICA PHARM EQ 225MG BASE N022104 004 May 20, 2008
VERAPAMIL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
VERAPAMIL HYDROCHLORIDE
AB MYLAN 100MG A078306 001 Aug 09, 2007
AB 120MG A075138 001 Apr 20, 1999
AB 180MG A075138 002 Apr 20, 1999
AB 200MG A078306 002 Aug 09, 2007
AB 240MG A075138 003 Apr 20, 1999
AB 300MG A078306 003 Aug 09, 2007
VERELAN
AB ALKERMES GAINESVILLE 120MG N019614 001 May 29, 1990
AB 180MG N019614 003 Jan 09, 1992
AB 240MG N019614 002 May 29, 1990
VERELAN PM
AB ALKERMES GAINESVILLE 100MG N020943 001 Nov 25, 1998
AB 200MG N020943 002 Nov 25, 1998
AB + 300MG N020943 003 Nov 25, 1998
VERELAN
+ ALKERMES GAINESVILLE 360MG N019614 004 May 10, 1996
SOLUTION;INTRAVENOUS
VERAPAMIL HYDROCHLORIDE
AP + HOSPIRA 10MG/4ML (2.5MG/ML) A070738 001 May 06, 1987
AP + 5MG/2ML (2.5MG/ML) A075136 001 Oct 20, 1998
AP + 5MG/2ML (2.5MG/ML) A070737 001 May 06, 1987
AP + 10MG/4ML (2.5MG/ML) A070737 002 May 06, 1987
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-364(of 371)
VERAPAMIL HYDROCHLORIDE
TABLET;ORAL
CALAN
AB GD SEARLE LLC 40MG N018817 003 Feb 23, 1988
AB 80MG N018817 001 Sep 10, 1984
AB + 120MG N018817 002 Sep 10, 1984
VERAPAMIL HYDROCHLORIDE
AB HERITAGE PHARMS INC 80MG A071880 001 Apr 05, 1988
AB 120MG A071881 001 Apr 05, 1988
AB MYLAN 80MG A071483 002 Feb 15, 1989
AB 120MG A071483 001 Feb 15, 1989
AB WATSON LABS 40MG A072924 001 Jun 29, 1993
AB 80MG A070995 001 Oct 01, 1986
AB 120MG A070994 001 Oct 01, 1986
TABLET, EXTENDED RELEASE;ORAL
CALAN SR
AB + PFIZER 120MG N019152 003 Mar 06, 1991
AB + 180MG N019152 002 Dec 15, 1989
AB + 240MG N019152 001 Dec 16, 1986
VERAPAMIL HYDROCHLORIDE
AB APOTEX CORP 120MG A200878 001 Apr 20, 2012
AB 180MG A200878 002 Apr 20, 2012
AB 240MG A200878 003 Apr 20, 2012
AB GLENMARK GENERICS 120MG A090700 001 Aug 03, 2011
AB 180MG A090700 002 Aug 03, 2011
AB 240MG A078906 001 Sep 17, 2009
AB IVAX SUB TEVA PHARMS 120MG A073568 002 Oct 10, 1997
AB 180MG A074330 001 Jan 31, 1994
AB 240MG A073568 001 Jul 31, 1992
AB MYLAN 120MG A074587 002 Feb 21, 1997
AB 180MG A074587 003 Sep 09, 1997
AB 240MG A074587 001 Mar 23, 1996
AB PAR PHARM 120MG A075072 001 May 25, 1999
AB 240MG A075072 003 May 25, 1999
AB SUN PHARM INDS INC 120MG A090529 001 Dec 30, 2011
AB 180MG A090529 002 Dec 30, 2011
AB 240MG A090529 003 Dec 30, 2011
COVERA-HS
BC + GD SEARLE LLC 180MG N020552 001 Feb 26, 1996
BC + 240MG N020552 002 Feb 26, 1996
VERTEPORFIN
INJECTABLE;INJECTION
VISUDYNE
+ VALEANT PHARMS INC 15MG/VIAL N021119 001 Apr 12, 2000
VIGABATRIN
FOR SOLUTION;ORAL
SABRIL
+ LUNDBECK LLC 500MG/PACKET N022006 001 Aug 21, 2009
TABLET;ORAL
SABRIL
+ LUNDBECK LLC 500MG N020427 001 Aug 21, 2009
VILAZODONE HYDROCHLORIDE
TABLET;ORAL
VIIBRYD
+ FOREST LABS INC 10MG N022567 001 Jan 21, 2011
20MG N022567 002 Jan 21, 2011
40MG N022567 003 Jan 21, 2011
VINBLASTINE SULFATE
INJECTABLE;INJECTION
VINBLASTINE SULFATE
+ EUROHLTH INTL 10MG/VIAL A089395 001 Apr 09, 1987
+ FRESENIUS KABI USA 1MG/ML A089515 001 Apr 29, 1987
VINCRISTINE SULFATE
INJECTABLE;INJECTION
VINCRISTINE SULFATE PFS
AP + HOSPIRA 1MG/ML A071484 001 Apr 19, 1988
AP TEVA PHARMS USA 1MG/ML A075493 001 Sep 01, 1999
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-365(of 371)
VINCRISTINE SULFATE
INJECTABLE, LIPOSOMAL;INTRAVENOUS
MARQIBO KIT
+ TALON THERAP
5MG/5ML (1MG/ML)
N202497 001 Aug 09, 2012
VINORELBINE
INJECTABLE;INJECTION
VINORELBINE
AP ONCO THERAPIES LTD
EQ 10MG BASE/ML
A200148 001 Aug 31, 2012
VINORELBINE TARTRATE
INJECTABLE;INJECTION
NAVELBINE
AP + PIERRE FABRE EQ 10MG BASE/ML
N020388 001 Dec 23, 1994
VINORELBINE TARTRATE
AP ACTAVIS TOTOWA EQ 10MG BASE/ML
A078011 001 Jul 22, 2009
AP BEDFORD EQ 10MG BASE/ML
A076461 001 Dec 11, 2003
AP DR REDDYS LABS LTD EQ 10MG BASE/ML
A202017 001 Sep 12, 2013
AP FRESENIUS KABI USA EQ 10MG BASE/ML
A076849 001 Apr 18, 2005
AP HIKMA MAPLE EQ 10MG BASE/ML
A075992 001 Jun 10, 2003
AP HOSPIRA EQ 10MG BASE/ML
A076827 001 Jun 02, 2005
AP JIANGSU HANSOH PHARM EQ 10MG BASE/ML
A091106 001 Sep 26, 2012
AP TEVA PHARMS USA EQ 10MG BASE/ML
A076028 001 Feb 03, 2003
VISMODEGIB
CAPSULE;ORAL
ERIVEDGE
+ GENENTECH
150MG
N203388 001 Jan 30, 2012
VITAMIN A PALMITATE
INJECTABLE;INJECTION
AQUASOL A
+ HOSPIRA
EQ 50,000 UNITS BASE/ML
N006823 001
VORAPAXAR SULFATE
TABLET;ORAL
ZONTIVITY
+ MERCK SHARP DOHME
EQ 2.08MG BASE
N204886 001 May 08, 2014
VORICONAZOLE
FOR SUSPENSION;ORAL
VFEND
AB + PF PRISM CV
200MG/5ML
N021630 001 Dec 19, 2003
VORICONAZOLE
AB MYLAN PHARMS INC
200MG/5ML
A202361 001 May 28, 2013
INJECTABLE;IV (INFUSION)
VFEND
AP + PF PRISM CV
200MG/VIAL
N021267 001 May 24, 2002
VORICONAZOLE
AP SANDOZ INC
200MG/VIAL
A090862 001 May 30, 2012
TABLET;ORAL
VFEND
AB PF PRISM CV
50MG
N021266 001 May 24, 2002
AB +
200MG
N021266 002 May 24, 2002
VORICONAZOLE
AB MYLAN PHARMS INC
50MG
A090547 001 Apr 22, 2010
AB
200MG
A090547 002 Apr 22, 2010
AB SANDOZ INC
50MG
A200265 001 Dec 12, 2011
AB
200MG
A200265 002 Dec 12, 2011
AB TEVA PHARMS
50MG
A091658 001 Apr 06, 2012
AB
200MG
A091658 002 Apr 06, 2012
VORINOSTAT
CAPSULE;ORAL
ZOLINZA
+ MERCK
100MG
N021991 001 Oct 06, 2006
VORTIOXETINE HYDROBROMIDE
TABLET;ORAL
BRINTELLIX
TAKEDA PHARMS USA
EQ 5MG BASE
N204447 001 Sep 30, 2013
EQ 10MG BASE
N204447 002 Sep 30, 2013
EQ 15MG BASE
N204447 003 Sep 30, 2013
+
EQ 20MG BASE
N204447 004 Sep 30, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-366(of 371)
WARFARIN SODIUM
TABLET;ORAL
COUMADIN
AB BRISTOL MYERS SQUIBB 1MG N009218 022 Mar 01, 1990
AB 2MG N009218 013
AB 2.5MG N009218 018
AB 3MG N009218 025 Nov 18, 1996
AB 4MG N009218 023 Aug 24, 1993
AB 5MG N009218 007
AB 6MG N009218 026 Nov 18, 1996
AB 7.5MG N009218 016
AB + 10MG N009218 005
JANTOVEN
AB USL PHARMA 1MG A040416 001 Oct 02, 2003
AB 2MG A040416 002 Oct 02, 2003
AB 2.5MG A040416 003 Oct 02, 2003
AB 3MG A040416 004 Oct 02, 2003
AB 4MG A040416 005 Oct 02, 2003
AB 5MG A040416 006 Oct 02, 2003
AB 6MG A040416 007 Oct 02, 2003
AB 7.5MG A040416 008 Oct 02, 2003
AB 10MG A040416 009 Oct 02, 2003
WARFARIN SODIUM
AB AMNEAL PHARMS 1MG A202202 001 Mar 04, 2013
AB 2MG A202202 002 Mar 04, 2013
AB 2.5MG A202202 003 Mar 04, 2013
AB 3MG A202202 004 Mar 04, 2013
AB 4MG A202202 005 Mar 04, 2013
AB 5MG A202202 006 Mar 04, 2013
AB 6MG A202202 007 Mar 04, 2013
AB 7.5MG A202202 008 Mar 04, 2013
AB 10MG A202202 009 Mar 04, 2013
AB BARR 1MG A040145 001 Mar 26, 1997
AB 2MG A040145 002 Mar 26, 1997
AB 2.5MG A040145 003 Mar 26, 1997
AB 3MG A040145 008 Nov 05, 1998
AB 4MG A040145 004 Mar 26, 1997
AB 5MG A040145 005 Mar 26, 1997
AB 6MG A040145 009 Nov 05, 1998
AB 7.5MG A040145 006 Mar 26, 1997
AB 10MG A040145 007 Mar 26, 1997
AB INVAGEN PHARMS 1MG A090935 001 May 25, 2011
AB 2MG A090935 002 May 25, 2011
AB 2.5MG A090935 003 May 25, 2011
AB 3MG A090935 004 May 25, 2011
AB 4MG A090935 005 May 25, 2011
AB 5MG A090935 006 May 25, 2011
AB 6MG A090935 007 May 25, 2011
AB 7.5MG A090935 008 May 25, 2011
AB 10MG A090935 009 May 25, 2011
AB IPCA LABS LTD 1MG A200104 001 Jun 27, 2013
AB 2MG A200104 002 Jun 27, 2013
AB 2.5MG A200104 003 Jun 27, 2013
AB 3MG A200104 004 Jun 27, 2013
AB 4MG A200104 005 Jun 27, 2013
AB 5MG A200104 006 Jun 27, 2013
AB 6MG A200104 007 Jun 27, 2013
AB 7.5MG A200104 008 Jun 27, 2013
AB 10MG A200104 009 Jun 27, 2013
AB MYLAN 1MG A040415 001 Sep 27, 2004
AB 2MG A040415 002 Sep 27, 2004
AB 2.5MG A040415 003 Sep 29, 2004
AB 3MG A040415 004 Sep 27, 2004
AB 4MG A040415 005 Sep 27, 2004
AB 5MG A040415 006 Sep 27, 2004
AB 6MG A040415 007 Sep 27, 2004
AB 7.5MG A040415 008 Sep 27, 2004
AB 10MG A040415 009 Sep 27, 2004
AB PLIVA 1MG A040616 009 Jul 05, 2006
AB 2MG A040616 001 Jul 05, 2006
AB 2.5MG A040616 002 Jul 05, 2006
AB 3MG A040616 003 Jul 05, 2006
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-367(of 371)
WARFARIN SODIUM
TABLET;ORAL
WARFARIN SODIUM
AB 4MG A040616 004 Jul 05, 2006
AB 5MG A040616 005 Jul 05, 2006
AB 6MG A040616 006 Jul 05, 2006
AB 7.5MG A040616 007 Jul 05, 2006
AB 10MG A040616 008 Jul 05, 2006
AB TARO 1MG A040301 002 Jul 15, 1999
AB 2MG A040301 003 Jul 15, 1999
AB 2.5MG A040301 004 Jul 15, 1999
AB 3MG A040301 005 Jul 15, 1999
AB 4MG A040301 006 Jul 15, 1999
AB 5MG A040301 007 Jul 15, 1999
AB 6MG A040301 008 Jul 15, 1999
AB 7.5MG A040301 009 Jul 15, 1999
AB 10MG A040301 001 Jul 15, 1999
AB ZYDUS PHARMS USA 1MG A040663 001 May 30, 2006
AB 2MG A040663 002 May 30, 2006
AB 2.5MG A040663 003 May 30, 2006
AB 3MG A040663 004 May 30, 2006
AB 4MG A040663 005 May 30, 2006
AB 5MG A040663 006 May 30, 2006
AB 6MG A040663 007 May 30, 2006
AB 7.5MG A040663 008 May 30, 2006
AB 10MG A040663 009 May 30, 2006
XENON XE-133
GAS;INHALATION
XENON XE 133
AA LANTHEUS MEDCL 20mCi/VIAL
N017284 002
10mCi/VIAL
N017284 001
ZAFIRLUKAST
TABLET;ORAL
ACCOLATE
AB ASTRAZENECA 10MG
N020547 003 Sep 17, 1999
AB + 20MG
N020547 001 Sep 26, 1996
ZAFIRLUKAST
AB DR REDDYS LABS LTD 10MG
A090372 001 Nov 18, 2010
AB 20MG
A090372 002 Nov 18, 2010
ZALEPLON
CAPSULE;ORAL
SONATA
AB PFIZER 5MG
N020859 001 Aug 13, 1999
AB + 10MG
N020859 002 Aug 13, 1999
ZALEPLON
AB AUROBINDO PHARMA 5MG
A078829 001 Jun 06, 2008
AB 10MG
A078829 002 Jun 06, 2008
AB CIPLA LTD 5MG
A077505 001 Jun 20, 2008
AB 10MG
A077505 002 Jun 20, 2008
AB HIKMA PHARMS LLC 5MG
A078147 001 Nov 25, 2008
AB 10MG
A078147 002 Nov 25, 2008
AB MYLAN 5MG
A077238 001 Jun 06, 2008
AB 10MG
A077238 002 Jun 06, 2008
AB ORCHID HLTHCARE 5MG
A090374 001 Sep 17, 2009
AB 10MG
A090374 002 Sep 17, 2009
AB ROXANE 5MG
A077237 001 Jun 06, 2008
AB 10MG
A077237 002 Jun 06, 2008
AB TEVA PHARMS 5MG
A077239 001 Jun 06, 2008
AB 10MG
A077239 002 Jun 06, 2008
AB UNICHEM 5MG
A078989 001 Jun 06, 2008
AB 10MG
A078989 002 Jun 06, 2008
AB UPSHER SMITH 5MG
A078706 001 Jun 06, 2008
AB 10MG
A078706 002 Jun 06, 2008
ZANAMIVIR
POWDER;INHALATION
RELENZA
+ GLAXOSMITHKLINE 5MG
N021036 001 Jul 26, 1999
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-368(of 371)
ZICONOTIDE ACETATE
INJECTABLE;INTRATHECAL
PRIALT
+ JAZZ PHARMS INTL 100MCG/1ML (100MCG/ML) N021060 002 Dec 28, 2004
+ 500MCG/20ML (25MCG/ML) N021060 001 Dec 28, 2004
+ 500MCG/5ML (100MCG/ML) N021060 004 Dec 28, 2004
ZIDOVUDINE
CAPSULE;ORAL
RETROVIR
AB + VIIV HLTHCARE 100MG N019655 001 Mar 19, 1987
ZIDOVUDINE
AB AUROBINDO PHARMA LTD 100MG A078128 001 Mar 27, 2006
AB CIPLA LTD 100MG A078349 001 May 23, 2007
INJECTABLE;INJECTION
RETROVIR
AP + VIIV HLTHCARE 10MG/ML N019951 001 Feb 02, 1990
ZIDOVUDINE
AP LUITPOLD 10MG/ML A091457 001 May 06, 2010
SYRUP;ORAL
RETROVIR
AA + VIIV HLTHCARE 50MG/5ML N019910 001 Sep 28, 1989
ZIDOVUDINE
AA AUROBINDO 50MG/5ML A077268 001 Sep 19, 2005
AA CIPLA LTD 50MG/5ML A077981 001 Jun 26, 2008
TABLET;ORAL
ZIDOVUDINE
AB AUROBINDO 300MG A077267 001 Sep 19, 2005
AB CIPLA 300MG A090561 001 Oct 27, 2010
AB + HETERO LABS LTD III 300MG A090092 001 Apr 25, 2008
AB MYLAN PHARMS INC 300MG A078922 001 Feb 14, 2008
AB ROXANE 300MG A076844 001 Sep 19, 2005
AB SUNSHINE LAKE 300MG A202058 001 Oct 07, 2011
ZILEUTON
TABLET;ORAL
ZYFLO
+ CHIESI USA INC 600MG N020471 003 Dec 09, 1996
TABLET, EXTENDED RELEASE;ORAL
ZYFLO CR
+ CHIESI USA INC 600MG N022052 001 May 30, 2007
ZINC ACETATE
CAPSULE;ORAL
GALZIN
TEVA EQ 25MG ZINC N020458 001 Jan 28, 1997
+ EQ 50MG ZINC N020458 002 Jan 28, 1997
ZINC CHLORIDE
INJECTABLE;INJECTION
ZINC CHLORIDE IN PLASTIC CONTAINER
+ HOSPIRA EQ 1MG ZINC/ML N018959 001 Jun 26, 1986
ZIPRASIDONE HYDROCHLORIDE
CAPSULE;ORAL
GEODON
AB + PFIZER EQ 20MG BASE N020825 001 Feb 05, 2001
AB EQ 40MG BASE N020825 002 Feb 05, 2001
AB EQ 60MG BASE N020825 003 Feb 05, 2001
AB EQ 80MG BASE N020825 004 Feb 05, 2001
ZIPRASIDONE HYDROCHLORIDE
AB APOTEX CORP EQ 20MG BASE A077561 001 Mar 02, 2012
AB EQ 40MG BASE A077561 002 Mar 02, 2012
AB EQ 60MG BASE A077561 003 Mar 02, 2012
AB EQ 80MG BASE A077561 004 Mar 02, 2012
AB DR REDDYS LABS INC EQ 20MG BASE A077565 001 Mar 02, 2012
AB EQ 40MG BASE A077565 002 Mar 02, 2012
AB EQ 60MG BASE A077565 003 Mar 02, 2012
AB EQ 80MG BASE A077565 004 Mar 02, 2012
AB LUPIN PHARMS EQ 20MG BASE A077560 001 Mar 02, 2012
AB EQ 40MG BASE A077560 002 Mar 02, 2012
AB EQ 60MG BASE A077560 003 Mar 02, 2012
AB EQ 80MG BASE A077560 004 Mar 02, 2012
AB MYLAN PHARMS INC EQ 20MG BASE A202395 001 Oct 10, 2013
AB EQ 40MG BASE A202395 002 Oct 10, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-369(of 371)
ZIPRASIDONE HYDROCHLORIDE
CAPSULE;ORAL
ZIPRASIDONE HYDROCHLORIDE
AB EQ 60MG BASE A202395 003 Oct 10, 2013
AB EQ 80MG BASE A202395 004 Oct 10, 2013
AB SANDOZ INC EQ 20MG BASE A077562 001 Jun 01, 2012
AB EQ 40MG BASE A077562 002 Jun 01, 2012
AB EQ 60MG BASE A077562 003 Jun 01, 2012
AB EQ 80MG BASE A077562 004 Jun 01, 2012
AB WOCKHARDT LTD EQ 20MG BASE A090348 001 Sep 05, 2012
AB EQ 40MG BASE A090348 002 Sep 05, 2012
AB EQ 60MG BASE A090348 003 Sep 05, 2012
AB EQ 80MG BASE A090348 004 Sep 05, 2012
SUSPENSION;ORAL
GEODON
+ PFIZER INC EQ 10MG BASE/ML N021483 001 Mar 29, 2006
ZIPRASIDONE MESYLATE
INJECTABLE;INTRAMUSCULAR
GEODON
+ PFIZER EQ 20MG BASE/ML N020919 001 Jun 21, 2002
ZOLEDRONIC ACID
INJECTABLE;IV (INFUSION)
RECLAST
AP + NOVARTIS EQ 5MG BASE/100ML N021817 001 Apr 16, 2007
ZOLEDRONIC ACID
AP ACS DOBFAR INFO SA EQ 4MG BASE/100ML N203231 001 Aug 02, 2013
AP EQ 5MG BASE/100ML A202828 001 Sep 23, 2013
AP ACTAVIS INC EQ 4MG BASE/5ML A202472 001 Mar 04, 2013
AP AGILA SPECLTS EQ 4MG BASE/5ML A202650 001 Mar 04, 2013
AP AKORN EQ 5MG BASE/100ML A200918 001 Aug 21, 2014
AP AKORN INC EQ 4MG BASE/5ML A202548 001 May 22, 2014
AP DR REDDYS LABS LTD EQ 4MG BASE/5ML A091186 001 Mar 04, 2013
AP EQ 5MG BASE/100ML A091363 001 Mar 29, 2013
AP EMCURE PHARMS LTD EQ 4MG BASE/5ML A201783 001 Mar 12, 2013
AP EQ 5MG BASE/100ML A201801 001 Mar 29, 2013
AP GLAND PHARMA LTD EQ 4MG BASE/5ML A202930 001 Aug 05, 2013
AP HIKMA FARMACEUTICA EQ 4MG BASE/5ML A202182 001 Jun 03, 2013
AP HOSPIRA INC EQ 5MG BASE/100ML A202837 001 Apr 05, 2013
AP PHARMACEUTICS EQ 4MG BASE/5ML A091170 001 Mar 04, 2013
AP EQ 5MG BASE/100ML A202163 001 Aug 05, 2013
AP PHARMS EQ 4MG BASE/5ML A202571 001 May 07, 2013
AP SAGENT PHARMS EQ 4MG BASE/5ML A091493 001 Nov 24, 2014
AP + SUN PHARMA GLOBAL EQ 4MG BASE/VIAL A090018 001 Mar 04, 2013
AP EQ 4MG BASE/5ML A202746 001 Mar 04, 2013
AP USV NORTH AMERICA EQ 4MG BASE/VIAL A202923 001 Sep 04, 2014
ZOMETA
AP + NOVARTIS EQ 4MG BASE/5ML N021223 002 Mar 07, 2003
AP + EQ 4MG BASE/100ML N021223 003 Jun 17, 2011
ZOLMITRIPTAN
SPRAY;NASAL
ZOMIG
ASTRAZENECA 2.5MG/SPRAY N021450 003 Sep 16, 2013
+ 5MG/SPRAY N021450 004 Sep 30, 2003
TABLET;ORAL
ZOLMITRIPTAN
AB APOTEX INC 2.5MG A202078 001 May 14, 2013
AB 5MG A202078 002 May 14, 2013
AB GLENMARK GENERICS 2.5MG A201779 001 May 14, 2013
AB 5MG A201779 002 May 14, 2013
AB INVAGEN PHARMS 2.5MG A204284 001 Apr 09, 2014
AB 5MG A204284 002 Apr 09, 2014
AB JUBILANT GENERICS 2.5MG A202279 001 Nov 20, 2014
AB 5MG A202279 002 Nov 20, 2014
AB MYLAN PHARMS INC 2.5MG A203186 001 May 14, 2013
AB 5MG A203186 002 May 14, 2013
AB SUN PHARMA GLOBAL 2.5MG A203476 001 Nov 13, 2014
AB 5MG A203476 002 Nov 13, 2014
AB TEVA PHARMS USA 2.5MG A090861 001 Mar 04, 2014
AB 5MG A090861 002 Mar 04, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST 3-370(of 371)
ZOLMITRIPTAN
TABLET;ORAL
ZOMIG
AB IPR 2.5MG N020768 001 Nov 25, 1997
AB + 5MG N020768 002 Nov 25, 1997
TABLET, ORALLY DISINTEGRATING;ORAL
ZOLMITRIPTAN
AB APOTEX INC 2.5MG A202476 001 May 14, 2013
AB 5MG A202476 002 May 14, 2013
AB GLENMARK GENERICS 2.5MG A202560 001 May 14, 2013
AB 5MG A202560 002 May 14, 2013
AB ZYDUS PHARMS USA INC 2.5MG A202890 001 May 15, 2013
AB 5MG A202890 002 May 15, 2013
ZOMIG-ZMT
AB ASTRAZENECA 2.5MG N021231 001 Feb 13, 2001
AB + 5MG N021231 002 Sep 17, 2001
ZOLPIDEM TARTRATE
SPRAY, METERED;ORAL
ZOLPIMIST
+ NOVADEL 5MG/SPRAY N022196 001 Dec 19, 2008
TABLET;ORAL
AMBIEN
AB SANOFI AVENTIS US 5MG N019908 001 Dec 16, 1992
AB + 10MG N019908 002 Dec 16, 1992
ZOLPIDEM TARTRATE
AB APOTEX INC 5MG A077884 001 Apr 23, 2007
AB 10MG A077884 002 Apr 23, 2007
AB AUROBINDO PHARMA 5MG A078413 001 May 04, 2007
AB 10MG A078413 002 May 04, 2007
AB CARLSBAD 5MG A077990 001 Apr 23, 2007
AB 10MG A077990 002 Apr 23, 2007
AB CIPLA LTD 5MG A077388 001 Jul 30, 2012
AB 10MG A077388 002 Jul 30, 2012
AB HIKMA 5MG A078129 001 Apr 30, 2008
AB 10MG A078129 002 Apr 30, 2008
AB INVAGEN PHARMS 5MG A078184 001 Sep 07, 2007
AB 10MG A078184 002 Sep 07, 2007
AB LEK PHARMS DD 5MG A077322 001 Apr 23, 2007
AB 10MG A077322 002 Apr 23, 2007
AB MYLAN 5MG A076578 001 Apr 23, 2007
AB 10MG A076578 002 Apr 23, 2007
AB RANBAXY 5MG A078055 001 Apr 23, 2007
AB 10MG A078055 002 Apr 23, 2007
AB ROXANE 5MG A077214 001 Apr 23, 2007
AB 10MG A077214 002 Apr 23, 2007
AB SUN PHARM INDS INC 5MG A077359 001 Apr 23, 2007
AB 10MG A077359 002 Apr 23, 2007
AB TEVA 5MG A076410 001 Apr 23, 2007
AB 10MG A076410 002 Apr 23, 2007
AB TORRENT PHARMS 5MG A077903 001 Aug 17, 2007
AB 10MG A077903 002 Aug 17, 2007
AB VINTAGE 5MG A078616 001 Nov 21, 2008
AB 10MG A078616 002 Nov 21, 2008
AB WOCKHARDT 5MG A078426 001 May 15, 2007
AB 10MG A078426 002 May 15, 2007
TABLET;SUBLINGUAL
EDLUAR
MEDA PHARMS 5MG N021997 001 Mar 13, 2009
+ 10MG N021997 002 Mar 13, 2009
INTERMEZZO
PURDUE PHARMA 1.75MG N022328 001 Nov 23, 2011
+ 3.5MG N022328 002 Nov 23, 2011
TABLET, EXTENDED RELEASE;ORAL
AMBIEN CR
AB SANOFI AVENTIS US 6.25MG N021774 002 Sep 02, 2005
AB + 12.5MG N021774 001 Sep 02, 2005
ZOLPIDEM TARTRATE
AB ACTAVIS ELIZABETH 6.25MG A078179 002 Oct 13, 2010
AB 12.5MG A078179 001 Jun 06, 2011
AB ACTAVIS LABS FL INC 6.25MG A090153 001 Mar 25, 2013
AB 12.5MG A090153 002 Mar 25, 2013
AB ANCHEN PHARMS 6.25MG A078148 002 Apr 14, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PRESCRIPTION DRUG PRODUCT LIST
3-371(of 371)
ZOLPIDEM TARTRATE
TABLET, EXTENDED RELEASE;ORAL
ZOLPIDEM TARTRATE
AB
12.5MG
A078148 001 Dec 03, 2010
AB APOTEX INC
6.25MG
A200266 001 Sep 10, 2013
AB
12.5MG
A200266 002 Sep 10, 2013
AB LUPIN LTD
6.25MG
A078970 001 Sep 11, 2013
AB
12.5MG
A078970 002 Sep 11, 2013
AB SANDOZ
6.25MG
A090107 001 Jul 01, 2011
AB
12.5MG
A090107 002 Jul 01, 2011
AB SYNTHON PHARMS
6.25MG
A078483 001 Apr 12, 2011
AB
12.5MG
A078483 002 Jun 06, 2011
ZONISAMIDE
CAPSULE;ORAL
ZONEGRAN
AB EISAI INC
25MG
N020789 003 Aug 22, 2003
AB
50MG
N020789 002 Aug 22, 2003
AB +
100MG
N020789 001 Mar 27, 2000
ZONISAMIDE
AB APOTEX INC
25MG
A077642 001 Dec 22, 2005
AB
50MG
A077642 002 Dec 22, 2005
AB
100MG
A077642 003 Dec 22, 2005
AB BANNER PHARMACAPS
25MG
A077813 001 Aug 16, 2006
AB
50MG
A077813 002 Aug 16, 2006
AB
100MG
A077813 003 Aug 16, 2006
AB GLENMARK GENERICS
25MG
A077651 001 Jan 30, 2006
AB
50MG
A077651 002 Jan 30, 2006
AB
100MG
A077651 003 Jan 30, 2006
AB INVAGEN PHARMS
25MG
A077869 001 May 31, 2006
AB
50MG
A077869 002 May 31, 2006
AB
100MG
A077869 003 May 31, 2006
AB MYLAN
25MG
A077637 001 Dec 22, 2005
AB
50MG
A077637 002 Dec 22, 2005
AB
100MG
A077637 003 Dec 22, 2005
AB MYLAN PHARMS INC
25MG
A077647 001 Dec 22, 2005
AB
50MG
A077647 002 Dec 22, 2005
AB
100MG
A077647 003 Dec 22, 2005
AB SUN PHARM INDS (IN)
25MG
A077634 001 Mar 17, 2006
AB
50MG
A077634 002 Mar 17, 2006
AB
100MG
A077634 003 Mar 17, 2006
AB WOCKHARDT
25MG
A077636 003 Jul 27, 2006
AB
50MG
A077636 002 Jul 27, 2006
AB
100MG
A077636 001 Dec 22, 2005
AB ZYDUS PHARMS USA
25MG
A077625 001 Oct 16, 2006
AB
50MG
A077625 002 Oct 16, 2006
AB
100MG
A077625 003 Oct 16, 2006
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
4-1(of 17)
ACETAMINOPHEN
SUPPOSITORY;RECTAL
ACEPHEN
G AND W LABS
120MG
N018060 001
325MG
A072344 001 Mar 27, 1992
325MG
N018060 003 Dec 18, 1986
650MG
A072237 001 Mar 27, 1992
650MG
N018060 002
ACETAMINOPHEN
PERRIGO NEW YORK
120MG
A070607 001 Apr 06, 1987
650MG
A070608 001 Dec 01, 1986
TARO PHARMS NORTH
120MG
N018337 003 Sep 12, 1983
325MG
N018337 002
+
650MG
N018337 001
INFANTS' FEVERALL
TARO PHARMS NORTH
80MG
N018337 004 Aug 26, 1992
NEOPAP
POLYMEDICA
120MG
N016401 001
TABLET, EXTENDED RELEASE;ORAL
ACETAMINOPHEN
OHM LABS
650MG
A076200 001 Mar 19, 2002
PERRIGO
650MG
A075077 001 Feb 25, 2000
RANBAXY LABS LTD
650MG
A078569 001 Dec 14, 2011
TYLENOL
+ MCNEIL CONS
650MG
N019872 001 Jun 08, 1994
+
650MG
N019872 002 Jan 11, 2001
ACETAMINOPHEN; ASPIRIN; CAFFEINE
TABLET;ORAL
ACETAMINOPHEN, ASPIRIN AND CAFFEINE
PERRIGO 250MG;250MG;65MG
A075794 001 Nov 26, 2001
EXCEDRIN (MIGRAINE)
+ NOVARTIS 250MG;250MG;65MG
N020802 001 Jan 14, 1998
ALCOHOL; CHLORHEXIDINE GLUCONATE
SOLUTION;TOPICAL
AVAGARD
+ 3M 61%;1%
N021074 001 Jun 07, 2001
ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE
TABLET, CHEWABLE;ORAL
FOAMCOAT
GUARDIAN DRUG 80MG;20MG
A071793 001 Sep 04, 1987
GAVISCON
SANOFI AVENTIS US 80MG;20MG
N018685 001 Dec 09, 1983
+ 160MG;40MG
N018685 002 Dec 09, 1983
ASPIRIN
CAPSULE;ORAL
ASPIRIN
+ PLX PHARMA 325MG
N203697 001 Jan 14, 2013
AVOBENZONE; ECAMSULE; OCTOCRYLENE
CREAM;TOPICAL
ANTHELIOS SX
+ LOREAL USA 2%;2%;10%
N021502 001 Jul 21, 2006
CAPITAL SOLEIL 15
+ LOREAL USA 2%;3%;10%
N021501 001 Oct 02, 2006
AVOBENZONE; ECAMSULE; OCTOCRYLENE; TITANIUM DIOXIDE
CREAM;TOPICAL
ANTHELIOS 20
+ LOREAL USA 2%;2%;10%;2%
N021471 001 Oct 05, 2006
ANTHELIOS 40
+ LOREAL USA 2%;3%;10%;5%
N022009 001 Mar 31, 2008
+ 2%;3%;10%;5%
N022009 002 Oct 29, 2009
AVOBENZONE; OCTINOXATE; OXYBENZONE
LOTION;TOPICAL
SHADE UVAGUARD
+ SCHERING PLOUGH 3%;7.5%;3%
N020045 001 Dec 07, 1992
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST 4-2(of 17)
BENTOQUATAM
LOTION;TOPICAL
IVY BLOCK
+ STAND HOMEOPATH 5% N020532 001 Aug 26, 1996
BUTENAFINE HYDROCHLORIDE
CREAM;TOPICAL
LOTRIMIN ULTRA
+ SCHERING PLOUGH 1% N021307 001 Dec 07, 2001
BUTOCONAZOLE NITRATE
CREAM;VAGINAL
FEMSTAT 3
+ BAYER 2% N020421 001 Dec 21, 1995
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE
TABLET, CHEWABLE;ORAL
CALCIUM CARBONATE, FAMOTIDINE AND MAGNESIUM HYDROXIDE
PERRIGO R AND D 800MG;10MG;165MG A077355 001 Feb 06, 2008
PEPCID COMPLETE
+ MCNEIL CONS 800MG;10MG;165MG N020958 001 Oct 16, 2000
CETIRIZINE HYDROCHLORIDE
CAPSULE;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
BANNER PHARMACAPS 5MG N022429 001 Jul 23, 2009
+ 10MG N022429 004 Jul 23, 2009
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
BANNER PHARMACAPS 5MG N022429 003 Jul 23, 2009
+ 10MG N022429 002 Jul 23, 2009
SYRUP;ORAL
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
AMNEAL PHARMS 5MG/5ML A090765 002 Oct 07, 2009
AUROBINDO PHARMA 5MG/5ML A090750 002 Feb 02, 2010
BIO PHARM INC 5MG/5ML A090474 002 Mar 30, 2009
CYPRESS PHARM 5MG/5ML A090300 001 Oct 10, 2008
PERRIGO R AND D 5MG/5ML A204226 001 Sep 09, 2013
5MG/5ML A090254 002 Apr 09, 2008
SILARX 5MG/5ML A091130 001 Apr 22, 2011
SUN PHARM INDS INC 5MG/5ML A091327 001 Oct 17, 2011
TARO 5MG/5ML A090182 002 Apr 22, 2008
5MG/5ML A201546 001 May 20, 2011
TRIS PHARMA INC 5MG/5ML A090572 001 Nov 16, 2012
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
AMNEAL PHARMS 5MG/5ML A090765 001 Oct 07, 2009
AUROBINDO PHARMA 5MG/5ML A090750 001 Feb 02, 2010
BIO PHARM INC 5MG/5ML A090474 001 Mar 30, 2009
CYPRESS PHARM 5MG/5ML A090300 002 Oct 10, 2008
PERRIGO R AND D 5MG/5ML A090254 001 Apr 09, 2008
SILARX 5MG/5ML A091130 002 Apr 22, 2011
SUN PHARM INDS INC 5MG/5ML A091327 002 Oct 17, 2011
TARO 5MG/5ML A090182 001 Apr 22, 2008
5MG/5ML A201546 002 May 20, 2011
TRIS PHARMA INC 5MG/5ML A090572 002 Nov 16, 2012
CHILDREN'S ZYRTEC ALLERGY
+ MCNEIL CONSUMER 5MG/5ML N022155 002 Nov 16, 2007
CHILDREN'S ZYRTEC HIVES RELIEF
+ MCNEIL CONSUMER 5MG/5ML N022155 001 Nov 16, 2007
TABLET;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
AMNEAL PHARMS NY 5MG A078780 001 Jan 21, 2010
10MG A078780 004 Jan 21, 2010
APOTEX INC 5MG A078317 001 Dec 27, 2007
10MG A078317 002 Dec 27, 2007
CADISTA PHARMS 5MG A078933 001 Jun 15, 2010
10MG A078933 002 Jun 15, 2010
CIPLA LTD 5MG A077318 001 Jul 25, 2013
10MG A077318 002 Jul 25, 2013
CONTRACT PHARMACAL 5MG A076047 001 Dec 27, 2007
10MG A076047 002 Dec 27, 2007
DR REDDYS LABS LTD 5MG A078343 004 Jan 15, 2008
10MG A078343 003 Jan 15, 2008
IPCA LABS LTD 5MG A202277 002 Mar 11, 2014
10MG A202277 004 Mar 11, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
4-3(of 17)
CETIRIZINE HYDROCHLORIDE
TABLET;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
MYLAN
5MG
A076677 001 Dec 27, 2007
10MG
A076677 002 Dec 27, 2007
ORCHID HLTHCARE
5MG
A078862 001 Feb 19, 2009
10MG
A078862 002 Feb 19, 2009
PERRIGO R AND D
5MG
A078336 001 Dec 27, 2007
10MG
A078336 002 Dec 27, 2007
RANBAXY
5MG
A077498 001 Dec 27, 2007
10MG
A077498 002 Dec 27, 2007
SANDOZ
5MG
A077946 001 Dec 27, 2007
10MG
A077946 002 Dec 27, 2007
SUN PHARM INDS INC
5MG
A077499 001 Dec 27, 2007
10MG
A077499 002 Dec 27, 2007
TARO
5MG
A078072 001 Jul 22, 2009
5MG
A078072 003 Jul 22, 2009
TORRENT PHARMS LLC
5MG
A079191 001 Apr 15, 2010
10MG
A079191 004 Apr 15, 2010
UNICHEM
5MG
A078680 003 Jun 26, 2009
10MG
A078680 004 Jun 26, 2009
UNIQUE PHARM LABS
5MG
A077829 001 Aug 26, 2009
10MG
A077829 004 Aug 26, 2009
WOCKHARDT
5MG
A078427 003 Dec 28, 2007
10MG
A078427 004 Dec 28, 2007
CETIRIZINE HYDROCHLORIDE HIVES
CADISTA PHARMS
5MG
A078933 003 Jun 15, 2010
10MG
A078933 004 Jun 15, 2010
DR REDDYS LABS LTD
5MG
A078343 001 Jan 15, 2008
10MG
A078343 002 Jan 15, 2008
IPCA LABS LTD
5MG
A202277 001 Mar 11, 2014
10MG
A202277 003 Mar 11, 2014
MYLAN
5MG
A076677 004 Dec 27, 2007
10MG
A076677 003 Dec 27, 2007
ORCHID HLTHCARE
5MG
A078862 003 Feb 19, 2009
10MG
A078862 004 Feb 19, 2009
PERRIGO R AND D
5MG
A078336 003 Dec 27, 2007
10MG
A078336 004 Dec 27, 2007
RANBAXY
5MG
A077498 003 Dec 27, 2007
10MG
A077498 004 Dec 27, 2007
SUN PHARM INDS INC
5MG
A077499 003 Dec 27, 2007
10MG
A077499 004 Dec 27, 2007
UNICHEM
5MG
A078680 001 Jun 26, 2009
10MG
A078680 002 Jun 26, 2009
UNIQUE PHARM LABS
5MG
A077829 003 Aug 26, 2009
10MG
A077829 002 Aug 26, 2009
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
AMNEAL PHARMS NY 5MG A078780 003 Jan 21, 2010
10MG A078780 002 Jan 21, 2010
TARO 10MG A078072 002 Jul 22, 2009
10MG A078072 004 Jul 22, 2009
TORRENT PHARMS LLC 5MG A079191 003 Apr 15, 2010
10MG A079191 002 Apr 15, 2010
ZYRTEC ALLERGY
MCNEIL CONSUMER 5MG N019835 003 Nov 16, 2007
+ 10MG N019835 004 Nov 16, 2007
ZYRTEC HIVES RELIEF
MCNEIL CONSUMER 5MG N019835 005 Nov 16, 2007
+ 10MG N019835 006 Nov 16, 2007
TABLET, CHEWABLE;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
SANDOZ 5MG
A078692 001 Feb 14, 2008
+ 10MG
A078692 002 Feb 14, 2008
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
SUN PHARMA GLOBAL 5MG
A090142 001 Aug 30, 2011
10MG
A090142 002 Aug 30, 2011
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
SUN PHARMA GLOBAL 5MG
A090142 003 Aug 30, 2011
10MG
A090142 004 Aug 30, 2011
TABLET, ORALLY DISINTEGRATING;ORAL
ZYRTEC ALLERGY
+ MCNEIL CONSUMER 10MG
N022578 001 Sep 03, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
4-4(of 17)
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
IVAX SUB TEVA PHARMS
5MG;120MG
A077170 001 Feb 25, 2008
SANDOZ
5MG;120MG
A077991 001 Mar 05, 2008
SUN PHARM INDS LTD
5MG;120MG
A090922 001 Sep 28, 2012
ZYRTEC-D 12 HOUR
+ MCNEIL
5MG;120MG
N021150 002 Nov 09, 2007
CHLORHEXIDINE GLUCONATE
AEROSOL, METERED;TOPICAL
EXIDINE
+ XTTRIUM
4%
N019127 001 Dec 24, 1984
CLOTH;TOPICAL
CHLORHEXIDINE GLUCONATE
+ SAGE PRODS
2%
N021669 001 Apr 25, 2005
SOLUTION;TOPICAL
BRIAN CARE
SOAPCO
4%
A071419 001 Dec 17, 1987
CHG SCRUB
ECOLAB
4%
N019258 002 Jul 22, 1986
CIDA-STAT
ECOLAB
2%
N019258 001 Jul 22, 1986
DYNA-HEX
BAJAJ MEDICAL LLC
0.75%
N020111 001 Sep 11, 1997
EXIDINE
+ XTTRIUM
2%
N019422 001 Dec 17, 1985
4%
N019125 001 Dec 24, 1984
HIBICLENS
+ MOLNLYCKE HLTH
4%
N017768 001
HIBISTAT
+ MOLNLYCKE HLTH
0.5%
N018300 001
SPONGE;TOPICAL
BIOSCRUB
GRIFFEN
4%
N019822 001 Mar 31, 1989
CHLORHEXIDINE GLUCONATE
BECTON DICKINSON
4%
A072525 001 Oct 24, 1989
PHARMASEAL SCRUB CARE
+ CAREFUSION
4%
N019793 001 Dec 02, 1988
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL
SPONGE;TOPICAL
CHLORAPREP ONE-STEP
+ CAREFUSION
2%;70% (3ML)
N020832 001 Jul 14, 2000
+
2%;70% (10.5ML)
N020832 004 Aug 20, 2003
+
2%;70% (26ML)
N020832 006 Nov 21, 2006
CHLORAPREP ONE-STEP FREPP
+ CAREFUSION
2%;70% (1.5ML)
N020832 003 Apr 26, 2002
CHLORAPREP WITH TINT
+ CAREFUSION
2%;70% (26ML)
N020832 002 May 03, 2005
+
2%;70% (10.5ML)
N020832 005 Apr 03, 2006
+
2%;70% (3ML)
N020832 007 Oct 10, 2006
SWAB;TOPICAL
CHLORAPREP ONE-STEP SEPP
+ CAREFUSION
2%;70% (0.67ML)
N021555 001 Oct 07, 2002
CHLORAPREP SINGLE SWABSTICK
+ CAREFUSION
2%;70% (1.75ML)
N021555 002 May 10, 2005
CHLORAPREP TRIPLE SWABSTICK
+ CAREFUSION
2%;70% (5.25ML)
N021555 003 Jun 10, 2009
PREVANTICS MAXI SWABSTICK
+ PROF DSPLS
3.15%;70% (5.1ML)
N021524 003 Jun 03, 2005
PREVANTICS SWAB
+ PROF DSPLS
3.15%;70% (1ML)
N021524 001 Jun 03, 2005
PREVANTICS SWABSTICK
+ PROF DSPLS
3.15%;70% (1.6ML)
N021524 002 Jun 03, 2005
CHLORPHENIRAMINE MALEATE
TABLET, EXTENDED RELEASE;ORAL
CHLOR-TRIMETON
+ SCHERING PLOUGH
12MG
N007638 002
CHLORPHENIRAMINE MALEATE
AVANTHI INC
12MG
A040829 001 May 13, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
4-5(of 17)
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
TABLET;ORAL
ADVIL ALLERGY AND CONGESTION RELIEF
+ PFIZER 4MG;200MG;10MG
N022113 001 Dec 21, 2011
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
SUSPENSION;ORAL
CHILDREN'S ADVIL ALLERGY SINUS
+ PFIZER 1MG/5ML;100MG/5ML;15MG/5ML
N021587 001 Feb 24, 2004
TABLET;ORAL
ADVIL ALLERGY SINUS
+ PFIZER 2MG;200MG;30MG
N021441 001 Dec 19, 2002
CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
CHLOR-TRIMETON
+ SCHERING PLOUGH
8MG;120MG
N018397 001
CIMETIDINE
TABLET;ORAL
CIMETIDINE
APOTEX
100MG
A074948 001 Jun 19, 1998
200MG
A074948 002 Jul 26, 2002
CONTRACT PHARMACAL
200MG
A074961 001 Jun 19, 1998
200MG
A074963 001 Jun 19, 1998
IVAX SUB TEVA PHARMS
200MG
A075345 001 Jun 16, 1999
PERRIGO
200MG
A075285 001 Oct 29, 1998
TAGAMET HB
+ MEDTECH PRODUCTS
200MG
N020238 002 Aug 21, 1996
CLEMASTINE FUMARATE
TABLET;ORAL
CLEMASTINE FUMARATE
PERRIGO
1.34MG
A074512 001 Nov 22, 1995
SANDOZ
1.34MG
A073458 001 Oct 31, 1993
TAVIST-1
+ NOVARTIS
1.34MG
N020925 001 Aug 21, 1992
CLOTRIMAZOLE
CREAM;VAGINAL
CLOTRIMAZOLE
ACTAVIS MID ATLANTIC
1%
A074165 001 Jul 16, 1993
TARO
1%
A072641 001 Dec 04, 1995
GYNE-LOTRIMIN
+ SCHERING PLOUGH
1%
N018052 002 Nov 30, 1990
GYNE-LOTRIMIN 3
+ SCHERING PLOUGH
2%
N020574 001 Nov 24, 1998
MYCELEX-7
BAYER HEALTHCARE LLC
1%
N018230 002 Dec 26, 1991
TRIVAGIZOLE 3
TARO
2%
N021143 001 Apr 12, 2000
CREAM, TABLET;TOPICAL, VAGINAL
GYNE-LOTRIMIN 3 COMBINATION PACK
+ BAYER HEALTHCARE LLC 200MG;200MG
N020526 002 Jul 29, 1996
GYNE-LOTRIMIN COMBINATION PACK
+ SCHERING PLOUGH 100MG;100MG
N020289 002 Apr 26, 1993
MYCELEX-7 COMBINATION PACK
BAYER HEALTHCARE LLC
1%;100MG
N020389 002 Jun 23, 1994
TABLET;VAGINAL
GYNE-LOTRIMIN
+ SCHERING PLOUGH
100MG
N017717 002 Nov 30, 1990
GYNE-LOTRIMIN 3
+ BAYER HEALTHCARE LLC
200MG
N020525 001 Jul 29, 1996
MYCELEX-7
BAYER HEALTHCARE LLC
100MG
N018182 002 Dec 26, 1991
CROMOLYN SODIUM
SPRAY, METERED;NASAL
CROMOLYN SODIUM
+ BAUSCH AND LOMB
5.2MG/SPRAY
A075702 001 Jul 03, 2001
PERRIGO
5.2MG/SPRAY
A075427 001 Dec 12, 2001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST 4-6(of 17)
DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE
+ AVANTHI INC 6MG;120MG A078648 001 Feb 27, 2013
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN
TABLET, EXTENDED RELEASE;ORAL
MUCINEX DM
RECKITT BENCKISER 30MG;600MG N021620 002 Apr 29, 2004
+ 60MG;1.2GM N021620 001 Apr 29, 2004
DEXTROMETHORPHAN POLISTIREX
SUSPENSION, EXTENDED RELEASE;ORAL
DELSYM
+ RECKITT BENCKISER EQ 30MG HBR/5ML N018658 001 Oct 08, 1982
DEXTROMETHORPHAN POLISTIREX
TRIS PHARMA INC EQ 30MG HBR/5ML A091135 001 May 25, 2012
DIPHENHYDRAMINE CITRATE; IBUPROFEN
TABLET;ORAL
ADVIL PM
+ PFIZER 38MG;200MG N021394 001 Dec 21, 2005
IBUPROFEN AND DIPHENHYDRAMINE CITRATE
DR REDDYS LABS LTD 38MG;200MG A090619 001 Jul 08, 2009
PERRIGO R AND D 38MG;200MG A079113 001 Dec 22, 2008
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN
CAPSULE;ORAL
ADVIL PM
+ PFIZER 25MG;EQ 200MG FREE ACID AND POTASSIUM N021393 001 Dec 21, 2005
SALT
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE
BANNER PHARMACAPS 25MG;EQ 200MG FREE ACID AND POTASSIUM A090397 001 Nov 22, 2010
SALT
STRIDES PHARMA 25MG;EQ 200MG FREE ACID AND POTASSIUM A200888 001 Mar 05, 2012
SALT
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM
TABLET;ORAL
ALEVE PM
+ BAYER HLTHCARE 25MG;220MG N205352 001 Jan 17, 2014
DOCOSANOL
CREAM;TOPICAL
ABREVA
+ GLAXOSMITHKLINE 10% N020941 001 Jul 25, 2000
DOXYLAMINE SUCCINATE
TABLET;ORAL
DOXYLAMINE SUCCINATE
LNK 25MG A040564 001 Aug 27, 2004
PERRIGO 25MG A040167 001 Sep 18, 1996
UNISOM
+ CHATTEM 25MG N018066 001
ESOMEPRAZOLE MAGNESIUM
CAPSULE, DELAYED RELEASE;ORAL
NEXIUM 24HR
+ ASTRAZENECA LP EQ 20MG BASE N204655 001 Mar 28, 2014
FAMOTIDINE
TABLET;ORAL
FAMOTIDINE
DR REDDYS LABS LTD 10MG A075758 001 Aug 17, 2001
20MG A077367 001 Sep 25, 2006
IVAX SUB TEVA PHARMS 10MG A075512 001 Jul 26, 2001
MYLAN 10MG A075674 001 Dec 21, 2001
PERRIGO 10MG A075400 001 Mar 18, 2005
20MG A077351 001 Sep 25, 2006
RANBAXY 10MG A090283 001 Nov 17, 2009
20MG A090283 002 Nov 17, 2009
TEVA 10MG A075312 001 May 31, 2001
WOCKHARDT 10MG A077146 001 Mar 07, 2005
20MG A090837 001 Aug 04, 2010
PEPCID AC
MCNEIL CONS 10MG N020325 001 Apr 28, 1995
+ 20MG N020325 002 Sep 23, 2003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST 4-7(of 17)
FAMOTIDINE
TABLET;ORAL
PEPCID AC
MCNEIL CONS 10MG N020902 001 Aug 05, 1999
TABLET, CHEWABLE;ORAL
FAMOTIDINE
PERRIGO 10MG A075715 001 Aug 22, 2003
PEPCID AC
+ MCNEIL CONS 20MG N020801 002 Dec 17, 2007
FEXOFENADINE HYDROCHLORIDE
SUSPENSION;ORAL
CHILDREN'S ALLEGRA ALLERGY
+ SANOFI AVENTIS US 30MG/5ML N201373 001 Jan 24, 2011
CHILDREN'S ALLEGRA HIVES
+ SANOFI AVENTIS US 30MG/5ML N201373 002 Jan 24, 2011
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
ACTAVIS MID ATLANTIC 30MG/5ML A203330 001 Nov 18, 2014
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
ACTAVIS MID ATLANTIC 30MG/5ML A203330 002 Nov 18, 2014
TABLET;ORAL
ALLEGRA ALLERGY
SANOFI AVENTIS US 60MG N020872 007 Jan 24, 2011
+ 180MG N020872 010 Jan 24, 2011
ALLEGRA HIVES
SANOFI AVENTIS US 60MG N020872 008 Jan 24, 2011
+ 180MG N020872 009 Jan 24, 2011
CHILDREN'S ALLEGRA ALLERGY
SANOFI AVENTIS US 30MG N020872 005 Jan 24, 2011
CHILDREN'S ALLEGRA HIVES
SANOFI AVENTIS US 30MG N020872 006 Jan 24, 2011
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
AUROLIFE PHARMA LLC 30MG A202039 001 Nov 19, 2014
DR REDDYS LABS LTD 30MG A076502 004 Apr 12, 2011
MYLAN 30MG A077081 004 Jul 21, 2011
SUN PHARM INDS 30MG A091567 002 Feb 06, 2012
TEVA 30MG A076447 004 Apr 13, 2011
WOCKHARDT LTD 30MG A079112 002 Feb 08, 2012
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
DR REDDYS LABS LTD 30MG A076502 005 Apr 12, 2011
MYLAN 30MG A077081 005 Jul 21, 2011
SUN PHARM INDS 30MG A091567 001 Feb 06, 2012
TEVA 30MG A076447 005 Apr 13, 2011
WOCKHARDT LTD 30MG A079112 001 Feb 08, 2012
FEXOFENADINE HYDROCHLORIDE ALLERGY
AUROLIFE PHARMA LLC 60MG A202039 002 Nov 19, 2014
180MG A202039 003 Nov 19, 2014
DR REDDYS LABS LTD 60MG A076502 006 Apr 12, 2011
180MG A076502 008 Apr 12, 2011
MYLAN 60MG A077081 006 Jul 21, 2011
180MG A077081 008 Jul 21, 2011
SUN PHARM INDS 60MG A091567 004 Feb 06, 2012
180MG A091567 006 Feb 06, 2012
TEVA 60MG A076447 006 Apr 13, 2011
180MG A076447 008 Apr 13, 2011
WOCKHARDT LTD 60MG A079112 004 Feb 08, 2012
180MG A079112 006 Feb 08, 2012
FEXOFENADINE HYDROCHLORIDE HIVES
DR REDDYS LABS LTD 60MG A076502 007 Apr 12, 2011
180MG A076502 009 Apr 12, 2011
MYLAN 60MG A077081 007 Jul 21, 2011
180MG A077081 009 Jul 21, 2011
SUN PHARM INDS 60MG A091567 003 Feb 06, 2012
180MG A091567 005 Feb 06, 2012
TEVA 60MG A076447 007 Apr 13, 2011
180MG A076447 009 Apr 13, 2011
WOCKHARDT LTD 60MG A079112 003 Feb 08, 2012
180MG A079112 005 Feb 08, 2012
TABLET, ORALLY DISINTEGRATING;ORAL
CHILDREN'S ALLEGRA ALLERGY
+ SANOFI AVENTIS US 30MG N021909 002 Jan 24, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
4-8(of 17)
FEXOFENADINE HYDROCHLORIDE
TABLET, ORALLY DISINTEGRATING;ORAL
CHILDREN'S ALLEGRA HIVES
+ SANOFI AVENTIS US 30MG
N021909 003 Jan 24, 2011
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
DR REDDYS LABS LTD 30MG
A202978 001 Jan 18, 2013
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
DR REDDYS LABS LTD 30MG
A202978 002 Jan 18, 2013
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
+ SANOFI AVENTIS US 60MG;120MG
N020786 002 Jan 24, 2011
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
+ SANOFI AVENTIS US 180MG;240MG
N021704 002 Jan 24, 2011
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
DR REDDYS LABS LTD
60MG;120MG
A076667 001 Nov 18, 2014
180MG;240MG
A079043 002 Jun 22, 2011
FLUTICASONE PROPIONATE
SPRAY, METERED;NASAL
FLONASE ALLERGY RELIEF
+ GLAXOSMITHKLINE CONS
0.05MG/SPRAY
N205434 001 Jul 23, 2014
GUAIFENESIN
TABLET, EXTENDED RELEASE;ORAL
GUAIFENESIN
PERRIGO R AND D
600MG
A078912 001 Nov 23, 2011
MUCINEX
+ RECKITT BENCKISER
1.2GM
N021282 002 Dec 18, 2002
600MG
N021282 001 Jul 12, 2002
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
MUCINEX D
+ RECKITT BENCKISER
1.2GM;120MG
N021585 002 Jun 22, 2004
600MG;60MG
N021585 001 Jun 22, 2004
IBUPROFEN
CAPSULE;ORAL
ADVIL LIQUI-GELS
+ PFIZER
EQ 200MG FREE ACID AND POTASSIUM SALT
N020402 001 Apr 20, 1995
ADVIL MIGRAINE LIQUI-GELS
+ PFIZER
EQ 200MG FREE ACID AND POTASSIUM SALT
N020402 002 Mar 16, 2000
IBUPROFEN
AMNEAL PHARMS
EQ 200MG FREE ACID AND POTASSIUM SALT
A202300 001 Dec 23, 2011
BANNER PHARMACAPS
EQ 200MG FREE ACID AND POTASSIUM SALT
A078682 001 Mar 24, 2009
+ CONTRACT PHARMACAL
200MG
A074782 001 Jul 06, 1998
MARKSANS PHARMA
EQ 200MG FREE ACID AND POTASSIUM SALT
A079205 001 Jun 26, 2009
P AND L DEV LLC
EQ 200MG FREE ACID AND POTASSIUM SALT
A077338 001 Jul 10, 2009
MIDOL LIQUID GELS
+ BANNER PHARMACAPS
200MG
N021472 001 Oct 18, 2002
SUSPENSION;ORAL
CHILDREN'S ADVIL
PFIZER
100MG/5ML
N020589 001 Jun 27, 1996
CHILDREN'S ADVIL-FLAVORED
PFIZER
100MG/5ML
N020589 002 Nov 07, 1997
CHILDREN'S ELIXSURE
MOBERG PHARMA NORTH
100MG/5ML
N021604 001 Jan 07, 2004
CHILDREN'S IBUPROFEN
PERRIGO
100MG/5ML
A074937 001 Dec 22, 1998
CHILDREN'S MOTRIN
+ MCNEIL
100MG/5ML
N020516 001 Jun 16, 1995
IBUPROFEN
ACTAVIS MID ATLANTIC
100MG/5ML
A074916 001 Apr 30, 1999
AMNEAL PHARMS
100MG/5ML
A200457 001 Aug 18, 2011
SUSPENSION/DROPS;ORAL
CHILDREN'S MOTRIN
+ MCNEIL CONS
40MG/ML
N020603 001 Jun 10, 1996
IBUPROFEN
PERRIGO
40MG/ML
A075217 001 Dec 16, 1998
TRIS PHARMA INC
40MG/ML
A079058 001 Aug 31, 2009
PEDIATRIC ADVIL
+ PFIZER
100MG/2.5ML
N020812 001 Jan 30, 1998
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
4-9(of 17)
IBUPROFEN
TABLET;ORAL
ADVIL
PFIZER
200MG
N018989 001 May 18, 1984
IBU-TAB 200
ALRA
200MG
A071057 001 Aug 11, 1988
IBUPROFEN
AMNEAL PHARMS
200MG
A079233 001 Mar 18, 2014
AMNEAL PHARMS NY
200MG
A071333 001 Feb 17, 1987
200MG
A072199 001 May 23, 1988
AVEMA PHARMA
200MG
A076460 001 Nov 26, 2003
CONTRACT PHARMACAL
200MG
A071732 001 Sep 10, 1987
200MG
A071735 001 Sep 10, 1987
200MG
A072299 001 Jul 01, 1988
200MG
A074931 001 Jul 20, 1998
DR REDDYS LA
200MG
A075661 001 Dec 12, 2001
DR REDDYS LABS INC
100MG
A076117 001 Nov 20, 2001
GRANULES INDIA
200MG
A079174 001 Dec 10, 2010
LNK
100MG
A076741 001 Jun 17, 2004
200MG
A075010 001 Mar 01, 1999
200MG
A075139 001 Mar 01, 1999
MARKSANS PHARMA
200MG
A091237 001 Feb 08, 2011
200MG
A091239 001 Feb 01, 2011
MCNEIL
200MG
A073019 001 Mar 30, 1994
MERRO PHARM
200MG
A070985 001 Oct 02, 1987
OHM
200MG
A071163 001 Jul 15, 1986
PAR PHARM
200MG
A070481 001 Sep 24, 1986
PERRIGO
200MG
A072096 001 Dec 08, 1987
200MG
A075995 001 Mar 14, 2002
PERRIGO R AND D
200MG
A077349 001 Jun 21, 2005
SVADS HOLDINGS SA
200MG
A079129 001 Mar 28, 2011
200MG
A091355 001 Apr 04, 2011
VINTAGE PHARMS
200MG
A071229 001 Apr 01, 1987
200MG
A071639 001 Feb 02, 1988
IBUPROHM
OHM LABS
200MG
A071214 001 Dec 01, 1986
JUNIOR STRENGTH ADVIL
PFIZER
100MG
N020267 002 Dec 13, 1996
JUNIOR STRENGTH IBUPROFEN
PERRIGO
100MG
A075367 001 Apr 22, 1999
JUNIOR STRENGTH MOTRIN
MCNEIL CONS
100MG
N020602 001 Jun 10, 1996
MOTRIN IB
+ MCNEIL
200MG
N019012 003 Dec 17, 1990
MOTRIN MIGRAINE PAIN
+ MCNEIL
200MG
N019012 004 Feb 25, 2000
PROFEN
CONTRACT PHARMACAL
200MG
A071265 001 Oct 15, 1986
TAB-PROFEN
PERRIGO
200MG
A072095 001 Dec 08, 1987
TABLET, CHEWABLE;ORAL
CHILDREN'S ADVIL
PFIZER
50MG
N020944 001 Dec 18, 1998
CHILDREN'S MOTRIN
MCNEIL CONS
50MG
N020601 001 Nov 15, 1996
IBUPROFEN
PERRIGO
50MG
A076359 001 Jan 16, 2004
100MG
A076359 002 Jan 16, 2004
JUNIOR STRENGTH ADVIL
PFIZER
100MG
N020944 002 Dec 18, 1998
JUNIOR STRENGTH MOTRIN
+ MCNEIL CONS
100MG
N020601 003 Nov 15, 1996
IBUPROFEN SODIUM
TABLET;ORAL
ADVIL
+ PFIZER CONS HLTHCARE
EQ 200MG BASE
N201803 001 Jun 12, 2012
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
4-10(of 17)
IBUPROFEN; PHENYLEPHRINE HYDROCHLORIDE
TABLET;ORAL
ADVIL CONGESTION RELIEF
+ PFIZER 200MG;10MG
N022565 001
May 27, 2010
IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE
PERRIGO R AND D 200MG;10MG
A203200 001
Jul 03, 2014
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE
CAPSULE;ORAL
ADVIL COLD AND SINUS
+ PFIZER
EQ 200MG FREE ACID AND POTASSIUM
N021374 001
May 30, 2002
SALT;30MG
SUSPENSION;ORAL
CHILDREN'S ADVIL COLD
PFIZER
100MG/5ML;15MG/5ML
N021373 001
Apr 18, 2002
CHILDREN'S MOTRIN COLD
+ MCNEIL CONS
100MG/5ML;15MG/5ML
N021128 001
Aug 01, 2000
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
PERRIGO 100MG/5ML;15MG/5ML
A076478 001
Nov 05, 2003
TABLET;ORAL
ADVIL COLD AND SINUS
+ PFIZER 200MG;30MG
N019771 001
Sep 19, 1989
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE
CONTRACT PHARMACAL
200MG;30MG
A075588 001
Apr 08, 2002
DR REDDYS LABS LTD
200MG;30MG
A077628 001
Aug 14, 2006
IBUPROHM COLD AND SINUS
OHM LABS
200MG;30MG
A074567 001
Apr 17, 2001
SINE-AID IB
MCNEIL CONS
200MG;30MG
N019899 001
Dec 31, 1992
INSULIN RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN R
+ LILLY
100 UNITS/ML
N018780 001
Oct 28, 1982
HUMULIN R PEN
+ LILLY
100 UNITS/ML
N018780 005
Aug 06, 1998
NOVOLIN R
+ NOVO NORDISK INC
100 UNITS/ML
N019938 001
Jun 25, 1991
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN 70/30
+ LILLY 30 UNITS/ML;70 UNITS/ML
N019717 001
Apr 25, 1989
HUMULIN 70/30 PEN
+ LILLY 30 UNITS/ML;70 UNITS/ML
N019717 002
Aug 06, 1998
NOVOLIN 70/30
+ NOVO NORDISK INC 30 UNITS/ML;70 UNITS/ML
N019991 001
Jun 25, 1991
INSULIN SUSP ISOPHANE RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN N
+ LILLY 100 UNITS/ML
N018781 001
Oct 28, 1982
NOVOLIN N
+ NOVO NORDISK INC 100 UNITS/ML
N019959 001
Jul 01, 1991
IODINE POVACRYLEX; ISOPROPYL ALCOHOL
SPONGE;TOPICAL
DURAPREP
+ 3M
EQ 0.7% IODINE;74% (6ML)
N021586 001
Sep 29, 2006
+
EQ 0.7% IODINE;74% (26ML)
N021586 002
Sep 29, 2006
KETOCONAZOLE
SHAMPOO;TOPICAL
NIZORAL A-D
+ JOHNSON AND JOHNSON
1%
N020310 001
Oct 10, 1997
KETOTIFEN FUMARATE
SOLUTION/DROPS;OPHTHALMIC
ALAWAY
+ BAUSCH AND LOMB
EQ 0.025% BASE
N021996 001
Dec 01, 2006
KETOTIFEN FUMARATE
AKORN
EQ 0.025% BASE
A077958 001
Jul 26, 2007
ALCON PHARMS LTD
EQ 0.025% BASE
A077200 001
Sep 02, 2008
ZADITOR
+ ALCON PHARMA
EQ 0.025% BASE
N021066 002
Oct 19, 2006
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST 4-11(of 17)
LANSOPRAZOLE
CAPSULE, DELAYED REL PELLETS;ORAL
LANSOPRAZOLE
DR REDDYS LABS LTD 15MG A202194 001 May 18, 2012
PERRIGO R AND D 15MG A202319 001 May 18, 2012
WOCKHARDT LTD 15MG A202727 001 May 18, 2012
PREVACID 24 HR
+ NOVARTIS 15MG N022327 001 May 18, 2009
LEVONORGESTREL
TABLET;ORAL
FALLBACK SOLO
LUPIN LTD 1.5MG A201446 001 Jun 19, 2014
LEVONORGESTREL
FAMY CARE LTD 1.5MG A202739 001 Oct 31, 2014
NOVEL LABS INC 1.5MG A202508 001 Feb 22, 2013
PERRIGO R AND D 0.75MG A090740 001 Dec 30, 2010
1.5MG A202334 001 Aug 20, 2014
+ WATSON LABS 0.75MG A078665 001 Aug 28, 2009
WATSON LABS INC 1.5MG A200670 001 Jul 12, 2012
OPCICON ONE-STEP
SUN PHARM INDS LTD 1.5MG A202635 001 Sep 11, 2014
PLAN B
+ TEVA BRANDED PHARM 0.75MG N021045 002 Aug 24, 2006
PLAN B ONE-STEP
+ TEVA BRANDED PHARM 1.5MG N021998 001 Jul 10, 2009
LOPERAMIDE HYDROCHLORIDE
CAPSULE;ORAL
LOPERAMIDE HYDROCHLORIDE
BANNER PHARMACAPS 1MG N021855 001 Aug 04, 2005
+ 2MG N021855 002 Aug 04, 2005
SOLUTION;ORAL
IMODIUM A-D
+ MCNEIL CONS 1MG/5ML N019487 001 Mar 01, 1988
LOPERAMIDE HYDROCHLORIDE
HI TECH PHARMA 1MG/5ML A074352 001 Nov 17, 1995
PERRIGO 1MG/5ML A073243 001 Jan 21, 1992
ROXANE 1MG/5ML A073079 001 Apr 30, 1992
WOCKHARDT 1MG/5ML A074730 001 Aug 28, 1997
SUSPENSION;ORAL
IMODIUM A-D
+ MCNEIL CONS 1MG/7.5ML N019487 002 Jul 08, 2004
LOPERAMIDE HYDROCHLORIDE
PERRIGO R AND D 1MG/7.5ML A091292 001 May 20, 2011
TABLET;ORAL
IMODIUM A-D
+ MCNEIL CONS 2MG N019860 001 Nov 22, 1989
LOPERAMIDE HYDROCHLORIDE
CONTRACT PHARMACAL 2MG A073254 001 Jul 30, 1993
LNK 2MG A076497 001 Jun 10, 2003
OHM LABS 2MG A074091 001 Dec 10, 1992
PERRIGO 2MG A075232 001 Jan 06, 2000
TABLET, CHEWABLE;ORAL
IMODIUM A-D EZ CHEWS
+ MCNEIL 2MG N020448 001 Jul 24, 1997
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE
TABLET;ORAL
IMODIUM MULTI-SYMPTOM RELIEF
+ MCNEIL CONS 2MG;125MG N021140 001 Nov 30, 2000
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
RANBAXY 2MG;125MG A077500 001 Sep 06, 2006
TABLET, CHEWABLE;ORAL
IMODIUM MULTI-SYMPTOM RELIEF
+ MCNEIL 2MG;125MG N020606 001 Jun 26, 1996
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE
PERRIGO 2MG;125MG A076029 001 Aug 30, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST 4-12(of 17)
LORATADINE
CAPSULE;ORAL
CLARITIN
+ SCHERING PLOUGH 10MG N021952 001 Jun 16, 2008
SUSPENSION;ORAL
LORATADINE
+ TARO 1MG/ML N021734 001 Oct 04, 2005
SYRUP;ORAL
CLARITIN
+ SCHERING PLOUGH 1MG/ML N020641 002 Nov 27, 2002
LORATADINE
PERRIGO 1MG/ML A075728 001 Aug 20, 2004
SILARX 1MG/ML A077421 001 Jun 29, 2006
TARO 1MG/ML A076805 001 Aug 20, 2004
TEVA 1MG/ML A075505 001 Nov 07, 2003
WOCKHARDT 1MG/ML A075815 001 Aug 20, 2004
TABLET;ORAL
CLARITIN
+ BAYER HEALTHCARE LLC 10MG N019658 002 Nov 27, 2002
CLARITIN HIVES RELIEF
+ BAYER HEALTHCARE LLC 10MG N019658 003 Nov 19, 2003
LORATADINE
APOTEX INC 10MG A076471 001 Feb 14, 2006
MYLAN 10MG A075790 001 Nov 07, 2008
10MG A076154 001 Aug 20, 2003
10MG A078447 001 Aug 12, 2011
PERRIGO 10MG A076301 001 Jun 25, 2004
RANBAXY 10MG A076134 001 Aug 18, 2003
SANDOZ 10MG A075209 001 Jan 21, 2003
TABLET, CHEWABLE;ORAL
CHILDREN'S CLARITIN
+ SCHERING PLOUGH 5MG N021891 001 Aug 23, 2006
TABLET, ORALLY DISINTEGRATING;ORAL
ALAVERT
PFIZER 10MG N021375 001 Dec 19, 2002
CLARITIN HIVES RELIEF REDITAB
+ BAYER HEALTHCARE LLC 10MG N020704 003 Nov 19, 2003
CLARITIN REDITABS
+ BAYER HEALTHCARE LLC 10MG N020704 002 Nov 27, 2002
+ SCHERING PLOUGH 5MG N021993 001 Dec 12, 2006
LORATADINE
ACTAVIS LABS FL INC 10MG A075990 001 Nov 03, 2003
IMPAX LABS 10MG A076011 001 Sep 29, 2003
PFIZER 10MG A075822 001 Feb 10, 2003
LORATADINE REDIDOSE
RANBAXY 10MG A077153 001 Apr 11, 2007
LORATADINE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
CLARITIN-D
+ SCHERING PLOUGH 5MG;120MG N019670 002 Nov 27, 2002
CLARITIN-D 24 HOUR
+ SCHERING PLOUGH 10MG;240MG N020470 002 Nov 27, 2002
LORATADINE AND PSEUDOEPHEDRINE SULFATE
ACTAVIS LABS FL INC 10MG;240MG A075706 001 Feb 21, 2003
IMPAX LABS 5MG;120MG A076050 001 Jan 30, 2003
10MG;240MG A075989 001 Mar 04, 2004
RANBAXY 10MG;240MG A076557 001 Sep 22, 2004
MENTHOL; METHYL SALICYLATE
PATCH;TOPICAL
SALONPAS
+ HISAMITSU PHARM CO 3%;10% N022029 001 Feb 20, 2008
3%;10% N022029 002 Nov 05, 2012
MICONAZOLE NITRATE
CREAM;TOPICAL, VAGINAL
MICONAZOLE 3 COMBINATION PACK
PERRIGO 2%;4% A076357 001 Mar 30, 2004
MONISTAT 3 COMBINATION PACK
MEDTECH PRODUCTS 2%;4% N021261 003 Jun 17, 2003
MONISTAT 3 COMBINATION PACK (PREFILLED)
+ MEDTECH PRODUCTS 2%;4% N021261 001 Feb 02, 2001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST 4-13(of 17)
MICONAZOLE NITRATE
CREAM;VAGINAL
MICONAZOLE 3
TARO 4% A076773 001 Mar 02, 2005
MICONAZOLE 7
ACTAVIS MID ATLANTIC 2% A074164 001 Mar 29, 1996
MICONAZOLE NITRATE
G AND W LABS INC 2% A074366 001 Feb 22, 1996
PERRIGO 2% A074760 001 May 15, 1997
PERRIGO R AND D 4% A091366 001 Jan 15, 2010
TARO 2% A074444 001 Jan 13, 1997
MONISTAT 3
+ MEDTECH PRODUCTS 4% N020827 001 Mar 30, 1998
MONISTAT 7
+ MEDTECH PRODUCTS 2% N017450 002 Feb 15, 1991
CREAM, SUPPOSITORY;TOPICAL, VAGINAL
M-ZOLE 3 COMBINATION PACK
ACTAVIS MID ATLANTIC 2%;200MG A074926 001 Apr 16, 1999
MICONAZOLE 7 COMBINATION PACK
G AND W LABS 100MG;2% A076585 001 Mar 26, 2004
MICONAZOLE NITRATE
PERRIGO R AND D 1.2GM;2% A079114 001 Jun 02, 2010
MICONAZOLE NITRATE COMBINATION PACK
PERRIGO 200MG;200MG A075329 001 Apr 20, 1999
MONISTAT 1 COMBINATION PACK
+ MEDTECH PRODUCTS 1.2GM;2% N021308 001 Jun 29, 2001
MONISTAT 7 COMBINATION PACK
+ MEDTECH PRODUCTS 100MG;2% N020288 002 Apr 26, 1993
MONISTAT-3 COMBINATION PACK
+ MEDTECH PRODUCTS 2%;200MG N020670 002 Apr 16, 1996
SUPPOSITORY;VAGINAL
MICONAZOLE NITRATE
ACTAVIS MID ATLANTIC 100MG A073507 001 Nov 19, 1993
G AND W LABS 100MG A074414 001 Apr 30, 1997
+ PERRIGO 100MG A074395 001 Mar 20, 1997
MONISTAT 7
+ MEDTECH PRODUCTS 100MG N018520 002 Feb 15, 1991
MINOXIDIL
AEROSOL, FOAM;TOPICAL
MEN'S ROGAINE
+ JOHNSON AND JOHNSON 5% N021812 001 Jan 20, 2006
MINOXIDIL
PERRIGO ISRAEL 5% A091344 001 Apr 28, 2011
WOMEN'S ROGAINE
+ JOHNSON AND JOHNSON 5% N021812 002 Feb 28, 2014
SOLUTION;TOPICAL
MINOXIDIL (FOR MEN)
ACTAVIS MID ATLANTIC 2% A074588 001 Apr 05, 1996
HI TECH PHARMA 2% A074731 001 Dec 24, 1996
PERRIGO 2% A075357 001 Jul 30, 1999
WOCKHARDT 2% A074767 001 Feb 28, 1997
MINOXIDIL (FOR WOMEN)
HI TECH PHARMA 2% A074731 002 May 11, 2005
PERRIGO 2% A075357 002 Jul 30, 1999
MINOXIDIL EXTRA STRENGTH (FOR MEN)
ACTAVIS MID ATLANTIC 5% A075518 001 Nov 17, 2000
AVACOR PRODS 5% A075619 001 Nov 17, 2000
PERRIGO 5% A075598 001 Jun 13, 2001
PERRIGO NEW YORK 5% A075737 001 Mar 15, 2002
WOCKHARDT 5% A075438 001 Feb 27, 2003
ROGAINE (FOR MEN)
+ JOHNSON AND JOHNSON 2% N019501 002 Feb 09, 1996
ROGAINE (FOR WOMEN)
+ JOHNSON AND JOHNSON 2% N019501 003 Feb 09, 1996
ROGAINE EXTRA STRENGTH (FOR MEN)
+ JOHNSON AND JOHNSON 5% N020834 001 Nov 14, 1997
THEROXIDIL
EI INC 2% A078176 001 Nov 09, 2007
5% A076239 001 Aug 24, 2004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST 4-14(of 17)
NAPHAZOLINE HYDROCHLORIDE; PHENIRAMINE MALEATE
SOLUTION/DROPS;OPHTHALMIC
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE
AKORN INC 0.025%;0.3% A202795 001 Jan 24, 2013
ALTAIRE PHARMS INC 0.02675%;0.315% A078208 001 Sep 27, 2010
NAPHCON-A
+ ALCON 0.025%;0.3% N020226 001 Jun 08, 1994
OPCON-A
+ BAUSCH AND LOMB 0.02675%;0.315% N020065 001 Jun 08, 1994
VISINE-A
+ JOHNSON AND JOHNSON 0.025%;0.3% N020485 001 Jan 31, 1996
NAPROXEN SODIUM
CAPSULE;ORAL
NAPROXEN SODIUM
+ BANNER PHARMACAPS EQ 200MG BASE N021920 001 Feb 17, 2006
TABLET;ORAL
ALEVE
+ BAYER EQ 200MG BASE N020204 002 Jan 11, 1994
NAPROXEN SODIUM
AMNEAL PHARMS NY EQ 200MG BASE A079096 001 Dec 16, 2008
CONTRACT PHARMACAL EQ 200MG BASE A074635 001 Jan 13, 1997
EQ 200MG BASE A074789 001 Feb 27, 1997
DR REDDYS LABS INC EQ 200MG BASE A075168 001 Jul 28, 1998
GRANULES INDIA EQ 200MG BASE A091353 001 Sep 20, 2011
MARKSANS PHARMA EQ 200MG BASE A090545 001 Mar 16, 2011
PERRIGO EQ 200MG BASE A074661 001 Jan 13, 1997
RANBAXY LABS LTD EQ 200MG BASE A091183 001 May 20, 2011
NAPROXEN SODIUM; PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
ALEVE-D SINUS & COLD
+ BAYER 200MG;120MG N021076 001 Nov 29, 1999
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE
DR REDDYS LABS INC EQ 220MG BASE;120MG A077381 001 Sep 27, 2006
PERRIGO EQ 200MG BASE;120MG A076518 001 Mar 17, 2004
NICOTINE
FILM, EXTENDED RELEASE;TRANSDERMAL
HABITROL
+ DR REDDYS LABS INC 7MG/24HR N020076 004 Nov 12, 1999
+ 14MG/24HR N020076 005 Nov 12, 1999
+ 21MG/24HR N020076 006 Nov 12, 1999
NICODERM CQ
+ SANOFI AVENTIS US 7MG/24HR N020165 006 Aug 02, 1996
+ 14MG/24HR N020165 005 Aug 02, 1996
+ 21MG/24HR N020165 004 Aug 02, 1996
NICOTINE
AVEVA 7MG/24HR A074612 002 Jul 28, 2003
14MG/24HR A074612 003 Oct 20, 1997
21MG/24HR A074612 001 Oct 20, 1997
NICOTINE POLACRILEX
GUM, CHEWING;BUCCAL
NICORETTE
+ GLAXOSMITHKLINE EQ 2MG BASE N018612 002 Feb 09, 1996
EQ 2MG BASE N018612 004 Sep 25, 2000
+ EQ 4MG BASE N020066 002 Feb 09, 1996
EQ 4MG BASE N020066 004 Sep 25, 2000
NICORETTE (MINT)
GLAXOSMITHKLINE EQ 2MG BASE N018612 003 Dec 23, 1998
EQ 4MG BASE N020066 003 Dec 23, 1998
NICOTINE POLACRILEX
ACTAVIS LABS NY INC EQ 2MG BASE A074507 001 Mar 15, 1999
EQ 2MG BASE A076569 001 Jul 29, 2004
EQ 2MG BASE A078699 001 Dec 29, 2008
EQ 2MG BASE A079216 001 Jul 08, 2009
EQ 4MG BASE A074707 001 Mar 19, 1999
EQ 4MG BASE A076568 002 Jul 29, 2004
EQ 4MG BASE A078697 001 Dec 29, 2008
EQ 4MG BASE A079038 001 Jul 08, 2009
EQ 4MG BASE A079219 001 Jul 08, 2009
IVAX SUB TEVA PHARMS EQ 2MG BASE A076880 001 Feb 18, 2009
EQ 4MG BASE A077850 001 Feb 18, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
4-15(of 17)
NICOTINE POLACRILEX
GUM, CHEWING;BUCCAL
NICOTINE POLACRILEX
PERRIGO
EQ 2MG BASE
A076775 001 Sep 16, 2004
EQ 2MG BASE
A076776 001 Sep 16, 2004
EQ 2MG BASE
A076777 001 Sep 16, 2004
EQ 4MG BASE
A076778 001 Sep 16, 2004
EQ 4MG BASE
A076779 001 Sep 16, 2004
EQ 4MG BASE
A076789 001 Sep 16, 2004
PERRIGO R AND D
EQ 2MG BASE
A078325 001 Oct 30, 2006
EQ 2MG BASE
A078547 001 May 24, 2007
EQ 2MG BASE
A078967 001 Apr 23, 2008
EQ 2MG BASE
A091349 001 Jul 20, 2011
EQ 4MG BASE
A078326 001 Oct 30, 2006
EQ 4MG BASE
A078546 001 May 24, 2007
EQ 4MG BASE
A078968 001 Apr 23, 2008
EQ 4MG BASE
A091354 001 Jul 20, 2011
WATSON LABS
EQ 2MG BASE
A079044 001 Jul 08, 2009
THRIVE
NOVARTIS
EQ 2MG BASE
A077658 001 Jun 19, 2007
EQ 4MG BASE
A077656 001 Jun 19, 2007
TROCHE/LOZENGE;ORAL
COMMIT
GLAXOSMITHKLINE CONS
EQ 2MG BASE
N021330 001 Oct 31, 2002
+
EQ 4MG BASE
N021330 002 Oct 31, 2002
NICORETTE
GLAXOSMITHKLINE CONS
EQ 2MG BASE
N022360 001 May 18, 2009
+
EQ 4MG BASE
N022360 002 May 18, 2009
NICOTINE POLACRILEX
PERRIGO R AND D
EQ 2MG BASE
A077007 001 Jan 31, 2006
EQ 2MG BASE
A090711 001 Jul 10, 2009
EQ 2MG BASE
A090821 001 Jul 10, 2009
EQ 2MG BASE
A203690 001 Oct 09, 2012
EQ 4MG BASE
A077007 002 Jan 31, 2006
EQ 4MG BASE
A090711 002 Jul 10, 2009
EQ 4MG BASE
A090821 002 Jul 10, 2009
EQ 4MG BASE
A203690 002 Oct 09, 2012
NIZATIDINE
TABLET;ORAL
AXID AR
+ PFIZER
75MG
N020555 001 May 09, 1996
NONOXYNOL-9
SPONGE;VAGINAL
TODAY
+ MAYER LABS INC
1GM
N018683 001 Apr 01, 1983
OMEPRAZOLE
TABLET, DELAYED RELEASE;ORAL
OMEPRAZOLE
+ DEXCEL PHARMA
20MG
N022032 001 Dec 04, 2007
OMEPRAZOLE MAGNESIUM
CAPSULE, DELAYED RELEASE;ORAL
OMEPRAZOLE MAGNESIUM
+ DR REDDYS LABS LTD
EQ 20MG BASE
A078878 001 Jun 05, 2009
TABLET, DELAYED RELEASE;ORAL
PRILOSEC OTC
+ ASTRAZENECA PHARMS
EQ 20MG BASE
N021229 001 Jun 20, 2003
OMEPRAZOLE; SODIUM BICARBONATE
CAPSULE;ORAL
ZEGERID OTC
+ MSD CONSUMER
20MG;1.1GM
N022281 001 Dec 01, 2009
FOR SUSPENSION;ORAL
ZEGERID OTC
+ MSD CONSUMER
20MG/PACKET;1.68GM/PACKET
N022283 001 Jun 17, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST 4-16(of 17)
ORLISTAT
CAPSULE;ORAL
ALLI
+ GLAXOSMITHKLINE CONS 60MG N021887 001 Feb 07, 2007
OXYBUTYNIN
FILM, EXTENDED RELEASE;TRANSDERMAL
OXYTROL FOR WOMEN
+ BAYER HEALTHCARE LLC 3.9MG/24HR N202211 001 Jan 25, 2013
OXYMETAZOLINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
OCUCLEAR
SCHERING PLOUGH 0.025% N018471 001 May 30, 1986
VISINE L.R.
+ JOHNSON AND JOHNSON 0.025% N019407 001 Mar 31, 1989
PERMETHRIN
LOTION;TOPICAL
NIX
+ MEDTECH PRODUCTS 1% N019918 001 May 02, 1990
PERMETHRIN
ACTAVIS MID ATLANTIC 1% A075014 001 Mar 28, 2000
PERRIGO NEW YORK 1% A076090 001 Dec 20, 2001
POLYETHYLENE GLYCOL 3350
FOR SOLUTION;ORAL
GLYCOLAX
KREMERS URBAN PHARMS 17GM/PACKET A090600 001 Oct 06, 2009
17GM/SCOOPFUL A090600 002 Oct 06, 2009
MIRALAX
+ SCHERING PLOUGH 17GM/SCOOPFUL N022015 001 Oct 06, 2006
POLYETHYLENE GLYCOL 3350
EMCURE PHARMS USA 17GM/SCOOPFUL A202071 001 Dec 28, 2012
MYLAN 17GM/PACKET A078915 001 Oct 06, 2009
17GM/SCOOPFUL A078915 002 Oct 06, 2009
NEXGEN PHARMA 17GM/SCOOPFUL A090812 001 Oct 07, 2009
NOVEL LABS INC 17GM/SCOOPFUL A091077 001 Oct 06, 2009
PAR PHARM 17GM/SCOOPFUL A079214 001 Jan 31, 2013
PERRIGO R AND D 17GM/PACKET A090685 001 Oct 06, 2009
17GM/SCOOPFUL A090685 002 Oct 06, 2009
POTASSIUM IODIDE
SOLUTION;ORAL
THYROSHIELD
+ ARCO PHARMS LLC 65MG/ML A077218 001 Jan 12, 2005
TABLET;ORAL
IOSAT
ANBEX 65MG N018664 002 May 12, 2011
+ 130MG N018664 001 Oct 14, 1982
THYROSAFE
+ RECIP 65MG A076350 001 Sep 10, 2002
POVIDONE-IODINE
SOLUTION;TOPICAL
POVIDONE IODINE
+ ALLEGIANCE HLTHCARE 1% N019522 001 Mar 31, 1989
SPONGE;TOPICAL
E-Z SCRUB 201
+ BECTON DICKINSON 20% N019240 001 Nov 29, 1985
E-Z SCRUB 241
+ BECTON DICKINSON 10% N019476 001 Jan 07, 1987
PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
PSEUDOEPHEDRINE HYDROCHLORIDE
PERRIGO 120MG A075153 001 Feb 26, 1999
RANBAXY 120MG A077442 001 Sep 28, 2005
SUDAFED 12 HOUR
+ MCNEIL CONS 120MG A073585 001 Oct 31, 1991
SUDAFED 24 HOUR
+ MCNEIL CONS 240MG N020021 002 Dec 15, 1992
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
OTC DRUG PRODUCT LIST
4-17(of 17)
PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
AFRINOL
+ SCHERING PLOUGH
120MG
N018191 001
PURIFIED WATER
SOLUTION;OPHTHALMIC
PUR-WASH
+ NIAGARA PHARMS
98.3%
N022305 001 Sep 01, 2011
RANITIDINE HYDROCHLORIDE
TABLET;ORAL
RANITIDINE HYDROCHLORIDE
APOTEX INC
EQ 150MG BASE
A200172 001 May 31, 2012
CONTRACT PHARMACAL
EQ 75MG BASE
A075094 001 Jun 21, 1999
DR REDDYS LABS LTD
EQ 75MG BASE
A075294 001 Mar 28, 2000
EQ 150MG BASE
A078192 001 Aug 31, 2007
IVAX SUB TEVA PHARMS
EQ 75MG BASE
A075296 001 Jan 14, 2000
MYLAN
EQ 75MG BASE
A075497 001 Jan 14, 2000
PERRIGO
EQ 75MG BASE
A076195 001 Aug 30, 2002
PERRIGO R AND D
EQ 150MG BASE
A091429 001 May 11, 2011
EQ 150MG BASE
A091429 002 May 11, 2011
SHASUN CHEMS
EQ 75MG BASE
A201745 001 Feb 29, 2012
SVADS HOLDINGS SA
EQ 150MG BASE
A200536 001 Jun 28, 2011
TORPHARM
EQ 75MG BASE
A075167 001 May 04, 2000
WOCKHARDT
EQ 75MG BASE
A076760 001 Feb 24, 2006
EQ 75MG BASE
A078884 001 Jul 31, 2008
ZANTAC 150
+ BOEHRINGER INGELHEIM
EQ 150MG BASE
N021698 001 Aug 31, 2004
EQ 150MG BASE
N021698 002 Mar 13, 2007
ZANTAC 75
BOEHRINGER INGELHEIM
EQ 75MG BASE
N020520 001 Dec 19, 1995
SODIUM CHLORIDE
AEROSOL, METERED;INHALATION
BRONCHO SALINE
+ BLAIREX
0.9%
N019912 001 Sep 03, 1992
SODIUM FLUORIDE; TRICLOSAN
PASTE;DENTAL
COLGATE TOTAL
+ COLGATE PALMOLIVE
0.24%;0.3%
N020231 001 Jul 11, 1997
TERBINAFINE
GEL;TOPICAL
LAMISIL AT
+ NOVARTIS
1%
N021958 001 Jul 24, 2006
TERBINAFINE HYDROCHLORIDE
CREAM;TOPICAL
LAMISIL
+ NOVARTIS
1%
N020980 001 Mar 09, 1999
TERBINAFINE HYDROCHLORIDE
TARO
1%
A077511 001 Jul 02, 2007
SOLUTION;TOPICAL
LAMISIL AT
+ NOVARTIS
1%
N021124 001 Mar 17, 2000
SPRAY;TOPICAL
LAMISIL AT
+ NOVARTIS
1%
N021124 002 Mar 17, 2000
TIOCONAZOLE
OINTMENT;VAGINAL
TIOCONAZOLE
PERRIGO
6.5%
A075915 001 Nov 21, 2001
VAGISTAT-1
+ NOVARTIS
6.5%
N020676 001 Feb 11, 1997
TRIAMCINOLONE ACETONIDE
SPRAY, METERED;NASAL
NASACORT ALLERGY 24 HOUR
+ SANOFI AVENTIS US
0.055MG/SPRAY
N020468 002 Oct 11, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST 5 - 1 of 4
DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT
ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST
ANTICOAGULANT 4% SODIUM CITRATE SOLUTION USP
INJECTABLE; INJECTION
NONE
HAEMONETICS N760305 Jun 30, 1978
MANUFACTURING INC
ANTICOAGULANT CITRATE DEXTROSE SOLUTION (ACD)
INJECTABLE; INJECTION
CITRA LABS LLC N020037 Aug 26, 2003
ACD-A SOLUTION
TERUMO BCT INC A010228 ANDA Feb 25, 2002
ADSOL WITH ACD-A
FENWAL INC N000922 Aug 29, 2002
ANTICOAGULANT CITRATE DEXTROSE SOLUTION FORMULA A
HAEMONETICS CORP A980728 ANDA Feb 06, 2002
AS3 SOLUTION/ACD-A
TERUMO BCT INC N001214 May 29, 2002
NONE
HAEMONETICS A710497 ANDA Nov 06, 1987
MANUFACTURING INC
ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP
INJECTABLE; INJECTION
NONE
FENWAL INC N160918 Mar 17, 1978
ANTICOAGULANT CITRATE DEXTROSE SOLUTION USP (ACD-A)
INJECTABLE; INJECTION
NONE
ARTERIOCYTE MEDICAL A110057 May 11, 2012
SYSTEMS, INC
ANTICOAGULANT CITRATE PHOSPHATE 2X DEXTROSE SOLUTION (CP2D)
INJECTABLE; INJECTION
CITRATE PHOSPHATE DOUBLE DEXTROSE/ADDITIVE SOLUTION 3
HAEMONETICS CORP N000127 Jan 18, 2002
ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION
INJECTABLE; INJECTION
NONE
TERUMO MEDICAL CORP N820528 Nov 03, 1982
ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION (CPDA)
INJECTABLE; INJECTION
CPDA-1 BLOOD-PACK UNIT (PL 146 PLASTIC) 250, 450, 500 ML BLOOD PACK UNITS
FENWAL INC N770420 May 12, 1978
ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE SOLUTION USP
INJECTABLE; INJECTION
BLOOD PACK UNIT CPDA-1 IN PLASTIC CONTAINER
FENWAL INC N940404 Jul 28, 1994
ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE ADENINE-1 SOLUTION
INJECTABLE; INJECTION
NONE
HAEMONETICS N800077 Nov 06, 1980
MANUFACTURING INC
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST 5 - 2 of 4
DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT
ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST
ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION
INJECTABLE; INJECTION
ADSOL IN PLASTIC CONTAINER
FENWAL INC N900223 Dec 27, 1991
ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION (CPD)
INJECTABLE; INJECTION
CPD ANTICOAGULANT IN PL 2209 PLASTIC CONTAINER
FENWAL INC N900224 Dec 27, 1991
MACOPRODUCTIONS SAS CPD/AS-1: MACOPHARMA LEUCOFLEX MTL1 LEUKOREDUCTION SYSTEM FOR BLOOD
COMPONENTS KNOWN AS MTL1-WB
MACOPRODUCTIONS SAS N040083 Nov 21, 2005
NONE
TERUMO BCT INC A070025 Jan 06, 2008
ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION USP
INJECTABLE; INJECTION
NONE
FENWAL INC N170401 Dec 06, 1977
N811012 Jun 28, 1983
HAEMONETICS N800222 Aug 23, 1982
MANUFACTURING INC
TERUMO MEDICAL CORP N781211 Jun 10, 1981
ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION USP WITH: AS-1:
DEXTROSE USP; SODIUM CHLORIDE USP; MANNITOL USP; ADENINE
INJECTABLE; INJECTION
ADSOL RED BLOOD CELL PRESERVATIVE SOLUTION
FENWAL INC N811104 May 16, 1983
ANTICOAGULANT CITRATE PHOSPHATE DEXTROSE SOLUTION USP WITH: AS-5:
DEXTROSE USP; SODIUM CHLORIDE USP; MANNITOL USP; ADENINE
INJECTABLE; INJECTION
OPTISOL RED BLOOD CELL PRESERVATIVE SOLUTION
TERUMO MEDICAL CORP N880217 Oct 07, 1988
ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION WITH:
AS-3: CITRIC ACID USP; MONOBASIC SODIUM PHOSPHATE USP; SODIUM CHLORIDE USP; ADENINE;
DEXTROSE USP; SODIUM CITRATE USP
INJECTABLE; INJECTION
AS-3 NUTRICEL ADDITIVE SYSTEM
HAEMONETICS 0.042GM/100ML;0.276GM/100ML; N820915 Oct 19, 1984
MANUFACTURING INC 0.410GM/100ML;0.30GM/100ML;
1.10GM/100ML;0.588GM/100ML
ANTICOAGULANT CITRATE PHOSPHATE DOUBLE DEXTROSE SOLUTION WITH:
AS-2: CITRIC ACID USP; DIBASIC SODIUM PHOSPHATE USP; SODIUM CHLORIDE USP; ADENINE;
DEXTROSE USP; SODIUM CITRATE USP
INJECTABLE; INJECTION
AS-2 NUTRICEL ADDITIVE SYSTEM
MEDSEP CORP 0.042GM/100ML;0.285GM/100ML; N820915 Sep 22, 1983
0.718GM/100ML;0.017GM/100ML;
0.396GM/100ML;0.588GM/100ML
ANTICOAGULANT SODIUM CITRATE 4% SOLUTION
INJECTABLE; INJECTION
NONE
HAEMONETICS N980123 Mar 03, 2000
CORPORATION
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST 5 - 3 of 4
DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT
ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST
ANTICOAGULANT SODIUM CITRATE SOLUTION
INJECTABLE; INJECTION
TRICITRASOL
CYTOSOL N010409 Jul 10, 2003
LABORATORIES INC
ANTICOAGULANT SODIUM CITRATE SOLUTION USP
INJECTABLE; INJECTION
NONE
FENWAL INC N770923 Jan 20, 1978
TERUMO MEDICAL CORP N781214 Feb 08, 1980
DEXTRAN 1 IN SODIUM CHLORIDE 0.6%
INJECTABLE; INJECTION
PROMIT
MEDA AB N830715 Oct 30, 1984
DEXTRAN 40, 10% IN DEXTROSE 5%
INJECTABLE; INJECTION
LMD IN GLASS BOTTLE
HOSPIRA INC 10GM/100ML;5GM/100ML A720563 ANDA Oct 30, 1992
NONE
B BRAUN MEDICAL INC 10GM/100ML;5GM/100ML N160767 Apr 06, 1970
DEXTRAN 40, 10% IN SODIUM CHLORIDE 0.9%
INJECTABLE; INJECTION
LMD IN PLASTIC CONTAINER
HOSPIRA INC 10GM/100ML;0.9GM/100ML A720562 ANDA Oct 30, 1992
NONE
B BRAUN MEDICAL INC 10GM/100ML;0.9GM/100ML N160767 Apr 06, 1970
DEXTRAN 70, 6% IN SODIUM CHLORIDE 0.9%
INJECTABLE; INJECTION
NONE
B BRAUN MEDICAL INC 6GM/100ML;0.9 GM/100ML N090024 Aug 18, 1969
HETASTARCH 6% IN LACTATED ELECTROLYTE INJECTION
INJECTABLE; INJECTION
HEXTEND
BIOTIME INC 6GM/100ML N200952 Mar 31, 1999
HETASTARCH 6% IN SODIUM CHLORIDE 0.9%
INJECTABLE; INJECTION
6% HETASTARCH IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA INC 6GM/100ML;0.9GM/100ML A740193 ANDA Jan 30, 1995
HESPAN IN PLASTIC CONTAINER
B BRAUN MEDICAL INC 6GM/100ML;0.9GM/100ML N890105 Apr 04, 1991
NONE
B BRAUN MEDICAL INC 6GM/100ML;0.9GM/100ML A740283 ANDA Oct 21, 1998
TEVA PARENTERAL 6GM/100ML;0.9GM/100ML A740592 ANDA Nov 12, 1998
MEDICINES INC
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST 5 - 4 of 4
DRUG PRODUCTS WITH APPROVAL UNDER SECTION 505 OF THE ACT
ADMINISTERED BY THE CENTER FOR BIOLOGICS EVALUATION AND RESEARCH LIST
HYDROXYETHYL STARCH 130/0.4 IN 6% SODIUM CHLORIDE 0.9%
INJECTABLE; INJECTION
NONE
B. BRAUN MEDICAL A110013 ANDA Jan 09, 2015
VOLUVEN
FRESENIUS KABI 6GM/100ML;0.9GM/100ML N070012 NDA Dec 27, 2007
DEUTSCHLAND GMBH
ISOPLATE SOLUTION IN THE 500 ML EXCEL CONTAINER
INJECTABLE; INJECTION
ISOPLATE SOLUTION
HAEMONETICS CORP N90067 Mar 05, 2013
LEUKOCYTE REDUCTION FILTRATION SYSTEM FOR WHOLE BLOOD WITH CPD ANTICOAGULANT AND
SOLX ADDITIVE
INJECTABLE; INJECTION
LEUKOSEP HWB-600-XL
HAEMONETICS CORP N110059 Apr 25, 2013
PENTASTARCH 10% IN SODIUM CHLORIDE 0.9%
INJECTABLE; INJECTION
PENTASPAN IN PLASTIC CONTAINER
B BRAUN MEDICAL INC 10GM/100ML;0.9GM/100ML N890104 Apr 04, 1991
RED BLOOD CELL PROCESSING SOLUTION
INJECTABLE; INJECTION
REJUVESOL
CITRA LABS LLC N950522 Feb 26, 1997
SODIUM CHLORIDE; SODIUM ACETATE; SODIUM CITRATE DIHYDRATE; SODIUM PHOSPHATE,
DIABASIC ANHYDROUS; SODIUM PHOSPHATE MONOBASIC, MONOHYDRATE
INJECTABLE; INJECTION
INTERSOL SOLUTION
FENWAL INC. 2.26G/500ML; 2.21G/500ML; 1.59G/500ML; N080041 Dec 09, 2009
1.53G/500ML; 0.465G/500ML
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-1(of 337)
ABARELIX
INJECTABLE;INTRAMUSCULAR
PLENAXIS
SPECIALITY EUROPEAN
100MG/VIAL
N021320 001 Nov 25, 2003
ACEBUTOLOL HYDROCHLORIDE
CAPSULE;ORAL
ACEBUTOLOL HYDROCHLORIDE
WATSON LABS
EQ 200MG BASE
A074007 001 Oct 18, 1995
EQ 400MG BASE
A074007 002 Oct 18, 1995
ACETAMINOPHEN
INJECTABLE;INJECTION
INJECTAPAP
ORTHO MCNEIL PHARM
100MG/ML
N017785 001 Mar 07, 1986
SUPPOSITORY;RECTAL
ACEPHEN
G AND W LABS
120MG
A072218 001 Mar 27, 1992
ACETAMINOPHEN
ABLE
120MG
A073106 001 Feb 27, 1995
325MG
A073107 001 Feb 27, 1995
650MG
A073108 001 Feb 27, 1995
ROXANE
120MG
A071010 001 May 12, 1987
650MG
A071011 001 May 12, 1987
TYLENOL
MCNEIL CONS
120MG
N017756 002
650MG
N017756 001
TABLET, EXTENDED RELEASE;ORAL
ACETAMINOPHEN
RANBAXY
650MG
A090205 001 Nov 18, 2009
ACETAMINOPHEN; ASPIRIN; CODEINE PHOSPHATE
CAPSULE;ORAL
ACETAMINOPHEN, ASPIRIN, AND CODEINE PHOSPHATE
MIKART 150MG;180MG;15MG
A081095 001 Oct 26, 1990
150MG;180MG;30MG
A081096 001 Oct 26, 1990
150MG;180MG;60MG
A081097 001 Oct 26, 1990
CODEINE, ASPIRIN, APAP FORMULA NO. 2
SCHERER LABS 150MG;180MG;15MG
A085640 001
CODEINE, ASPIRIN, APAP FORMULA NO. 3
SCHERER LABS 150MG;180MG;30MG
A085639 001
CODEINE, ASPIRIN, APAP FORMULA NO. 4
SCHERER LABS 150MG;180MG;60MG
A085638 001
ACETAMINOPHEN; BUTALBITAL
CAPSULE;ORAL
BANCAP
FOREST PHARMS
325MG;50MG
A088889 001 Jan 16, 1986
BUCET
MALLINCKRODT
650MG;50MG
A088991 001 Jun 28, 1985
PHRENILIN FORTE
VALEANT
650MG;50MG
A088831 001 Jun 19, 1985
TENCON
MALLINCKRODT
650MG;50MG
A089405 001 May 15, 1990
TRIAPRIN
DUNHALL
325MG;50MG
A089268 001 Jul 02, 1987
TABLET;ORAL
BUTALBITAL AND ACETAMINOPHEN
HALSEY 325MG;50MG
A089568 001 Oct 05, 1988
WATSON LABS 325MG;50MG
A087550 001 Oct 19, 1984
BUTAPAP
MIKART 650MG;50MG
A089988 001 Oct 26, 1992
PHRENILIN
VALEANT 325MG;50MG
A087811 001 Jun 19, 1985
SEDAPAP
MAYRAND 650MG;50MG
A088944 001 Oct 17, 1985
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
CAPSULE;ORAL
ANOQUAN
SHIRE 325MG;50MG;40MG
A087628 001 Oct 01, 1986
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
GRAHAM DM 325MG;50MG;40MG
A088743 001 Jul 18, 1985
325MG;50MG;40MG
A088765 001 Mar 27, 1985
325MG;50MG;40MG
A089067 001 Apr 19, 1985
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-2(of 337)
ACETAMINOPHEN; BUTALBITAL; CAFFEINE
CAPSULE;ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
HIKMA PHARMS LLC 500MG;50MG;40MG A040261 001 Oct 28, 1998
MALLINCKRODT 325MG;50MG;40MG A088758 001 Mar 27, 1985
BUTALIBITAL, ACETAMINOPHEN AND CAFFEINE
GILBERT LABS 325MG;50MG;40MG A088825 001 Dec 05, 1984
ESGIC-PLUS
MIKART 500MG;50MG;40MG A040085 001 Mar 28, 1996
FEMCET
MALLINCKRODT 325MG;50MG;40MG A089102 001 Jun 19, 1985
MEDIGESIC PLUS
US CHEM 325MG;50MG;40MG A089115 001 Jan 14, 1986
TRIAD
MALLINCKRODT 325MG;50MG;40MG A089023 001 Jun 19, 1985
TABLET;ORAL
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE
ABLE 325MG;50MG;40MG A040390 001 Jul 23, 2001
500MG;50MG;40MG A040394 001 Jul 23, 2001
GILBERT LABS 325MG;50MG;40MG A087629 001 Nov 13, 1984
HIKMA PHARMS LLC 500MG;50MG;40MG A040336 001 Aug 18, 1999
MIKART 750MG;50MG;40MG A040496 001 Dec 23, 2003
MIRROR PHARMS 325MG;50MG;40MG A040864 001 Dec 01, 2008
MIRROR PHARMS LLC 500MG;50MG;40MG A040883 001 Dec 23, 2008
MUTUAL PHARM 325MG;50MG;40MG A040601 001 Jul 29, 2005
VINTAGE PHARMS 500MG;50MG;40MG A040513 001 Aug 25, 2003
WATSON LABS 325MG;50MG;40MG A089536 001 Feb 16, 1988
500MG;50MG;40MG A040267 001 Jul 30, 1998
ESGIC
FOREST PHARMS 325MG;50MG;40MG A089660 001 Dec 23, 1988
ESGIC-PLUS
MIKART 500MG;50MG;40MG A089451 001 May 23, 1988
FIORICET
WATSON PHARMS 325MG;50MG;40MG A088616 001 Nov 09, 1984
ACETAMINOPHEN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
CAPSULE;ORAL
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE
ABLE 325MG;50MG;40MG;30MG A076528 001 Aug 21, 2003
PHRENILIN WITH CAFFEINE AND CODEINE
VALEANT 325MG;50MG;40MG;30MG A074911 001 Aug 22, 2001
ACETAMINOPHEN; CAFFEINE; DIHYDROCODEINE BITARTRATE
CAPSULE;ORAL
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
MIKART 356.4MG;30MG;16MG A040109 001 Aug 26, 1997
WRASER PHARMS LLC 356.4MG;30MG;16MG A040688 001 Apr 03, 2007
DHC PLUS
PHARM RES ASSOC 356.4MG;30MG;16MG A088584 001 Mar 04, 1986
SYNALGOS-DC-A
LEITNER PHARMS 356.4MG;30MG;16MG A089166 001 May 14, 1986
TABLET;ORAL
ACETAMINOPHEN, CAFFEINE, AND DIHYDROCODEINE BITARTRATE
BOCA PHARMA LLC 712.8MG;60MG;32MG A040701 001 Apr 03, 2007
MIKART 712.8MG;60MG;32MG A040316 001 Apr 28, 1999
WEST-WARD PHARM CORP 712.8MG;60MG;32MG A040637 001 Sep 22, 2006
ACETAMINOPHEN; CLEMASTINE FUMARATE; PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET;ORAL
TAVIST ALLERGY/SINUS/HEADACHE
NOVARTIS 500MG;EQ 0.25MG BASE;30MG N021082 001 Mar 01, 2001
ACETAMINOPHEN; CODEINE PHOSPHATE
CAPSULE;ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
TEVA 300MG;15MG A088537 001 Jun 04, 1984
300MG;30MG A088324 001 Dec 29, 1983
300MG;60MG A088599 001 Jun 01, 1984
PHENAPHEN W/ CODEINE NO. 2
ROBINS AH 325MG;15MG A084444 001
PHENAPHEN W/ CODEINE NO. 3
ROBINS AH 325MG;30MG A084445 001
PHENAPHEN W/ CODEINE NO. 4
ROBINS AH 325MG;60MG A084446 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-3(of 337)
ACETAMINOPHEN; CODEINE PHOSPHATE
CAPSULE;ORAL
PROVAL #3
SOLVAY 325MG;30MG A085685 001
TYLENOL W/ CODEINE NO. 3
ORTHO MCNEIL PHARM 300MG;30MG A087422 001
TYLENOL W/ CODEINE NO. 4
ORTHO MCNEIL PHARM 300MG;60MG A087421 001
SOLUTION;ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
ACTAVIS MID ATLANTIC 120MG/5ML;12MG/5ML A085861 001
DAVA PHARMS INC 120MG/5ML;12MG/5ML A040098 001 Sep 20, 1996
ROXANE 120MG/5ML;12MG/5ML A086366 001
TYLENOL W/ CODEINE
ORTHO MCNEIL PHARM 120MG/5ML;12MG/5ML A085057 001
SUSPENSION;ORAL
CAPITAL AND CODEINE
ACTAVIS MID ATLANTIC 120MG/5ML;12MG/5ML A085883 001
TABLET;ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
ABLE 300MG;30MG A040452 001 Aug 01, 2002
300MG;60MG A040459 001 Aug 01, 2002
AM THERAP 300MG;15MG A089478 001 Mar 03, 1987
300MG;15MG A089481 001 Mar 03, 1987
300MG;30MG A089479 001 Mar 03, 1987
300MG;30MG A089482 001 Mar 03, 1987
300MG;60MG A089480 001 Mar 03, 1987
300MG;60MG A089483 001 Mar 03, 1987
DURAMED PHARMS BARR 300MG;15MG A040223 001 Nov 18, 1997
300MG;15MG A088353 001 Feb 06, 1984
300MG;30MG A040223 002 Nov 18, 1997
300MG;30MG A088354 001 Feb 06, 1984
300MG;60MG A040223 003 Nov 18, 1997
300MG;60MG A088355 001 Feb 06, 1984
EVERYLIFE 325MG;30MG A085217 001
HALSEY 300MG;15MG A083871 001
300MG;30MG A083872 001
300MG;60MG A086549 001
KV PHARM 300MG;30MG A085288 001
300MG;60MG A085365 001
325MG;15MG A085364 001
325MG;45MG **Federal Register A085363 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
LEDERLE 300MG;30MG A087141 001
MIKART 300MG;30MG A089238 001 Feb 25, 1986
300MG;60MG A089244 001 Feb 25, 1986
650MG;30MG A089231 001 Mar 03, 1986
650MG;60MG A089363 001 Sep 09, 1991
MUTUAL PHARM 300MG;15MG A085795 001
300MG;15MG A089671 001 Feb 10, 1988
300MG;30MG A085794 001
300MG;30MG A089672 001 Feb 10, 1988
300MG;60MG A087653 001 Apr 13, 1982
300MG;60MG A089673 001 Feb 10, 1988
PURACAP PHARM 300MG;30MG A087762 001 Dec 10, 1982
PUREPAC PHARM 300MG;30MG A086681 001
300MG;30MG A089080 001 Jul 17, 1986
300MG;60MG A086683 001
ROXANE 300MG;15MG A084659 001
300MG;30MG A084656 001
300MG;60MG A084667 001
500MG;15MG A089511 001 Apr 25, 1989
500MG;30MG A089512 001 Apr 25, 1989
500MG;60MG A089513 001 Apr 25, 1989
SANDOZ 300MG;15MG A087433 001
300MG;30MG A081250 001 Jul 16, 1992
300MG;30MG A085291 002
300MG;30MG A085917 001
300MG;60MG A081249 001 Jul 16, 1992
300MG;60MG A085964 001
300MG;60MG A087423 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-4(of 337)
ACETAMINOPHEN; CODEINE PHOSPHATE
TABLET;ORAL
ACETAMINOPHEN AND CODEINE PHOSPHATE
SUPERPHARM 300MG;15MG A089183 001 Oct 18, 1985
300MG;30MG A089184 001 Oct 18, 1985
300MG;30MG A089253 001 May 19, 1986
300MG;60MG A089185 001 Oct 18, 1985
300MG;60MG A089254 001 May 19, 1986
USL PHARMA 300MG;30MG A087919 001 Jun 22, 1982
300MG;60MG A087920 001 Jun 22, 1982
VALEANT PHARM INTL 300MG;30MG A085896 001
VITARINE 300MG;30MG A085676 001
WARNER CHILCOTT 300MG;15MG A085992 001
300MG;30MG A085218 002
300MG;60MG A087306 001
WATSON LABS 300MG;15MG A087277 001 May 26, 1982
300MG;15MG A089997 001 Dec 28, 1994
300MG;30MG A087276 001 May 26, 1982
300MG;30MG A089998 001 Dec 28, 1994
300MG;60MG A087275 001 May 26, 1982
300MG;60MG A089999 001 Dec 28, 1994
WATSON LABS FLORIDA 300MG;15MG A040443 001 Jan 22, 2003
300MG;30MG A040443 002 Jan 22, 2003
300MG;60MG A040443 003 Jan 22, 2003
WHITEWORTH TOWN PLSN 300MG;30MG A084360 001
300MG;60MG A085607 001
CAPITAL AND CODEINE
CARNRICK 325MG;30MG A083643 001
CODRIX
WATSON LABS FLORIDA 500MG;15MG A040447 001 Feb 26, 2003
500MG;30MG A040441 001 Mar 27, 2003
500MG;60MG A040488 001 Mar 28, 2003
EMPRACET W/ CODEINE PHOSPHATE #3
GLAXOSMITHKLINE 300MG;30MG A083951 001
EMPRACET W/ CODEINE PHOSPHATE #4
GLAXOSMITHKLINE 300MG;60MG A083951 002
PAPA-DEINE #3
VANGARD 300MG;30MG A088037 001 Mar 20, 1984
PAPA-DEINE #4
VANGARD 300MG;60MG A088715 001 Mar 20, 1984
PHENAPHEN-650 W/ CODEINE
ROBINS AH 650MG;30MG A085856 001
TYLENOL W/ CODEINE
ORTHO MCNEIL PHARM 325MG;7.5MG A085056 001
325MG;15MG A085056 002
325MG;30MG A085056 003
325MG;60MG A085056 004
TYLENOL W/ CODEINE NO. 1
JANSSEN PHARMS 300MG;7.5MG A085055 001
TYLENOL W/ CODEINE NO. 2
JANSSEN PHARMS 300MG;15MG A085055 002
ACETAMINOPHEN; DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
DRIXORAL PLUS
SCHERING PLOUGH 500MG;3MG;60MG N019453 001 May 22, 1987
ACETAMINOPHEN; HYDROCODONE BITARTRATE
CAPSULE;ORAL
ACETAMINOPHEN AND HYDROCODONE BITARTRATE
CENT PHARMS 500MG;5MG A088898 001 Mar 27, 1985
ALLAY
IVAX PHARMS 500MG;5MG A089907 001 Jan 13, 1989
BANCAP HC
FOREST PHARMS 500MG;5MG A087961 001 Mar 17, 1983
CO-GESIC
CENT PHARMS 500MG;5MG A089360 001 Mar 02, 1988
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
MALLINCKRODT 500MG;5MG A088956 001 Jul 19, 1985
500MG;5MG A089006 001 Aug 09, 1985
MIKART 500MG;5MG A081067 001 Nov 30, 1989
500MG;5MG A081068 001 Nov 30, 1989
500MG;5MG A081069 001 Nov 30, 1989
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-5(of 337)
ACETAMINOPHEN; HYDROCODONE BITARTRATE
CAPSULE;ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
500MG;5MG A081070 001 Nov 30, 1989
500MG;5MG A089008 001 Feb 21, 1986
LORCET-HD
MALLINCKRODT 500MG;5MG A087336 001 Jul 08, 1982
SOLUTION;ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
MALLINCKRODT 500MG/15ML;7.5MG/15ML A040418 001 Jun 27, 2001
MALLINCKRODT INC 500MG/15ML;10MG/15ML A040508 001 Aug 29, 2003
MIKART 500MG/15ML;5MG/15ML A081226 001 Oct 27, 1992
500MG/15ML;5MG/15ML A089557 001 Apr 29, 1992
500MG/15ML;7.5MG/15ML A081051 001 Aug 28, 1992
NESHER PHARMS 500MG/15ML;7.5MG/15ML A040366 001 Jan 23, 2002
PHARM ASSOC 500MG/15ML;7.5MG/15ML A040182 001 Mar 13, 1998
VINTAGE PHARMS 500MG/15ML;7.5MG/15ML A040520 001 Oct 30, 2003
TABLET;ORAL
ANEXSIA
MALLINCKRODT 500MG;5MG A089160 001 Apr 23, 1987
750MG;10MG A040468 001 Oct 31, 2002
ANEXSIA 7.5/650
MALLINCKRODT 650MG;7.5MG A089725 001 Sep 30, 1987
CO-GESIC
UCB INC 500MG;5MG A087757 001 May 03, 1982
DURADYNE DHC
FOREST PHARMS 500MG;5MG A087809 001 Mar 17, 1983
HY-PHEN
ASCHER 500MG;5MG A087677 001 May 03, 1982
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
ABLE 325MG;5MG A040478 001 Nov 08, 2002
325MG;7.5MG A040464 001 Oct 23, 2002
325MG;10MG A040464 002 Oct 23, 2002
500MG;5MG A040477 001 Nov 06, 2002
500MG;7.5MG A040490 001 May 21, 2003
500MG;10MG A040473 001 Nov 06, 2002
650MG;7.5MG A040474 001 Jan 02, 2003
650MG;10MG A040476 001 Oct 23, 2002
750MG;7.5MG A040469 001 Oct 25, 2002
ACTAVIS LABS FL INC 500MG;10MG A040148 002 Feb 14, 1997
AMNEAL PHARMS NY 500MG;5MG A040729 001 Aug 25, 2006
500MG;7.5MG A040748 001 Aug 25, 2006
500MG;10MG A040813 001 Feb 23, 2007
650MG;7.5MG A040754 001 Aug 25, 2006
650MG;10MG A040757 001 Aug 25, 2006
750MG;7.5MG A040769 001 Aug 28, 2006
BARR 500MG;2.5MG A040307 001 Jul 26, 2000
500MG;5MG A040308 001 Jul 26, 2000
500MG;5MG A088577 001 Dec 21, 1984
500MG;7.5MG A040307 002 Jul 26, 2000
500MG;10MG A040309 001 Jul 26, 2000
650MG;7.5MG A040307 003 Jul 26, 2000
650MG;10MG A040307 004 Jul 26, 2000
750MG;7.5MG A040308 002 Jul 26, 2000
CARACO 500MG;5MG A090265 001 Dec 23, 2008
500MG;7.5MG A090265 002 Dec 23, 2008
500MG;10MG A090265 003 Dec 23, 2008
650MG;7.5MG A090380 001 Dec 23, 2008
650MG;10MG A090380 002 Dec 23, 2008
660MG;10MG A090380 003 Dec 23, 2008
750MG;7.5MG A090380 004 Dec 23, 2008
HALSEY 500MG;5MG A089554 001 Jun 12, 1987
IVAX PHARMS 500MG;5MG A089696 001 Apr 21, 1988
MALLINCKRODT 500MG;5MG A040084 002 Jun 01, 1995
500MG;7.5MG A040201 001 Feb 27, 1998
500MG;10MG A040201 002 Feb 27, 1998
650MG;10MG A040084 004 Oct 16, 1996
660MG;10MG A040084 003 Jul 29, 1996
750MG;7.5MG A040084 001 Jun 01, 1995
MIKART 500MG;2.5MG A089698 001 Aug 25, 1989
500MG;5MG A089271 001 Jul 16, 1986
500MG;5MG A089697 001 Jan 28, 1992
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-6(of 337)
ACETAMINOPHEN; HYDROCODONE BITARTRATE
TABLET;ORAL
HYDROCODONE BITARTRATE AND ACETAMINOPHEN
500MG;7.5MG
A089699 001 Aug 25, 1989
650MG;5MG
A040849 001 Jun 09, 2010
650MG;7.5MG
A089689 001 Jun 29, 1988
650MG;10MG
A081223 001 May 29, 1992
MUTUAL PHARM
500MG;5MG
A040236 001 Sep 25, 1997
650MG;7.5MG
A040240 002 Nov 26, 1997
650MG;10MG
A040240 001 Nov 26, 1997
750MG;7.5MG
A040236 002 Sep 25, 1997
RANBAXY
500MG;5MG
A040825 001 Aug 16, 2007
500MG;10MG
A040824 001 Aug 16, 2007
RANBAXY LABS LTD
325MG;10MG
A040826 001 Aug 16, 2007
750MG;7.5MG
A040822 001 Aug 16, 2007
SANDOZ
500MG;5MG
A040149 001 Jan 27, 1997
750MG;7.5MG
A040149 002 Jan 27, 1997
UCB INC
500MG;10MG
A040210 001 Aug 13, 1997
650MG;7.5MG
A040134 001 Nov 21, 1996
USL PHARMA
500MG;5MG
A089290 001 May 29, 1987
500MG;5MG
A089291 001 May 29, 1987
VINTAGE PHARMS
500MG;2.5MG
A040144 002 Apr 25, 1997
500MG;5MG
A089831 001 Sep 07, 1988
500MG;5MG
A089971 001 Dec 02, 1988
500MG;7.5MG
A040144 001 Feb 22, 1996
500MG;10MG
A040356 001 May 31, 2000
650MG;7.5MG
A040155 001 Apr 14, 1997
650MG;10MG
A040143 001 Feb 22, 1996
660MG;10MG
A040358 001 May 31, 2000
750MG;7.5MG
A040157 001 Apr 12, 1996
VINTAGE PHARMS LLC
500MG;5MG
A040281 001 Sep 30, 1998
500MG;7.5MG
A040280 001 Sep 30, 1998
650MG;7.5MG
A040280 002 Sep 30, 1998
650MG;10MG
A040280 003 Sep 30, 1998
750MG;7.5MG
A040281 002 Sep 30, 1998
WATSON LABS
325MG;7.5MG
A040248 001 Apr 28, 2000
325MG;10MG
A040248 002 Apr 28, 2000
500MG;2.5MG
A040123 003 Mar 04, 1996
500MG;2.5MG
A081079 001 Aug 30, 1991
500MG;5MG
A040122 001 Mar 04, 1996
500MG;5MG
A089883 001 Dec 01, 1988
500MG;7.5MG
A040123 004 Mar 04, 1996
500MG;7.5MG
A081080 001 Aug 30, 1991
650MG;7.5MG
A040094 001 Sep 29, 1995
650MG;7.5MG
A040123 001 Mar 04, 1996
650MG;10MG
A040094 002 Sep 29, 1995
650MG;10MG
A040123 002 Mar 04, 1996
660MG;10MG
A040094 003 Aug 08, 2000
750MG;7.5MG
A040122 002 Mar 04, 1996
750MG;7.5MG
A081083 001 Aug 30, 1991
750MG;10MG
A040094 004 Mar 22, 1999
WATSON LABS FLORIDA
500MG;5MG
A040493 001 May 28, 2003
660MG;10MG
A040495 001 May 28, 2003
750MG;7.5MG
A040494 001 May 28, 2003
LORTAB
UCB INC
500MG;5MG
A087722 001 Jul 09, 1982
500MG;10MG
A040100 001 Jan 26, 1996
NORCET
ABANA
500MG;5MG
A088871 001 May 15, 1986
TYCOLET
ORTHO MCNEIL PHARM
500MG;5MG
A089385 001 Aug 27, 1986
VICODIN
ABBOTT
500MG;5MG
A085667 001
ABBVIE
500MG;5MG
A088058 001 Jan 07, 1983
VICODIN ES
ABBVIE
750MG;7.5MG
A089736 001 Dec 09, 1988
VICODIN HP
ABBVIE
660MG;10MG
A040117 001 Sep 23, 1996
ZYDONE
VINTAGE PHARMS LLC
400MG;5MG
A040288 001 Nov 27, 1998
400MG;7.5MG
A040288 002 Nov 27, 1998
400MG;10MG
A040288 003 Nov 27, 1998
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-7(of 337)
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE
CAPSULE;ORAL
OXYCODONE AND ACETAMINOPHEN
ACTAVIS ELIZABETH 500MG;5MG A040199 001 Dec 30, 1998
BARR 500MG;5MG A040304 001 Oct 02, 2000
DURAMED PHARMS BARR 500MG;5MG A040289 001 Mar 16, 1999
HALSEY 500MG;5MG A089994 001 May 04, 1989
MALLINCKRODT 500MG;5MG A040257 001 Aug 04, 1998
MUTUAL PHARM 500MG;5MG A040219 001 Jan 22, 1998
VINTAGE PHARMS 500MG;5MG A040106 001 Jul 30, 1996
VINTAGE PHARMS LLC 500MG;5MG A040303 001 Dec 30, 1999
WATSON LABS 500MG;5MG A040234 001 Oct 30, 1997
ROXILOX
ROXANE 500MG;5MG A040061 001 Jul 03, 1995
TYLOX
JANSSEN PHARMS 500MG;5MG A088790 001 Dec 12, 1984
TYLOX-325
ORTHO MCNEIL PHARM 325MG;5MG A088246 001 Nov 08, 1984
SOLUTION;ORAL
OXYCODONE AND ACETAMINOPHEN
MALLINCKRODT INC 325MG/5ML;5MG/5ML A040680 001 Sep 29, 2006
TABLET;ORAL
OXYCODONE 2.5/APAP 500
BRISTOL MYERS SQUIBB 500MG;2.5MG A085910 001
OXYCODONE 5/APAP 500
BRISTOL MYERS SQUIBB 500MG;5MG A085911 001
OXYCODONE AND ACETAMINOPHEN
ACTAVIS ELIZABETH 325MG;5MG A040203 001 Mar 15, 1999
325MG;7.5MG A040800 001 Apr 03, 2012
325MG;10MG A040800 002 Apr 03, 2012
AMNEAL PHARMS NY 500MG;7.5MG A040789 001 Nov 27, 2007
650MG;10MG A040789 002 Nov 27, 2007
BARR 325MG;5MG A087406 001
COASTAL PHARMS 500MG;7.5MG A090177 005 Oct 20, 2008
650MG;10MG A090177 006 Oct 20, 2008
DURAMED PHARMS BARR 325MG;5MG A040272 001 Jun 30, 1998
MALLINCKRODT 500MG;7.5MG A040550 001 Jun 30, 2004
650MG;10MG A040550 002 Jun 30, 2004
MIKART 400MG;2.5MG A040679 001 May 16, 2006
400MG;5MG A040687 001 Apr 27, 2006
400MG;7.5MG A040698 001 Apr 27, 2006
400MG;10MG A040692 001 Apr 27, 2006
500MG;10MG A040676 001 Apr 19, 2006
WATSON LABS 500MG;7.5MG A040371 001 Dec 29, 2000
650MG;10MG A040371 002 Dec 29, 2000
PERCOCET
VINTAGE PHARMS LLC 325MG;5MG A085106 002
500MG;7.5MG A040341 001 Jul 26, 1999
650MG;10MG A040341 002 Jul 26, 1999
ROXICET 5/500
ROXANE 500MG;5MG A089775 001 Jan 12, 1989
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE
CAPSULE;ORAL
TYLOX
ORTHO MCNEIL PHARM 500MG;4.5MG;0.38MG A085375 001
ACETAMINOPHEN; PENTAZOCINE HYDROCHLORIDE
TABLET;ORAL
ACETAMINOPHEN AND PENTAZOCINE HYDROCHLORIDE
GAVIS PHARMS 650MG;EQ 25MG BASE A076202 001 Aug 02, 2002
WATSON LABS 650MG;EQ 25MG BASE A074699 001 Mar 24, 2000
TALACEN
SANOFI AVENTIS US 650MG;EQ 25MG BASE N018458 001 Sep 23, 1982
ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE
TABLET;ORAL
DARVOCET
AAIPHARMA LLC 325MG;32.5MG N016844 001
DOLENE AP-65
LEDERLE 650MG;65MG A085100 001
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
MYLAN 650MG;65MG A083978 001
SANDOZ 650MG;65MG A089959 001 Jul 18, 1989
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-8(of 337)
ACETAMINOPHEN; PROPOXYPHENE HYDROCHLORIDE
TABLET;ORAL
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN
VINTAGE PHARMS 650MG;65MG A040507 001 Jul 30, 2003
WATSON LABS 650MG;65MG A040139 001 Dec 16, 1996
WYGESIC
CARACO 650MG;65MG A084999 001
ACETAMINOPHEN; PROPOXYPHENE NAPSYLATE
TABLET;ORAL
DARVOCET A500
XANODYNE PHARM 500MG;100MG A076429 001 Sep 10, 2003
DARVOCET-N 100
XANODYNE PHARM 650MG;100MG N017122 002
DARVOCET-N 50
XANODYNE PHARM 325MG;50MG N017122 001
PROPACET 100
TEVA 650MG;100MG A070107 001 Jun 12, 1985
PROPOXYPHENE NAPSYLATE AND ACETAMINOPHEN
ABLE 650MG;100MG A075838 001 Jul 11, 2001
ACTAVIS ELIZABETH 650MG;100MG A070910 001 Jan 02, 1987
CORNERSTONE 325MG;100MG A076743 001 May 07, 2004
500MG;100MG A076750 001 Jun 28, 2004
HALSEY 325MG;50MG A072105 001 May 13, 1988
650MG;100MG A072106 001 May 13, 1988
IVAX SUB TEVA PHARMS 650MG;100MG A070146 001 Aug 02, 1985
MALLINCKRODT 650MG;100MG A075738 001 Feb 02, 2001
MIRROR PHARMS 650MG;100MG A077821 001 Feb 11, 2008
MUTUAL PHARM 325MG;50MG A070115 001 Jun 12, 1985
650MG;100MG A070116 001 Jun 12, 1985
650MG;100MG A070615 001 Mar 21, 1986
650MG;100MG A070771 001 Mar 21, 1986
650MG;100MG A070775 001 Mar 21, 1986
MYLAN 650MG;100MG A072195 001 Feb 16, 1988
MYLAN PHARMS INC 650MG;100MG A070145 001 Jun 12, 1985
SANDOZ 650MG;100MG A070443 001 Jan 23, 1986
SUPERPHARM 650MG;100MG A071319 001 Jan 06, 1987
TEVA 650MG;100MG A070732 001 Jan 03, 1986
650MG;100MG A074119 001 Dec 19, 1994
VINTAGE PHARMS 325MG;50MG A074843 002 Feb 15, 2001
650MG;100MG A074843 001 Feb 12, 1997
WATSON LABS 325MG;50MG A070398 001 Dec 18, 1986
650MG;100MG A070399 001 Dec 18, 1986
WATSON LABS FLORIDA 500MG;100MG A077196 001 Jun 28, 2005
650MG;100MG A076609 001 Nov 16, 2004
WOCKHARDT LTD 325MG;50MG A077677 001 Mar 16, 2007
650MG;100MG A077677 002 Mar 16, 2007
ACETAMINOPHEN; TRAMADOL HYDROCHLORIDE
TABLET;ORAL
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN
WATSON LABS 325MG;37.5MG A076914 001 Jul 26, 2006
ACETAZOLAMIDE
TABLET;ORAL
ACETAZOLAMIDE
ALRA 250MG A083320 001
ASCOT 250MG A087686 001 Oct 20, 1982
MUTUAL PHARM 250MG A089753 001 Jun 22, 1988
VANGARD 250MG A087654 001 Feb 05, 1982
WATSON LABS 250MG A084498 002
250MG A088882 001 Oct 22, 1985
DIAMOX
TEVA BRANDED PHARM 125MG **Federal Register determination N008943 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
250MG **Federal Register determination N008943 002
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-9(of 337)
ACETAZOLAMIDE SODIUM
INJECTABLE;INJECTION
ACETAZOLAMIDE SODIUM
HOSPIRA EQ 500MG BASE/VIAL A040108 001 Oct 30, 1995
DIAMOX
TEVA WOMENS EQ 500MG BASE/VIAL **Federal Register N009388 001 Dec 05, 1990
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
ACETIC ACID, GLACIAL
SOLUTION/DROPS;OTIC
ACETASOL
ACTAVIS MID ATLANTIC 2% A087146 001
ACETIC ACID
KV PHARM 2% A085493 001
ORLEX
WARNER CHILCOTT 2% A086845 001
ACETIC ACID, GLACIAL; ALUMINUM ACETATE
SOLUTION/DROPS;OTIC
BOROFAIR
PHARMAFAIR 2%;0.79% A088606 001 Aug 21, 1985
DOMEBORO
BAYER PHARMS 2%;0.79% A084476 001
ACETIC ACID, GLACIAL; DESONIDE
SOLUTION/DROPS;OTIC
TRIDESILON
BAYER PHARMS 2%;0.05% N017914 001
ACETIC ACID, GLACIAL; HYDROCORTISONE
SOLUTION/DROPS;OTIC
ACETIC ACID W/ HYDROCORTISONE
KV PHARM 2%;1% A085492 001
HYDROCORTISONE AND ACETIC ACID
BAUSCH AND LOMB 2%;1% A040097 001 Oct 31, 1994
WOCKHARDT 2%;1% A040168 001 Aug 30, 1996
ORLEX HC
WARNER CHILCOTT 2%;1% A086844 001
ACETIC ACID, GLACIAL; HYDROCORTISONE; NEOMYCIN SULFATE
SUSPENSION/DROPS;OTIC
NEO-CORT-DOME
BAYER PHARMS 2%;1%;EQ 0.35% BASE N050238 001
ACETOHEXAMIDE
TABLET;ORAL
ACETOHEXAMIDE
BARR 250MG A070869 001 Feb 09, 1987
500MG A070870 001 Feb 09, 1987
USL PHARMA 250MG A070753 001 Nov 03, 1986
500MG A070754 001 Nov 03, 1986
WATSON LABS 250MG A071893 001 Nov 25, 1987
500MG A071894 001 Nov 25, 1987
DYMELOR
LILLY 250MG N013378 002
500MG N013378 001
ACETOPHENAZINE MALEATE
TABLET;ORAL
TINDAL
SCHERING 20MG N012254 002
ACETRIZOATE SODIUM
SOLUTION;INTRAUTERINE
SALPIX
ORTHO MCNEIL PHARM 53% N009008 001
ACETYLCHOLINE CHLORIDE
FOR SOLUTION;OPHTHALMIC
MIOCHOL
NOVARTIS 20MG/VIAL N016211 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-10(of 337)
ACETYLCYSTEINE
SOLUTION;INHALATION, ORAL
ACETYLCYSTEINE
HOSPIRA 10% A071364 001 May 01, 1989
20% A071365 001 May 01, 1989
ROXANE 10% A072323 001 Apr 30, 1992
10% A072621 001 Sep 30, 1992
20% A072324 001 Apr 30, 1992
20% A072622 001 Sep 30, 1992
MUCOMYST
APOTHECON 10% N013601 002
20% N013601 001
MUCOSIL-10
DEY 10% A070575 001 Oct 14, 1986
MUCOSIL-20
DEY 20% A070576 001 Oct 14, 1986
ACETYLCYSTEINE; ISOPROTERENOL HYDROCHLORIDE
SOLUTION;INHALATION
MUCOMYST W/ ISOPROTERENOL
MEAD JOHNSON 10%;0.05% N017366 001
ACETYLDIGITOXIN
TABLET;ORAL
ACYLANID
NOVARTIS 0.1MG N009436 001
ACRISORCIN
CREAM;TOPICAL
AKRINOL
SCHERING 2MG/GM N012470 001
ACYCLOVIR
CAPSULE;ORAL
ACYCLOVIR
ACTAVIS ELIZABETH 200MG A074906 001 Aug 26, 1997
DAVA PHARMS INC 200MG A074872 001 Apr 22, 1997
HERITAGE PHARMS INC 200MG A074889 001 Oct 31, 1997
IVAX SUB TEVA PHARMS 200MG A074674 001 Apr 22, 1997
LEK PHARM 200MG A074750 001 Apr 22, 1997
MYLAN 200MG A074977 001 Apr 13, 1998
ROXANE 200MG A074570 002 Apr 22, 1997
TEVA 200MG A074828 001 Apr 22, 1997
TEVA PHARMS 200MG A074914 001 Nov 26, 1997
WATSON LABS 200MG A075101 001 Apr 15, 1998
TABLET;ORAL
ACYCLOVIR
ACTAVIS ELIZABETH 400MG A074870 001 Jun 05, 1997
800MG A074870 002 Jun 05, 1997
DAVA PHARMS INC 400MG A074834 001 Apr 24, 1997
800MG A074834 002 Apr 24, 1997
HERITAGE PHARMS INC 400MG A074891 001 Oct 31, 1997
800MG A074891 002 Oct 31, 1997
IVAX SUB TEVA PHARMS 400MG A074836 001 Apr 22, 1997
800MG A074836 002 Apr 22, 1997
LEK PHARM 400MG A074658 001 Apr 22, 1997
800MG A074658 002 Apr 22, 1997
MYLAN 400MG A074976 001 Apr 13, 1998
800MG A074976 002 Apr 13, 1998
TEVA 200MG **Federal Register determination A074556 001 Apr 22, 1997
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
TEVA PHARMS 400MG A075021 001 Mar 18, 1998
800MG A075021 002 Mar 18, 1998
ACYCLOVIR SODIUM
INJECTABLE;INJECTION
ACYCLOVIR
ABBVIE EQ 50MG BASE/ML A075114 001 Jul 26, 1999
ACYCLOVIR SODIUM
APOTHECON EQ 1GM BASE/VIAL A074897 002 Feb 27, 1998
EQ 500MG BASE/VIAL A074897 001 Feb 27, 1998
HIKMA MAPLE EQ 1GM BASE/VIAL A074913 002 Oct 15, 1997
EQ 500MG BASE/VIAL A074913 001 Oct 15, 1997
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-11(of 337)
ACYCLOVIR SODIUM
INJECTABLE;INJECTION
ACYCLOVIR SODIUM
HOSPIRA EQ 1GM BASE/VIAL A074663 002 Apr 22, 1997
EQ 1GM BASE/VIAL A074758 002 Apr 22, 1997
EQ 25MG BASE/ML A074720 001 Apr 22, 1997
EQ 50MG BASE/ML A075065 001 Feb 25, 1999
EQ 500MG BASE/VIAL A074663 001 Apr 22, 1997
EQ 500MG BASE/VIAL A074758 001 Apr 22, 1997
TEVA PARENTERAL EQ 1GM BASE/VIAL A074969 002 Aug 26, 1997
EQ 50MG BASE/ML A075627 001 Mar 28, 2001
EQ 500MG BASE/VIAL A074969 001 Aug 26, 1997
ZOVIRAX
GLAXOSMITHKLINE EQ 1GM BASE/VIAL **Federal Register N018603 002 Jun 29, 1989
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 250MG BASE/VIAL **Federal Register N018603 003 Aug 30, 1983
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 500MG BASE/VIAL **Federal Register N018603 001 Oct 22, 1982
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
ADAPALENE
SOLUTION;TOPICAL
DIFFERIN
GALDERMA LABS LP 0.1% N020338 001 May 31, 1996
ADENOSINE
INJECTABLE;INJECTION
ADENOSINE
HIKMA MAPLE 3MG/ML A076501 001 Jun 16, 2004
TEVA PHARMS USA 3MG/ML A076564 001 Jun 16, 2004
3MG/ML A078676 001 Jul 31, 2008
ALATROFLOXACIN MESYLATE
INJECTABLE;INJECTION
TROVAN PRESERVATIVE FREE
PFIZER EQ 200MG BASE/VIAL N020760 001 Dec 18, 1997
EQ 300MG BASE/VIAL N020760 002 Dec 18, 1997
ALBUMIN CHROMATED CR-51 SERUM
INJECTABLE;INJECTION
CHROMALBIN
ISO TEX 100uCi/VIAL N017835 001
250uCi/VIAL N017835 002
500uCi/VIAL N017835 003
ALBUMIN IODINATED I-125 SERUM
INJECTABLE;INJECTION
RADIO-IODINATED (I 125) SERUM ALBUMIN (HUMAN)
BAYER PHARMS 2.5uCi/AMP N017846 001
RADIOIODINATED SERUM ALBUMIN (HUMAN) IHSA I 125
MALLINCKRODT 6.67uCi/ML N017844 003
10uCi/ML N017844 001
100uCi/ML N017844 002
ALBUMIN IODINATED I-131 SERUM
INJECTABLE;INJECTION
MEGATOPE
ISO TEX 2mCi/VIAL N017837 003
5uCi/AMP N017837 004
20uCi/AMP N017837 005
ALBUTEROL
AEROSOL, METERED;INHALATION
ALBUTEROL
ARMSTRONG PHARMS 0.09MG/INH A072273 001 Aug 14, 1996
GENPHARM 0.09MG/INH A073045 001 Aug 19, 1997
IVAX SUB TEVA PHARMS 0.09MG/INH A073272 001 Dec 28, 1995
PLIVA 0.09MG/INH A074072 001 Aug 01, 1996
PROVENTIL
SCHERING 0.09MG/INH N017559 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-12(of 337)
ALBUTEROL
AEROSOL, METERED;INHALATION
VENTOLIN
GLAXOSMITHKLINE 0.09MG/INH N018473 001
ALBUTEROL SULFATE
CAPSULE;INHALATION
VENTOLIN ROTACAPS
GLAXOSMITHKLINE EQ 0.2MG BASE N019489 001 May 04, 1988
SOLUTION;INHALATION
ALBUTEROL SULFATE
ACTAVIS MID ATLANTIC EQ 0.083% BASE A073533 001 Sep 26, 1995
APOTEX INC EQ 0.021% BASE A078623 001 Apr 05, 2010
EQ 0.042% BASE A078623 002 Apr 05, 2010
EQ 0.083% BASE A075717 001 Feb 02, 2007
EQ 0.5% BASE A076391 001 Apr 01, 2003
BAUSCH AND LOMB EQ 0.083% BASE A075358 001 Mar 29, 2000
COPLEY PHARM EQ 0.083% BASE A073495 001 May 28, 1993
EQ 0.5% BASE A073307 001 Nov 27, 1991
ROXANE EQ 0.083% BASE A075129 001 Feb 13, 2001
WOCKHARDT EU OPERATN EQ 0.083% BASE A075394 001 Nov 22, 1999
PROVENTIL
SCHERING EQ 0.083% BASE N019243 002 Jan 14, 1987
EQ 0.5% BASE N019243 001 Jan 14, 1987
VENTOLIN
GLAXOSMITHKLINE EQ 0.083% BASE N019773 001 Apr 23, 1992
EQ 0.5% BASE N019269 002 Jan 16, 1987
SYRUP;ORAL
ALBUTEROL SULFATE
ACTAVIS MID ATLANTIC EQ 2MG BASE/5ML A075262 001 Mar 30, 1999
MOVA EQ 2MG BASE/5ML A074302 001 Sep 30, 1994
WATSON LABS EQ 2MG BASE/5ML A073165 001 Apr 29, 1993
PROVENTIL
SCHERING EQ 2MG BASE/5ML N018062 001 Jan 19, 1983
VENTOLIN
GLAXOSMITHKLINE EQ 2MG BASE/5ML N019621 001 Jun 10, 1987
TABLET;ORAL
ALBUTEROL SULFATE
AM THERAP EQ 2MG BASE A072449 001 Dec 05, 1989
EQ 4MG BASE A072450 001 Dec 05, 1989
COPLEY PHARM EQ 2MG BASE A072966 001 Nov 22, 1991
EQ 4MG BASE A072967 001 Nov 22, 1991
DAVA PHARMS INC EQ 2MG BASE A072859 001 Dec 20, 1989
EQ 4MG BASE A072860 001 Dec 20, 1989
PLIVA EQ 2MG BASE A072316 001 Dec 05, 1989
EQ 4MG BASE A072317 001 Dec 05, 1989
SANDOZ EQ 2MG BASE A072151 001 Dec 05, 1989
EQ 4MG BASE A072152 001 Dec 05, 1989
TEVA EQ 2MG BASE A072619 001 Dec 05, 1989
EQ 2MG BASE A072779 001 Jun 25, 1993
EQ 2MG BASE A072938 001 Mar 30, 1990
EQ 4MG BASE A072620 001 Dec 05, 1989
EQ 4MG BASE A072780 001 Jun 25, 1993
EQ 4MG BASE A072939 001 Mar 30, 1990
UCB INC EQ 2MG BASE A073120 001 Sep 29, 1992
EQ 4MG BASE A073121 001 Sep 29, 1992
WARNER CHILCOTT EQ 2MG BASE A072817 001 Jan 09, 1990
EQ 4MG BASE A072818 001 Jan 09, 1990
WATSON LABS EQ 2MG BASE A072629 001 Jan 31, 1991
EQ 2MG BASE A072764 001 Aug 28, 1991
EQ 4MG BASE A072630 001 Jan 31, 1991
EQ 4MG BASE A072765 001 Aug 28, 1991
PROVENTIL
SCHERING EQ 2MG BASE N017853 001 May 07, 1982
EQ 4MG BASE N017853 002 May 07, 1982
VENTOLIN
GLAXOSMITHKLINE EQ 2MG BASE N019112 001 Jul 10, 1986
EQ 4MG BASE N019112 002 Jul 10, 1986
TABLET, EXTENDED RELEASE;ORAL
PROVENTIL
SCHERING EQ 4MG BASE N019383 001 Jul 13, 1987
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-13(of 337)
ALBUTEROL SULFATE
TABLET, EXTENDED RELEASE;ORAL
VOLMAX
MURO EQ 4MG BASE N019604 002 Dec 23, 1992
EQ 8MG BASE N019604 001 Dec 23, 1992
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE
SOLUTION;INHALATION
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE
APOTEX INC EQ 0.083% BASE;0.017% A077117 001 Dec 31, 2007
SANDOZ INC EQ 0.083% BASE;0.017% A076867 001 Dec 21, 2006
ALCLOMETASONE DIPROPIONATE
CREAM;TOPICAL
ACLOVATE
FOUGERA PHARMS 0.05% N018707 001 Dec 14, 1982
OINTMENT;TOPICAL
ACLOVATE
FOUGERA PHARMS 0.05% N018702 001 Dec 14, 1982
ALCOHOL
INJECTABLE;INJECTION
ALCOHOL 5% IN DEXTROSE 5%
MILES 5ML/100ML A083483 001
ALCOHOL; DEXTROSE
INJECTABLE;INJECTION
ALCOHOL 5% IN D5-W
HOSPIRA 5ML/100ML;5GM/100ML A083263 001
ALCOHOL 5% IN DEXTROSE 5% IN WATER
BAXTER HLTHCARE 5ML/100ML;5GM/100ML A083256 001
ALENDRONATE SODIUM
TABLET;ORAL
ALENDRONATE SODIUM
MYLAN EQ 35MG BASE A078638 001 Aug 04, 2008
EQ 70MG BASE A078638 002 Aug 04, 2008
SANDOZ EQ 5MG BASE A075871 001 Apr 22, 2009
EQ 10MG BASE A075871 002 Apr 22, 2009
EQ 35MG BASE A075871 004 Apr 22, 2009
EQ 40MG BASE A075871 003 Apr 22, 2009
EQ 70MG BASE A075871 005 Apr 22, 2009
TEVA PHARMS EQ 35MG BASE A076184 002 Aug 04, 2008
EQ 70MG BASE A076184 001 Feb 06, 2008
FOSAMAX
MERCK AND CO INC EQ 5MG BASE **Federal Register N020560 003 Apr 25, 1997
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 10MG BASE **Federal Register N020560 001 Sep 29, 1995
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 35MG BASE **Federal Register N020560 004 Oct 20, 2000
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 40MG BASE **Federal Register N020560 002 Sep 29, 1995
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
ALGLUCERASE
INJECTABLE;INJECTION
CEREDASE
GENZYME 10 UNITS/ML N020057 004 May 08, 1992
80 UNITS/ML N020057 003 Apr 05, 1991
ALISKIREN HEMIFUMARATE; VALSARTAN
TABLET;ORAL
VALTURNA
NOVARTIS EQ 150MG BASE;160MG N022217 001 Sep 16, 2009
EQ 300MG BASE;320MG N022217 002 Sep 16, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-14(of 337)
ALKAVERVIR
TABLET;ORAL
VERILOID
3M 2MG N007336 002
3MG N007336 003
ALLOPURINOL
TABLET;ORAL
ALLOPURINOL
MUTUAL PHARM 100MG A070466 001 Dec 24, 1985
300MG A070467 001 Dec 24, 1985
PURACAP PHARM 100MG A070150 001 Dec 10, 1985
300MG A070147 001 Dec 10, 1985
PUREPAC PHARM 100MG A070579 001 Apr 14, 1986
300MG A070580 001 Apr 14, 1986
SANDOZ 100MG A070268 001 Dec 31, 1985
300MG A070269 001 Dec 31, 1985
SUPERPHARM 100MG A070950 001 Nov 30, 1988
300MG A070951 001 Nov 30, 1988
WATSON LABS 100MG N018241 001 Nov 16, 1984
100MG N018785 001 Sep 28, 1984
300MG N018241 002 Nov 16, 1984
300MG N018785 002 Sep 28, 1984
LOPURIN
ABBOTT 100MG N018297 001
300MG N018297 002
ALPRAZOLAM
SOLUTION;ORAL
ALPRAZOLAM
ROXANE 0.5MG/5ML A074314 001 Oct 31, 1993
TABLET;ORAL
ALPRAZOLAM
IVAX SUB TEVA PHARMS 0.25MG A074294 001 Jul 29, 1994
0.5MG A074294 002 Jul 29, 1994
1MG A074294 003 Jul 29, 1994
2MG A074294 004 Jul 29, 1994
ROXANE 0.25MG A074199 001 Oct 19, 1993
0.5MG A074199 002 Oct 19, 1993
1MG A074199 003 Oct 19, 1993
TEVA 0.25MG A074085 001 Feb 16, 1994
0.5MG A074085 002 Feb 16, 1994
1MG A074085 003 Feb 16, 1994
2MG A074085 004 Feb 26, 1996
WATSON LABS 0.25MG A074456 001 Aug 31, 1995
0.25MG A074479 001 Jan 21, 1997
0.5MG A074456 002 Aug 31, 1995
0.5MG A074479 002 Jan 21, 1997
1MG A074456 003 Aug 31, 1995
1MG A074479 003 Jan 21, 1997
TABLET, EXTENDED RELEASE;ORAL
ALPRAZOLAM
ANI PHARMS INC 0.5MG A077979 001 Feb 28, 2007
1MG A077979 002 Feb 28, 2007
2MG A077979 003 Feb 28, 2007
3MG A077979 004 Feb 28, 2007
SANDOZ INC 0.5MG A077777 001 Jun 30, 2006
1MG A077777 002 Jun 30, 2006
2MG A077777 003 Jun 30, 2006
3MG A077777 004 Jun 30, 2006
VINTAGE PHARMS 0.5MG A078442 001 Oct 15, 2007
1MG A078442 002 Oct 15, 2007
2MG A078442 003 Oct 15, 2007
3MG A078442 004 Oct 15, 2007
TABLET, ORALLY DISINTEGRATING;ORAL
NIRAVAM
UCB INC 0.25MG **Federal Register determination N021726 001 Jan 19, 2005
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
0.5MG **Federal Register determination N021726 002 Jan 19, 2005
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-15(of 337)
ALPRAZOLAM
TABLET, ORALLY DISINTEGRATING;ORAL
NIRAVAM
1MG **Federal Register determination N021726 003 Jan 19, 2005
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
2MG **Federal Register determination N021726 004 Jan 19, 2005
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
ALPROSTADIL
INJECTABLE;INJECTION
CAVERJECT
PFIZER 0.005MG/ML N020755 001 Oct 31, 1997
0.01MG/ML N020755 002 Oct 01, 1997
0.02MG/ML N020755 003 Oct 01, 1997
EDEX
AUXILIUM PHARMS LLC 0.005MG/VIAL N020649 001 Jun 12, 1997
ALSEROXYLON
TABLET;ORAL
RAUTENSIN
NOVARTIS 2MG N009215 001
RAUWILOID
3M 2MG N008867 001
ALUMINUM HYDROXIDE; MAGNESIUM TRISILICATE
TABLET, CHEWABLE;ORAL
ALUMINUM HYDROXIDE AND MAGNESIUM TRISILICATE
PENNEX 80MG;20MG A089449 001 Nov 27, 1987
FOAMICON
NOVARTIS 80MG;20MG A072687 001 Jun 28, 1989
AMANTADINE HYDROCHLORIDE
CAPSULE;ORAL
AMANTADINE HYDROCHLORIDE
ACTAVIS ELIZABETH 100MG A077659 001 Feb 23, 2006
WATSON LABS 100MG A071382 001 Jan 21, 1987
SYMADINE
SOLVAY 100MG A071000 001 Sep 04, 1986
SYMMETREL
ENDO PHARMS 100MG N016020 001
SYRUP;ORAL
AMANTADINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC 50MG/5ML A072655 001 Oct 30, 1990
TEVA PHARMS 50MG/5ML A073115 001 Aug 23, 1991
SYMMETREL
ENDO PHARMS 50MG/5ML N016023 002
TABLET;ORAL
SYMMETREL
ENDO PHARMS 100MG N018101 001
AMBENONIUM CHLORIDE
TABLET;ORAL
MYTELASE
SANOFI AVENTIS US 10MG N010155 002
AMCINONIDE
CREAM;TOPICAL
CYCLOCORT
ASTELLAS 0.025% N018116 001
0.1% N018116 002
LOTION;TOPICAL
CYCLOCORT
ASTELLAS 0.1% N019729 001 Jun 13, 1988
OINTMENT;TOPICAL
CYCLOCORT
ASTELLAS 0.1% N018498 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-16(of 337)
AMDINOCILLIN
INJECTABLE;INJECTION
COACTIN
ROCHE 1GM/VIAL N050565 003 Dec 21, 1984
250MG/VIAL N050565 001 Dec 21, 1984
500MG/VIAL N050565 002 Dec 21, 1984
AMIFOSTINE
INJECTABLE;INJECTION
ETHYOL
CLINIGEN HLTHCARE 375MG/VIAL N020221 002 Sep 10, 1999
AMIKACIN SULFATE
INJECTABLE;INJECTION
AMIKACIN SULFATE
ABBOTT EQ 250MG BASE/ML A063265 001 Nov 30, 1994
EQ 250MG BASE/ML A063266 001 Oct 31, 1994
ASTRAZENECA EQ 50MG BASE/ML A063167 001 Dec 14, 1995
EQ 250MG BASE/ML A063169 001 Dec 14, 1995
HIKMA MAPLE EQ 50MG BASE/ML A063274 001 May 18, 1992
EQ 250MG BASE/ML A063275 001 May 18, 1992
HOSPIRA EQ 50MG BASE/ML A063263 001 Nov 30, 1994
EQ 50MG BASE/ML A063350 001 Jul 30, 1993
EQ 62.5MG BASE/ML A063283 001 Oct 31, 1994
EQ 250MG BASE/ML A063264 001 Nov 30, 1994
EQ 250MG BASE/ML A063350 002 Jul 30, 1993
EQ 250MG BASE/ML A064098 001 Jun 26, 1995
EQ 250MG BASE/ML A064099 001 Jun 20, 1995
TEVA PHARMS USA EQ 50MG BASE/ML A064045 001 Sep 28, 1993
AMIKACIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA EQ 500MG BASE/100ML A064146 001 Apr 02, 1997
AMIKIN
APOTHECON EQ 50MG BASE/ML A062311 001
EQ 50MG BASE/ML A062562 001 Sep 20, 1984
EQ 50MG BASE/ML N050495 001
EQ 250MG BASE/ML A062311 002
EQ 250MG BASE/ML A062562 002 Sep 20, 1984
EQ 250MG BASE/ML N050495 002
AMIKIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
APOTHECON EQ 5MG BASE/ML N050618 002 Nov 30, 1987
EQ 10MG BASE/ML N050618 001 Nov 30, 1987
AMILORIDE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
SANDOZ EQ 5MG ANHYDROUS;50MG A073357 001 Nov 27, 1991
TEVA EQ 5MG ANHYDROUS;50MG A070795 001 Apr 17, 1988
WATSON LABS EQ 5MG ANHYDROUS;50MG A073334 001 Jul 19, 1991
HYDRO-RIDE
PAR PHARM EQ 5MG ANHYDROUS;50MG A070347 001 Dec 25, 1990
MODURETIC 5-50
MERCK EQ 5MG ANHYDROUS;50MG N018201 001
AMINO ACIDS
INJECTABLE;INJECTION
AMINESS 5.2% ESSENTIAL AMINO ACIDS W/ HISTADINE
HOSPIRA 5.2% (5.2GM/100ML) N018901 001 Apr 06, 1984
AMINOSYN 3.5% IN PLASTIC CONTAINER
ABBOTT 3.5% (3.5GM/100ML) N018804 001 May 15, 1984
3.5% (3.5GM/100ML) N018875 001 Aug 08, 1984
AMINOSYN II 3.5%
HOSPIRA 3.5% (3.5GM/100ML) N019438 001 Apr 03, 1986
AMINOSYN II 3.5% IN PLASTIC CONTAINER
ABBOTT 3.5% (3.5GM/100ML) N019491 001 Oct 10, 1986
AMINOSYN II 5%
HOSPIRA 5% (5GM/100ML) N019438 002 Apr 03, 1986
AMINOSYN-HBC 7% IN PLASTIC CONTAINER
ABBOTT 7% (7GM/100ML) N019400 001 Jul 23, 1986
BRANCHAMIN 4%
BAXTER HLTHCARE 4% (4GM/100ML) N018678 001 Sep 28, 1984
FREAMINE 8.5%
B BRAUN 8.5% (8.5GM/100ML) N016822 001
FREAMINE II 8.5%
B BRAUN 8.5% (8.5GM/100ML) N016822 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-17(of 337)
AMINO ACIDS
INJECTABLE;INJECTION
HEPATASOL 8%
BAXTER HLTHCARE 8% (8GM/100ML)
A020360 001 Apr 04, 1996
NEOPHAM 6.4%
HOSPIRA 6.4% (6.4GM/100ML)
N018792 001 Jan 17, 1984
NOVAMINE 11.4%
HOSPIRA INC 11.4% (11.4GM/100ML)
N017957 003 Aug 09, 1982
NOVAMINE 15%
HOSPIRA INC 15% (75GM/500ML)
N017957 004 Nov 28, 1986
NOVAMINE 15% SULFITE FREE IN PLASTIC CONTAINER
BAXTER HLTHCARE 15% (15GM/100ML)
N020107 001 Feb 05, 1993
NOVAMINE 8.5%
HOSPIRA INC 8.5% (8.5GM/100ML)
N017957 002 Aug 09, 1982
RENAMIN W/O ELECTROLYTES
BAXTER HLTHCARE 6.5% (6.5GM/100ML)
N017493 007 Oct 15, 1982
TRAVASOL 10% W/O ELECTROLYTES
BAXTER HLTHCARE 10% (10GM/100ML)
N017493 006
TRAVASOL 5.5% W/O ELECTROLYTES
BAXTER HLTHCARE 5.5% (5.5GM/100ML)
N017493 004
TRAVASOL 8.5% W/O ELECTROLYTES
BAXTER HLTHCARE 8.5% (8.5GM/100ML)
N017493 005
AMINO ACIDS; CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM
PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE;INJECTION
AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
ABBOTT 3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML N019714 001
Sep 12, 1988
;22.4MG/100ML;261MG/100ML;205MG/100ML
HOSPIRA INC 3.5%;36.8MG/100ML;25GM/100ML;51MG/100ML N019683 001
Nov 07, 1988
;22.4MG/100ML;261MG/100ML;205MG/100ML
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER
ABBOTT 4.25%;36.8MG/100ML;20GM/100ML;51MG/100M N019714 002
Sep 12, 1988
L;22.4MG/100ML;261MG/100ML;205MG/100ML
HOSPIRA INC 4.25%;36.8MG/100ML;20GM/100ML;51MG/100M N019683 002
Nov 07, 1988
L;22.4MG/100ML;261MG/100ML;205MG/100ML
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
ABBOTT 4.25%;36.8MG/100ML;25GM/100ML;51MG/100M N019714 004
Sep 12, 1988
L;22.4MG/100ML;261MG/100ML;205MG/100ML
HOSPIRA INC 4.25%;36.8MG/100ML;25GM/100ML;51MG/100M N019683 003
Nov 07, 1988
L;22.4MG/100ML;261MG/100ML;205MG/100ML
AMINOSYN II 5% W/ ELECTROLYTES IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER
ABBOTT 5%;36.8MG/100ML;25GM/100ML;51MG/100ML;2 N019714 003
Sep 12, 1988
2.4MG/100ML;261MG/100ML;205MG/100ML
HOSPIRA INC 5%;36.8MG/100ML;25GM/100ML;51MG/100ML;2 N019683 004
Nov 07, 1988
2.4MG/100ML;261MG/100ML;205MG/100ML
AMINO ACIDS; DEXTROSE
INJECTABLE;INJECTION
AMINOSYN 3.5% W/ DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 3.5%;25GM/100ML
N019118 001
Oct 11, 1984
AMINOSYN 3.5% W/ DEXTROSE 5% IN PLASTIC CONTAINER
ABBOTT 3.5%;5GM/100ML
N019120 001
Oct 11, 1984
AMINOSYN 4.25% W/ DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 4.25%;25GM/100ML
N019119 001
Oct 11, 1984
AMINOSYN II 3.5% IN DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 3.5%;25GM/100ML
N019505 002
Nov 07, 1986
3.5%;25GM/100ML
N019713 006
Sep 09, 1988
HOSPIRA 3.5%;25GM/100ML
N019681 001
Nov 01, 1988
AMINOSYN II 3.5% IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBOTT 3.5%;5GM/100ML
N019506 001
Nov 07, 1986
3.5%;5GM/100ML
N019713 002
Sep 09, 1988
HOSPIRA 3.5%;5GM/100ML
N019681 002
Nov 01, 1988
AMINOSYN II 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER
ABBOTT 4.25%;10GM/100ML
N019713 001
Sep 09, 1988
HOSPIRA 4.25%;10GM/100ML
N019681 004
Nov 01, 1988
AMINOSYN II 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER
ABBOTT 4.25%;20GM/100ML
N019713 004
Sep 09, 1988
HOSPIRA 4.25%;20GM/100ML
N019681 005
Nov 01, 1988
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-18(of 337)
AMINO ACIDS; DEXTROSE
INJECTABLE;INJECTION
AMINOSYN II 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 4.25%;25GM/100ML
N019504 002
Nov 07, 1986
4.25%;25GM/100ML
N019713 005
Sep 09, 1988
HOSPIRA 4.25%;25GM/100ML
N019681 003
Nov 01, 1988
AMINOSYN II 5% IN DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 5%;25GM/100ML
N019565 001
Dec 17, 1986
5%;25GM/100ML
N019713 003
Sep 09, 1988
HOSPIRA 5%;25GM/100ML
N019681 006
Nov 01, 1988
TRAVASOL 2.75% IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;10GM/100ML
N019520 002
Sep 23, 1988
TRAVASOL 2.75% IN DEXTROSE 15% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;15GM/100ML
N019520 003
Sep 23, 1988
TRAVASOL 2.75% IN DEXTROSE 20% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;20GM/100ML
N019520 004
Sep 23, 1988
TRAVASOL 2.75% IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;25GM/100ML
N019520 005
Sep 23, 1988
TRAVASOL 2.75% IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;5GM/100ML
N019520 001
Sep 23, 1988
TRAVASOL 4.25% IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;10GM/100ML
N019520 007
Sep 23, 1988
TRAVASOL 4.25% IN DEXTROSE 15% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;15GM/100ML
N019520 008
Sep 23, 1988
TRAVASOL 4.25% IN DEXTROSE 20% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;20GM/100ML
N019520 009
Sep 23, 1988
TRAVASOL 4.25% IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;25GM/100ML
N019520 010
Sep 23, 1988
TRAVASOL 4.25% IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;5GM/100ML
N019520 006
Sep 23, 1988
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; POTASSIUM
PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE;INJECTION
AMINOSYN II 4.25% W/ ELECT AND ADJUSTED PHOSPHATE IN DEXTROSE 10% IN PLASTIC CONTAINER
ABBOTT 4.25%;10GM/100ML;51MG/100ML;176.5MG/100 N019712 002 Sep 08, 1988
ML;22.4MG/100ML;104.5MG/100ML;205MG/100
ML
HOSPIRA INC 4.25%;10GM/100ML;51MG/100ML;176.5MG/100 N019682 003 Nov 01, 1988
ML;22.4MG/100ML;104.5MG/100ML;205MG/100
ML
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC;
SODIUM CHLORIDE
INJECTABLE;INJECTION
AMINOSYN II 3.5% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 3.5%;25GM/100ML;51MG/100ML;22.4MG/100ML N019564 002
Dec 16, 1986
;261MG/100ML;205MG/100ML
AMINOSYN II 4.25% W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
ABBOTT 4.25%;25GM/100ML;51MG/100ML;22.4MG/100M N019564 004
Dec 16, 1986
L;261MG/100ML;205MG/100ML
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE,
DIBASIC, HEPTAHYDRATE
INJECTABLE;INJECTION
AMINOSYN II 3.5% M IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBOTT 3.5%;5GM/100ML;30MG/100ML;97MG/100ML;12
N019564 001 Dec 16, 1986
0MG/100ML;49.3MG/100ML
3.5%;5GM/100ML;30MG/100ML;97MG/100ML;12
N019712 001 Sep 08, 1988
0MG/100ML;49.3MG/100ML
HOSPIRA INC 3.5%;5GM/100ML;30MG/100ML;97MG/100ML;12
N019682 001 Nov 01, 1988
0MG/100ML;49.3MG/100ML
AMINOSYN II 4.25% M IN DEXTROSE 10% IN PLASTIC CONTAINER
ABBOTT 4.25%;10GM/100ML;30MG/100ML;97MG/100ML;
N019564 003 Dec 16, 1986
120MG/100ML;49.3MG/100ML
HOSPIRA INC 4.25%;5GM/100ML;30MG/100ML;97MG/100ML;1
N019682 002 Nov 01, 1988
20MG/100ML;49.3MG/100ML
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM
CHLORIDE
INJECTABLE;INJECTION
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;10GM/100ML;51MG/100ML;261MG/100ML N020147 002
Oct 23, 1995
;216MG/100ML;112MG/100ML
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;15GM/100ML;51MG/100ML;261MG/100ML N020147 003
Oct 23, 1995
;216MG/100ML;112MG/100ML
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-19(of 337)
AMINO ACIDS; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM
CHLORIDE
INJECTABLE;INJECTION
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;20GM/100ML;51MG/100ML;261MG/100ML N020147 004
Oct 23, 1995
;216MG/100ML;112MG/100ML
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;25GM/100ML;51MG/100ML;261MG/100ML N020147 005
Oct 23, 1995
;216MG/100ML;112MG/100ML
TRAVASOL 2.75% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2.75%;5GM/100ML;51MG/100ML;261MG/100ML; N020147 001
Oct 23, 1995
216MG/100ML;112MG/100ML
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;10GM/100ML;51MG/100ML;261MG/100ML N020147 007
Oct 23, 1995
;297MG/100ML;77MG/100ML
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 15% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;15GM/100ML;51MG/100ML;261MG/100ML N020147 008
Oct 23, 1995
;297MG/100ML;77MG/100ML
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 20% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;20GM/100ML;51MG/100ML;261MG/100ML N020147 009
Oct 23, 1995
;297MG/100ML;77MG/100ML
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 25% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;25GM/100ML;51MG/100ML;261MG/100ML N020147 010
Oct 23, 1995
;297MG/100ML;77MG/100ML
TRAVASOL 4.25% SULFITE FREE W/ ELECTROLYTES IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4.25%;5GM/100ML;51MG/100ML;261MG/100ML; N020147 006
Oct 23, 1995
297MG/100ML;77MG/100ML
AMINO ACIDS; MAGNESIUM ACETATE; PHOSPHORIC ACID; POTASSIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
AMINOSYN 3.5% M IN PLASTIC CONTAINER
ABBOTT 3.5%;21MG/100ML;40MG/100ML;128MG/100ML; N018804 002
May 15, 1984
234MG/100ML
3.5%;21MG/100ML;40MG/100ML;128MG/100ML; N018875 002
Aug 08, 1984
234MG/100ML
AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
AMINOSYN 3.5% M
HOSPIRA 3.5%;21MG/100ML;128MG/100ML;234MG/100ML N017789 005
AMINO ACIDS; MAGNESIUM ACETATE; POTASSIUM ACETATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC,
HEPTAHYDRATE
INJECTABLE;INJECTION
AMINOSYN II 3.5% M IN PLASTIC CONTAINER
ABBOTT 3.5%;32MG/100ML;128MG/100ML;222MG/100ML N019493 001 Oct 16, 1986
;49MG/100ML
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM ACETATE; POTASSIUM CHLORIDE; SODIUM ACETATE
INJECTABLE;INJECTION
VEINAMINE 8%
HOSPIRA INC 8%;61MG/100ML;211MG/100ML;56MG/100ML;38 N017957 001
8MG/100ML
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM CHLORIDE
INJECTABLE;INJECTION
AMINOSYN II 7% W/ ELECTROLYTES
HOSPIRA 7%;102MG/100ML;45MG/100ML;522MG/100ML;4 N019437 006 Apr 03, 1986
10MG/100ML
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM PHOSPHATE, DIBASIC,
HEPTAHYDRATE
INJECTABLE;INJECTION
AMINOSYN II 3.5% M
HOSPIRA 3.5%;30MG/100ML;97MG/100ML;120MG/100ML; N019437 007 Apr 03, 1986
49MG/100ML
AMINO ACIDS; MAGNESIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
TRAVASOL 3.5% W/ ELECTROLYTES
BAXTER HLTHCARE 3.5%;51MG/100ML;131MG/100ML;218MG/100ML
N017493 003
;35MG/100ML
TRAVASOL 5.5% W/ ELECTROLYTES
BAXTER HLTHCARE 5.5%;102MG/100ML;522MG/100ML;431MG/100M
N017493 001
L;224MG/100ML
TRAVASOL 8.5% W/ ELECTROLYTES
BAXTER HLTHCARE 8.5%;102MG/100ML;522MG/100ML;594MG/100M
N017493 002
L;154MG/100ML
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-20(of 337)
AMINOCAPROIC ACID
INJECTABLE;INJECTION
AMICAR
CLOVER PHARMS 250MG/ML **Federal Register
N015229 002
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
AMINOCAPROIC ACID
ABRAXIS PHARM 250MG/ML
A070522 001
Jun 17, 1986
BAXTER HLTHCARE 250MG/ML
N018590 001
Oct 29, 1982
HOSPIRA 250MG/ML
A070888 001
Jun 16, 1988
AMINOGLUTETHIMIDE
TABLET;ORAL
CYTADREN
NOVARTIS 250MG
N018202 001
AMINOHIPPURATE SODIUM
INJECTABLE;INJECTION
AMINOHIPPURATE SODIUM
MERCK 20%
N005619 001
AMINOPHYLLINE
ENEMA;RECTAL
SOMOPHYLLIN
FISONS 300MG/5ML
N018232 001
Apr 02, 1982
INJECTABLE;INJECTION
AMINOPHYLLIN
GD SEARLE LLC 25MG/ML
A087243 001
May 24, 1982
25MG/ML
A087621 001
May 24, 1982
AMINOPHYLLINE
ABRAXIS PHARM 25MG/ML
A084568 001
25MG/ML
A087200 001
25MG/ML
A087250 001
Jan 06, 1982
25MG/ML
A087886 001
Aug 30, 1983
25MG/ML
A088407 001
Jan 25, 1984
ELKINS SINN 25MG/ML
A087239 001
HOSPIRA 25MG/ML
A087601 001
Jul 23, 1982
INTL MEDICATION 25MG/ML
A087209 001
Feb 01, 1982
25MG/ML
A087867 001
Nov 10, 1983
25MG/ML
A087868 001
Nov 10, 1983
KING PHARMS 25MG/ML
A086606 001
LUITPOLD 25MG/ML
A087240 001
LYPHOMED 25MG/ML
A087431 001
PHARMA SERVE NY 25MG/ML
A087387 001
Jun 03, 1983
25MG/ML
A087392 001
Dec 15, 1983
SMITH AND NEPHEW 25MG/ML
A088429 001
May 30, 1985
25MG/ML
A088749 001
May 30, 1985
TEVA PARENTERAL 25MG/ML
A081142 001
Sep 25, 1991
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45%
HOSPIRA 100MG/100ML
A088147 002
May 03, 1983
200MG/100ML
A088147 003
May 03, 1983
AMINOPHYLLINE IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
HOSPIRA 100MG/100ML
N018924 001
Dec 12, 1984
200MG/100ML
N018924 002
Dec 12, 1984
400MG/100ML
N018924 003
Dec 12, 1984
500MG/100ML
N018924 004
Dec 12, 1984
SOLUTION;ORAL
AMINOPHYLLINE
MORTON GROVE 105MG/5ML
A088156 001
Dec 05, 1983
ROXANE 105MG/5ML
A088126 001
Aug 19, 1983
AMINOPHYLLINE DYE FREE
ACTAVIS MID ATLANTIC 105MG/5ML
A087727 001
Apr 16, 1982
SOMOPHYLLIN
FISONS 105MG/5ML
A086466 001
SOMOPHYLLIN-DF
FISONS 105MG/5ML
A087045 001
SUPPOSITORY;RECTAL
TRUPHYLLINE
G AND W LABS 250MG
A085498 001
Mar 23, 1983
500MG
A085498 002
Jan 03, 1983
TABLET;ORAL
AMINOPHYLLIN
GD SEARLE LLC 100MG
N002386 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-21(of 337)
AMINOPHYLLINE
TABLET;ORAL
AMINOPHYLLIN
200MG
N002386 003
AMINOPHYLLINE
ASCOT
100MG
A087522 001 Feb 12, 1982
200MG
A087523 001 Feb 12, 1982
BARR
100MG
A088297 001 Aug 19, 1983
200MG
A088298 001 Aug 19, 1983
DURAMED PHARMS BARR
100MG
A088182 001 Mar 31, 1983
200MG
A088183 001 Mar 31, 1983
HALSEY
100MG
A084674 001
HIKMA INTL PHARMS
100MG
A084540 001
200MG
A085003 001
IMPAX LABS
100MG
A084574 001
200MG
A084576 001
KV PHARM
100MG
A085284 001
200MG
A085289 001
LANNETT
100MG
A084588 001
200MG
A084588 002
PAL PAK
100MG
A084533 001
PANRAY
100MG
A084552 001
200MG
A084552 002
PUREPAC PHARM
100MG
A084699 001
200MG
A085333 001
ROXANE
100MG
A087500 001 Feb 09, 1982
200MG
A087501 001 Feb 09, 1982
SANDOZ
100MG
A085261 003
100MG
A085262 002
200MG
A085261 002
VALEANT PHARM INTL
200MG
A084563 001
VANGARD
100MG
A088314 001 Oct 03, 1983
200MG
A088319 001 Oct 03, 1983
VINTAGE PHARMS
100MG
A085409 001
200MG
A085410 001
WATSON LABS
100MG
A085567 001
200MG
A085564 001
TABLET, DELAYED RELEASE;ORAL
AMINOPHYLLINE
IMPAX LABS
100MG
A084577 001
200MG
A084575 001
TABLICAPS
100MG
A084632 002
VALE
100MG
A084531 001
200MG
A084530 001
TABLET, EXTENDED RELEASE;ORAL
PHYLLOCONTIN
PHARM RES ASSOC
225MG
A086760 001
AMINOSALICYLATE SODIUM
POWDER;ORAL
P.A.S. SODIUM
CENTURY PHARMS
4GM/PACKET
A080947 001
SODIUM AMINOSALICYLATE
HEXCEL
100%
A080097 001
TABLET;ORAL
PARASAL SODIUM
PANRAY
1GM
N006811 011
500MG
N006811 006
SODIUM P.A.S.
LANNETT
500MG
A080138 002
TEEBACIN
CONSOLIDATED MIDLAND
500MG
N007320 002
AMINOSALICYLATE SODIUM; AMINOSALICYLIC ACID
TABLET;ORAL
NEOPASALATE
MEDPOINTE PHARM HLC 846MG;112MG
A080059 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-22(of 337)
AMINOSALICYLIC ACID
TABLET;ORAL
PARASAL
PANRAY 1GM N006811 002
500MG N006811 001
AMINOSALICYLIC ACID RESIN COMPLEX
POWDER;ORAL
REZIPAS
BRISTOL MYERS SQUIBB EQ 500MG BASE/GM N009052 001
AMIODARONE HYDROCHLORIDE
INJECTABLE;INJECTION
AMIODARONE HYDROCHLORIDE
BEDFORD 50MG/ML A076018 001 Oct 15, 2002
BEDFORD LABS 50MG/ML A076299 001 Oct 24, 2002
BEN VENUE 50MG/ML A076088 001 Oct 15, 2002
HOSPIRA 50MG/ML A076108 001 Oct 15, 2002
INTL MEDICATION SYS 50MG/ML N021594 001 Feb 04, 2004
PAR STERILE PRODUCTS 50MG/ML A076394 001 Apr 25, 2003
TEVA PHARMS USA 50MG/ML A076163 001 Sep 05, 2003
CORDARONE
WYETH PHARMS INC 50MG/ML N020377 001 Aug 03, 1995
TABLET;ORAL
AMIODARONE HYDROCHLORIDE
TEVA 200MG A074895 001 Apr 16, 1999
AMITRIPTYLINE HYDROCHLORIDE
CONCENTRATE;ORAL
ENDEP
ROCHE 40MG/ML A085749 001
INJECTABLE;INJECTION
AMITRIPTYLINE HYDROCHLORIDE
WATSON LABS 10MG/ML A085594 001
ELAVIL
ASTRAZENECA 10MG/ML N012704 001
TABLET;ORAL
AMITID
BRISTOL MYERS SQUIBB 10MG A086454 001
25MG A086454 002
50MG A086454 003
75MG A086454 004
100MG A086454 005
AMITRIL
WARNER CHILCOTT 10MG A083939 001
25MG A083937 001
50MG A083938 002
75MG A084957 001
100MG A085093 001
150MG A086295 001
AMITRIPTYLINE HYDROCHLORIDE
AM THERAP 25MG A088672 001 Nov 20, 1984
50MG A088673 001 Nov 20, 1984
75MG A088674 001 Nov 20, 1984
100MG A088675 001 Nov 20, 1984
COPLEY PHARM 10MG A088421 001 Apr 30, 1984
25MG A088422 001 Apr 30, 1984
50MG A088423 001 Apr 30, 1984
75MG A088424 001 Apr 30, 1984
100MG A088425 001 Apr 30, 1984
150MG A088426 001 Apr 30, 1984
HALSEY 10MG A085923 001
25MG A085922 001
50MG A085925 001
50MG A087557 001 Mar 05, 1982
75MG A085926 001 May 20, 1983
100MG A085927 001 May 20, 1983
LEDERLE 10MG A086744 001
10MG A087366 001 Jan 04, 1982
25MG A086746 001
25MG A087367 001 May 03, 1982
50MG A086743 001
50MG A087181 001 Jan 04, 1982
75MG A086745 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-23(of 337)
AMITRIPTYLINE HYDROCHLORIDE
TABLET;ORAL
AMITRIPTYLINE HYDROCHLORIDE
75MG A087369 001 Jan 04, 1982
100MG A086747 001
100MG A087368 001 May 03, 1982
150MG A087370 001 Jan 04, 1982
MUTUAL PHARM 10MG A085744 001
25MG A085627 001
50MG A085745 001
75MG A085743 001
100MG A085742 002 May 11, 1982
150MG A089423 001 Feb 17, 1987
PAR PHARM 10MG A088697 001 Sep 25, 1984
25MG A088698 001 Sep 25, 1984
50MG A088699 001 Sep 25, 1984
75MG A088700 001 Sep 25, 1984
100MG A088701 001 Sep 25, 1984
150MG A088702 001 Sep 25, 1984
PLIVA 10MG A088883 001 Sep 26, 1984
25MG A088884 001 Sep 26, 1984
50MG A088885 001 Sep 26, 1984
75MG A088886 001 Sep 26, 1984
100MG A088887 001 Sep 26, 1984
150MG A088888 001 Sep 26, 1984
PUREPAC PHARM 10MG A088075 001 Sep 16, 1983
10MG A088084 001 Jul 18, 1983
25MG A088076 001 May 20, 1983
25MG A088085 001 Jul 18, 1983
50MG A088077 001 Sep 16, 1983
50MG A088105 001 Jul 18, 1983
75MG A088078 001 Sep 16, 1983
75MG A088106 001 Jul 18, 1983
100MG A088079 001 Sep 16, 1983
100MG A088107 001 Jul 18, 1983
ROXANE 10MG A086002 001
10MG A086144 001
25MG A085944 001
25MG A086145 001
50MG A085945 001
50MG A086143 001
75MG A086004 001
75MG A086147 001
100MG A086003 001
100MG A086146 001
150MG A086090 001
150MG A086148 001
SUPERPHARM 10MG A088853 001 Nov 13, 1984
25MG A088854 001 Nov 13, 1984
50MG A088855 001 Nov 13, 1984
75MG A088856 001 Nov 13, 1984
100MG A088857 001 Nov 13, 1984
TEVA 10MG A084910 003
10MG A086610 001
25MG A085031 001
25MG A086859 001
50MG A085032 001
50MG A086857 001
75MG A085030 001
75MG A086860 001
100MG A085836 001
100MG A086854 001
150MG A086853 001
UCB INC 10MG A085864 001
25MG A085935 001
50MG A085936 001
75MG A086337 001
100MG A086336 001
150MG A086335 001
USL PHARMA 25MG A087775 001 Feb 10, 1982
VANGARD 10MG A087632 001 Feb 01, 1982
50MG A087616 001 Feb 08, 1982
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-24(of 337)
AMITRIPTYLINE HYDROCHLORIDE
TABLET;ORAL
AMITRIPTYLINE HYDROCHLORIDE
75MG A087617 001 Feb 05, 1982
100MG A087639 001 Feb 08, 1982
WATSON LABS 10MG A085816 001
10MG A088620 001 Mar 02, 1984
25MG A085817 001
25MG A088621 001 Mar 02, 1984
50MG A085815 001
50MG A088622 001 Mar 02, 1984
75MG A085819 001
75MG A088633 001 Mar 02, 1984
100MG A085820 001
100MG A088634 001 Mar 02, 1984
150MG A085821 001
150MG A088635 001 Mar 02, 1984
WEST WARD 10MG A087647 001 Mar 05, 1982
25MG A087278 001
ELAVIL
ASTRAZENECA 10MG N012703 001
25MG N012703 003
50MG N012703 004
75MG N012703 005
100MG N012703 006
150MG N012703 007
ENDEP
ROCHE 10MG A083639 001
25MG A083639 002
50MG A083639 003
75MG A083639 004
100MG A083639 005
150MG A085303 001
AMITRIPTYLINE HYDROCHLORIDE; CHLORDIAZEPOXIDE
TABLET;ORAL
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE
MUTUAL PHARM EQ 12.5MG BASE;5MG A070765 001 Dec 10, 1986
EQ 25MG BASE;10MG A070766 001 Dec 10, 1986
PAR PHARM EQ 12.5MG BASE;5MG A072277 001 May 09, 1988
EQ 25MG BASE;10MG A072278 001 May 09, 1988
USL PHARMA EQ 12.5MG BASE;5MG A070477 001 Jan 12, 1988
EQ 25MG BASE;10MG A070478 001 Jan 12, 1988
WATSON LABS EQ 12.5MG BASE;5MG A072052 001 Dec 16, 1988
EQ 25MG BASE;10MG A072053 001 Dec 16, 1988
LIMBITROL
VALEANT PHARM INTL EQ 12.5MG BASE;5MG N016949 001
LIMBITROL DS
VALEANT PHARM INTL EQ 25MG BASE;10MG N016949 002
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
TABLET;ORAL
ETRAFON 2-10
SCHERING 10MG;2MG N014713 007
ETRAFON 2-25
SCHERING 25MG;2MG N014713 004
ETRAFON-A
SCHERING 10MG;4MG N014713 002
ETRAFON-FORTE
SCHERING 25MG;4MG N014713 006
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
IVAX SUB TEVA PHARMS 10MG;2MG A070935 001 Sep 11, 1986
10MG;4MG A070937 001 Sep 11, 1986
25MG;2MG A070936 001 Sep 11, 1986
25MG;4MG A070938 001 Sep 11, 1986
50MG;4MG A070939 001 Sep 12, 1986
MUTUAL PHARM 10MG;2MG A071077 001 Nov 12, 1986
10MG;4MG A071078 001 Nov 12, 1986
25MG;2MG A070297 001 Nov 12, 1986
25MG;4MG A071079 001 Nov 12, 1986
PAR PHARM 10MG;2MG A070565 001 Sep 11, 1986
10MG;4MG A070620 001 Sep 11, 1986
25MG;2MG A070621 001 Sep 11, 1986
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-25(of 337)
AMITRIPTYLINE HYDROCHLORIDE; PERPHENAZINE
TABLET;ORAL
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE
25MG;4MG A070595 001 Sep 11, 1986
50MG;4MG A070574 001 Sep 11, 1986
SANDOZ 10MG;2MG A071062 001 Nov 27, 1987
10MG;4MG A071862 001 Dec 21, 1987
25MG;2MG A071063 001 Nov 27, 1987
25MG;4MG A071064 001 Nov 27, 1987
50MG;4MG A071863 001 Dec 21, 1987
WATSON LABS 10MG;2MG A070373 001 Aug 25, 1986
10MG;2MG A072539 001 Feb 15, 1989
10MG;2MG A073007 001 Oct 17, 1991
10MG;4MG A070375 001 Aug 25, 1986
10MG;4MG A072540 001 Feb 15, 1989
10MG;4MG A073009 001 Oct 17, 1991
25MG;2MG A070374 001 Aug 25, 1986
25MG;2MG A072541 001 Feb 15, 1989
25MG;2MG A073008 001 Oct 17, 1991
25MG;4MG A070376 001 Aug 25, 1986
25MG;4MG A072134 001 Feb 15, 1989
25MG;4MG A073010 001 Oct 17, 1991
50MG;4MG A070377 001 Nov 04, 1986
50MG;4MG A071558 001 Mar 02, 1987
50MG;4MG A072135 001 Feb 15, 1989
TRIAVIL 2-10
NEW RIVER 10MG;2MG N014715 004
TRIAVIL 2-25
NEW RIVER 25MG;2MG N014715 002
TRIAVIL 4-10
NEW RIVER 10MG;4MG N014715 003
TRIAVIL 4-25
NEW RIVER 25MG;4MG N014715 005
TRIAVIL 4-50
NEW RIVER 50MG;4MG N014715 006
AMLEXANOX
PASTE;DENTAL
APHTHASOL
ULURU 5% N020511 001 Dec 17, 1996
PATCH;TOPICAL
AMLEXANOX
ULURU 2MG N021727 001 Sep 29, 2004
AMLODIPINE BESYLATE
TABLET;ORAL
AMLODIPINE BESYLATE
GEDEON RICHTER USA EQ 2.5MG BASE A077333 001 Jul 17, 2007
EQ 5MG BASE A077333 002 Jul 17, 2007
EQ 10MG BASE A077333 003 Jul 17, 2007
GENPHARM EQ 2.5MG BASE A077362 001 Jul 09, 2007
EQ 5MG BASE A077362 002 Jul 09, 2007
EQ 10MG BASE A077362 003 Jul 09, 2007
MUTUAL PHARMA EQ 2.5MG BASE A078081 001 Jan 31, 2008
EQ 5MG BASE A078081 002 Jan 31, 2008
EQ 10MG BASE A078081 003 Jan 31, 2008
PURACAP PHARM EQ 2.5MG BASE A078131 001 Sep 04, 2007
EQ 5MG BASE A078131 002 Sep 04, 2007
EQ 10MG BASE A078131 003 Sep 04, 2007
SANDOZ EQ 2.5MG BASE A076859 001 Sep 10, 2007
EQ 5MG BASE A076859 002 Sep 10, 2007
EQ 10MG BASE A076859 003 Sep 10, 2007
SYNTHON PHARMS EQ 2.5MG BASE A077080 001 Jun 27, 2007
EQ 5MG BASE A077080 002 Jun 27, 2007
EQ 10MG BASE A077080 003 Jun 27, 2007
TABLET, ORALLY DISINTEGRATING;ORAL
AMLODIPINE BESYLATE
SYNTHON PHARMS EQ 2.5MG BASE N022026 001 Sep 27, 2007
EQ 5MG BASE N022026 002 Sep 27, 2007
EQ 10MG BASE N022026 003 Sep 27, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-26(of 337)
AMLODIPINE MALEATE
TABLET;ORAL
AMVAZ
DR REDDYS LABS INC 2.5MG
N021435 001 Oct 31, 2003
5MG
N021435 002 Oct 31, 2003
10MG
N021435 003 Oct 31, 2003
AMMONIUM CHLORIDE
INJECTABLE;INJECTION
AMMONIUM CHLORIDE
ABBOTT 5MEQ/ML
A083130 001
GD SEARLE LLC 3MEQ/ML
A086205 001
AMMONIUM CHLORIDE 0.9% IN NORMAL SALINE
MCGAW 900MG/100ML
N006580 001
AMMONIUM CHLORIDE 2.14%
B BRAUN 40MEQ/100ML
A085734 001
AMODIAQUINE HYDROCHLORIDE
TABLET;ORAL
CAMOQUIN HYDROCHLORIDE
PARKE DAVIS EQ 200MG BASE
N006441 001
AMOXAPINE
TABLET;ORAL
AMOXAPINE
SANDOZ 25MG
A072943 001 Jun 28, 1991
50MG
A072944 001 Jun 28, 1991
100MG
A072878 001 Jun 28, 1991
150MG
A072879 001 Jun 28, 1991
WATSON LABS 25MG
A072418 001 May 11, 1989
50MG
A072419 001 May 11, 1989
100MG
A072420 001 May 11, 1989
150MG
A072421 001 May 11, 1989
ASENDIN
LEDERLE 25MG
N018021 001
50MG
N018021 002
100MG
N018021 003
150MG
N018021 004
AMOXICILLIN
CAPSULE;ORAL
AMOXICILLIN
LABS ATRAL 250MG
A062528 001 Aug 07, 1985
500MG
A062528 002 Aug 07, 1985
MYLAN 250MG
A062067 001
500MG
A062067 002
TEVA 250MG
A062853 001 Dec 22, 1987
250MG
A063030 001 Feb 28, 1989
500MG
A062854 001 Dec 22, 1987
500MG
A063031 001 Feb 28, 1989
AMOXIL
GLAXOSMITHKLINE 250MG
N050459 001
500MG
N050459 002
TRIMOX
APOTHECON 250MG
A061885 001
250MG
A062098 001
250MG
A062152 001
250MG
A063099 001 Mar 20, 1992
500MG
A061885 002
500MG
A062098 002
500MG
A062152 002
500MG
A063099 002 Mar 20, 1992
UTIMOX
PARKE DAVIS 250MG
A062107 001
500MG
A062107 002
WYMOX
WYETH AYERST 250MG
A062120 001
500MG
A062120 002
FOR SUSPENSION;ORAL
AMOXICILLIN
AM ANTIBIOTICS 125MG/5ML
A062059 001
250MG/5ML
A062059 002
MYLAN 125MG/5ML
A062090 001
250MG/5ML
A062090 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-27(of 337)
AMOXICILLIN
FOR SUSPENSION;ORAL
AMOXICILLIN
RANBAXY 200MG/5ML A065113 001 Nov 29, 2002
400MG/5ML A065113 002 Nov 29, 2002
TEVA 125MG/5ML A062946 001 Nov 01, 1988
250MG/5ML A063001 001 Jan 06, 1989
AMOXIL
GLAXOSMITHKLINE 50MG/ML N050460 005
125MG/5ML N050460 001
250MG/5ML N050460 002
LAROTID
GLAXOSMITHKLINE 50MG/ML N050460 006
POLYMOX
APOTHECON 125MG/5ML A061851 001
125MG/5ML A062323 001
250MG/5ML A061851 002
250MG/5ML A062323 002
TRIMOX
APOTHECON 50MG/ML A061886 001
125MG/5ML A061886 002
125MG/5ML A062099 001
125MG/5ML A062154 001
125MG/5ML A062885 001 Mar 08, 1988
250MG/5ML A061886 003
250MG/5ML A062099 002
250MG/5ML A062154 002
250MG/5ML A062885 002 Mar 08, 1988
UTIMOX
PARKE DAVIS 125MG/5ML A062127 001
250MG/5ML A062127 002
WYMOX
WYETH AYERST 125MG/5ML A062131 001
250MG/5ML A062131 002
TABLET;ORAL
AMOXICILLIN
DAVA PHARMS INC 875MG A065344 001 Jan 15, 2009
TABLET, CHEWABLE;ORAL
AMOXICILLIN
APOTHECON 125MG A064131 001 May 06, 1996
250MG A064131 002 May 06, 1996
DAVA PHARMS INC 125MG A064139 001 Jan 29, 1996
250MG A064139 002 Jan 29, 1996
RANBAXY 200MG A065060 001 Nov 29, 2000
400MG A065060 002 Nov 29, 2000
TEVA 125MG A064031 001 Dec 19, 1996
250MG A064031 002 Dec 19, 1996
AMOXIL
DR REDDYS LABS INC 200MG N050761 001 Apr 15, 1999
400MG N050761 002 Apr 15, 1999
TABLET, FOR SUSPENSION;ORAL
AMOXICILLIN
AUROBINDO PHARMA LTD 200MG A065324 001 Jan 17, 2007
400MG A065324 002 Jan 17, 2007
DISPERMOX
RANBAXY LABS LTD 200MG A065080 002 Aug 11, 2003
400MG A065080 001 Aug 11, 2003
600MG A065159 001 Dec 04, 2003
AMOXICILLIN; CLAVULANATE POTASSIUM
TABLET;ORAL
AMOXICILLIN AND CLAVULANATE POTASSIUM
APOTEX INC 250MG;EQ 125MG BASE A065333 001 Feb 24, 2009
500MG;EQ 125MG BASE A065333 002 Feb 24, 2009
875MG;EQ 125MG BASE A065317 003 Oct 20, 2008
RANBAXY LABS 500MG;EQ 125MG BASE A065109 001 Nov 04, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-28(of 337)
AMPHETAMINE ADIPATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE ADIPATE; DEXTROAMPHETAMINE SULFATE
CAPSULE;ORAL
DELCOBESE
TEVA 1.25MG;1.25MG;1.25MG;1.25MG **Federal A083564 001
Register determination that product was
not discontinued or withdrawn for
safety or efficacy reasons**
2.5MG;2.5MG;2.5MG;2.5MG **Federal A083564 002
Register determination that product was
not discontinued or withdrawn for
safety or efficacy reasons**
3.75MG;3.75MG;3.75MG;3.75MG **Federal A083564 003
Register determination that product was
not discontinued or withdrawn for
safety or efficacy reasons**
5MG;5MG;5MG;5MG **Federal Register A083564 004
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
TABLET;ORAL
DELCOBESE
TEVA 1.25MG;1.25MG;1.25MG;1.25MG A083563 004
2.5MG;2.5MG;2.5MG;2.5MG A083563 003
3.75MG;3.75MG;3.75MG;3.75MG A083563 002
5MG;5MG;5MG;5MG A083563 001
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE
SULFATE
TABLET;ORAL
ADDERALL 10
TEVA WOMENS 2.5MG;2.5MG;2.5MG;2.5MG N011522 007 Feb 13, 1996
ADDERALL 12.5
TEVA WOMENS 3.125MG;3.125MG;3.125MG;3.125MG N011522 012 Aug 31, 2000
ADDERALL 15
TEVA WOMENS 3.75MG;3.75MG;3.75MG;3.75MG N011522 013 Aug 31, 2000
ADDERALL 20
TEVA WOMENS 5MG;5MG;5MG;5MG N011522 008 Feb 13, 1996
ADDERALL 30
TEVA WOMENS 7.5MG;7.5MG;7.5MG;7.5MG N011522 010 May 12, 1997
ADDERALL 5
TEVA WOMENS 1.25MG;1.25MG;1.25MG;1.25MG N011522 009 May 12, 1997
ADDERALL 7.5
TEVA WOMENS 1.875MG;1.875MG;1.875MG;1.875MG N011522 011 Aug 31, 2000
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE
TEVA PHARMS 1.25MG;1.25MG;1.25MG;1.25MG A040472 001 Sep 30, 2003
2.5MG;2.5MG;2.5MG;2.5MG A040472 002 Sep 30, 2003
5MG;5MG;5MG;5MG A040472 003 Sep 30, 2003
7.5MG;7.5MG;7.5MG;7.5MG A040472 004 Sep 30, 2003
AMPHETAMINE RESIN COMPLEX; DEXTROAMPHETAMINE RESIN COMPLEX
CAPSULE, EXTENDED RELEASE;ORAL
BIPHETAMINE 12.5
UCB INC EQ 6.25MG BASE;EQ 6.25MG BASE N010093 007
BIPHETAMINE 20
UCB INC EQ 10MG BASE;EQ 10MG BASE N010093 003
BIPHETAMINE 7.5
UCB INC EQ 3.75MG BASE;EQ 3.75MG BASE N010093 009
AMPHETAMINE SULFATE
TABLET;ORAL
AMPHETAMINE SULFATE
LANNETT 5MG A083901 001 Aug 31, 1984
10MG A083901 002 Aug 31, 1984
AMPHOTERICIN B
CREAM;TOPICAL
FUNGIZONE
APOTHECON 3% N050314 001
INJECTABLE;INJECTION
AMPHOTERICIN B
ABBOTT 50MG/VIAL A064141 001 Dec 23, 1996
ABRAXIS PHARM 50MG/VIAL A062728 001 Apr 13, 1987
TEVA PARENTERAL 50MG/VIAL A064062 001 Mar 31, 1995
FUNGIZONE
APOTHECON 50MG/VIAL A060517 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-29(of 337)
AMPHOTERICIN B
LOTION;TOPICAL
FUNGIZONE
APOTHECON 3%
A060570 001
OINTMENT;TOPICAL
FUNGIZONE
APOTHECON 3%
N050313 001
SUSPENSION;ORAL
FUNGIZONE
BRISTOL MYERS SQUIBB 100MG/ML
N050341 003
AMPICILLIN SODIUM
INJECTABLE;INJECTION
AMPICILLIN SODIUM
APOTHECON EQ 1GM BASE/VIAL
A062860 004 Feb 05, 1988
EQ 2GM BASE/VIAL
A062860 005 Feb 05, 1988
EQ 125MG BASE/VIAL
A062860 001 Feb 05, 1988
EQ 250MG BASE/VIAL
A062860 002 Feb 05, 1988
EQ 500MG BASE/VIAL
A062860 003 Feb 05, 1988
CONSOLIDATED PHARM EQ 1GM BASE/VIAL
A061936 003
EQ 2GM BASE/VIAL
A061936 004
EQ 125MG BASE/VIAL
A061936 005
EQ 250MG BASE/VIAL
A061936 001
EQ 500MG BASE/VIAL
A061936 002
HANFORD GC EQ 1GM BASE/VIAL
A063139 001 Apr 15, 1993
EQ 2GM BASE/VIAL
A063141 001 Apr 15, 1993
EQ 125MG BASE/VIAL
A063143 001 Apr 15, 1993
EQ 500MG BASE/VIAL
A063147 001 Apr 15, 1993
HIKMA MAPLE EQ 1GM BASE/VIAL
A062692 004 Jun 24, 1986
EQ 2GM BASE/VIAL
A062692 005 Jun 24, 1986
EQ 10GM BASE/VIAL
A062692 006 Jun 24, 1986
EQ 125MG BASE/VIAL
A062692 001 Jun 24, 1986
EQ 250MG BASE/VIAL
A062692 002 Jun 24, 1986
EQ 500MG BASE/VIAL
A062692 003 Jun 24, 1986
INTL MEDICATION EQ 1GM BASE/VIAL
A062634 002 Jan 09, 1987
EQ 2GM BASE/VIAL
A062634 003 Jan 09, 1987
LILLY EQ 1GM BASE/VIAL
A062565 002 Apr 04, 1985
EQ 2GM BASE/VIAL
A062565 003 Jun 24, 1986
EQ 500MG BASE/VIAL
A062565 001 Apr 04, 1985
WATSON LABS INC EQ 1GM BASE/VIAL
A062816 004 Oct 24, 1988
EQ 2GM BASE/VIAL
A062816 005 Oct 24, 1988
EQ 10GM BASE/VIAL
A062994 001 Sep 15, 1988
EQ 125MG BASE/VIAL
A062816 001 Oct 24, 1988
EQ 250MG BASE/VIAL
A062816 002 Oct 24, 1988
EQ 500MG BASE/VIAL
A062816 003 Oct 24, 1988
OMNIPEN-N
WYETH AYERST EQ 1GM BASE/VIAL
A060626 004
EQ 1GM BASE/VIAL
A062718 004 Dec 16, 1986
EQ 2GM BASE/VIAL
A060626 005
EQ 2GM BASE/VIAL
A062718 005 Dec 16, 1986
EQ 125MG BASE/VIAL
A060626 001
EQ 125MG BASE/VIAL
A062718 001 Dec 16, 1986
EQ 250MG BASE/VIAL
A060626 002
EQ 250MG BASE/VIAL
A062718 002 Dec 16, 1986
EQ 500MG BASE/VIAL
A060626 003
EQ 500MG BASE/VIAL
A062718 003 Dec 16, 1986
PENBRITIN-S
WYETH AYERST EQ 1GM BASE/VIAL
N050072 004
EQ 2GM BASE/VIAL
N050072 005
EQ 4GM BASE/VIAL
N050072 006
EQ 125MG BASE/VIAL
N050072 001
EQ 250MG BASE/VIAL
N050072 002
EQ 500MG BASE/VIAL
N050072 003
POLYCILLIN-N
BRISTOL EQ 1GM BASE/VIAL
N050309 004
EQ 2GM BASE/VIAL
N050309 005
EQ 125MG BASE/VIAL
N050309 001
EQ 250MG BASE/VIAL
N050309 002
EQ 500MG BASE/VIAL
N050309 003
TOTACILLIN-N
GLAXOSMITHKLINE EQ 1GM BASE/VIAL
A060677 004
EQ 1GM BASE/VIAL
A062727 001 Dec 19, 1986
EQ 2GM BASE/VIAL
A060677 005
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-30(of 337)
AMPICILLIN SODIUM
INJECTABLE;INJECTION
TOTACILLIN-N
EQ 2GM BASE/VIAL
A062727 002 Dec 19, 1986
EQ 10GM BASE/VIAL
A060677 006
EQ 125MG BASE/VIAL
A060677 001
EQ 250MG BASE/VIAL
A060677 002
EQ 500MG BASE/VIAL
A060677 003
AMPICILLIN SODIUM; SULBACTAM SODIUM
INJECTABLE;INJECTION
UNASYN
PFIZER EQ 500MG BASE/VIAL;EQ 250MG BASE/VIAL
N050608 003 Dec 31, 1986
AMPICILLIN/AMPICILLIN TRIHYDRATE
CAPSULE;ORAL
AMCILL
PARKE DAVIS
EQ 250MG BASE
A062041 001
EQ 500MG BASE
A062041 002
AMPICILLIN TRIHYDRATE
AM ANTIBIOTICS
EQ 250MG BASE
A061602 001
EQ 500MG BASE
A061602 002
IVAX SUB TEVA PHARMS
EQ 250MG BASE
A060765 001
EQ 500MG BASE
A060765 002
LEDERLE
EQ 250MG BASE
A062208 001
EQ 500MG BASE
A062208 002
MYLAN
EQ 250MG BASE
A061755 001
EQ 500MG BASE
A061755 002
PUREPAC PHARM
EQ 250MG BASE
A061853 001
EQ 500MG BASE
A061853 002
TEVA
EQ 250MG BASE
A061502 001
EQ 500MG BASE
A061502 002
VITARINE
EQ 250MG BASE
A061387 001
EQ 500MG BASE
A061387 003
OMNIPEN (AMPICILLIN)
WYETH AYERST
250MG
A060624 001
500MG
A060624 002
PENBRITIN
WYETH AYERST
EQ 250MG BASE
A060908 001
EQ 500MG BASE
A060908 002
PFIZERPEN-A
PFIZER
EQ 250MG BASE
A062050 001
EQ 500MG BASE
A062050 002
POLYCILLIN
BRISTOL
EQ 250MG BASE
N050310 001
EQ 500MG BASE
N050310 002
PRINCIPEN
APOTHECON
EQ 250MG BASE
A062888 001 Mar 04, 1988
EQ 500MG BASE
A062888 002 Mar 04, 1988
BRISTOL MYERS SQUIBB
EQ 250MG BASE
A061392 001
EQ 500MG BASE
A061392 002
PRINCIPEN '250'
APOTHECON
EQ 250MG BASE
A062157 002
EQ 250MG BASE
N050056 001
PRINCIPEN '500'
APOTHECON
EQ 500MG BASE
A062157 001
EQ 500MG BASE
N050056 002
TOTACILLIN
GLAXOSMITHKLINE
EQ 250MG BASE
A060060 001
EQ 250MG BASE
A062212 001
EQ 500MG BASE
A060060 002
EQ 500MG BASE
A062212 002
FOR SUSPENSION;ORAL
AMCILL
PARKE DAVIS
EQ 125MG BASE/5ML
A062030 001
EQ 250MG BASE/5ML
A062030 002
AMPICILLIN TRIHYDRATE
AM ANTIBIOTICS
EQ 125MG BASE/5ML
A061601 001
EQ 250MG BASE/5ML
A061601 002
MYLAN
EQ 125MG BASE/5ML
A061829 002
EQ 250MG BASE/5ML
A061829 001
PUREPAC PHARM
EQ 125MG BASE/5ML
A061980 001
EQ 250MG BASE/5ML
A061980 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-31(of 337)
AMPICILLIN/AMPICILLIN TRIHYDRATE
FOR SUSPENSION;ORAL
AMPICILLIN TRIHYDRATE
TEVA
EQ 125MG BASE/5ML
A061370 001
EQ 250MG BASE/5ML
A061370 002
OMNIPEN (AMPICILLIN)
WYETH AYERST
100MG/ML
A060625 001
125MG/5ML
A060625 002
250MG/5ML
A060625 003
500MG/5ML
A060625 004
PENBRITIN
WYETH AYERST
EQ 100MG BASE/ML
N050019 001
EQ 125MG BASE/5ML
N050019 002
EQ 250MG BASE/5ML
N050019 003
PFIZERPEN-A
PFIZER
EQ 125MG BASE/5ML
A062049 001
EQ 250MG BASE/5ML
A062049 002
POLYCILLIN
APOTHECON
EQ 125MG BASE/5ML
A062297 001
EQ 250MG BASE/5ML
A062297 002
BRISTOL
EQ 100MG BASE/ML
N050308 004
EQ 125MG BASE/5ML
N050308 001
EQ 250MG BASE/5ML
N050308 002
EQ 500MG BASE/5ML
N050308 003
PRINCIPEN
APOTHECON
EQ 100MG BASE/ML
A061394 001
EQ 125MG BASE/5ML
A061394 002
EQ 250MG BASE/5ML
A061394 003
PRINCIPEN '125'
APOTHECON
EQ 125MG BASE/5ML
A060127 002
EQ 125MG BASE/5ML
A062151 001
PRINCIPEN '250'
APOTHECON
EQ 250MG BASE/5ML
A060127 001
EQ 250MG BASE/5ML
A062151 002
TOTACILLIN
GLAXOSMITHKLINE
EQ 125MG BASE/5ML
A060666 001
EQ 125MG BASE/5ML
A062223 001
EQ 250MG BASE/5ML
A060666 002
EQ 250MG BASE/5ML
A062223 002
TABLET, CHEWABLE;ORAL
POLYCILLIN
BRISTOL
EQ 125MG BASE
N050093 001
AMPICILLIN/AMPICILLIN TRIHYDRATE; PROBENECID
CAPSULE;ORAL
PRINCIPEN W/ PROBENECID
APOTHECON
EQ 389MG BASE;111MG
A062150 001
EQ 389MG BASE;111MG
N050488 001
FOR SUSPENSION;ORAL
POLYCILLIN-PRB
APOTHECON
EQ 3.5GM BASE/BOT;1GM/BOT
A061898 001
BRISTOL
EQ 3.5GM BASE/BOT;1GM/BOT
N050457 001
PROBAMPACIN
TEVA
EQ 3.5GM BASE/BOT;1GM/BOT
A061741 001
AMPRENAVIR
CAPSULE;ORAL
AGENERASE
GLAXOSMITHKLINE
50MG
N021007 001
Apr 15, 1999
150MG
N021007 002
Apr 15, 1999
SOLUTION;ORAL
AGENERASE
GLAXOSMITHKLINE
15MG/ML **Federal Register
N021039 001
Apr 15, 1999
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
ANAGRELIDE HYDROCHLORIDE
CAPSULE;ORAL
AGRYLIN
SHIRE LLC
EQ 1MG BASE
N020333 002
Mar 14, 1997
ANAGRELIDE HYDROCHLORIDE
ROXANE
EQ 0.5MG BASE
A076489 001
Apr 18, 2005
EQ 1MG BASE
A076489 002
Apr 18, 2005
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-32(of 337)
ANAGRELIDE HYDROCHLORIDE
CAPSULE;ORAL
ANAGRELIDE HYDROCHLORIDE
SANDOZ INC
EQ 0.5MG BASE
A076683 001
Apr 18, 2005
EQ 1MG BASE
A076683 002
Apr 18, 2005
WATSON LABS
EQ 0.5MG BASE
A076417 001
Apr 18, 2005
EQ 1MG BASE
A076417 002
Apr 18, 2005
ANASTROZOLE
TABLET;ORAL
ANASTROZOLE
IMPAX LABS INC
1MG
A091242 001
May 31, 2012
KUDCO IRELAND
1MG
A091331 001
Jan 05, 2011
SYNTHON PHARMS
1MG
A078322 001
Jun 28, 2010
WATSON LABS
1MG
A078984 001
Jun 28, 2010
ANILERIDINE HYDROCHLORIDE
TABLET;ORAL
LERITINE
MERCK
EQ 25MG BASE
N010585 002
ANILERIDINE PHOSPHATE
INJECTABLE;INJECTION
LERITINE
MERCK
25MG/ML
N010520 003
ANISINDIONE
TABLET;ORAL
MIRADON
SCHERING
50MG
N010909 003
ANISOTROPINE METHYLBROMIDE
TABLET;ORAL
ANISOTROPINE METHYLBROMIDE
WATSON LABS
50MG
A086046 001
VALPIN 50
ENDO PHARMS
50MG
N013428 001
ANTAZOLINE PHOSPHATE; NAPHAZOLINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
VASOCON-A
NOVARTIS
0.5%;0.05%
N018746 002
Jul 11, 1994
APOMORPHINE HYDROCHLORIDE
INJECTABLE;SUBCUTANEOUS
APOKYN
US WORLDMEDS
20MG/2ML (10MG/ML)
N021264 001
Apr 20, 2004
APROTININ
INJECTABLE;INJECTION
TRASYLOL
BAYER HLTHCARE
10,000KIU/ML
N020304 001
Dec 29, 1993
ARBUTAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
GENESA
GENSIA AUTOMEDICS
0.05MG/ML
N020420 001
Sep 12, 1997
ARDEPARIN SODIUM
INJECTABLE;INJECTION
NORMIFLO
PHARMACIA AND UPJOHN
5,000 UNITS/0.5ML **Federal Register
N020227 002
May 23, 1997
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
10,000 UNITS/0.5ML **Federal Register
N020227 001
May 23, 1997
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
ARGATROBAN
SOLUTION;IV (INFUSION)
ARGATROBAN IN DEXTROSE
SANDOZ
125MG/125ML (1MG/ML)
N201743 001
May 09, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-33(of 337)
ARIPIPRAZOLE
TABLET, ORALLY DISINTEGRATING;ORAL
ABILIFY
OTSUKA
20MG **Federal Register determination
N021729 004 Jun 07, 2006
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
30MG **Federal Register determination
N021729 005 Jun 07, 2006
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
ARMODAFINIL
TABLET;ORAL
ARMODAFINIL
MYLAN PHARMS INC
50MG
A200043 001 Jun 01, 2012
150MG
A200043 002 Jun 01, 2012
250MG
A200043 003 Jun 01, 2012
WATSON LABS INC
100MG
A200156 002 Aug 29, 2012
200MG
A200156 004 Aug 29, 2012
NUVIGIL
CEPHALON
100MG
N021875 002 Mar 26, 2009
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;
PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A
PALMITATE; VITAMIN E
INJECTABLE;INJECTION
BEROCCA PN
ROCHE 50MG/ML;0.03MG/ML;0.0025MG/ML;7.5MG/ML; N006071 003 Oct 10, 1985
100
IU/ML;0.2MG/ML;20MG/ML;2MG/ML;1.8MG/ML;
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;
PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE HYDROCHLORIDE; VITAMIN A;
VITAMIN E
INJECTABLE;INJECTION
M.V.C. 9+3
ABRAXIS PHARM 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N018440 002 Aug 08, 1985
0
IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/
M.V.I.-12
HOSPIRA 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N008809 004 Aug 08, 1985
0
IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/
MVC PLUS
WATSON LABS 10MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N018439 002 Aug 08, 1985
0
IU/ML;0.04MG/ML;4MG/ML;0.4MG/ML;0.36MG/
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;
PYRIDOXINE HYDROCHLORIDE; RIBOFLAVIN; THIAMINE HYDROCHLORIDE; VITAMIN A; VITAMIN E
INJECTABLE;INJECTION
M.V.I.-12
HOSPIRA 20MG/ML;0.006MG/ML;0.5MCG/ML;1.5MG/ML;2 N008809 005 Apr 22, 2004
0
IU/ML;0.6MG/ML;4MG/ML;0.4MG/ML;0.36MG/M
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; DEXPANTHENOL; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE;
PYRIDOXINE; RIBOFLAVIN 5'-PHOSPHATE SODIUM; THIAMINE; VITAMIN A; VITAMIN E
INJECTABLE;INJECTION
M.V.I.-12 LYOPHILIZED
ASTRAZENECA 100MG/VIAL;0.06MG/VIAL;0.005MG/VIAL;15M N018933 002 Aug 08, 1985
G/VIAL;5MCG/VIAL;0.4MG/VIAL;40MG/VIAL;4
MG/VIAL;3.6MG/VIAL;3MG/VIAL;1MG/VIAL;10
MG/VIAL
ASCORBIC ACID; BIOTIN; CYANOCOBALAMIN; ERGOCALCIFEROL; FOLIC ACID; NIACINAMIDE; PANTOTHENIC ACID;
PHYTONADIONE; PYRIDOXINE; RIBOFLAVIN; THIAMINE; VITAMIN A PALMITATE; VITAMIN E
INJECTABLE;INJECTION
VITAPED
HOSPIRA N/A,80MG/VIAL;N/A,0.02MG/VIAL;N/A,0.001 N020176 001 Dec 29, 1993
MG/VIAL;400
IU/10ML,N/A;N/A,0.14MG/VIAL;N/A,17MG/VI
AL;N/A,5MG/VIAL;0.2MG/10ML,N/A;N/A,1MG/
VIAL;N/A,1.4MG/VIAL;N/A,1.2MG/VIAL;EQ
2,300 UNITS BASE/10ML,N/A;7 IU/10ML,N/A
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-34(of 337)
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE;
SODIUM SULFATE
FOR SOLUTION;ORAL
MOVIPREP
NOVEL LABS INC 4.7GM;100GM;1.015GM;5.9GM;2.691GM;7.5GM
A090145 001 Jan 25, 2012
ASPIRIN
TABLET;ORAL
BAYER EXTRA STRENGTH ASPIRIN FOR MIGRAINE PAIN
BAYER 500MG
N021317 001 Oct 18, 2001
TABLET, EXTENDED RELEASE;ORAL
8-HOUR BAYER
BAYER 650MG
N016030 001
MEASURIN
BAYER 650MG
N016030 002
ASPIRIN; BUTALBITAL
TABLET;ORAL
AXOTAL
SAVAGE LABS 650MG;50MG
A088305 001 Oct 13, 1983
ASPIRIN; BUTALBITAL; CAFFEINE
CAPSULE;ORAL
BUTALBITAL, ASPIRIN AND CAFFEINE
MUTUAL PHARM 325MG;50MG;40MG
A078149 001 Jun 13, 2007
WATSON LABS 325MG;50MG;40MG
A086231 002 Feb 12, 1985
TABLET;ORAL
BUTALBITAL, ASPIRIN AND CAFFEINE
ACTAVIS ELIZABETH
325MG;50MG;40MG
A086710 002 Aug 23, 1983
HALSEY
325MG;50MG;40MG
A089448 001 Dec 01, 1986
IVAX PHARMS
325MG;50MG;40MG
A085441 002 Oct 31, 1984
PURACAP PHARM
325MG;50MG;40MG
A087048 002 Dec 09, 1983
QUANTUM PHARMICS
325MG;50MG;40MG
A088972 001 Jun 18, 1985
SANDOZ
325MG;50MG;40MG
A086398 002 Apr 06, 1984
WATSON LABS
325MG;50MG;40MG
A086237 002 Mar 23, 1984
FIORINAL
WATSON LABS INC
325MG;50MG;40MG
N017534 003 Apr 16, 1986
LANORINAL
LANNETT
325MG;50MG;40MG
A086986 002 Oct 18, 1985
ASPIRIN; BUTALBITAL; CAFFEINE; CODEINE PHOSPHATE
CAPSULE;ORAL
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE
VINTAGE PHARMS LLC 325MG;50MG;40MG;30MG
A075351 001 Mar 05, 1999
WATSON LABS 325MG;50MG;40MG;30MG
A074359 001 Aug 31, 1995
ASPIRIN; CAFFEINE; ORPHENADRINE CITRATE
TABLET;ORAL
INVAGESIC
SANDOZ 385MG;30MG;25MG
A074817 001 Nov 27, 1996
INVAGESIC FORTE
SANDOZ 770MG;60MG;50MG
A074817 002 Nov 27, 1996
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE
STEVENS J 385MG;30MG;25MG
A074988 001 Apr 30, 1999
770MG;60MG;50MG
A074988 002 Apr 30, 1999
ORPHENGESIC
PRINSTON INC 385MG;30MG;25MG
A075141 001 May 29, 1998
ORPHENGESIC FORTE
PRINSTON INC 770MG;60MG;50MG
A075141 002 May 29, 1998
ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE
CAPSULE;ORAL
COMPOUND 65
ALRA
389MG;32.4MG;65MG
A084553 002 Aug 17, 1983
DARVON COMPOUND
XANODYNE PHARM
389MG;32.4MG;32MG
N010996 006 Mar 08, 1983
DARVON COMPOUND-65
XANODYNE PHARM
389MG;32.4MG;65MG
N010996 007 Mar 08, 1983
PROPOXYPHENE COMPOUND 65
IVAX SUB TEVA PHARMS
389MG;32.4MG;65MG
A083077 002 Dec 07, 1984
SANDOZ
389MG;32.4MG;65MG
A080044 002 Sep 16, 1983
TEVA
389MG;32.4MG;65MG
A089025 001 Mar 29, 1985
PROPOXYPHENE COMPOUND-65
SANDOZ
389MG;32.4MG;65MG
A083101 002 Jun 24, 1985
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DISCONTINUED DRUG PRODUCT LIST 6-35(of 337)
ASPIRIN; CAFFEINE; PROPOXYPHENE HYDROCHLORIDE
CAPSULE;ORAL
PROPOXYPHENE HYDROCHLORIDE W/ ASPIRIN AND CAFFEINE
WATSON LABS 389MG;32.4MG;65MG A085732 002 Sep 03, 1984
ASPIRIN; CARISOPRODOL
TABLET;ORAL
CARISOPRODOL COMPOUND
WATSON LABS 325MG;200MG A088809 001 Oct 03, 1985
ASPIRIN; CARISOPRODOL; CODEINE PHOSPHATE
TABLET;ORAL
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE
MIRROR PHARMS 325MG;200MG;16MG A040860 001 Jan 07, 2010
PROSAM LABS 325MG;200MG;16MG A040283 001 Dec 29, 1998
ASPIRIN; HYDROCODONE BITARTRATE
TABLET;ORAL
AZDONE
SCHWARZ PHARMA 500MG;5MG **Federal Register A089420 001 Jan 25, 1988
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
VICOPRIN
ABBOTT 500MG;5MG A086333 001 Sep 14, 1983
ASPIRIN; MEPROBAMATE
TABLET;ORAL
EQUAGESIC
CARACO 325MG;200MG N011702 003 Dec 29, 1983
MEPRO-ASPIRIN
SANDOZ 325MG;200MG A089127 001 Mar 02, 1987
MEPROBAMATE AND ASPIRIN
PAR PHARM 325MG;200MG A089126 001 Aug 19, 1986
MICRAININ
MEDPOINTE PHARM HLC 325MG;200MG A084978 001
Q-GESIC
QUANTUM PHARMICS 325MG;200MG A088740 001 Jun 01, 1984
ASPIRIN; METHOCARBAMOL
TABLET;ORAL
METHOCARBAMOL AND ASPIRIN
IVAX SUB TEVA PHARMS 325MG;400MG A087211 001 Dec 22, 1982
MCNEIL 325MG;400MG A089193 001 Feb 12, 1986
PAR PHARM 325MG;400MG A089657 001 Nov 04, 1988
ROBAXISAL
ROBINS AH 325MG;400MG N012281 001
ASPIRIN; OXYCODONE HYDROCHLORIDE; OXYCODONE TEREPHTHALATE
TABLET;ORAL
CODOXY
HALSEY 325MG;4.5MG;0.38MG A087464 001 Jul 01, 1982
OXYCODONE AND ASPIRIN
MUTUAL PHARM 325MG;4.5MG;0.38MG A040260 001 Jul 17, 1998
325MG;4.5MG;0.38MG A087794 001 May 26, 1982
WATSON LABS 325MG;4.5MG;0.38MG A040255 001 Feb 27, 1998
OXYCODONE AND ASPIRIN (HALF-STRENGTH)
ROXANE 325MG;2.25MG;0.19MG A087742 001 Jun 04, 1982
PERCODAN
ENDO PHARMS 325MG;4.5MG;0.38MG N007337 006
PERCODAN-DEMI
ENDO PHARMS 325MG;2.25MG;0.19MG N007337 005
ROXIPRIN
ROXANE 325MG;4.5MG;0.38MG A087743 001 Jun 04, 1982
ASPIRIN; PENTAZOCINE HYDROCHLORIDE
TABLET;ORAL
TALWIN COMPOUND
SANOFI AVENTIS US 325MG;EQ 12.5MG BASE N016891 001
ASPIRIN; PRAVASTATIN SODIUM
TABLET, TABLET;ORAL
PRAVIGARD PAC (COPACKAGED)
BRISTOL MYERS SQUIBB 325MG,N/A;N/A,80MG N021387 006 Jun 24, 2003
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DISCONTINUED DRUG PRODUCT LIST 6-36(of 337)
ASPIRIN; PRAVASTATIN SODIUM
TABLET, TABLET, TABLET;ORAL
PRAVIGARD PAC (COPACKAGED)
BRISTOL MYERS SQUIBB 81MG,N/A;N/A,20MG N021387 001 Jun 24, 2003
81MG,N/A;N/A,40MG N021387 002 Jun 24, 2003
81MG,N/A;N/A,80MG N021387 003 Jun 24, 2003
325MG,N/A;N/A,20MG N021387 004 Jun 24, 2003
325MG,N/A;N/A,40MG N021387 005 Jun 24, 2003
ASPIRIN; PROPOXYPHENE HYDROCHLORIDE
CAPSULE;ORAL
DARVON W/ ASA
XANODYNE PHARM 325MG;65MG N010996 005
ASPIRIN; PROPOXYPHENE NAPSYLATE
CAPSULE;ORAL
DARVON-N W/ ASA
AAIPHARMA LLC 325MG;100MG N016829 001
TABLET;ORAL
DARVON-N W/ ASA
AAIPHARMA LLC 325MG;100MG N016863 001
ATAZANAVIR SULFATE
CAPSULE;ORAL
REYATAZ
BRISTOL MYERS SQUIBB EQ 100MG BASE **Federal Register N021567 001 Jun 20, 2003
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
ATENOLOL
INJECTABLE;INJECTION
TENORMIN
ASTRAZENECA 0.5MG/ML **Federal Register N019058 001 Sep 13, 1989
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
TABLET;ORAL
ATENOLOL
ABLE 25MG A076907 001 Jul 30, 2004
50MG A076907 002 Jul 30, 2004
100MG A076907 003 Jul 30, 2004
APOTHECON 50MG A073317 001 Mar 20, 1992
100MG A073318 001 Mar 20, 1992
MYLAN 25MG A074126 003 Aug 26, 1998
50MG A074126 001 Mar 23, 1994
100MG A074126 002 Mar 23, 1994
NOSTRUM LABS 50MG A074127 001 Feb 21, 1995
100MG A074127 002 Feb 21, 1995
PLIVA 25MG A074101 001 Jul 17, 1997
50MG A074101 002 Jul 17, 1997
100MG A074101 003 Jul 17, 1997
SANDOZ 25MG A074265 001 Feb 28, 1994
50MG A074265 002 Feb 28, 1994
100MG A074265 003 Feb 28, 1994
SCS 50MG A073676 001 Oct 30, 1992
100MG A073676 002 Oct 30, 1992
TEVA 50MG A073315 001 May 28, 1993
100MG A073316 001 May 28, 1993
TEVA PHARMS 50MG A074120 001 Feb 24, 1995
100MG A074120 002 Feb 24, 1995
WATSON LABS 50MG A073352 001 Dec 27, 1991
100MG A073353 001 Dec 27, 1991
ATENOLOL; CHLORTHALIDONE
TABLET;ORAL
ATENOLOL AND CHLORTHALIDONE
NOSTRUM LABS 50MG;25MG A074404 001 May 14, 1998
100MG;25MG A074404 002 May 14, 1998
PLIVA 50MG;25MG A074107 001 Sep 24, 1997
100MG;25MG A074107 002 Sep 24, 1997
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DISCONTINUED DRUG PRODUCT LIST 6-37(of 337)
ATOMOXETINE HYDROCHLORIDE
CAPSULE;ORAL
ATOMOXETINE HYDROCHLORIDE
ZYDUS PHARMS USA INC 18MG A079017 001 Sep 17, 2010
25MG A079017 002 Sep 17, 2010
40MG A079017 003 Sep 17, 2010
60MG A079017 004 Sep 17, 2010
80MG A079017 005 Sep 17, 2010
100MG A079017 006 Sep 17, 2010
STRATTERA
LILLY 5MG N021411 001 Nov 26, 2002
ATORVASTATIN CALCIUM
TABLET;ORAL
ATORVASTATIN CALCIUM
TEVA PHARMS EQ 10MG BASE A078773 001 May 29, 2012
EQ 20MG BASE A078773 002 May 29, 2012
EQ 40MG BASE A078773 003 May 29, 2012
EQ 80MG BASE A078773 004 May 29, 2012
ATOVAQUONE
TABLET;ORAL
MEPRON
GLAXOSMITHKLINE LLC 250MG **Federal Register determination N020259 001 Nov 25, 1992
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
ATRACURIUM BESYLATE
INJECTABLE;INJECTION
ATRACURIUM BESYLATE
BAXTER HLTHCARE 10MG/ML A074824 001 Sep 30, 1997
BAXTER HLTHCARE CORP 10MG/ML A074753 001 Jan 23, 1997
HOSPIRA 10MG/ML A074632 001 Dec 23, 1996
10MG/ML A074740 001 Mar 28, 1997
TEVA PARENTERAL 10MG/ML A074784 001 Jun 11, 1997
WATSON LABS INC 10MG/ML A074945 001 Jul 28, 1998
ATRACURIUM BESYLATE PRESERVATIVE FREE
BAXTER HLTHCARE 10MG/ML A074825 001 Sep 30, 1997
BAXTER HLTHCARE CORP 10MG/ML A074768 001 Jan 23, 1997
HOSPIRA 10MG/ML A074633 001 Dec 23, 1996
10MG/ML A074639 001 Mar 25, 1997
10MG/ML A074741 001 Mar 28, 1997
WATSON LABS INC 10MG/ML A074944 001 Jul 28, 1998
TRACRIUM
HOSPIRA 10MG/ML **Federal Register N018831 002 Jun 20, 1985
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
TRACRIUM PRESERVATIVE FREE
HOSPIRA 10MG/ML **Federal Register N018831 001 Nov 23, 1983
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
ATROPINE
INJECTABLE;INJECTION
ATROPINE
ABBVIE EQ 2MG SULFATE/0.7ML A071295 001 Jan 30, 1987
ATROPINE SULFATE
AEROSOL, METERED;INHALATION
ATROPINE SULFATE
US ARMY EQ 0.36MG BASE/INH N020056 001 Sep 19, 1990
ATROPINE SULFATE; DIFENOXIN HYDROCHLORIDE
TABLET;ORAL
MOTOFEN HALF-STRENGTH
VALEANT 0.025MG;0.5MG N017744 001
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
CAPSULE;ORAL
DIPHENOXYLATE HYDROCHLORIDE W/ ATROPINE SULFATE
SCHERER RP 0.025MG;2.5MG A086440 001
SOLUTION;ORAL
COLONAID
MEDPOINTE PHARM HLC 0.025MG/5ML;2.5MG/5ML A085735 001
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DISCONTINUED DRUG PRODUCT LIST
6-38(of 337)
ATROPINE SULFATE; DIPHENOXYLATE HYDROCHLORIDE
SOLUTION;ORAL
LOMANATE
ALPHARMA US PHARMS
0.025MG/5ML;2.5MG/5ML
A085746 001
LOMOTIL
GD SEARLE LLC
0.025MG/5ML;2.5MG/5ML
N012699 001
TABLET;ORAL
COLONAID
MEDPOINTE PHARM HLC
0.025MG;2.5MG
A085737 001
DI-ATRO
MD PHARM
0.025MG;2.5MG
A085266 001
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE
ABLE
0.025MG;2.5MG
A040395 001 Nov 27, 2000
ASCOT
0.025MG;2.5MG
A087934 001 Jul 19, 1983
HEATHER
0.025MG;2.5MG
A086798 001
HIKMA PHARMS LLC
0.025MG;2.5MG
A087765 001 Mar 15, 1982
INWOOD LABS
0.025MG;2.5MG
A085509 001
IVAX PHARMS
0.025MG;2.5MG
A086727 001
KV PHARM
0.025MG;2.5MG
A085659 001
LEDERLE
0.025MG;2.5MG
A086950 001
MUTUAL PHARM
0.025MG;2.5MG
A085506 001
PARKE DAVIS
0.025MG;2.5MG
A087131 001
PVT FORM
0.025MG;2.5MG
A085766 001
R AND S PHARMA
0.025MG;2.5MG
A085035 001
ROXANE
0.025MG;2.5MG
A086057 001
SANDOZ
0.025MG;2.5MG
A086173 001
USL PHARMA
0.025MG;2.5MG
A087842 001 Mar 29, 1982
VALEANT PHARM INTL
0.025MG;2.5MG
A087195 001 Feb 16, 1982
WATSON LABS
0.025MG;2.5MG
A085876 001
LO-TROL
VANGARD
0.025MG;2.5MG
A088009 001 Mar 25, 1983
LOGEN
SUPERPHARM
0.025MG;2.5MG
A088962 001 May 10, 1985
LOW-QUEL
HALSEY
0.025MG;2.5MG
A085211 001
ATROPINE SULFATE; EDROPHONIUM CHLORIDE
INJECTABLE;INJECTION
ENLON-PLUS
MYLAN INSTITUTIONAL 0.14MG/ML;10MG/ML
N019677 001 Nov 06, 1991
ATROPINE SULFATE; MEPERIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
ATROPINE AND DEMEROL
ABBVIE 0.4MG/ML;50MG/ML
A087853 001 Nov 26, 1982
0.4MG/ML;75MG/ML
A087847 001 Nov 26, 1982
0.4MG/ML;100MG/ML
A087848 001 Nov 26, 1982
MEPERIDINE AND ATROPINE SULFATE
WYETH AYERST 0.4MG/ML;50MG/ML
A085121 001
0.4MG/ML;75MG/ML
A085121 002
0.4MG/ML;100MG/ML
A085121 003
ATROPINE; PRALIDOXIME CHLORIDE
INJECTABLE;INTRAMUSCULAR
ATNAA
US ARMY 2.1MG/0.7ML;600MG/0.7ML;600MG/0.7ML
N021175 001 Jan 17, 2002
AZATADINE MALEATE
TABLET;ORAL
OPTIMINE
SCHERING 1MG
N017601 001
AZATADINE MALEATE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
TRINALIN
SCHERING
1MG;120MG
N018506 001 Mar 23, 1982
AZATHIOPRINE
TABLET;ORAL
IMURAN
PROMETHEUS LABS
25MG
N016324 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-39(of 337)
AZATHIOPRINE SODIUM
INJECTABLE;INJECTION
IMURAN
PROMETHEUS LABS
EQ 100MG BASE/VIAL
N017391 001
AZELASTINE HYDROCHLORIDE
SPRAY, METERED;NASAL
ASTEPRO
MEDA PHARMS
EQ 0.125MG BASE/SPRAY
N022203 001
Oct 15, 2008
AZITHROMYCIN
CAPSULE;ORAL
ZITHROMAX
PFIZER
EQ 250MG BASE **Federal Register
N050670 001
Nov 01, 1991
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
FOR SUSPENSION;ORAL
AZITHROMYCIN
SANDOZ
EQ 100MG BASE/5ML
A065297 001
Sep 18, 2006
EQ 200MG BASE/5ML
A065297 002
Sep 18, 2006
INJECTABLE;INJECTION
AZITHROMYCIN
PLIVA HRVATSKA DOO EQ 500MG BASE/VIAL
A065265 001
Jan 18, 2007
TEVA PARENTERAL EQ 2.5GM BASE/VIAL
N050809 002
Dec 19, 2006
EQ 500MG BASE/VIAL
N050809 001
Dec 19, 2006
AZITHROMYCIN DIHYDRATE; TROVAFLOXACIN MESYLATE
FOR SUSPENSION, TABLET;ORAL
TROVAN/ZITHROMAX COMPLIANCE PAK
PFIZER
EQ 1GM BASE,N/A;N/A,EQ 100MG BASE
N050762 001
Dec 18, 1998
AZLOCILLIN SODIUM
INJECTABLE;INJECTION
AZLIN
BAYER PHARMS
EQ 2GM BASE/VIAL
A062388 001
Sep 08, 1982
EQ 2GM BASE/VIAL
A062417 001
Oct 12, 1982
EQ 2GM BASE/VIAL
N050562 001
Sep 03, 1982
EQ 3GM BASE/VIAL
A062388 002
Sep 08, 1982
EQ 3GM BASE/VIAL
A062417 002
Oct 12, 1982
EQ 3GM BASE/VIAL
N050562 002
Sep 03, 1982
EQ 4GM BASE/VIAL
A062388 003
Sep 08, 1982
EQ 4GM BASE/VIAL
A062417 003
Oct 12, 1982
EQ 4GM BASE/VIAL
N050562 003
Sep 03, 1982
AZTREONAM
INJECTABLE;INJECTION
AZACTAM
BRISTOL MYERS SQUIBB 500MG/VIAL
N050580 001
Dec 31, 1986
AZACTAM IN PLASTIC CONTAINER
BRISTOL MYERS SQUIBB
10MG/ML
N050632 003
May 24, 1989
BACAMPICILLIN HYDROCHLORIDE
FOR SUSPENSION;ORAL
SPECTROBID
PFIZER
125MG/5ML
N050556 001
Mar 23, 1982
TABLET;ORAL
SPECTROBID
PFIZER
400MG
N050520 001
800MG
N050520 002
Sep 12, 1983
BACITRACIN
INJECTABLE;INJECTION
BACITRACIN
PFIZER
50,000 UNITS/VIAL
A060282 001
OINTMENT;OPHTHALMIC
BACIGUENT
PHARMACIA AND UPJOHN
500 UNITS/GM
A060734 001
BACITRACIN
LILLY
500 UNITS/GM
A060687 001
PHARMADERM
500 UNITS/GM
A062158 001
PHARMAFAIR
500 UNITS/GM
A062453 001
Mar 28, 1984
OINTMENT;TOPICAL
BACITRACIN
COMBE
500 UNITS/GM
A062799 001
May 14, 1987
NASKA
500 UNITS/GM
A062857 001
Nov 13, 1987
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-40(of 337)
BACITRACIN
POWDER;FOR RX COMPOUNDING
BACI-RX
X GEN PHARMS 5,000,000 UNITS/BOT
A061580 001
BACITRACIN
APOTHEKERNES 5,000,000 UNITS/BOT
A061699 001
PADDOCK LLC 5,000,000 UNITS/BOT
A062456 001 Jul 27, 1983
BACITRACIN ZINC
POWDER;FOR RX COMPOUNDING
ZIBA-RX
X GEN PHARMS 500,000 UNITS/BOT
A061737 001
BACITRACIN ZINC; HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
CORTISPORIN
CITRON PHARMA LLC 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000
N050416 002
UNITS/GM
ZINC BACITRACIN,NEOMYCIN SULFATE,POLYMYXIN B SULFATE & HYDROCORTISONE
PHARMAFAIR 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000
A062389 001 Jul 02, 1982
UNITS/GM
OINTMENT;TOPICAL
NEOMYCIN & POLYMYXIN B SULFATES & BACITRACIN ZINC & HYDROCORTISONE
PHARMAFAIR 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;5,000
A062381 001 Sep 06, 1985
UNITS/GM
BACITRACIN ZINC; LIDOCAINE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;TOPICAL
LANABIOTIC
COMBE 400 UNITS/GM;40MG/GM;EQ 5MG
A062499 001 Jun 03, 1985
BASE/GM;5,000 UNITS/GM
BACITRACIN ZINC; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE
PHARMAFAIR 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000
A062386 001 Sep 09, 1982
UNITS/GM
BACITRACIN-NEOMYCIN-POLYMYXIN
PHARMADERM 400 UNITS/GM;EQ 3.5MG BASE/GM;5,000
A062167 001
UNITS/GM
NEO-POLYCIN
DOW PHARM 500 UNITS/GM;EQ 3.5MG BASE/GM;10,000
A060647 001
UNITS/GM
NEOSPORIN
CITRON PHARMA LLC 400 UNITS/GM;EQ 3.5MG BASE/GM;10,000
N050417 001
UNITS/GM
OINTMENT;TOPICAL
BACITRACIN ZINC-NEOMYCIN SULFATE-POLYMYXIN B SULFATE
NASKA 400 UNITS/GM;EQ 3.5MG BASE/GM;5,000
A062833 001 Nov 09, 1987
UNITS/GM
BACITRACIN ZINC; POLYMYXIN B SULFATE
AEROSOL;TOPICAL
POLYSPORIN
GLAXOSMITHKLINE 10,000 UNITS/GM;2,000,000 UNITS/GM
N050167 002 Mar 01, 1985
OINTMENT;OPHTHALMIC
OCUMYCIN
PHARMAFAIR 500 UNITS/GM;10,000 UNITS/GM
A062430 001 Apr 08, 1983
POLYSPORIN
MONARCH PHARMS 500 UNITS/GM;10,000 UNITS/GM
A061229 001
OINTMENT;TOPICAL
BACITRACIN ZINC-POLYMYXIN B SULFATE
NASKA 500 UNITS/GM;10,000 UNITS/GM
A062849 001 Nov 13, 1987
BACITRACIN; HYDROCORTISONE ACETATE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE
ALTANA 400 UNITS/GM;1%;EQ 3.5MG BASE/GM;10,000
A060731 002
UNITS/GM
BACITRACIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
MYCITRACIN
PHARMACIA AND UPJOHN 500 UNITS/GM;EQ 3.5MG BASE/GM;10,000
A061048 001
UNITS/GM
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-41(of 337)
BACITRACIN; POLYMYXIN B SULFATE
DISC;TOPICAL
LANABIOTIC
COMBE 500 UNITS/GM;5,000 UNITS/GM
N050598 001 Sep 22, 1986
BACLOFEN
TABLET;ORAL
BACLOFEN
TEVA 10MG
A073043 001 Feb 27, 1992
20MG
A073044 001 Feb 27, 1992
USL PHARMA 10MG
A071260 001 May 06, 1988
20MG
A071261 001 May 06, 1988
WATSON LABS 10MG
A073092 001 Jan 28, 1994
10MG
A074698 001 Aug 20, 1996
20MG
A073093 001 Jan 28, 1994
20MG
A074698 002 Aug 20, 1996
LIORESAL
NOVARTIS 10MG
N017851 001
20MG
N017851 003 Jan 20, 1982
TABLET, ORALLY DISINTEGRATING;ORAL
KEMSTRO
UCB INC
10MG
N021589 001 Oct 30, 2003
20MG
N021589 002 Oct 30, 2003
BECLOMETHASONE DIPROPIONATE
AEROSOL, METERED;INHALATION
BECLOVENT
GLAXOSMITHKLINE
0.042MG/INH
N018153 001
VANCERIL
SCHERING
0.042MG/INH
N017573 001
VANCERIL DOUBLE STRENGTH
SCHERING
0.084MG/INH
N020486 001 Dec 24, 1996
AEROSOL, METERED;NASAL
BECONASE
GLAXOSMITHKLINE
0.042MG/INH
N018584 001
VANCENASE
SCHERING
0.042MG/INH
N018521 001
BECLOMETHASONE DIPROPIONATE MONOHYDRATE
SPRAY, METERED;NASAL
VANCENASE AQ
SCHERING EQ 0.042MG DIPROP/SPRAY
N019589 001 Dec 23, 1987
EQ 0.084MG DIPROP/SPRAY
N020469 001 Jun 26, 1996
BENAZEPRIL HYDROCHLORIDE
TABLET;ORAL
BENAZEPRIL HYDROCHLORIDE
GENPHARM 5MG
A076476 001 Feb 11, 2004
10MG
A076476 002 Feb 11, 2004
20MG
A076476 003 Feb 11, 2004
40MG
A076476 004 Feb 11, 2004
BENAZEPRIL HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
MYLAN PHARMS INC
5MG;6.25MG
A076612 001 Feb 11, 2004
10MG;12.5MG
A076612 002 Feb 11, 2004
20MG;12.5MG
A076612 003 Feb 11, 2004
20MG;25MG
A076612 004 Feb 11, 2004
BENDROFLUMETHIAZIDE
TABLET;ORAL
NATURETIN-10
APOTHECON
10MG
N012164 003
NATURETIN-2.5
APOTHECON
2.5MG
N012164 001
NATURETIN-5
APOTHECON
5MG
N012164 002
BENOXINATE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
BENOXINATE HYDROCHLORIDE
SOLA BARNES HIND
0.4%
A084149 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-42(of 337)
BENTIROMIDE
SOLUTION;ORAL
CHYMEX
SAVAGE LABS
500MG/7.5ML
N018366 001 Dec 29, 1983
BENZONATATE
CAPSULE;ORAL
BENZONATATE
NESHER PHARMS
100MG
A040795 001 Oct 31, 2007
200MG
A040795 002 Oct 31, 2007
TESSALON
PFIZER
200MG
N011210 003 Jun 25, 1999
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE
GEL;TOPICAL
BENZACLIN
VALEANT BERMUDA
5%;EQ 1% BASE
N050756 002 Apr 20, 2007
BENZPHETAMINE HYDROCHLORIDE
TABLET;ORAL
BENZPHETAMINE HYDROCHLORIDE
COREPHARMA
50MG
A040714 001 Oct 29, 2007
DIDREX
PHARMACIA AND UPJOHN
25MG
N012427 003
BENZQUINAMIDE HYDROCHLORIDE
INJECTABLE;INJECTION
EMETE-CON
PFIZER
EQ 50MG BASE/VIAL
N016820 001
SUPPOSITORY;RECTAL
EMETE-CON
ROERIG
EQ 100MG BASE
N016818 006
BENZTHIAZIDE
TABLET;ORAL
AQUATAG
SOLVAY
25MG
N016001 001
50MG
N016001 002
BENZTHIAZIDE
PVT FORM
50MG
A083206 001
EXNA
AH ROBINS INC
50MG
N012489 001
FOVANE
PFIZER
50MG
N012128 002
URESE
PFIZER
25MG
N012128 003
BENZTROPINE MESYLATE
TABLET;ORAL
BENZTROPINE MESYLATE
LANNETT HOLDINGS INC
0.5MG
A088877 001 Apr 11, 1985
1MG
A088894 001 Apr 11, 1985
2MG
A088895 001 Apr 11, 1985
MUTUAL PHARM
1MG
A081264 001 Jan 23, 1992
2MG
A081265 001 Jan 23, 1992
PROSAM LABS
0.5MG
A040699 001 Feb 14, 2008
1MG
A040705 001 Feb 14, 2008
2MG
A040706 001 Feb 14, 2008
QUANTUM PHARMICS
0.5MG
A088514 001 Jan 31, 1984
1MG
A088510 001 Jan 31, 1984
2MG
A088511 001 Jan 31, 1984
USL PHARMA
0.5MG
A089211 001 Jun 14, 1988
1MG
A089212 001 Jun 14, 1988
2MG
A089213 001 Jun 14, 1988
COGENTIN
MERCK
0.5MG
N009193 004
1MG
N009193 003
2MG
N009193 002
BENZYL BENZOATE
EMULSION;TOPICAL
BENZYL BENZOATE
LANNETT
50%
A084535 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-43(of 337)
BEPRIDIL HYDROCHLORIDE
TABLET;ORAL
BEPADIN
MEDPOINTE PHARM HLC
200MG
N019001 001 Dec 28, 1990
300MG
N019001 002 Dec 28, 1990
400MG
N019001 003 Dec 28, 1990
VASCOR
JOHNSON AND JOHNSON
200MG
N019002 001 Dec 28, 1990
300MG
N019002 002 Dec 28, 1990
400MG
N019002 003 Dec 28, 1990
BETA CAROTENE
CAPSULE;ORAL
SOLATENE
ROCHE
30MG
N017589 001
BETAMETHASONE
CREAM;TOPICAL
CELESTONE
SCHERING
0.2%
N014762 001
SYRUP;ORAL
CELESTONE
MERCK SHARP DOHME
0.6MG/5ML
N014215 002
TABLET;ORAL
CELESTONE
SCHERING
0.6MG
N012657 003
BETAMETHASONE BENZOATE
CREAM;TOPICAL
UTICORT
PARKE DAVIS
0.025%
N016998 002
GEL;TOPICAL
UTICORT
PARKE DAVIS
0.025%
N017244 001
LOTION;TOPICAL
UTICORT
PARKE DAVIS
0.025%
N017528 001
OINTMENT;TOPICAL
UTICORT
PARKE DAVIS
0.025%
N018089 001
BETAMETHASONE DIPROPIONATE
CREAM;TOPICAL
ALPHATREX
SAVAGE LABS
EQ 0.05% BASE
N019138 001 Jun 26, 1984
BETAMETHASONE DIPROPIONATE
PERRIGO NEW YORK
EQ 0.05% BASE
A072536 001 Jan 31, 1990
EQ 0.05% BASE
A074579 001 Nov 26, 1997
PHARMADERM
EQ 0.05% BASE
N019136 001 Jun 26, 1984
TARO
EQ 0.05% BASE
A071143 001 Jun 17, 1987
TEVA
EQ 0.05% BASE
A071476 001 Aug 10, 1987
DIPROSONE
SCHERING
EQ 0.05% BASE
N017536 001
CREAM, AUGMENTED;TOPICAL
DIPROLENE
SCHERING
EQ 0.05% BASE
N019408 001 Jan 31, 1986
DISC;TOPICAL
DIPROSONE
SCHERING
EQ 0.1% BASE
N017829 001
GEL, AUGMENTED;TOPICAL
DIPROLENE
SCHERING
EQ 0.05% BASE
N019408 002 Nov 22, 1991
LOTION;TOPICAL
ALPHATREX
SAVAGE LABS
EQ 0.05% BASE
A070273 001 Aug 12, 1985
BETAMETHASONE DIPROPIONATE
ALPHARMA US PHARMS
EQ 0.05% BASE
A071085 001 Feb 03, 1987
PHARMADERM
EQ 0.05% BASE
A070274 001 Aug 12, 1985
TARO
EQ 0.05% BASE
A072276 001 Aug 24, 1988
EQ 0.05% BASE
A074272 001 Sep 30, 1994
TEVA PHARMS
EQ 0.05% BASE
A071882 001 Jun 06, 1988
DIPROSONE
SCHERING
EQ 0.05% BASE
N017781 001
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DISCONTINUED DRUG PRODUCT LIST 6-44(of 337)
BETAMETHASONE DIPROPIONATE
OINTMENT;TOPICAL
ALPHATREX
SAVAGE LABS EQ 0.05% BASE N019143 001 Sep 04, 1984
BETAMETHASONE DIPROPIONATE
PERRIGO NEW YORK EQ 0.05% BASE A072526 001 Jan 31, 1990
PHARMADERM EQ 0.05% BASE N019140 001 Sep 04, 1984
TEVA EQ 0.05% BASE A071477 001 Aug 10, 1987
DIPROSONE
SCHERING EQ 0.05% BASE N017691 001
BETAMETHASONE SODIUM PHOSPHATE
INJECTABLE;INJECTION
BETAMETHASONE SODIUM PHOSPHATE
WATSON LABS EQ 3MG BASE/ML A085738 001
CELESTONE
SCHERING EQ 3MG BASE/ML **Federal Register N017561 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
BETAMETHASONE VALERATE
CREAM;TOPICAL
BETADERM
ROACO EQ 0.1% BASE N018839 001 Jun 30, 1983
BETAMETHASONE VALERATE
PERRIGO NEW YORK EQ 0.1% BASE A070053 001 Jun 10, 1986
PHARMADERM EQ 0.1% BASE N018860 002 Aug 31, 1983
PHARMAFAIR EQ 0.1% BASE A070485 001 May 29, 1987
TARO EQ 0.1% BASE A070062 001 May 14, 1985
BETATREX
SAVAGE LABS EQ 0.1% BASE N018862 001 Aug 31, 1983
VALISONE
SCHERING EQ 0.01% BASE N016322 002
EQ 0.1% BASE N016322 001
LOTION;TOPICAL
BETAMETHASONE VALERATE
PHARMADERM EQ 0.1% BASE N018870 001 Aug 31, 1983
PHARMAFAIR EQ 0.1% BASE A070484 001 May 29, 1987
TEVA PHARMS EQ 0.1% BASE A071883 001 Apr 22, 1988
BETATREX
SAVAGE LABS EQ 0.1% BASE N018867 001 Aug 31, 1983
VALISONE
SCHERING EQ 0.1% BASE N016932 001
OINTMENT;TOPICAL
BETA-VAL
TEVA EQ 0.1% BASE A070069 001 Dec 19, 1985
BETAMETHASONE VALERATE
PERRIGO NEW YORK EQ 0.1% BASE A071478 001 Dec 23, 1987
PHARMADERM EQ 0.1% BASE N018864 001 Aug 31, 1983
PHARMAFAIR EQ 0.1% BASE A070486 001 May 29, 1987
BETATREX
SAVAGE LABS EQ 0.1% BASE N018863 001 Aug 31, 1983
VALISONE
SCHERING EQ 0.1% BASE N016740 001
BETAXOLOL HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
BETAXOLOL HYDROCHLORIDE
APOTEX INC EQ 0.5% BASE A075446 001 Sep 28, 2000
TABLET;ORAL
KERLONE
SANOFI AVENTIS US 10MG N019507 001 Oct 27, 1989
20MG N019507 002 Oct 27, 1989
BETAXOLOL HYDROCHLORIDE; CHLORTHALIDONE
TABLET;ORAL
KERLEDEX
SANOFI AVENTIS US 5MG;12.5MG N019807 001 Oct 30, 1992
10MG;12.5MG N019807 002 Oct 30, 1992
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DISCONTINUED DRUG PRODUCT LIST 6-45(of 337)
BETAXOLOL HYDROCHLORIDE; PILOCARPINE HYDROCHLORIDE
SUSPENSION/DROPS;OPHTHALMIC
BETOPTIC PILO
ALCON EQ 0.25% BASE;1.75% N020619 001 Apr 17, 1997
BETAZOLE HYDROCHLORIDE
INJECTABLE;INJECTION
HISTALOG
LILLY 50MG/ML N009344 001
BETHANECHOL CHLORIDE
INJECTABLE;INJECTION
URECHOLINE
ODYSSEY PHARMS 5MG/ML **Federal Register determination N006536 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
TABLET;ORAL
BETHANECHOL CHLORIDE
ABLE 5MG A040492 001 Jul 27, 2004
10MG A040483 001 Jul 27, 2004
25MG A040485 001 Jul 27, 2004
50MG A040509 001 Jul 27, 2004
ACTAVIS ELIZABETH 5MG A040552 001 Oct 28, 2004
10MG A040553 001 Oct 28, 2004
25MG A040554 001 Oct 28, 2004
50MG A040551 001 Oct 28, 2004
ASCOT 10MG A088288 001 Jun 08, 1983
25MG A088289 001 Jun 08, 1983
IVAX SUB TEVA PHARMS 25MG A084689 001
LANNETT 5MG A084702 001
10MG A084712 001
25MG A084074 001
LANNETT HOLDINGS INC 5MG A040703 001 Mar 27, 2008
50MG A040677 001 Mar 27, 2008
SANDOZ 5MG A084353 001
10MG A084378 001
10MG A084379 001
25MG A084383 001
25MG A084384 001
WATSON LABS 5MG A084402 001
5MG A085230 002
5MG A085841 001
10MG A084408 001
10MG A085228 001
10MG A085842 001
25MG A084441 001
25MG A085229 001
25MG A085839 001
50MG A087397 001
50MG A087444 001
DUVOID
WELLSPRING PHARM 10MG A086262 001
25MG A086263 001
50MG A085882 003
MYOTONACHOL
GLENWOOD 5MG A084188 001
10MG A084188 003
25MG A084188 004
URECHOLINE
ODYSSEY PHARMS 5MG N006536 003
10MG N006536 002
25MG N006536 004
50MG N006536 005
BETHANIDINE SULFATE
TABLET;ORAL
TENATHAN
ROBINS AH 10MG N017675 001
25MG N017675 002
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DISCONTINUED DRUG PRODUCT LIST 6-46(of 337)
BEXAROTENE
CAPSULE;ORAL
BEXAROTENE
BANNER PHARMACAPS 75MG A203174 001 Aug 12, 2014
BICALUTAMIDE
TABLET;ORAL
BICALUTAMIDE
KUDCO IRELAND 50MG A077995 001 Jul 06, 2009
ROXANE 50MG A078285 001 Mar 24, 2011
SYNTHON PHARMS 50MG A077973 001 Jul 06, 2009
BIMATOPROST
SOLUTION/DROPS;OPHTHALMIC
LUMIGAN
ALLERGAN 0.03% **Federal Register determination N021275 001 Mar 16, 2001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
BIPERIDEN LACTATE
INJECTABLE;INJECTION
AKINETON
ABBVIE 5MG/ML N012418 002
BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE
FOR SOLUTION, TABLET, DELAYED RELEASE;ORAL
HALFLYTELY
BRAINTREE 5MG,N/A;N/A,210GM;N/A,0.74GM;N/A,2.86GM N021551 003 Jul 16, 2010
;N/A,5.6GM
BISMUTH SUBSALICYLATE; METRONIDAZOLE; TETRACYCLINE HYDROCHLORIDE
TABLET, CHEWABLE, TABLET, CAPSULE;ORAL
HELIDAC
PROMETHEUS LABS 262.4MG,N/A,N/A;N/A,250MG,N/A;N/A,N/A,5 N050719 001 Aug 15, 1996
00MG
BISOPROLOL FUMARATE
TABLET;ORAL
BISOPROLOL FUMARATE
MUTUAL PHARM 5MG A075474 001 Oct 25, 2002
10MG A075474 002 Oct 25, 2002
BISOPROLOL FUMARATE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE
ACTAVIS ELIZABETH 2.5MG;6.25MG A075672 001 Sep 25, 2000
5MG;6.25MG A075672 002 Sep 25, 2000
10MG;6.25MG A075672 003 Sep 25, 2000
APOTHECON 2.5MG;6.25MG A075642 002 Dec 27, 2000
5MG;6.25MG A075642 001 Dec 27, 2000
10MG;6.25MG A075642 003 Dec 27, 2000
IVAX SUB TEVA PHARMS 2.5MG;6.25MG A075632 001 Sep 27, 2000
5MG;6.25MG A075632 002 Sep 27, 2000
10MG;6.25MG A075632 003 Sep 27, 2000
SANDOZ 2.5MG;6.25MG A075527 001 Sep 25, 2000
5MG;6.25MG A075527 003 Sep 25, 2000
10MG;6.25MG A075527 002 Sep 25, 2000
TEVA 2.5MG;6.25MG A075686 001 Jan 19, 2001
5MG;6.25MG A075686 002 Jan 19, 2001
10MG;6.25MG A075686 003 Jan 19, 2001
WATSON LABS 2.5MG;6.25MG A075469 001 Sep 25, 2000
5MG;6.25MG A075469 002 Sep 25, 2000
10MG;6.25MG A075469 003 Sep 25, 2000
BITOLTEROL MESYLATE
AEROSOL, METERED;INHALATION
TORNALATE
SANOFI AVENTIS US 0.37MG/INH N018770 001 Dec 28, 1984
SOLUTION;INHALATION
TORNALATE
SANOFI AVENTIS US 0.2% N019548 001 Feb 19, 1992
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DISCONTINUED DRUG PRODUCT LIST 6-47(of 337)
BLEOMYCIN SULFATE
INJECTABLE;INJECTION
BLENOXANE
BRISTOL MYERS SQUIBB EQ 15 UNITS BASE/VIAL N050443 001
EQ 30 UNITS BASE/VIAL N050443 002 Sep 07, 1995
BLEOMYCIN SULFATE
PHARMACHEMIE BV EQ 15 UNITS BASE/VIAL A065201 001 Dec 13, 2007
TEVA PARENTERAL EQ 15 UNITS BASE/VIAL A064084 001 Jun 01, 1996
EQ 30 UNITS BASE/VIAL A064084 002 Jun 01, 1996
BRETYLIUM TOSYLATE
INJECTABLE;INJECTION
BRETYLIUM TOSYLATE
ABRAXIS PHARM 50MG/ML A070134 001 Apr 29, 1986
100MG/ML A071298 001 Feb 13, 1987
ASTRAZENECA 50MG/ML A071151 001 Aug 10, 1987
50MG/ML A071152 001 Aug 10, 1987
50MG/ML A071153 001 Aug 10, 1987
HIKMA MAPLE 50MG/ML A070545 001 May 14, 1986
50MG/ML A070546 001 May 14, 1986
HOSPIRA 50MG/ML N019030 001 Apr 29, 1986
50MG/ML N019033 001 Apr 29, 1986
INTL MEDICATION 50MG/ML A070119 001 Apr 29, 1986
LUITPOLD 50MG/ML A070891 001 Jul 26, 1988
BRETYLIUM TOSYLATE IN DEXTROSE 5%
ABBOTT 200MG/100ML N019005 002 Apr 29, 1986
400MG/100ML N019005 003 Apr 29, 1986
800MG/100ML N019005 001 Apr 29, 1986
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 200MG/100ML N019837 002 Apr 12, 1989
400MG/100ML N019837 001 Apr 12, 1989
HOSPIRA INC 200MG/100ML N019008 002 Apr 29, 1986
400MG/100ML N019008 003 Apr 29, 1986
800MG/100ML N019008 001 Apr 29, 1986
BRETYLOL
HOSPIRA 50MG/ML N017954 001
BRIMONIDINE TARTRATE
SOLUTION/DROPS;OPHTHALMIC
ALPHAGAN
ALLERGAN 0.2% N020613 001 Sep 06, 1996
0.5% N020490 001 Mar 13, 1997
BRIMONIDINE TARTRATE
TEVA PARENTERAL 0.2% A076372 001 Sep 10, 2004
BROMFENAC SODIUM
SOLUTION/DROPS;OPHTHALMIC
XIBROM
BAUSCH AND LOMB INC EQ 0.09% ACID N021664 001 Mar 24, 2005
BROMOCRIPTINE MESYLATE
CAPSULE;ORAL
BROMOCRIPTINE MESYLATE
LEK PHARM EQ 5MG BASE A075100 001 Dec 10, 1998
BROMODIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE;ORAL
AMBODRYL
PARKE DAVIS 25MG N007984 001
BROMODIPHENHYDRAMINE HYDROCHLORIDE; CODEINE PHOSPHATE
SYRUP;ORAL
AMBENYL
FOREST LABS 12.5MG/5ML;10MG/5ML N009319 006 Jan 10, 1984
BROMANYL
ALPHARMA US PHARMS 12.5MG/5ML;10MG/5ML A088343 001 Aug 15, 1984
BROMODIPHENHYDRAMINE HYDROCHLORIDE AND CODEINE PHOSPHATE
WOCKHARDT 12.5MG/5ML;10MG/5ML A088626 001 Oct 12, 1984
BROMPHENIRAMINE MALEATE
ELIXIR;ORAL
BROMPHENIRAMINE MALEATE
ALPHARMA US PHARMS 2MG/5ML A086936 001
KV PHARM 2MG/5ML A085466 001
PHARM ASSOC 2MG/5ML A087517 001
USL PHARMA 2MG/5ML A087964 001 Jan 25, 1983
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DISCONTINUED DRUG PRODUCT LIST 6-48(of 337)
BROMPHENIRAMINE MALEATE
INJECTABLE;INJECTION
BROMPHENIRAMINE MALEATE
WATSON LABS 10MG/ML A083821 001
100MG/ML A083820 001
DIMETANE-TEN
WYETH AYERST 10MG/ML N011418 002
TABLET;ORAL
BROMPHENIRAMINE MALEATE
BARR 4MG A084468 001
IVAX SUB TEVA PHARMS 4MG A084351 001
NEWTRON PHARMS 4MG A086987 001
NEXGEN PHARMA INC 4MG A086187 001
PAR PHARM 4MG A087009 001
PIONEER PHARMS 4MG A088604 001 Jul 13, 1984
SANDOZ 4MG A083215 001
VITARINE 4MG A085850 001
WATSON LABS 4MG A083123 001
4MG A085769 001
DIMETANE
WYETH CONS 4MG N010799 003
TABLET, EXTENDED RELEASE;ORAL
DIMETANE
WYETH CONS 8MG N010799 010 Jun 10, 1983
12MG N010799 011 Jun 10, 1983
BROMPHENIRAMINE MALEATE; DEXTROMETHORPHAN HYDROBROMIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
SYRUP;ORAL
BROMANATE DM
ALPHARMA US PHARMS 2MG/5ML;10MG/5ML;30MG/5ML A088722 001 Mar 07, 1985
BROMFED-DM
WOCKHARDT 2MG/5ML;10MG/5ML;30MG/5ML A089681 001 Dec 22, 1988
DIMETANE-DX
ROBINS AH 2MG/5ML;10MG/5ML;30MG/5ML N019279 001 Aug 24, 1984
BROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
EFIDAC 24 PSEUDOEPHEDRINE HYDROCHLORIDE/BROMPHENIRAMINE MALEATE
ALZA 16MG;240MG N019672 001 Mar 29, 1996
BUCLIZINE HYDROCHLORIDE
TABLET;ORAL
BUCLADIN-S
STUART PHARMS 50MG N010911 006
BUDESONIDE
AEROSOL, METERED;NASAL
RHINOCORT
ASTRAZENECA 0.032MG/INH N020233 001 Feb 14, 1994
POWDER, METERED;INHALATION
PULMICORT
ASTRAZENECA 0.16MG/INH N020441 002 Jun 24, 1997
0.32MG/INH N020441 003 Jun 24, 1997
SPRAY, METERED;NASAL
RHINOCORT
ASTRAZENECA PHARMS 0.064MG/INH N020746 002 Oct 01, 1999
SUSPENSION;INHALATION
BUDESONIDE
APOTEX INC 0.25MG/2ML A078202 001 Mar 30, 2009
0.5MG/2ML A078202 002 Mar 30, 2009
BUMETANIDE
INJECTABLE;INJECTION
BUMETANIDE
HOSPIRA 0.25MG/ML A074160 001 Oct 30, 1997
TEVA PARENTERAL 0.25MG/ML A074613 001 Nov 18, 1997
BUMEX
VALIDUS PHARMS INC 0.25MG/ML N018226 001 Feb 28, 1983
TABLET;ORAL
BUMEX
VALIDUS PHARMS INC 0.5MG N018225 002 Feb 28, 1983
1MG N018225 001 Feb 28, 1983
2MG N018225 003 Jun 14, 1985
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DISCONTINUED DRUG PRODUCT LIST 6-49(of 337)
BUPIVACAINE
INJECTABLE, LIPOSOMAL;INJECTION
EXPAREL
PACIRA PHARMS INC 133MG/10ML (13.3MG/ML) N022496 001 Oct 28, 2011
BUPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION
BUPIVACAINE HYDROCHLORIDE
HOSPIRA 0.75% A070587 001 Mar 03, 1987
BUPIVACAINE HYDROCHLORIDE KIT
HOSPIRA 0.075% N019978 001 Sep 03, 1992
0.114% N019978 002 Sep 03, 1992
0.23% N019978 003 Sep 03, 1992
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE
INTL MEDICATED 0.25% A076012 001 Jan 09, 2002
0.5% A076012 002 Jan 09, 2002
0.75% A076012 003 Jan 09, 2002
BUPIVACAINE HYDROCHLORIDE; EPINEPHRINE
INJECTABLE;INJECTION
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE
HOSPIRA 0.25%;0.005MG/ML A071166 001 Jun 16, 1988
0.5%;0.005MG/ML A071169 001 Jun 16, 1988
0.75%;0.005MG/ML A071171 001 Jun 16, 1988
BUPIVACAINE HYDROCHLORIDE; LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
DUOCAINE
AMPHASTAR PHARMS INC EQ 0.375% (37.5MG/10ML);EQ 1% N021496 001 May 23, 2003
(100MG/10ML)
BUPRENORPHINE HYDROCHLORIDE
TABLET;SUBLINGUAL
SUBUTEX
RECKITT BENCKISER EQ 2MG BASE N020732 002 Oct 08, 2002
EQ 8MG BASE N020732 003 Oct 08, 2002
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE
TABLET;SUBLINGUAL
SUBOXONE
RECKITT BENCKISER EQ 2MG BASE;EQ 0.5MG BASE N020733 001 Oct 08, 2002
EQ 8MG BASE;EQ 2MG BASE N020733 002 Oct 08, 2002
BUPROPION HYDROCHLORIDE
TABLET;ORAL
BUPROPION HYDROCHLORIDE
SANDOZ 75MG A075613 002 Oct 10, 2000
100MG A075613 001 Oct 10, 2000
TEVA 75MG A075310 001 Nov 29, 1999
100MG A075310 002 Nov 29, 1999
WELLBUTRIN
GLAXOSMITHKLINE 50MG N018644 001 Dec 30, 1985
TABLET, EXTENDED RELEASE;ORAL
BUPROPION HYDROCHLORIDE
ACTAVIS LABS FL INC 300MG A077715 002 Jun 13, 2007
IMPAX LABS 300MG A077415 002 Dec 15, 2006
SANDOZ 100MG A076845 001 Jul 14, 2005
150MG A076834 001 Jul 14, 2005
150MG A076845 002 Jul 14, 2005
WELLBUTRIN SR
GLAXOSMITHKLINE 50MG N020358 001 Oct 04, 1996
ZYBAN
GLAXOSMITHKLINE 100MG N020711 002 May 14, 1997
BUSPIRONE HYDROCHLORIDE
CAPSULE;ORAL
BUSPAR
BRISTOL MYERS SQUIBB 5MG N021190 001 Dec 20, 2000
7.5MG N021190 002 Dec 20, 2000
10MG N021190 003 Dec 20, 2000
15MG N021190 004 Dec 20, 2000
TABLET;ORAL
BUSPAR
BRISTOL MYERS SQUIBB 5MG N018731 001 Sep 29, 1986
10MG N018731 002 Sep 29, 1986
15MG N018731 003 Apr 22, 1996
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DISCONTINUED DRUG PRODUCT LIST 6-50(of 337)
BUSPIRONE HYDROCHLORIDE
TABLET;ORAL
BUSPAR
30MG
N018731 004 Apr 22, 1996
BUSPIRONE HYDROCHLORIDE
APOTEX
5MG
A075521 001 Apr 05, 2002
10MG
A075521 002 Apr 05, 2002
15MG
A075521 003 Apr 05, 2002
EGIS
5MG
A075119 001 Mar 14, 2002
10MG
A075119 002 Mar 14, 2002
15MG
A075119 003 Jan 23, 2003
IVAX SUB TEVA PHARMS
5MG
A075385 001 Mar 01, 2002
10MG
A075385 002 Mar 01, 2002
15MG
A075385 003 Mar 01, 2002
NESHER PHARMS
5MG
A075572 001 Feb 27, 2002
10MG
A075572 002 Feb 27, 2002
15MG
A075572 003 Feb 27, 2002
PROSAM LABS
5MG
A075388 001 May 09, 2002
10MG
A075388 002 May 09, 2002
15MG
A075388 003 May 09, 2002
SANDOZ
5MG
A075413 001 Mar 19, 2002
10MG
A075413 002 Mar 19, 2002
15MG
A075413 003 Mar 19, 2002
BUTABARBITAL SODIUM
CAPSULE;ORAL
BUTICAPS
MEDPOINTE PHARM HLC
15MG
A085381 001
30MG
A085381 002
50MG
A085381 003
100MG
A085381 004
ELIXIR;ORAL
BUTABARB
ALPHARMA US PHARMS
30MG/5ML
A085873 001
BUTABARBITAL SODIUM
WOCKHARDT
30MG/5ML
A085383 001
BUTALAN
LANNETT
33.3MG/5ML
A085880 001
SARISOL
HALSEY
30MG/5ML
A084723 001
TABLET;ORAL
BUTABARBITAL
BUNDY
30MG
A085550 001
BUTABARBITAL SODIUM
SANDOZ
15MG
A084292 003 Feb 09, 1982
15MG
A085938 001
30MG
A084272 002
30MG
A085934 001
SOLVAY
16.2MG
A083606 001
32.4MG
A083898 001
48.6MG
A083897 001
97.2MG
A083896 001
TEVA
15MG
A088632 001 May 18, 1985
30MG
A088631 001 May 01, 1985
WATSON LABS
15MG
A085764 001
30MG
A085772 001
WHITEWORTH TOWN PLSN
15MG
A083325 002
30MG
A083337 001
BUTISOL SODIUM
MEDA PHARMS
15MG
N000793 002
100MG
N000793 005
SARISOL NO. 1
HALSEY
15MG
A084719 001
SARISOL NO. 2
HALSEY
30MG
A084719 002
SODIUM BUTABARBITAL
HIKMA PHARMS LLC
15MG
A085418 001
30MG
A085432 001
IVAX SUB TEVA PHARMS
15MG
A083484 001
30MG
A084040 001
LANNETT
15MG
A085849 001
30MG
A085866 001
100MG
A085881 001
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DISCONTINUED DRUG PRODUCT LIST
6-51(of 337)
BUTABARBITAL SODIUM
TABLET;ORAL
SODIUM BUTABARBITAL
MARSHALL PHARMA
16.2MG
A083524 001
32.4MG
A083858 001
BUTENAFINE HYDROCHLORIDE
CREAM;TOPICAL
MENTAX-TC
MYLAN
1%
N021408 001
Oct 17, 2002
BUTOCONAZOLE NITRATE
CREAM;VAGINAL
FEMSTAT
ROCHE PALO
2%
N019215 001
Nov 25, 1985
GYNAZOLE-1
ELAN PHARMA INTL LTD
2%
N019881 001
Feb 07, 1997
SUPPOSITORY;VAGINAL
FEMSTAT
ROCHE PALO
100MG
N019359 001
Nov 25, 1985
BUTORPHANOL TARTRATE
INJECTABLE;INJECTION
BUTORPHANOL TARTRATE
APOTEX INC
2MG/ML
A075697 001
Oct 23, 2001
HIKMA FARMACEUTICA
2MG/ML
A078247 001
Apr 29, 2009
HOSPIRA
1MG/ML
A075342 001
Nov 04, 1999
1MG/ML
A075559 001
Mar 20, 2000
2MG/ML
A075342 002
Nov 04, 1999
2MG/ML
A075559 002
Mar 20, 2000
BUTORPHANOL TARTRATE PRESERVATIVE FREE
APOTEX INC
1MG/ML
A075695 001
Oct 23, 2001
2MG/ML
A075695 002
Oct 23, 2001
HOSPIRA
1MG/ML
A074620 001
Jan 22, 1997
1MG/ML
A075170 001
Sep 28, 1998
2MG/ML
A074620 002
Jan 22, 1997
2MG/ML
A075170 002
Sep 28, 1998
STADOL
APOTHECON
2MG/ML
N017857 004
STADOL PRESERVATIVE FREE
APOTHECON
1MG/ML
N017857 001
2MG/ML
N017857 002
SPRAY, METERED;NASAL
STADOL
BRISTOL MYERS SQUIBB
1MG/SPRAY
N019890 001
Dec 12, 1991
CABERGOLINE
TABLET;ORAL
DOSTINEX
PHARMACIA AND UPJOHN
0.5MG
N020664 001
Dec 23, 1996
CAFFEINE; ERGOTAMINE TARTRATE
SUPPOSITORY;RECTAL
CAFERGOT
NOVARTIS
100MG;2MG
N009000 002
TABLET;ORAL
CAFERGOT
NOVARTIS
100MG;1MG
N006620 001
WIGRAINE
ORGANON USA INC
100MG;1MG
A086562 001
CALCIFEDIOL
CAPSULE;ORAL
CALDEROL
ORGANON USA INC
0.02MG
N018312 001
0.05MG
N018312 002
CALCIPOTRIENE
OINTMENT;TOPICAL
DOVONEX
LEO PHARMA AS
0.005%
N020273 001
Dec 29, 1993
SOLUTION;TOPICAL
DOVONEX
LEO PHARM
0.005% **Federal Register determination
N020611 001
Mar 03, 1997
that product was not discontinued or
withdrawn for safety or efficacy
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DISCONTINUED DRUG PRODUCT LIST
6-52(of 337)
CALCIPOTRIENE
SOLUTION;TOPICAL
DOVONEX
reasons**
CALCITONIN HUMAN
INJECTABLE;INJECTION
CIBACALCIN
NOVARTIS
0.5MG/VIAL
N018470 001
Oct 31, 1986
CALCITONIN SALMON
INJECTABLE;INJECTION
CALCIMAR
SANOFI AVENTIS US
200 IU/ML
N017769 001
400 IU/VIAL
N017497 001
CALCITONIN-SALMON
ASTRAZENECA
200 IU/ML
A073690 001
Apr 14, 1995
MIACALCIN
SEBELA IRELAND LTD
100 IU/ML
N017808 001
Jul 03, 1986
CALCITRIOL
INJECTABLE;INJECTION
CALCITRIOL
HOSPIRA
0.001MG/ML
A075816 001
Jan 16, 2004
0.002MG/ML
A075816 002
Jan 16, 2004
TEVA PARENTERAL
0.001MG/ML
A075823 001
Mar 31, 2003
0.002MG/ML
A075823 002
Mar 31, 2003
CALCIUM ACETATE
CAPSULE;ORAL
PHOSLO
FRESENIUS MEDCL
EQ 84.5MG CALCIUM
N021160 001
Apr 02, 2001
EQ 169MG CALCIUM
N021160 002
Apr 02, 2001
TABLET;ORAL
CALCIUM ACETATE
ROXANE
EQ 169MG CALCIUM
A077693 001
Jan 30, 2008
PHOSLO
FRESENIUS MEDCL
EQ 169MG CALCIUM
N019976 001
Dec 10, 1990
CALCIUM CARBONATE; RISEDRONATE SODIUM
TABLET, TABLET;ORAL
ACTONEL WITH CALCIUM (COPACKAGED)
WARNER CHILCOTT EQ 500MG BASE,N/A;N/A,35MG **Federal
N021823 001
Aug 12, 2005
Register determination that product was
not discontinued or withdrawn for
safety or efficacy reasons**
CALCIUM CHLORIDE; DEXTROSE; LACTIC ACID; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM
BICARBONATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
PRISMASOL B22GK 2/2.5 IN PLASTIC CONTAINER
GAMBRO RENAL PRODS 3.68GM/1000ML;20GM/1000ML;5.4GM/1000ML;
N021703 012 Oct 10, 2008
3.05GM/1000ML;0.157GM/1000ML;2.21GM/100
0ML;7.07GM/1000ML
PRISMASOL BGK 4/0 IN PLASTIC CONTAINER
GAMBRO RENAL PRODS N/A/1000ML;20GM/1000ML;5.4GM/1000ML;3.0
N021703 005 Oct 25, 2006
5GM/1000ML;0.314GM/1000ML;3.09GM/1000ML
;6.46GM/1000ML
PRISMASOL BGK 4/3.5 IN PLASTIC CONTAINER
GAMBRO RENAL PRODS 5.15GM/1000ML;20GM/1000ML;5.4GM/1000ML;
N021703 008 Oct 25, 2006
2.03GM/1000ML;0.314GM/1000ML;3.09GM/100
0ML;6.46GM/1000ML
PRISMASOL BK 0/0 IN PLASTIC CONTAINER
GAMBRO RENAL PRODS N/A/1000ML;N/A/1000ML;5.4GM/1000ML;3.05
N021703 007 Oct 25, 2006
GM/1000ML;N/A/1000ML;3.09GM/1000ML;6.46
GM/1000ML
PRISMASOL BK 4/2.5 IN PLASTIC CONTAINER
GAMBRO RENAL PRODS 3.68GM/1000ML;N/A/1000ML;5.4GM/1000ML;3
N021703 009 Oct 25, 2006
.05GM/1000ML;0.314GM/1000ML;3.09GM/1000
ML;6.46GM/1000ML
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM
CHLORIDE
INJECTABLE;INJECTION
ISOLYTE R W/ DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 37MG/100ML;5GM/100ML;31MG/100ML;120MG/1 N018271 001
00ML;330MG/100ML;88MG/100ML
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DISCONTINUED DRUG PRODUCT LIST 6-53(of 337)
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM
CHLORIDE; SODIUM CITRATE
INJECTABLE;INJECTION
ISOLYTE E IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 35MG/100ML;5GM/100ML;30MG/100ML;74MG/10 N019867 001
Dec 20, 1993
0ML;640MG/100ML;500MG/100ML;74MG/100ML
ISOLYTE E W/ DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 35MG/100ML;5GM/100ML;30MG/100ML;74MG/10 N018269 002
Jan 17, 1983
0ML;640MG/100ML;500MG/100ML;74MG/100ML
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
SOLUTION;INTRAPERITONEAL
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER
B BRAUN 29MG/100ML;2.5GM/100ML;15MG/100ML;610MG
N018460 006
Jan 29, 1986
/100ML;560MG/100ML
DIALYTE W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
B BRAUN 29MG/100ML;1.5GM/100ML;15MG/100ML;610MG
N018460 001
/100ML;560MG/100ML
DIALYTE W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
B BRAUN 29MG/100ML;4.25GM/100ML;15MG/100ML;610M
N018460 003
G/100ML;560MG/100ML
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
SOLUTION;INTRAPERITONEAL
DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER
B BRAUN 26MG/100ML;1.5GM/100ML;15MG/100ML;560MG
N018460 002
/100ML;390MG/100ML
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER
B BRAUN 26MG/100ML;5GM/100ML;5MG/100ML;530MG/10
N018460 008
Jan 29, 1986
0ML;450MG/100ML
DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER
B BRAUN 26MG/100ML;4.25GM/100ML;15MG/100ML;560M
N018460 004
G/100ML;390MG/100ML
INPERSOL-LC/LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
FRESENIUS 18.4MG/100ML;1.5GM/100ML;5.08MG/100ML;5
A020374 001
Jun 13, 1994
38MG/100ML;448MG/100ML
INPERSOL-LC/LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
FRESENIUS 18.4MG/100ML;2.5GM/100ML;5.08MG/100ML;5
A020374 002
Jun 13, 1994
38MG/100ML;448MG/100ML
INPERSOL-LC/LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER
FRESENIUS 18.4MG/100ML;3.5GM/100ML;5.08MG/100ML;5
A020374 003
Jun 13, 1994
38MG/100ML;448MG/100ML
INPERSOL-LC/LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
FRESENIUS 18.4MG/100ML;4.25GM/100ML;5.08MG/100ML;
A020374 004
Jun 13, 1994
538MG/100ML;448MG/100ML
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER
B BRAUN 33MG/100ML;5GM/100ML;30MG/100ML;860MG/1
N018256 001
00ML
BAXTER HLTHCARE 33MG/100ML;5GM/100ML;30MG/100ML;860MG/1
N016695 001
00ML
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
INJECTABLE;INJECTION
DEXTROSE 4% IN MODIFIED LACTATED RINGER'S IN PLASTIC CONTAINER
B BRAUN 4MG/100ML;4GM/100ML;6MG/100ML;120MG/100
N019634 002
Feb 24, 1988
ML;62MG/100ML
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER
B BRAUN 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1
N017510 001
00ML;310MG/100ML
MILES 20MG/100ML;5GM/100ML;30MG/100ML;600MG/1
N018499 001
00ML;310MG/100ML
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
HOSPIRA 20MG/100ML;5GM/100ML;104MG/100ML;600MG/ N019685 005
Oct 17, 1988
100ML;310MG/100ML
20MG/100ML;5GM/100ML;179MG/100ML;600MG/ N019685 006
Oct 17, 1988
100ML;310MG/100ML
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
HOSPIRA 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019685 007
Oct 17, 1988
100ML;310MG/100ML
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
HOSPIRA 20MG/100ML;5GM/100ML;254MG/100ML;600MG/ N019685 003
Oct 17, 1988
100ML;310MG/100ML
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-54(of 337)
CALCIUM CHLORIDE; DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
INJECTABLE;INJECTION
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER
HOSPIRA 20MG/100ML;5GM/100ML;104MG/100ML;600MG/ N019685 001 Oct 17, 1988
100ML;310MG/100ML
CALCIUM CHLORIDE; DEXTROSE; SODIUM CHLORIDE; SODIUM LACTATE
SOLUTION;INTRAPERITONEAL
INPERSOL-ZM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER
FRESENIUS MEDCL 25.7MG/100ML;1.5GM/100ML;538MG/100ML;44 N019395 001 Mar 26, 1986
8MG/100ML
INPERSOL-ZM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER
FRESENIUS MEDCL 25.7MG/100ML;2.5GM/100ML;538MG/100ML;44 N019395 002 Mar 26, 1986
8MG/100ML
INPERSOL-ZM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER
FRESENIUS MEDCL 25.7MG/100ML;4.25GM/100ML;538MG/100ML;4 N019395 003 Mar 26, 1986
48MG/100ML
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
TPN ELECTROLYTES IN PLASTIC CONTAINER
ABBOTT 16.5MG/ML;25.4MG/ML;74.6MG/ML;121MG/ML; N019399 001 Jun 16, 1986
16.1MG/ML
CALCIUM CHLORIDE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM
CITRATE
INJECTABLE;INJECTION
ISOLYTE E IN PLASTIC CONTAINER
B BRAUN 35MG/100ML;30MG/100ML;74MG/100ML;640MG/
N018899 001 Oct 31, 1983
100ML;500MG/100ML;74MG/100ML
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
ACETATED RINGER'S IN PLASTIC CONTAINER
B BRAUN 20MG/100ML;30MG/100ML;380MG/100ML;600MG
N018725 001 Nov 29, 1982
/100ML
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
RINGER'S IN PLASTIC CONTAINER
B BRAUN 33MG/100ML;30MG/100ML;860MG/100ML
N018721 001 Nov 09, 1982
SOLUTION;IRRIGATION
RINGER'S IN PLASTIC CONTAINER
ABBOTT 33MG/100ML;30MG/100ML;860MG/100ML
N018462 001
CALCIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM CHLORIDE; SODIUM LACTATE
INJECTABLE;INJECTION
LACTATED RINGER'S IN PLASTIC CONTAINER
ABBOTT
20MG/100ML;30MG/100ML;600MG/100ML;310MG
N019485 001 Oct 24, 1985
/100ML
B BRAUN
20MG/100ML;30MG/100ML;600MG/100ML;310MG
N018023 001
/100ML
MILES
20MG/100ML;30MG/100ML;600MG/100ML;310MG
N018417 001
/100ML
CALCIUM GLUCEPTATE
INJECTABLE;INJECTION
CALCIUM GLUCEPTATE
ABBOTT
EQ 90MG CALCIUM/5ML
A080001 001
EQ 90MG CALCIUM/5ML
A083159 001
ABRAXIS PHARM
EQ 90MG CALCIUM/5ML
A089373 001 Apr 30, 1987
LILLY
EQ 90MG CALCIUM/5ML
N006470 001
CALCIUM METRIZOATE; MEGLUMINE METRIZOATE; METRIZOATE MAGNESIUM; METRIZOATE SODIUM
INJECTABLE;INJECTION
ISOPAQUE 440
GE HEALTHCARE 0.78MG/ML;75.9MG/ML;0.15MG/ML;16.6MG/ML
N016847 001
CALCIUM; MEGLUMINE; METRIZOIC ACID
INJECTABLE;INJECTION
ISOPAQUE 280
GE HEALTHCARE 0.35MG/ML;140.1MG/ML;461.8MG/ML
N017506 001
CANDICIDIN
OINTMENT;VAGINAL
VANOBID
SANOFI AVENTIS US 0.6MG/GM
A061596 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-55(of 337)
CANDICIDIN
TABLET;VAGINAL
VANOBID
SANOFI AVENTIS US 3MG
A061613 001
CAPTOPRIL
TABLET;ORAL
CAPOTEN
PAR PHARM 37.5MG
N018343 006 Sep 17, 1986
75MG
N018343 007 Jun 13, 1995
150MG
N018343 004 Jun 13, 1995
CAPTOPRIL
APOTHECON 12.5MG
A074472 001 Mar 31, 1995
25MG
A074472 002 Mar 31, 1995
50MG
A074472 003 Mar 31, 1995
100MG
A074472 004 Mar 31, 1995
DAVA PHARMS INC 12.5MG
A074423 001 Feb 13, 1996
25MG
A074423 002 Feb 13, 1996
50MG
A074423 003 Feb 13, 1996
100MG
A074423 004 Feb 13, 1996
EGIS PHARMS 12.5MG
A074748 004 May 29, 1997
25MG
A074748 002 May 29, 1997
50MG
A074748 001 May 29, 1997
100MG
A074748 003 May 29, 1997
IVAX SUB TEVA PHARMS 12.5MG
A074590 004 Aug 30, 1996
25MG
A074590 002 Aug 30, 1996
50MG
A074590 001 Aug 30, 1996
100MG
A074590 003 Aug 30, 1996
PAR PHARM 12.5MG
A074493 001 Feb 13, 1996
25MG
A074493 002 Feb 13, 1996
50MG
A074493 003 Feb 13, 1996
100MG
A074493 004 Feb 13, 1996
PRINSTON INC 12.5MG
A074477 001 Feb 13, 1996
25MG
A074477 002 Feb 13, 1996
50MG
A074477 003 Feb 13, 1996
100MG
A074477 004 Feb 13, 1996
PUREPAC PHARM 12.5MG
A074640 001 Mar 31, 1997
25MG
A074640 002 Mar 31, 1997
50MG
A074640 003 Mar 31, 1997
100MG
A074640 004 Mar 31, 1997
SANDOZ 12.5MG
A074481 001 Feb 13, 1996
12.5MG
A074519 001 Feb 13, 1996
25MG
A074481 002 Feb 13, 1996
25MG
A074519 002 Feb 13, 1996
50MG
A074481 003 Feb 13, 1996
50MG
A074519 003 Feb 13, 1996
100MG
A074481 004 Feb 13, 1996
100MG
A074519 004 Feb 13, 1996
TEVA 12.5MG
A074433 001 Feb 13, 1996
12.5MG
A074483 001 Feb 13, 1996
25MG
A074433 002 Feb 13, 1996
25MG
A074483 002 Feb 13, 1996
50MG
A074433 003 Feb 13, 1996
50MG
A074483 003 Feb 13, 1996
100MG
A074433 004 Feb 13, 1996
100MG
A074483 004 Feb 13, 1996
TEVA PHARMS 12.5MG
A074462 001 Feb 13, 1996
25MG
A074462 002 Feb 13, 1996
50MG
A074462 003 Feb 13, 1996
100MG
A074462 004 Feb 13, 1996
VINTAGE PHARMS LLC 12.5MG
A074418 001 Feb 13, 1996
25MG
A074418 002 Feb 13, 1996
50MG
A074418 003 Feb 13, 1996
100MG
A074418 004 Feb 13, 1996
WATSON LABS 12.5MG
A074451 001 Feb 13, 1996
12.5MG
A074576 001 Apr 23, 1996
25MG
A074451 002 Feb 13, 1996
25MG
A074576 002 Apr 23, 1996
50MG
A074451 003 Feb 13, 1996
50MG
A074576 003 Apr 23, 1996
100MG
A074451 004 Feb 13, 1996
100MG
A074576 004 Apr 23, 1996
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-56(of 337)
CAPTOPRIL; HYDROCHLOROTHIAZIDE
TABLET;ORAL
CAPOZIDE 25/15
APOTHECON 25MG;15MG **Federal Register N018709 001 Oct 12, 1984
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
CAPOZIDE 25/25
APOTHECON 25MG;25MG **Federal Register N018709 002 Oct 12, 1984
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
CAPOZIDE 50/15
APOTHECON 50MG;15MG **Federal Register N018709 004 Oct 12, 1984
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
CAPOZIDE 50/25
APOTHECON 50MG;25MG **Federal Register N018709 003 Oct 12, 1984
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
CAPTOPRIL AND HYDROCHLOROTHIAZIDE
IVAX SUB TEVA PHARMS 25MG;15MG A075055 001 Jun 18, 1998
25MG;25MG A075055 002 Jun 18, 1998
50MG;15MG A075055 004 Jun 18, 1998
50MG;25MG A075055 003 Jun 18, 1998
VINTAGE PHARMS LLC 25MG;15MG A074788 001 Dec 29, 1997
25MG;25MG A074788 002 Dec 29, 1997
50MG;15MG A074788 004 Dec 29, 1997
50MG;25MG A074788 003 Dec 29, 1997
WATSON LABS 50MG;25MG A074832 001 Dec 29, 1997
CARBACHOL
SOLUTION;INTRAOCULAR
CARBACHOL
PHARMAFAIR 0.01% A070292 001 May 21, 1986
CARBASTAT
NOVARTIS 0.01% A073677 001 Apr 28, 1995
CARBAMAZEPINE
SUSPENSION;ORAL
CARBAMAZEPINE
TARO 100MG/5ML A075875 001 Dec 21, 2000
TABLET;ORAL
CARBAMAZEPINE
ACTAVIS ELIZABETH 200MG A071696 001 Nov 09, 1987
INWOOD LABS 200MG A070231 001 Aug 14, 1986
PLIVA 200MG A071479 001 Jul 24, 1987
USL PHARMA 200MG A070300 001 May 15, 1986
WARNER CHILCOTT 200MG A070429 001 Jan 02, 1987
TERIL
TARO 200MG A076525 001 Sep 26, 2003
TABLET, CHEWABLE;ORAL
CARBAMAZEPINE
JUBILANT CADISTA 100MG A071940 001 Feb 01, 1988
CARBENICILLIN DISODIUM
INJECTABLE;INJECTION
GEOPEN
ROERIG EQ 1GM BASE/VIAL N050306 001
EQ 2GM BASE/VIAL N050306 004
EQ 5GM BASE/VIAL N050306 002
EQ 10GM BASE/VIAL N050306 006
EQ 30GM BASE/VIAL N050306 007
PYOPEN
GLAXOSMITHKLINE EQ 1GM BASE/VIAL N050298 001
EQ 2GM BASE/VIAL N050298 002
EQ 5GM BASE/VIAL N050298 003
EQ 10GM BASE/VIAL N050298 006
EQ 20GM BASE/VIAL N050298 007
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DISCONTINUED DRUG PRODUCT LIST 6-57(of 337)
CARBENICILLIN INDANYL SODIUM
TABLET;ORAL
GEOCILLIN
PFIZER EQ 382MG BASE N050435 001
CARBIDOPA; LEVODOPA
TABLET;ORAL
CARBIDOPA AND LEVODOPA
SANDOZ 10MG;100MG A073586 001 Jun 29, 1995
25MG;100MG A073587 001 Jun 29, 1995
25MG;250MG A073620 001 Jun 29, 1995
SCS 10MG;100MG A074080 001 Mar 25, 1994
25MG;100MG A074080 002 Mar 25, 1994
25MG;250MG A074080 003 Mar 25, 1994
WATSON LABS 10MG;100MG A073381 001 Sep 28, 1993
25MG;100MG A073382 001 Sep 28, 1993
25MG;250MG A073383 001 Sep 28, 1993
TABLET, EXTENDED RELEASE;ORAL
CARBIDOPA AND LEVODOPA
KV PHARM 50MG;200MG A076663 001 Jun 24, 2004
TABLET, FOR SUSPENSION;ORAL
CARBILEV
RANBAXY 10MG;100MG A076643 001 Jun 10, 2005
25MG;100MG A076643 002 Jun 10, 2005
25MG;250MG A076643 003 Jun 10, 2005
TABLET, ORALLY DISINTEGRATING;ORAL
CARBIDOPA AND LEVODOPA
IMPAX LABS 10MG;100MG A090631 001 Jun 08, 2010
25MG;100MG A090631 002 Jun 08, 2010
25MG;250MG A090631 003 Jun 08, 2010
PARCOPA
UCB INC 10MG;100MG **Federal Register A076699 001 Aug 27, 2004
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
25MG;100MG **Federal Register A076699 002 Aug 27, 2004
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
25MG;250MG **Federal Register A076699 003 Aug 27, 2004
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
CARBINOXAMINE MALEATE
ELIXIR;ORAL
CLISTIN
MCNEIL 4MG/5ML **Federal Register N008955 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
TABLET;ORAL
CLISTIN
ORTHO MCNEIL PHARM 4MG N008915 001
CARBOPLATIN
INJECTABLE;INJECTION
CARBOPLATIN
CIPLA LTD 50MG/VIAL A077383 001 Jan 27, 2006
150MG/VIAL A077383 002 Jan 27, 2006
450MG/VIAL A077383 003 Jan 27, 2006
EUROHLTH INTL 50MG/VIAL A076099 001 Oct 14, 2004
150MG/VIAL A076099 002 Oct 14, 2004
450MG/VIAL A076099 003 Oct 14, 2004
FRESENIUS KABI USA 50MG/VIAL A076235 001 Oct 14, 2004
150MG/VIAL A076235 002 Oct 14, 2004
450MG/VIAL A076235 003 Oct 14, 2004
HOSPIRA 50MG/VIAL A076473 001 Oct 27, 2004
150MG/VIAL A076473 002 Oct 27, 2004
450MG/VIAL A076473 003 Oct 27, 2004
ONCO THERAPIES LTD 50MG/VIAL A091510 001 May 29, 2012
150MG/VIAL A091510 002 May 29, 2012
450MG/VIAL A091510 003 May 29, 2012
PLIVA 50MG/VIAL A076602 001 Nov 16, 2004
150MG/VIAL A076602 002 Nov 16, 2004
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DISCONTINUED DRUG PRODUCT LIST 6-58(of 337)
CARBOPLATIN
INJECTABLE;INJECTION
CARBOPLATIN
450MG/VIAL A076602 003 Nov 16, 2004
SANDOZ 50MG/VIAL A076959 001 Mar 18, 2005
150MG/VIAL A076959 002 Mar 18, 2005
450MG/VIAL A076959 003 Mar 18, 2005
WATSON LABS 50MG/VIAL A076162 001 Oct 14, 2004
150MG/VIAL A076162 002 Oct 14, 2004
450MG/VIAL A076162 003 Oct 14, 2004
PARAPLATIN
CORDEN PHARMA 50MG/VIAL N019880 001 Mar 03, 1989
150MG/VIAL N019880 002 Mar 03, 1989
450MG/VIAL N019880 003 Mar 03, 1989
INJECTABLE;IV (INFUSION)
CARBOPLATIN
FRESENIUS KABI USA 50MG/5ML (10MG/ML) A077247 001 Oct 21, 2004
50MG/5ML (10MG/ML) A077266 001 Feb 15, 2006
150MG/15ML (10MG/ML) A077247 002 Oct 21, 2004
150MG/15ML (10MG/ML) A077266 002 Feb 15, 2006
PHARMACHEMIE BV 50MG/5ML (10MG/ML) A077679 001 Feb 25, 2009
150MG/15ML (10MG/ML) A077679 002 Feb 25, 2009
450MG/45ML (10MG/ML) A077679 003 Feb 25, 2009
TEVA PARENTERAL 50MG/5ML (10MG/ML) A077389 001 Mar 30, 2007
150MG/15ML (10MG/ML) A077389 002 Mar 30, 2007
450MG/45ML (10MG/ML) A077389 003 Mar 30, 2007
PARAPLATIN
CORDENPHARMA 50MG/5ML (10MG/ML) N020452 001 Jul 14, 2003
150MG/15ML (10MG/ML) N020452 002 Jul 14, 2003
450MG/45ML (10MG/ML) N020452 003 Jul 14, 2003
600MG/60ML (10MG/ML) N020452 004 Jan 15, 2004
CARISOPRODOL
CAPSULE;ORAL
SOMA
MEDA PHARMS 250MG N011792 003
TABLET;ORAL
CARISOPRODOL
ABLE 350MG A040421 001 Jun 21, 2001
COREPHARMA 350MG A040397 001 Sep 21, 2000
HIKMA INTL PHARMS 350MG A040124 001 Jan 24, 1996
PIONEER PHARMS 350MG A089390 001 Oct 13, 1988
PROSAM LABS 350MG A040188 001 Mar 07, 1997
SANDOZ 350MG A081025 001 Apr 13, 1989
350MG A089566 001 Aug 30, 1988
WATSON LABS 350MG A040152 001 Dec 03, 1996
350MG A085433 001
350MG A086179 001
RELA
SCHERING 350MG N012155 001
CARPHENAZINE MALEATE
CONCENTRATE;ORAL
PROKETAZINE
WYETH AYERST 50MG/ML N014173 001
TABLET;ORAL
PROKETAZINE
WYETH AYERST 12.5MG N012768 001
25MG N012768 002
50MG N012768 004
CARPROFEN
TABLET;ORAL
RIMADYL
ROCHE 100MG N018550 002 Dec 31, 1987
150MG N018550 003 Dec 31, 1987
CARTEOLOL HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
CARTEOLOL HYDROCHLORIDE
APOTEX INC 1% A076097 001 Feb 06, 2002
TABLET;ORAL
CARTROL
ABBVIE 2.5MG N019204 001 Dec 28, 1988
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DISCONTINUED DRUG PRODUCT LIST 6-59(of 337)
CARTEOLOL HYDROCHLORIDE
TABLET;ORAL
CARTROL
5MG N019204 002 Dec 28, 1988
10MG N019204 003 Dec 28, 1988
CARVEDILOL
TABLET;ORAL
CARVEDILOL
WOCKHARDT LTD 3.125MG A078786 001 Dec 22, 2009
6.25MG A078786 002 Dec 22, 2009
12.5MG A078786 003 Dec 22, 2009
25MG A078786 004 Dec 22, 2009
CEFACLOR
CAPSULE;ORAL
CECLOR
LILLY EQ 250MG BASE N050521 001
EQ 500MG BASE N050521 002
CEFACLOR
CEPH INTL EQ 250MG BASE A062205 001
EQ 500MG BASE A062205 002
DAVA PHARMS INC EQ 250MG BASE A064107 001 Apr 27, 1995
EQ 500MG BASE A064107 002 Apr 27, 1995
IVAX SUB TEVA PHARMS EQ 250MG BASE A064061 001 Apr 27, 1995
EQ 500MG BASE A064061 002 Apr 27, 1995
RANBAXY EQ 250MG BASE A064156 001 Aug 28, 1997
EQ 500MG BASE A064156 002 Aug 28, 1997
TEVA EQ 250MG BASE A064081 001 Sep 16, 1996
EQ 250MG BASE A064145 001 Jun 24, 1996
EQ 500MG BASE A064081 002 Sep 16, 1996
EQ 500MG BASE A064145 002 Jun 24, 1996
WATSON LABS INC EQ 250MG BASE A064148 001 May 23, 1996
EQ 500MG BASE A064148 002 May 23, 1996
FOR SUSPENSION;ORAL
CECLOR
LILLY EQ 125MG BASE/5ML N050522 001
EQ 250MG BASE/5ML N050522 002
CEFACLOR
DAVA PHARMS INC EQ 125MG BASE/5ML A064114 001 Apr 28, 1995
EQ 187MG BASE/5ML A064115 001 Apr 28, 1995
EQ 250MG BASE/5ML A064116 001 Apr 28, 1995
EQ 375MG BASE/5ML A064110 001 Apr 28, 1995
FACTA FARMA EQ 125MG BASE/5ML A062206 001
EQ 187MG BASE/5ML A062206 003 Apr 20, 1988
EQ 250MG BASE/5ML A062206 002
EQ 375MG BASE/5ML A062206 004 Apr 20, 1988
IVAX SUB TEVA PHARMS EQ 125MG BASE/5ML A064087 001 Apr 28, 1995
EQ 187MG BASE/5ML A064086 001 Apr 28, 1995
EQ 250MG BASE/5ML A064085 001 Apr 28, 1995
EQ 375MG BASE/5ML A064070 001 Apr 28, 1995
RANBAXY EQ 125MG BASE/5ML A064166 001 Oct 02, 1997
EQ 187MG BASE/5ML A064165 001 Oct 02, 1997
EQ 250MG BASE/5ML A064164 001 Oct 02, 1997
EQ 375MG BASE/5ML A064155 001 Oct 02, 1997
WATSON LABS INC EQ 125MG BASE/5ML A064204 001 Feb 18, 1998
EQ 187MG BASE/5ML A064205 001 Feb 18, 1998
EQ 250MG BASE/5ML A064206 001 Feb 18, 1998
EQ 375MG BASE/5ML A064207 001 Feb 18, 1998
TABLET, CHEWABLE;ORAL
RANICLOR
RANBAXY LABS LTD EQ 125MG BASE A065092 001 Dec 22, 2003
EQ 187MG BASE A065092 002 Dec 22, 2003
EQ 250MG BASE A065092 003 Dec 22, 2003
EQ 375MG BASE A065092 004 Dec 22, 2003
TABLET, EXTENDED RELEASE;ORAL
CECLOR CD
LILLY EQ 375MG BASE N050673 001 Jun 28, 1996
EQ 500MG BASE N050673 002 Jun 28, 1996
CEFACLOR
WORLD GEN EQ 500MG BASE A065057 001 Jan 05, 2001
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DISCONTINUED DRUG PRODUCT LIST
6-60(of 337)
CEFADROXIL/CEFADROXIL HEMIHYDRATE
CAPSULE;ORAL
CEFADROXIL
IVAX SUB TEVA PHARMS
EQ 500MG BASE
A062766 001
Mar 03, 1987
PUREPAC PHARM
EQ 500MG BASE
A063017 001
Jan 05, 1989
RANBAXY LABS LTD
EQ 500MG BASE
A065015 001
Jun 22, 1999
TEVA
EQ 500MG BASE
A062695 001
Feb 10, 1989
DURICEF
WARNER CHILCOTT
EQ 250MG BASE
N050512 002
EQ 500MG BASE
N050512 001
ULTRACEF
BRISTOL
EQ 500MG BASE
A062378 001
Mar 16, 1982
FOR SUSPENSION;ORAL
CEFADROXIL
ANI PHARMS INC
EQ 125MG BASE/5ML
A062698 001
Mar 01, 1989
EQ 250MG BASE/5ML
A062698 002
Mar 01, 1989
EQ 250MG BASE/5ML
A065278 001
Jan 20, 2006
EQ 500MG BASE/5ML
A062698 003
Mar 01, 1989
EQ 500MG BASE/5ML
A065278 002
Jan 20, 2006
APOTHECON
EQ 125MG BASE/5ML
A062334 001
EQ 250MG BASE/5ML
A062334 002
EQ 500MG BASE/5ML
A062334 003
DURICEF
WARNER CHILCOTT
EQ 125MG BASE/5ML
N050527 002
EQ 250MG BASE/5ML
N050527 003
EQ 500MG BASE/5ML
N050527 001
ULTRACEF
BRISTOL
EQ 125MG BASE/5ML
A062376 001
Mar 16, 1982
EQ 250MG BASE/5ML
A062376 002
Mar 16, 1982
EQ 500MG BASE/5ML
A062376 003
Mar 16, 1982
TABLET;ORAL
CEFADROXIL
RANBAXY
EQ 1GM BASE
A065018 001
Apr 23, 1999
DURICEF
WARNER CHILCOTT
EQ 1GM BASE
N050528 001
ULTRACEF
APOTHECON
EQ 1GM BASE
A062390 001
Jun 10, 1982
BRISTOL
EQ 1GM BASE
A062408 001
Aug 31, 1982
CEFAMANDOLE NAFATE
INJECTABLE;INJECTION
MANDOL
LILLY
EQ 1GM BASE/VIAL
A062560 001
Sep 10, 1985
EQ 1GM BASE/VIAL
N050504 002
EQ 2GM BASE/VIAL
A062560 002
Sep 10, 1985
EQ 2GM BASE/VIAL
N050504 003
EQ 10GM BASE/VIAL
N050504 004
EQ 500MG BASE/VIAL
N050504 001
CEFAZOLIN SODIUM
INJECTABLE;INJECTION
ANCEF
GLAXOSMITHKLINE
EQ 1GM BASE/VIAL
N050461 003
EQ 5GM BASE/VIAL **Federal Register
N050461 004
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 10GM BASE/VIAL
N050461 005
EQ 250MG BASE/VIAL **Federal Register
N050461 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 500MG BASE/VIAL
N050461 002
ANCEF IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE EQ 10MG BASE/ML
N050566 003
Jun 08, 1983
EQ 20MG BASE/ML
N050566 004
Jun 08, 1983
ANCEF IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE
EQ 10MG BASE/ML
N050566 001
Jun 08, 1983
EQ 20MG BASE/ML
N050566 002
Jun 08, 1983
CEFAZOLIN AND DEXTROSE
B BRAUN
EQ 500MG BASE/VIAL
N050779 001
Jul 27, 2000
CEFAZOLIN SODIUM
ABRAXIS PHARM
EQ 1GM BASE/VIAL
A062688 003
Nov 17, 1986
EQ 10GM BASE/VIAL
A062688 004
Nov 17, 1986
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-61(of 337)
CEFAZOLIN SODIUM
INJECTABLE;INJECTION
CEFAZOLIN SODIUM
EQ 20GM BASE/VIAL
A062688 005
Aug 03, 1987
EQ 500MG BASE/VIAL
A062688 002
Nov 17, 1986
AUROBINDO PHARMA EQ 1GM BASE/VIAL
A065395 002
Aug 08, 2008
EQ 500MG BASE/VIAL
A065395 001
Aug 08, 2008
BEDFORD EQ 1GM BASE/VIAL
A062894 003
Jul 21, 1988
EQ 5GM BASE/VIAL
A062894 004
Jul 21, 1988
EQ 10GM BASE/VIAL
A062894 005
Jul 21, 1988
EQ 250MG BASE/VIAL
A062894 001
Jul 21, 1988
EQ 500MG BASE/VIAL
A062894 002
Jul 21, 1988
CEPHAZONE PHARMA EQ 1GM BASE/VIAL
A065280 002
Mar 18, 2009
EQ 10GM BASE/VIAL
A065295 001
Mar 18, 2009
EQ 20GM BASE/VIAL
A065296 001
Mar 18, 2009
EQ 500MG BASE/VIAL
A065280 001
Mar 18, 2009
FRESENIUS KABI USA EQ 1GM BASE/VIAL
A064169 002
Aug 14, 1998
EQ 10GM BASE/VIAL
A064170 001
Mar 18, 1998
EQ 20GM BASE/VIAL
A064170 002
Mar 18, 1998
EQ 500MG BASE/VIAL
A064169 001
Aug 14, 1998
GLAXOSMITHKLINE EQ 1GM BASE/VIAL
A064033 001
Oct 31, 1993
HIKMA MAPLE EQ 1GM BASE/VIAL
A062807 003
Jan 12, 1988
EQ 5GM BASE/VIAL
A062807 004
Jan 12, 1988
EQ 10GM BASE/VIAL
A062807 005
Jan 12, 1988
EQ 20GM BASE/VIAL
A062807 006
Jan 12, 1988
EQ 250MG BASE/VIAL
A062807 001
Jan 12, 1988
EQ 500MG BASE/VIAL
A062807 002
Jan 12, 1988
STERI PHARMA EQ 1GM BASE/VIAL
A063208 001
Dec 27, 1991
EQ 500MG BASE/VIAL
A063216 001
Dec 27, 1991
TEVA PHARMS EQ 1GM BASE/VIAL
A063016 003
Mar 14, 1989
EQ 5GM BASE/VIAL
A063018 001
Mar 05, 1990
EQ 10GM BASE/VIAL
A063018 002
Mar 05, 1990
EQ 250MG BASE/VIAL
A063016 001
Mar 14, 1989
EQ 500MG BASE/VIAL
A063016 002
Mar 14, 1989
WATSON LABS INC EQ 1GM BASE/VIAL
A062988 003
Dec 29, 1989
EQ 5GM BASE/VIAL
A062989 001
Dec 29, 1989
EQ 10GM BASE/VIAL
A062989 002
Dec 29, 1989
EQ 20GM BASE/VIAL
A062989 003
Dec 29, 1989
EQ 250MG BASE/VIAL
A062988 001
Dec 29, 1989
EQ 500MG BASE/VIAL
A062988 002
Dec 29, 1989
KEFZOL
ACS DOBFAR EQ 20GM BASE/VIAL
A061773 005
Sep 08, 1987
EQ 250MG BASE/VIAL
A061773 001
LILLY EQ 1GM BASE/VIAL
A062557 002
Sep 10, 1985
EQ 500MG BASE/VIAL
A062557 001
Sep 10, 1985
CEFDINIR
CAPSULE;ORAL
OMNICEF
ABBVIE 300MG
N050739 001
Dec 04, 1997
FOR SUSPENSION;ORAL
OMNICEF
ABBVIE 125MG/5ML
N050749 001
Dec 04, 1997
250MG/5ML
N050749 002
Jul 29, 2004
CEFEPIME HYDROCHLORIDE
INJECTABLE;INJECTION
CEFEPIME HYDROCHLORIDE
SANDOZ EQ 1GM BASE/VIAL
A090291 002
Dec 21, 2010
EQ 2GM BASE/VIAL
A090291 003
Dec 21, 2010
EQ 500MG BASE/VIAL
A090291 001
Dec 21, 2010
CEFIXIME
FOR SUSPENSION;ORAL
SUPRAX
LEDERLE 100MG/5ML
N050622 001
Apr 28, 1989
TABLET;ORAL
SUPRAX
LEDERLE 200MG **Federal Register determination
N050621 001
Apr 28, 1989
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
400MG
N050621 002
Apr 28, 1989
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-62(of 337)
CEFMENOXIME HYDROCHLORIDE
INJECTABLE;INJECTION
CEFMAX
TAP PHARM EQ 1GM BASE/VIAL N050571 002 Dec 30, 1987
EQ 2GM BASE/VIAL N050571 003 Dec 30, 1987
EQ 500MG BASE/VIAL N050571 001 Dec 30, 1987
CEFMETAZOLE SODIUM
INJECTABLE;INJECTION
ZEFAZONE
PHARMACIA AND UPJOHN EQ 1GM BASE/VIAL N050637 001 Dec 11, 1989
EQ 2GM BASE/VIAL N050637 002 Dec 11, 1989
ZEFAZONE IN PLASTIC CONTAINER
PHARMACIA AND UPJOHN EQ 20MG BASE/ML **Federal Register N050683 001 Dec 29, 1992
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 40MG BASE/ML **Federal Register N050683 002 Dec 29, 1992
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
CEFONICID SODIUM
INJECTABLE;INJECTION
MONOCID
GLAXOSMITHKLINE EQ 1GM BASE/VIAL A063295 001 Jul 26, 1993
EQ 1GM BASE/VIAL N050579 002 May 23, 1984
EQ 2GM BASE/VIAL N050579 003 May 23, 1984
EQ 10GM BASE/VIAL N050579 004 May 23, 1984
EQ 500MG BASE/VIAL N050579 001 May 23, 1984
CEFOPERAZONE SODIUM
INJECTABLE;INJECTION
CEFOBID
PFIZER EQ 1GM BASE/VIAL A063333 001 Mar 31, 1995
EQ 1GM BASE/VIAL N050551 001 Nov 18, 1982
EQ 2GM BASE/VIAL A063333 002 Mar 31, 1995
EQ 2GM BASE/VIAL N050551 002 Nov 18, 1982
EQ 10GM BASE/VIAL N050551 003 Mar 05, 1990
CEFOBID IN PLASTIC CONTAINER
PFIZER EQ 20MG BASE/ML N050613 002 Jul 31, 1987
EQ 40MG BASE/ML N050613 001 Jul 23, 1986
CEFORANIDE
INJECTABLE;INJECTION
PRECEF
APOTHECON 1GM/VIAL A062579 002 Nov 26, 1984
2GM/VIAL A062579 003 Nov 26, 1984
10GM/VIAL A062579 004 Nov 26, 1984
20GM/VIAL A062579 005 Nov 26, 1984
500MG/VIAL A062579 001 Nov 26, 1984
BRISTOL 1GM/VIAL N050554 002 May 24, 1984
2GM/VIAL N050554 003 May 24, 1984
10GM/VIAL N050554 004 May 24, 1984
20GM/VIAL N050554 005 May 24, 1984
500MG/VIAL N050554 001 May 24, 1984
CEFOTAXIME SODIUM
INJECTABLE;INJECTION
CEFOTAXIME
FRESENIUS KABI USA EQ 1GM BASE/VIAL A064200 002 Mar 24, 2000
EQ 2GM BASE/VIAL A064200 003 Mar 24, 2000
EQ 10GM BASE/VIAL A064201 001 Mar 24, 2000
EQ 20GM BASE/VIAL A064201 002 Mar 24, 2000
EQ 500MG BASE/VIAL A064200 001 Mar 24, 2000
CEFOTAXIME AND DEXTROSE 2.4% IN PLASTIC CONTAINER
B BRAUN EQ 2GM BASE N050792 001 Jul 29, 2004
CEFOTAXIME AND DEXTROSE 3.9% IN PLASTIC CONTAINER
B BRAUN EQ 1GM BASE N050792 002 Jul 29, 2004
CEFOTAXIME SODIUM
AUROBINDO PHARMA EQ 1GM BASE/VIAL A065517 002 Nov 06, 2009
EQ 2GM BASE/VIAL A065517 003 Nov 06, 2009
EQ 500MG BASE/VIAL A065517 001 Nov 06, 2009
AUROBINDO PHARMA LTD EQ 10GM BASE/VIAL A065516 001 Nov 06, 2009
CEPHAZONE PHARMA EQ 10GM BASE/VIAL A065348 001 Jan 25, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-63(of 337)
CEFOTAXIME SODIUM
INJECTABLE;INJECTION
CLAFORAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
SANOFI AVENTIS US EQ 20MG BASE/ML N050596 001 May 20, 1985
EQ 40MG BASE/ML N050596 003 May 20, 1985
CEFOTETAN DISODIUM
INJECTABLE;INJECTION
CEFOTAN
ASTRAZENECA EQ 1GM BASE/VIAL A063293 001 Apr 29, 1993
EQ 1GM BASE/VIAL N050588 001 Dec 27, 1985
EQ 2GM BASE/VIAL A063293 002 Apr 29, 1993
EQ 2GM BASE/VIAL N050588 002 Dec 27, 1985
EQ 10GM BASE/VIAL N050588 003 Apr 25, 1988
CEFOTAN IN PLASTIC CONTAINER
ASTRAZENECA EQ 20MG BASE/ML N050694 002 Jul 30, 1993
EQ 40MG BASE/ML N050694 001 Jul 30, 1993
CEFOTIAM HYDROCHLORIDE
INJECTABLE;INJECTION
CERADON
TAKEDA EQ 1GM BASE/VIAL N050601 001 Dec 30, 1988
CEFOXITIN SODIUM
INJECTABLE;INJECTION
CEFOXITIN
FRESENIUS KABI USA EQ 1GM BASE/VIAL A065012 001 Jul 03, 2000
EQ 2GM BASE/VIAL A065012 002 Jul 03, 2000
EQ 10GM BASE/VIAL A065011 001 Jul 03, 2000
MEFOXIN
MYLAN INSTITUTIONAL EQ 1GM BASE/VIAL A062757 001 Jan 08, 1987
EQ 1GM BASE/VIAL N050517 001
EQ 2GM BASE/VIAL A062757 002 Jan 08, 1987
EQ 2GM BASE/VIAL N050517 002
EQ 10GM BASE/VIAL N050517 003
MEFOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
MERCK EQ 20MG BASE/ML N050581 003 Sep 20, 1984
EQ 40MG BASE/ML N050581 004 Sep 20, 1984
MEFOXIN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
MERCK EQ 20MG BASE/ML N050581 002 Sep 20, 1984
EQ 40MG BASE/ML N050581 001 Sep 20, 1984
CEFPIRAMIDE SODIUM
INJECTABLE;INJECTION
CEFPIRAMIDE SODIUM
WYETH AYERST EQ 1GM BASE/VIAL N050633 002 Jan 31, 1989
EQ 2GM BASE/VIAL N050633 003 Jan 31, 1989
EQ 10GM BASE/VIAL N050633 005 Jan 31, 1989
CEFPODOXIME PROXETIL
FOR SUSPENSION;ORAL
BANAN
SANKYO EQ 50MG BASE/5ML N050688 002 Aug 07, 1992
EQ 100MG BASE/5ML N050688 001 Aug 07, 1992
VANTIN
PHARMACIA AND UPJOHN EQ 50MG BASE/5ML N050675 001 Aug 07, 1992
EQ 100MG BASE/5ML N050675 002 Aug 07, 1992
TABLET;ORAL
BANAN
SANKYO EQ 100MG BASE N050687 001 Aug 07, 1992
EQ 200MG BASE N050687 002 Aug 07, 1992
VANTIN
PHARMACIA AND UPJOHN EQ 100MG BASE N050674 001 Aug 07, 1992
EQ 200MG BASE N050674 002 Aug 07, 1992
CEFPROZIL
FOR SUSPENSION;ORAL
CEFPROZIL
RANBAXY LABS LTD 125MG/5ML A065202 001 Jun 30, 2006
250MG/5ML A065202 002 Jun 30, 2006
CEFZIL
CORDEN PHARMA 125MG/5ML N050665 001 Dec 23, 1991
250MG/5ML N050665 002 Dec 23, 1991
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-64(of 337)
CEFPROZIL
TABLET;ORAL
CEFPROZIL
RANBAXY LABS LTD 250MG A065198 001 Dec 13, 2006
500MG A065198 002 Dec 13, 2006
CEFZIL
CORDEN PHARMA 250MG N050664 001 Dec 23, 1991
500MG N050664 002 Dec 23, 1991
CEFTAZIDIME
INJECTABLE;INJECTION
CEFTAZIDIME
AUROBINDO PHARMA LTD 1GM/VIAL A065481 002 May 28, 2010
2GM/VIAL A065481 003 May 28, 2010
6GM/VIAL A065482 001 May 28, 2010
500MG/VIAL A065481 001 May 28, 2010
CEPTAZ
GLAXOSMITHKLINE 1GM/VIAL N050646 002 Sep 27, 1990
2GM/VIAL N050646 003 Sep 27, 1990
10GM/VIAL N050646 004 Sep 27, 1990
500MG/VIAL N050646 001 Sep 27, 1990
PENTACEF
GLAXOSMITHKLINE 1GM/VIAL A063322 001 Nov 07, 1995
1GM/VIAL A064006 001 Mar 31, 1992
2GM/VIAL A063322 002 Nov 07, 1995
2GM/VIAL A064006 002 Mar 31, 1992
6GM/VIAL A064008 001 Mar 31, 1992
10GM/VIAL A064008 002 Mar 31, 1992
TAZIDIME
LILLY 1GM/VIAL A062655 001 Nov 20, 1985
2GM/VIAL A062655 002 Nov 20, 1985
TAZIDIME IN PLASTIC CONTAINER
LILLY 1GM/VIAL A062739 001 Jul 10, 1986
2GM/VIAL A062739 002 Jul 10, 1986
CEFTAZIDIME SODIUM
INJECTABLE;INJECTION
CEFTAZIDIME SODIUM IN PLASTIC CONTAINER
BAXTER HLTHCARE EQ 10MG BASE/ML A063221 001 Apr 29, 1993
EQ 20MG BASE/ML A063221 002 Apr 29, 1993
EQ 40MG BASE/ML A063221 003 Apr 29, 1993
FORTAZ IN PLASTIC CONTAINER
COVIS INJECTABLES EQ 10MG BASE/ML N050634 001 Apr 28, 1989
CEFTIZOXIME SODIUM
INJECTABLE;INJECTION
CEFIZOX
ASTELLAS EQ 1GM BASE/VIAL A063294 002 Mar 31, 1994
EQ 1GM BASE/VIAL N050560 002 Sep 15, 1983
EQ 2GM BASE/VIAL A063294 003 Mar 31, 1994
EQ 2GM BASE/VIAL N050560 003 Sep 15, 1983
EQ 10GM BASE/VIAL N050560 005 Mar 19, 1993
EQ 500MG BASE/VIAL N050560 001 Sep 15, 1983
CEFIZOX IN DEXTROSE 5% IN PLASTIC CONTAINER
ASTELLAS EQ 20MG BASE/ML N050589 001 Oct 03, 1984
EQ 40MG BASE/ML N050589 002 Oct 03, 1984
CEFIZOX IN PLASTIC CONTAINER
ASTELLAS EQ 20MG BASE/ML N050589 003 Apr 13, 1995
EQ 40MG BASE/ML N050589 004 Apr 13, 1995
CEFTRIAXONE SODIUM
INJECTABLE;INJECTION
CEFTRIAXONE
AGILA SPECLTS EQ 10GM BASE/VIAL A091068 001 Jan 07, 2013
AUROBINDO PHARMA LTD EQ 10GM BASE/VIAL A065504 001 Jul 31, 2008
FRESENIUS KABI USA EQ 10GM BASE/VIAL A065252 001 Feb 15, 2006
TEVA EQ 10GM BASE/VIAL A065274 001 May 01, 2006
ROCEPHIN
HOFFMANN LA ROCHE EQ 1GM BASE/VIAL A062654 002 Apr 30, 1987
EQ 2GM BASE/VIAL A062654 003 Apr 30, 1987
EQ 10GM BASE/VIAL N050585 005 Dec 21, 1984
EQ 250MG BASE/VIAL A063239 001 Aug 13, 1993
EQ 500MG BASE/VIAL A062654 001 Apr 30, 1987
ROCHE EQ 1GM BASE/VIAL A062510 003 Mar 12, 1985
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-65(of 337)
CEFTRIAXONE SODIUM
INJECTABLE;INJECTION
ROCEPHIN
EQ 250MG BASE/VIAL A062510 001 Mar 12, 1985
EQ 500MG BASE/VIAL A062510 002 Mar 12, 1985
ROCEPHIN W/ DEXTROSE IN PLASTIC CONTAINER
HOFFMANN LA ROCHE EQ 10MG BASE/ML N050624 001 Feb 11, 1987
EQ 20MG BASE/ML N050624 002 Feb 11, 1987
EQ 40MG BASE/ML N050624 003 Feb 11, 1987
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
CEFTRIAXONE
AUROBINDO PHARMA LTD EQ 1GM BASE/VIAL A065505 003 Jul 31, 2008
EQ 2GM BASE/VIAL A065505 004 Jul 31, 2008
EQ 250MG BASE/VIAL A065505 001 Jul 31, 2008
EQ 500MG BASE/VIAL A065505 002 Jul 31, 2008
CEPHAZONE PHARMA EQ 1GM BASE/VIAL A065294 003 Mar 26, 2007
EQ 2GM BASE/VIAL A065294 004 Mar 26, 2007
EQ 250MG BASE/VIAL A065294 001 Mar 26, 2007
EQ 500MG BASE/VIAL A065294 002 Mar 26, 2007
FRESENIUS KABI USA EQ 1GM BASE/VIAL A065245 003 Feb 15, 2006
EQ 2GM BASE/VIAL A065245 004 Feb 15, 2006
EQ 500MG BASE/VIAL A065245 002 Feb 15, 2006
STERI PHARMA EQ 1GM BASE/VIAL A065268 001 Feb 28, 2007
EQ 2GM BASE/VIAL A065268 002 Feb 28, 2007
TEVA EQ 1GM BASE/VIAL A065262 001 Jun 29, 2006
EQ 2GM BASE/VIAL A065262 002 Jun 29, 2006
TEVA PHARMS USA EQ 1GM BASE/VIAL A065227 003 Mar 15, 2007
EQ 2GM BASE/VIAL A065227 004 Mar 15, 2007
EQ 250MG BASE/VIAL A065227 001 Mar 15, 2007
EQ 500MG BASE/VIAL A065227 002 Mar 15, 2007
ROCEPHIN
HOFFMANN LA ROCHE EQ 1GM BASE/VIAL N050585 003 Dec 21, 1984
EQ 2GM BASE/VIAL N050585 004 Dec 21, 1984
EQ 250MG BASE/VIAL N050585 001 Dec 21, 1984
EQ 500MG BASE/VIAL N050585 002 Dec 21, 1984
CEFTRIAXONE SODIUM; LIDOCAINE
INJECTABLE;INJECTION
ROCEPHIN KIT
HOFFMANN LA ROCHE EQ 1GM BASE/VIAL,N/A;N/A,1% N050585 006 May 08, 1996
EQ 500MG BASE/VIAL,N/A;N/A,1% N050585 007 May 08, 1996
CEFUROXIME AXETIL
TABLET;ORAL
CEFUROXIME AXETIL
RANBAXY LABS LTD EQ 125MG BASE A065043 003 Feb 15, 2002
EQ 250MG BASE A065043 002 Feb 15, 2002
EQ 500MG BASE A065043 001 Feb 15, 2002
SANDOZ EQ 250MG BASE A065126 001 Oct 28, 2003
EQ 500MG BASE A065126 002 Oct 28, 2003
CEFUROXIME SODIUM
INJECTABLE;INJECTION
CEFUROXIME SODIUM
FRESENIUS KABI USA EQ 1.5GM BASE/VIAL A065001 002 May 30, 2001
EQ 7.5GM BASE/VIAL A065002 001 Sep 28, 1998
TEVA PHARMS EQ 7.5GM BASE/VIAL A064191 001 Apr 16, 1998
WATSON LABS INC EQ 1.5GM BASE/VIAL A064035 002 Feb 26, 1993
EQ 7.5GM BASE/VIAL A064036 001 Feb 26, 1993
CEFUROXIME SODIUM IN PLASTIC CONTAINER
SAMSON MEDCL EQ 75GM BASE/VIAL A065251 001 Dec 30, 2009
EQ 225GM BASE/VIAL A065251 002 Dec 30, 2009
KEFUROX
ACS DOBFAR EQ 1.5GM BASE/VIAL A062591 002 Jan 10, 1986
EQ 7.5GM BASE/VIAL A062591 003 Dec 17, 1987
LILLY EQ 1.5GM BASE/VIAL A062592 002 Jan 10, 1986
KEFUROX IN PLASTIC CONTAINER
LILLY EQ 1.5GM BASE/VIAL A062590 002 Jan 10, 1986
ZINACEF IN PLASTIC CONTAINER
COVIS INJECTABLES EQ 15MG BASE/ML N050643 001 Apr 28, 1989
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
CEFUROXIME SODIUM
FRESENIUS KABI USA EQ 750MG BASE/VIAL A065001 001 May 30, 2001
TEVA PHARMS EQ 1.5GM BASE/VIAL A064192 001 Apr 16, 1998
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-66(of 337)
CEFUROXIME SODIUM
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
CEFUROXIME SODIUM
EQ 750MG BASE/VIAL
A064192 002 Apr 16, 1998
WATSON LABS INC EQ 750MG BASE/VIAL
A064035 001 Feb 26, 1993
KEFUROX
ACS DOBFAR EQ 750MG BASE/VIAL
A062591 001 Jan 10, 1986
INJECTABLE;INTRAVENOUS
KEFUROX
LILLY EQ 750MG BASE/VIAL
A062592 001 Jan 10, 1986
KEFUROX IN PLASTIC CONTAINER
LILLY EQ 750MG BASE/VIAL
A062590 001 Jan 10, 1986
CELLULOSE SODIUM PHOSPHATE
POWDER;ORAL
CALCIBIND
MISSION PHARMA 2.5GM/PACKET
N018757 002 Dec 28, 1982
300GM/BOT
N018757 003 Oct 16, 1984
CEPHALEXIN
CAPSULE;ORAL
CEPHALEXIN
APOTHECON EQ 250MG BASE
A062973 001 Nov 08, 1988
EQ 250MG BASE
A063063 001 Sep 29, 1989
EQ 250MG BASE
A063186 001 Dec 30, 1994
EQ 500MG BASE
A062974 001 Nov 23, 1988
EQ 500MG BASE
A063063 002 Sep 29, 1989
EQ 500MG BASE
A063186 002 Dec 30, 1994
BARR EQ 250MG BASE
A062773 001 Jun 26, 1987
EQ 500MG BASE
A062775 001 Apr 22, 1987
FACTA FARMA EQ 250MG BASE
A062118 001
EQ 500MG BASE
A062118 002
IVAX SUB TEVA PHARMS EQ 250MG BASE
A061969 001
EQ 500MG BASE
A061969 002
PUREPAC PHARM EQ 250MG BASE
A062809 001 Apr 22, 1987
EQ 500MG BASE
A062809 002 Apr 22, 1987
STEVENS J EQ 250MG BASE
A062870 001 Mar 17, 1988
EQ 500MG BASE
A062869 001 Mar 17, 1988
TEVA EQ 250MG BASE
A062760 001 Apr 24, 1987
EQ 250MG BASE
A062821 001 Feb 05, 1988
EQ 500MG BASE
A062761 001 Apr 24, 1987
EQ 500MG BASE
A062823 001 Feb 05, 1988
YOSHITOMI EQ 250MG BASE
A062872 001 Jun 20, 1988
EQ 500MG BASE
A062871 001 Jul 05, 1988
KEFLEX
SHIONOGI INC EQ 333MG BASE
N050405 004 May 12, 2006
FOR SUSPENSION;ORAL
CEPHALEXIN
APOTHECON EQ 125MG BASE/5ML
A062986 001 Apr 18, 1991
EQ 250MG BASE/5ML
A062987 001 Jul 25, 1989
BARR EQ 125MG BASE/5ML
A062778 001 Aug 06, 1987
EQ 250MG BASE/5ML
A062777 001 Aug 06, 1987
FACTA FARMA EQ 100MG BASE/ML
A062117 001
EQ 125MG BASE/5ML
A062117 002
EQ 250MG BASE/5ML
A062117 003
HIKMA PHARMS EQ 125MG BASE/5ML
A065444 001 Aug 28, 2009
EQ 250MG BASE/5ML
A065444 002 Aug 28, 2009
RANBAXY EQ 125MG BASE/5ML
A065081 001 Jul 27, 2001
EQ 250MG BASE/5ML
A065081 002 Jul 27, 2001
TEVA EQ 125MG BASE/5ML
A062767 001 Jun 16, 1987
EQ 125MG BASE/5ML
A062873 001 May 23, 1988
EQ 250MG BASE/5ML
A062768 001 Jun 16, 1987
EQ 250MG BASE/5ML
A062867 001 Apr 15, 1988
VITARINE EQ 125MG BASE/5ML
A062779 001 Dec 22, 1987
EQ 250MG BASE/5ML
A062781 001 Dec 22, 1987
YUNG SHIN PHARM EQ 125MG BASE/5ML
A065336 001 Jul 25, 2007
EQ 250MG BASE/5ML
A065336 002 Jul 25, 2007
KEFLEX
SHIONOGI INC EQ 100MG BASE/ML
N050406 003
EQ 125MG BASE/5ML
N050406 001
EQ 250MG BASE/5ML
N050406 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-67(of 337)
CEPHALEXIN
TABLET;ORAL
CEPHALEXIN
BARR EQ 250MG BASE A062826 001 Aug 17, 1987
EQ 500MG BASE A062827 001 Aug 17, 1987
VITARINE EQ 1GM BASE A062863 003 Aug 11, 1988
EQ 250MG BASE A062863 001 Aug 11, 1988
EQ 500MG BASE A062863 002 Aug 11, 1988
KEFLET
LILLY EQ 1GM BASE N050440 002
EQ 250MG BASE A062745 001 Dec 01, 1986
EQ 250MG BASE N050440 003 Feb 26, 1987
EQ 500MG BASE A062745 002 Dec 01, 1986
EQ 500MG BASE N050440 001
TABLET, FOR SUSPENSION;ORAL
PANIXINE DISPERDOSE
RANBAXY LABS LTD EQ 125MG BASE A065100 002 Sep 11, 2003
EQ 250MG BASE A065100 001 Sep 11, 2003
CEPHALEXIN HYDROCHLORIDE
TABLET;ORAL
KEFTAB
LILLY EQ 250MG BASE N050614 001 Oct 29, 1987
EQ 333MG BASE N050614 003 May 16, 1988
EQ 500MG BASE N050614 002 Oct 29, 1987
CEPHALOGLYCIN
CAPSULE;ORAL
KAFOCIN
LILLY 250MG N050219 001
CEPHALOTHIN SODIUM
INJECTABLE;INJECTION
CEPHALOTHIN
INTL MEDICATION EQ 1GM BASE/VIAL A062426 002 May 03, 1985
EQ 2GM BASE/VIAL A062426 003 May 03, 1985
EQ 4GM BASE/VIAL A062426 004 May 03, 1985
EQ 500MG BASE/VIAL A062426 001 May 03, 1985
CEPHALOTHIN SODIUM
ABBOTT EQ 1GM BASE/VIAL A062547 001 Sep 11, 1985
EQ 1GM BASE/VIAL A062548 001 Sep 11, 1985
EQ 2GM BASE/VIAL A062547 002 Sep 11, 1985
EQ 2GM BASE/VIAL A062548 002 Sep 11, 1985
ABRAXIS PHARM EQ 1GM BASE/VIAL A062666 002 Jun 10, 1987
EQ 2GM BASE/VIAL A062666 001 Jun 10, 1987
BRISTOL EQ 1GM BASE/VIAL A062464 001 May 07, 1984
EQ 2GM BASE/VIAL A062464 002 May 07, 1984
EQ 4GM BASE/VIAL A062464 003 May 07, 1984
CEPHALOTHIN SODIUM W/ DEXTROSE IN PLASTIC CONTAINER
BAXTER HLTHCARE EQ 20MG BASE/ML A062422 003 Jan 31, 1984
EQ 20MG BASE/ML A062422 005 Jul 16, 1991
EQ 20MG BASE/ML A062730 001 Mar 05, 1987
EQ 40MG BASE/ML A062422 004 Jan 31, 1984
EQ 40MG BASE/ML A062422 006 Jul 16, 1991
EQ 40MG BASE/ML A062730 002 Mar 05, 1987
CEPHALOTHIN SODIUM W/ SODIUM CHLORIDE IN PLASTIC CONTAINER
BAXTER HLTHCARE EQ 20MG BASE/ML A062422 001 Jan 31, 1984
EQ 40MG BASE/ML A062422 002 Jan 31, 1984
KEFLIN
LILLY EQ 1GM BASE/VIAL N050482 001
EQ 2GM BASE/VIAL N050482 002
EQ 4GM BASE/VIAL N050482 003
EQ 20GM BASE/VIAL N050482 007
KEFLIN IN PLASTIC CONTAINER
LILLY EQ 1GM BASE/VIAL A062549 001 Sep 10, 1985
EQ 2GM BASE/VIAL A062549 002 Sep 10, 1985
SEFFIN
GLAXOSMITHKLINE EQ 1GM BASE/VIAL A062435 001 Nov 15, 1983
EQ 2GM BASE/VIAL A062435 002 Nov 15, 1983
EQ 10GM BASE/VIAL A062435 003 Nov 15, 1983
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-68(of 337)
CEPHAPIRIN SODIUM
INJECTABLE;INJECTION
CEFADYL
APOTHECON EQ 1GM BASE/VIAL
A061769 001
EQ 1GM BASE/VIAL
A062724 001 Dec 23, 1986
EQ 1GM BASE/VIAL
A062961 002 Sep 20, 1988
EQ 1GM BASE/VIAL
N050446 001
EQ 2GM BASE/VIAL
A061769 002
EQ 2GM BASE/VIAL
A062724 002 Dec 23, 1986
EQ 2GM BASE/VIAL
A062961 003 Sep 20, 1988
EQ 2GM BASE/VIAL
N050446 002
EQ 4GM BASE/VIAL
A061769 003
EQ 4GM BASE/VIAL
A062961 004 Sep 20, 1988
EQ 4GM BASE/VIAL
N050446 003
EQ 20GM BASE/VIAL
N050446 004
EQ 500MG BASE/VIAL
A062961 001 Sep 20, 1988
EQ 500MG BASE/VIAL
N050446 005
CEPHAPIRIN SODIUM
ABRAXIS PHARM EQ 1GM BASE/VIAL
A062723 002 Nov 17, 1986
EQ 2GM BASE/VIAL
A062723 003 Nov 17, 1986
EQ 4GM BASE/VIAL
A062723 004 Nov 17, 1986
EQ 20GM BASE/VIAL
A062723 005 Nov 17, 1986
EQ 500MG BASE/VIAL
A062723 001 Nov 17, 1986
HIKMA MAPLE EQ 1GM BASE/VIAL
A062720 002 Jul 02, 1987
EQ 2GM BASE/VIAL
A062720 003 Jul 02, 1987
EQ 20GM BASE/VIAL
A062720 004 Jul 02, 1987
EQ 500MG BASE/VIAL
A062720 001 Jul 02, 1987
CEPHRADINE
CAPSULE;ORAL
ANSPOR
GLAXOSMITHKLINE 250MG
A061859 001
500MG
A061859 002
CEPHRADINE
BARR 250MG
A062850 001 Apr 22, 1988
500MG
A062851 001 Apr 22, 1988
IVAX SUB TEVA PHARMS 250MG
A062762 001 Mar 06, 1987
500MG
A062762 002 Mar 06, 1987
TEVA 250MG
A062683 001 Jan 09, 1987
500MG
A062683 002 Jan 09, 1987
VITARINE 250MG
A062813 001 Feb 25, 1988
500MG
A062813 002 Feb 25, 1988
VELOSEF
APOTHECON 250MG
A061764 001
500MG
A061764 002
VELOSEF '250'
ERSANA 250MG
N050548 001
VELOSEF '500'
ERSANA 500MG
N050548 002
FOR SUSPENSION;ORAL
ANSPOR
GLAXOSMITHKLINE 125MG/5ML
A061866 001
250MG/5ML
A061866 002
CEPHRADINE
BARR 125MG/5ML
A062858 001 May 19, 1988
250MG/5ML
A062859 001 May 19, 1988
TEVA 125MG/5ML
A062693 001 Jan 09, 1987
250MG/5ML
A062693 002 Jan 09, 1987
VELOSEF '125'
APOTHECON 125MG/5ML
A061763 001
VELOSEF '250'
APOTHECON 250MG/5ML
A061763 002
INJECTABLE;INJECTION
VELOSEF
APOTHECON 1GM/VIAL
A061976 004
2GM/VIAL
A061976 003
4GM/VIAL
A061976 005
250MG/VIAL
A061976 001
500MG/VIAL
A061976 002
TABLET;ORAL
VELOSEF
BRISTOL MYERS SQUIBB 1GM
N050530 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-69(of 337)
CERIVASTATIN SODIUM
TABLET;ORAL
BAYCOL
BAYER PHARMS 0.05MG N020740 001 Jun 26, 1997
0.1MG N020740 002 Jun 26, 1997
0.2MG N020740 003 Jun 26, 1997
0.3MG N020740 004 Jun 26, 1997
0.4MG N020740 005 May 24, 1999
0.8MG N020740 006 Jul 24, 2000
CERULETIDE DIETHYLAMINE
INJECTABLE;INJECTION
TYMTRAN
PHARMACIA AND UPJOHN 0.02MG/ML N018296 001
CETIRIZINE HYDROCHLORIDE
SYRUP;ORAL
CETIRIZINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC 5MG/5ML A078617 001 Feb 02, 2010
APOTEX INC 5MG/5ML A078412 001 Jun 18, 2008
AUROBINDO PHARMA LTD 5MG/5ML A090751 001 Dec 16, 2009
RANBAXY LABS LTD 5MG/5ML A077472 001 Jun 18, 2008
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY
ACTAVIS MID ATLANTIC 5MG/5ML A090378 002 May 09, 2008
APOTEX INC 5MG/5ML A090188 002 Apr 22, 2008
RANBAXY LABS LTD 5MG/5ML A090183 002 Apr 24, 2008
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF
ACTAVIS MID ATLANTIC 5MG/5ML A090378 001 May 09, 2008
APOTEX INC 5MG/5ML A090188 001 Apr 22, 2008
RANBAXY LABS LTD 5MG/5ML A090183 001 Apr 24, 2008
TABLET;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
ACTAVIS ELIZABETH 5MG A078615 003 Dec 28, 2007
10MG A078615 004 Dec 28, 2007
TABLET, CHEWABLE;ORAL
CETIRIZINE HYDROCHLORIDE ALLERGY
SUN PHARM INDS INC 5MG A077631 004 Jan 11, 2008
10MG A077631 003 Jan 11, 2008
CETIRIZINE HYDROCHLORIDE HIVES RELIEF
SUN PHARM INDS INC 5MG A077631 001 Jan 11, 2008
10MG A077631 002 Jan 11, 2008
CHILDREN'S ZYRTEC ALLERGY
MCNEIL CONS 5MG **Federal Register determination N021621 003 Nov 16, 2007
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
10MG **Federal Register determination N021621 004 Nov 16, 2007
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
CHILDREN'S ZYRTEC HIVES RELIEF
MCNEIL CONS 5MG **Federal Register determination N021621 005 Nov 16, 2007
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
10MG **Federal Register determination N021621 006 Nov 16, 2007
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
CETRORELIX
INJECTABLE;INJECTION
CETROTIDE
EMD SERONO INC EQ 3MG BASE/ML N021197 002 Aug 11, 2000
CETYL ALCOHOL; COLFOSCERIL PALMITATE; TYLOXAPOL
FOR SUSPENSION;INTRATRACHEAL
EXOSURF NEONATAL
GLAXOSMITHKLINE 12MG/VIAL;108MG/VIAL;8MG/VIAL N020044 001 Aug 02, 1990
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-70(of 337)
CHENODIOL
TABLET;ORAL
CHENIX
SIGMA TAU
250MG
N018513 002 Jul 28, 1983
CHLOPHEDIANOL HYDROCHLORIDE
SYRUP;ORAL
ULO
3M
25MG/5ML
N012126 001
CHLORAMPHENICOL
CAPSULE;ORAL
AMPHICOL
FERRANTE
100MG
A060058 001
CHLOROMYCETIN
PARKEDALE
50MG
A060591 001
100MG
A060591 003
CREAM;TOPICAL
CHLOROMYCETIN
PARKE DAVIS
1%
N050183 001
FOR SOLUTION;OPHTHALMIC
CHLOROMYCETIN
PARKEDALE
25MG/VIAL
N050143 001
INJECTABLE;INJECTION
CHLOROMYCETIN
PARKE DAVIS
250MG/ML
N050153 001
OINTMENT;OPHTHALMIC
CHLORAMPHENICOL
ALTANA
1%
A060133 001
CHLOROFAIR
PHARMAFAIR
1%
A062439 001 Apr 21, 1983
CHLOROMYCETIN
PARKEDALE
1%
N050156 001
CHLOROPTIC S.O.P.
ALLERGAN
1%
A061187 001
ECONOCHLOR
ALCON
1%
A061648 001
SOLUTION/DROPS;OPHTHALMIC
CHLORAMPHENICOL
AKORN
0.5%
A062042 001
ALCON
0.5%
A062628 001 Sep 25, 1985
CHLOROFAIR
PHARMAFAIR
0.5%
A062437 001 Apr 14, 1983
CHLOROPTIC
ALLERGAN
0.5%
N050091 001
ECONOCHLOR
ALCON
0.5%
A061645 001
OPHTHOCHLOR
PARKEDALE
0.5%
A061220 001
OPTOMYCIN
OPTOPICS
0.5%
A062171 001 Mar 31, 1982
SOLUTION/DROPS;OTIC
CHLOROMYCETIN
PARKEDALE
0.5%
N050205 001
CHLORAMPHENICOL PALMITATE
SUSPENSION;ORAL
CHLOROMYCETIN PALMITATE
PARKE DAVIS
EQ 150MG BASE/5ML
A062301 001
EQ 150MG BASE/5ML
N050152 001
CHLORAMPHENICOL SODIUM SUCCINATE
INJECTABLE;INJECTION
CHLORAMPHENICOL
ELKINS SINN EQ 1GM BASE/VIAL
A062406 001 Nov 09, 1982
CHLORAMPHENICOL SODIUM SUCCINATE
GRUPPO LEPETIT EQ 1GM BASE/VIAL A062278 001
CHLOROMYCETIN
PARKEDALE EQ 1GM BASE/VIAL N050155 001
MYCHEL-S
ANGUS EQ 1GM BASE/VIAL A060132 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-71(of 337)
CHLORAMPHENICOL; DESOXYRIBONUCLEASE; FIBRINOLYSIN
OINTMENT;TOPICAL
ELASE-CHLOROMYCETIN
PARKE DAVIS 10MG/GM;666 UNITS/GM;1 UNITS/GM
N050294 001
CHLORAMPHENICOL; HYDROCORTISONE ACETATE
FOR SUSPENSION;OPHTHALMIC
CHLOROMYCETIN HYDROCORTISONE
PARKEDALE 12.5MG/VIAL;25MG/VIAL
N050202 001
CHLORAMPHENICOL; HYDROCORTISONE ACETATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
OPHTHOCORT
PARKEDALE 10MG/GM;5MG/GM;10,000 UNITS/GM
N050201 002
CHLORAMPHENICOL; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
CHLOROMYXIN
PARKE DAVIS 1%;10,000 UNITS/GM
N050203 002
CHLORAMPHENICOL; PREDNISOLONE
OINTMENT;OPHTHALMIC
CHLOROPTIC-P S.O.P.
ALLERGAN 1%;0.5%
A061188 001
CHLORDIAZEPOXIDE
CAPSULE, EXTENDED RELEASE;ORAL
LIBRELEASE
VALEANT PHARM INTL 30MG
N017813 001 Sep 12, 1983
TABLET;ORAL
LIBRITABS
VALEANT PHARM INTL 5MG
A085482 001
10MG
A085481 001
25MG
A085488 001
CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE;ORAL
A-POXIDE
ABBOTT 5MG
A085447 001
5MG
A085517 001
10MG
A085447 002
10MG
A085518 001
25MG
A085447 003
25MG
A085513 001
CHLORDIAZACHEL
RACHELLE 5MG
A085086 001
10MG
A084639 001
25MG
A085087 001
CHLORDIAZEPOXIDE HYDROCHLORIDE
ASCOT 5MG
A087525 001 Jan 07, 1982
10MG
A087524 001 Jan 07, 1982
25MG
A087512 001 Jan 07, 1982
FERRANTE 5MG
A085118 001
10MG
A085119 001
25MG
A085120 001
HALSEY 5MG
A085340 001
10MG
A085339 001
25MG
A084685 001
HIKMA PHARMS LLC 5MG
A085014 001
10MG
A085000 001
25MG
A085294 001
IMPAX LABS 5MG
A086213 001
10MG
A085113 001
25MG
A086212 001
IVAX SUB TEVA PHARMS 5MG
A083741 001
10MG
A083742 001
25MG
A083570 001
LEDERLE 5MG
A086892 001
5MG
A087234 001
10MG
A086876 001
10MG
A087037 001
25MG
A086893 001
25MG
A087231 001
MAST MM 10MG
A086217 001
MYLAN 5MG
A084886 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-72(of 337)
CHLORDIAZEPOXIDE HYDROCHLORIDE
CAPSULE;ORAL
CHLORDIAZEPOXIDE HYDROCHLORIDE
10MG
A084601 001
25MG
A084887 001
PARKE DAVIS
5MG
A085163 001
10MG
A084598 001
25MG
A085164 001
PIONEER PHARMS
10MG
A089533 001 Jul 15, 1988
25MG
A089558 001 Jul 15, 1988
PUREPAC PHARM
5MG
A085155 001
10MG
A084939 002
25MG
A085144 001
ROXANE
5MG
A084706 001
10MG
A084700 001
25MG
A084705 001
SANDOZ
5MG
A084678 001
5MG
A084919 001
10MG
A084041 001
10MG
A084920 001
25MG
A084679 002
25MG
A084823 001
SUPERPHARM
5MG
A088987 001 Apr 25, 1985
10MG
A088986 001 Apr 25, 1985
25MG
A088988 001 Apr 25, 1985
TEVA
5MG
A088705 001 Jan 18, 1985
10MG
A088706 001 Jan 18, 1985
25MG
A086494 001
25MG
A088707 001 Jan 18, 1985
USL PHARMA
5MG
A084644 001
25MG
A084645 001
VANGARD
5MG
A088129 001 Mar 28, 1983
10MG
A088010 001 Mar 28, 1983
25MG
A088130 001 Mar 28, 1983
WATSON LABS
5MG
A086383 001
10MG
A086294 001
25MG
A086382 001
LIBRIUM
VALEANT PHARM INTL
5MG
N012249 002
10MG
N012249 001
25MG
N012249 003
LYGEN
ALRA
5MG
A085107 001
10MG
A085009 001
25MG
A085108 001
INJECTABLE;INJECTION
LIBRIUM
VALEANT PHARMS LLC
100MG/AMP
N012301 001
CHLORDIAZEPOXIDE; ESTROGENS, ESTERIFIED
TABLET;ORAL
MENRIUM 10-4
ROCHE
10MG;0.4MG
N014740 006
MENRIUM 5-2
ROCHE
5MG;0.2MG
N014740 002
MENRIUM 5-4
ROCHE
5MG;0.4MG
N014740 004
CHLORHEXIDINE GLUCONATE
SOLUTION;DENTAL
CHLORHEXIDINE GLUCONATE
APOTEX INC
0.12%
A075561 001 Nov 14, 2000
SOLUTION;TOPICAL
EXIDINE
XTTRIUM
2.5%
N019421 001 Dec 17, 1985
MICRODERM
J AND J
4%
A072255 001 Apr 15, 1991
PREVACARE R
J AND J
0.5%
A072292 001 Jan 28, 1992
STERI-STAT
MATRIX MEDCL
4%
A070104 001 Jul 24, 1986
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-73(of 337)
CHLORHEXIDINE GLUCONATE
SPONGE;TOPICAL
CHLORHEXIDINE GLUCONATE
KENDALL IL 4% N019490 001 Mar 27, 1987
E-Z SCRUB
BECTON DICKINSON 4% A073416 001 Mar 14, 2000
HIBICLENS
MOLNLYCKE HLTH 4% **Federal Register determination N018423 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
MICRODERM
J AND J 4% A072295 001 Feb 28, 1991
CHLORMERODRIN HG-197
INJECTABLE;INJECTION
CHLORMERODRIN HG 197
BRACCO 0.6-1.4mCi/ML N017269 001
CHLORMEZANONE
TABLET;ORAL
TRANCOPAL
SANOFI AVENTIS US 100MG N011467 003
200MG N011467 005
CHLOROPROCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
NESACAINE-MPF
FRESENIUS KABI USA 2% N009435 003
3% N009435 004
CHLOROQUINE HYDROCHLORIDE
INJECTABLE;INJECTION
ARALEN HYDROCHLORIDE
SANOFI AVENTIS US EQ 40MG BASE/ML N006002 002
CHLOROQUINE PHOSPHATE
TABLET;ORAL
CHLOROQUINE PHOSPHATE
MD PHARM EQ 150MG BASE A087228 001
PUREPAC PHARM EQ 150MG BASE A080886 001
TEVA EQ 150MG BASE A087504 001 Jan 13, 1982
WATSON LABS EQ 150MG BASE A087979 001 Dec 21, 1982
EQ 300MG BASE A088030 001 Dec 21, 1982
CHLOROQUINE PHOSPHATE; PRIMAQUINE PHOSPHATE
TABLET;ORAL
ARALEN PHOSPHATE W/ PRIMAQUINE PHOSPHATE
SANOFI AVENTIS US EQ 300MG BASE;EQ 45MG BASE N014860 002
CHLOROTHIAZIDE
TABLET;ORAL
CHLOROTHIAZIDE
ABC HOLDING 250MG A085569 001
HIKMA INTL PHARMS 250MG A086028 001 Jul 14, 1982
500MG A087736 001 Jul 14, 1982
LEDERLE 250MG A086940 001
500MG A086938 001
SANDOZ 250MG A085485 001
WATSON LABS 250MG A085165 001
250MG A085173 001
250MG A086795 001 Aug 15, 1983
500MG A084026 001 Sep 01, 1982
500MG A086796 001 Aug 15, 1983
DIURIL
OAK PHARMS AKORN 250MG N011145 004
500MG N011145 002
CHLOROTHIAZIDE; METHYLDOPA
TABLET;ORAL
ALDOCLOR-150
MERCK 150MG;250MG N016016 001
ALDOCLOR-250
MERCK 250MG;250MG N016016 002
METHYLDOPA AND CHLOROTHIAZIDE
PAR PHARM 150MG;250MG A070783 001 Nov 06, 1987
250MG;250MG A070654 001 Nov 06, 1987
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-74(of 337)
CHLOROTHIAZIDE; RESERPINE
TABLET;ORAL
CHLOROTHIAZIDE AND RESERPINE
HIKMA PHARMS LLC 250MG;0.125MG A088557 001 Dec 22, 1983
500MG;0.125MG A088365 001 Dec 22, 1983
CHLOROTHIAZIDE W/ RESERPINE
WATSON LABS 250MG;0.125MG A084853 001
500MG;0.125MG A088151 001 Jun 09, 1983
CHLOROTHIAZIDE-RESERPINE
MYLAN 250MG;0.125MG A087744 001 May 06, 1982
500MG;0.125MG A087745 001 May 06, 1982
DIUPRES-250
MERCK 250MG;0.125MG N011635 003 Aug 26, 1987
DIUPRES-500
MERCK 500MG;0.125MG N011635 006 Aug 26, 1987
CHLOROTRIANISENE
CAPSULE;ORAL
CHLOROTRIANISENE
BANNER PHARMACAPS 12MG A084652 001
TACE
SANOFI AVENTIS US 12MG N008102 004
25MG N011444 001
72MG N016235 001
CHLOROXINE
SHAMPOO;TOPICAL
CAPITROL
WESTWOOD SQUIBB 2% N017594 001
CHLORPHENESIN CARBAMATE
TABLET;ORAL
MAOLATE
PHARMACIA AND UPJOHN 400MG N014217 002
CHLORPHENIRAMINE MALEATE
CAPSULE, EXTENDED RELEASE;ORAL
CHLORPHENIRAMINE MALEATE
SANDOZ 12MG A070797 001 Aug 12, 1988
TELDRIN
GLAXOSMITHKLINE 8MG N017369 001
12MG N017369 002
INJECTABLE;INJECTION
CHLOR-TRIMETON
SCHERING PLOUGH 10MG/ML N008826 001
100MG/ML N008794 001
CHLORPHENIRAMINE MALEATE
BEL MAR 10MG/ML A080821 001
ELKINS SINN 10MG/ML A080797 001
WATSON LABS 10MG/ML A083593 001
10MG/ML A086096 001
100MG/ML A086095 001
PYRIDAMAL 100
BEL MAR 100MG/ML A083733 001
SYRUP;ORAL
CHLOR-TRIMETON
SCHERING 2MG/5ML N006921 006
CHLORPHENIRAMINE MALEATE
PHARM ASSOC 2MG/5ML A087520 001 Feb 10, 1982
TABLET;ORAL
ANTAGONATE
BAYER PHARMS 4MG A083381 001
CHLOR-TRIMETON
SCHERING 4MG N006921 002
CHLORPHENIRAMINE MALEATE
ANABOLIC 4MG A083078 001
BELL PHARMA 4MG A083062 001
ELKINS SINN 4MG A080938 001
IMPAX LABS 4MG A080809 001
IVAX SUB TEVA PHARMS 4MG A080779 001
KV PHARM 4MG A087164 001
LEDERLE 4MG A086941 001
MUTUAL PHARM 4MG A080700 001
NEWTRON PHARMS 4MG A086519 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-75(of 337)
CHLORPHENIRAMINE MALEATE
TABLET;ORAL
CHLORPHENIRAMINE MALEATE
PANRAY 4MG A083243 001
PHARMAVITE 4MG A085104 001
PHARMERAL 4MG A083753 001
PIONEER PHARMS 4MG A088556 001 Jul 13, 1984
PUREPAC PHARM 4MG A086306 001
PVT FORM 4MG A080786 001
ROXANE 4MG A080626 001
SANDOZ 4MG A080961 001
VITARINE 4MG A085837 001
WATSON LABS 4MG A080696 001
4MG A080791 001
4MG A085139 001
WEST WARD 4MG A083787 001
KLOROMIN
HALSEY 4MG A083629 001
PHENETRON
LANNETT 4MG A080846 001
TABLET, EXTENDED RELEASE;ORAL
CHLOR-TRIMETON
SCHERING PLOUGH 8MG N007638 001
EFIDAC 24 CHLORPHENIRAMINE MALEATE
ALZA 16MG N019746 002 Nov 18, 1994
CHLORPHENIRAMINE MALEATE; PHENYLPROPANOLAMINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
COLD CAPSULE IV
GRAHAM DM 12MG;75MG N018793 001 Apr 25, 1985
COLD CAPSULE V
GRAHAM DM 8MG;75MG N018794 001 Apr 23, 1985
TABLET, EXTENDED RELEASE;ORAL
TRIAMINIC-12
NOVARTIS 12MG;75MG N018115 001
CHLORPHENIRAMINE MALEATE; PSEUDOEPHEDRINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
CODIMAL-L.A. 12
SCHWARZ PHARMA 12MG;120MG N018935 001 Apr 15, 1985
ISOCLOR
FISONS 8MG;120MG N018747 001 Mar 06, 1986
PSEUDOEPHEDRINE HYDROCHLORIDE AND CHLORPHENIRAMINE MALEATE
CENT PHARMS 8MG;120MG N019428 001 Aug 02, 1988
GRAHAM DM 8MG;120MG N018844 001 Mar 20, 1985
12MG;120MG N018843 001 Mar 18, 1985
KV PHARM 12MG;120MG A071455 001 Mar 01, 1989
CHLORPHENIRAMINE POLISTIREX; CODEINE POLISTIREX
SUSPENSION, EXTENDED RELEASE;ORAL
CODEPREX
UCB INC EQ 4MG MALEATE/5ML;EQ 20MG BASE/5ML N021369 001 Jun 21, 2004
PENNTUSS
FISONS EQ 4MG MALEATE/5ML;EQ 10MG BASE/5ML N018928 001 Aug 14, 1985
CHLORPHENTERMINE HYDROCHLORIDE
TABLET;ORAL
PRE-SATE
PARKE DAVIS EQ 65MG BASE N014696 001
CHLORPROMAZINE
SUPPOSITORY;RECTAL
THORAZINE
GLAXOSMITHKLINE 25MG **Federal Register determination N009149 024
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
100MG **Federal Register determination N009149 033
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-76(of 337)
CHLORPROMAZINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
THORAZINE
GLAXOSMITHKLINE 30MG N011120 016
75MG N011120 017
150MG N011120 018
200MG N011120 019
300MG N011120 020
CONCENTRATE;ORAL
CHLORPROMAZINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC 100MG/ML A086863 001
PHARM ASSOC 30MG/ML A040231 001 Dec 30, 1999
100MG/ML A040224 001 Jan 26, 1999
WOCKHARDT 30MG/ML A087032 001 Jul 08, 1982
100MG/ML A087053 001
CHLORPROMAZINE HYDROCHLORIDE INTENSOL
ROXANE 30MG/ML A088157 001 Apr 27, 1983
100MG/ML A088158 001 Apr 27, 1983
SONAZINE
SANDOZ 30MG/ML A080983 004
100MG/ML A080983 005
THORAZINE
GLAXOSMITHKLINE 30MG/ML **Federal Register N009149 032
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
100MG/ML **Federal Register N009149 043
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
INJECTABLE;INJECTION
CHLORPROMAZINE HYDROCHLORIDE
ABRAXIS PHARM 25MG/ML A084911 001
MARSAM PHARMS LLC 25MG/ML A089563 001 Apr 15, 1988
WATSON LABS 25MG/ML A080365 001
25MG/ML A085591 001
WYETH AYERST 25MG/ML A080370 001
THORAZINE
GLAXOSMITHKLINE 25MG/ML N009149 011
SYRUP;ORAL
CHLORPROMAZINE HYDROCHLORIDE
ALPHARMA US PHARMS 10MG/5ML A086712 001
SONAZINE
SANDOZ 10MG/5ML A083040 001
THORAZINE
GLAXOSMITHKLINE 10MG/5ML **Federal Register N009149 022
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
TABLET;ORAL
CHLORPROMAZINE HYDROCHLORIDE
ABBOTT 10MG A084414 001
25MG A084415 001
50MG A084411 001
100MG A084412 001
200MG A084413 001
IVAX SUB TEVA PHARMS 10MG A083549 001
25MG A083549 002
50MG A083549 003
100MG A083574 001
200MG A083575 001
KV PHARM 10MG A085750 002 Jan 04, 1982
25MG A085751 001
50MG A085484 001
100MG A085752 001
200MG A085748 002 Jan 04, 1982
LEDERLE 10MG A084803 001
25MG A084801 001
50MG A084800 001
100MG A084789 001
200MG A084802 001
PUREPAC PHARM 10MG A080403 004
25MG A080403 001
50MG A080403 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-77(of 337)
CHLORPROMAZINE HYDROCHLORIDE
TABLET;ORAL
CHLORPROMAZINE HYDROCHLORIDE
100MG
A080403 003
200MG
A080403 005
PVT FORM 25MG
A080340 001
50MG
A080340 002
200MG
A080340 003
ROXANE 10MG
A085331 001
25MG
A085331 002
50MG
A085331 003
100MG
A085331 004
200MG
A085331 005
VANGARD 10MG
A088038 001 Aug 16, 1982
25MG
A087645 001
50MG
A087646 001
WATSON LABS 10MG
A085959 001
25MG
A085956 001
50MG
A085960 001
100MG
A085957 001
200MG
A085958 001
WEST WARD 10MG
A087783 001 Sep 16, 1982
25MG
A087865 001 Sep 16, 1982
50MG
A087878 001 Sep 15, 1982
100MG
A087884 001 Sep 15, 1982
200MG
A087880 001 Sep 16, 1982
PROMAPAR
PARKE DAVIS 10MG
A086886 001
25MG
A084423 001
50MG
A086887 001
100MG
A086888 001
200MG
A086885 001
THORAZINE
GLAXOSMITHKLINE 10MG
N009149 002
25MG
N009149 007
50MG
N009149 013
100MG
N009149 018
200MG
N009149 020
CHLORPROPAMIDE
TABLET;ORAL
CHLORPROPAMIDE
ANI PHARMS INC 100MG
A088768 001 Oct 11, 1984
100MG
A088812 001 Oct 19, 1984
100MG
A088840 001 Oct 25, 1984
100MG
A088918 001 Oct 16, 1984
100MG
A089446 001 Nov 17, 1986
250MG
A088813 001 Oct 19, 1984
250MG
A088919 001 Oct 16, 1984
250MG
A089447 001 Nov 17, 1986
DAVA PHARMS INC 100MG
A089561 001 Sep 04, 1987
250MG
A089562 001 Sep 04, 1987
HALSEY 100MG
A089321 001 Jan 16, 1986
250MG
A088662 001 Jan 09, 1986
PAR PHARM 100MG
A088175 001 Feb 27, 1984
250MG
A088176 001 Feb 27, 1984
SANDOZ 100MG
A088725 001 Aug 31, 1984
250MG
A084669 001
250MG
A088726 001 Aug 31, 1984
SUPERPHARM 100MG
A088694 001 Sep 17, 1984
250MG
A088695 001 Sep 17, 1984
TEVA PHARMS USA 250MG
A087353 001
USL PHARMA 100MG
A088708 001 Aug 30, 1984
250MG
A088709 001 Aug 30, 1984
WATSON LABS 100MG
A086865 001 Sep 24, 1984
100MG
A088608 001 Apr 12, 1984
250MG
A086866 001
250MG
A088568 001 Apr 12, 1984
WATSON LABS INC 100MG
A088852 001 Sep 26, 1984
250MG
A088826 001 Sep 26, 1984
GLUCAMIDE
TEVA PHARMS USA 250MG
A088641 001 Oct 11, 1984
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-78(of 337)
CHLORPROTHIXENE
CONCENTRATE;ORAL
TARACTAN
ROCHE 100MG/5ML
N016149 002
INJECTABLE;INJECTION
TARACTAN
ROCHE 12.5MG/ML
N012487 001
TABLET;ORAL
TARACTAN
ROCHE 10MG
N012486 005
25MG
N012486 004
50MG
N012486 003
100MG
N012486 001
CHLORTETRACYCLINE HYDROCHLORIDE
OINTMENT;OPHTHALMIC
AUREOMYCIN
LEDERLE 1%
N050404 001
CHLORTHALIDONE
TABLET;ORAL
CHLORTHALIDONE
ABBOTT 25MG
A087364 001
50MG
A087384 001
ASCOT 25MG
A087698 001 Oct 20, 1982
50MG
A087699 001 Oct 20, 1982
BARR LABS INC 25MG
A088902 001 Sep 19, 1985
50MG
A088903 001 Sep 19, 1985
DAVA PHARMS INC 25MG
A087451 001
50MG
A087450 001
IVAX PHARMS 25MG
A087555 001
25MG
A088164 001 Jan 09, 1984
50MG
A087176 001
50MG
A087947 001 Feb 27, 1984
KV PHARM 25MG
A087311 001
50MG
A087312 001
MUTUAL PHARM 25MG
A087292 001
25MG
A089285 001 Jul 21, 1986
25MG
A089738 001 Sep 19, 1988
50MG
A087293 001
50MG
A089286 001 Jul 21, 1986
50MG
A089739 001 Sep 19, 1988
PIONEER PHARMS 50MG
A089591 001 Jul 21, 1988
PUREPAC PHARM 25MG
A088139 001 Jul 16, 1986
50MG
A088140 001 Aug 11, 1983
SANDOZ 25MG
A087380 001
50MG
A087118 001
50MG
A087381 001
SUPERPHARM 25MG
A087473 001 Feb 09, 1983
50MG
A087247 001 Feb 09, 1983
TEVA 50MG
A088651 001 May 30, 1985
USL PHARMA 25MG
A089051 001 Jun 01, 1987
50MG
A089052 001 Jun 01, 1987
VANGARD 25MG
A088012 001 Jul 14, 1982
50MG
A088073 001 Mar 25, 1983
WARNER CHILCOTT 25MG
A087515 001 Jan 24, 1983
50MG
A087516 001 Feb 09, 1983
WATSON LABS 25MG
A087050 001
25MG
A087100 001
25MG
A087296 001
25MG
A087706 001
50MG
A087029 001
50MG
A087082 001
50MG
A087521 001
50MG
A087689 001
HYGROTON
SANOFI AVENTIS US 25MG
N012283 004
50MG
N012283 003
THALITONE
CITRON PHARMA LLC 25MG
N019574 002 Feb 12, 1992
MONARCH PHARMS 25MG
A088051 001 Nov 12, 1982
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-79(of 337)
CHLORTHALIDONE; CLONIDINE HYDROCHLORIDE
TABLET;ORAL
CLONIDINE HYDROCHLORIDE AND CHLORTHALIDONE
PAR PHARM 15MG;0.1MG A071179 001 Dec 16, 1987
15MG;0.2MG A071178 001 Dec 16, 1987
15MG;0.3MG A071142 001 Dec 16, 1987
COMBIPRES
BOEHRINGER INGELHEIM 15MG;0.1MG N017503 001
15MG;0.2MG N017503 002
15MG;0.3MG N017503 003 Apr 10, 1984
CHLORTHALIDONE; METOPROLOL TARTRATE
CAPSULE;ORAL
LOPRESSIDONE
NOVARTIS 25MG;100MG N019451 001 Dec 31, 1987
25MG;200MG N019451 002 Dec 31, 1987
CHLORTHALIDONE; RESERPINE
TABLET;ORAL
DEMI-REGROTON
SANOFI AVENTIS US 25MG;0.125MG N015103 002
REGROTON
SANOFI AVENTIS US 50MG;0.25MG N015103 001
CHLORZOXAZONE
TABLET;ORAL
CHLORZOXAZONE
ACTAVIS ELIZABETH 250MG A088928 001 May 08, 1987
500MG A040113 001 Sep 29, 1995
MUTUAL PHARM 500MG A089970 001 Sep 27, 1990
OHM LABS 250MG A081298 001 Dec 29, 1993
500MG A081299 001 Dec 29, 1993
PAR PHARM 250MG A087981 001 Sep 20, 1983
PIONEER PHARMS 250MG A089592 001 Jan 06, 1989
500MG A089948 001 Jan 06, 1989
SANDOZ 250MG A089852 001 May 04, 1988
500MG A089853 001 May 04, 1988
WATSON LABS 250MG A086901 001
250MG A086948 001 Aug 09, 1982
500MG A040137 001 Aug 09, 1996
500MG A081019 001 Jul 29, 1991
500MG A081040 001 Aug 22, 1989
PARAFLEX
ORTHO MCNEIL PHARM 250MG **Federal Register determination N011300 003
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
STRIFON FORTE DSC
FERNDALE LABS 500MG A081008 001 Dec 23, 1988
CHOLESTYRAMINE
BAR, CHEWABLE;ORAL
CHOLYBAR
PARKE DAVIS EQ 4GM RESIN/BAR A071621 001 May 26, 1988
EQ 4GM RESIN/BAR A071739 001 May 26, 1988
POWDER;ORAL
CHOLESTYRAMINE
IVAX SUB TEVA PHARMS EQ 4GM RESIN/PACKET A074771 001 Jul 09, 1997
EQ 4GM RESIN/SCOOPFUL A074771 002 Jul 09, 1997
TEVA EQ 4GM RESIN/PACKET A074347 001 May 28, 1998
EQ 4GM RESIN/SCOOPFUL A074347 002 May 28, 1998
TEVA PHARMS EQ 4GM RESIN/PACKET A074554 001 Oct 02, 1996
EQ 4GM RESIN/SCOOPFUL A074554 002 Oct 02, 1996
CHOLESTYRAMINE LIGHT
TEVA EQ 4GM RESIN/PACKET A074348 001 May 28, 1998
EQ 4GM RESIN/SCOOPFUL A074348 002 May 28, 1998
TEVA PHARMS EQ 4GM RESIN/PACKET A074555 001 Sep 30, 1998
EQ 4GM RESIN/SCOOPFUL A074555 002 Sep 30, 1998
LOCHOLEST
SANDOZ EQ 4GM RESIN/PACKET A074561 001 Aug 15, 1996
EQ 4GM RESIN/SCOOPFUL A074561 002 Aug 15, 1996
LOCHOLEST LIGHT
SANDOZ EQ 4GM RESIN/PACKET A074562 001 Aug 15, 1996
EQ 4GM RESIN/SCOOPFUL A074562 002 Aug 15, 1996
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-80(of 337)
CHOLESTYRAMINE
POWDER;ORAL
QUESTRAN
BRISTOL MYERS EQ 4GM RESIN/PACKET N016640 001
EQ 4GM RESIN/SCOOPFUL N016640 003
QUESTRAN LIGHT
BRISTOL MYERS EQ 4GM RESIN/PACKET N019669 001 Dec 05, 1988
EQ 4GM RESIN/SCOOPFUL N019669 003 Dec 05, 1988
TABLET;ORAL
QUESTRAN
APOTHECON EQ 1GM RESIN A073403 001 Apr 28, 1994
EQ 800MG RESIN A073403 002 Dec 27, 1999
CHORIOGONADOTROPIN ALFA
INJECTABLE;INJECTION
OVIDREL
EMD SERONO 0.25MG/VIAL N021149 001 Sep 20, 2000
CHROMIC CHLORIDE
INJECTABLE;INJECTION
CHROMIC CHLORIDE
ABRAXIS PHARM EQ 0.004MG CHROMIUM/ML N019271 001 May 05, 1987
CHROMIC PHOSPHATE P-32
INJECTABLE;INJECTION
PHOSPHOCOL P32
MALLINCKRODT 5mCi/ML N017084 001
CHYMOPAPAIN
INJECTABLE;INJECTION
CHYMODIACTIN
CHART MEDCL 4,000 UNITS/VIAL N018663 002 Aug 21, 1984
10,000 UNITS/VIAL **Federal Register N018663 001 Nov 10, 1982
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
DISCASE
ABBOTT 12,500 UNITS/VIAL N018625 001 Jan 18, 1984
CHYMOTRYPSIN
FOR SOLUTION;OPHTHALMIC
ALPHA CHYMAR
SOLA BARNES HIND 750 UNITS/VIAL N011837 001
CATARASE
CIBA 300 UNITS/VIAL N016938 001
NOVARTIS 150 UNITS/VIAL N018121 001
ZOLYSE
ALCON 750 UNITS/VIAL N011903 001
CICLOPIROX
SOLUTION;TOPICAL
CICLOPIROX
APOTEX INC 8% A078172 001 Sep 18, 2007
MYLAN PHARMS INC 8% A078567 001 Sep 18, 2007
TEVA PHARMS 8% A078079 001 Sep 18, 2007
CILASTATIN SODIUM; IMIPENEM
INJECTABLE;INJECTION
PRIMAXIN
MERCK EQ 250MG BASE/VIAL;250MG/VIAL A062756 001 Jan 08, 1987
EQ 500MG BASE/VIAL;500MG/VIAL A062756 002 Jan 08, 1987
POWDER;INTRAMUSCULAR
PRIMAXIN
MERCK EQ 750MG BASE/VIAL;750MG/VIAL N050630 002 Dec 14, 1990
CILOSTAZOL
TABLET;ORAL
CILOSTAZOL
ACTAVIS ELIZABETH 100MG A077028 002 Nov 26, 2004
COREPHARMA 50MG A077150 001 Mar 11, 2005
100MG A077022 001 Nov 23, 2004
IVAX SUB TEVA PHARMS 100MG A077020 002 Mar 01, 2005
MUTUAL PHARM 50MG A077208 002 Mar 29, 2006
100MG A077208 001 Mar 29, 2006
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-81(of 337)
CIMETIDINE
SUSPENSION;ORAL
TAGAMET HB 200
GLAXOSMITHKLINE
200MG/20ML
N020951 001 Jul 09, 1999
TABLET;ORAL
CIMETIDINE
CYCLE PHARMS LTD
300MG
A074361 001 Dec 23, 1994
400MG
A074361 002 Dec 23, 1994
800MG
A074371 001 Dec 23, 1994
DAVA PHARMS INC
300MG
A074340 001 Jun 23, 1995
400MG
A074340 002 Jun 23, 1995
800MG
A074339 001 Jun 23, 1995
IVAX SUB TEVA PHARMS
200MG
A074401 001 May 30, 1995
200MG
A074424 001 Jul 28, 1995
300MG
A074401 002 May 30, 1995
300MG
A074424 002 Jul 28, 1995
400MG
A074401 003 May 30, 1995
400MG
A074424 003 Jul 28, 1995
800MG
A074402 001 May 30, 1995
800MG
A074424 004 Jul 28, 1995
LEK PHARMS
100MG
A075122 001 Jun 19, 1998
200MG
A074250 001 Jun 29, 1995
200MG
A075122 002 Jun 19, 1998
300MG
A074250 002 Jun 29, 1995
400MG
A074250 003 Jun 29, 1995
800MG
A074250 004 Jun 29, 1995
PERRIGO
100MG
A074972 001 Jun 19, 1998
PLIVA
200MG
A074568 001 Feb 27, 1997
300MG
A074568 002 Feb 27, 1997
400MG
A074568 003 Feb 27, 1997
SANDOZ
200MG
A074100 001 Jan 31, 1995
200MG
A074506 001 Jan 24, 1996
300MG
A074100 002 Jan 31, 1995
300MG
A074506 002 Jan 24, 1996
400MG
A074100 003 Jan 31, 1995
400MG
A074506 003 Jan 24, 1996
800MG
A074100 004 Jan 31, 1995
800MG
A074506 004 Jan 24, 1996
TEVA
200MG
A074365 001 Feb 28, 1995
300MG
A074365 002 Feb 28, 1995
400MG
A074365 003 Feb 28, 1995
800MG
A074365 004 Feb 28, 1995
VINTAGE PHARMS LLC
200MG
A074281 001 May 17, 1994
300MG
A074281 002 May 17, 1994
400MG
A074281 003 May 17, 1994
800MG
A074329 001 May 17, 1994
WATSON LABS
200MG
A075425 001 Jul 29, 1999
WATSON LABS INC
200MG
A074349 001 Aug 30, 1996
300MG
A074349 002 Aug 30, 1996
400MG
A074349 003 Aug 30, 1996
800MG
A074316 001 Feb 28, 1996
TAGAMET
GLAXOSMITHKLINE
200MG
N017920 002
300MG
N017920 003
400MG
N017920 004 Dec 14, 1983
800MG
N017920 005 Apr 30, 1986
TAGAMET HB
MEDTECH PRODUCTS
100MG
N020238 001 Jun 19, 1995
CIMETIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
CIMETIDINE HYDROCHLORIDE
HOSPIRA
EQ 300MG BASE/2ML
A074296 001 Mar 28, 1997
EQ 300MG BASE/2ML
A074344 001 Jan 31, 1995
EQ 300MG BASE/2ML
A074345 001 Jan 31, 1995
EQ 300MG BASE/2ML
A074412 001 Mar 28, 1997
EQ 300MG BASE/2ML
A074422 001 Jan 31, 1995
LUITPOLD
EQ 300MG BASE/2ML
A074353 001 Dec 20, 1994
TEVA PARENTERAL
EQ 300MG BASE/2ML
A074252 001 Nov 26, 1997
VINTAGE PHARMS LLC
EQ 300MG BASE/2ML
A074005 001 Aug 31, 1994
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA EQ 6MG BASE/ML
A074269 001 Dec 27, 1994
EQ 90MG BASE/100ML
A074468 005 Dec 29, 1994
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-82(of 337)
CIMETIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
CIMETIDINE HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
EQ 120MG BASE/100ML A074468 006 Dec 29, 1994
EQ 180MG BASE/100ML A074468 003 Dec 29, 1994
EQ 240MG BASE/100ML A074468 004 Dec 29, 1994
EQ 360MG BASE/100ML A074468 001 Dec 29, 1994
EQ 480MG BASE/100ML A074468 002 Dec 29, 1994
TAGAMET
GLAXOSMITHKLINE EQ 300MG BASE/2ML N017939 002
TAGAMET HYDROCHLORIDE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
GLAXOSMITHKLINE EQ 6MG BASE/ML N019434 001 Oct 31, 1985
SOLUTION;ORAL
CIMETIDINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC EQ 300MG BASE/5ML A074176 001 Jun 01, 1994
ANI PHARMS INC EQ 300MG BASE/5ML A074859 001 Jul 09, 1998
EQ 300MG BASE/5ML A075110 001 Jun 18, 1998
APOTEX INC EQ 300MG BASE/5ML A075560 001 Mar 15, 2000
CYCLE PHARMS LTD EQ 300MG BASE/5ML A074541 001 Aug 05, 1997
VINTAGE PHARMS LLC EQ 300MG BASE/5ML A074251 001 Dec 22, 1994
TAGAMET
GLAXOSMITHKLINE EQ 300MG BASE/5ML N017924 001
CINOXACIN
CAPSULE;ORAL
CINOBAC
LILLY 250MG N018067 001
500MG N018067 002
CINOXACIN
TEVA 250MG A073005 001 Feb 28, 1992
500MG A073006 001 Feb 28, 1992
CIPROFLOXACIN
INJECTABLE;INJECTION
CIPRO
BAYER HLTHCARE 1200MG/120ML (10MG/ML) N019847 003 Dec 26, 1990
CIPRO IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAYER PHARMS 200MG/100ML N019858 001 Dec 26, 1990
CIPROFLOXACIN
BEDFORD LABS 200MG/20ML (10MG/ML) A076992 001 Aug 28, 2006
400MG/40ML (10MG/ML) A076992 002 Aug 28, 2006
1200MG/120ML (10MG/ML) A076993 001 Aug 28, 2006
FRESENIUS KABI USA 200MG/20ML (10MG/ML) A076484 001 Aug 28, 2006
400MG/40ML (10MG/ML) A076484 002 Aug 28, 2006
TEVA PHARMS USA 200MG/20ML (10MG/ML) A077782 001 Aug 28, 2006
400MG/40ML (10MG/ML) A077782 002 Aug 28, 2006
CIPROFLOXACIN IN DEXTROSE 5%
HIKMA FARMACEUTICA 200MG/100ML A076757 001 Apr 21, 2008
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 200MG/100ML A077888 001 Mar 18, 2008
400MG/200ML A077888 002 Mar 18, 2008
BEDFORD 200MG/100ML A078114 001 Mar 18, 2008
400MG/200ML A078114 002 Mar 18, 2008
TEVA PHARMS 200MG/100ML A077138 001 Mar 18, 2008
400MG/200ML A077138 002 Mar 18, 2008
CIPROFLOXACIN HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
CIPROFLOXACIN HYDROCHLORIDE
APOTEX INC EQ 0.3% BASE A075928 001 Jun 09, 2004
TABLET;ORAL
CIPROFLOXACIN HYDROCHLORIDE
BARR EQ 250MG BASE A074124 001 Jun 09, 2004
EQ 500MG BASE A074124 002 Jun 09, 2004
EQ 750MG BASE A074124 003 Jun 09, 2004
NOSTRUM LABS EQ 250MG BASE A076138 001 Jun 09, 2004
EQ 500MG BASE A076138 002 Jun 09, 2004
EQ 750MG BASE A076138 003 Jun 09, 2004
PLIVA EQ 100MG BASE A076426 001 Jun 15, 2005
EQ 250MG BASE A076426 002 Jun 15, 2005
EQ 500MG BASE A076426 003 Jun 15, 2005
EQ 750MG BASE A076426 004 Jun 15, 2005
SANDOZ EQ 100MG BASE A075939 001 Mar 03, 2005
EQ 250MG BASE A075939 002 Jun 09, 2004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-83(of 337)
CIPROFLOXACIN HYDROCHLORIDE
TABLET;ORAL
CIPROFLOXACIN HYDROCHLORIDE
EQ 250MG BASE A076593 002 Jun 09, 2004
EQ 500MG BASE A075939 003 Jun 09, 2004
EQ 500MG BASE A076593 003 Jun 09, 2004
EQ 750MG BASE A075939 004 Jun 09, 2004
EQ 750MG BASE A076593 004 Jun 09, 2004
TEVA EQ 250MG BASE A076136 001 Jun 09, 2004
EQ 500MG BASE A076136 002 Jun 09, 2004
EQ 750MG BASE A076136 003 Jun 09, 2004
TABLET, EXTENDED RELEASE;ORAL
PROQUIN XR
DEPOMED INC EQ 500MG BASE N021744 001 May 19, 2005
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
CIPRO XR
BAYER HLTHCARE 212.6MG;EQ 287.5MG BASE N021473 001 Dec 13, 2002
425.2MG;EQ 574.9MG BASE N021473 002 Aug 28, 2003
CIPROFLOXACIN EXTENDED RELEASE
DR REDDYS LABS LTD 212.6MG;EQ 287.5MG BASE A077701 002 Oct 31, 2007
SANDOZ 212.6MG;EQ 287.5MG BASE A078712 001 Dec 11, 2007
CISAPRIDE MONOHYDRATE
SUSPENSION;ORAL
PROPULSID
JANSSEN PHARMS EQ 1MG BASE/ML N020398 001 Sep 15, 1995
TABLET;ORAL
PROPULSID
JANSSEN PHARMS EQ 10MG BASE N020210 001 Jul 29, 1993
EQ 20MG BASE N020210 002 Dec 23, 1993
TABLET, ORALLY DISINTEGRATING;ORAL
PROPULSID QUICKSOLV
JANSSEN PHARMA EQ 20MG BASE N020767 001 Nov 07, 1997
CISPLATIN
INJECTABLE;INJECTION
CISPLATIN
BEDFORD 10MG/VIAL A074713 001 Nov 14, 2000
50MG/VIAL A074713 002 Nov 14, 2000
TEVA PHARMS USA 1MG/ML A074814 001 May 16, 2000
PLATINOL
HQ SPCLT PHARMA 10MG/VIAL N018057 001
50MG/VIAL N018057 002
PLATINOL-AQ
HQ SPCLT PHARMA 0.5MG/ML N018057 003 Jul 18, 1984
CITALOPRAM HYDROBROMIDE
SOLUTION;ORAL
CELEXA
FOREST LABS EQ 10MG BASE/5ML **Federal Register N021046 001 Dec 22, 1999
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
CITALOPRAM HYDROBROMIDE
APOTEX INC EQ 10MG BASE/5ML A077601 001 Nov 15, 2005
TABLET;ORAL
CELEXA
FOREST LABS EQ 60MG BASE N020822 004 Jul 17, 1998
CITALOPRAM HYDROBROMIDE
ACTAVIS ELIZABETH EQ 10MG BASE A077033 001 Oct 28, 2004
EQ 20MG BASE A077033 002 Oct 28, 2004
EQ 40MG BASE A077033 003 Oct 28, 2004
COREPHARMA EQ 10MG BASE A077036 001 Oct 28, 2004
EQ 20MG BASE A077036 002 Oct 28, 2004
EQ 40MG BASE A077036 003 Oct 28, 2004
MUTUAL PHARM EQ 10MG BASE A077052 001 Jul 03, 2006
EQ 20MG BASE A077052 002 Jul 03, 2006
EQ 40MG BASE A077052 003 Jul 03, 2006
NATCO PHARMA LTD EQ 20MG BASE A077141 002 Apr 10, 2008
EQ 40MG BASE A077141 001 Apr 10, 2008
ROXANE EQ 10MG BASE A077041 001 Nov 23, 2004
EQ 20MG BASE A077041 002 Nov 23, 2004
EQ 40MG BASE A077041 003 Nov 23, 2004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-84(of 337)
CITALOPRAM HYDROBROMIDE
TABLET;ORAL
CITALOPRAM HYDROBROMIDE
SANDOZ EQ 10MG BASE A077035 001 Oct 28, 2004
EQ 10MG BASE A077040 001 Aug 17, 2005
EQ 20MG BASE A077035 002 Oct 28, 2004
EQ 20MG BASE A077040 002 Aug 17, 2005
EQ 40MG BASE A077035 003 Oct 28, 2004
EQ 40MG BASE A077040 003 Aug 17, 2005
TARO EQ 10MG BASE A077278 001 Mar 22, 2006
EQ 20MG BASE A077278 002 Mar 22, 2006
EQ 40MG BASE A077278 003 Mar 22, 2006
TEVA PHARMS EQ 10MG BASE A077213 001 Mar 31, 2006
EQ 20MG BASE A077213 002 Mar 31, 2006
EQ 40MG BASE A077213 003 Mar 31, 2006
WATSON LABS EQ 10MG BASE A077034 001 Jun 30, 2005
EQ 20MG BASE A077034 002 Jun 30, 2005
EQ 40MG BASE A077034 003 Jun 30, 2005
TABLET, ORALLY DISINTEGRATING;ORAL
CITALOPRAM HYDROBROMIDE
BIOVAIL LABS INTL EQ 10MG BASE N021763 001 Dec 20, 2005
EQ 20MG BASE N021763 002 Dec 20, 2005
EQ 40MG BASE N021763 003 Dec 20, 2005
CITRIC ACID; MAGNESIUM OXIDE; SODIUM CARBONATE
SOLUTION;IRRIGATION
IRRIGATING SOLUTION G IN PLASTIC CONTAINER
BAXTER HLTHCARE 3.24GM/100ML;380MG/100ML;430MG/100ML N018519 001 Jun 22, 1982
UROLOGIC G IN PLASTIC CONTAINER
HOSPIRA 3.24GM/100ML;380MG/100ML;430MG/100ML N018904 001 May 27, 1983
CLADRIBINE
INJECTABLE;INJECTION
LEUSTATIN
JANSSEN PHARMS 1MG/ML **Federal Register determination N020229 001 Feb 26, 1993
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
CLARITHROMYCIN
FOR SUSPENSION;ORAL
BIAXIN
ABBVIE 187MG/5ML N050698 003 Sep 30, 1998
TABLET;ORAL
CLARITHROMYCIN
IVAX SUB TEVA PHARMS 250MG A065137 001 May 31, 2005
500MG A065137 002 May 31, 2005
TABLET, EXTENDED RELEASE;ORAL
CLARITHROMYCIN
RANBAXY 1GM A065210 001 Jan 26, 2005
SANDOZ 500MG A065250 001 Aug 25, 2005
CLEMASTINE FUMARATE
SYRUP;ORAL
CLEMASTINE FUMARATE
ACTAVIS MID ATLANTIC EQ 0.5MG BASE/5ML A074075 001 Oct 31, 1993
APOTEX INC EQ 0.5MG BASE/5ML A075703 001 Nov 27, 2000
SILARX EQ 0.5MG BASE/5ML A074884 001 Dec 17, 1997
TEVA PHARMS EQ 0.5MG BASE/5ML A073095 001 Apr 21, 1992
TAVIST
NOVARTIS EQ 0.5MG BASE/5ML N018675 001 Jun 28, 1985
TABLET;ORAL
CLEMASTINE FUMARATE
TEVA 1.34MG A073282 001 Jan 31, 1992
1.34MG A073282 002 Dec 03, 1992
TAVIST
NOVARTIS 2.68MG N017661 001
TAVIST-1
NOVARTIS 1.34MG N017661 002
1.34MG N017661 003 Aug 21, 1992
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-85(of 337)
CLIDINIUM BROMIDE
CAPSULE;ORAL
QUARZAN
ROCHE 2.5MG N010355 001
5MG N010355 002
CLINDAMYCIN HYDROCHLORIDE
CAPSULE;ORAL
CLEOCIN
PHARMACIA AND UPJOHN EQ 75MG BASE A061809 001
EQ 150MG BASE A061809 002
CLINDAMYCIN HYDROCHLORIDE
TEVA EQ 75MG BASE A063027 001 Sep 20, 1989
WATSON LABS EQ 75MG BASE A063082 001 Jul 31, 1991
CLINDAMYCIN PALMITATE HYDROCHLORIDE
FOR SOLUTION;ORAL
CLEOCIN
PHARMACIA AND UPJOHN EQ 75MG BASE/5ML A061827 001
CLINDAMYCIN PHOSPHATE
CREAM;VAGINAL
CLEOCIN
PHARMACIA AND UPJOHN EQ 2% BASE N050680 001 Aug 11, 1992
INJECTABLE;INJECTION
CLEOCIN PHOSPHATE
PHARMACIA AND UPJOHN EQ 150MG BASE/ML A061839 001
CLINDAMYCIN PHOSPHATE
ABRAXIS PHARM EQ 150MG BASE/ML A062747 001 Jun 03, 1988
ASTRAZENECA EQ 150MG BASE/ML A062928 001 Feb 13, 1989
BEDFORD EQ 150MG BASE/ML A063163 001 Jun 30, 1994
BRISTOL MYERS SQUIBB EQ 150MG BASE/ML A062908 001 Feb 01, 1989
HIKMA MAPLE EQ 150MG BASE/ML A062806 001 Oct 15, 1987
EQ 150MG BASE/ML A062953 001 Apr 21, 1988
EQ 150MG BASE/ML A063068 001 Aug 28, 1989
LOCH EQ 150MG BASE/ML A062905 001 May 09, 1988
MARSAM PHARMS LLC EQ 150MG BASE/ML A062913 001 Oct 20, 1988
SOLOPAK EQ 150MG BASE/ML A062819 001 Mar 15, 1988
EQ 150MG BASE/ML A062852 001 Mar 17, 1988
TEVA PARENTERAL EQ 150MG BASE/ML A063041 001 Dec 29, 1989
EQ 150MG BASE/ML A063282 001 May 29, 1992
WATSON LABS EQ 150MG BASE/ML A062900 001 Jun 08, 1988
EQ 150MG BASE/ML A063079 001 Mar 05, 1990
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%
ABRAXIS PHARM EQ 12MG BASE/ML N050636 001 Dec 22, 1989
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBVIE EQ 6MG BASE/ML A065027 001 Jun 29, 2001
EQ 12MG BASE/ML A065027 002 Jun 29, 2001
EQ 18MG BASE/ML A065027 003 Jun 29, 2001
BAXTER HLTHCARE EQ 6MG BASE/ML N050648 001 Dec 29, 1989
EQ 12MG BASE/ML N050648 002 Dec 29, 1989
EQ 900MG BASE/100ML N050648 003 Dec 29, 1989
SOLUTION;TOPICAL
CLEOCIN T
PHARMACIA AND UPJOHN EQ 1% BASE A062363 001 Feb 08, 1982
CLINDAMYCIN PHOSPHATE
COPLEY PHARM EQ 1% BASE A062944 001 Jan 11, 1989
RENAISSANCE PHARMA EQ 1% BASE A064108 001 Sep 27, 1996
VINTAGE PHARMS EQ 1% BASE A062930 001 Jun 28, 1989
CLIOQUINOL; NYSTATIN
OINTMENT;TOPICAL
NYSTAFORM
BAYER PHARMS 10MG/GM;100,000 UNITS/GM N050235 001
CLOBAZAM
TABLET;ORAL
ONFI
LUNDBECK LLC 5MG N202067 001 Oct 21, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-86(of 337)
CLOBETASOL PROPIONATE
CREAM;TOPICAL
CLOBETASOL PROPIONATE
RENAISSANCE PHARMA 0.05% A075338 001 Feb 09, 2001
TEVA PHARMS USA 0.05% A074087 001 Feb 16, 1994
CLOBETASOL PROPIONATE (EMOLLIENT)
RENAISSANCE PHARMA 0.05% A075733 001 Aug 22, 2001
OINTMENT;TOPICAL
CLOBETASOL PROPIONATE
ACTAVIS MID ATLANTIC 0.05% A074128 001 Aug 03, 1994
RENAISSANCE PHARMA 0.05% A075057 001 Aug 12, 1998
SOLUTION;TOPICAL
CLOBETASOL PROPIONATE
G AND W LABS INC 0.05% A074331 001 Dec 15, 1995
TEMOVATE
FOUGERA PHARMS 0.05% **Federal Register determination N019966 001 Feb 22, 1990
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
CLOFAZIMINE
CAPSULE;ORAL
LAMPRENE
NOVARTIS 100MG N019500 001 Dec 15, 1986
CLOFIBRATE
CAPSULE;ORAL
ATROMID-S
WYETH AYERST 500MG N016099 002
CLOFIBRATE
BANNER PHARMACAPS 500MG A073396 001 Mar 20, 1992
SANDOZ 500MG A072191 001 May 02, 1988
TEVA 500MG A072600 001 Jul 25, 1991
USL PHARMA 500MG A070531 001 Jun 16, 1986
WATSON LABS 500MG A071603 001 Sep 18, 1987
CLOMIPHENE CITRATE
TABLET;ORAL
MILOPHENE
MILEX 50MG A072196 001 Dec 20, 1988
CLOMIPRAMINE HYDROCHLORIDE
CAPSULE;ORAL
CLOMIPRAMINE HYDROCHLORIDE
SANDOZ 25MG A074953 001 Jun 25, 1997
50MG A074953 002 Jun 25, 1997
75MG A074953 003 Jun 25, 1997
TEVA 25MG A074849 001 Apr 04, 1997
50MG A074849 002 Apr 04, 1997
75MG A074849 003 Apr 04, 1997
WATSON LABS 25MG A074600 001 Nov 27, 1996
25MG A074751 001 Sep 30, 1998
50MG A074600 002 Nov 27, 1996
50MG A074751 002 Sep 30, 1998
75MG A074600 003 Nov 27, 1996
75MG A074751 003 Sep 30, 1998
CLONAZEPAM
TABLET;ORAL
CLONAZEPAM
APOTEX INC 0.5MG A075468 001 Oct 06, 2000
1MG A075468 002 Oct 06, 2000
2MG A075468 003 Oct 06, 2000
SANDOZ 0.5MG A074925 001 Sep 30, 1997
1MG A074925 002 Sep 30, 1997
2MG A074925 003 Sep 30, 1997
TEVA 0.5MG A074920 001 Aug 04, 1998
1MG A074920 002 Aug 04, 1998
2MG A074920 003 Aug 04, 1998
KLONOPIN
ROCHE 0.125MG N017533 005 Apr 09, 1997
0.25MG N017533 006 Apr 09, 1997
TABLET, ORALLY DISINTEGRATING;ORAL
KLONOPIN RAPIDLY DISINTEGRATING
ROCHE 0.125MG **Federal Register N020813 001 Dec 23, 1997
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-87(of 337)
CLONAZEPAM
TABLET, ORALLY DISINTEGRATING;ORAL
KLONOPIN RAPIDLY DISINTEGRATING
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
0.25MG **Federal Register determination N020813 002 Dec 23, 1997
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
0.5MG **Federal Register determination N020813 003 Dec 23, 1997
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
1MG **Federal Register determination N020813 004 Dec 23, 1997
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
2MG **Federal Register determination N020813 005 Dec 23, 1997
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
CLONIDINE
SUSPENSION, EXTENDED RELEASE;ORAL
CLONIDINE
TRIS PHARMA INC EQ 0.09MG BASE/ML N022499 001 Dec 03, 2009
TABLET, EXTENDED RELEASE;ORAL
CLONIDINE
TRIS PHARMA INC EQ 0.17MG BASE N022500 001 Dec 03, 2009
EQ 0.26MG BASE N022500 002 Dec 03, 2009
CLONIDINE HYDROCHLORIDE
TABLET;ORAL
CLONIDINE HYDROCHLORIDE
AM THERAP 0.1MG A070881 001 Jul 08, 1986
0.2MG A070882 001 Jul 08, 1986
0.3MG A070883 001 Jul 08, 1986
DURAMED PHARMS BARR 0.1MG A071103 001 Aug 14, 1986
0.2MG A071102 001 Aug 14, 1986
0.3MG A071101 001 Aug 14, 1986
INTERPHARM 0.1MG A071252 001 Oct 01, 1986
0.2MG A071253 001 Oct 01, 1986
0.3MG A071254 001 Oct 01, 1986
PAR PHARM 0.1MG A070461 001 Jul 08, 1986
0.2MG A070460 001 Jul 08, 1986
0.3MG A070459 001 Jul 08, 1986
SANDOZ 0.1MG A070887 001 Aug 31, 1988
0.2MG A070886 001 Aug 31, 1988
0.3MG A071294 001 Aug 31, 1988
TEVA 0.1MG A070747 001 Jul 08, 1986
0.2MG A070702 001 Jul 08, 1986
0.3MG A070659 001 Jul 08, 1986
WARNER CHILCOTT 0.1MG A072138 001 Jun 13, 1988
0.2MG A072139 001 Jun 13, 1988
0.3MG A072140 001 Jun 13, 1988
WATSON LABS 0.1MG A070395 001 Mar 23, 1987
0.1MG A070965 001 Jul 08, 1986
0.2MG A070396 001 Mar 23, 1987
0.2MG A070964 001 Jul 08, 1986
0.3MG A070397 001 Mar 23, 1987
0.3MG A070963 001 Jul 08, 1986
TABLET, EXTENDED RELEASE;ORAL
JENLOGA
CONCORDIA PHARMS INC 0.1MG N022331 001 Sep 30, 2009
0.2MG N022331 002 May 25, 2010
CLORAZEPATE DIPOTASSIUM
CAPSULE;ORAL
CLORAZEPATE DIPOTASSIUM
ABLE 3.75MG A071777 001 Jul 14, 1987
7.5MG A071778 001 Jul 14, 1987
15MG A071779 001 Jul 14, 1987
AM THERAP 3.75MG A071429 001 Jun 23, 1987
7.5MG A071430 001 Jun 23, 1987
15MG A071431 001 Jun 23, 1987
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-88(of 337)
CLORAZEPATE DIPOTASSIUM
CAPSULE;ORAL
CLORAZEPATE DIPOTASSIUM
DAVA PHARMS INC 3.75MG A071742 001 Dec 14, 1987
7.5MG A071743 001 Dec 14, 1987
15MG A071744 001 Dec 14, 1987
GD SEARLE LLC 3.75MG A071727 001 Dec 18, 1987
7.5MG A071728 001 Dec 18, 1987
15MG A071729 001 Dec 18, 1987
MYLAN 3.75MG A071509 001 Oct 19, 1987
7.5MG A071510 001 Oct 19, 1987
15MG A071511 001 Oct 19, 1987
PUREPAC PHARM 3.75MG A071924 001 Apr 25, 1988
7.5MG A071925 001 Apr 25, 1988
15MG A071926 001 Apr 25, 1988
QUANTUM PHARMICS 3.75MG A071549 001 Sep 12, 1988
7.5MG A071550 001 Sep 12, 1988
15MG A071522 001 Sep 12, 1988
SANDOZ 3.75MG A072219 001 Aug 26, 1988
7.5MG A072220 001 Aug 26, 1988
15MG A072112 001 Aug 26, 1988
USL PHARMA 3.75MG A071242 001 Jun 23, 1987
7.5MG A071243 001 Jun 23, 1987
15MG A071244 001 Jun 23, 1987
WARNER CHILCOTT 3.75MG A071774 001 Mar 01, 1988
7.5MG A071775 001 Mar 01, 1988
15MG A071776 001 Mar 01, 1988
WATSON LABS 3.75MG A071878 001 Mar 15, 1988
7.5MG A071879 001 Mar 15, 1988
15MG A071860 001 Mar 15, 1988
TRANXENE
RECORDATI RARE 3.75MG N017105 001
7.5MG N017105 002
15MG N017105 003
TABLET;ORAL
CLORAZEPATE DIPOTASSIUM
ABLE 3.75MG A071780 001 Jun 26, 1987
7.5MG A071781 001 Jun 26, 1987
15MG A071782 001 Jun 26, 1987
AM THERAP 3.75MG A071747 001 Jun 23, 1987
7.5MG A071748 001 Jun 23, 1987
15MG A071749 001 Jun 23, 1987
LEDERLE 3.75MG A072013 001 Dec 15, 1987
7.5MG A072014 001 Dec 15, 1987
15MG A072015 001 Dec 15, 1987
PUREPAC PHARM 3.75MG A072330 001 Aug 08, 1988
7.5MG A072331 001 Aug 08, 1988
15MG A072332 001 Aug 08, 1988
QUANTUM PHARMICS 3.75MG A071730 001 Oct 26, 1987
7.5MG A071731 001 Oct 26, 1987
15MG A071702 001 Oct 26, 1987
SANDOZ 3.75MG A072512 001 May 11, 1990
7.5MG A072513 001 May 11, 1990
15MG A072514 001 May 11, 1990
WARNER CHILCOTT 3.75MG A071828 001 Mar 03, 1988
7.5MG A071829 001 Mar 03, 1988
15MG A071830 001 Mar 03, 1988
WATSON LABS 3.75MG A071852 001 Feb 09, 1988
7.5MG A071853 001 Feb 09, 1988
15MG A071854 001 Feb 09, 1988
TRANXENE SD
RECORDATI RARE 11.25MG N017105 005
22.5MG N017105 004
CLOTRIMAZOLE
CREAM;TOPICAL
LOTRIMIN
SCHERING PLOUGH 1% N017619 001
MYCELEX
BAYER HEALTHCARE LLC 1% N018183 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-89(of 337)
CLOTRIMAZOLE
LOTION;TOPICAL
LOTRIMIN
SCHERING
1%
N018813 001 Feb 17, 1984
SOLUTION;TOPICAL
LOTRIMIN
SCHERING PLOUGH
1%
N017613 001
MYCELEX
BAYER HLTHCARE
1%
N018181 001
TABLET;VAGINAL
GYNIX
TEVA PHARMS
100MG
A073249 001 Feb 13, 1998
MYCELEX-G
BAYER PHARMS
500MG
N019069 001 Apr 19, 1985
TROCHE/LOZENGE;ORAL
MYCELEX
BAYER HLTHCARE
10MG
N018713 001 Jun 17, 1983
CLOXACILLIN SODIUM
CAPSULE;ORAL
CLOXACILLIN SODIUM
APOTHECON
EQ 250MG BASE
A061452 001
EQ 500MG BASE
A061452 002
TEVA
EQ 250MG BASE
A062240 001
EQ 500MG BASE
A062240 002
CLOXAPEN
GLAXOSMITHKLINE
EQ 250MG BASE
A061806 001
EQ 250MG BASE
A062233 001
EQ 500MG BASE
A061806 002
EQ 500MG BASE
A062233 002
FOR SOLUTION;ORAL
CLOXACILLIN SODIUM
TEVA
EQ 125MG BASE/5ML
A062268 001
EQ 125MG BASE/5ML
A062978 001 Apr 06, 1989
TEGOPEN
APOTHECON
EQ 125MG BASE/5ML
A061453 001
EQ 125MG BASE/5ML
N050192 001
CLOZAPINE
TABLET;ORAL
CLOZAPINE
PAR PHARM
25MG
A075162 001 Apr 26, 2005
100MG
A075162 002 Apr 26, 2005
SANDOZ
25MG
A074546 001 Aug 30, 1996
100MG
A074546 002 Aug 30, 1996
TABLET, ORALLY DISINTEGRATING;ORAL
FAZACLO ODT
JAZZ PHARMS III 50MG
N021590 003 Jun 03, 2005
COBALT CHLORIDE CO-57; CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; INTRINSIC FACTOR
N/A;N/A
RUBRATOPE-57 KIT
BRACCO N/A;N/A;N/A;N/A N016089 001
COBALT CHLORIDE CO-60; CYANOCOBALAMIN; CYANOCOBALAMIN CO-60; INTRINSIC FACTOR
N/A;N/A
RUBRATOPE-60 KIT
BRACCO N/A;N/A;N/A;N/A N016090 001
CODEINE PHOSPHATE; PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
SYRUP;ORAL
PHENERGAN VC W/ CODEINE
ANI PHARMS
10MG/5ML;5MG/5ML;6.25MG/5ML
N008306 005 Apr 02, 1984
PHERAZINE VC W/ CODEINE
HALSEY
10MG/5ML;5MG/5ML;6.25MG/5ML
A088870 001 Mar 02, 1987
PROMETHAZINE VC W/ CODEINE
CENCI
10MG/5ML;5MG/5ML;6.25MG/5ML
A088816 001 Nov 22, 1985
WOCKHARDT
10MG/5ML;5MG/5ML;6.25MG/5ML
A088896 001 Jan 04, 1985
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DISCONTINUED DRUG PRODUCT LIST 6-90(of 337)
CODEINE PHOSPHATE; PROMETHAZINE HYDROCHLORIDE
SYRUP;ORAL
PHENERGAN W/ CODEINE
ANI PHARMS 10MG/5ML;6.25MG/5ML N008306 004 Apr 02, 1984
PHERAZINE W/ CODEINE
HALSEY 10MG/5ML;6.25MG/5ML A088739 001 Dec 23, 1988
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE
PHARM ASSOC 10MG/5ML;6.25MG/5ML A089647 001 Dec 22, 1988
PROMETHAZINE W/ CODEINE
CENCI 10MG/5ML;6.25MG/5ML A088814 001 Nov 22, 1985
CODEINE PHOSPHATE; PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
SYRUP;ORAL
ACTIFED W/ CODEINE
GLAXOSMITHKLINE 10MG/5ML;30MG/5ML;1.25MG/5ML N012575 003 Apr 04, 1984
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES W/ CODEINE
CENCI 10MG/5ML;30MG/5ML;1.25MG/5ML A089018 001 Jul 23, 1986
TRIPROLIDINE HCL, PSEUDOEPHEDRINE HCL AND CODEINE PHOSPHATE
WOCKHARDT 10MG/5ML;30MG/5ML;1.25MG/5ML A088833 001 Nov 16, 1984
COLCHICINE; PROBENECID
TABLET;ORAL
COLBENEMID
MERCK 0.5MG;500MG N012383 001
PROBEN-C
WATSON LABS 0.5MG;500MG A085552 001
PROBENECID AND COLCHICINE
BEECHAM 0.5MG;500MG A084321 001
IMPAX LABS 0.5MG;500MG A083720 002
IVAX SUB TEVA PHARMS 0.5MG;500MG A083734 001
SANDOZ 0.5MG;500MG A086130 001
PROBENECID W/ COLCHICINE
LEDERLE 0.5MG;500MG A086954 001
WATSON LABS 0.5MG;500MG A083221 001
COLESEVELAM HYDROCHLORIDE
CAPSULE;ORAL
WELCHOL
DAIICHI SANKYO 375MG N021141 001 May 26, 2000
COLISTIN SULFATE
SUSPENSION;ORAL
COLY-MYCIN S
PARKE DAVIS EQ 25MG BASE/5ML N050355 001
CONIVAPTAN HYDROCHLORIDE
INJECTABLE;IV (INFUSION)
VAPRISOL
CUMBERLAND PHARMS 20MG/4ML (5MG/ML) N021697 001 Dec 29, 2005
COPPER
INTRAUTERINE DEVICE;INTRAUTERINE
CU-7
GD SEARLE LLC 89MG N017408 001
TATUM-T
GD SEARLE LLC 120MG N018205 001
CORTICOTROPIN
INJECTABLE;INJECTION
ACTH
PARKEDALE 25 UNITS/VIAL N008317 002
40 UNITS/VIAL N008317 004
ACTHAR
SANOFI AVENTIS US 25 UNITS/VIAL N007504 002
40 UNITS/VIAL N007504 003
CORTICOTROPIN
ORGANICS LAGRANGE 40 UNITS/ML N010831 001
80 UNITS/ML N010831 002
WATSON LABS 40 UNITS/VIAL A088772 001 Nov 21, 1984
H.P. ACTHAR GEL
QUESTCOR PHARMS 40 UNITS/ML N008372 006
PURIFIED CORTROPHIN GEL
ORGANON USA INC 40 UNITS/ML N008975 001
80 UNITS/ML N008975 002
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DISCONTINUED DRUG PRODUCT LIST 6-91(of 337)
CORTICOTROPIN-ZINC HYDROXIDE
INJECTABLE;INJECTION
CORTROPHIN-ZINC
ORGANON USA INC 40 UNITS/ML N009854 001
CORTISONE ACETATE
INJECTABLE;INJECTION
CORTISONE ACETATE
PHARMACIA AND UPJOHN 25MG/ML N008126 002
WATSON LABS 25MG/ML A083147 003
25MG/ML A085677 001
50MG/ML A083147 004
50MG/ML A085677 002
CORTONE
MERCK 25MG/ML N007110 002
50MG/ML N007110 003
TABLET;ORAL
CORTISONE ACETATE
BARR 25MG A083471 001
ELKINS SINN 25MG A080836 001
EVERYLIFE 25MG A084246 001
HEATHER 25MG A085736 001
IMPAX LABS 25MG N009458 001
INWOOD LABS 25MG A080731 001
IVAX SUB TEVA PHARMS 25MG A080630 001
25MG A083536 001
LANNETT 25MG A080694 001
PANRAY 5MG N008284 002
25MG N008284 001
PHARMACIA AND UPJOHN 5MG N008126 003
10MG N008126 004
25MG N008126 001
PUREPAC PHARM 25MG A080493 001
VITARINE 25MG A080333 001
WATSON LABS 25MG A085884 001
WHITEWORTH TOWN PLSN 25MG A080341 001
CORTONE
MERCK 25MG N007750 003
COSYNTROPIN
SOLUTION;INTRAVENOUS
COSYNTROPIN
SANDOZ 0.25MG/ML (0.25MG/ML) N022028 001 Feb 21, 2008
CROMOLYN SODIUM
AEROSOL, METERED;INHALATION
INTAL
KING PFIZER 0.8MG/INH N018887 001 Dec 05, 1985
CAPSULE;INHALATION
INTAL
SANOFI AVENTIS US 20MG **Federal Register determination N016990 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
CAPSULE;ORAL
GASTROCROM
UCB INC 100MG N019188 001 Dec 22, 1989
CONCENTRATE;ORAL
CROMOLYN SODIUM
GENERA PHARMS 100MG/5ML A090954 001 Dec 18, 2009
SOLUTION;INHALATION
CROMOLYN SODIUM
ACTAVIS MID ATLANTIC 10MG/ML A075067 001 Jul 19, 1999
APOTEX INC 10MG/ML A075333 001 Apr 30, 2002
PHARMASCIENCE INC 10MG/ML A075437 001 Apr 21, 2000
ROXANE 10MG/ML A075175 001 Sep 30, 1999
WATSON LABS 10MG/ML A076469 001 Jun 17, 2005
INTAL
KING PHARMS 10MG/ML N018596 001 May 28, 1982
SOLUTION/DROPS;OPHTHALMIC
CROMOLYN SODIUM
APOTEX INC 4% A075615 001 Jan 26, 2001
CROMOPTIC
KING PHARMS 4% A075088 001 Apr 27, 1999
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DISCONTINUED DRUG PRODUCT LIST 6-92(of 337)
CROMOLYN SODIUM
SOLUTION/DROPS;OPHTHALMIC
OPTICROM
ALLERGAN 4% N018155 001 Oct 03, 1984
SPRAY, METERED;NASAL
CROMOLYN SODIUM
ACTAVIS MID ATLANTIC 5.2MG/SPRAY A074800 001 Jul 26, 2001
HH AND P 5.2MG/SPRAY A077976 001 Sep 07, 2007
NASALCROM
BLACKSMITH BRANDS 5.2MG/SPRAY **Federal Register N020463 001 Jan 03, 1997
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
CRYPTENAMINE ACETATES
INJECTABLE;INJECTION
UNITENSEN
MEDPOINTE PHARM HLC 260CSR UNIT/ML N008814 001
CRYPTENAMINE TANNATES
TABLET;ORAL
UNITENSEN
MEDPOINTE PHARM HLC 260CSR UNIT N009217 001
CUPRIC SULFATE
INJECTABLE;INJECTION
CUPRIC SULFATE
ABRAXIS PHARM EQ 0.4MG COPPER/ML N019350 001 May 05, 1987
CYANOCOBALAMIN
GEL, METERED;NASAL
NASCOBAL
PAR PHARM 0.5MG/INH N019722 001 Nov 05, 1996
INJECTABLE;INJECTION
BERUBIGEN
PHARMACIA AND UPJOHN 1MG/ML N006798 001
BETALIN 12
LILLY 0.1MG/ML A080855 001
1MG/ML A080855 002
COBAVITE
WATSON LABS 0.1MG/ML A083013 001
1MG/ML A083064 001
CYANOCOBALAMIN
ABRAXIS PHARM 0.03MG/ML A080510 003
0.1MG/ML A080510 001
1MG/ML A080510 002
AKORN 1MG/ML A087969 001 Nov 10, 1983
DELL LABS 0.03MG/ML A080689 001
0.1MG/ML A080689 002
1MG/ML A080689 003
FRESENIUS KABI USA 0.1MG/ML A080557 002
HIKMA MAPLE 1MG/ML A080515 002
LUITPOLD 0.03MG/ML A080668 001
LYPHOMED 1MG/ML A083075 001
MYLAN INSTITUTIONAL 1MG/ML A040451 001 Sep 23, 2003
SANOFI AVENTIS US 1MG/ML A080564 001
SOLOPAK 1MG/ML A087551 001 Feb 29, 1984
WARNER CHILCOTT 1MG/ML N007085 002
WATSON LABS 0.1MG/ML A080573 002
0.1MG/ML A083120 001
1MG/ML A080573 001
1MG/ML A083120 002
WYETH AYERST 0.1MG/ML A080554 001
1MG/ML A080554 002
REDISOL
MERCK 1MG/ML N006668 010
RUBIVITE
BEL MAR 0.03MG/ML N010791 004
0.05MG/ML N010791 001
0.1MG/ML N010791 002
0.12MG/ML N010791 005
1MG/ML N010791 003
RUBRAMIN PC
BRISTOL MYERS SQUIBB 0.1MG/ML N006799 002
1MG/ML N006799 004
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DISCONTINUED DRUG PRODUCT LIST
6-93(of 337)
CYANOCOBALAMIN
INJECTABLE;INJECTION
RUBRAMIN PC
1MG/ML
N006799 010 Apr 28, 1988
RUVITE
SAVAGE LABS 1MG/ML
A080570 002
VI-TWEL
BAYER HLTHCARE 1MG/ML
N007012 002
SPRAY, METERED;NASAL
CALOMIST
PAR PHARM 25MCG/SPRAY
N022102 001 Jul 27, 2007
TABLET;ORAL
CYANOCOBALAMIN
WEST WARD 1MG
A084264 001
CYANOCOBALAMIN CO-57
CAPSULE;ORAL
RUBRATOPE-57
BRACCO 0.5-1uCi
N016089 002
CYANOCOBALAMIN CO-60
CAPSULE;ORAL
RUBRATOPE-60
BRACCO 0.5-1uCi
N016090 002
CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; CYANOCOBALAMIN CO-58
N/A;N/A
DICOPAC KIT
GE HEALTHCARE N/A;N/A;N/A
N017406 001
CYANOCOBALAMIN; CYANOCOBALAMIN CO-57; INTRINSIC FACTOR
N/A;N/A
CYANOCOBALAMIN CO 57 SCHILLING TEST KIT
MALLINCKRODT 0.1MG;0.5uCi;60MG
N016635 001
CYANOCOBALAMIN; TANNIC ACID; ZINC ACETATE
INJECTABLE;INJECTION
DEPINAR
ARMOUR PHARM 0.5MG/ML;2.3MG/ML;1MG/ML
N011208 001
CYCLACILLIN
FOR SUSPENSION;ORAL
CYCLAPEN-W
WYETH AYERST 125MG/5ML
N050508 001
250MG/5ML
N050508 002
500MG/5ML
N050508 003
TABLET;ORAL
CYCLACILLIN
TEVA 250MG
A062895 001 Aug 04, 1988
500MG
A062895 002 Aug 04, 1988
CYCLAPEN-W
WYETH AYERST 250MG
N050509 001
500MG
N050509 002
CYCLIZINE LACTATE
INJECTABLE;INJECTION
MAREZINE
GLAXOSMITHKLINE 50MG/ML
N009495 001
CYCLOBENZAPRINE HYDROCHLORIDE
TABLET;ORAL
CYCLOBENZAPRINE HYDROCHLORIDE
PROSAM LABS 5MG
A077291 001 Feb 03, 2006
SANDOZ 5MG
A072854 002 Feb 03, 2006
10MG
A072854 001 Nov 19, 1991
10MG
A073683 001 Feb 26, 1993
WATSON LABS 10MG
A073143 001 Nov 27, 1991
10MG
A074436 001 Nov 30, 1994
FLEXERIL
JANSSEN RES AND DEV 5MG
N017821 001
10MG
N017821 002
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DISCONTINUED DRUG PRODUCT LIST 6-94(of 337)
CYCLOPENTOLATE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
AK-PENTOLATE
AKORN 1% A085555 001
AKPENTOLATE
AKORN 2% A040165 001 Jan 13, 1997
CYCLOPENTOLATE HYDROCHLORIDE
ALCON PHARMS LTD 1% A089162 001 Jan 24, 1991
SOLA BARNES HIND 1% A084150 001
1% A084863 001
PENTOLAIR
PHARMAFAIR 0.5% A088643 001 Feb 09, 1987
1% A088150 001 Feb 25, 1983
CYCLOPHOSPHAMIDE
INJECTABLE;INJECTION
CYCLOPHOSPHAMIDE
BAXTER HLTHCARE 1GM/VIAL A088374 001 Sep 24, 1986
100MG/VIAL A088371 001 Jul 03, 1986
200MG/VIAL A088372 001 Jul 03, 1986
500MG/VIAL A088373 001 Jul 03, 1986
CYTOXAN
BAXTER HLTHCARE 100MG/VIAL N012142 001
200MG/VIAL N012142 002
CYTOXAN (LYOPHILIZED)
BAXTER HLTHCARE 1GM/VIAL N012142 010 Sep 24, 1985
2GM/VIAL N012142 009 Dec 10, 1985
500MG/VIAL N012142 008 Jan 04, 1984
LYOPHILIZED CYTOXAN
BAXTER HLTHCARE 100MG/VIAL N012142 006 Dec 05, 1985
200MG/VIAL N012142 007 Dec 10, 1985
NEOSAR
BEDFORD 1GM/VIAL A087442 004 Jul 08, 1983
2GM/VIAL A087442 005 Mar 30, 1989
100MG/VIAL A087442 001 Feb 16, 1982
200MG/VIAL A087442 002 Feb 16, 1982
500MG/VIAL A087442 003 Feb 16, 1982
TEVA PARENTERAL 1GM/VIAL A040015 004 Apr 29, 1993
2GM/VIAL A040015 005 Apr 29, 1993
100MG/VIAL A040015 001 Apr 29, 1993
200MG/VIAL A040015 002 Apr 29, 1993
500MG/VIAL A040015 003 Apr 29, 1993
TABLET;ORAL
CYTOXAN
BAXTER HLTHCARE 25MG N012141 002
50MG N012141 001
CYCLOSPORINE
CAPSULE;ORAL
NEORAL
NOVARTIS 50MG N050715 003 Jul 14, 1995
SOLUTION;ORAL
CYCLOSPORINE
APOTEX INC 100MG/ML A065167 001 Jan 05, 2005
CYCLOTHIAZIDE
TABLET;ORAL
ANHYDRON
LILLY 2MG N013157 002
FLUIDIL
PHARMACIA AND UPJOHN 2MG N018173 001
CYCRIMINE HYDROCHLORIDE
TABLET;ORAL
PAGITANE
LILLY 1.25MG N008951 001
2.5MG N008951 002
CYPROHEPTADINE HYDROCHLORIDE
SYRUP;ORAL
CYPROHEPTADINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC 2MG/5ML A086833 001
HALSEY 2MG/5ML A089199 001 Jul 03, 1986
MORTON GROVE 2MG/5ML A087001 001 Nov 04, 1982
NASKA 2MG/5ML A089021 001 Dec 21, 1987
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DISCONTINUED DRUG PRODUCT LIST 6-95(of 337)
CYPROHEPTADINE HYDROCHLORIDE
SYRUP;ORAL
PERIACTIN
MERCK 2MG/5ML N013220 002
TABLET;ORAL
CYPROHEPTADINE HYDROCHLORIDE
AM THERAP 4MG A088798 001 Feb 15, 1985
ASCOT 4MG A087685 001 Oct 25, 1982
DURAMED PHARMS BARR 4MG A088232 001 Oct 25, 1983
HALSEY 4MG A089057 001 Jul 03, 1986
KV PHARM 4MG A086737 001
MD PHARM 4MG A087566 001 Nov 10, 1982
MYLAN 4MG A086678 001
PIONEER PHARMS 4MG A087839 001 Feb 08, 1984
PLIVA 4MG A088205 001 Jul 26, 1983
SANDOZ 4MG A086808 001
SUPERPHARM 4MG A087405 001
TG UNITED LABS 4MG A088212 001 May 26, 1983
VITARINE 4MG A087284 001
WATSON LABS 4MG A085245 001
4MG A086165 001
4MG A086580 001
PERIACTIN
MERCK 4MG N012649 001
CYSTEINE HYDROCHLORIDE
INJECTABLE;INJECTION
CYSTEINE HYDROCHLORIDE
HOSPIRA 7.25% **Federal Register determination N019523 001 Oct 22, 1986
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
CYTARABINE
INJECTABLE;INJECTION
CYTARABINE
TEVA PARENTERAL 1GM/VIAL N016793 003 Dec 21, 1987
2GM/VIAL N016793 004 Dec 21, 1987
100MG/VIAL N016793 001
500MG/VIAL N016793 002
DACARBAZINE
INJECTABLE;INJECTION
DACARBAZINE
ABRAXIS PHARM 100MG/VIAL A070962 001 Aug 28, 1986
200MG/VIAL A070990 001 Aug 28, 1986
DALFOPRISTIN; QUINUPRISTIN
INJECTABLE;IV (INFUSION)
SYNERCID
KING PHARMS 420MG/VIAL;180MG/VIAL N050748 002 Aug 24, 2000
DALTEPARIN SODIUM
INJECTABLE;INJECTION
FRAGMIN
EISAI INC 7,500 IU/0.75ML N020287 008 Apr 04, 2002
INJECTABLE;SUBCUTANEOUS
FRAGMIN
EISAI INC 10,000IU/0.4ML (25,000IU/ML) N020287 002 May 01, 2007
95,000IU/9.5ML (10,000IU/ML) N020287 007 Apr 04, 2002
DANAPAROID SODIUM
INJECTABLE;INJECTION
ORGARAN
AGI 750 UNITS/0.6ML N020430 001 Dec 24, 1996
DANAZOL
CAPSULE;ORAL
DANAZOL
AM THERAP 200MG A071569 001 Dec 30, 1987
DANOCRINE
SANOFI AVENTIS US 50MG N017557 003
100MG N017557 004
200MG N017557 002
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DISCONTINUED DRUG PRODUCT LIST 6-96(of 337)
DAPIPRAZOLE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
DAPIPRAZOLE HYDROCHLORIDE
FERA PHARMS 0.5% N019849 001 Dec 31, 1990
DAPTOMYCIN
INJECTABLE;IV (INFUSION)
CUBICIN
CUBIST 250MG/VIAL N021572 001 Sep 12, 2003
DARUNAVIR ETHANOLATE
TABLET;ORAL
PREZISTA
JANSSEN PRODS EQ 300MG BASE **Federal Register N021976 001 Jun 23, 2006
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 400MG BASE **Federal Register N021976 003 Oct 21, 2008
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
DAUNORUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
CERUBIDINE
SANOFI AVENTIS US EQ 20MG BASE/VIAL A061876 001
WYETH AYERST EQ 20MG BASE/VIAL N050484 001
DAUNORUBICIN HYDROCHLORIDE
TEVA PARENTERAL EQ 20MG BASE/VIAL A064212 001 Jun 23, 1998
EQ 50MG BASE/VIAL A064212 002 May 03, 1999
DECAMETHONIUM BROMIDE
INJECTABLE;INJECTION
SYNCURINE
GLAXOSMITHKLINE 1MG/ML N006931 002
DEFEROXAMINE MESYLATE
INJECTABLE;INJECTION
DEFEROXAMINE MESYLATE
WATSON LABS 2GM/VIAL A076806 002 Mar 31, 2006
500MG/VIAL A076806 001 Mar 31, 2006
DEMECARIUM BROMIDE
SOLUTION/DROPS;OPHTHALMIC
HUMORSOL
MERCK 0.125% N011860 002
0.25% N011860 001
DEMECLOCYCLINE HYDROCHLORIDE
CAPSULE;ORAL
DECLOMYCIN
LEDERLE 150MG N050262 001
SYRUP;ORAL
DECLOMYCIN
LEDERLE 75MG/5ML N050257 001
TABLET;ORAL
DECLOMYCIN
COREPHARMA 75MG N050261 001
150MG N050261 002
300MG N050261 003
DESERPIDINE
TABLET;ORAL
HARMONYL
ABBVIE 0.1MG N010796 001
0.25MG N010796 002
DESERPIDINE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
ORETICYL 25
ABBVIE 0.125MG;25MG N012148 001
ORETICYL 50
ABBVIE 0.125MG;50MG N012148 003
ORETICYL FORTE
ABBVIE 0.25MG;25MG N012148 002
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6-97(of 337)
DESERPIDINE; METHYCLOTHIAZIDE
TABLET;ORAL
ENDURONYL
ABBOTT 0.25MG;5MG
N012775 001
ENDURONYL FORTE
ABBOTT 0.5MG;5MG
N012775 002
METHYCLOTHIAZIDE AND DESERPIDINE
WATSON LABS
0.25MG;5MG
A088486 001
Aug 10, 1984
0.5MG;5MG
A088452 001
Aug 10, 1984
DESIPRAMINE HYDROCHLORIDE
CAPSULE;ORAL
PERTOFRANE
SANOFI AVENTIS US
25MG
N013621 001
50MG
N013621 002
TABLET;ORAL
DESIPRAMINE HYDROCHLORIDE
ANI PHARMS INC
25MG
A071800 001
Dec 08, 1987
50MG
A071801 001
Dec 08, 1987
75MG
A071802 001
Dec 08, 1987
100MG
A071803 001
May 29, 1997
150MG
A071804 001
May 29, 1997
USL PHARMA
25MG
A071864 001
Sep 09, 1987
50MG
A071865 001
Sep 09, 1987
75MG
A071866 001
Sep 09, 1987
100MG
A071867 001
Sep 09, 1987
DESLANOSIDE
INJECTABLE;INJECTION
CEDILANID-D
NOVARTIS
0.2MG/ML
N009282 002
DESMOPRESSIN ACETATE
INJECTABLE;INJECTION
DDAVP
FERRING PHARMS INC
0.015MG/ML
N018938 002
Apr 25, 1995
DESMOPRESSIN ACETATE
BEDFORD
0.004MG/ML
A074575 001
Feb 18, 2000
DESMOPRESSIN ACETATE PRESERVATIVE FREE
BEDFORD
0.004MG/ML
A074574 001
Feb 18, 2000
SOLUTION;NASAL
CONCENTRAID
FERRING
0.01%
N019776 001
Dec 26, 1990
SPRAY, METERED;NASAL
DDAVP
FERRING PHARMS INC
0.01MG/SPRAY
N017922 002
Feb 06, 1989
STIMATE
CSL BEHRING
0.15MG/SPRAY
N020355 001
Mar 07, 1994
DESOGESTREL; ETHINYL ESTRADIOL
TABLET;ORAL-21
DESOGEN
ORGANON USA INC
0.15MG;0.03MG
N020071 001
Dec 10, 1992
DESOGESTREL AND ETHINYL ESTRADIOL
DURAMED PHARMS BARR
0.15MG;0.03MG
A075256 001
Aug 12, 1999
ORTHO-CEPT
JANSSEN PHARMS
0.15MG;0.03MG
N020301 001
Dec 14, 1992
TABLET;ORAL-28
MIRCETTE
TEVA BRANDED PHARM
0.15MG,N/A;0.02MG,0.01MG;0.02MG,0.01MG
N020713 001
Apr 22, 1998
**Federal Register determination that
product was not discontinued or
withdrawn for safety or efficacy
reasons**
DESONIDE
CREAM;TOPICAL
DESONIDE
TEVA PHARMS
0.05%
A074027 001
Sep 28, 1992
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DISCONTINUED DRUG PRODUCT LIST 6-98(of 337)
DESOXIMETASONE
CREAM;TOPICAL
TOPICORT
TARO PHARMS NORTH 0.25% **Federal Register determination N017856 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
TOPICORT LP
TARO PHARMS NORTH 0.05% N018309 001
GEL;TOPICAL
TOPICORT
TARO PHARMS NORTH 0.05% N018586 001 Mar 29, 1982
OINTMENT;TOPICAL
DESOXIMETASONE
ALTANA 0.25% A073440 001 Apr 01, 1998
TOPICORT
TARO PHARMS NORTH 0.25% N018763 001 Sep 30, 1983
DESOXYCORTICOSTERONE ACETATE
INJECTABLE;INJECTION
DOCA
ORGANON USA INC 5MG/ML N001104 001
PELLET;IMPLANTATION
PERCORTEN
NOVARTIS 125MG N005151 001
DESOXYCORTICOSTERONE PIVALATE
INJECTABLE;INJECTION
PERCORTEN
NOVARTIS 25MG/ML N008822 001
DESVENLAFAXINE FUMARATE
TABLET, EXTENDED RELEASE;ORAL
DESVENLAFAXINE
TEVA PHARMS USA EQ 50MG BASE N205208 001 Oct 11, 2013
EQ 100MG BASE N205208 002 Oct 11, 2013
DEXAMETHASONE
AEROSOL;TOPICAL
AEROSEB-DEX
ALLERGAN HERBERT 0.01% **Federal Register determination A083296 002
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
DECASPRAY
MERCK 0.04% **Federal Register determination N012731 002
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
ELIXIR;ORAL
DECADRON
MERCK 0.5MG/5ML N012376 002
DEXAMETHASONE
ALPHARMA US PHARMS 0.5MG/5ML A088997 001 Oct 10, 1986
HEXADROL
ORGANON USA INC 0.5MG/5ML N012674 001
GEL;TOPICAL
DECADERM
MERCK 0.1% N013538 001
SUSPENSION/DROPS;OPHTHALMIC
DEXAMETHASONE
WATSON LABS 0.1% A089170 001 May 09, 1989
TABLET;ORAL
DECADRON
MERCK 0.25MG **Federal Register determination N011664 004
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
0.5MG **Federal Register determination N011664 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
0.75MG **Federal Register determination N011664 002
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
1.5MG N011664 003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-99(of 337)
DEXAMETHASONE
TABLET;ORAL
DECADRON
4MG N011664 005
6MG N011664 006 Jul 30, 1982
DEXAMETHASONE
IMPAX LABS 0.75MG A085376 001
MUTUAL PHARM 0.25MG A084013 001
0.25MG A084764 001
0.5MG A084084 001
0.5MG A084766 001
0.75MG A084081 001
0.75MG A084765 001
1.5MG A084086 001
1.5MG A084763 001
PAR PHARM 0.25MG A088149 001 Apr 28, 1983
PHOENIX LABS NY 0.75MG A083806 001
PVT FORM 0.75MG A083420 001
ROXANE 0.25MG A084614 001
SANDOZ 0.75MG A080399 001
UPSHER SMITH 0.75MG A087534 001
1.5MG A087533 001
WATSON LABS 0.25MG A085455 001
0.5MG A085458 001
0.75MG A080968 001
0.75MG A084457 001
0.75MG A085818 001
1.5MG A085456 001
1.5MG A085840 001
WHITEWORTH TOWN PLSN 0.75MG A084327 001
DEXONE 0.5
SOLVAY 0.5MG A084991 001
DEXONE 0.75
SOLVAY 0.75MG A084993 001
DEXONE 1.5
SOLVAY 1.5MG A084990 001
DEXONE 4
SOLVAY 4MG A084992 001
HEXADROL
ORGANON USA INC 0.5MG N012675 004
0.75MG N012675 007
1.5MG N012675 009
4MG N012675 010
DEXAMETHASONE ACETATE
INJECTABLE;INJECTION
DECADRON-LA
MERCK EQ 8MG BASE/ML **Federal Register N016675 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
DEXAMETHASONE ACETATE
WATSON LABS EQ 8MG BASE/ML A084315 001
EQ 16MG BASE/ML A087711 001 May 24, 1982
DEXAMETHASONE SODIUM PHOSPHATE
AEROSOL;NASAL
DEXACORT
UCB INC EQ 0.1MG PHOSPHATE/INH N014242 001
AEROSOL, METERED;INHALATION
DEXACORT
UCB INC EQ 0.1MG PHOSPHATE/INH N013413 001
CREAM;TOPICAL
DECADRON
MERCK EQ 0.1% PHOSPHATE N011983 002
INJECTABLE;INJECTION
DECADRON
MERCK EQ 4MG PHOSPHATE/ML N012071 002
EQ 24MG PHOSPHATE/ML **Federal Register N012071 004
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
DEXACEN-4
CENT PHARMS EQ 4MG PHOSPHATE/ML A084342 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-100(of 337)
DEXAMETHASONE SODIUM PHOSPHATE
INJECTABLE;INJECTION
DEXAMETHASONE
ABRAXIS PHARM EQ 4MG PHOSPHATE/ML
A088448 001 Jan 25, 1984
FRESENIUS KABI USA EQ 10MG PHOSPHATE/ML
A088469 001 Jan 25, 1984
DEXAMETHASONE SODIUM PHOSPHATE
AKORN
EQ 4MG PHOSPHATE/ML
A084493 001
BEL MAR
EQ 4MG PHOSPHATE/ML
A084752 001
DELL LABS
EQ 4MG PHOSPHATE/ML
A083161 001
HIKMA MAPLE
EQ 4MG PHOSPHATE/ML
A084282 001
INTL MEDICATION
EQ 20MG PHOSPHATE/ML
A088522 001 Feb 17, 1984
LYPHOMED
EQ 4MG PHOSPHATE/ML
A087065 001
TEVA PARENTERAL
EQ 4MG PHOSPHATE/ML
A081125 001 Aug 31, 1990
EQ 10MG PHOSPHATE/ML
A081126 001 Aug 31, 1990
WATSON LABS
EQ 4MG PHOSPHATE/ML
A083702 001
EQ 4MG PHOSPHATE/ML
A084355 001
EQ 4MG PHOSPHATE/ML
A089169 001 Apr 09, 1986
EQ 10MG PHOSPHATE/ML
A087668 001 Jul 01, 1982
EQ 24MG PHOSPHATE/ML
A085606 001
WYETH AYERST
EQ 4MG PHOSPHATE/ML
A085641 001
HEXADROL
ORGANON USA INC
EQ 4MG PHOSPHATE/ML
N014694 002
EQ 10MG PHOSPHATE/ML
N014694 003
EQ 20MG PHOSPHATE/ML
N014694 004
OINTMENT;OPHTHALMIC
DECADRON
MERCK
EQ 0.05% PHOSPHATE
N011977 001
DEXAIR
PHARMAFAIR
EQ 0.05% PHOSPHATE
A088071 001 Dec 28, 1982
MAXIDEX
ALCON
EQ 0.05% PHOSPHATE
A083342 001
SOLUTION/DROPS;OPHTHALMIC
DEXAIR
PHARMAFAIR
EQ 0.1% PHOSPHATE
A088433 001 Dec 15, 1983
DEXAMETHASONE SODIUM PHOSPHATE
SOLA BARNES HIND EQ 0.1% PHOSPHATE
A084170 001
EQ 0.1% PHOSPHATE
A084173 001
SOLUTION/DROPS;OPHTHALMIC, OTIC
DECADRON
MERCK EQ 0.1% PHOSPHATE
N011984 001
SOLUTION/DROPS;OTIC
DEXAMETHASONE SODIUM PHOSPHATE
AKORN EQ 0.1% PHOSPHATE
A084855 001
DEXAMETHASONE SODIUM PHOSPHATE; LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
DECADRON W/ XYLOCAINE
MERCK EQ 4MG PHOSPHATE/ML;10MG/ML
N013334 002
DEXAMETHASONE SODIUM PHOSPHATE; NEOMYCIN SULFATE
OINTMENT;OPHTHALMIC
NEODECADRON
MERCK
EQ 0.05% PHOSPHATE;EQ 3.5MG BASE/GM
N050324 001
SOLUTION/DROPS;OPHTHALMIC
NEODECADRON
MERCK
EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML
N050322 001
NEOMYCIN SULFATE AND DEXAMETHASONE SODIUM PHOSPHATE
BAUSCH AND LOMB EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML
A064055 001 Oct 30, 1995
NEOMYCIN SULFATE-DEXAMETHASONE SODIUM PHOSPHATE
ALCON PHARMS LTD EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML
A062714 001 Jul 21, 1986
PHARMAFAIR EQ 0.1% PHOSPHATE;EQ 3.5MG BASE/ML
A062539 001 Jan 10, 1985
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
OINTMENT;OPHTHALMIC
DEXACIDIN
NOVARTIS
0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
A062566 001 Feb 22, 1985
DEXASPORIN
PHARMAFAIR
0.1%;EQ 3.5MG BASE/GM;10,000 UNITS/GM
A062411 001 May 16, 1983
SUSPENSION/DROPS;OPHTHALMIC
DEXACIDIN
NOVARTIS
0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A062544 001 Oct 29, 1984
DEXASPORIN
PHARMAFAIR
0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A062428 001 May 18, 1983
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-101(of 337)
DEXAMETHASONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
SUSPENSION/DROPS;OPHTHALMIC
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE
ALCON PHARMS LTD 0.1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A062721 001
Nov 17, 1986
DEXBROMPHENIRAMINE MALEATE
SYRUP;ORAL
DISOMER
SCHERING 2MG/5ML
N011814 002
TABLET;ORAL
DISOMER
SCHERING 2MG
N011814 001
DEXBROMPHENIRAMINE MALEATE; PSEUDOEPHEDRINE SULFATE
TABLET;ORAL
DISOPHROL
SCHERING
2MG;60MG
N012394 002
TABLET, EXTENDED RELEASE;ORAL
BROMPHERIL
COPLEY PHARM
6MG;120MG
A089116 001
Jan 22, 1987
DISOBROM
SANDOZ
6MG;120MG
A070770 001
Sep 30, 1991
DISOPHROL
SCHERING PLOUGH
6MG;120MG
N013483 004
Sep 13, 1982
DRIXORAL
SCHERING PLOUGH
6MG;120MG **Federal Register
N013483 003
Sep 13, 1982
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
RESPORAL
PIONEER PHARMS
6MG;120MG
A089139 001
Jun 16, 1988
DEXCHLORPHENIRAMINE MALEATE
SYRUP;ORAL
POLARAMINE
SCHERING
2MG/5ML
A086837 001
Jul 19, 1982
TABLET;ORAL
DEXCHLORPHENIRAMINE MALEATE
ANI PHARMS INC
2MG
A088682 001
Jan 17, 1986
POLARAMINE
SCHERING
2MG
A086835 001
DEXTROAMPHETAMINE SULFATE
CAPSULE;ORAL
DEXAMPEX
TEVA
15MG
A085355 001
CAPSULE, EXTENDED RELEASE;ORAL
DEXTROAMPHETAMINE SULFATE
ABLE
5MG
A076814 001
Aug 25, 2004
10MG
A076814 002
Aug 25, 2004
15MG
A076814 003
Aug 25, 2004
ELIXIR;ORAL
DEXEDRINE
GLAXOSMITHKLINE
5MG/5ML **Federal Register
A083902 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
TABLET;ORAL
DEXAMPEX
TEVA
5MG
A083735 001
10MG
A083735 002
DEXEDRINE
GLAXOSMITHKLINE
5MG
A084935 001
DEXTROAMPHETAMINE SULFATE
HALSEY
10MG
A083930 001
LANNETT
5MG
A083903 001
10MG
A083903 003
15MG
A085652 001
MAST MM
5MG
A086521 001
NESHER PHARMS
5MG
A040365 001
Oct 31, 2002
10MG
A040367 001
Oct 31, 2002
PUREPAC PHARM
5MG
A084125 001
SANDOZ
5MG
A085370 001
10MG
A085371 001
VINTAGE PHARMS LLC
5MG
A040299 001
May 13, 1999
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-102(of 337)
DEXTROAMPHETAMINE SULFATE
TABLET;ORAL
DEXTROAMPHETAMINE SULFATE
VITARINE 5MG A084986 001
10MG A085892 001
DEXTROSTAT
SHIRE 5MG A084051 001
10MG A084051 002
FERNDEX
FERNDALE LABS 5MG A084001 001
DEXTROMETHORPHAN HYDROBROMIDE; PROMETHAZINE HYDROCHLORIDE
SYRUP;ORAL
PHERAZINE DM
HALSEY 15MG/5ML;6.25MG/5ML A088913 001 Mar 02, 1987
PROMETH W/ DEXTROMETHORPHAN
ACTAVIS MID ATLANTIC 15MG/5ML;6.25MG/5ML A088762 001 Oct 31, 1984
PROMETHAZINE HYDROCHLORIDE AND DESTROMETHORPHAN HYDROBROMIDE
ANI PHARMS 15MG/5ML;6.25MG/5ML N011265 002 Apr 02, 1984
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE
AMNEAL PHARMS 15MG/5ML;6.25MG/5ML A090575 001 Feb 08, 2011
TRIS PHARMA INC 15MG/5ML;6.25MG/5ML A091687 001 Jun 28, 2012
DEXTROSE
INJECTABLE;INJECTION
DEXTROSE 10% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML N018046 001
MILES 10GM/100ML N018504 001
DEXTROSE 2.5% IN PLASTIC CONTAINER
B BRAUN 2.5GM/100ML N018358 001
2.5GM/100ML N019626 001 Feb 02, 1988
DEXTROSE 38.5% IN PLASTIC CONTAINER
ABBOTT 38.5GM/100ML N018923 001 Sep 19, 1984
DEXTROSE 5% IN PLASTIC CONTAINER
DHL 5GM/100ML N019971 001 Sep 28, 1995
DEXTROSE 60%
B BRAUN 60GM/100ML N017995 002 Sep 22, 1982
DEXTROSE 60% IN PLASTIC CONTAINER
B BRAUN 60GM/100ML N017995 001
BAXTER HLTHCARE 60GM/100ML N020047 002 Jul 02, 1991
HOSPIRA 60GM/100ML N019346 001 Jan 25, 1985
DEXTROSE 7.7% IN PLASTIC CONTAINER
B BRAUN 7.7GM/100ML N019626 003 Feb 02, 1988
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE
INJECTABLE;INJECTION
ISOLYTE P W/ DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;31MG/100ML;130MG/100ML;26MG/1 N019025 001 Dec 27, 1984
00ML;320MG/100ML
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
ISOLYTE H W/ DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;30MG/100ML;97MG/100ML;220MG/1 N018273 001
00ML;140MG/100ML
DEXTROSE; MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM
GLUCONATE
INJECTABLE;INJECTION
ISOLYTE S W/ DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;30MG/100ML;37MG/100ML;370MG/1 N018274 001
00ML;530MG/100ML;500MG/100ML
DEXTROSE; POTASSIUM CHLORIDE
INJECTABLE;INJECTION
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;37MG/100ML N019699 001 Sep 29, 1989
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;75MG/100ML N019699 002 Sep 29, 1989
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;110MG/100ML N019699 003 Sep 29, 1989
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML N018744 003 Nov 09, 1982
5GM/100ML;220MG/100ML N019699 005 Sep 29, 1989
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-103(of 337)
DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM LACTATE; SODIUM CHLORIDE; SODIUM PHOSPHATE, MONOBASIC
ANHYDROUS
INJECTABLE;INJECTION
IONOSOL T AND DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 5GM/100ML;111MG/100ML;256MG/100ML;146MG N019514 001 May 08, 1986
/100ML;207MG/100ML
DEXTROSE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, DIBASIC; SODIUM ACETATE; SODIUM CHLORIDE
INJECTABLE;INJECTION
ISOLYTE M W/ DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;150MG/100ML;130MG/100ML;280MG N018270 001
/100ML;91MG/100ML
DEXTROSE; POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.075%
B BRAUN 5GM/100ML;75MG/100ML;200MG/100ML N018268 009
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;150MG/100ML;200MG/100ML N018268 004
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML;200MG/100ML N018268 005
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;300MG/100ML;200MG/100ML N018268 006
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;75MG/100ML;330MG/100ML N018268 011 Jan 18, 1986
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;150MG/100ML;330MG/100ML N018268 012 Jan 18, 1986
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML;330MG/100ML N018268 013 Jan 18, 1986
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 0.30% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;300MG/100ML;330MG/100ML N018268 014 Jan 18, 1986
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.075%
B BRAUN 5GM/100ML;75MG/100ML;450MG/100ML N018268 010
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;150MG/100ML;450MG/100ML N018268 001
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;220MG/100ML;450MG/100ML N018268 002
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;300MG/100ML;450MG/100ML N018268 003
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;224MG/100ML;450MG/100ML N018008 003
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;300MG/100ML;450MG/100ML N018008 001
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER
BAXTER HLTHCARE 5GM/100ML;75MG/100ML;450MG/100ML N018008 002
DEXTROSE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;200MG/100ML N018386 001
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;450MG/100ML N018229 001
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 10GM/100ML;900MG/100ML N018047 001
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 2.5GM/100ML;450MG/100ML N018030 001
HOSPIRA 2.5GM/100ML;450MG/100ML N018096 001
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 2.5GM/100ML;900MG/100ML N018376 001
DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
ABBOTT 3.3GM/100ML;300MG/100ML N018055 001
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;110MG/100ML N018030 005
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;200MG/100ML N018030 004
MILES 5GM/100ML;200MG/100ML N018399 001
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER
ABBOTT 5GM/100ML;225MG/100ML N019482 001 Oct 04, 1985
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
ABBOTT 5GM/100ML;300MG/100ML N019486 001 Oct 04, 1985
MILES 5GM/100ML;300MG/100ML N018501 001
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML;330MG/100ML N018030 003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-104(of 337)
DEXTROSE; SODIUM CHLORIDE
INJECTABLE;INJECTION
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
ABBOTT 5GM/100ML;450MG/100ML
N019484 001 Oct 04, 1985
B BRAUN 5GM/100ML;450MG/100ML
N018030 002
MILES 5GM/100ML;450MG/100ML
N018400 001
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ABBOTT
5GM/100ML;900MG/100ML
N019483 001 Oct 04, 1985
B BRAUN
5GM/100ML;900MG/100ML
N018026 001
MILES
5GM/100ML;900MG/100ML
N018500 001
DEXTROTHYROXINE SODIUM
TABLET;ORAL
CHOLOXIN
ABBVIE
1MG
N012302 005
2MG
N012302 002
4MG
N012302 004
6MG
N012302 006
DEZOCINE
INJECTABLE;INJECTION
DALGAN
ASTRAZENECA
5MG/ML
N019082 001 Dec 29, 1989
10MG/ML
N019082 002 Dec 29, 1989
15MG/ML
N019082 003 Dec 29, 1989
DIATRIZOATE MEGLUMINE
INJECTABLE;INJECTION
ANGIOVIST 282
BAYER HLTHCARE
60%
A087726 001 Sep 23, 1982
CARDIOGRAFIN
BRACCO
85%
N011620 002
DIATRIZOATE MEGLUMINE
BRACCO
76%
N010040 017
HYPAQUE
GE HEALTHCARE
30%
N016403 002
60%
N016403 001
RENO-60
BRACCO
60%
N010040 016
RENO-DIP
BRACCO
30%
N010040 012
UROVIST MEGLUMINE DIU/CT
BAYER HLTHCARE
30%
A087739 001 Sep 23, 1982
SOLUTION;URETERAL
RENO-30
BRACCO
30%
N010040 021
UROVIST CYSTO
BAYER HLTHCARE
30%
A087729 001 Sep 23, 1982
UROVIST CYSTO PEDIATRIC
BAYER HLTHCARE
30%
A087731 001 Sep 23, 1982
SOLUTION;URETHRAL
HYPAQUE-CYSTO
GE HEALTHCARE
30%
N016403 003
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
INJECTABLE;INJECTION
ANGIOVIST 292
BAYER HLTHCARE
52%;8%
A087724 001 Sep 23, 1982
ANGIOVIST 370
BAYER HLTHCARE
66%;10%
A087723 001 Sep 23, 1982
DIATRIZOATE-60
INTL MEDICATION
52%;8%
A088166 001 Jun 17, 1983
HYPAQUE-76
GE HEALTHCARE
66%;10%
A086505 001
HYPAQUE-M,75%
GE HEALTHCARE
50%;25%
N010220 003
HYPAQUE-M,90%
GE HEALTHCARE
60%;30%
N010220 002
MD-60
MALLINCKRODT
52%;8%
A087074 001
MD-76
MALLINCKRODT
66%;10%
A087073 001
RENOCAL-76
BRACCO
66%;10%
A089347 001 Jun 01, 1988
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DISCONTINUED DRUG PRODUCT LIST 6-105(of 337)
DIATRIZOATE MEGLUMINE; DIATRIZOATE SODIUM
INJECTABLE;INJECTION
RENOGRAFIN-60
BRACCO 52%;8% N010040 006
RENOVIST
BRACCO 34.3%;35% N010040 020
RENOVIST II
BRACCO 28.5%;29.1% N010040 019
SOLUTION;ORAL, RECTAL
GASTROVIST
BAYER HLTHCARE 66%;10% A087728 001 Sep 23, 1982
DIATRIZOATE SODIUM
FOR SOLUTION;ORAL, RECTAL
HYPAQUE
GE HEALTHCARE 100% N011386 001
INJECTABLE;INJECTION
HYPAQUE
GE HEALTHCARE 25% N009561 003
50% N009561 001
MD-50
MALLINCKRODT 50% A087075 001
UROVIST SODIUM 300
BAYER HLTHCARE 50% A087725 001 Sep 23, 1982
SOLUTION;ORAL, RECTAL
HYPAQUE
GE HEALTHCARE 40% N011386 003
SOLUTION;URETERAL
HYPAQUE SODIUM 20%
GE HEALTHCARE 20% N009561 002
DIAZEPAM
CAPSULE, EXTENDED RELEASE;ORAL
VALRELEASE
ROCHE 15MG N018179 001
GEL;RECTAL
DIASTAT
VALEANT PHARMS NORTH 5MG/ML (5MG/ML) **Federal Register N020648 002 Jul 29, 1997
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
10MG/2ML (5MG/ML) N020648 003 Jul 29, 1997
15MG/3ML (5MG/ML) N020648 004 Jul 29, 1997
20MG/4ML (5MG/ML) N020648 005 Jul 29, 1997
INJECTABLE;INJECTION
DIAZEPAM
ABRAXIS PHARM 5MG/ML A070662 001 Jun 25, 1986
HIKMA MAPLE 5MG/ML A070311 001 Dec 16, 1985
5MG/ML A070312 001 Dec 16, 1985
5MG/ML A070313 001 Dec 16, 1985
5MG/ML A071308 001 Jul 17, 1987
5MG/ML A071309 001 Jul 17, 1987
5MG/ML A071310 001 Jul 17, 1987
HOSPIRA 5MG/ML A071584 001 Oct 13, 1987
MARSAM PHARMS LLC 5MG/ML A072371 001 Jan 29, 1993
PARENTA PHARMS 5MG/ML A076815 001 Apr 15, 2004
US ARMY 5MG/ML N020124 001 Dec 05, 1990
WARNER CHILCOTT 5MG/ML A071613 001 Oct 22, 1987
5MG/ML A071614 001 Oct 22, 1987
WATSON LABS 5MG/ML A070296 001 Feb 12, 1986
5MG/ML A070911 001 Aug 28, 1986
5MG/ML A070912 001 Aug 28, 1986
5MG/ML A070930 001 Dec 01, 1986
WATSON LABS INC 5MG/ML A072370 001 Jan 29, 1993
5MG/ML A072397 001 Jan 29, 1993
DIZAC
PHARMACIA AND UPJOHN 5MG/ML N019287 001 Jun 18, 1993
VALIUM
ROCHE 5MG/ML N016087 001
TABLET;ORAL
DIAZEPAM
ACTAVIS ELIZABETH 2MG A070781 001 Mar 19, 1986
5MG A070706 001 Mar 19, 1986
10MG A070707 001 Mar 19, 1986
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DISCONTINUED DRUG PRODUCT LIST 6-106(of 337)
DIAZEPAM
TABLET;ORAL
DIAZEPAM
DAVA PHARMS INC 2MG A070226 001 Sep 26, 1985
5MG A070227 001 Sep 26, 1985
10MG A070228 001 Sep 26, 1985
DURAMED PHARMS BARR 2MG A070894 001 Aug 27, 1986
5MG A070895 001 Aug 27, 1986
10MG A070896 001 Aug 27, 1986
FERNDALE LABS 2MG A070903 001 Apr 01, 1987
5MG A070904 001 Apr 01, 1987
10MG A070905 001 Apr 01, 1987
HALSEY 2MG A070987 001 Aug 15, 1986
5MG A070996 001 Aug 15, 1986
10MG A070956 001 Aug 15, 1986
IVAX SUB TEVA PHARMS 2MG A070360 001 Sep 04, 1985
5MG A070361 001 Sep 04, 1985
10MG A070362 001 Sep 04, 1985
MARTEC USA LLC 10MG A072402 001 Apr 25, 1989
PAR PHARM 2MG A070462 001 Feb 25, 1986
5MG A070463 001 Feb 25, 1986
10MG A070464 001 Feb 25, 1986
PIONEER PHARMS 2MG A070787 001 Aug 02, 1988
5MG A070788 001 Aug 02, 1988
10MG A070776 001 Aug 02, 1988
ROXANE 2MG A070356 001 Jun 17, 1986
5MG A070357 001 Jun 17, 1986
10MG A070358 001 Jun 17, 1986
SANDOZ 2MG A070302 001 Dec 20, 1985
5MG A070303 001 Dec 20, 1985
10MG A070304 001 Dec 20, 1985
TEVA PHARMS 5MG A070153 001 Nov 01, 1985
WARNER CHILCOTT 2MG A070209 001 Sep 04, 1985
5MG A070210 001 Sep 04, 1985
10MG A070222 001 Sep 04, 1985
WATSON LABS 2MG A070456 001 Nov 01, 1985
5MG A070457 001 Nov 01, 1985
10MG A070458 001 Nov 01, 1985
Q-PAM
QUANTUM PHARMICS 2MG A070423 001 Dec 12, 1985
2MG A072431 001 Apr 29, 1988
5MG A070424 001 Dec 12, 1985
5MG A072432 001 Apr 29, 1988
10MG A070425 001 Dec 12, 1985
10MG A072433 001 Apr 29, 1988
DIAZOXIDE
CAPSULE;ORAL
PROGLYCEM
TEVA BRANDED PHARM 50MG N017425 001
100MG N017425 002
INJECTABLE;INJECTION
DIAZOXIDE
ABRAXIS PHARM 15MG/ML A071519 001 Aug 26, 1987
HYPERSTAT
SCHERING 15MG/ML N016996 001
DIBUCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
HEAVY SOLUTION NUPERCAINE
NOVARTIS 2.5MG/ML N006203 001
DICHLORPHENAMIDE
TABLET;ORAL
DARANIDE
TARO 50MG **Federal Register determination N011366 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
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DISCONTINUED DRUG PRODUCT LIST 6-107(of 337)
DICLOFENAC POTASSIUM
TABLET;ORAL
CATAFLAM
NOVARTIS 25MG **Federal Register determination N020142 001 Nov 24, 1993
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
DICLOFENAC POTASSIUM
MUTUAL PHARM 50MG A075470 001 Feb 21, 2002
SANDOZ 50MG A075582 001 Feb 23, 2001
WATSON LABS 50MG A075152 001 Nov 27, 1998
DICLOFENAC SODIUM
SOLUTION/DROPS;OPHTHALMIC
DICLOFENAC SODIUM
APOTEX INC 0.1% A077600 001 Nov 13, 2008
FALCON PHARMS 0.1% N020809 001 May 04, 1998
TABLET, DELAYED RELEASE;ORAL
DICLOFENAC SODIUM
NOSTRUM LABS 50MG A074986 001 Feb 26, 1999
75MG A074986 002 Feb 26, 1999
PLIVA 50MG A074432 002 Jul 29, 1999
75MG A074432 003 Jul 29, 1999
ROXANE 25MG A074391 001 Jun 29, 1995
50MG A074391 002 Jun 29, 1995
75MG A074391 003 Jun 29, 1995
TEVA 50MG A074723 001 Mar 30, 1999
75MG A074390 001 Aug 15, 1996
TEVA PHARMS 25MG A074459 001 Jun 25, 1997
50MG A074459 002 Jun 25, 1997
75MG A074459 003 Jun 25, 1997
VOLTAREN
NOVARTIS 25MG N019201 001 Jul 28, 1988
50MG N019201 002 Jul 28, 1988
75MG N019201 003 Jul 28, 1988
DICLOXACILLIN SODIUM
CAPSULE;ORAL
DYCILL
GLAXOSMITHKLINE EQ 250MG BASE A060254 002
EQ 250MG BASE A062238 001
EQ 500MG BASE A060254 003
EQ 500MG BASE A062238 002
PATHOCIL
WYETH AYERST EQ 250MG BASE N050011 002
EQ 500MG BASE N050011 003 Mar 28, 1983
FOR SUSPENSION;ORAL
DICLOXACILLIN SODIUM
APOTHECON EQ 62.5MG BASE/5ML A061455 001
DYNAPEN
APOTHECON EQ 62.5MG BASE/5ML N050337 002
PATHOCIL
WYETH AYERST EQ 62.5MG BASE/5ML N050092 001
DICUMAROL
CAPSULE;ORAL
DICUMAROL
LILLY 25MG N005509 003
50MG N005509 001
TABLET;ORAL
DICUMAROL
ABBVIE 25MG N005545 003
50MG N005545 004
100MG N005545 005
DICYCLOMINE HYDROCHLORIDE
CAPSULE;ORAL
DICYCLOMINE HYDROCHLORIDE
HIKMA PHARMS LLC 10MG A040204 001 Feb 28, 1997
MUTUAL PHARM 10MG A084505 001 Oct 21, 1986
PIONEER PHARMS 10MG A089361 001 Jan 10, 1989
WATSON LABS 10MG A083179 001 Feb 12, 1986
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DISCONTINUED DRUG PRODUCT LIST
6-108(of 337)
DICYCLOMINE HYDROCHLORIDE
INJECTABLE;INJECTION
DICYCLOMINE HYDROCHLORIDE
WATSON LABS
10MG/ML
A080614 001 Feb 11, 1986
SYRUP;ORAL
DICYCLOMINE HYDROCHLORIDE
ALPHARMA US PHARMS
10MG/5ML
A084479 001
TABLET;ORAL
DICYCLOMINE HYDROCHLORIDE
HIKMA PHARMS LLC
20MG
A040161 001 Oct 01, 1996
MUTUAL PHARM
20MG
A084600 001 Jul 29, 1985
PIONEER PHARMS
20MG
A088585 001 Aug 20, 1986
WATSON LABS
20MG
A084361 001 Feb 06, 1986
DIDANOSINE
FOR SOLUTION;ORAL
VIDEX
BRISTOL MYERS SQUIBB
100MG/PACKET
N020155 003 Oct 09, 1991
167MG/PACKET
N020155 004 Oct 09, 1991
250MG/PACKET
N020155 005 Oct 09, 1991
375MG/PACKET
N020155 006 Oct 09, 1991
TABLET, CHEWABLE;ORAL
VIDEX
BRISTOL MYERS SQUIBB
25MG
N020154 002 Oct 09, 1991
50MG
N020154 003 Oct 09, 1991
100MG
N020154 004 Oct 09, 1991
150MG
N020154 005 Oct 09, 1991
200MG
N020154 006 Oct 28, 1999
DIENESTROL
CREAM;VAGINAL
DIENESTROL
ORTHO MCNEIL PHARM
0.01%
N006110 005
DV
SANOFI AVENTIS US
0.01%
A083518 001
ESTRAGUARD
SOLVAY
0.01%
A084436 001
SUPPOSITORY;VAGINAL
DV
SANOFI AVENTIS US
0.7MG
A083517 001
DIETHYLCARBAMAZINE CITRATE
TABLET;ORAL
HETRAZAN
LEDERLE
50MG
N006459 001
DIETHYLPROPION HYDROCHLORIDE
TABLET;ORAL
DIETHYLPROPION HYDROCHLORIDE
SANDOZ
25MG
A085916 001
TEVA
25MG
A088642 001 Sep 20, 1984
TG UNITED LABS
25MG
A088267 001 Aug 25, 1983
25MG
A088268 001 Aug 25, 1983
UCB INC
25MG
A085544 001
WATSON LABS
25MG
A085741 001
TENUATE
SANOFI AVENTIS US
25MG
N017668 001
TEPANIL
3M
25MG
N011673 001
TABLET, EXTENDED RELEASE;ORAL
TENUATE
SANOFI AVENTIS US
75MG
N017669 001
TEPANIL TEN-TAB
3M
75MG
N017956 001
DIETHYLSTILBESTROL
INJECTABLE;INJECTION
STILBESTROL
BRISTOL MYERS SQUIBB
0.2MG/ML
N004056 003
0.5MG/ML
N004056 004
1MG/ML
N004056 005
5MG/ML
N004056 006
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DISCONTINUED DRUG PRODUCT LIST 6-109(of 337)
DIETHYLSTILBESTROL
SUPPOSITORY;VAGINAL
DIETHYLSTILBESTROL
LILLY
0.1MG
N004040 001
0.5MG
N004040 002
STILBESTROL
BRISTOL MYERS SQUIBB
0.1MG
N004056 001
0.5MG
N004056 002
TABLET;ORAL
DIETHYLSTILBESTROL
LILLY
0.1MG
N004041 002
0.5MG
N004041 003
1MG
N004041 004
5MG
N004041 005
STILBESTROL
TABLICAPS
0.5MG
A083004 001
1MG
A083002 001
5MG
A083006 001
STILBETIN
BRISTOL MYERS SQUIBB
0.1MG
N004056 007
0.25MG
N004056 017
0.5MG
N004056 008
1MG
N004056 009
5MG
N004056 010
TABLET, DELAYED RELEASE;ORAL
DIETHYLSTILBESTROL
LILLY
0.1MG
N004039 002
0.25MG
N004039 005
0.5MG
N004039 003
1MG
N004039 004
5MG
N004039 006
STILBESTROL
TABLICAPS
0.5MG
A083003 001
1MG
A083005 001
5MG
A083007 001
STILBETIN
BRISTOL MYERS SQUIBB
0.1MG
N004056 011
0.5MG
N004056 012
1MG
N004056 013
5MG
N004056 014
DIETHYLSTILBESTROL DIPHOSPHATE
INJECTABLE;INJECTION
STILPHOSTROL
BAYER PHARMS
250MG/5ML
N010010 001
TABLET;ORAL
STILPHOSTROL
BAYER PHARMS
50MG
N010010 002
DIFLORASONE DIACETATE
CREAM;TOPICAL
DIFLORASONE DIACETATE
FOUGERA PHARMS
0.05%
A075187 001 Mar 30, 1998
FLORONE
PHARMACIA AND UPJOHN
0.05%
N017741 001
FLORONE E
PHARMACIA AND UPJOHN
0.05%
N019259 001 Aug 28, 1985
PSORCON
TARO PHARMS NORTH
0.05%
N020205 001 Nov 20, 1992
OINTMENT;TOPICAL
PSORCON
PHARMACIA AND UPJOHN
0.05%
N019260 001 Aug 28, 1985
PSORCON E
PHARMACIA AND UPJOHN
0.05%
N017994 001
DIFLUNISAL
TABLET;ORAL
DIFLUNISAL
PUREPAC PHARM
250MG
A074285 001 May 07, 1996
500MG
A074285 002 May 07, 1996
ROXANE
250MG
A073562 001 Nov 27, 1992
500MG
A073563 001 Nov 27, 1992
SANDOZ
500MG
A074604 001 Jun 10, 1996
TEVA
250MG
A073679 001 Jul 31, 1992
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DISCONTINUED DRUG PRODUCT LIST 6-110(of 337)
DIFLUNISAL
TABLET;ORAL
DIFLUNISAL
WATSON LABS 250MG A074400 001 Jul 17, 1997
500MG A074400 002 Jul 17, 1997
DOLOBID
MERCK 250MG **Federal Register determination N018445 001 Apr 19, 1982
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
500MG N018445 002 Apr 19, 1982
DIGITOXIN
INJECTABLE;INJECTION
CRYSTODIGIN
LILLY 0.2MG/ML A084100 005
DIGOXIN
CAPSULE;ORAL
LANOXICAPS
GLAXOSMITHKLINE LLC 0.05MG N018118 002 Jul 26, 1982
0.1MG N018118 003 Jul 26, 1982
0.15MG N018118 004 Sep 24, 1984
0.2MG N018118 001 Jul 26, 1982
INJECTABLE;INJECTION
DIGOXIN
ABRAXIS PHARM 0.25MG/ML A083217 001
HOSPIRA 0.25MG/ML A040093 001 May 16, 1996
0.25MG/ML A040206 001 Aug 28, 1998
WYETH AYERST 0.25MG/ML A084386 001
DIGOXIN PEDIATRIC
HOSPIRA 0.1MG/ML A040092 001 Apr 25, 1996
TABLET;ORAL
DIGOXIN
SUN PHARM INDS INC 0.125MG A076363 001 Jan 31, 2003
0.25MG A076363 002 Jan 31, 2003
LANOXIN
COVIS PHARMA 0.375MG N020405 005 Sep 30, 1997
0.5MG N020405 006 Sep 30, 1997
DIHYDROERGOTAMINE MESYLATE; HEPARIN SODIUM; LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
EMBOLEX
NOVARTIS 0.5MG/0.5ML;2,500 N018885 001 Nov 30, 1984
UNITS/0.5ML;5.33MG/0.5ML
0.5MG/0.7ML;5,000 N018885 002 Nov 30, 1984
UNITS/0.7ML;7.46MG/0.7ML
DILTIAZEM HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
CARDIZEM SR
BIOVAIL 60MG N019471 001 Jan 23, 1989
90MG N019471 002 Jan 23, 1989
120MG N019471 003 Jan 23, 1989
180MG N019471 004 Jan 23, 1989
DILTIAZEM HYDROCHLORIDE
BIOVAIL 60MG A074845 001 Sep 15, 1999
90MG A074845 002 Sep 15, 1999
120MG A074845 003 Sep 15, 1999
120MG N020939 001 Jan 28, 2000
180MG N020939 002 Jan 28, 2000
240MG N020939 003 Jan 28, 2000
300MG N020939 004 Jan 28, 2000
360MG N020939 005 Sep 14, 2001
420MG N020939 006 Sep 14, 2001
NESHER PHARMS 120MG A076563 002 Sep 12, 2006
180MG A076563 003 Sep 12, 2006
240MG A076563 004 Sep 12, 2006
300MG A076563 005 Sep 12, 2006
360MG A076563 006 Sep 12, 2006
420MG A076563 001 Sep 12, 2006
TEVA 60MG A074079 001 Nov 30, 1993
90MG A074079 002 Nov 30, 1993
120MG A074079 003 Nov 30, 1993
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DISCONTINUED DRUG PRODUCT LIST 6-111(of 337)
DILTIAZEM HYDROCHLORIDE
INJECTABLE;INJECTION
CARDIZEM
BIOVAIL 100MG/VIAL N020792 001 Sep 05, 1997
BIOVAIL LABS INTL 5MG/ML N020027 001 Oct 24, 1991
25MG/VIAL **Federal Register N020027 003 Aug 18, 1995
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
DILTIAZEM HYDROCHLORIDE
AGILA SPECLTS 5MG/ML A075375 001 Sep 30, 1999
HOSPIRA 5MG/ML A075004 001 Feb 16, 2000
5MG/ML A075106 001 Apr 29, 1999
TEVA PHARMS USA 5MG/ML A074894 001 Aug 26, 1997
TABLET;ORAL
DILTIAZEM HYDROCHLORIDE
APOTHECON 30MG A074051 001 Mar 31, 1993
60MG A074051 002 Mar 31, 1993
90MG A074051 003 Mar 31, 1993
120MG A074051 004 Mar 31, 1993
DAVA PHARMS INC 30MG A074093 001 Nov 05, 1992
60MG A074093 002 Nov 05, 1992
90MG A074093 003 Nov 05, 1992
120MG A074093 004 Nov 05, 1992
IVAX SUB TEVA PHARMS 30MG A074168 001 Mar 03, 1995
60MG A074168 002 Mar 03, 1995
90MG A074168 003 Mar 03, 1995
120MG A074168 004 Mar 03, 1995
TEVA 30MG A074084 001 Feb 25, 1994
60MG A074084 002 Feb 25, 1994
TEVA PHARMS 30MG A074067 001 Nov 05, 1992
60MG A074067 002 Nov 05, 1992
90MG A074067 003 Nov 05, 1992
120MG A074067 004 Nov 05, 1992
DILTIAZEM MALATE
TABLET, EXTENDED RELEASE;ORAL
TIAMATE
MERCK EQ 120MG HCL N020506 001 Oct 04, 1996
EQ 180MG HCL N020506 002 Oct 04, 1996
EQ 240MG HCL N020506 003 Oct 04, 1996
DILTIAZEM MALATE; ENALAPRIL MALEATE
TABLET, EXTENDED RELEASE;ORAL
TECZEM
BIOVAIL EQ 180MG HCL;5MG N020507 001 Oct 04, 1996
DIMENHYDRINATE
INJECTABLE;INJECTION
DIMENHYDRINATE
BAXTER HLTHCARE 50MG/ML A084767 001
WATSON LABS 50MG/ML A080615 001
50MG/ML A083531 001
WYETH AYERST 50MG/ML A084316 001
LIQUID;ORAL
DIMENHYDRINATE
ALRA 12.5MG/4ML A080715 001
TABLET;ORAL
DIMENHYDRINATE
HEATHER 50MG A080841 001
NEXGEN PHARMA INC 50MG A085985 001
WATSON LABS 50MG A085166 001
DIMYRISTOYL LECITHIN; PERFLEXANE
INJECTABLE;INTRAVENOUS
IMAGENT
IMCOR PHARMS CO 0.92MG/VIAL;0.092MG/VIAL N021191 001 May 31, 2002
DINOPROST TROMETHAMINE
INJECTABLE;INJECTION
PROSTIN F2 ALPHA
PHARMACIA AND UPJOHN EQ 5MG BASE/ML N017434 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-112(of 337)
DIPHEMANIL METHYLSULFATE
TABLET;ORAL
PRANTAL
SCHERING
100MG
N008114 004
DIPHENHYDRAMINE HYDROCHLORIDE
CAPSULE;ORAL
BENADRYL
MCNEIL CONS
25MG
N005845 007
50MG
N005845 001
DIPHENHYDRAMINE HYDROCHLORIDE
ALRA
25MG
A080519 004
50MG
A080519 003
ANABOLIC
50MG
A083275 001
ELKINS SINN
25MG
A085701 001
50MG
A085701 002
HALSEY
50MG
A087914 001 Jun 04, 1984
HEATHER
25MG
A084524 001
50MG
A083953 001
HIKMA PHARMS LLC
50MG
A083567 001
IMPAX LABS
25MG
A080807 001
50MG
A080807 002
IVAX SUB TEVA PHARMS
25MG
A080762 001
50MG
A080762 002
LANNETT
25MG
A080868 001
50MG
A080868 002
LEDERLE
25MG
A086874 001
50MG
A086875 001
LNK
25MG
A087977 001 Jan 27, 1983
50MG
A087978 001 Jan 27, 1983
MK LABS
25MG
A083087 001
50MG
A083087 002
MUTUAL PHARM
25MG
A084506 001
25MG
A089488 001 Jan 02, 1987
50MG
A089489 001 Jan 02, 1987
NEWTRON PHARMS
25MG
A086543 001
50MG
A086544 001
NEXGEN PHARMA INC
25MG
A083634 001
PERRIGO
25MG
A083061 001
50MG
A083061 002
PIONEER PHARMS
25MG
A089101 001 Dec 20, 1985
50MG
A088880 001 Dec 20, 1985
PUREPAC PHARM
25MG
A085156 001
50MG
A085150 001
PVT FORM
25MG
A083027 001
50MG
A083027 002
ROXANE
50MG
A080635 001
SANDOZ
25MG
A080832 001
25MG
A080845 002
50MG
A080832 002
50MG
A080845 001
SUPERPHARM
25MG
A089040 001 May 15, 1985
50MG
A089041 001 May 15, 1985
TEVA
25MG
A085874 001
50MG
A085874 002
VALEANT PHARM INTL
25MG
A080596 001
50MG
A080592 001
VANGARD
25MG
A088034 001 Oct 27, 1982
50MG
A087630 001
WATSON LABS
25MG
A080728 001
25MG
A083797 001
25MG
A085138 001
50MG
A080727 001
50MG
A083797 002
50MG
A085083 001
WHITEWORTH TOWN PLSN
25MG
A083441 001
50MG
A080800 001
ELIXIR;ORAL
BELIX
HALSEY
12.5MG/5ML
A086586 001 Oct 03, 1983
BENADRYL
MCNEIL CONS
12.5MG/5ML
N005845 004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-113(of 337)
DIPHENHYDRAMINE HYDROCHLORIDE
ELIXIR;ORAL
DIBENIL
CENCI 12.5MG/5ML
A088304 001 Dec 16, 1983
DIPHEN
USL PHARMA 12.5MG/5ML
A084640 001
DIPHENHYDRAMINE HYDROCHLORIDE
BUNDY
12.5MG/5ML
A083674 001
CENCI
12.5MG/5ML
A087941 001 Dec 17, 1982
KV PHARM
12.5MG/5ML
A085621 001
LANNETT
12.5MG/5ML
A080939 002
LEDERLE
12.5MG/5ML
A086937 001
MK LABS
12.5MG/5ML
A083088 002
NASKA
12.5MG/5ML
A088680 001 May 31, 1985
PERRIGO
12.5MG/5ML
A083063 001
PUREPAC PHARM
12.5MG/5ML
A083237 001 Jan 25, 1982
PVT FORM
12.5MG/5ML
A085287 001
ROXANE
12.5MG/5ML
A080643 001
HYDRAMINE
ALPHARMA US PHARMS
12.5MG/5ML
A080763 002
INJECTABLE;INJECTION
BENADRYL
MCNEIL CONS
10MG/ML
N006146 001
50MG/ML
N006146 002
BENADRYL PRESERVATIVE FREE
MCNEIL CONS
50MG/ML
N009486 001
DIPHENHYDRAMINE HYDROCHLORIDE
BEL MAR 10MG/ML
A080822 001
HIKMA MAPLE 50MG/ML
A083183 001
LYPHOMED 10MG/ML
A087066 001
WATSON LABS 10MG/ML
A083533 001
WATSON LABS INC 10MG/ML
A080873 001
50MG/ML
A080873 002
WYETH AYERST 50MG/ML
A080577 001
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE
ABRAXIS PHARM
50MG/ML
A080586 002
INTL MEDICATION
50MG/ML
A084094 001
WATSON LABS INC
50MG/ML
A080873 003
SYRUP;ORAL
ANTITUSSIVE
PERRIGO
12.5MG/5ML
A071292 001 Apr 10, 1987
BELDIN
HALSEY
12.5MG/5ML
A089179 001 Jun 05, 1986
BENYLIN
PARKE DAVIS
12.5MG/5ML
N006514 004
DIPHEN
MORTON GROVE
12.5MG/5ML
A070118 001 Oct 01, 1985
DIPHENHYDRAMINE HYDROCHLORIDE
ALPHARMA US PHARMS
12.5MG/5ML
A070497 001 Apr 25, 1989
CUMBERLAND SWAN
12.5MG/5ML
A073611 001 Aug 20, 1992
HI TECH PHARMA
12.5MG/5ML
A072416 001 Sep 28, 1990
HYDRAMINE
ALPHARMA US PHARMS
12.5MG/5ML
A070205 001 Jan 28, 1986
SILPHEN
SILARX
12.5MG/5ML
A072646 001 Feb 27, 1992
VICKS FORMULA 44
WARNER CHILCOTT
12.5MG/5ML
A070524 001 Jan 14, 1987
DIPHENHYDRAMINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE
SOLUTION;ORAL
BENYLIN
PARKE DAVIS
12.5MG/5ML;30MG/5ML
N019014 001 Jun 11, 1985
DIPHENIDOL HYDROCHLORIDE
TABLET;ORAL
VONTROL
GLAXOSMITHKLINE
EQ 25MG BASE
N016033 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-114(of 337)
DIPHENYLPYRALINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
HISPRIL
GLAXOSMITHKLINE 5MG N011945 001
DIPIVEFRIN HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
AKPRO
AKORN 0.1% A074382 001 Sep 29, 1995
DIPIVEFRIN HYDROCHLORIDE
BAUSCH AND LOMB 0.1% A074188 001 May 19, 1995
FALCON PHARMS 0.1% A073636 001 Jun 30, 1994
PROPINE
ALLERGAN 0.1% N018239 001
DIPYRIDAMOLE
INJECTABLE;INJECTION
DIPYRIDAMOLE
AGILA SPECLTS 5MG/ML A075769 001 Nov 27, 2002
HOSPIRA 5MG/ML A074601 001 Dec 19, 1997
TEVA PHARMS USA 5MG/ML A074952 001 Nov 26, 1997
IV PERSANTINE
BOEHRINGER INGELHEIM 5MG/ML N019817 001 Dec 13, 1990
TABLET;ORAL
DIPYRIDAMOLE
GLENMARK GENERICS 25MG A088999 001 Feb 05, 1991
50MG A089000 001 Feb 05, 1991
75MG A089001 001 Feb 05, 1991
PROSAM LABS 25MG A040542 001 Apr 21, 2006
50MG A040542 002 Apr 21, 2006
75MG A040542 003 Apr 21, 2006
PUREPAC PHARM 50MG A089426 001 Jul 12, 1990
75MG A089427 001 Jul 12, 1990
SANDOZ 25MG A086944 002 Apr 16, 1991
50MG A087562 001 Feb 25, 1992
75MG A087561 001 Feb 25, 1992
WATSON LABS 50MG A087160 001 Jun 07, 1996
DIRITHROMYCIN
TABLET, DELAYED RELEASE;ORAL
DYNABAC
LILLY RES LABS 250MG N050678 001 Jun 19, 1995
DISOPYRAMIDE PHOSPHATE
CAPSULE;ORAL
DISOPYRAMIDE PHOSPHATE
INTERPHARM EQ 100MG BASE A071190 001 Jan 15, 1987
EQ 150MG BASE A071191 001 Jan 15, 1987
IVAX SUB TEVA PHARMS EQ 100MG BASE A070186 001 Nov 18, 1985
EQ 150MG BASE A070187 001 Nov 18, 1985
MUTUAL PHARM EQ 100MG BASE A070351 001 Dec 17, 1985
EQ 150MG BASE A070352 001 Dec 17, 1985
MYLAN EQ 100MG BASE A070138 001 Jun 14, 1985
EQ 150MG BASE A070139 001 Jun 14, 1985
SANDOZ EQ 100MG BASE A070470 001 Dec 10, 1985
EQ 150MG BASE A070471 001 Dec 10, 1985
SUPERPHARM EQ 100MG BASE A070940 001 Feb 09, 1987
EQ 150MG BASE A070941 001 Feb 09, 1987
WATSON LABS EQ 100MG BASE A070240 001 Feb 02, 1986
EQ 150MG BASE A070241 001 Feb 02, 1986
CAPSULE, EXTENDED RELEASE;ORAL
DISOPYRAMIDE PHOSPHATE
NESHER PHARMS EQ 150MG BASE A071200 001 Dec 15, 1987
DISULFIRAM
TABLET;ORAL
ANTABUSE
TEVA WOMENS 250MG N007883 003
500MG N007883 002
DISULFIRAM
PAR PHARM 250MG A088792 001 Aug 14, 1984
500MG A088793 001 Aug 14, 1984
WATSON LABS 250MG A086889 001
250MG A087973 001 Aug 05, 1983
500MG A086890 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-115(of 337)
DISULFIRAM
TABLET;ORAL
DISULFIRAM
500MG A087974 001 Aug 05, 1983
DIVALPROEX SODIUM
TABLET, DELAYED RELEASE;ORAL
DEPAKOTE CP
ABBOTT EQ 250MG BASE N019794 001 Jul 11, 1990
EQ 500MG BASE N019794 002 Jul 11, 1990
DIVALPROEX SODIUM
MYLAN EQ 125MG VALPROIC ACID A077254 001 Jul 29, 2008
EQ 250MG VALPROIC ACID A077254 002 Jul 29, 2008
EQ 500MG VALPROIC ACID A077254 003 Jul 29, 2008
TABLET, EXTENDED RELEASE;ORAL
DIVALPROEX SODIUM
TEVA PHARMS USA EQ 500MG VALPROIC ACID A078700 001 Aug 03, 2009
DOBUTAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
DOBUTAMINE HYDROCHLORIDE
ASTRAZENECA EQ 12.5MG BASE/ML A074098 001 Feb 21, 1995
BAXTER HLTHCARE EQ 12.5MG BASE/ML A074381 001 Sep 26, 1996
HOSPIRA EQ 1.25GM BASE/100ML A074634 001 Sep 27, 1996
LUITPOLD EQ 12.5MG BASE/ML A074545 001 Jun 25, 1998
TEVA PARENTERAL EQ 12.5MG BASE/ML A074206 001 Oct 19, 1993
WATSON LABS EQ 12.5MG BASE/ML A074114 001 Nov 30, 1993
WATSON LABS INC EQ 12.5MG BASE/ML A074279 001 Feb 18, 1998
EQ 12.5MG BASE/ML A074995 001 Mar 31, 1998
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5%
HOSPIRA EQ 50MG BASE/100ML N020269 001 Oct 19, 1993
EQ 100MG BASE/100ML N020269 002 Oct 19, 1993
EQ 200MG BASE/100ML N020269 003 Oct 19, 1993
DOBUTREX
LILLY EQ 12.5MG BASE/ML N017820 002
DOCETAXEL
INJECTABLE;INJECTION
DOCETAXEL
APOTEX INC 20MG/0.5ML (40MG/ML) N022312 001 Jan 11, 2012
80MG/2ML (40MG/ML) N022312 002 Jan 11, 2012
TAXOTERE
SANOFI AVENTIS US 40MG/ML **Federal Register N020449 001 May 14, 1996
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
DONEPEZIL HYDROCHLORIDE
SOLUTION;ORAL
ARICEPT
EISAI INC 5MG/5ML N021719 001 Oct 18, 2004
TABLET;ORAL
DONEPEZIL HYDROCHLORIDE
ACCORD HLTHCARE 5MG A201335 001 Aug 29, 2011
10MG A201335 002 Aug 29, 2011
TABLET, ORALLY DISINTEGRATING;ORAL
DONEPEZIL HYDROCHLORIDE
MUTUAL PHARM 5MG A077975 002 Dec 11, 2009
10MG A077975 001 Dec 11, 2009
DOPAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
DOPAMINE HYDROCHLORIDE
ABBOTT 40MG/ML A070656 001 Jan 24, 1989
80MG/ML A070657 001 Jan 24, 1989
ABRAXIS PHARM 40MG/ML A070012 001 Jun 12, 1985
40MG/ML A070058 001 Mar 20, 1985
80MG/ML A070013 001 Jun 12, 1985
80MG/ML A070059 001 Mar 20, 1985
160MG/ML A070364 001 Dec 04, 1985
ASTRAZENECA 40MG/ML A070087 001 Oct 23, 1985
40MG/ML N018656 001 Jun 28, 1983
80MG/ML A070089 001 Oct 23, 1985
80MG/ML A070090 001 Oct 23, 1985
80MG/ML A070091 001 Oct 23, 1985
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-116(of 337)
DOPAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
DOPAMINE HYDROCHLORIDE
160MG/ML A070092 001 Oct 23, 1985
160MG/ML A070093 001 Oct 23, 1985
160MG/ML A070094 001 Oct 23, 1985
BAXTER HLTHCARE 40MG/ML N018398 001
80MG/ML N018398 002 Mar 22, 1982
HOSPIRA 40MG/ML A074403 001 May 23, 1996
INTL MEDICATION 40MG/ML N018014 001
LYPHOMED 40MG/ML N018549 001 Mar 11, 1983
SMITH AND NEPHEW 40MG/ML A070011 001 Aug 29, 1985
40MG/ML A070046 001 Aug 29, 1985
80MG/ML A070047 001 Aug 29, 1985
TEVA PARENTERAL 40MG/ML A072999 001 Oct 23, 1991
80MG/ML A073000 001 Oct 23, 1991
WARNER CHILCOTT 40MG/ML A070558 001 Sep 20, 1985
40MG/ML N018138 001
80MG/ML A070559 001 Sep 20, 1985
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5%
HOSPIRA 1.6MG/ML N020542 001 Aug 30, 1995
INTROPIN
HOSPIRA 40MG/ML N017395 001
80MG/ML N017395 002
160MG/ML N017395 003
DORZOLAMIDE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
DORZOLAMIDE HYDROCHLORIDE
APOTEX INC EQ 2% BASE A078395 001 Oct 28, 2008
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE
SOLUTION/DROPS;OPHTHALMIC
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE
APOTEX INC EQ 2% BASE;EQ 0.5% BASE A078201 001 Oct 28, 2008
DOXACURIUM CHLORIDE
INJECTABLE;INJECTION
NUROMAX
ABBVIE EQ 1MG BASE/ML N019946 001 Mar 07, 1991
DOXAPRAM HYDROCHLORIDE
INJECTABLE;INJECTION
DOXAPRAM HYDROCHLORIDE
WATSON LABS 20MG/ML A073529 001 Jan 30, 1992
DOXAZOSIN MESYLATE
TABLET;ORAL
DOXAZOSIN MESYLATE
ACTAVIS ELIZABETH EQ 1MG BASE A075574 001 Oct 18, 2000
EQ 2MG BASE A075574 002 Oct 18, 2000
EQ 4MG BASE A075574 003 Oct 18, 2000
EQ 8MG BASE A075574 004 Oct 18, 2000
GENPHARM EQ 1MG BASE A075466 001 Oct 18, 2000
EQ 2MG BASE A075466 002 Oct 18, 2000
EQ 4MG BASE A075466 003 Oct 18, 2000
EQ 8MG BASE A075466 004 Oct 18, 2000
IVAX SUB TEVA PHARMS EQ 1MG BASE A075453 001 Oct 18, 2000
EQ 2MG BASE A075453 002 Oct 18, 2000
EQ 4MG BASE A075453 003 Oct 18, 2000
EQ 8MG BASE A075453 004 Oct 18, 2000
NESHER PHARMS EQ 1MG BASE A075609 001 Oct 18, 2000
EQ 2MG BASE A075609 002 Oct 18, 2000
EQ 4MG BASE A075609 003 Oct 18, 2000
EQ 8MG BASE A075609 004 Oct 18, 2000
SANDOZ EQ 1MG BASE A075432 001 Oct 18, 2000
EQ 1MG BASE A075646 001 Oct 18, 2000
EQ 2MG BASE A075432 002 Oct 18, 2000
EQ 2MG BASE A075646 002 Oct 18, 2000
EQ 4MG BASE A075432 003 Oct 18, 2000
EQ 4MG BASE A075646 003 Oct 18, 2000
EQ 8MG BASE A075432 004 Oct 18, 2000
EQ 8MG BASE A075646 004 Oct 18, 2000
TEVA EQ 1MG BASE A075353 001 Jan 12, 2001
EQ 2MG BASE A075353 002 Jan 12, 2001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-117(of 337)
DOXAZOSIN MESYLATE
TABLET;ORAL
DOXAZOSIN MESYLATE
EQ 4MG BASE
A075353 003 Jan 12, 2001
EQ 8MG BASE
A075353 004 Jan 12, 2001
WATSON LABS INC
EQ 1MG BASE
A075426 001 Oct 18, 2000
EQ 2MG BASE
A075426 002 Oct 18, 2000
EQ 4MG BASE
A075426 003 Oct 18, 2000
EQ 8MG BASE
A075426 004 Oct 18, 2000
DOXEPIN HYDROCHLORIDE
CAPSULE;ORAL
DOXEPIN HYDROCHLORIDE
DAVA PHARMS INC
EQ 10MG BASE
A071685 001 Jan 05, 1988
EQ 25MG BASE
A071686 001 Jan 05, 1988
EQ 50MG BASE
A071673 001 Jan 05, 1988
EQ 75MG BASE
A071674 001 Jan 05, 1988
EQ 100MG BASE
A071675 001 Jan 05, 1988
EQ 150MG BASE
A071676 001 Jan 05, 1988
MUTUAL PHARM
EQ 25MG BASE
A071502 001 Feb 18, 1988
EQ 50MG BASE
A071653 001 Feb 18, 1988
EQ 75MG BASE
A071654 001 Feb 18, 1988
EQ 100MG BASE
A071521 001 Feb 18, 1988
NEW RIVER
EQ 10MG BASE
N016987 001
EQ 25MG BASE
N016987 002
EQ 50MG BASE
N016987 003
EQ 75MG BASE
N016987 006
EQ 100MG BASE
N016987 004
EQ 150MG BASE
N016987 007 Apr 13, 1987
PAR PHARM
EQ 10MG BASE
A071697 001 Nov 09, 1987
EQ 25MG BASE
A071437 001 Nov 09, 1987
EQ 50MG BASE
A071595 001 Nov 09, 1987
EQ 75MG BASE
A071608 001 Nov 09, 1987
EQ 100MG BASE
A071422 001 Nov 09, 1987
PUREPAC PHARM
EQ 10MG BASE
A073054 001 Dec 28, 1990
EQ 25MG BASE
A072109 001 Dec 28, 1990
EQ 50MG BASE
A073055 001 Dec 28, 1990
EQ 75MG BASE
A072386 001 Sep 08, 1988
EQ 100MG BASE
A072110 001 Sep 08, 1988
EQ 150MG BASE
A072387 001 Sep 08, 1988
QUANTUM PHARMICS
EQ 10MG BASE
A070972 001 Sep 29, 1987
EQ 25MG BASE
A070973 001 Sep 29, 1987
EQ 50MG BASE
A070931 001 Sep 29, 1987
EQ 75MG BASE
A070932 001 Sep 29, 1987
EQ 100MG BASE
A072375 001 Mar 15, 1989
EQ 150MG BASE
A072376 001 Mar 15, 1989
SANDOZ
EQ 10MG BASE
A071487 001 Mar 02, 1987
EQ 25MG BASE
A070827 001 May 15, 1986
EQ 50MG BASE
A070828 001 May 15, 1986
EQ 75MG BASE
A070825 001 May 15, 1986
EQ 100MG BASE
A071562 001 Mar 02, 1987
WATSON LABS
EQ 10MG BASE
A070952 001 Mar 04, 1987
EQ 10MG BASE
A071485 001 Apr 30, 1987
EQ 10MG BASE
A072985 001 Mar 29, 1991
EQ 25MG BASE
A070953 001 May 15, 1986
EQ 25MG BASE
A071486 001 Apr 30, 1987
EQ 25MG BASE
A072986 001 Mar 29, 1991
EQ 50MG BASE
A070954 001 May 15, 1986
EQ 50MG BASE
A071238 001 Apr 30, 1987
EQ 50MG BASE
A072987 001 Mar 29, 1991
EQ 75MG BASE
A071326 001 Apr 30, 1987
EQ 75MG BASE
A071763 001 Feb 09, 1988
EQ 100MG BASE
A070955 001 May 15, 1986
EQ 100MG BASE
A071239 001 Apr 30, 1987
EQ 150MG BASE
A071764 001 Feb 09, 1988
SINEQUAN
PFIZER
EQ 10MG BASE
N016798 003
EQ 25MG BASE
N016798 001
EQ 50MG BASE
N016798 002
EQ 75MG BASE
N016798 006
EQ 100MG BASE
N016798 005
EQ 150MG BASE
N016798 007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-118(of 337)
DOXEPIN HYDROCHLORIDE
CONCENTRATE;ORAL
DOXEPIN HYDROCHLORIDE
PHARM ASSOC EQ 10MG BASE/ML A075924 001 Jan 15, 2004
SINEQUAN
PFIZER EQ 10MG BASE/ML N017516 001
DOXORUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
ADRIAMYCIN PFS
PHARMACIA AND UPJOHN 2MG/ML A063165 001 Jan 30, 1991
2MG/ML N050629 001 Dec 23, 1987
200MG/100ML A063165 002 Jan 30, 1991
200MG/100ML N050629 002 May 03, 1988
ADRIAMYCIN RDF
PHARMACIA AND UPJOHN 10MG/VIAL N050467 001
20MG/VIAL N050467 003 May 20, 1985
50MG/VIAL N050467 002
150MG/VIAL N050467 004 Jul 22, 1987
RUBEX
BRISTOL MYERS SQUIBB 10MG/VIAL A062926 001 Apr 13, 1989
50MG/VIAL A062926 002 Apr 13, 1989
100MG/VIAL A062926 003 Apr 13, 1989
DOXYCYCLINE
CAPSULE;ORAL
DOXYCYCLINE
PAR PHARM EQ 75MG BASE A065055 004 Apr 18, 2005
SANDOZ INC EQ 50MG BASE A065032 001 Jun 30, 2000
EQ 100MG BASE A065032 002 Jun 30, 2000
WATSON LABS EQ 50MG BASE A065041 001 Apr 28, 2000
EQ 100MG BASE A065041 002 Apr 28, 2000
FOR SUSPENSION;ORAL
DOXYCHEL
RACHELLE EQ 25MG BASE/5ML A061720 001
TABLET;ORAL
DOXYCYCLINE
MUTUAL PHARM EQ 50MG BASE A065471 001 Apr 17, 2009
EQ 75MG BASE A065471 002 Apr 17, 2009
EQ 100MG BASE A065471 003 Apr 17, 2009
SANDOZ INC EQ 50MG BASE A065353 001 Nov 27, 2006
EQ 75MG BASE A065353 002 Nov 27, 2006
EQ 100MG BASE A065353 003 Nov 27, 2006
DOXYCYCLINE HYCLATE
CAPSULE;ORAL
DOXY-LEMMON
TEVA EQ 50MG BASE A062497 001 Aug 23, 1984
EQ 100MG BASE A062497 002 Jun 15, 1984
DOXYCYCLINE HYCLATE
HALSEY EQ 50MG BASE A062119 002 May 24, 1985
EQ 100MG BASE A062119 001 May 24, 1985
HEATHER EQ 50MG BASE A062463 001 Dec 07, 1983
EQ 100MG BASE A062463 002 Dec 07, 1983
INTERPHARM EQ 50MG BASE A062763 001 Sep 02, 1988
EQ 100MG BASE A062763 002 Sep 02, 1988
MUTUAL PHARM EQ 50MG BASE A062418 001 Jan 28, 1983
EQ 100MG BASE A062418 002 Jan 28, 1983
PAR PHARM EQ 50MG BASE A062434 001 Oct 19, 1984
EQ 100MG BASE A062442 001 Dec 22, 1983
PVT FORM EQ 50MG BASE A062631 001 Jul 24, 1986
EQ 100MG BASE A062631 002 Jul 24, 1986
RANBAXY EQ 50MG BASE A062479 001 Dec 23, 1983
EQ 100MG BASE A062479 002 Dec 23, 1983
SUPERPHARM EQ 50MG BASE A062469 001 Oct 31, 1984
EQ 100MG BASE A062469 002 Oct 31, 1984
WARNER CHILCOTT EQ 50MG BASE A062594 001 Dec 05, 1985
EQ 100MG BASE A062594 002 Dec 05, 1985
WATSON LABS EQ 50MG BASE A061717 001
EQ 50MG BASE A062142 001
EQ 100MG BASE A061717 002
EQ 100MG BASE A062142 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-119(of 337)
DOXYCYCLINE HYCLATE
CAPSULE;ORAL
PERIOSTAT
COLLAGENEX EQ 20MG BASE N050744 001 Sep 30, 1998
CAPSULE, COATED PELLETS;ORAL
DOXYCYCLINE HYCLATE
PLIVA EQ 100MG BASE A063187 001 Jun 30, 1992
CAPSULE, DELAYED RELEASE;ORAL
DORYX
MAYNE PHARMA INTL EQ 75MG BASE N050582 002 Aug 13, 2001
EQ 100MG BASE N050582 001 Jul 22, 1985
WARNER CHILCOTT EQ 100MG BASE A062653 001 Oct 30, 1985
INJECTABLE;INJECTION
DOXYCHEL HYCLATE
RACHELLE EQ 100MG BASE/VIAL A061953 001
DOXYCYCLINE
EUROHLTH INTL EQ 200MG BASE/VIAL A062569 002 Mar 09, 1988
HIKMA MAPLE EQ 100MG BASE/VIAL A062450 001 Oct 27, 1983
EQ 200MG BASE/VIAL A062450 002 Oct 27, 1983
DOXYCYCLINE HYCLATE
HIKMA MAPLE EQ 100MG BASE/VIAL A062992 001 Feb 16, 1989
EQ 200MG BASE/VIAL A062992 002 Feb 16, 1989
VIBRAMYCIN
PFIZER EQ 100MG BASE/VIAL N050442 002
EQ 200MG BASE/VIAL N050442 001
TABLET;ORAL
DOXY-LEMMON
TEVA EQ 100MG BASE A062581 001 Mar 15, 1985
DOXYCYCLINE HYCLATE
BLU CARIBE INC EQ 50MG BASE A062269 003
HEATHER EQ 100MG BASE A062462 001 May 11, 1983
INTERPHARM EQ 100MG BASE A062764 001 Sep 02, 1988
MUTUAL PHARM EQ 100MG BASE A062391 001 Sep 30, 1982
SUPERPHARM EQ 100MG BASE A062494 001 Feb 20, 1985
WARNER CHILCOTT EQ 100MG BASE A062593 001 Aug 28, 1985
WATSON LABS EQ 50MG BASE A062392 001 Mar 31, 1983
EQ 100MG BASE A062392 002 Mar 31, 1983
PERIOSTAT
GALDERMA LABS LP EQ 20MG BASE **Federal Register N050783 001 Feb 02, 2001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
VIBRA-TABS
PFIZER EQ 100MG BASE **Federal Register N050533 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
DOXYLAMINE SUCCINATE
CAPSULE;ORAL
UNISOM
PFIZER 25MG N019440 001 Feb 05, 1986
TABLET;ORAL
DECAPRYN
SANOFI AVENTIS US 12.5MG N006412 015
25MG N006412 014
DOXY-SLEEP-AID
PAR PHARM 25MG A070156 001 Jul 02, 1987
DOXYLAMINE SUCCINATE
COPLEY PHARM 25MG A088900 002 Feb 12, 1988
QUANTUM PHARMICS 25MG A088603 001 Aug 07, 1984
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
BENDECTIN
SANOFI AVENTIS US 10MG;10MG **Federal Register N010598 002
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-120(of 337)
DROMOSTANOLONE PROPIONATE
INJECTABLE;INJECTION
DROLBAN
LILLY 50MG/ML N012936 001
DROPERIDOL
INJECTABLE;INJECTION
DROPERIDOL
ABRAXIS PHARM 2.5MG/ML A070992 001 Nov 17, 1986
2.5MG/ML A070993 001 Nov 17, 1986
ASTRAZENECA 2.5MG/ML A072018 001 Oct 20, 1988
2.5MG/ML A072019 001 Oct 19, 1988
2.5MG/ML A072020 001 Oct 19, 1988
2.5MG/ML A072021 001 Oct 19, 1988
HOSPIRA 2.5MG/ML A071645 001 Apr 07, 1988
2.5MG/ML A072272 001 Aug 31, 1995
LUITPOLD 2.5MG/ML A072335 001 Oct 24, 1988
SMITH AND NEPHEW 2.5MG/ML A071750 001 Sep 06, 1988
SOLOPAK 2.5MG/ML A071754 001 Sep 06, 1988
2.5MG/ML A071755 001 Sep 06, 1988
WATSON LABS 2.5MG/ML A073520 001 Nov 27, 1991
2.5MG/ML A073521 001 Nov 27, 1991
2.5MG/ML A073523 001 Nov 27, 1991
DROPERIDOL; FENTANYL CITRATE
INJECTABLE;INJECTION
FENTANYL CITRATE AND DROPERIDOL
ASTRAZENECA 2.5MG/ML;EQ 0.05MG BASE/ML A072026 001 Apr 13, 1989
2.5MG/ML;EQ 0.05MG BASE/ML A072027 001 Apr 13, 1989
2.5MG/ML;EQ 0.05MG BASE/ML A072028 001 Apr 13, 1989
HOSPIRA 2.5MG/ML;EQ 0.05MG BASE/ML A071982 001 May 04, 1988
INNOVAR
AKORN MFG 2.5MG/ML;EQ 0.05MG BASE/ML N016049 001
DYCLONINE HYDROCHLORIDE
SOLUTION;TOPICAL
DYCLONE
ASTRAZENECA 0.5% **Federal Register determination N009925 002
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
1% **Federal Register determination N009925 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
DYDROGESTERONE
TABLET;ORAL
GYNOREST
SOLVAY 5MG N017388 001
10MG N017388 002
DYPHYLLINE
ELIXIR;ORAL
NEOTHYLLINE
TEVA 160MG/15ML N007794 003
INJECTABLE;INJECTION
NEOTHYLLINE
TEVA 250MG/ML N009088 001
TABLET;ORAL
DILOR
SAVAGE LABS 200MG A084514 001
DILOR-400
SAVAGE LABS 400MG A084751 001
NEOTHYLLINE
TEVA 200MG N007794 001
400MG N007794 002
ECHOTHIOPHATE IODIDE
FOR SOLUTION;OPHTHALMIC
PHOSPHOLINE IODIDE
WYETH PHARMS INC 0.03% N011963 002
0.06% N011963 004
0.25% N011963 003
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DISCONTINUED DRUG PRODUCT LIST 6-121(of 337)
ECONAZOLE NITRATE
CREAM;TOPICAL
SPECTAZOLE
MERZ PHARMS LLC 1% N018751 001 Dec 23, 1982
EDETATE CALCIUM DISODIUM
TABLET;ORAL
CALCIUM DISODIUM VERSENATE
MEDICIS 500MG N008922 002
EDROPHONIUM CHLORIDE
INJECTABLE;INJECTION
EDROPHONIUM CHLORIDE
HOSPIRA 10MG/ML A040131 001 Feb 24, 1998
WATSON LABS 10MG/ML A040044 001 Mar 20, 1996
EDROPHONIUM CHLORIDE PRESERVATIVE FREE
WATSON LABS 10MG/ML A040043 001 Mar 20, 1996
REVERSOL
ORGANON USA INC 10MG/ML A089624 001 May 13, 1988
EFAVIRENZ
CAPSULE;ORAL
SUSTIVA
BRISTOL MYERS SQUIBB 100MG **Federal Register determination N020972 002 Sep 17, 1998
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
TABLET;ORAL
SUSTIVA
BRISTOL MYERS SQUIBB 300MG **Federal Register determination N021360 001 Feb 01, 2002
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
EFLORNITHINE HYDROCHLORIDE
INJECTABLE;INJECTION
ORNIDYL
SANOFI AVENTIS US 200MG/ML N019879 002 Nov 28, 1990
ENALAPRIL MALEATE
TABLET;ORAL
ENALAPRIL MALEATE
APOTHECON 2.5MG A075583 001 Aug 22, 2000
5MG A075583 002 Aug 22, 2000
10MG A075583 003 Aug 22, 2000
20MG A075583 004 Aug 22, 2000
IVAX SUB TEVA PHARMS 2.5MG A075482 001 Aug 22, 2000
5MG A075482 002 Aug 22, 2000
10MG A075482 003 Aug 22, 2000
20MG A075482 004 Aug 22, 2000
KRKA DD NOVO MESTO 2.5MG A075370 001 Aug 22, 2000
5MG A075370 002 Aug 22, 2000
10MG A075369 001 Aug 22, 2000
20MG A075369 002 Aug 22, 2000
MYLAN 2.5MG A075472 001 Aug 22, 2000
5MG A075472 002 Aug 22, 2000
10MG A075472 003 Aug 22, 2000
20MG A075472 004 Aug 22, 2000
RANBAXY 2.5MG A075556 001 Aug 22, 2000
5MG A075556 002 Aug 22, 2000
10MG A075556 003 Aug 22, 2000
20MG A075556 004 Aug 22, 2000
SANDOZ 2.5MG A075048 001 Aug 22, 2000
5MG A075048 002 Aug 22, 2000
10MG A075048 003 Aug 22, 2000
20MG A075048 004 Aug 22, 2000
SANDOZ INC 2.5MG A075496 001 Aug 22, 2000
2.5MG A075621 001 Aug 22, 2000
5MG A075496 002 Aug 22, 2000
5MG A075621 002 Aug 22, 2000
10MG A075459 001 Aug 22, 2000
10MG A075621 003 Aug 22, 2000
20MG A075459 002 Aug 22, 2000
20MG A075621 004 Aug 22, 2000
WATSON LABS 2.5MG A075501 001 Aug 22, 2000
5MG A075501 002 Aug 22, 2000
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DISCONTINUED DRUG PRODUCT LIST 6-122(of 337)
ENALAPRIL MALEATE
TABLET;ORAL
ENALAPRIL MALEATE
10MG A075501 003 Aug 22, 2000
20MG A075501 004 Aug 22, 2000
ENALAPRIL MALEATE; FELODIPINE
TABLET, EXTENDED RELEASE;ORAL
LEXXEL
ASTRAZENECA 5MG;2.5MG N020668 002 Oct 28, 1998
5MG;5MG N020668 001 Dec 27, 1996
ENALAPRIL MALEATE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE
IVAX SUB TEVA PHARMS 5MG;12.5MG A075736 001 Mar 25, 2003
10MG;25MG A075736 002 Mar 25, 2003
SANDOZ INC 5MG;12.5MG A076116 001 Sep 19, 2001
10MG;25MG A076116 002 Sep 19, 2001
ENALAPRILAT
INJECTABLE;INJECTION
ENALAPRILAT
HOSPIRA 1.25MG/ML A075456 001 Aug 22, 2000
1.25MG/ML A075571 001 Aug 22, 2000
VASOTEC
BIOVAIL LABS INTL 1.25MG/ML N019309 001 Feb 09, 1988
ENFLURANE
LIQUID;INHALATION
ENFLURANE
ABBOTT 99.9% A070803 001 Sep 08, 1987
ENOXACIN
TABLET;ORAL
PENETREX
SANOFI AVENTIS US 200MG N019616 004 Dec 31, 1991
400MG N019616 005 Dec 31, 1991
ENOXAPARIN SODIUM
INJECTABLE;SUBCUTANEOUS
LOVENOX (PRESERVATIVE FREE)
SANOFI AVENTIS US 90MG/0.6ML (150MG/ML) **Federal N020164 006 Jun 02, 2000
Register determination that product was
not discontinued or withdrawn for
safety or efficacy reasons**
EPINEPHRINE
AEROSOL, METERED;INHALATION
BRONKAID MIST
STERLING 0.25MG/INH N016803 001
EPINEPHRINE
ARMSTRONG PHARMS 0.2MG/INH A087907 001 May 23, 1984
PRIMATENE MIST
WYETH CONS 0.2MG/INH N016126 001
INJECTABLE;INJECTION
SUS-PHRINE SULFITE-FREE
FOREST LABS 1.5MG/AMP N007942 003 Feb 05, 1999
5MG/ML N007942 001
INJECTABLE;INTRAMUSCULAR
EPI E Z PEN JR
MYLAN SPECLT 0.15MG/DELIVERY N019430 004 Aug 03, 1995
EPIPEN E Z PEN
MYLAN SPECLT 0.3MG/DELIVERY N019430 003 Aug 03, 1995
EPINEPHRINE BITARTRATE
AEROSOL, METERED;INHALATION
BRONITIN MIST
WYETH CONS 0.3MG/INH N016126 002
MEDIHALER-EPI
3M 0.3MG/INH N010374 003
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DISCONTINUED DRUG PRODUCT LIST
6-123(of 337)
EPINEPHRINE BITARTRATE; ETIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
DURANEST
ASTRAZENECA 0.005MG/ML;1%
N017751 006
0.005MG/ML;1.5%
N017751 007
DENTSPLY PHARM 0.005MG/ML;1.5%
N021384 001
EPINEPHRINE BITARTRATE; PRILOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
CITANEST FORTE
ASTRAZENECA 0.005MG/ML;4%
N014763 008
EPINEPHRINE; ETIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
DURANEST
ASTRAZENECA 0.005MG/ML;0.5%
N017751 004
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
ALPHACAINE HYDROCHLORIDE W/ EPINEPHRINE
CARLISLE 0.01MG/ML;2%
A084720 001
0.02MG/ML;2%
A084732 001
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
GRAHAM CHEM 0.01MG/ML;2%
A080504 004 Oct 19, 1983
0.02MG/ML;2%
A080504 005 Oct 19, 1983
HIKMA MAPLE 0.01MG/ML;1%
A080406 001
0.01MG/ML;2%
A080406 002
HOSPIRA 0.005MG/ML;1%
A089649 001 Jun 21, 1988
0.005MG/ML;1.5%
A089650 001 Jun 21, 1988
LIDOCAINE HYDROCHLORIDE W/ EPINEPHRINE
ABBOTT
0.01MG/ML;1%
A083154 001
BEL MAR
0.01MG/ML;1%
A080820 001
0.01MG/ML;2%
A080757 001
DELL LABS
0.01MG/ML;1%
A083389 001
0.01MG/ML;2%
A083390 001
INTL MEDICATION
0.01MG/ML;1%
A086402 001
WATSON LABS
0.01MG/ML;1%
A080377 003
0.01MG/ML;1%
A085463 001
0.01MG/ML;2%
A080377 004
LIDOCATON
PHARMATON
0.01MG/ML;2%
A084729 001 Aug 17, 1983
0.02MG/ML;2%
A084728 001 Aug 17, 1983
XYLOCAINE DENTAL WITH EPINEPHRINE
DENTSPLY PHARM
0.01MG/ML;2%
N021381 001
0.02MG/ML;2%
N021381 002
XYLOCAINE W/ EPINEPHRINE
ASTRAZENECA
0.005MG/ML;1%
N010418 006
0.005MG/ML;1.5%
N010418 010
0.005MG/ML;2%
N010418 008
FRESENIUS KABI USA
0.01MG/ML;2%
N006488 003
PATCH;IONTOPHORESIS, TOPICAL
LIDOSITE TOPICAL SYSTEM KIT
VYTERIS
1.05MG/PATCH;100MG/PATCH
N021504 001 May 06, 2004
SOLUTION;IONTOPHORESIS
IONTOCAINE
IOMED
0.01MG/ML;2%
N020530 001 Dec 21, 1995
SOLUTION;IONTOPHORESIS, TOPICAL
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE
EMPI 0.01MG/ML;2%
N021486 001 Oct 26, 2004
EPINEPHRINE; PROCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
PROCAINE HYDROCHLORIDE W/ EPINEPHRINE
BEL MAR
0.02MG/ML;1%
A080758 001
0.02MG/ML;2%
A080759 001
EPIRUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
EPIRUBICIN HYDROCHLORIDE
EBEWE PHARMA
50MG/25ML (2MG/ML)
A065339 001 Dec 22, 2009
200MG/100ML (2MG/ML)
A065339 002 Dec 22, 2009
HOSPIRA
50MG/25ML (2MG/ML)
A065343 002 Apr 19, 2007
MUSTAFA NEVSAT
50MG/25ML (2MG/ML)
A090266 001 Apr 15, 2011
200MG/100ML (2MG/ML)
A090266 002 Apr 15, 2011
MYLAN INSTITUTIONAL
50MG/25ML (2MG/ML)
A065371 001 Nov 28, 2007
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DISCONTINUED DRUG PRODUCT LIST
6-124(of 337)
EPIRUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
EPIRUBICIN HYDROCHLORIDE
200MG/100ML (2MG/ML)
A065371 002 Nov 28, 2007
INJECTABLE;IV (INFUSION)
EPIRUBICIN HYDROCHLORIDE
HOSPIRA
50MG/VIAL
N050807 001 Sep 15, 2006
200MG/VIAL
N050807 002 Sep 15, 2006
EPLERENONE
TABLET;ORAL
INSPRA
GD SEARLE LLC
100MG
N021437 003 Sep 27, 2002
EPROSARTAN MESYLATE
TABLET;ORAL
TEVETEN
ABBVIE
EQ 300MG BASE
N020738 004 Dec 22, 1997
ERGOCALCIFEROL
CAPSULE;ORAL
DELTALIN
LILLY
50,000 IU
A080884 001
VITAMIN D
CHASE CHEM
50,000 IU
A080747 001
EVERYLIFE
50,000 IU
A080956 001
IMPAX LABS
50,000 IU
A080951 001
LANNETT
50,000 IU
A080825 001
VITARINE
50,000 IU
A084053 001
WEST WARD
50,000 IU
A083102 001
ERGOLOID MESYLATES
CAPSULE;ORAL
HYDERGINE LC
NOVARTIS
1MG
N018706 001 Jan 18, 1983
SOLUTION;ORAL
HYDERGINE
NOVARTIS
1MG/ML
N018418 001
TABLET;ORAL
ERGOLOID MESYLATES
MUTUAL PHARM
1MG
A088891 001 Nov 01, 1985
WATSON LABS
1MG
A086433 001 May 27, 1982
1MG
A087244 001 Aug 16, 1982
GERIMAL
WATSON LABS
1MG
A088207 001 Mar 22, 1984
HYDERGINE
NOVARTIS
0.5MG
N017993 003
TABLET;SUBLINGUAL
ALKERGOT
SANDOZ
0.5MG
A085153 001
1MG
A087417 001
CIRCANOL
3M
0.5MG
A084868 001
1MG
A085809 001
DEAPRIL-ST
BRISTOL MYERS SQUIBB
1MG
A085020 002
ERGOLOID MESYLATES
KV PHARM
0.5MG
A085899 001
0.5MG
A086265 001
1MG
A085900 001
1MG
A086264 001
LEDERLE
0.5MG
A086984 001
1MG
A086985 001
MUTUAL PHARM
0.5MG
A087407 001
1MG
A087552 001
SUPERPHARM
0.5MG
A089233 001 Sep 23, 1986
1MG
A089234 001 Sep 23, 1986
VANGARD
0.5MG
A088013 001 Sep 20, 1982
1MG
A088014 001 Sep 20, 1982
WATSON LABS
0.5MG
A084930 001
0.5MG
A087233 001
1MG
A085177 001
1MG
A087183 001
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DISCONTINUED DRUG PRODUCT LIST
6-125(of 337)
ERGOLOID MESYLATES
TABLET;SUBLINGUAL
GERIMAL
WATSON LABS 0.5MG
A086189 001
1MG
A086188 001
HYDERGINE
NOVARTIS 0.5MG
N009087 002
1MG
N009087 001
HYDROGENATED ERGOT ALKALOIDS
IVAX PHARMS 0.5MG
A087186 001
1MG
A087185 001
ERGOTAMINE TARTRATE
AEROSOL, METERED;INHALATION
MEDIHALER ERGOTAMINE
3M
0.36MG/INH
N012102 001
TABLET;SUBLINGUAL
ERGOSTAT
PARKE DAVIS
2MG
A088337 001 Jun 08, 1984
WIGRETTES
ORGANON USA INC
2MG
A086750 001 Jul 29, 1982
ERYTHROMYCIN
CAPSULE, DELAYED REL PELLETS;ORAL
ERYC
PARKE DAVIS
250MG
A062546 001 Jul 25, 1985
250MG
A062618 001 Sep 25, 1985
WARNER CHILCOTT LLC
250MG
A062338 001
ERYC 125
PARKE DAVIS
125MG
A062648 001 Oct 24, 1985
ERYC SPRINKLES
HOSPIRA
125MG
N050593 001 Jul 22, 1985
ERYTHROMYCIN
BARR
250MG
A063098 001 May 04, 1989
GEL;TOPICAL
E-GLADES
RENAISSANCE PHARMA
2%
A065009 001 Mar 18, 2002
EMGEL
ALTANA
2%
A063107 001 Aug 23, 1991
LOTION;TOPICAL
E-SOLVE 2
SYOSSET
2%
A062467 001 Jul 03, 1985
OINTMENT;OPHTHALMIC
ERYTHROMYCIN
PHARMADERM
5MG/GM
A062446 001 Sep 26, 1983
PHARMAFAIR
5MG/GM
A062481 001 Apr 05, 1984
ILOTYCIN
DISTA
0.5%
N050368 001
POWDER;FOR RX COMPOUNDING
ERYTHROMYCIN
PADDOCK LLC
100%
N050610 001 Nov 07, 1986
SOLUTION;TOPICAL
A/T/S
TARO PHARMS NORTH
2%
A062405 001 Nov 18, 1982
ERYDERM
ARBOR PHARMS INC
2%
A062290 001
ERYMAX
MERZ PHARMS
2%
A062508 002 Jul 11, 1985
ERYTHROMYCIN
ALPHARMA US PHARMS
1.5%
A062328 001 Apr 19, 1982
2%
A062326 001 Apr 19, 1982
2%
A062327 001 Apr 19, 1982
2%
A062342 001 Feb 25, 1982
2%
A062957 001 Jul 21, 1988
BAUSCH AND LOMB
2%
A064039 001 Jan 27, 1994
LILLY
2%
N050532 001
PHARMAFAIR
1.5%
A062485 001 Jul 11, 1984
2%
A062616 001 Jul 25, 1985
RENAISSANCE PHARMA
2%
A064127 001 Feb 14, 1997
SANSAC
DOW PHARM
2%
A062522 001 Jan 24, 1985
STATICIN
WESTWOOD SQUIBB
1.5%
N050526 001
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DISCONTINUED DRUG PRODUCT LIST
6-126(of 337)
ERYTHROMYCIN
SOLUTION;TOPICAL
T-STAT
WESTWOOD SQUIBB
2%
A062436 001 Mar 09, 1983
SWAB;TOPICAL
C-SOLVE-2
IVAX SUB TEVA PHARMS
2%
A062751 001 Jul 30, 1993
ERYCETTE
JOHNSON AND JOHNSON
2%
N050594 001 Feb 15, 1985
ERYTHROMYCIN
FOUGERA PHARMS
2%
A065320 001 Jul 25, 2006
RENAISSANCE PHARMA
2%
A064128 001 Jul 03, 1996
T-STAT
WESTWOOD SQUIBB
2%
A062748 001 Jul 23, 1987
TABLET, DELAYED RELEASE;ORAL
E-BASE
BARR
333MG
A063028 001 May 15, 1990
333MG
A063086 001 May 15, 1990
500MG
A062999 001 Nov 25, 1988
E-MYCIN
ARBOR PHARMS INC
250MG
A060272 001
333MG
A060272 002
ILOTYCIN
DISTA
250MG
A061910 001
R-P MYCIN
SOLVAY
250MG
A061659 001
ROBIMYCIN
ROBINS AH
250MG
A061633 001
ERYTHROMYCIN ESTOLATE
CAPSULE;ORAL
ERYTHROMYCIN ESTOLATE
BARR
EQ 125MG BASE
A062162 001
EQ 250MG BASE
A062162 002
IVAX SUB TEVA PHARMS
EQ 250MG BASE
A062237 001
WATSON LABS
EQ 250MG BASE
A062087 001
ILOSONE
LILLY
EQ 125MG BASE
A061897 001
EQ 250MG BASE
A061897 002
FOR SUSPENSION;ORAL
ILOSONE
DISTA
EQ 125MG BASE/5ML
A061893 001
SUSPENSION;ORAL
ERYTHROMYCIN ESTOLATE
ALPHARMA US PHARMS
EQ 125MG BASE/5ML
A062353 001 Nov 18, 1982
EQ 250MG BASE/5ML
A062409 001 Dec 16, 1982
BARR
EQ 125MG BASE/5ML
A062169 001 Oct 17, 1990
EQ 250MG BASE/5ML
A062169 002 Oct 17, 1990
LIFE LABS
EQ 250MG BASE/5ML
A062362 001 Dec 17, 1982
ILOSONE
LILLY
EQ 125MG BASE/5ML
A061894 001
EQ 125MG BASE/5ML
N050010 001
EQ 250MG BASE/5ML
A061894 002
EQ 250MG BASE/5ML
N050010 002
SUSPENSION/DROPS;ORAL
ILOSONE
LILLY
EQ 100MG BASE/ML
A061894 003
TABLET;ORAL
ILOSONE
LILLY
EQ 500MG BASE
A061896 001
TABLET, CHEWABLE;ORAL
ILOSONE
DISTA
EQ 125MG BASE
A061895 001
EQ 250MG BASE
A061895 002
ERYTHROMYCIN ESTOLATE; SULFISOXAZOLE ACETYL
SUSPENSION;ORAL
ILOSONE SULFA
LILLY EQ 125MG BASE/5ML;EQ 600MG BASE/5ML
N050599 001 Sep 29, 1989
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DISCONTINUED DRUG PRODUCT LIST
6-127(of 337)
ERYTHROMYCIN ETHYLSUCCINATE
GRANULE;ORAL
ERYTHROMYCIN ETHYLSUCCINATE
BARR
EQ 200MG BASE/5ML
A062055 001
PEDIAMYCIN
ROSS LABS
EQ 200MG BASE/5ML
A062305 001
SUSPENSION;ORAL
E-MYCIN E
PHARMACIA AND UPJOHN
EQ 200MG BASE/5ML
A062198 001
EQ 400MG BASE/5ML
A062198 002
ERYTHROMYCIN ETHYLSUCCINATE
ALPHARMA US PHARMS
EQ 200MG BASE/5ML
A062200 001
EQ 400MG BASE/5ML
A062200 002
DISTA
EQ 200MG BASE/5ML
A062177 001
EQ 400MG BASE/5ML
A062177 002
NASKA
EQ 400MG BASE/5ML
A062674 001 Mar 10, 1987
PARKE DAVIS
EQ 200MG BASE/5ML
A062231 001
EQ 400MG BASE/5ML
A062231 002
PHARMAFAIR
EQ 200MG BASE/5ML
A062559 001 Mar 15, 1985
EQ 400MG BASE/5ML
A062558 001 Mar 15, 1985
WYAMYCIN E
WYETH AYERST
EQ 200MG BASE/5ML
A062123 002
EQ 400MG BASE/5ML
A062123 001
SUSPENSION/DROPS;ORAL
PEDIAMYCIN
ROSS LABS
EQ 100MG BASE/2.5ML
A062305 002
TABLET;ORAL
E.E.S. 400
ARBOR PHARMS LLC
EQ 400MG BASE
A061905 001
ERYTHROMYCIN ETHYLSUCCINATE
BARR
EQ 400MG BASE
A062256 001
MYLAN
EQ 400MG BASE
A062847 001 Sep 14, 1988
TABLET, CHEWABLE;ORAL
E.E.S.
ARBOR PHARMS INC
EQ 200MG BASE
N050297 002
ERYPED
ARBOR PHARMS INC
EQ 200MG BASE
N050297 003 Jul 05, 1988
PEDIAMYCIN
ROSS LABS
EQ 200MG BASE
A062306 001
ERYTHROMYCIN ETHYLSUCCINATE; SULFISOXAZOLE ACETYL
GRANULE;ORAL
ERYZOLE
ALRA
EQ 200MG BASE/5ML;EQ 600MG BASE/5ML
A062758 001 Jun 15, 1988
PEDIAZOLE
ROSS LABS
EQ 200MG BASE/5ML;EQ 600MG BASE/5ML
N050529 001
ERYTHROMYCIN GLUCEPTATE
INJECTABLE;INJECTION
ILOTYCIN GLUCEPTATE
DISTA
EQ 1GM BASE/VIAL
N050370 003
EQ 250MG BASE/VIAL
N050370 001
EQ 500MG BASE/VIAL
N050370 002
ERYTHROMYCIN LACTOBIONATE
INJECTABLE;INJECTION
ERYTHROCIN
ABBOTT
EQ 1GM BASE/VIAL
A062586 002 Jan 04, 1988
EQ 500MG BASE/VIAL
A062586 001 Jan 04, 1988
HOSPIRA
EQ 1GM BASE/VIAL
N050182 003
EQ 1GM BASE/VIAL
N050609 002 Sep 24, 1986
EQ 500MG BASE/VIAL
N050182 002
ERYTHROMYCIN
ELKINS SINN
EQ 1GM BASE/VIAL
A062563 002 Mar 28, 1985
EQ 500MG BASE/VIAL
A062563 001 Mar 28, 1985
ERYTHROMYCIN LACTOBIONATE
ABRAXIS PHARM
EQ 1GM BASE/VIAL
A062604 002 Nov 24, 1986
EQ 500MG BASE/VIAL
A062604 001 Nov 24, 1986
BAXTER HLTHCARE
EQ 1GM BASE/VIAL
A062993 002 May 09, 1989
EQ 500MG BASE/VIAL
A062993 001 May 09, 1989
TEVA PARENTERAL
EQ 1GM BASE/VIAL
A063253 002 Jul 30, 1993
EQ 500MG BASE/VIAL
A063253 001 Jul 30, 1993
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DISCONTINUED DRUG PRODUCT LIST 6-128(of 337)
ERYTHROMYCIN STEARATE
TABLET;ORAL
BRISTAMYCIN
BRISTOL EQ 250MG BASE A061304 001
EQ 250MG BASE A061887 001
ERYPAR
PARKE DAVIS EQ 250MG BASE A062032 001
EQ 500MG BASE A062032 002
WARNER CHILCOTT EQ 250MG BASE A062322 001
ERYTHROCIN STEARATE
ARBOR PHARMS LLC EQ 125MG BASE A060359 002
EQ 500MG BASE A060359 003
ERYTHROMYCIN STEARATE
ANI PHARMS INC EQ 250MG BASE A061461 001
EQ 250MG BASE A061591 001
EQ 500MG BASE A061461 002
EQ 500MG BASE A063179 001 May 15, 1990
LEDERLE EQ 250MG BASE A062089 001
EQ 500MG BASE A062089 002
MYLAN EQ 250MG BASE A061505 001
EQ 500MG BASE A061505 002
PUREPAC PHARM EQ 250MG BASE A061743 001
WATSON LABS EQ 250MG BASE A062121 002
EQ 500MG BASE A062121 001
ETHRIL 250
BRISTOL MYERS SQUIBB EQ 250MG BASE A061605 001
ETHRIL 500
BRISTOL MYERS SQUIBB EQ 500MG BASE A061605 002
PFIZER-E
PFIZER EQ 250MG BASE A061791 001
EQ 500MG BASE A061791 002
WYAMYCIN S
WYETH AYERST EQ 250MG BASE A061675 001
EQ 500MG BASE A061675 002
ESCITALOPRAM OXALATE
CAPSULE;ORAL
ESCITALOPRAM OXALATE
MYLAN PHARMS INC EQ 5MG BASE A077660 001 Jul 31, 2007
EQ 10MG BASE A077660 002 Jul 31, 2007
EQ 20MG BASE A077660 003 Jul 31, 2007
ESMOLOL HYDROCHLORIDE
INJECTABLE;INJECTION
BREVIBLOC
BAXTER HLTHCARE 10MG/ML N019386 003 Aug 15, 1988
20MG/ML N019386 007 May 28, 2003
ESTAZOLAM
TABLET;ORAL
PROSOM
ABBOTT 1MG **Federal Register determination N019080 001 Dec 26, 1990
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
2MG **Federal Register determination N019080 002 Dec 26, 1990
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
ESTRADIOL
FILM, EXTENDED RELEASE;TRANSDERMAL
ESCLIM
WOMEN FIRST HLTHCARE 0.025MG/24HR N020847 001 Aug 04, 1998
0.0375MG/24HR N020847 002 Aug 04, 1998
0.05MG/24HR N020847 003 Aug 04, 1998
0.075MG/24HR N020847 004 Aug 04, 1998
0.1MG/24HR N020847 005 Aug 04, 1998
ESTRADIOL
ORTHO MCNEIL PHARM 0.05MG/24HR N021048 001 Sep 20, 1999
0.075MG/24HR N021048 002 Sep 20, 1999
0.1MG/24HR N021048 003 Sep 20, 1999
FEMPATCH
PARKE DAVIS 0.025MG/24HR N020417 001 Dec 03, 1996
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DISCONTINUED DRUG PRODUCT LIST 6-129(of 337)
ESTRADIOL
FILM, EXTENDED RELEASE;TRANSDERMAL
VIVELLE
NOVARTIS 0.025MG/24HR N020323 005 Aug 16, 2000
0.0375MG/24HR N020323 001 Oct 28, 1994
0.075MG/24HR N020323 003 Oct 28, 1994
GEL;TOPICAL
ESTROGEL
ASCEND THERAPS US 0.06% N021166 001 Feb 09, 2004
TABLET;ORAL
ESTRACE
BRISTOL MYERS SQUIBB 0.5MG A081295 001 Jun 30, 1993
1MG A084499 001
2MG A084500 001
ESTRADIOL
HERITAGE PHARMS INC 0.5MG A040275 001 Dec 29, 1998
1MG A040275 002 Dec 29, 1998
2MG A040275 003 Dec 29, 1998
LANNETT HOLDINGS INC 0.5MG A040138 001 Jan 30, 1998
1MG A040138 002 Jan 30, 1998
2MG A040138 003 Jan 30, 1998
GYNODIOL
DURAMED PHARMS BARR 0.5MG A040212 001 Dec 29, 1997
1MG A040212 002 Dec 29, 1997
1.5MG A040212 003 Dec 29, 1997
2MG A040212 004 Dec 29, 1997
INNOFEM
NOVO NORDISK INC 0.5MG A040312 001 Nov 19, 1999
1MG A040312 002 Nov 19, 1999
2MG A040312 003 Nov 19, 1999
TABLET;VAGINAL
VAGIFEM
NOVO NORDISK INC 25MCG N020908 001 Mar 26, 1999
ESTRADIOL CYPIONATE
INJECTABLE;INJECTION
DEPO-ESTRADIOL
PHARMACIA AND UPJOHN 1MG/ML A085470 001
3MG/ML A085470 002
ESTRADIOL CYPIONATE
WATSON LABS 5MG/ML A085620 001
ESTRADIOL CYPIONATE; MEDROXYPROGESTERONE ACETATE
INJECTABLE;INTRAMUSCULAR
LUNELLE
PHARMACIA AND UPJOHN 5MG/0.5ML;25MG/0.5ML N020874 001 Oct 05, 2000
ESTRADIOL CYPIONATE; TESTOSTERONE CYPIONATE
INJECTABLE;INJECTION
DEPO-TESTADIOL
PHARMACIA AND UPJOHN 2MG/ML;50MG/ML N017968 001
TESTOSTERONE CYPIONATE-ESTRADIOL CYPIONATE
WATSON LABS 2MG/ML;50MG/ML A085603 001 Mar 13, 1986
ESTRADIOL VALERATE
INJECTABLE;INJECTION
ESTRADIOL VALERATE
SANDOZ 10MG/ML A040628 001 Oct 04, 2007
20MG/ML A040628 002 Oct 04, 2007
40MG/ML A040628 003 Oct 04, 2007
WATSON LABS 10MG/ML A083546 001
40MG/ML A083714 001
WATSON LABS INC 20MG/ML A083547 001
ESTRADIOL VALERATE; TESTOSTERONE ENANTHATE
INJECTABLE;INJECTION
DITATE-DS
SAVAGE LABS 8MG/ML;180MG/ML A086423 001
TESTOSTERONE ENANTHATE AND ESTRADIOL VALERATE
WATSON LABS 4MG/ML;90MG/ML A085865 001
8MG/ML;180MG/ML A085860 001
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DISCONTINUED DRUG PRODUCT LIST 6-130(of 337)
ESTRADIOL; NORGESTIMATE
TABLET;ORAL
PREFEST
TEVA WOMENS 1MG,1MG;1MG,1MG;N/A,0.09MG **Federal N021040 001 Oct 22, 1999
Register determination that product was
not discontinued or withdrawn for
safety or efficacy reasons**
ESTROGENS, CONJUGATED
TABLET;ORAL
PREMARIN
WYETH PHARMS INC 2.5MG N004782 002
ESTROGENS, CONJUGATED SYNTHETIC A
CREAM;VAGINAL
SYNTHETIC CONJUGATED ESTROGENS A
TEVA WOMENS 0.625MG/GM N021788 001 Nov 28, 2008
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE
TABLET;ORAL-28
PREMPHASE (PREMARIN;CYCRIN 14/14)
WYETH PHARMS INC 0.625MG;0.625MG;N/A,5MG N020303 002 Dec 30, 1994
PREMPRO (PREMARIN;CYCRIN)
WYETH PHARMS INC 0.625MG;0.625MG;2.5MG;2.5MG N020303 001 Dec 30, 1994
ESTROGENS, CONJUGATED; MEPROBAMATE
TABLET;ORAL
MILPREM-200
MEDPOINTE PHARM HLC 0.45MG;200MG N011045 002
MILPREM-400
MEDPOINTE PHARM HLC 0.45MG;400MG N011045 001
PMB 200
WYETH AYERST 0.45MG;200MG N010971 005
PMB 400
WYETH AYERST 0.45MG;400MG N010971 003
ESTROGENS, ESTERIFIED
TABLET;ORAL
AMNESTROGEN
BRISTOL MYERS SQUIBB 0.3MG A083266 001
0.625MG A083266 002
1.25MG A083266 003
2.5MG A083266 004
ESTERIFIED ESTROGENS
PVT FORM 0.625MG A083414 001
1.25MG A083765 001
2.5MG A085907 001
SANDOZ 1.25MG A085302 001
ESTRATAB
SOLVAY 0.3MG A086715 001
0.625MG A083209 001
1.25MG A083856 001
2.5MG A083857 001
EVEX
ROCHE PALO 0.625MG A084215 001
1.25MG A083376 002
FEMOGEN
PVT FORM 0.625MG A085076 001
1.25MG A085008 001
2.5MG A085007 001
ESTRONE
INJECTABLE;INJECTION
ESTROGENIC SUBSTANCE
WYETH AYERST 2MG/ML A083488 001
ESTRONE
WATSON LABS 2MG/ML A083397 001
5MG/ML A085239 001
NATURAL ESTROGENIC SUBSTANCE-ESTRONE
WATSON LABS 2MG/ML A085237 001 Nov 23, 1982
THEELIN
PARKEDALE 1MG/ML N003977 001
2MG/ML N003977 002
5MG/ML N003977 003
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DISCONTINUED DRUG PRODUCT LIST 6-131(of 337)
ESTROPIPATE
CREAM;VAGINAL
OGEN
PHARMACIA AND UPJOHN 1.5MG/GM A084710 001
TABLET;ORAL
ESTROPIPATE
DURAMED PHARMS BARR 0.75MG A040296 001 Nov 01, 1999
1.5MG A040296 002 Nov 01, 1999
3MG A040296 003 Nov 01, 1999
MYLAN 3MG A040359 003 Aug 26, 1999
WATSON LABS 6MG A081216 001 Sep 23, 1993
ORTHO-EST
SUN PHARM INDS INC 0.75MG A089567 001 Feb 27, 1991
1.5MG A089582 001 Jul 17, 1991
ESZOPICLONE
TABLET;ORAL
ESZOPICLONE
WOCKHARDT LTD 1MG A091165 001 Jul 14, 2011
2MG A091165 002 Jul 14, 2011
3MG A091165 003 Jul 14, 2011
ETHACRYNIC ACID
TABLET;ORAL
EDECRIN
ATON 50MG N016092 002
ETHAMBUTOL HYDROCHLORIDE
TABLET;ORAL
ETHAMBUTOL HYDROCHLORIDE
VERSAPHARM INC 100MG A075095 001 Nov 30, 1999
400MG A075095 002 Nov 30, 1999
MYAMBUTOL
STI PHARMA LLC 200MG N016320 002
500MG N016320 004
ETHCHLORVYNOL
CAPSULE;ORAL
ETHCHLORVYNOL
BANNER PHARMACAPS 100MG A084463 001
200MG A084463 002
500MG A084463 003
750MG A084463 004
PLACIDYL
ABBVIE 100MG N010021 004
200MG N010021 007
500MG N010021 002
750MG N010021 010
ETHINAMATE
CAPSULE;ORAL
VALMID
DISTA 500MG N009750 001
ETHINYL ESTRADIOL
TABLET;ORAL
ESTINYL
SCHERING 0.02MG N005292 001
0.05MG N005292 002
0.5MG N005292 003
FEMINONE
PHARMACIA AND UPJOHN 0.05MG N016649 001
LYNORAL
ORGANON USA INC 0.01MG N005490 003
0.05MG N005490 002
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE
TABLET;ORAL-21
DEMULEN 1/35-21
GD SEARLE LLC 0.035MG;1MG **Federal Register N018168 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
DEMULEN 1/50-21
GD SEARLE LLC 0.05MG;1MG N016927 001
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6-132(of 337)
ETHINYL ESTRADIOL; ETHYNODIOL DIACETATE
TABLET;ORAL-21
ZOVIA 1/35E-21
WATSON LABS
0.035MG;1MG
A072720 001
Dec 30, 1991
ZOVIA 1/50E-21
WATSON LABS
0.05MG;1MG
A072722 001
Dec 30, 1991
TABLET;ORAL-28
DEMULEN 1/35-28
GD SEARLE LLC
0.035MG;1MG
N018160 001
DEMULEN 1/50-28
GD SEARLE LLC
0.05MG;1MG
N016936 001
ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE
TABLET;ORAL-28
NORQUEST FE
GD SEARLE LLC 0.035MG;75MG;1MG
N018926 001
Jul 18, 1986
ETHINYL ESTRADIOL; FERROUS FUMARATE; NORETHINDRONE ACETATE
TABLET;ORAL-28
NORLESTRIN FE 1/50
PARKE DAVIS 0.05MG;75MG;1MG
N016766 001
NORLESTRIN FE 2.5/50
PARKE DAVIS 0.05MG;75MG;2.5MG
N016854 001
ETHINYL ESTRADIOL; LEVONORGESTREL
TABLET;ORAL
LYBREL
WYETH PHARMS INC 0.02MG;0.09MG **Federal Register
N021864 001
May 22, 2007
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
PREVEN EMERGENCY CONTRACEPTIVE KIT
TEVA BRANDED PHARM
0.05MG;0.25MG
N020946 001
Sep 01, 1998
TABLET;ORAL-21
ALESSE
WYETH PHARMS
0.02MG;0.1MG **Federal Register
N020683 001
Mar 27, 1997
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
AVIANE-21
DURAMED PHARMS BARR
0.02MG;0.1MG
A075796 002
Apr 30, 2001
ENPRESSE-21
DURAMED PHARMS BARR
0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1
A075809 001
Jul 16, 2001
25MG
LESSINA-21
BARR
0.02MG;0.1MG
A075803 001
Mar 20, 2002
LEVLITE
BAYER HLTHCARE
0.02MG;0.1MG
N020860 001
Jul 13, 1998
LEVONORGESTREL AND ETHINYL ESTRADIOL
BARR
0.02MG;0.1MG
A075862 001
Apr 29, 2003
LEVORA 0.15/30-21
WATSON LABS
0.03MG;0.15MG
A073592 001
Dec 13, 1993
NORDETTE-21
TEVA BRANDED PHARM
0.03MG;0.15MG
N018668 001
May 10, 1982
PORTIA-21
BARR
0.03MG;0.15MG
A075866 001
May 23, 2002
TRIPHASIL-21
WYETH PHARMS
0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1
N019192 001
Nov 01, 1984
25MG **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
TRIVORA-21
WATSON LABS
0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1
A074538 001
Dec 18, 1997
25MG
TABLET;ORAL-28
ALESSE
WYETH PHARMS
0.02MG;0.1MG
N020683 002
Mar 27, 1997
LEVLITE
BAYER HLTHCARE
0.02MG;0.1MG
N020860 002
Jul 13, 1998
LEVONORGESTREL AND ETHINYL ESTRADIOL
BARR 0.02MG;0.1MG A075862 002 Apr 29, 2003
TRIPHASIL-28
WYETH PHARMS INC 0.03MG;0.03MG;0.04MG;0.05MG;0.075MG;0.1 N019190 001 Nov 01, 1984
25MG
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DISCONTINUED DRUG PRODUCT LIST
6-133(of 337)
ETHINYL ESTRADIOL; NORETHINDRONE
TABLET;ORAL-21
BALZIVA-21
BARR
0.035MG;0.4MG
A076198 001
Apr 22, 2004
BREVICON 21-DAY
WATSON LABS
0.035MG;0.5MG
N017566 001
GENCEPT 10/11-21
BARR
0.035MG;0.035MG;0.5MG;1MG
A072694 001
Feb 28, 1992
MODICON 21
ORTHO MCNEIL PHARM
0.035MG;0.5MG
N017488 001
N.E.E. 1/35 21
LPI
0.035MG;1MG
A071541 001
Dec 14, 1987
NORCEPT-E 1/35 21
ORTHO MCNEIL PHARM
0.035MG;1MG
A071545 001
Feb 09, 1989
NORETHIN 1/35E-21
WATSON LABS
0.035MG;1MG
A071480 001
Apr 12, 1988
NORETHINDRONE AND ETHINYL ESTRADIOL
WATSON LABS 0.035MG;0.4MG
A078379 001
Feb 23, 2010
0.035MG;0.5MG
A070684 001
Jan 29, 1987
0.035MG;1MG
A070685 001
Jan 29, 1987
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11)
WATSON LABS 0.035MG;0.035MG;0.5MG;1MG
A071043 001
Apr 01, 1988
NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)
WATSON LABS
0.035MG;0.035MG;0.5MG;1MG
A071041 001
Sep 24, 1991
NORTREL 0.5/35-21
BARR
0.035MG;0.5MG
A072692 001
Feb 28, 1992
ORTHO-NOVUM 1/35-21
ORTHO MCNEIL PHARM
0.035MG;1MG
N017489 002
ORTHO-NOVUM 10/11-21
ORTHO MCNEIL JANSSEN
0.035MG;0.035MG;0.5MG;1MG
N018354 001
Jan 11, 1982
ORTHO-NOVUM 7/14-21
ORTHO MCNEIL PHARM
0.035MG;0.035MG;0.5MG;1MG
N019004 001
Apr 04, 1984
ORTHO-NOVUM 7/7/7-21
JANSSEN PHARMS
0.035MG;0.035MG;0.035MG;0.5MG;0.75MG;1M
N018985 001
Apr 04, 1984
G
OVCON-35
WARNER CHILCOTT
0.035MG;0.4MG
N018127 001
OVCON-50
WARNER CHILCOTT
0.05MG;1MG
N018128 001
TRI-NORINYL 21-DAY
WATSON LABS
0.035MG;0.035MG;0.035MG;0.5MG;0.5MG;1MG
N018977 001
Apr 13, 1984
TABLET;ORAL-28
GENCEPT 10/11-28
BARR
0.035MG;0.035MG;0.5MG;1MG
A072697 001
Feb 28, 1992
N.E.E. 1/35 28
LPI
0.035MG;1MG
A071542 001
Dec 14, 1987
NORCEPT-E 1/35 28
ORTHO MCNEIL PHARM
0.035MG;1MG
A071546 001
Feb 09, 1989
NORETHIN 1/35E-28
WATSON LABS
0.035MG;1MG
A071481 001
Apr 12, 1988
NORETHINDRONE AND ETHINYL ESTRADIOL
WATSON LABS 0.035MG,0.035MG,0.035MG;0.5MG,0.75MG,1M
A076393 001
Feb 04, 2010
G
NORETHINDRONE AND ETHINYL ESTRADIOL (7/14)
WATSON LABS
0.035MG,0.035MG;0.035MG,0.035MG;0.5MG,1
A071042 001
Sep 24, 1991
MG;0.5MG,1MG
ORTHO-NOVUM 10/11-28
ORTHO MCNEIL JANSSEN
0.035MG;0.035MG;0.5MG;1MG
N018354 002
Jan 11, 1982
ORTHO-NOVUM 7/14-28
ORTHO MCNEIL PHARM
0.035MG;0.035MG;0.5MG;1MG
N019004 002
Apr 04, 1984
OVCON-50
WARNER CHILCOTT LLC
0.05MG;1MG
N017576 001
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
CAPSULE;ORAL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
WARNER CHILCOTT
0.02MG;1MG
N204426 001
Apr 19, 2013
TABLET;ORAL
FEMHRT
WARNER CHILCOTT LLC
0.005MG;1MG
N021065 002
Oct 15, 1999
TABLET;ORAL-21
ESTROSTEP 21
WARNER CHILCOTT LLC
0.02MG;0.035MG;0.03MG;1MG;1MG;1MG
N020130 001
Oct 09, 1996
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6-134(of 337)
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE
TABLET;ORAL-21
NORLESTRIN 21 1/50
PARKE DAVIS
0.05MG;1MG
N016749 001
NORLESTRIN 21 2.5/50
PARKE DAVIS
0.05MG;2.5MG
N016852 001
TABLET;ORAL-28
NORLESTRIN 28 1/50
PARKE DAVIS
0.05MG;1MG
N016723 001
ETHINYL ESTRADIOL; NORGESTIMATE
TABLET;ORAL-21
ORTHO CYCLEN-21
JANSSEN PHARMS
0.035MG;0.25MG
N019653 001 Dec 29, 1989
ORTHO TRI-CYCLEN
JANSSEN PHARMS
0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;
N019697 002 Jul 03, 1992
0.25MG
TABLET;ORAL-28
NORGESTIMATE AND ETHINYL ESTRADIOL
WATSON LABS
0.025MG;0.025MG;0.025MG;0.18MG;0.215MG;
A090479 001 Mar 09, 2011
0.25MG
0.035MG;0.035MG;0.035MG;0.18MG;0.215MG;
A076626 001 Aug 17, 2006
0.25MG
0.035MG;0.25MG
A076627 001 Aug 17, 2006
TRI LO SPRINTEC
BARR LABS INC
0.025MG,0.025MG,0.025MG;0.18MG,0.215MG,
A076784 001 Jun 29, 2009
0.25MG
ETHINYL ESTRADIOL; NORGESTREL
TABLET;ORAL-21
LO/OVRAL
WYETH PHARMS INC
0.03MG;0.3MG
N017612 001
LOW-OGESTREL-21
WATSON LABS
0.03MG;0.3MG
A075288 001 Jul 28, 1999
OGESTREL 0.5/50-21
WATSON LABS
0.05MG;0.5MG
A075406 001 Dec 15, 1999
OVRAL
WYETH PHARMS
0.05MG;0.5MG
N016672 001
TABLET;ORAL-28
LOW-OGESTREL-28
WATSON LABS
0.03MG;0.3MG
A075288 002 Jul 28, 1999
OVRAL-28
WYETH PHARMS
0.05MG;0.5MG
N016806 001
ETHOPROPAZINE HYDROCHLORIDE
TABLET;ORAL
PARSIDOL
PARKE DAVIS
10MG
N009078 003
50MG
N009078 006
100MG
N009078 008
ETHOTOIN
TABLET;ORAL
PEGANONE
RECORDATI RARE
500MG
N010841 003
ETHOXZOLAMIDE
TABLET;ORAL
CARDRASE
PHARMACIA AND UPJOHN
62.5MG
N011047 002
125MG
N011047 001
ETHAMIDE
ALLERGAN
125MG
N016144 001
ETHYLESTRENOL
ELIXIR;ORAL
MAXIBOLIN
ORGANON USA INC
2MG/5ML
N014006 002
TABLET;ORAL
MAXIBOLIN
ORGANON USA INC
2MG
N014005 002
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DISCONTINUED DRUG PRODUCT LIST 6-135(of 337)
ETHYNODIOL DIACETATE; MESTRANOL
TABLET;ORAL-20
OVULEN
GD SEARLE LLC 1MG;0.1MG N016029 002
TABLET;ORAL-21
OVULEN-21
GD SEARLE LLC 1MG;0.1MG N016029 003
TABLET;ORAL-28
OVULEN-28
GD SEARLE LLC 1MG;0.1MG N016705 001
ETIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
DURANEST
ASTRAZENECA 0.5% N017751 003
1% N017751 005
ETIDRONATE DISODIUM
INJECTABLE;INJECTION
DIDRONEL
MGI PHARMA INC 50MG/ML N019545 001 Apr 20, 1987
ETODOLAC
CAPSULE;ORAL
ETODOLAC
AAIPHARMA LLC 300MG A074929 001 Jan 30, 1998
ANI PHARMS INC 200MG A074899 001 Jul 08, 1997
300MG A074899 002 Jul 08, 1997
MYLAN 200MG A074932 001 May 16, 1997
200MG A075071 001 Sep 30, 1998
300MG A074932 002 May 16, 1997
300MG A075071 002 Sep 30, 1998
SANDOZ 200MG A074840 001 Aug 29, 1997
200MG A074942 001 Sep 30, 1997
300MG A074840 002 Aug 29, 1997
300MG A074942 002 Sep 30, 1997
VINTAGE PHARMS LLC 200MG A074842 001 Jul 17, 1997
300MG A074842 002 Jul 17, 1997
WATSON LABS 200MG A074844 001 Dec 23, 1997
300MG A074844 002 Dec 23, 1997
LODINE
WYETH PHARMS INC 200MG N018922 002 Jan 31, 1991
300MG N018922 003 Jan 31, 1991
TABLET;ORAL
ETODOLAC
AAIPHARMA LLC 400MG A074927 001 Oct 30, 1997
IVAX SUB TEVA PHARMS 400MG A074883 001 Feb 28, 1997
500MG A074883 002 Nov 20, 1998
MYLAN 400MG A075012 001 Sep 30, 1998
500MG A075012 002 Sep 30, 1998
PROSAM LABS 400MG A074819 001 Feb 28, 1997
500MG A074819 002 Apr 28, 1998
RANBAXY LABS LTD 400MG A075226 001 Nov 24, 1998
500MG A075226 002 Nov 24, 1998
SANDOZ 400MG A074839 001 Jul 11, 1997
400MG A074846 001 Feb 28, 1997
TEVA 400MG A074847 001 Apr 23, 1999
500MG A074847 002 Apr 23, 1999
VINTAGE PHARMS LLC 400MG A074841 001 Jun 27, 1997
WATSON LABS 400MG A074892 001 Apr 16, 1997
400MG A075069 001 Apr 16, 1998
500MG A074892 002 Oct 29, 1998
LODINE
WYETH PHARMS INC 400MG N018922 004 Jul 29, 1993
500MG N018922 005 Jun 28, 1996
TABLET, EXTENDED RELEASE;ORAL
ETODOLAC
ACTAVIS ELIZABETH 400MG A075696 001 Jul 31, 2000
SANDOZ 400MG A075943 001 Jul 26, 2002
500MG A075943 002 Jul 26, 2002
600MG A075943 003 Jul 26, 2002
WATSON LABS FLORIDA 400MG A075829 001 Nov 30, 2001
500MG A075829 002 Nov 30, 2001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-136(of 337)
ETODOLAC
TABLET, EXTENDED RELEASE;ORAL
LODINE XL
WYETH PHARMS INC 400MG N020584 001 Oct 25, 1996
500MG N020584 003 Jan 20, 1998
600MG N020584 002 Oct 25, 1996
ETOPOSIDE
CAPSULE;ORAL
VEPESID
DAVA PHARMS INC 50MG N019557 001 Dec 30, 1986
100MG N019557 002 Dec 30, 1986
INJECTABLE;INJECTION
ETOPOSIDE
HOSPIRA 20MG/ML A074320 001 Aug 30, 1995
20MG/ML A074351 001 Aug 30, 1995
PHARMACHEMIE BV 20MG/ML A074227 001 Feb 22, 1996
PIERRE FABRE 20MG/ML A074813 001 Jul 09, 1997
TEVA PARENTERAL 20MG/ML A074510 001 Jun 29, 1995
TEVA PHARMS USA 20MG/ML A074284 001 Feb 10, 1994
WATSON LABS 20MG/ML A074228 001 Oct 15, 1996
WATSON LABS INC 20MG/ML A074968 001 Jan 09, 1998
TOPOSAR
TEVA PARENTERAL 20MG/ML A074166 001 Feb 27, 1995
VEPESID
CORDEN PHARMA 20MG/ML N018768 001 Nov 10, 1983
ETOPOSIDE PHOSPHATE
INJECTABLE;INJECTION
ETOPOPHOS PRESERVATIVE FREE
BRISTOL MYERS SQUIBB EQ 1GM BASE/VIAL N020906 002 Feb 27, 1998
EQ 500MG BASE/VIAL N020906 001 Feb 27, 1998
ETRETINATE
CAPSULE;ORAL
TEGISON
ROCHE 10MG N019369 001 Sep 30, 1986
25MG N019369 002 Sep 30, 1986
EVANS BLUE
INJECTABLE;INJECTION
EVANS BLUE
PARKE DAVIS 0.5% **Federal Register determination N008041 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
FAMOTIDINE
INJECTABLE;INJECTION
FAMOTIDINE
APOTEX INC 10MG/ML A075942 001 Aug 02, 2002
APOTHECON 10MG/ML A075707 001 Apr 16, 2001
HIKMA MAPLE 10MG/ML A075799 001 Apr 30, 2002
HOSPIRA 10MG/ML A075705 001 Apr 16, 2001
10MG/ML A075870 001 Nov 23, 2001
10MG/ML A075905 001 Nov 23, 2001
FAMOTIDINE PRESERVATIVE FREE
APOTEX INC 10MG/ML A076324 001 Nov 27, 2002
APOTHECON 10MG/ML A075708 001 Apr 16, 2001
HIKMA MAPLE 10MG/ML A075789 001 Apr 30, 2002
HOSPIRA 10MG/ML A075669 001 Apr 16, 2001
FAMOTIDINE PRESERVATIVE FREE (PHARMACY BULK)
APOTEX INC 10MG/ML A076322 001 Nov 27, 2002
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER
ABBVIE 0.4MG/ML A075729 001 Dec 17, 2001
PEPCID
MERCK 10MG/ML N019510 001 Nov 04, 1986
PEPCID PRESERVATIVE FREE
MERCK 10MG/ML N019510 004 Nov 04, 1986
PEPCID PRESERVATIVE FREE IN PLASTIC CONTAINER
MERCK SHARP DOHME 0.4MG/ML N020249 001 Feb 18, 1994
TABLET;ORAL
FAMOTIDINE
ACTAVIS ELIZABETH 20MG A075650 001 Sep 14, 2001
40MG A075650 002 Sep 14, 2001
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DISCONTINUED DRUG PRODUCT LIST
6-137(of 337)
FAMOTIDINE
TABLET;ORAL
FAMOTIDINE
APOTEX 10MG
A075610 001 Mar 12, 2002
MUTUAL PHARM 20MG
A075639 002 Dec 12, 2001
40MG
A075639 001 Dec 12, 2001
MYLAN PHARMS INC 20MG
A075457 001 Apr 18, 2001
40MG
A075457 002 Apr 18, 2001
SANDOZ 10MG
A076101 001 Oct 21, 2002
20MG
A075302 001 Apr 16, 2001
20MG
A075607 001 May 10, 2001
20MG
A075793 001 Apr 16, 2001
40MG
A075302 002 Apr 16, 2001
40MG
A075607 002 May 10, 2001
40MG
A075793 002 Apr 16, 2001
WATSON LABS 10MG
A075404 001 Nov 28, 2001
20MG
A075062 002 Apr 16, 2001
40MG
A075062 001 Apr 16, 2001
TABLET, CHEWABLE;ORAL
PEPCID AC
MCNEIL CONS 10MG
N020801 001 Sep 24, 1998
TABLET, ORALLY DISINTEGRATING;ORAL
FLUXID
UCB INC 20MG
N021712 001 Sep 24, 2004
40MG
N021712 002 Sep 24, 2004
PEPCID RPD
MERCK 20MG
N020752 001 May 28, 1998
40MG
N020752 002 May 28, 1998
FELODIPINE
TABLET, EXTENDED RELEASE;ORAL
FELODIPINE
WOCKHARDT LTD 2.5MG
A091484 001 Aug 15, 2012
5MG
A091484 002 Aug 15, 2012
10MG
A091484 003 Aug 15, 2012
FENOFIBRATE
CAPSULE;ORAL
ANTARA (MICRONIZED)
LUPIN ATLANTIS 87MG
N021695 002 Nov 30, 2004
LIPIDIL
ABBVIE 100MG
N019304 001 Dec 31, 1993
LIPOFEN
CIPHER PHARMS INC 100MG
N021612 002 Jan 11, 2006
TRICOR (MICRONIZED)
ABBVIE 67MG
N019304 002 Feb 09, 1998
134MG
N019304 003 Jun 30, 1999
200MG
N019304 004 Jun 30, 1999
TABLET;ORAL
FENOFIBRATE
MYLAN 107MG
A076520 002 Dec 29, 2005
TRICOR
ABBOTT 54MG
N021203 001 Sep 04, 2001
160MG
N021203 003 Sep 04, 2001
TRIGLIDE
SKYEPHARMA AG 50MG
N021350 001 May 07, 2005
FENOLDOPAM MESYLATE
INJECTABLE;INJECTION
FENOLDOPAM MESYLATE
LUITPOLD EQ 10MG BASE/ML
A076656 001 Dec 01, 2003
TEVA PARENTERAL EQ 10MG BASE/ML
A077826 001 Mar 07, 2007
FENOPROFEN CALCIUM
CAPSULE;ORAL
FENOPROFEN CALCIUM
AM THERAP EQ 200MG BASE
A072307 001 Aug 22, 1988
EQ 300MG BASE
A072308 001 Aug 22, 1988
HALSEY EQ 200MG BASE
A072355 001 Aug 17, 1988
EQ 300MG BASE
A072356 001 Aug 17, 1988
PAR PHARM EQ 200MG BASE
A072437 001 Aug 22, 1988
EQ 300MG BASE
A072438 001 Aug 22, 1988
QUANTUM PHARMICS EQ 200MG BASE
A072214 001 Aug 17, 1988
EQ 300MG BASE
A071738 001 Aug 17, 1988
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DISCONTINUED DRUG PRODUCT LIST 6-138(of 337)
FENOPROFEN CALCIUM
CAPSULE;ORAL
FENOPROFEN CALCIUM
SANDOZ EQ 200MG BASE A072394 001 Oct 17, 1988
EQ 300MG BASE A072395 001 Oct 17, 1988
WARNER CHILCOTT EQ 200MG BASE A072946 001 Apr 30, 1991
EQ 300MG BASE A072472 001 Apr 30, 1991
WATSON LABS EQ 200MG BASE A072294 001 Aug 17, 1988
EQ 200MG BASE A072981 001 Aug 19, 1991
EQ 300MG BASE A072293 001 Aug 17, 1988
EQ 300MG BASE A072982 001 Aug 19, 1991
NALFON
XSPIRE EQ 300MG BASE N017604 002
TABLET;ORAL
FENOPROFEN CALCIUM
ACTAVIS ELIZABETH EQ 600MG BASE A072274 001 May 02, 1988
AM THERAP EQ 600MG BASE A072309 001 Aug 17, 1988
DAVA PHARMS INC EQ 600MG BASE A072326 001 Aug 17, 1988
HALSEY EQ 600MG BASE A072357 001 Aug 17, 1988
IVAX SUB TEVA PHARMS EQ 600MG BASE A072557 001 Aug 29, 1988
MUTUAL PHARM EQ 600MG BASE A072902 001 Dec 21, 1990
PAR PHARM EQ 600MG BASE A072429 001 Aug 17, 1988
QUANTUM PHARMICS EQ 600MG BASE A072194 001 Aug 17, 1988
SANDOZ EQ 600MG BASE A072396 001 Oct 17, 1988
USL PHARMA EQ 600MG BASE A072362 001 Aug 17, 1988
WATSON LABS EQ 600MG BASE A072165 001 Aug 17, 1988
EQ 600MG BASE A072407 001 Aug 17, 1988
EQ 600MG BASE A072602 001 Oct 11, 1988
NALFON
DISTA EQ 600MG BASE N017710 001
FENTANYL
FILM, EXTENDED RELEASE;TRANSDERMAL
FENTANYL-100
NOVEN 100MCG/HR A077775 004 Oct 16, 2009
FENTANYL-25
NOVEN 25MCG/HR A077775 001 Oct 16, 2009
FENTANYL-50
NOVEN 50MCG/HR A077775 002 Oct 16, 2009
FENTANYL-75
NOVEN 75MCG/HR A077775 003 Oct 16, 2009
FENTANYL CITRATE
FILM;BUCCAL
ONSOLIS
MEDA PHARMS EQ 0.2MG BASE N022266 001 Jul 16, 2009
EQ 0.4MG BASE N022266 002 Jul 16, 2009
EQ 0.6MG BASE N022266 003 Jul 16, 2009
EQ 0.8MG BASE N022266 004 Jul 16, 2009
EQ 1.2MG BASE N022266 005 Jul 16, 2009
INJECTABLE;INJECTION
FENTANYL CITRATE
ABBOTT EQ 0.05MG BASE/ML A070636 001 Apr 30, 1990
EQ 0.05MG BASE/ML A070637 001 Apr 30, 1990
WATSON LABS EQ 0.05MG BASE/ML A073488 001 Jun 30, 1992
FENTANYL CITRATE PRESERVATIVE FREE
WATSON LABS INC EQ 0.05MG BASE/ML A074917 001 Feb 03, 1998
TABLET;BUCCAL, SUBLINGUAL
FENTANYL CITRATE
WATSON LABS EQ 0.1MG BASE A079075 001 Jan 07, 2011
EQ 0.2MG BASE A079075 002 Jan 07, 2011
EQ 0.4MG BASE A079075 003 Jan 07, 2011
EQ 0.6MG BASE A079075 004 Jan 07, 2011
EQ 0.8MG BASE A079075 005 Jan 07, 2011
FENTORA
CEPHALON EQ 0.3MG BASE N021947 006 Mar 02, 2007
TROCHE/LOZENGE;ORAL
FENTANYL
CEPHALON EQ 0.1MG BASE N020195 007 Oct 30, 1995
EQ 0.2MG BASE N020195 001 Oct 04, 1993
EQ 0.3MG BASE N020195 002 Oct 04, 1993
EQ 0.4MG BASE N020195 003 Oct 04, 1993
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-139(of 337)
FENTANYL HYDROCHLORIDE
SYSTEM;IONTOPHORESIS, TRANSDERMAL
IONSYS
INCLINE THERAP
10.8MCG
N021338 001
May 22, 2006
FERRIC AMMONIUM CITRATE
FOR SOLUTION;ORAL
FERRISELTZ
OTSUKA
600MG/PACKET
N020292 001
Oct 14, 1997
FERROUS CITRATE, FE-59
INJECTABLE;INJECTION
FERROUS CITRATE FE 59
MALLINCKRODT
25uCi/ML
N016729 001
FERROUS SULFATE; FOLIC ACID
CAPSULE;ORAL
FOLVRON
LEDERLE
182MG;0.33MG
N006012 003
FERUMOXIDES
INJECTABLE;INJECTION
FERIDEX I.V.
AMAG PHARMS INC
EQ 11.2MG IRON/ML
N020416 001
Aug 30, 1996
FERUMOXSIL
SUSPENSION;ORAL
GASTROMARK
AMAG PHARMS INC
EQ 0.175MG IRON/ML
N020410 001
Dec 06, 1996
FEXOFENADINE HYDROCHLORIDE
CAPSULE;ORAL
ALLEGRA
SANOFI AVENTIS US
60MG
N020625 001
Jul 25, 1996
FEXOFENADINE HYDROCHLORIDE
BARR
60MG
A076169 001
Jul 13, 2005
FIBRINOGEN, I-125
INJECTABLE;INJECTION
IBRIN
GE HEALTHCARE
154uCi/VIAL
N017879 001
RADIONUCLIDE-LABELED (125 I) FIBRINOGEN (HUMAN) SENSOR
ABBOTT
140uCi/ML
N017787 001
FINASTERIDE
TABLET;ORAL
FINASTERIDE
IVAX SUB TEVA PHARMS
5MG
A076340 001
Jun 19, 2006
FLAVOXATE HYDROCHLORIDE
TABLET;ORAL
URISPAS
ORTHO MCNEIL JANSSEN
100MG
N016769 001
FLECAINIDE ACETATE
TABLET;ORAL
FLECAINIDE ACETATE
APOTEX INC
50MG
A079164 001
Jul 09, 2009
100MG
A079164 002
Jul 09, 2009
150MG
A079164 003
Jul 09, 2009
SANDOZ
50MG
A076030 001
Oct 28, 2002
100MG
A076030 002
Oct 28, 2002
150MG
A076030 003
Oct 28, 2002
TAMBOCOR
CNTY LINE PHARMS
50MG
N018830 004
Aug 23, 1988
100MG
N018830 001
Oct 31, 1985
150MG
N018830 003
Jun 03, 1988
200MG
N018830 002
Oct 31, 1985
FLOXURIDINE
INJECTABLE;INJECTION
FUDR
HOSPIRA
500MG/VIAL **Federal Register
N016929 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-140(of 337)
FLUCONAZOLE
FOR SUSPENSION;ORAL
FLUCONAZOLE
TARO PHARM INDS 50MG/5ML
A076918 001
Dec 18, 2006
200MG/5ML
A076918 002
Dec 18, 2006
INJECTABLE;INJECTION
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER
AGILA SPECLTS 200MG/100ML (2MG/ML)
A076888 001
Mar 25, 2005
400MG/200ML (2MG/ML)
A076888 002
Mar 25, 2005
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
AGILA SPECLTS 200MG/100ML (2MG/ML)
A076889 001
Mar 25, 2005
400MG/200ML (2MG/ML)
A076889 002
Mar 25, 2005
HOSPIRA 200MG/100ML (2MG/ML)
A076617 001
Jul 29, 2004
400MG/200ML (2MG/ML)
A076617 002
Jul 29, 2004
TEVA PHARMS 200MG/100ML (2MG/ML)
A076837 001
Jan 13, 2005
400MG/200ML (2MG/ML)
A076837 002
Jan 13, 2005
TABLET;ORAL
FLUCONAZOLE
GEDEON RICHTER USA 50MG
A076432 001
Jul 29, 2004
100MG
A076432 002
Jul 29, 2004
150MG
A076432 003
Jul 29, 2004
200MG
A076432 004
Jul 29, 2004
HARRIS PHARM 50MG
A078423 001
Mar 07, 2011
100MG
A078423 002
Mar 07, 2011
150MG
A078423 003
Mar 07, 2011
200MG
A078423 004
Mar 07, 2011
MYLAN PHARMS INC 50MG
A076042 001
Jul 29, 2004
100MG
A076042 002
Jul 29, 2004
150MG
A076042 003
Jul 29, 2004
200MG
A076042 004
Jul 29, 2004
PLIVA 50MG
A076424 001
Jul 29, 2004
100MG
A076424 002
Jul 29, 2004
150MG
A076424 003
Jul 29, 2004
200MG
A076424 004
Jul 29, 2004
RANBAXY LABS LTD 50MG
A076386 001
Jul 29, 2004
100MG
A076386 002
Jul 29, 2004
150MG
A076386 003
Jul 29, 2004
200MG
A076386 004
Jul 29, 2004
ROXANE 50MG
A076213 001
Jul 29, 2004
100MG
A076213 002
Jul 29, 2004
150MG
A076213 003
Jul 29, 2004
200MG
A076213 004
Jul 29, 2004
SANDOZ 50MG
A076086 001
Jul 29, 2004
100MG
A076086 002
Jul 29, 2004
150MG
A076086 003
Jul 29, 2004
200MG
A076086 004
Jul 29, 2004
FLUDARABINE PHOSPHATE
INJECTABLE;INJECTION
FLUDARA
GENZYME CORP 50MG/VIAL
N020038 001
Apr 18, 1991
TABLET;ORAL
OFORTA
SANOFI AVENTIS US 10MG
N022273 001
Dec 18, 2008
FLUDEOXYGLUCOSE F-18
INJECTABLE;INJECTION
FLUDEOXYGLUCOSE F 18
DOWNSTATE CLINCL 4-40mCi/ML **Federal Register
N020306 001
Aug 19, 1994
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
4-90mCi/ML **Federal Register
N020306 002
Sep 25, 2001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
INJECTABLE;INTRAVENOUS
FLUDEOXYGLUCOSE F18
WEILL MEDCL COLL 10-100mCi/ML **Federal Register
N021768 001
Aug 05, 2004
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-141(of 337)
FLUDROCORTISONE ACETATE
TABLET;ORAL
FLORINEF
CITRON PHARMA LLC 0.1MG N010060 001
FLUMAZENIL
INJECTABLE;INJECTION
FLUMAZENIL
APOTEX INC 0.5MG/5ML (0.1MG/ML) A076755 002 Oct 12, 2004
1MG/10ML (0.1MG/ML) A076755 001 Oct 12, 2004
TEVA PHARMS USA 0.5MG/5ML (0.1MG/ML) A076589 002 Oct 12, 2004
1MG/10ML (0.1MG/ML) A076589 001 Oct 12, 2004
ROMAZICON
HOFFMANN LA ROCHE 1MG/10ML (0.1MG/ML) **Federal Register N020073 001 Dec 20, 1991
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
0.5MG/5ML (0.1MG/ML) **Federal Register N020073 002 Dec 20, 1991
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
FLUMETHASONE PIVALATE
CREAM;TOPICAL
LOCORTEN
NOVARTIS 0.03% N016379 001
FLUNISOLIDE
AEROSOL, METERED;INHALATION
AEROBID
ROCHE PALO 0.25MG/INH N018340 001 Aug 17, 1984
SPRAY, METERED;NASAL
NASALIDE
IVAX RES 0.025MG/SPRAY N018148 001
NASAREL
TEVA BRANDED PHARM 0.029MG/SPRAY N020409 001 Mar 08, 1995
FLUOCINOLONE ACETONIDE
CREAM;TOPICAL
FLUOCET
ALPHARMA US PHARMS 0.025% A088360 001 Jan 16, 1984
FLUOCINOLONE ACETONIDE
ALPHARMA US PHARMS 0.01% A088361 001 Jan 16, 1984
PERRIGO NEW YORK 0.01% A086810 001 Mar 04, 1982
0.025% A086811 001 Mar 04, 1982
PHARMADERM 0.01% A088047 001 Dec 16, 1982
0.025% A088045 001 Dec 16, 1982
PHARMAFAIR 0.01% A088499 001 Aug 02, 1984
0.025% A088506 001 Aug 02, 1984
TARO 0.01% A040035 001 Oct 31, 1994
0.01% A087102 001 Apr 27, 1982
0.025% A040042 001 Oct 31, 1994
USL PHARMA 0.01% A088757 001 Feb 11, 1985
0.025% A088756 001 Mar 28, 1985
FLUONID
ALLERGAN HERBERT 0.025% A087156 002 Sep 06, 1984
FLUOTREX
SAVAGE LABS 0.01% A088174 001 May 06, 1983
0.025% A088173 001 Mar 09, 1983
SYNALAR-HP
MEDIMETRIKS PHARMS 0.2% N016161 002
GEL;TOPICAL
FLUONID
ALLERGAN HERBERT 0.025% A087300 001 May 27, 1982
OINTMENT;TOPICAL
FLUOCINOLONE ACETONIDE
PHARMADERM 0.025% A088046 001 Dec 16, 1982
PHARMAFAIR 0.025% A088507 001 Feb 27, 1984
USL PHARMA 0.025% A088742 001 Feb 08, 1985
FLUONID
ALLERGAN HERBERT 0.025% A087157 001 Sep 06, 1984
FLUOTREX
SAVAGE LABS 0.025% A088172 001 Mar 09, 1983
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-142(of 337)
FLUOCINOLONE ACETONIDE
SOLUTION;TOPICAL
FLUOCINOLONE ACETONIDE
ALPHARMA US PHARMS 0.01% A087159 001 Jun 16, 1982
BAUSCH AND LOMB 0.01% A040059 001 Dec 20, 1993
MORTON GROVE 0.01% A088312 001 Jan 27, 1984
PHARMADERM 0.01% A088048 001 Dec 16, 1982
PHARMAFAIR 0.01% A088449 001 Feb 08, 1984
FLUONID
ALLERGAN HERBERT 0.01% A087158 001 Mar 17, 1983
FLUOTREX
SAVAGE LABS 0.01% A088171 001 Mar 09, 1983
FLUOCINONIDE
CREAM;TOPICAL
FLUOCINONIDE
PERRIGO NEW YORK 0.05% A071790 001 Jul 13, 1988
TARO 0.05% A071500 001 Jun 10, 1987
FLUOCINONIDE EMULSIFIED BASE
G AND W LABS INC 0.05% A074204 001 Jun 13, 1995
LIDEX
CNTY LINE PHARMS 0.05% N016908 002
LIDEX-E
CNTY LINE PHARMS 0.05% N016908 003
GEL;TOPICAL
LIDEX
CNTY LINE PHARMS 0.05% **Federal Register determination N017373 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
OINTMENT;TOPICAL
LIDEX
CNTY LINE PHARMS 0.05% **Federal Register determination N016909 002
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
SOLUTION;TOPICAL
FLUOCINONIDE
TARO 0.05% A072857 001 Aug 02, 1989
TEVA PHARMS 0.05% A072522 001 Sep 28, 1990
FLUORESCEIN SODIUM
INJECTABLE;INJECTION
FUNDUSCEIN-25
NOVARTIS 25% N017869 001
FLUOROMETHOLONE
CREAM;TOPICAL
OXYLONE
PHARMACIA AND UPJOHN 0.025% N011748 001
SUSPENSION/DROPS;OPHTHALMIC
FLUOR-OP
NOVARTIS 0.1% A070185 001 Feb 27, 1986
FLUOROMETHOLONE ACETATE; TOBRAMYCIN
SUSPENSION/DROPS;OPHTHALMIC
TOBRASONE
ALCON 0.1%;0.3% N050628 001 Jul 21, 1989
FLUOROMETHOLONE; SULFACETAMIDE SODIUM
SUSPENSION/DROPS;OPHTHALMIC
FML-S
ALLERGAN 0.1%;10% N019525 001 Sep 29, 1989
FLUOROURACIL
INJECTABLE;INJECTION
ADRUCIL
PHARMACIA AND UPJOHN 50MG/ML A081222 001 Jun 28, 1991
50MG/ML N017959 001
TEVA PARENTERAL 50MG/ML A040023 001 Oct 18, 1991
50MG/ML A081225 001 Aug 28, 1991
FLUOROURACIL
ABIC 50MG/ML A088929 001 Mar 04, 1986
ABRAXIS PHARM 50MG/ML A089152 001 Mar 21, 1986
50MG/ML A089428 001 Jan 12, 1987
50MG/ML A089519 001 Mar 12, 1987
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-143(of 337)
FLUOROURACIL
INJECTABLE;INJECTION
FLUOROURACIL
BEDFORD 50MG/ML A089508 001 Jan 26, 1988
EBEWE PHARMA 500MG/10ML (50MG/ML) A040772 001 Aug 11, 2008
FRESENIUS KABI USA 50MG/ML A040291 001 Mar 24, 1999
50MG/ML A040379 001 Nov 15, 2000
MARCHAR 50MG/ML A087791 001 Jan 18, 1983
SMITH AND NEPHEW 50MG/ML A088766 001 Dec 28, 1984
50MG/ML A088767 001 Dec 28, 1984
50MG/ML A089434 001 Mar 26, 1987
SPECTRUM PHARMS 50MG/ML A087792 001 Oct 13, 1982
VALEANT 500MG/10ML (50MG/ML) N012209 001
SOLUTION;TOPICAL
FLUOROPLEX
ELORAC 1% N016765 001
FLUOXETINE HYDROCHLORIDE
CAPSULE;ORAL
FLUOXETINE
MUTUAL PHARMA EQ 10MG BASE A075787 001 Jan 29, 2002
EQ 20MG BASE A075787 002 Jan 29, 2002
WATSON LABS EQ 10MG BASE A075662 001 Jan 29, 2002
EQ 20MG BASE A075662 002 Jan 29, 2002
FLUOXETINE HYDROCHLORIDE
BARR EQ 40MG BASE A076251 001 May 18, 2005
CARLSBAD EQ 10MG BASE A076022 001 Jan 30, 2002
EQ 20MG BASE A076022 002 Jan 30, 2002
CR DOUBLE CRANE EQ 10MG BASE A076165 001 Feb 01, 2002
EQ 20MG BASE A076165 002 Feb 01, 2002
PAR PHARM EQ 10MG BASE A076922 001 Dec 16, 2004
EQ 20MG BASE A076922 002 Dec 16, 2004
SANDOZ EQ 10MG BASE A075807 001 Jan 29, 2002
EQ 20MG BASE A075807 002 Jan 29, 2002
WOCKHARDT LTD EQ 10MG BASE A078143 001 Jan 16, 2008
EQ 20MG BASE A078143 002 Jan 16, 2008
EQ 40MG BASE A078143 003 Jan 16, 2008
PROZAC
ELI LILLY AND CO EQ 60MG BASE N018936 004 Jun 15, 1999
SOLUTION;ORAL
FLUOXETINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC EQ 20MG BASE/5ML A075690 001 Jan 31, 2002
APOTEX INC EQ 20MG BASE/5ML A075292 001 Feb 07, 2002
HI TECH PHARMA EQ 20MG BASE/5ML A075525 001 Jun 27, 2002
PROZAC
LILLY EQ 20MG BASE/5ML N020101 001 Apr 24, 1991
TABLET;ORAL
FLUOXETINE HYDROCHLORIDE
BARR EQ 10MG BASE A075810 001 Feb 01, 2002
IVAX SUB TEVA PHARMS EQ 10MG BASE A075865 001 Feb 28, 2002
EQ 40MG BASE A075865 003 Aug 30, 2004
SANDOZ EQ 10MG BASE A076024 001 Jan 29, 2002
PROZAC
LILLY EQ 10MG BASE N020974 001 Mar 09, 1999
EQ 20MG BASE N020974 002 Mar 09, 1999
FLUOXYMESTERONE
TABLET;ORAL
ANDROID-F
VALEANT PHARM INTL 10MG A087196 001
FLUOXYMESTERONE
VALEANT PHARM INTL 10MG A088221 001 May 05, 1983
WATSON LABS 2MG A088260 001 Dec 06, 1983
5MG A088265 001 Dec 06, 1983
10MG A088309 001 Dec 06, 1983
HALOTESTIN
PHARMACIA AND UPJOHN 2MG N010611 002
5MG N010611 006
10MG N010611 010
ORA-TESTRYL
BRISTOL MYERS SQUIBB 2MG N011359 001
5MG N011359 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-144(of 337)
FLUPHENAZINE DECANOATE
INJECTABLE;INJECTION
FLUPHENAZINE DECANOATE
AGILA SPECLTS 25MG/ML A075918 001 Aug 17, 2001
HOSPIRA 25MG/ML A074966 001 Apr 16, 1998
TEVA PARENTERAL 25MG/ML A074795 001 Sep 10, 1996
PROLIXIN DECANOATE
BRISTOL MYERS SQUIBB 25MG/ML N016727 001
FLUPHENAZINE ENANTHATE
INJECTABLE;INJECTION
PROLIXIN ENANTHATE
APOTHECON 25MG/ML N016110 001
FLUPHENAZINE HYDROCHLORIDE
CONCENTRATE;ORAL
FLUPHENAZINE HYDROCHLORIDE
TEVA PHARMS 5MG/ML A073058 001 Aug 30, 1991
PERMITIL
SCHERING 5MG/ML N016008 001
PROLIXIN
APOTHECON 5MG/ML A070533 001 Nov 07, 1985
ELIXIR;ORAL
FLUPHENAZINE HYDROCHLORIDE
ANI PHARMS INC 2.5MG/5ML A081310 001 Apr 29, 1993
PROLIXIN
APOTHECON 2.5MG/5ML N012145 003
INJECTABLE;INJECTION
PROLIXIN
APOTHECON 2.5MG/ML N011751 005
TABLET;ORAL
FLUPHENAZINE HYDROCHLORIDE
WATSON LABS 1MG A088555 001 Dec 18, 1987
2.5MG A088544 001 Dec 18, 1987
5MG A088527 001 Dec 18, 1987
10MG A088550 001 Dec 18, 1987
PERMITIL
SCHERING 0.25MG N012034 001
2.5MG N012034 004
5MG N012034 005
10MG N012034 006
PROLIXIN
APOTHECON 1MG N011751 004
2.5MG N011751 001
5MG N011751 003
10MG N011751 002
TABLET, EXTENDED RELEASE;ORAL
PERMITIL
SCHERING 1MG N012419 004
FLUPREDNISOLONE
TABLET;ORAL
ALPHADROL
PHARMACIA AND UPJOHN 1.5MG N012259 002
FLURANDRENOLIDE
LOTION;TOPICAL
FLURANDRENOLIDE
ALPHARMA US PHARMS 0.05% A087203 001 Apr 29, 1982
OINTMENT;TOPICAL
CORDRAN
AQUA PHARMS 0.025% **Federal Register determination N012806 004
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
0.05% **Federal Register determination N012806 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-145(of 337)
FLURANDRENOLIDE; NEOMYCIN SULFATE
CREAM;TOPICAL
CORDRAN-N
LILLY 0.05%;EQ 3.5MG BASE/GM N050346 001
OINTMENT;TOPICAL
CORDRAN-N
LILLY 0.05%;EQ 3.5MG BASE/GM N050345 001
FLURAZEPAM HYDROCHLORIDE
CAPSULE;ORAL
DALMANE
VALEANT PHARM INTL 15MG N016721 001
30MG N016721 002
FLURAZEPAM HYDROCHLORIDE
HALSEY 15MG A071808 001 Jan 07, 1988
30MG A071809 001 Jan 07, 1988
HIKMA PHARMS LLC 15MG A071107 001 Dec 08, 1986
30MG A071108 001 Dec 08, 1986
MUTUAL PHARM 15MG A070454 001 Aug 04, 1986
30MG A070455 001 Aug 04, 1986
PAR PHARM 15MG A070444 001 Mar 20, 1986
30MG A070445 001 Mar 20, 1986
PUREPAC PHARM 15MG A071927 001 Sep 09, 1987
30MG A071551 001 Sep 09, 1987
SANDOZ 15MG A071716 001 Jul 31, 1991
30MG A071717 001 Jul 31, 1991
SUPERPHARM 15MG A071659 001 Aug 04, 1988
30MG A071660 001 Aug 04, 1988
USL PHARMA 15MG A070562 001 Jul 09, 1987
30MG A070563 001 Jul 09, 1987
WARNER CHILCOTT 15MG A071767 001 Dec 04, 1987
30MG A071768 001 Dec 04, 1987
WATSON LABS 15MG A071205 001 Nov 25, 1986
15MG A072368 001 Mar 30, 1989
30MG A071068 001 Nov 25, 1986
30MG A072369 001 Mar 30, 1989
FLURBIPROFEN
TABLET;ORAL
FLURBIPROFEN
IVAX SUB TEVA PHARMS 50MG A074411 001 May 31, 1995
100MG A074411 002 May 31, 1995
PLIVA 50MG A074647 001 Apr 01, 1997
100MG A074647 002 Apr 01, 1997
SANDOZ 50MG A074448 001 Jul 28, 1995
100MG A074448 002 Jul 28, 1995
TEVA 50MG A074405 002 May 24, 1995
100MG A074405 001 May 24, 1995
THERAGEN 100MG A074560 002 May 16, 1997
FLUTAMIDE
CAPSULE;ORAL
EULEXIN
SCHERING 125MG N018554 001 Jan 27, 1989
FLUTAMIDE
SANDOZ 125MG A075818 001 Sep 18, 2001
FLUTICASONE PROPIONATE
AEROSOL, METERED;INHALATION
FLOVENT
GLAXOSMITHKLINE 0.044MG/INH N020548 001 Mar 27, 1996
0.11MG/INH N020548 002 Mar 27, 1996
0.22MG/INH N020548 003 Mar 27, 1996
CREAM;TOPICAL
CUTIVATE
FOUGERA PHARMS 0.05% **Federal Register determination N019958 001 Dec 18, 1990
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
FLUTICASONE PROPIONATE
NESHER PHARMS 0.05% A076865 001 Sep 10, 2004
OINTMENT;TOPICAL
FLUTICASONE PROPIONATE
TARO PHARM INDS 0.005% A077145 001 Jun 14, 2005
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DISCONTINUED DRUG PRODUCT LIST 6-146(of 337)
FLUTICASONE PROPIONATE
POWDER;INHALATION
FLOVENT
GLAXOSMITHKLINE 0.044MG/INH N020549 001 Nov 07, 1997
0.088MG/INH N020549 002 Nov 07, 1997
0.22MG/INH N020549 003 Nov 07, 1997
FLUVOXAMINE MALEATE
TABLET;ORAL
FLUVOXAMINE MALEATE
ACTAVIS ELIZABETH 25MG A075901 001 Dec 28, 2000
50MG A075901 002 Dec 28, 2000
100MG A075901 003 Dec 28, 2000
IVAX SUB TEVA PHARMS 25MG A075898 001 Mar 12, 2001
50MG A075898 002 Mar 12, 2001
100MG A075898 003 Mar 12, 2001
MUTUAL PHARM 25MG A076125 001 Apr 29, 2002
50MG A076125 002 Apr 29, 2002
100MG A076125 003 Apr 29, 2002
MYLAN 50MG A075950 001 Oct 15, 2001
100MG A075950 002 Oct 15, 2001
SANDOZ 25MG A075887 001 Jan 05, 2001
50MG A075887 002 Jan 05, 2001
100MG A075887 003 Jan 05, 2001
SUN PHARM INDS INC 25MG A075900 001 Feb 23, 2006
50MG A075900 002 Feb 23, 2006
100MG A075900 003 Feb 23, 2006
SYNTHON PHARMS 25MG A075899 001 Jan 17, 2001
50MG A075899 002 Jan 17, 2001
100MG A075899 003 Jan 17, 2001
WATSON LABS 25MG A075894 001 Apr 18, 2001
50MG A075894 002 Apr 18, 2001
100MG A075894 003 Apr 18, 2001
LUVOX
SOLVAY 25MG N020243 001 Dec 05, 1994
50MG N020243 002 Dec 05, 1994
100MG N020243 003 Dec 05, 1994
150MG N020243 004 Dec 05, 1994
FOLIC ACID
INJECTABLE;INJECTION
FOLIC ACID
BEN VENUE 5MG/ML A081066 001 Dec 29, 1993
FOLVITE
HIKMA (MAPLE) 5MG/ML N005897 008
TABLET;ORAL
FOLIC ACID
BARR 1MG A089177 001 Jan 08, 1986
EVERYLIFE 1MG A080755 001
HALSEY 1MG A083598 001
IMPAX LABS 1MG A080686 001
IVAX SUB TEVA PHARMS 1MG A083000 001
JUBILANT CADISTA 1MG A040514 001 Jun 14, 2005
LANNETT 1MG A080816 001
LILLY 1MG N006135 003
MK LABS 1MG A083526 001
MUTUAL PHARM 1MG A040582 001 Jul 18, 2005
NEXGEN PHARMA INC 1MG A084915 001
PHARMERAL 1MG A084158 001
PIONEER PHARMS 1MG A088949 001 Sep 13, 1985
PUREPAC PHARM 1MG A080784 001
SANDOZ 1MG A084472 001
TABLICAPS 1MG A083133 002
UDL 1MG A088199 001 Mar 29, 1983
USL PHARMA 1MG A087828 001 May 13, 1982
VALEANT PHARM INTL 1MG A080903 001
VANGARD 1MG A088730 001 Mar 23, 1984
VINTAGE PHARMS 1MG A086296 001
WATSON LABS 1MG A083141 001
1MG A085141 002
WHITEWORTH TOWN PLSN 1MG A080691 002
FOLICET
MISSION PHARMA 1MG A087438 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-147(of 337)
FOLIC ACID
TABLET;ORAL
FOLVITE
HIKMA (MAPLE) 1MG N005897 004
FOLLITROPIN ALFA/BETA
INJECTABLE;INTRAMUSCULAR, SUBCUTANEOUS
FOLLISTIM
ORGANON USA INC 75 IU/VIAL N020582 001 Sep 29, 1997
150 IU/VIAL N020582 002 Sep 29, 1997
INJECTABLE;SUBCUTANEOUS
FOLLISTIM AQ
ORGANON USA INC 150 IU/0.18ML N021211 003 Feb 11, 2004
GONAL-F
EMD SERONO 37.5 IU/VIAL N020378 003 May 25, 2000
37.5 IU/VIAL N021765 001 Mar 25, 2004
75 IU/VIAL N020378 001 Sep 29, 1997
150 IU/VIAL N020378 002 Sep 29, 1997
150 IU/VIAL N021765 003 Mar 25, 2004
FOMEPIZOLE
INJECTABLE;INJECTION
FOMEPIZOLE
MYLAN INSTITUTIONAL 1.5GM/1.5ML (1GM/ML) A079033 001 Apr 07, 2009
FOMIVIRSEN SODIUM
INJECTABLE;INJECTION
VITRAVENE PRESERVATIVE FREE
NOVARTIS 6.6MG/ML N020961 001 Aug 26, 1998
FORMOTEROL FUMARATE
POWDER;INHALATION
FORADIL CERTIHALER
NOVARTIS 0.0085MG/INH N021592 001 Dec 15, 2006
FOSAPREPITANT DIMEGLUMINE
POWDER;INTRAVENOUS
EMEND
MERCK AND CO INC EQ 115MG BASE/VIAL N022023 001 Jan 25, 2008
FOSINOPRIL SODIUM
TABLET;ORAL
FOSINOPRIL SODIUM
RANBAXY LABS LTD 10MG A076580 001 Apr 23, 2004
20MG A076580 002 Apr 23, 2004
40MG A076580 003 Apr 23, 2004
SANDOZ 10MG A076188 001 Oct 08, 2004
20MG A076188 002 Oct 08, 2004
40MG A076188 003 Oct 08, 2004
WATSON LABS 10MG A076987 001 Dec 23, 2004
10MG A077531 001 Aug 31, 2006
20MG A076987 002 Dec 23, 2004
20MG A077531 002 Aug 31, 2006
40MG A076987 003 Dec 23, 2004
40MG A077531 003 Aug 31, 2006
MONOPRIL
BRISTOL MYERS SQUIBB 10MG N019915 002 May 16, 1991
20MG N019915 003 May 16, 1991
40MG N019915 004 Mar 28, 1995
FOSINOPRIL SODIUM; HYDROCHLOROTHIAZIDE
TABLET;ORAL
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE
MYLAN 10MG;12.5MG A077705 001 Aug 14, 2006
20MG;12.5MG A077705 002 Aug 14, 2006
TEVA 10MG;12.5MG A076945 001 Jul 05, 2006
20MG;12.5MG A076945 002 Jul 05, 2006
WATSON LABS 10MG;12.5MG A077144 001 Aug 16, 2005
20MG;12.5MG A077144 002 Aug 16, 2005
MONOPRIL-HCT
BRISTOL MYERS SQUIBB 10MG;12.5MG N020286 002 Nov 30, 1994
20MG;12.5MG N020286 001 Nov 30, 1994
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-148(of 337)
FOSPHENYTOIN SODIUM
INJECTABLE;INJECTION
FOSPHENYTOIN SODIUM
APOTEX INC
EQ 50MG PHENYTOIN NA/ML
A078126 001 Aug 06, 2007
TEVA PHARMS USA
EQ 50MG PHENYTOIN NA/ML
A076886 001 Aug 06, 2007
FOSPROPOFOL DISODIUM
SOLUTION;INTRAVENOUS
LUSEDRA
EISAI INC
1050MG/30ML (35MG/ML)
N022244 001 Dec 12, 2008
FURAZOLIDONE
SUSPENSION;ORAL
FUROXONE
SHIRE
50MG/15ML
N011323 002
TABLET;ORAL
FUROXONE
SHIRE
100MG
N011270 002
FUROSEMIDE
INJECTABLE;INJECTION
FUROSEMIDE
ABRAXIS PHARM
10MG/ML
N018507 001 Jul 30, 1982
10MG/ML
N019036 001 Aug 13, 1984
ASTRAZENECA
10MG/ML
A070014 001 Sep 09, 1985
10MG/ML
A070095 001 Sep 09, 1985
10MG/ML
A070096 001 Sep 09, 1985
HIKMA MAPLE
10MG/ML
A071439 001 Sep 14, 1990
10MG/ML
N018267 001
HOSPIRA
10MG/ML
A070578 001 Jul 08, 1987
10MG/ML
A072080 001 Aug 13, 1991
10MG/ML
A074337 001 Oct 31, 1994
INTL MEDICATION
10MG/ML
N018025 001
MARSAM PHARMS LLC
10MG/ML
A074017 001 Jun 30, 1994
ORGANON USA INC
10MG/ML
A070017 001 Dec 15, 1986
SMITH AND NEPHEW
10MG/ML
A070023 001 Feb 05, 1986
10MG/ML
A070078 001 Feb 05, 1986
WARNER CHILCOTT
10MG/ML
N018420 001 Feb 26, 1982
WATSON LABS
10MG/ML
A070019 001 Sep 22, 1986
10MG/ML
A070604 001 Jan 02, 1987
WYETH AYERST
10MG/ML
N018670 001 Jul 20, 1982
LASIX
SANOFI AVENTIS US
10MG/ML
N016363 001
SOLUTION;ORAL
LASIX
SANOFI AVENTIS US
10MG/ML
N017688 001
TABLET;ORAL
FUROSEMIDE
DAVA PHARMS INC
20MG
N018415 001 Jul 27, 1982
40MG
N018415 002 Jul 27, 1982
80MG
N018415 003 Nov 26, 1984
INTL MEDICATION
20MG
N018753 001 Feb 28, 1984
40MG
N018753 002 Feb 28, 1984
KALAPHARM
20MG
N018868 001 Jun 28, 1983
40MG
N018868 002 Jun 28, 1983
MUTUAL PHARM
20MG
A070043 001 Sep 26, 1985
40MG
N018790 001 Nov 29, 1983
80MG
A070100 001 Jan 26, 1988
SANDOZ
40MG
N018750 002 Jul 30, 1984
SUPERPHARM
20MG
N018370 002 Jun 26, 1984
40MG
N018370 001 Feb 10, 1983
WARNER CHILCOTT
20MG
N018419 001 Jan 31, 1983
40MG
N018419 002 Jan 31, 1983
80MG
N018419 003 Nov 13, 1984
WATSON LABS
20MG
A070412 001 Feb 26, 1986
20MG
A070449 001 Nov 22, 1985
20MG
A071379 001 Jan 02, 1987
20MG
N018369 001 May 14, 1982
40MG
A070413 001 Feb 26, 1986
40MG
A070450 001 Nov 22, 1985
40MG
N018369 002 May 14, 1982
80MG
A070528 001 Jan 07, 1986
80MG
A071594 001 Feb 09, 1988
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-149(of 337)
GABAPENTIN
CAPSULE;ORAL
GABAPENTIN
IVAX SUB TEVA PHARMS 100MG A075477 001 Mar 23, 2005
300MG A075477 002 Mar 23, 2005
400MG A075477 003 Mar 23, 2005
MUTUAL PHARM 100MG A076537 001 Jun 30, 2005
300MG A076537 002 Jun 30, 2005
400MG A076537 003 Jun 30, 2005
SANDOZ 100MG A075428 001 Jan 24, 2006
100MG A075539 001 Apr 06, 2005
300MG A075428 002 Jan 24, 2006
300MG A075539 002 Apr 06, 2005
400MG A075428 003 Jan 24, 2006
400MG A075539 003 Apr 06, 2005
WATSON LABS 100MG A075485 003 May 11, 2007
300MG A075485 002 May 11, 2007
400MG A075485 001 May 11, 2007
TABLET;ORAL
GABAPENTIN
RANBAXY 600MG A076605 001 Sep 14, 2005
800MG A076605 002 Sep 14, 2005
SANDOZ 600MG A076120 001 Jan 27, 2006
600MG A076877 001 Jul 06, 2006
800MG A076120 002 Jan 27, 2006
800MG A076877 002 Jul 06, 2006
TEVA 600MG A075827 001 Dec 15, 2004
800MG A075827 002 Dec 15, 2004
GADODIAMIDE
INJECTABLE;INJECTION
OMNISCAN
GE HEALTHCARE 14.35GM/50ML (287MG/ML) N022066 001 Sep 05, 2007
GALANTAMINE HYDROBROMIDE
TABLET;ORAL
GALANTAMINE HYDROBROMIDE
ACTAVIS ELIZABETH EQ 4MG BASE A077585 001 Sep 15, 2009
EQ 8MG BASE A077585 002 Sep 15, 2009
EQ 12MG BASE A077585 003 Sep 15, 2009
YABAO PHARM EQ 4MG BASE A077604 001 Feb 06, 2009
EQ 8MG BASE A077604 002 Feb 06, 2009
EQ 12MG BASE A077604 003 Feb 06, 2009
GALLAMINE TRIETHIODIDE
INJECTABLE;INJECTION
FLAXEDIL
DAVIS AND GECK 20MG/ML N007842 001
100MG/ML N007842 002
GALLIUM CITRATE GA-67
INJECTABLE;INJECTION
GALLIUM CITRATE GA 67
GE HEALTHCARE 1mCi/ML N017700 001
NEOSCAN
GE HEALTHCARE 2mCi/ML N017655 001
GALLIUM NITRATE
INJECTABLE;INJECTION
GANITE
CHAPTER 7 TRUSTEE 25MG/ML N019961 002 Jan 17, 1991
GANCICLOVIR
CAPSULE;ORAL
CYTOVENE
ROCHE PALO 250MG **Federal Register determination N020460 001 Dec 22, 1994
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
500MG **Federal Register determination N020460 002 Dec 12, 1997
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
GANCICLOVIR
RANBAXY LABS LTD 250MG A076457 001 Jun 27, 2003
500MG A076457 002 Jun 27, 2003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-150(of 337)
GANCICLOVIR
IMPLANT;IMPLANTATION
VITRASERT
BAUSCH AND LOMB 4.5MG
N020569 001 Mar 04, 1996
GANCICLOVIR SODIUM
INJECTABLE;INJECTION
GANCICLOVIR SODIUM
EUROHLTH INTL EQ 500MG BASE/VIAL
A076222 001 Jul 16, 2003
GATIFLOXACIN
SOLUTION/DROPS;OPHTHALMIC
GATIFLOXACIN
APOTEX INC 0.3%
A079084 001 Aug 19, 2011
GEFITINIB
TABLET;ORAL
IRESSA
ASTRAZENECA 250MG
N021399 001 May 05, 2003
GEMFIBROZIL
CAPSULE;ORAL
GEMFIBROZIL
MYLAN 300MG
A073466 001 Jan 25, 1993
PUREPAC PHARM 300MG
A072929 001 Jan 29, 1993
LOPID
PFIZER PHARMS 200MG
N018422 001
300MG
N018422 002
TABLET;ORAL
GEMFIBROZIL
MYLAN 600MG
A074452 001 Feb 16, 1995
PUREPAC PHARM 600MG
A074360 001 Aug 31, 1994
SANDOZ 600MG
A074615 001 Sep 29, 1995
WATSON LABS 600MG
A074156 001 Oct 24, 1994
600MG
A074442 001 Apr 28, 1995
GEMTUZUMAB OZOGAMICIN
INJECTABLE;INJECTION
MYLOTARG
WYETH PHARMS INC 5MG/VIAL
N021174 001 May 17, 2000
GENTAMICIN SULFATE
CREAM;TOPICAL
GARAMYCIN
SCHERING EQ 0.1% BASE
A060462 001
GENTAFAIR
PHARMAFAIR EQ 0.1% BASE
A062458 001 Sep 01, 1983
GENTAMICIN SULFATE
ALPHARMA US PHARMS EQ 0.1% BASE
A062471 001 Sep 27, 1983
G AND W LABS INC EQ 0.1% BASE
A064056 001 Apr 29, 1994
PHARMADERM EQ 1MG BASE/GM
A062530 001 Jul 05, 1984
INJECTABLE;INJECTION
APOGEN
KING PHARMS EQ 10MG BASE/ML
A062289 001
EQ 40MG BASE/ML
A062289 002
BRISTAGEN
BRISTOL EQ 40MG BASE/ML
A062288 001
GARAMYCIN
SCHERING EQ 1MG BASE/ML
A061716 002
EQ 10MG BASE/ML
A061739 001
EQ 40MG BASE/ML
A061716 001
GENTAFAIR
PHARMAFAIR EQ 40MG BASE/ML
A062493 001 Aug 28, 1985
GENTAMICIN
INTL MEDICATION EQ 1MG BASE/ML
A062325 003 Jun 23, 1982
EQ 40MG BASE/ML
A062325 001
EQ 100MG BASE/100ML
A062325 004 Jun 23, 1982
GENTAMICIN SULFATE
ABBOTT EQ 1.2MG BASE/ML
A062413 001 Aug 11, 1983
EQ 1.4MG BASE/ML
A062413 002 Aug 11, 1983
EQ 1.6MG BASE/ML
A062413 003 Aug 11, 1983
EQ 1.8MG BASE/ML
A062413 004 Aug 11, 1983
EQ 2MG BASE/ML
A062413 005 Aug 11, 1983
EQ 60MG BASE/100ML
A062413 006 Aug 11, 1983
EQ 70MG BASE/100ML
A062413 007 Aug 11, 1983
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-151(of 337)
GENTAMICIN SULFATE
INJECTABLE;INJECTION
GENTAMICIN SULFATE
EQ 80MG BASE/100ML A062413 008 Aug 11, 1983
EQ 90MG BASE/100ML A062413 009 Aug 11, 1983
EQ 100MG BASE/100ML A062413 010 Aug 11, 1983
FRESENIUS KABI USA EQ 10MG BASE/ML A062356 001 Mar 04, 1982
EQ 40MG BASE/ML A062356 002 Mar 04, 1982
HIKMA MAPLE EQ 10MG BASE/ML A062251 002
EQ 40MG BASE/ML A062251 001
KALAPHARM EQ 40MG BASE/ML A062354 001 Apr 05, 1982
PHARM SPEC EQ 40MG BASE/ML A062340 001 Mar 28, 1983
SOLOPAK EQ 10MG BASE/ML A062507 001 Jun 06, 1985
EQ 40MG BASE/ML A062507 002 Jun 06, 1985
TEVA PARENTERAL EQ 10MG BASE/ML A063149 001 Nov 21, 1991
EQ 40MG BASE/ML A063106 002 Nov 21, 1991
WATSON LABS EQ 10MG BASE/ML A062318 002
EQ 40MG BASE/ML A062318 001
WYETH AYERST EQ 10MG BASE/ML A062264 001
EQ 40MG BASE/ML A062264 002
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
HOSPIRA EQ 1.2MG BASE/ML A062588 001 Jan 06, 1986
EQ 1.4MG BASE/ML A062588 002 Jan 06, 1986
EQ 1.6MG BASE/ML A062588 003 Jan 06, 1986
EQ 1.8MG BASE/ML A062588 004 Jan 06, 1986
EQ 2MG BASE/ML A062588 005 Jan 06, 1986
EQ 60MG BASE/100ML A062588 006 Jan 06, 1986
EQ 70MG BASE/100ML A062588 007 Jan 06, 1986
EQ 80MG BASE/100ML A062588 008 Jan 06, 1986
EQ 90MG BASE/100ML A062588 009 Jan 06, 1986
EQ 100MG BASE/100ML A062588 010 Jan 06, 1986
U-GENCIN
PHARMACIA AND UPJOHN EQ 10MG BASE/ML A062248 001
EQ 40MG BASE/ML A062248 002
INJECTABLE;INTRATHECAL
GARAMYCIN
SCHERING EQ 2MG BASE/ML N050505 001
OINTMENT;OPHTHALMIC
GARAMYCIN
SCHERING EQ 0.3% BASE N050425 001
GENTACIDIN
NOVARTIS EQ 0.3% BASE A062501 001 Jul 26, 1984
GENTAFAIR
PHARMAFAIR EQ 3MG BASE/GM A062443 001 May 26, 1983
OINTMENT;TOPICAL
GARAMYCIN
SCHERING EQ 0.1% BASE A060463 001
GENTAFAIR
PHARMAFAIR EQ 0.1% BASE A062444 001 May 26, 1983
GENTAMICIN SULFATE
ALPHARMA US PHARMS EQ 0.1% BASE A062496 001 Mar 14, 1984
G AND W LABS INC EQ 0.1% BASE A064054 001 Apr 29, 1994
PHARMADERM EQ 0.1% BASE A062534 001 Oct 10, 1984
SOLUTION/DROPS;OPHTHALMIC
GARAMYCIN
SCHERING EQ 0.3% BASE N050039 002
GENTACIDIN
NOVARTIS EQ 0.3% BASE A062480 001 Mar 30, 1984
GENTAFAIR
PHARMAFAIR EQ 0.3% BASE A062440 001 May 03, 1983
GENTAMICIN SULFATE
ALCON PHARMS LTD EQ 0.3% BASE A062523 001 Nov 25, 1985
PACO EQ 3MG BASE/ML A062932 001 Nov 07, 1988
GENTIAN VIOLET
SUPPOSITORY;VAGINAL
GVS
SAVAGE LABS 0.4% A083513 001
TAMPON;VAGINAL
GENAPAX
KEY PHARMS 5MG A085017 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-152(of 337)
GLATIRAMER ACETATE
FOR SOLUTION;SUBCUTANEOUS
COPAXONE
TEVA PHARMS USA 20MG/VIAL N020622 001 Dec 20, 1996
GLIMEPIRIDE
TABLET;ORAL
GLIMEPIRIDE
COREPHARMA 1MG A077274 001 Oct 06, 2005
2MG A077274 002 Oct 06, 2005
4MG A077274 003 Oct 06, 2005
MYLAN 1MG A077486 001 Feb 10, 2006
2MG A077486 002 Feb 10, 2006
4MG A077486 003 Feb 10, 2006
RANBAXY 3MG A077366 001 Oct 06, 2005
6MG A077366 002 Oct 06, 2005
RANBAXY LABS LTD 1MG A076875 001 Oct 06, 2005
2MG A076875 002 Oct 06, 2005
4MG A076875 003 Oct 06, 2005
8MG A076875 004 Oct 06, 2005
WATSON LABS 1MG A077280 001 Feb 03, 2006
2MG A077280 002 Feb 03, 2006
4MG A077280 003 Feb 03, 2006
GLIPIZIDE
TABLET;ORAL
GLIPIZIDE
BARR LABS INC 5MG A074619 001 Apr 04, 1997
10MG A074619 002 Apr 04, 1997
SANDOZ 5MG A074542 001 Jun 20, 1995
10MG A074542 002 Jun 20, 1995
TEVA 5MG A074387 001 Mar 04, 1996
10MG A074387 002 Mar 04, 1996
VINTAGE PHARMS LLC 5MG A074378 001 Nov 28, 1994
10MG A074378 002 Nov 28, 1994
WATSON LABS 5MG A074370 001 Nov 22, 1994
10MG A074370 002 Nov 22, 1994
GLUCOTROL
PFIZER 2.5MG N017783 003 May 11, 1993
GLIPIZIDE; METFORMIN HYDROCHLORIDE
TABLET;ORAL
METAGLIP
BRISTOL MYERS SQUIBB 2.5MG;250MG N021460 001 Oct 21, 2002
2.5MG;500MG N021460 002 Oct 21, 2002
5MG;500MG N021460 003 Oct 21, 2002
GLUCAGON HYDROCHLORIDE
INJECTABLE;INJECTION
GLUCAGON
LILLY EQ 1MG BASE/VIAL N012122 001
EQ 10MG BASE/VIAL N012122 002
GLUTETHIMIDE
CAPSULE;ORAL
DORIDEN
SANOFI AVENTIS US 500MG N009519 008
TABLET;ORAL
DORIDEN
SANOFI AVENTIS US 250MG N009519 002
500MG N009519 005
GLUTETHIMIDE
HALSEY 250MG A089458 001 Oct 10, 1986
500MG A089459 001 Oct 10, 1986
LANNETT 250MG A083475 001
500MG A085571 001
SANDOZ 500MG A083234 002
UCB INC 500MG A085171 001
VITARINE 500MG A087297 001
WATSON LABS 500MG A084362 001
500MG A085763 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-153(of 337)
GLYBURIDE
TABLET;ORAL
GLYBURIDE
ACTAVIS ELIZABETH 1.5MG A075947 001 Nov 14, 2002
3MG A075947 002 Nov 14, 2002
6MG A075947 003 Nov 14, 2002
GLYBURIDE (MICRONIZED)
SANDOZ 1.5MG A075174 001 Jun 22, 1998
3MG A075174 002 Jun 22, 1998
SANOFI AVENTIS US 1.5MG N020055 001 Apr 17, 1992
3MG N020055 002 Apr 17, 1992
6MG N020055 003 Mar 08, 2000
GLYNASE
PHARMACIA AND UPJOHN 4.5MG N020051 003 Sep 24, 1993
MICRONASE
PHARMACIA AND UPJOHN 1.25MG N017498 001 May 01, 1984
2.5MG N017498 002 May 01, 1984
5MG N017498 003 May 01, 1984
GLYBURIDE; METFORMIN HYDROCHLORIDE
TABLET;ORAL
GLYBURIDE AND METFORMIN HYDROCHLORIDE
TEVA 1.25MG;250MG A076821 001 Jan 27, 2005
2.5MG;500MG A076821 002 Jan 27, 2005
5MG;500MG A076821 003 Jan 27, 2005
GLYCINE
SOLUTION;IRRIGATION
GLYCINE 1.5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 1.5GM/100ML N018522 001 Feb 19, 1982
HOSPIRA 1.5GM/100ML N017633 001
GLYCOPYRROLATE
INJECTABLE;INJECTION
GLYCOPYRROLATE
ABRAXIS PHARM 0.2MG/ML A088475 001 Jun 12, 1984
HOSPIRA 0.2MG/ML A089393 001 Jun 15, 1988
TEVA PARENTERAL 0.2MG/ML A081169 001 Sep 10, 1991
WATSON LABS 0.2MG/ML A086947 001 Jun 24, 1983
ROBINUL
ROBINS AH 0.2MG/ML N014764 001
TABLET;ORAL
GLYCOPYRROLATE
COREPHARMA 1MG A040568 001 Dec 22, 2004
2MG A040568 002 Dec 22, 2004
HIKMA PHARMS LLC 1MG A040836 001 Mar 05, 2009
2MG A040836 002 Mar 05, 2009
WATSON LABS 1MG A085562 001
1MG A086902 001
2MG A085563 001
2MG A086178 001
2MG A086900 001
GONADORELIN ACETATE
INJECTABLE;INJECTION
LUTREPULSE KIT
FERRING 0.8MG/VIAL N019687 001 Oct 10, 1989
3.2MG/VIAL N019687 002 Oct 10, 1989
GONADORELIN HYDROCHLORIDE
INJECTABLE;INJECTION
FACTREL
HIKMA (MAPLE) EQ 0.1MG BASE/VIAL N018123 001 Sep 30, 1982
EQ 0.2MG BASE/VIAL N018123 002 Sep 30, 1982
EQ 0.5MG BASE/VIAL N018123 003 Sep 30, 1982
GONADOTROPIN, CHORIONIC
INJECTABLE;INJECTION
A.P.L.
FERRING 5,000 UNITS/VIAL N017055 001
10,000 UNITS/VIAL N017055 002
20,000 UNITS/VIAL N017055 003
CHORIONIC GONADOTROPIN
BEL MAR 5,000 UNITS/VIAL N017054 001
10,000 UNITS/VIAL N017054 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-154(of 337)
GONADOTROPIN, CHORIONIC
INJECTABLE;INJECTION
CHORIONIC GONADOTROPIN
FERRING
2,000 UNITS/VIAL
N017016 009
Dec 27, 1984
2,000 UNITS/VIAL
N017016 011
Feb 16, 1990
5,000 UNITS/VIAL
N017016 006
15,000 UNITS/VIAL
N017016 010
Feb 15, 1985
20,000 UNITS/VIAL
N017016 004
FRESENIUS KABI USA
5,000 UNITS/VIAL
N017067 001
15,000 UNITS/VIAL
N017067 004
20,000 UNITS/VIAL
N017067 003
FOLLUTEIN
BRISTOL MYERS SQUIBB 10,000 UNITS/VIAL
N017056 001
GRAMICIDIN; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
SOLUTION/DROPS;OPHTHALMIC
NEO-POLYCIN
DOW PHARM 0.025MG/ML;EQ 1.75MG BASE/ML;10,000
A060427 001
UNITS/ML
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN
IPHARM 0.025MG/ML;EQ 1.75MG BASE/ML;10,000
A062818 001
Oct 11, 1988
UNITS/ML
WATSON LABS 0.025MG/ML;EQ 1.75MG BASE/ML;10,000
A062788 001
Jun 11, 1987
UNITS/ML
NEOMYCIN SULFATE AND POLYMYXIN B SULFATE GRAMICIDIN
PHARMAFAIR 0.025MG/ML;EQ 1.75MG BASE/ML;10,000
A062383 001
Aug 31, 1982
UNITS/ML
GRANISETRON HYDROCHLORIDE
INJECTABLE;INJECTION
GRANISETRON HYDROCHLORIDE
APOTEX INC EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
A078197 001
Dec 31, 2007
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
A078198 001
Jun 30, 2008
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
A078198 002
Jun 30, 2008
SANDOZ EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
A078808 001
Apr 29, 2008
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE
TEVA PHARMS USA
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
A077165 001
Dec 31, 2007
KYTRIL
ROCHE
EQ 0.1MG BASE/ML (EQ 0.1MG BASE/ML)
N020239 003
Sep 17, 2004
**Federal Register determination that
product was not discontinued or
withdrawn for safety or efficacy
reasons**
EQ 1MG BASE/ML (EQ 1MG BASE/ML)
N020239 004
Mar 11, 1994
**Federal Register determination that
product was not discontinued or
withdrawn for safety or efficacy
reasons**
EQ 3MG BASE/ML **Federal Register
N020239 001
Dec 29, 1993
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 4MG BASE/4ML (EQ 1MG BASE/ML)
N020239 002
Mar 11, 1994
**Federal Register determination that
product was not discontinued or
withdrawn for safety or efficacy
reasons**
SOLUTION;ORAL
GRANISOL
PEDIATRX
EQ 2MG BASE/10ML
A078334 001
Feb 28, 2008
KYTRIL
ROCHE
EQ 2MG BASE/10ML
N021238 001
Jun 27, 2001
TABLET;ORAL
GRANISETRON HYDROCHLORIDE
BARR
EQ 1MG BASE
A078221 001
Dec 31, 2007
KYTRIL
ROCHE
EQ 1MG BASE
N020305 001
Mar 16, 1995
EQ 2MG BASE
N020305 002
Jun 15, 1998
GREPAFLOXACIN HYDROCHLORIDE
TABLET;ORAL
RAXAR
OTSUKA
EQ 200MG BASE
N020695 001
Nov 06, 1997
EQ 400MG BASE
N020695 002
May 14, 1998
EQ 600MG BASE
N020695 003
May 14, 1998
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-155(of 337)
GRISEOFULVIN, MICROCRYSTALLINE
CAPSULE;ORAL
GRISACTIN
WYETH AYERST 125MG N050051 002
250MG N050051 001
SUSPENSION;ORAL
GRIFULVIN V
JOHNSON AND JOHNSON 125MG/5ML N050448 001
TABLET;ORAL
FULVICIN-U/F
ELORAC 250MG A060569 002
500MG A060569 001
GRIFULVIN V
J AND J 125MG A060618 001
250MG A060618 002
500MG A060618 003
VALEANT LUXEMBOURG 125MG A062279 001
250MG **Federal Register determination A062279 002
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
GRISACTIN
WYETH AYERST 500MG A060212 001
GRISEOFULVIN, MICROSIZE
SUSPENSION;ORAL
GRIFULVIN V
VALEANT LUXEMBOURG 125MG/5ML A062483 001 Jan 26, 1984
GRISEOFULVIN, ULTRAMICROCRYSTALLINE
TABLET;ORAL
FULVICIN P/G
ELORAC 125MG A061996 001
250MG A061996 002
FULVICIN P/G 165
ELORAC 165MG A061996 003 Apr 06, 1982
FULVICIN P/G 330
ELORAC 330MG A061996 004 Apr 06, 1982
GRISACTIN ULTRA
WYETH AYERST 125MG A062178 001
165MG A062438 001 Nov 17, 1983
250MG A062178 002
330MG A062438 002 Nov 17, 1983
ULTRAGRIS-165
PLIVA 165MG A062645 001 Jun 30, 1992
ULTRAGRIS-330
PLIVA 330MG A062646 001 Jun 30, 1992
GUANABENZ ACETATE
TABLET;ORAL
GUANABENZ ACETATE
ANI PHARMS INC EQ 4MG BASE A074267 001 Jun 01, 1994
EQ 8MG BASE A074267 002 Jun 01, 1994
SANDOZ EQ 4MG BASE A074517 001 Sep 30, 1998
EQ 8MG BASE A074517 002 Sep 30, 1998
WATSON LABS EQ 4MG BASE A074025 001 Feb 28, 1994
EQ 8MG BASE A074025 002 Feb 28, 1994
WYTENSIN
WYETH AYERST EQ 4MG BASE N018587 001 Sep 07, 1982
EQ 8MG BASE N018587 002 Sep 07, 1982
EQ 16MG BASE N018587 003 Sep 07, 1982
GUANADREL SULFATE
TABLET;ORAL
HYLOREL
PHARMACIA AND UPJOHN 10MG N018104 001 Dec 29, 1982
25MG N018104 002 Dec 29, 1982
GUANETHIDINE MONOSULFATE
TABLET;ORAL
GUANETHIDINE MONOSULFATE
WATSON LABS EQ 10MG SULFATE A086113 001 Mar 26, 1985
EQ 25MG SULFATE A086114 001 Mar 26, 1985
ISMELIN
NOVARTIS EQ 10MG SULFATE N012329 001
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DISCONTINUED DRUG PRODUCT LIST 6-156(of 337)
GUANETHIDINE MONOSULFATE
TABLET;ORAL
ISMELIN
EQ 25MG SULFATE N012329 002
GUANETHIDINE MONOSULFATE; HYDROCHLOROTHIAZIDE
TABLET;ORAL
ESIMIL
NOVARTIS 10MG;25MG N013553 001
GUANFACINE HYDROCHLORIDE
TABLET;ORAL
GUANFACINE HYDROCHLORIDE
WATSON LABS EQ 1MG BASE A074762 001 Jun 25, 1997
EQ 2MG BASE A074762 002 Jun 25, 1997
TENEX
PROMIUS PHARMA EQ 3MG BASE N019032 003 Nov 07, 1988
HALAZEPAM
TABLET;ORAL
PAXIPAM
SCHERING 20MG N017736 003
40MG N017736 004
HALCINONIDE
CREAM;TOPICAL
HALOG
WESTWOOD SQUIBB 0.025% N017818 001
HALOG-E
RANBAXY 0.1% N018234 001
OINTMENT;TOPICAL
HALOG
BRISTOL MYERS SQUIBB 0.025% N018125 001
SOLUTION;TOPICAL
HALOG
RANBAXY 0.1% N017823 001
HALOBETASOL PROPIONATE
OINTMENT;TOPICAL
HALOBETASOL PROPIONATE
FOUGERA PHARMS 0.05% A076903 001 Dec 16, 2004
G AND W LABS INC 0.05% A077109 001 Jun 14, 2005
HALOFANTRINE HYDROCHLORIDE
TABLET;ORAL
HALFAN
GLAXOSMITHKLINE 250MG N020250 001 Jul 24, 1992
HALOPERIDOL
TABLET;ORAL
HALDOL
ORTHO MCNEIL 0.5MG N015921 001
1MG N015921 002
2MG N015921 003
5MG N015921 004
10MG N015921 005
20MG N015921 006 Feb 02, 1982
HALDOL SOLUTAB
ORTHO MCNEIL PHARM 1MG N017079 001
HALOPERIDOL
DURAMED PHARMS BARR 0.5MG A071216 001 Dec 04, 1986
1MG A071217 001 Dec 04, 1986
2MG A071218 001 Dec 04, 1986
5MG A071219 001 Dec 04, 1986
10MG A071220 001 Jul 07, 1987
20MG A071221 001 Jul 07, 1987
LEDERLE 0.5MG A072727 001 Sep 19, 1989
1MG A072728 001 Sep 19, 1989
2MG A072729 001 Sep 19, 1989
5MG A072730 001 Sep 19, 1989
10MG A072731 001 Sep 19, 1989
20MG A072732 001 Sep 19, 1989
MUTUAL PHARM 0.5MG A071156 001 Jan 02, 1987
1MG A071157 001 Jan 02, 1987
2MG A071172 001 Jan 02, 1987
5MG A071212 001 Jan 07, 1988
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DISCONTINUED DRUG PRODUCT LIST
6-157(of 337)
HALOPERIDOL
TABLET;ORAL
HALOPERIDOL
10MG
A071173 001 Jan 07, 1988
20MG
A071177 001 Jan 07, 1988
PAR PHARM
20MG
A071328 001 Jul 20, 1987
PUREPAC PHARM
0.5MG
A071071 001 Nov 03, 1986
1MG
A071072 001 Nov 03, 1986
2MG
A071073 001 Nov 03, 1986
5MG
A071074 001 Nov 03, 1986
10MG
A071075 001 Aug 04, 1987
20MG
A071076 001 Aug 04, 1987
QUANTUM PHARMICS
0.5MG
A071255 001 Feb 17, 1987
1MG
A071269 001 Feb 17, 1987
2MG
A071256 001 Feb 17, 1987
5MG
A071257 001 Feb 17, 1987
ROXANE
0.5MG
A071128 001 Feb 17, 1987
1MG
A071129 001 Feb 17, 1987
2MG
A071130 001 Feb 17, 1987
5MG
A071131 001 Feb 17, 1987
10MG
A071132 001 May 12, 1987
20MG
A071133 001 May 12, 1987
ROYCE LABS
0.5MG
A071722 001 Dec 24, 1987
1MG
A071723 001 Dec 24, 1987
2MG
A071724 001 Dec 24, 1987
5MG
A071725 001 Dec 24, 1987
10MG
A072121 001 Dec 24, 1987
20MG
A072122 001 Dec 24, 1987
SCS
0.5MG
A070720 001 Jun 10, 1986
1MG
A070721 001 Jun 10, 1986
2MG
A070722 001 Jun 10, 1986
5MG
A070723 001 Jun 10, 1986
10MG
A070724 001 Jun 10, 1986
20MG
A070725 001 Sep 24, 1986
VINTAGE
0.5MG
A071233 001 Nov 03, 1986
1MG
A071234 001 Nov 03, 1986
2MG
A071235 001 Nov 03, 1986
5MG
A071236 001 Nov 03, 1986
10MG
A071237 001 Jul 20, 1987
WATSON LABS
0.5MG
A070981 001 Mar 06, 1987
0.5MG
A071571 001 Jun 03, 1988
1MG
A070982 001 Mar 06, 1987
1MG
A071572 001 Jun 03, 1988
2MG
A070983 001 Mar 06, 1987
2MG
A071573 001 Jun 03, 1988
5MG
A070984 001 Mar 06, 1987
5MG
A071374 001 Jun 03, 1988
10MG
A071375 001 Jun 03, 1988
10MG
A072113 001 Aug 27, 1991
20MG
A071376 001 Jun 03, 1988
20MG
A072353 001 Aug 27, 1991
HALOPERIDOL DECANOATE
INJECTABLE;INJECTION
HALOPERIDOL DECANOATE
HOSPIRA
EQ 50MG BASE/ML
A075176 001 Feb 09, 2000
EQ 100MG BASE/ML
A075176 002 Feb 09, 2000
SANDOZ
EQ 50MG BASE/ML
A076463 001 Jun 24, 2005
EQ 100MG BASE/ML
A076463 002 Jun 24, 2005
HALOPERIDOL LACTATE
CONCENTRATE;ORAL
HALDOL
ORTHO MCNEIL
EQ 2MG BASE/ML
N015922 001
HALOPERIDOL
ALPHARMA
EQ 2MG BASE/ML
A070318 001 Apr 11, 1986
MORTON GROVE
EQ 2MG BASE/ML
A070710 001 Mar 07, 1986
SCS
EQ 2MG BASE/ML
A070726 001 Jun 10, 1986
TEVA
EQ 2MG BASE/ML
A071015 001 Aug 25, 1987
HALOPERIDOL INTENSOL
ROXANE
EQ 2MG BASE/ML
A072045 001 Apr 12, 1988
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DISCONTINUED DRUG PRODUCT LIST
6-158(of 337)
HALOPERIDOL LACTATE
INJECTABLE;INJECTION
HALOPERIDOL
ABRAXIS PHARM EQ 5MG BASE/ML
A071187 001 Jan 20, 1987
APOTEX INC EQ 5MG BASE/ML
A076791 001 Aug 25, 2004
EQ 5MG BASE/ML
A076828 001 Aug 25, 2004
MARSAM PHARMS LLC EQ 5MG BASE/ML
A072516 001 Feb 25, 1993
EQ 5MG BASE/ML
A072517 001 Feb 25, 1993
SANDOZ EQ 5MG BASE/ML
A076464 001 Sep 29, 2004
SMITH AND NEPHEW EQ 5MG BASE/ML
A070802 001 Dec 14, 1987
SOLOPAK EQ 5MG BASE/ML
A070800 001 Dec 14, 1987
EQ 5MG BASE/ML
A070801 001 Dec 14, 1987
EQ 5MG BASE/ML
A070864 001 Dec 14, 1987
WATSON LABS EQ 5MG BASE/ML
A070713 001 May 17, 1988
EQ 5MG BASE/ML
A070714 001 May 17, 1988
EQ 5MG BASE/ML
A070744 001 May 17, 1988
SOLUTION;ORAL
HALOPERIDOL LACTATE
ACTAVIS MID ATLANTIC EQ 1MG BASE/ML
A074536 001 Nov 02, 1995
HALOPROGIN
CREAM;TOPICAL
HALOTEX
WESTWOOD SQUIBB 1%
N016942 001
SOLUTION;TOPICAL
HALOTEX
WESTWOOD SQUIBB 1%
N016943 001
HALOTHANE
LIQUID;INHALATION
FLUOTHANE
WYETH AYERST 99.99%
N011338 001
HALOTHANE
BH 99.99%
A084977 001
HALOCARBON 99.99%
A080810 001
HOSPIRA 99.99%
A083254 001
HEPARIN CALCIUM
INJECTABLE;INJECTION
CALCIPARINE
SANOFI AVENTIS US 25,000 UNITS/ML
N018237 001
HEPARIN SODIUM
INJECTABLE;INJECTION
HEPARIN LOCK FLUSH
HOSPIRA 100 UNITS/ML
N005264 010
INTL MEDICATION 10 UNITS/ML
A086357 001
500 UNITS/ML
A086357 002
LUITPOLD 10 UNITS/ML
A089063 001 Oct 09, 1985
100 UNITS/ML
A089064 001 Oct 09, 1985
PARKE DAVIS 10 UNITS/ML
N017346 006
SMITH AND NEPHEW 10 UNITS/ML
A087904 001 Apr 20, 1983
10 UNITS/ML
A087958 001 Apr 20, 1983
10 UNITS/ML
A088458 001 Jul 26, 1984
10 UNITS/ML
A088580 001 Oct 25, 1984
100 UNITS/ML
A087906 001 Apr 20, 1983
100 UNITS/ML
A087959 001 Apr 20, 1983
100 UNITS/ML
A088460 001 Jul 26, 1984
100 UNITS/ML
A088581 001 Oct 25, 1984
SOLOPAK 10 UNITS/ML
A087903 001 Apr 20, 1983
10 UNITS/ML
A088457 001 Oct 25, 1984
100 UNITS/ML
A087905 001 Apr 20, 1983
100 UNITS/ML
A088459 001 Jul 26, 1984
HEPARIN SODIUM
ABRAXIS PHARM 1,000 UNITS/ML
N017033 001
1,000 UNITS/ML
N017979 001
5,000 UNITS/ML
N017979 003
10,000 UNITS/ML
N017979 002
AKORN 1,000 UNITS/ML
N017486 001
5,000 UNITS/ML
N017486 002
10,000 UNITS/ML
N017486 003
20,000 UNITS/ML
N017486 004
40,000 UNITS/ML
N017486 005
BAXTER HLTHCARE CORP 1,000 UNITS/ML
N017007 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-159(of 337)
HEPARIN SODIUM
INJECTABLE;INJECTION
HEPARIN SODIUM
2,500 UNITS/ML N017007 007
5,000 UNITS/ML N017007 002
5,000 UNITS/0.5ML N017007 010
7,500 UNITS/ML N017007 003
10,000 UNITS/ML N017007 004
15,000 UNITS/ML N017007 005
20,000 UNITS/ML N017007 006
CHAMBERLIN PARENTERL 1,000 UNITS/ML N017130 001
5,000 UNITS/ML N017130 002
10,000 UNITS/ML N017130 003
20,000 UNITS/ML N017130 004
DELL LABS 1,000 UNITS/ML N017540 001
5,000 UNITS/ML N017540 002
10,000 UNITS/ML N017540 003
20,000 UNITS/ML N017540 004
40,000 UNITS/ML N017540 005
FRESENIUS KABI USA 1,000 UNITS/ML N017651 005
5,000 UNITS/ML N017029 002
10,000 UNITS/ML N017651 003
20,000 UNITS/ML N017651 008
HIKMA MAPLE 5,000 UNITS/0.5ML N017037 013 Apr 07, 1986
HOSPIRA 2,500 UNITS/ML A088099 001 Apr 28, 1983
10,000 UNITS/ML A040095 001 Jul 26, 1996
LILLY 1,000 UNITS/ML N005521 001
10,000 UNITS/ML N005521 002
20,000 UNITS/ML N005521 004
LUITPOLD 1,000 UNITS/ML A087452 001 Oct 31, 1983
ORGANON USA INC 1,000 UNITS/ML N000552 008
5,000 UNITS/ML N000552 009
10,000 UNITS/ML N000552 010
PARKE DAVIS 1,000 UNITS/ML N017346 001
5,000 UNITS/ML N017346 002
7,500 UNITS/ML N017346 003
10,000 UNITS/ML N017346 004
20,000 UNITS/ML N017346 005
PHARM SPEC 1,000 UNITS/ML N017780 001
5,000 UNITS/ML N017780 002
10,000 UNITS/ML N017780 003
20,000 UNITS/ML N017780 004
40,000 UNITS/ML N017780 005
PHARMACIA AND UPJOHN 1,000 UNITS/ML N004570 001
5,000 UNITS/ML N004570 002
10,000 UNITS/ML N004570 003
SMITH AND NEPHEW 1,000 UNITS/ML A088239 001 Jul 26, 1984
SOLOPAK 1,000 UNITS/ML A087043 001
5,000 UNITS/ML A087077 001
5,000 UNITS/0.5ML A087395 001
10,000 UNITS/ML A087107 001
10,000 UNITS/0.5ML A087363 001
WATSON LABS 1,000 UNITS/ML N017064 002
2,500 UNITS/ML N017064 015
3,000 UNITS/ML N017064 016
4,000 UNITS/ML N017064 017
5,000 UNITS/ML N017064 003
6,000 UNITS/ML N017064 018
7,500 UNITS/ML N017064 019
10,000 UNITS/ML N017064 004
20,000 UNITS/ML N017064 005
40,000 UNITS/ML N017064 006
WATSON LABS INC 1,000 UNITS/ML A040007 001 Jun 07, 1996
1,000 UNITS/ML A040008 001 Oct 10, 1995
HEPARIN SODIUM 1,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
MCGAW 200 UNITS/100ML N019130 001 Dec 31, 1984
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 200 UNITS/100ML N019042 001 Mar 29, 1985
HEPARIN SODIUM 10,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 2,000 UNITS/100ML N018814 002 Jul 09, 1985
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5%
HOSPIRA 10,000 UNITS/100ML N018911 006 Jan 30, 1985
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-160(of 337)
HEPARIN SODIUM
INJECTABLE;INJECTION
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.45%
HOSPIRA 10,000 UNITS/100ML
N018911 001 Jan 30, 1985
10,000 UNITS/100ML
N018916 005 Jan 31, 1984
HEPARIN SODIUM 10,000 UNITS IN SODIUM CHLORIDE 0.9%
HOSPIRA 10,000 UNITS/100ML
N018911 003 Jan 30, 1985
10,000 UNITS/100ML
N018916 002 Jan 31, 1984
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5%
HOSPIRA 5,000 UNITS/100ML
N018911 007 Jan 30, 1985
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 5,000 UNITS/100ML N019802 001 Jul 20, 1992
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.9%
HOSPIRA 5,000 UNITS/100ML N018911 005 Jan 30, 1985
5,000 UNITS/100ML N018916 003 Jan 31, 1984
HEPARIN SODIUM 2,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
MCGAW 200 UNITS/100ML N019130 003 Dec 31, 1984
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 200 UNITS/100ML
N019042 002 Mar 29, 1985
HEPARIN SODIUM 20,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4,000 UNITS/100ML
N018814 001 Oct 31, 1983
HEPARIN SODIUM 25,000 UNITS AND DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 5,000 UNITS/100ML
N018814 003 Jul 09, 1985
10,000 UNITS/100ML
N018814 004 Jul 02, 1987
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5%
HOSPIRA 5,000 UNITS/100ML
N018911 009 Jan 30, 1985
10,000 UNITS/100ML
N018911 008 Jan 30, 1985
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 5,000 UNITS/100ML
N019134 001 Mar 29, 1985
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 5,000 UNITS/100ML N019802 005 Jul 20, 1992
10,000 UNITS/100ML N019802 002 Jul 20, 1992
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9%
HOSPIRA 5,000 UNITS/100ML N018911 004 Jan 30, 1985
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 5,000 UNITS/100ML N019135 001 Mar 29, 1985
5,000 UNITS/100ML N019802 003 Jul 20, 1992
HOSPIRA 5,000 UNITS/100ML N018916 009 Jan 31, 1984
HEPARIN SODIUM 5,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
BAXTER HLTHCARE 500 UNITS/100ML
N018609 003 Apr 28, 1982
HEPARIN SODIUM 5,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER
MCGAW 1,000 UNITS/100ML
N019130 002 Dec 31, 1984
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.45%
HOSPIRA 100 UNITS/ML
N018911 002 Jan 30, 1985
100 UNITS/ML
N018916 004 Jan 31, 1984
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9%
HOSPIRA 1,000 UNITS/100ML
N018916 001 Jan 31, 1984
HEPARIN SODIUM 5,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 1,000 UNITS/100ML
N019042 004 Mar 29, 1985
HEPARIN SODIUM PRESERVATIVE FREE
HOSPIRA
2,000 UNITS/ML
N005264 013 Apr 07, 1986
2,500 UNITS/ML
N005264 014 Apr 07, 1986
PHARMA SERVE NY
1,000 UNITS/ML
A086129 001
WATSON LABS INC
1,000 UNITS/ML
A089464 001 Jun 03, 1986
LIPO-HEPIN
3M
1,000 UNITS/0.5ML
N017027 001
1,000 UNITS/ML
N017027 006
5,000 UNITS/0.5ML
N017027 002
5,000 UNITS/ML
N017027 008
7,500 UNITS/0.5ML
N017027 010
10,000 UNITS/0.5ML
N017027 003
10,000 UNITS/ML
N017027 009
15,000 UNITS/0.5ML
N017027 011
20,000 UNITS/0.5ML
N017027 004
20,000 UNITS/ML
N017027 007
40,000 UNITS/ML
N017027 005
LIQUAEMIN LOCK FLUSH
ORGANON USA INC
100 UNITS/ML
N000552 007
LIQUAEMIN SODIUM
ORGANON USA INC
1,000 UNITS/ML
N000552 004
5,000 UNITS/ML
N000552 003
10,000 UNITS/ML
N000552 005
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-161(of 337)
HEPARIN SODIUM
INJECTABLE;INJECTION
LIQUAEMIN SODIUM
20,000 UNITS/ML
N000552 001
40,000 UNITS/ML
N000552 002
LIQUAEMIN SODIUM PRESERVATIVE FREE
ORGANON USA INC
1,000 UNITS/ML
N000552 011 Apr 11, 1986
5,000 UNITS/ML
N000552 012 Apr 11, 1986
10,000 UNITS/ML
N000552 013 Apr 11, 1986
PANHEPRIN
HOSPIRA
1,000 UNITS/ML
N005264 004
5,000 UNITS/ML
N005264 006
10,000 UNITS/ML
N005264 007
20,000 UNITS/ML
N005264 008
40,000 UNITS/ML
N005264 009
SODIUM HEPARIN
ABRAXIS PHARM
5,000 UNITS/ML
N017033 002
10,000 UNITS/ML
N017033 003
20,000 UNITS/ML
N017033 004
BAXTER HLTHCARE
1,000 UNITS/ML
N017036 001 Mar 04, 1988
HETACILLIN
FOR SUSPENSION;ORAL
VERSAPEN
BRISTOL
EQ 112.5MG AMPICIL/ML
A061398 001
EQ 112.5MG AMPICIL/5ML
N050060 001
EQ 112.5MG AMPICIL/ML
N050060 003
EQ 225MG AMPICIL/5ML
A061398 002
HETACILLIN POTASSIUM
CAPSULE;ORAL
VERSAPEN-K
BRISTOL
EQ 225MG AMPICIL
A061396 001
EQ 450MG AMPICIL
A061396 002
HEXACHLOROPHENE
AEROSOL;TOPICAL
SEPTISOL
VESTAL LABS
0.23%
N017424 001
TURGEX
XTTRIUM
3%
N018375 001
EMULSION;TOPICAL
HEXA-GERM
HUNTINGTON LABS
3%
N017411 001
PHISOHEX
SANOFI AVENTIS US
3%
N008402 001
SOY-DOME
BAYER PHARMS
3%
N017405 001
TURGEX
XTTRIUM
3%
N019055 001 Nov 30, 1984
SOAP;TOPICAL
GAMOPHEN
ARBROOK
2%
N006270 003
SOLUTION;TOPICAL
DIAL
DIAL
0.25%
N017421 002
GERMA-MEDICA
HUNTINGTON LABS
1%
N017412 001
GERMA-MEDICA "MG"
HUNTINGTON LABS
0.25%
N017412 002
SEPTI-SOFT
CALGON
0.25%
N017460 001
SEPTISOL
VESTAL LABS
0.25%
N017423 001
SPONGE;TOPICAL
E-Z SCRUB
BECTON DICKINSON
450MG
N017452 001
HEXASCRUB
PROF DSPLS
3%
N018363 001
PHISO-SCRUB
SANOFI AVENTIS US
3%
N017446 001
SCRUBTEAM SURGICAL SPONGEBRUSH
3M 330MG N017413 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-162(of 337)
HEXAFLUORENIUM BROMIDE
INJECTABLE;INJECTION
MYLAXEN
MEDPOINTE PHARM HLC 20MG/ML N009789 003
HEXOCYCLIUM METHYLSULFATE
TABLET;ORAL
TRAL
ABBVIE 25MG N010599 001
HEXYLCAINE HYDROCHLORIDE
SOLUTION;TOPICAL
CYCLAINE
MERCK 5% N008472 001
HISTAMINE PHOSPHATE
INJECTABLE;INJECTION
HISTAMINE PHOSPHATE
LILLY EQ 0.1MG BASE/ML N000734 003
EQ 0.2MG BASE/ML N000734 002
EQ 1MG BASE/ML N000734 001
HISTRELIN ACETATE
INJECTABLE;INJECTION
SUPPRELIN
SHIRE EQ 0.2MG BASE/ML N019836 001 Dec 24, 1991
EQ 0.5MG BASE/ML N019836 002 Dec 24, 1991
EQ 1MG BASE/ML N019836 003 Dec 24, 1991
HOMATROPINE METHYLBROMIDE
TABLET;ORAL
HOMAPIN-10
MISSION PHARMA 10MG A086308 001
HOMAPIN-5
MISSION PHARMA 5MG A086309 001
TABLET, CHEWABLE;ORAL
EQUIPIN
MISSION PHARMA 3MG A086310 001
HOMATROPINE METHYLBROMIDE; HYDROCODONE BITARTRATE
SYRUP;ORAL
HYCODAN
ENDO PHARMS 1.5MG/5ML;5MG/5ML N005213 002 Jul 26, 1988
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE
IVAX SUB TEVA PHARMS 1.5MG/5ML;5MG/5ML A040285 001 Jul 19, 1999
HYDROPANE
HALSEY 1.5MG/5ML;5MG/5ML A088066 001 Jun 28, 1985
TABLET;ORAL
HOMATROPRINE METHYLBROMIDE AND HYDROCODONE BITARTRATE
ACTAVIS ELIZABETH 1.5MG;5MG A040295 001 Dec 01, 2000
HYCODAN
ENDO PHARMS 1.5MG;5MG N005213 001 Jul 26, 1988
HYALURONIDASE
INJECTABLE;INJECTION
HYDASE
AKORN INC 150 UNITS/ML N021716 001 Oct 25, 2005
VITRASE
BAUSCH AND LOMB 6,200 UNITS/VIAL N021640 001 May 05, 2004
WYDASE
BAXTER HLTHCARE 150 UNITS/ML N006343 002
150 UNITS/VIAL **Federal Register N006343 006
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
1,500 UNITS/VIAL **Federal Register N006343 005
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
HYDRALAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
APRESOLINE
NOVARTIS 20MG/ML N008303 003
HYDRALAZINE HYDROCHLORIDE
ABRAXIS PHARM 20MG/ML A089532 001 Aug 11, 1987
SMITH AND NEPHEW 20MG/ML A088518 001 Apr 20, 1984
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-163(of 337)
HYDRALAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
HYDRALAZINE HYDROCHLORIDE
SOLOPAK
20MG/ML
A088517 001 Aug 22, 1985
TEVA PARENTERAL
20MG/ML
A040373 001 Feb 23, 2000
TABLET;ORAL
APRESOLINE
NOVARTIS
10MG
N008303 004
25MG
N008303 001
50MG
N008303 002
100MG
N008303 005
DRALZINE
TEVA
25MG
A084301 001
HYDRALAZINE HYDROCHLORIDE
ACTAVIS ELIZABETH
25MG
A088560 001 Oct 04, 1984
50MG
A088649 001 Oct 18, 1984
ASCOT
25MG
A088310 001 Dec 19, 1984
50MG
A088311 001 Dec 19, 1984
HALSEY
10MG
A089218 001 Jan 22, 1986
25MG
A089130 001 Jan 15, 1986
50MG
A089222 001 Jan 22, 1986
100MG
A089178 001 Jan 15, 1986
IMPAX LABS
25MG
A084922 001
50MG
A084923 001
IVAX SUB TEVA PHARMS
10MG
A084443 001
25MG
A084437 001
50MG
A084469 002
100MG
A084581 001
MUTUAL PHARM
10MG
A088728 001 Apr 11, 1985
10MG
A089359 001 Jul 25, 1986
25MG
A084106 002
25MG
A089258 001 May 05, 1986
50MG
A084107 002
50MG
A089259 001 May 05, 1986
100MG
A088729 001 Apr 11, 1985
PUREPAC PHARM
25MG
A088177 001 Jul 29, 1983
50MG
A088178 001 Aug 15, 1983
QUANTUM PHARMICS
10MG
A088671 001 May 01, 1984
25MG
A088657 001 Jun 15, 1984
50MG
A088652 001 May 08, 1984
100MG
A088686 001 May 01, 1984
SANDOZ
10MG
A083241 001
25MG
A083560 001
50MG
A083561 001
50MG
A085088 001
SUPERPHARM
10MG
A088787 001 Aug 28, 1984
25MG
A088788 001 Aug 28, 1984
50MG
A088789 001 Aug 28, 1984
TG UNITED LABS
10MG
A088846 001 Feb 26, 1985
25MG
A088847 001 Feb 26, 1985
50MG
A088848 001 Feb 26, 1985
100MG
A088849 001 Feb 26, 1985
USL PHARMA
25MG
A087780 001 Mar 29, 1982
50MG
A087751 001 Mar 29, 1982
VANGARD
25MG
A087712 001
50MG
A087908 001 May 07, 1982
VITARINE
25MG
A086088 001
WATSON LABS
25MG
A084504 001
25MG
A085532 002 May 24, 1982
50MG
A084503 001
50MG
A085533 002 May 25, 1982
WEST WARD
25MG
A088240 001 May 27, 1983
50MG
A088241 001 May 27, 1983
ZYDUS PHARMS USA
10MG
A040858 001 Feb 26, 2010
25MG
A040858 002 Feb 26, 2010
50MG
A040858 003 Feb 26, 2010
100MG
A040858 004 Feb 26, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-164(of 337)
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE
CAPSULE;ORAL
APRESAZIDE
NOVARTIS 25MG;25MG
A084735 001
50MG;50MG
A084810 001
100MG;50MG
A084811 001
HYDRA-ZIDE
PAR PHARM 100MG;50MG
A088961 001 Oct 21, 1985
HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
SOLVAY 25MG;25MG
A087608 001 Feb 08, 1982
50MG;50MG
A087213 001 Feb 08, 1982
100MG;50MG
A087609 001 Feb 08, 1982
SUPERPHARM 25MG;25MG
A089200 001 Feb 09, 1987
50MG;50MG
A089201 001 Feb 09, 1987
WATSON LABS 25MG;25MG
A085457 001 Mar 04, 1982
50MG;50MG
A085446 001 Mar 04, 1982
100MG;50MG
A085440 001 Mar 04, 1982
HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 100/50
IVAX PHARMS 100MG;50MG
A088358 001 Apr 10, 1984
HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 25/25
IVAX PHARMS 25MG;25MG
A088356 001 Apr 10, 1984
HYDRALAZINE HYDROCHLORIDE W/ HYDROCHLOROTHIAZIDE 50/50
IVAX PHARMS 50MG;50MG
A088357 001 Apr 10, 1984
TABLET;ORAL
APRESOLINE-ESIDRIX
NOVARTIS 25MG;15MG
N012026 002
HYDRALAZINE AND HYDROCHLORTHIAZIDE
WATSON LABS 25MG;15MG
A085827 001
HYDROCHLOROTHIAZIDE W/ HYDRALAZINE
WATSON LABS 25MG;15MG
A085373 001
HYDRALAZINE HYDROCHLORIDE; HYDROCHLOROTHIAZIDE; RESERPINE
TABLET;ORAL
CAM-AP-ES
TG UNITED LABS 25MG;15MG;0.1MG
A084897 001
HYDRALAZINE HYDROCHLORIDE, HYDROCHLOROTHIAZIDE AND RESERPINE
IVAX SUB TEVA PHARMS 25MG;15MG;0.1MG
A084291 001
HYDRALAZINE HYDROCHLORIDE-HYDROCHLOROTHIAZIDE-RESERPINE
MYLAN 25MG;15MG;0.1MG
A087085 001
HYDRALAZINE, HYDROCHLOROTHIAZIDE W/ RESERPINE
WATSON LABS 25MG;15MG;0.1MG
A085771 001
HYDRAP-ES
SANDOZ 25MG;15MG;0.1MG
A084876 001
HYDROCHLOROTHIAZIDE W/ RESERPINE AND HYDRALAZINE
WATSON LABS 25MG;15MG;0.1MG
A083770 001
HYDROSERPINE PLUS (R-H-H)
IVAX SUB TEVA PHARMS 25MG;15MG;0.1MG
A083877 001
RESERPINE, HYDRALAZINE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
MUTUAL PHARM 25MG;15MG;0.1MG
A088570 001 Apr 10, 1984
SOLVAY 25MG;15MG;0.1MG
A088376 001 Oct 28, 1983
WATSON LABS 25MG;15MG;0.1MG
A085549 001
25MG;15MG;0.1MG
A087556 001
RESERPINE, HYDROCHLOROTHIAZIDE, AND HYDRALAZINE HYDROCHLORIDE
LEDERLE 25MG;15MG;0.1MG
A087709 001 May 13, 1982
SER-A-GEN
SOLVAY 25MG;15MG;0.1MG
A087210 001
SER-AP-ES
NOVARTIS 25MG;15MG;0.1MG
N012193 005
UNIPRES
SOLVAY 25MG;15MG;0.1MG
A085893 001
25MG;15MG;0.1MG
A086298 001
HYDRALAZINE HYDROCHLORIDE; RESERPINE
TABLET;ORAL
DRALSERP
SANDOZ 25MG;0.1MG
A084617 001
SERPASIL-APRESOLINE
NOVARTIS 25MG;0.1MG
N009296 004
50MG;0.2MG
N009296 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-165(of 337)
HYDROCHLOROTHIAZIDE
CAPSULE;ORAL
HYDROCHLOROTHIAZIDE
HIKMA INTL PHARMS 12.5MG
A077885 001 Nov 26, 2007
SOLUTION;ORAL
HYDROCHLOROTHIAZIDE
MORTON GROVE 50MG/5ML
A089661 001 Jun 20, 1988
ROXANE 50MG/5ML
A088587 001 Jul 02, 1984
HYDROCHLOROTHIAZIDE INTENSOL
ROXANE 100MG/ML
A088588 001 Jul 02, 1984
TABLET;ORAL
ESIDRIX
NOVARTIS 25MG
N011793 005
50MG
N011793 008
100MG
N011793 009
HYDRO-D
HALSEY 25MG
A086504 001
50MG
A083891 002
HYDROCHLOROTHIAZIDE
ABC HOLDING 50MG
A085672 001
ACTAVIS ELIZABETH 25MG
A085054 002
50MG
A085208 001
ALRA 25MG
A086369 001
50MG
A083554 001
ASCOT 25MG
A087539 001 Feb 03, 1982
50MG
A087540 001 Feb 03, 1982
BARR 50MG
A084771 001
DAVA PHARMS INC 100MG
A087060 001
ELKINS SINN 50MG
A085152 002
HEATHER 50MG
A084135 001
HIKMA PHARMS LLC 25MG
A084878 002 Jul 12, 2006
IMPAX LABS 25MG
A084029 001
50MG
A083607 002
100MG
A085098 001
INWOOD LABS 25MG
A084776 001
25MG
A085067 001
50MG
A084776 002
IVAX SUB TEVA PHARMS 50MG
A084658 001
100MG
A085022 001
MAST MM 25MG
A086192 001
50MG
A086192 002
MUTUAL PHARM 25MG
A083972 001
50MG
A083972 002
100MG
A083972 003
MYLAN 25MG
A084880 001
50MG
A085112 001
PVT FORM 50MG
A086597 001
ROXANE 25MG
A085004 001
50MG
A084536 002
50MG
A085005 001
SANDOZ 25MG
A083899 001
25MG
A087565 001 Mar 09, 1982
50MG
A084912 001
50MG
A085219 001
SOLVAY 25MG A085323 001
SUPERPHARM 25MG
A088827 001 Dec 28, 1984
50MG
A088828 001 Dec 28, 1984
100MG
A088829 001 Dec 28, 1984
TEVA 25MG
A088924 001 Feb 07, 1985
50MG
A088923 001 Feb 07, 1985
TG UNITED LABS 25MG
A085683 001
50MG
A083965 001
USL PHARMA 25MG
A087827 001 Apr 19, 1982
50MG
A087752 001 Apr 19, 1982
VANGARD 25MG
A087638 001
50MG
A087610 001
WARNER CHILCOTT 25MG
A087586 001 May 03, 1982
50MG
A087587 001 May 03, 1982
WATSON LABS 25MG
A081189 001 Jan 24, 1992
25MG
A083458 001
25MG
A085232 002
50MG
A083232 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-166(of 337)
HYDROCHLOROTHIAZIDE
TABLET;ORAL
HYDROCHLOROTHIAZIDE
50MG
A083456 001
50MG
A085233 001
50MG
A086087 001
50MG
A086594 001
100MG
A081190 001
Jan 24, 1992
100MG
A085099 001
100MG
A087002 001
WEST WARD
25MG
A084899 001
WHITEWORTH TOWN PLSN
25MG
A083809 002
50MG
A083809 001
100MG
A085347 001
HYDRODIURIL
MERCK
25MG
N011835 003
50MG
N011835 006
100MG
N011835 007
ORETIC
ABBVIE
25MG
N011971 001
ZIDE
SOLVAY
50MG
A083925 001
HYDROCHLOROTHIAZIDE; IRBESARTAN
TABLET;ORAL
AVALIDE
SANOFI AVENTIS US
12.5MG;75MG **Federal Register
N020758 001
Sep 30, 1997
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
25MG;300MG **Federal Register
N020758 004
Mar 15, 2005
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
IRBESARTAN AND HYDROCHLOROTHIAZIDE
TEVA 25MG;300MG
A077369 003
Mar 30, 2012
HYDROCHLOROTHIAZIDE; LABETALOL HYDROCHLORIDE
TABLET;ORAL
NORMOZIDE
SCHERING 25MG;100MG
N019046 001
Apr 06, 1987
25MG;200MG
N019046 002
Apr 06, 1987
25MG;300MG
N019046 003
Apr 06, 1987
25MG;400MG
N019046 004
Apr 06, 1987
TRANDATE HCT
GLAXOSMITHKLINE 25MG;100MG
N019174 001
Apr 10, 1987
25MG;200MG
N019174 002
Apr 10, 1987
25MG;300MG
N019174 003
Apr 10, 1987
25MG;400MG
N019174 004
Apr 10, 1987
HYDROCHLOROTHIAZIDE; LISINOPRIL
TABLET;ORAL
LISINOPRIL AND HYDROCHLOROTHIAZIDE
SANDOZ 12.5MG;10MG
A075926 001
Jul 01, 2002
12.5MG;20MG
A075926 002
Jul 01, 2002
25MG;20MG
A075926 003
Jul 01, 2002
TEVA 12.5MG;10MG
A075869 001
Jul 01, 2002
12.5MG;20MG
A075869 002
Jul 01, 2002
25MG;20MG
A075869 003
Jul 01, 2002
PRINZIDE
MERCK 25MG;20MG
N019778 002
Feb 16, 1989
HYDROCHLOROTHIAZIDE; LOSARTAN POTASSIUM
TABLET;ORAL
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE
WATSON LABS
12.5MG;50MG
A200180 001
Jan 12, 2011
12.5MG;100MG
A200180 002
Jan 12, 2011
25MG;100MG
A200180 003
Jan 12, 2011
HYDROCHLOROTHIAZIDE; METHYLDOPA
TABLET;ORAL
ALDORIL 15
MERCK
15MG;250MG
N013402 001
ALDORIL 25
MERCK
25MG;250MG
N013402 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-167(of 337)
HYDROCHLOROTHIAZIDE; METHYLDOPA
TABLET;ORAL
ALDORIL D30
MERCK 30MG;500MG
N013402 003
ALDORIL D50
MERCK 50MG;500MG
N013402 004
METHYLDOPA AND HYDROCHLOROTHIAZIDE
DAVA PHARMS INC
15MG;250MG
A072507 001 Jun 02, 1989
25MG;250MG
A072508 001 Jun 02, 1989
30MG;500MG
A072509 001 Jun 02, 1989
50MG;500MG
A072510 001 Jun 02, 1989
IVAX SUB TEVA PHARMS
15MG;250MG
A071458 001 Mar 08, 1988
25MG;250MG
A071459 001 Mar 08, 1988
30MG;500MG
A071460 001 Mar 08, 1988
50MG;500MG
A071461 001 Mar 08, 1988
PAR PHARM
15MG;250MG
A070616 001 Feb 02, 1987
25MG;250MG
A070612 001 Feb 02, 1987
30MG;500MG
A070613 001 Feb 02, 1987
50MG;500MG
A070614 001 Feb 02, 1987
PARKE DAVIS
15MG;250MG
A071897 001 Nov 23, 1987
25MG;250MG
A071898 001 Nov 23, 1987
30MG;500MG
A071899 001 Nov 23, 1987
50MG;500MG
A071900 001 Nov 23, 1987
PUREPAC PHARM
15MG;250MG
A070853 001 Oct 08, 1986
25MG;250MG
A070688 001 Apr 24, 1986
30MG;500MG
A070854 001 Oct 08, 1986
50MG;500MG
A070689 001 Apr 24, 1986
SANDOZ
15MG;250MG
A070182 001 Jan 15, 1986
15MG;250MG
A070829 001 Mar 09, 1987
25MG;250MG
A070183 001 Jan 15, 1986
25MG;250MG
A070830 001 Mar 09, 1987
30MG;500MG
A070543 001 Jan 15, 1986
50MG;500MG
A070544 001 Jan 15, 1986
TEVA
15MG;250MG
A071819 001 Apr 08, 1988
25MG;250MG
A071820 001 Apr 08, 1988
30MG;500MG
A071821 001 Apr 08, 1988
50MG;500MG
A071822 001 Apr 08, 1988
WATSON LABS
15MG;250MG
A070365 001 Mar 19, 1986
15MG;250MG
A070958 001 Feb 06, 1989
15MG;250MG
A071920 001 Aug 29, 1988
25MG;250MG
A070366 001 Apr 16, 1986
25MG;250MG
A070959 001 Jan 19, 1989
25MG;250MG
A071921 001 Aug 29, 1988
30MG;500MG
A070367 001 Mar 19, 1986
30MG;500MG
A071069 001 Jan 19, 1989
30MG;500MG
A071922 001 Aug 29, 1988
50MG;500MG
A070368 001 Apr 16, 1986
50MG;500MG
A070960 001 Feb 06, 1989
50MG;500MG
A071923 001 Aug 29, 1988
HYDROCHLOROTHIAZIDE; METOPROLOL TARTRATE
TABLET;ORAL
LOPRESSOR HCT
US PHARMS HOLDINGS I 50MG;100MG
N018303 003 Dec 31, 1984
HYDROCHLOROTHIAZIDE; MOEXIPRIL HYDROCHLORIDE
TABLET;ORAL
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
PADDOCK LLC 12.5MG;7.5MG
A090096 001 Sep 25, 2008
12.5MG;15MG
A090096 002 Sep 25, 2008
25MG;15MG
A090096 003 Sep 25, 2008
HYDROCHLOROTHIAZIDE; PINDOLOL
TABLET;ORAL
VISKAZIDE
NOVARTIS 25MG;5MG
N018872 001 Jul 22, 1987
25MG;10MG
N018872 002 Jul 22, 1987
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DISCONTINUED DRUG PRODUCT LIST
6-168(of 337)
HYDROCHLOROTHIAZIDE; PROPRANOLOL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
INDERIDE LA 120/50
WYETH AYERST
50MG;120MG
N019059 002 Jul 03, 1985
INDERIDE LA 160/50
WYETH AYERST
50MG;160MG
N019059 003 Jul 03, 1985
INDERIDE LA 80/50
WYETH AYERST
50MG;80MG
N019059 001 Jul 03, 1985
TABLET;ORAL
INDERIDE-80/25
WYETH PHARMS INC
25MG;80MG
N018031 002
PROPRANOLOL HYDROCHLORIDE & HYDROCHLOROTHIAZIDE
DURAMED PHARMS BARR 25MG;40MG
A071126 001 Mar 02, 1987
25MG;80MG
A071127 001 Mar 02, 1987
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE
ACTAVIS ELIZABETH
25MG;40MG
A070851 001 May 15, 1986
25MG;80MG
A070852 001 May 15, 1986
BARR
25MG;40MG
A070704 001 Oct 01, 1986
25MG;80MG
A070705 001 Oct 01, 1986
IVAX SUB TEVA PHARMS
25MG;40MG
A071552 001 Dec 01, 1988
25MG;80MG
A071553 001 Dec 01, 1988
SANDOZ
25MG;40MG
A071060 001 Aug 26, 1987
25MG;80MG
A071061 001 Aug 26, 1987
WARNER CHILCOTT
25MG;40MG
A071771 001 Jan 26, 1988
25MG;80MG
A071772 001 Jan 26, 1988
WATSON LABS
25MG;40MG
A070301 001 Apr 18, 1986
25MG;40MG
A071498 001 Dec 18, 1991
25MG;80MG
A070305 001 Apr 18, 1986
25MG;80MG
A071501 001 Dec 18, 1991
HYDROCHLOROTHIAZIDE; RESERPINE
TABLET;ORAL
H.R.-50
WHITEWORTH TOWN PLSN
50MG;0.125MG
A085338 001
HYDRO-RESERP
ABC HOLDING
50MG;0.125MG
A084714 002 Jun 29, 1982
HYDRO-SERP "25"
SANDOZ
25MG;0.125MG
A084827 001
HYDRO-SERP "50"
SANDOZ
50MG;0.125MG
A085213 001
HYDROCHLOROTHIAZIDE W/ RESERPINE
IVAX SUB TEVA PHARMS 25MG;0.1MG
A083572 001
25MG;0.125MG
A083571 001
50MG;0.1MG
A083568 001
50MG;0.125MG
A083573 001
PHARMERAL 25MG;0.125MG
A085421 001
50MG;0.125MG
A085420 001
ROXANE 50MG;0.125MG
A084603 001
WATSON LABS 25MG;0.125MG
A084466 001
25MG;0.125MG
A085317 001
25MG;0.125MG
A086330 002
50MG;0.125MG
A083666 001
50MG;0.125MG
A084467 001
50MG;0.125MG
A086331 001
HYDROPRES 25
MERCK 25MG;0.125MG
N011958 002
HYDROPRES 50
MERCK 50MG;0.125MG
N011958 003
RESERPINE AND HYDROCHLOROTHIAZIDE
BARR 25MG;0.125MG
A084580 001
50MG;0.125MG
A084579 001
SANDOZ 50MG;0.125MG
A088200 001 Jan 31, 1984
RESERPINE AND HYDROCHLOROTHIAZIDE-50
WEST WARD 50MG;0.125MG
A088189 001 May 10, 1984
SERPASIL-ESIDRIX #1
NOVARTIS 25MG;0.1MG
N011878 003
SERPASIL-ESIDRIX #2
NOVARTIS 50MG;0.1MG
N011878 005
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-169(of 337)
HYDROCHLOROTHIAZIDE; SPIRONOLACTONE
TABLET;ORAL
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE
ASCOT 25MG;25MG
A088025 001 Nov 23, 1984
MUTUAL PHARM 25MG;25MG
A087267 001
PUREPAC PHARM 25MG;25MG
A087999 001 Nov 06, 1985
SANDOZ 25MG;25MG
A086881 001
SUPERPHARM 25MG;25MG
A089137 001 Aug 26, 1985
WATSON LABS 25MG;25MG
A087398 001
SPIRONOLACTONE W/ HYDROCHLOROTHIAZIDE
IVAX PHARMS 25MG;25MG
A087004 002 May 24, 1982
LEDERLE 25MG;25MG
A087511 001
PARKE DAVIS 25MG;25MG
A087948 001 Feb 22, 1983
PUREPAC PHARM 25MG;25MG
A088054 001 Aug 18, 1983
UPSHER SMITH 25MG;25MG
A087553 001
USL PHARMA 25MG;25MG
A087651 001
VANGARD 25MG;25MG
A087655 001
WATSON LABS 25MG;25MG
A085974 001
25MG;25MG
A086026 001
HYDROCHLOROTHIAZIDE; TIMOLOL MALEATE
TABLET;ORAL
TIMOLIDE 10-25
MERCK 25MG;10MG
N018061 001
HYDROCHLOROTHIAZIDE; TRIAMTERENE
CAPSULE;ORAL
DYAZIDE
GLAXOSMITHKLINE LLC 25MG;50MG
N016042 002
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
BARR 25MG;37.5MG
A074970 001 Jan 06, 1998
NOVARTIS 25MG;37.5MG
A074857 001 Sep 09, 1997
VITARINE 25MG;50MG
A071737 001 Feb 12, 1988
TABLET;ORAL
TRIAMTERENE AND HYDROCHLOROTHIAZIDE
AM THERAP 50MG;75MG
A072022 001 Apr 17, 1988
QUANTUM PHARMICS 50MG;75MG
A071980 001 Apr 17, 1988
WATSON LABS 50MG;75MG
A071969 001 Apr 17, 1988
HYDROCODONE BITARTRATE; PHENYLPROPANOLAMINE HYDROCHLORIDE
SYRUP;ORAL
CODAMINE
ALPHARMA US PHARMS
5MG/5ML;25MG/5ML
A075103 001 Sep 29, 2000
HYDROCORTAMATE HYDROCHLORIDE
OINTMENT;TOPICAL
MAGNACORT
PFIZER
0.5%
N010554 001
HYDROCORTISONE
AEROSOL;TOPICAL
AEROSEB-HC
ALLERGAN HERBERT
0.5%
A085805 001
CREAM;TOPICAL
CORT-DOME
BAYER PHARMS
0.5%
N009585 003
1%
N009585 001
DERMACORT
MONARCH PHARMS
1%
A083011 002
ELDECORT
VALEANT PHARM INTL
1%
A080459 001
2.5%
A084055 001
FLEXICORT
WESTWOOD SQUIBB
0.5%
A087136 003 Apr 08, 1982
1%
A087136 002 Apr 08, 1982
2.5%
A087136 001 Apr 08, 1982
H-CORT
PHARM ASSOC
0.5%
A086823 001
HC #1
BAYER PHARMS
0.5%
A080438 001
HC #4
BAYER PHARMS
1%
A080438 002
HC (HYDROCORTISONE)
C AND M PHARMA
0.5%
A080482 003
1%
A080482 004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-170(of 337)
HYDROCORTISONE
CREAM;TOPICAL
HI-COR
C AND M PHARMA
2.5%
A080483 001
HYDROCORTISONE
ALPHARMA US PHARMS
2.5%
A089754 001 Feb 01, 1989
ALTANA
0.5%
A080848 002
1%
A080848 003
AMBIX
1%
A086080 001
2.5%
A086271 001
EVERYLIFE
0.5%
A080452 001
1%
A080452 002
G AND W LABS
1%
A084059 001
INGRAM PHARM
0.5%
A080456 002
1%
A080456 003
IVAX PHARMS
1%
A085733 001
NASKA
1%
A089706 001 Mar 10, 1988
PERRIGO NEW YORK
0.5%
A084970 002
1%
A085026 001
PHARMADERM
1%
A088845 001 Feb 27, 1986
2.5%
A089413 001 Dec 16, 1986
PHARMAFAIR
1%
A087838 001 Jul 28, 1982
STIEFEL
1%
A086170 001
SYOSSET
0.5%
A085527 001
TARO
0.5%
A086154 001
1%
A086155 001
TEVA
0.5%
A080400 002
1%
A080400 003
1%
A085191 001
2.5%
A080400 004
TOPIDERM
1%
A089273 001 Feb 17, 1989
USL PHARMA
1%
A088027 001 Sep 27, 1983
2.5%
A088029 001 Sep 27, 1983
WHITEWORTH TOWN PLSN
1%
A080496 002
HYTONE
VALEANT INTL
1%
A080472 003
2.5%
A080472 004
NOGENIC HC
IVAX PHARMS
1%
A087427 001 Apr 04, 1988
NUTRACORT
DOW PHARM
0.5%
A080442 002
1%
A080442 003
PENECORT
ALLERGAN HERBERT
1%
A088216 001 Jun 06, 1984
PROCTOCORT
MONARCH PHARMS
1%
A083011 001
SYNACORT
MEDICIS
0.5%
A087459 001
GEL;TOPICAL
NUTRACORT
HEALTHPOINT
1%
A084698 001
PENECORT
ALLERGAN HERBERT
1%
A088215 001 Jun 06, 1984
INJECTABLE;INJECTION
CORTEF
PHARMACIA AND UPJOHN
50MG/ML
N009864 001
LOTION;TOPICAL
ACTICORT
BAKER NORTON
1%
A086535 001
ALA-CORT
CROWN LABS
1%
A083201 001
BALNEOL-HC
SOLVAY
1%
A088041 001 Dec 03, 1982
BETA-HC
BETA DERMAC
1%
A089495 001 Jan 25, 1988
CETACORT
DOW PHARM
0.5%
A080426 002
1%
A080426 001
CORT-DOME
BAYER PHARMS
0.5%
N009895 003
1%
N009895 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-171(of 337)
HYDROCORTISONE
LOTION;TOPICAL
DERMACORT
SOLVAY 0.5%
A084573 002
1%
A086462 001
EPICORT
BLULINE 0.5%
A083219 002
GLYCORT
HERAN 1%
A087489 001 Oct 03, 1983
H-CORT
PHARM ASSOC 0.5%
A086824 001
HYDROCORTISONE
ALPHARMA US PHARMS 0.5%
A087317 001 Jun 07, 1982
1%
A087315 001 Jun 07, 1982
MERICON 0.5%
A085282 001
1%
A085282 002 Feb 26, 1987
NASKA 1%
A089705 001 Apr 25, 1988
PERRIGO NEW YORK 0.5%
A085662 001
1%
A085663 001
TARO 1%
A089024 001 Feb 12, 1986
HYTONE
VALEANT INTL 1%
A080473 003
2.5%
A080473 004 Nov 30, 1982
NUTRACORT
DOW PHARM 0.5%
A080443 002
1%
A080443 003
STIE-CORT
PERRIGO CO 1%
A089066 001 Nov 25, 1985
OINTMENT;TOPICAL
CORTRIL
PFIZER GLOBAL 1%
N009176 001
2.5%
N009176 002
HC (HYDROCORTISONE)
C AND M PHARMA 0.5%
A080481 001
1%
A080481 002
HYDROCORTISONE
ALTANA 0.5%
A080489 002
1%
A080489 003
AMBIX 1%
A086079 001
2.5%
A086272 001
NASKA 1%
A089704 001 Mar 10, 1988
PERRIGO NEW YORK 0.5%
A084969 003
1%
A085028 001
PHARMADERM 1%
A088842 001 Feb 09, 1987
TARO 0.5%
A086256 001
2.5%
A040310 001 Dec 29, 2000
USL PHARMA 1%
A088061 001 Sep 27, 1983
2.5%
A088039 001 Sep 27, 1983
HYTONE
DERMIK LABS 1%
A080474 003
2.5%
A080474 004
PENECORT
ALLERGAN HERBERT 2.5%
A088217 001 Jun 06, 1984
POWDER;FOR RX COMPOUNDING
H-CORT
TORCH 100%
A087834 001 Mar 29, 1982
HYDROCORTISONE
PADDOCK LLC 100%
A088082 001 Apr 08, 1983
SOLUTION;TOPICAL
PENECORT
ALLERGAN HERBERT 1%
A088214 001 Jun 06, 1984
TEXACORT
MISSION PHARMA 1%
A080425 001
TABLET;ORAL
CORTRIL
PFIZER 10MG
N009127 005
20MG
N009127 003
HYDROCORTISONE
BARR 20MG
A083999 001
ELKINS SINN 20MG
A080624 001
FERRANTE 10MG
A080568 001
20MG
A080568 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-172(of 337)
HYDROCORTISONE
TABLET;ORAL
HYDROCORTISONE
HIKMA INTL PHARMS 20MG A083365 001
IMPAX LABS 20MG A080781 001
INWOOD LABS 20MG A080732 001
LANNETT 20MG A085070 001
NEXGEN PHARMA INC 20MG A083140 001
PANRAY 10MG N009659 001
20MG N009659 002
PARKE DAVIS 20MG A084243 001
PUREPAC PHARM 10MG A084247 003 Aug 31, 1982
20MG A080395 001
20MG A084247 002
ROXANE 10MG A088539 001 Mar 21, 1984
SANDOZ 20MG A080642 002
WATSON LABS 20MG A080355 001
WHITEWORTH TOWN PLSN 10MG A080344 001
20MG A080344 002
HYDROCORTONE
MERCK 10MG N008506 007
20MG N008506 011
TABLET;VAGINAL
CORTRIL
PFIPHARMECS 10MG N009796 001
HYDROCORTISONE ACETATE
CREAM;TOPICAL
HEMSOL-HC
ABLE 1% A081274 001 Jun 19, 1992
HYDROCORTISONE ACETATE
CENCI 1% A080419 001 Jan 25, 1982
PARKE DAVIS 1% A089914 001 Jan 03, 1989
PUREPAC PHARM 0.5% A086050 001
1% A086052 001
INJECTABLE;INJECTION
CORTEF ACETATE
PHARMACIA AND UPJOHN 50MG/ML N009378 002
CORTRIL
PFIZER 25MG/ML N009164 001
HYDROCORTISONE ACETATE
AKORN 25MG/ML N009637 001
50MG/ML N009637 002
BEL MAR 25MG/ML A083739 001
50MG/ML A083739 002
WATSON LABS 25MG/ML A083128 001
25MG/ML A083759 001
50MG/ML A083759 002
50MG/ML A085214 001
HYDROCORTONE
MERCK 25MG/ML N008228 001
50MG/ML N008228 004
LOTION;TOPICAL
DRICORT
INGRAM PHARM 0.5% A086207 001
OINTMENT;OPHTHALMIC
HYDROCORTISONE ACETATE
FERA PHARMS 0.5% A080828 001
OINTMENT;OPHTHALMIC, OTIC
HYDROCORTONE
MERCK 1.5% N009018 003
OINTMENT;TOPICAL
CORTEF ACETATE
PHARMACIA AND UPJOHN 1% N008917 002
2.5% **Federal Register determination N008917 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
PASTE;TOPICAL
ORABASE HCA
COLGATE 0.5% A083205 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-173(of 337)
HYDROCORTISONE ACETATE; NEOMYCIN SULFATE
CREAM;TOPICAL
NEO-CORTEF
PHARMACIA AND UPJOHN
1%;EQ 3.5MG BASE/GM
A061049 001
2.5%;EQ 3.5MG BASE/GM
A061049 002
OINTMENT;OPHTHALMIC
NEO-CORTEF
PHARMACIA AND UPJOHN
0.5%;EQ 3.5MG BASE/GM
A060610 001
1.5%;EQ 3.5MG BASE/GM
A060610 002
OINTMENT;TOPICAL
NEO-CORTEF
PHARMACIA AND UPJOHN
0.5%;EQ 3.5MG BASE/GM
A060751 001
1%;EQ 3.5MG BASE/GM
A060751 002
2.5%;EQ 3.5MG BASE/GM
A060751 003
SUSPENSION/DROPS;OPHTHALMIC
COR-OTICIN
AKORN
1.5%;EQ 3.5MG BASE/ML
A060188 001
NEO-CORTEF
PHARMACIA AND UPJOHN
0.5%;EQ 3.5MG BASE/ML
A060612 002
1.5%;EQ 3.5MG BASE/ML
A060612 001
HYDROCORTISONE ACETATE; OXYTETRACYCLINE HYDROCHLORIDE
SUSPENSION;OPHTHALMIC
TERRA-CORTRIL
PFIZER 1.5%;EQ 5MG BASE/ML
A061016 001
HYDROCORTISONE ACETATE; PRAMOXINE HYDROCHLORIDE
AEROSOL, METERED;TOPICAL
HYDROCORTISONE ACETATE 1% AND PRAMOXINE HYDROCHLORIDE 1%
VINTAGE PHARMS
1%;1%
A089440 001 May 17, 1988
LOTION;TOPICAL
PRAMOSONE
FERNDALE LABS
0.5%;1%
A083213 002
HYDROCORTISONE ACETATE; UREA
CREAM;TOPICAL
CARMOL HC
FOUGERA PHARMS
1%;10%
A080505 001
HYDROCORTISONE BUTYRATE
CREAM;TOPICAL
LOCOID
YAMANOUCHI
0.1%
N018795 001 Jan 07, 1983
OINTMENT;TOPICAL
LOCOID
YAMANOUCHI
0.1%
N019106 001 Jul 03, 1984
SOLUTION;TOPICAL
LOCOID
YAMANOUCHI
0.1%
N019819 001 Sep 15, 1988
HYDROCORTISONE CYPIONATE
SUSPENSION;ORAL
CORTEF
PHARMACIA AND UPJOHN
EQ 10MG BASE/5ML
N009900 001
HYDROCORTISONE SODIUM PHOSPHATE
INJECTABLE;INJECTION
HYDROCORTONE
MERCK
EQ 50MG BASE/ML
N012052 001
HYDROCORTISONE SODIUM SUCCINATE
INJECTABLE;INJECTION
A-HYDROCORT
ABBOTT
EQ 1GM BASE/VIAL
A089580 001 Apr 11, 1989
EQ 100MG BASE/VIAL
A085928 001
EQ 100MG BASE/VIAL
A089577 001 Apr 11, 1989
EQ 250MG BASE/VIAL
A089578 001 Apr 11, 1989
EQ 500MG BASE/VIAL
A089579 001 Apr 11, 1989
HOSPIRA
EQ 1GM BASE/VIAL
A085932 001
EQ 100MG BASE/VIAL
A085929 001
EQ 250MG BASE/VIAL
A085930 001
EQ 500MG BASE/VIAL
A085931 001
HYDROCORTISONE SODIUM SUCCINATE
ABRAXIS PHARM EQ 1GM BASE/VIAL
A088670 001 Jun 08, 1984
EQ 100MG BASE/VIAL
A088667 001 Jun 08, 1984
EQ 100MG BASE/VIAL
A088712 001 Jun 08, 1984
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-174(of 337)
HYDROCORTISONE SODIUM SUCCINATE
INJECTABLE;INJECTION
HYDROCORTISONE SODIUM SUCCINATE
EQ 250MG BASE/VIAL
A088668 001 Jun 08, 1984
EQ 500MG BASE/VIAL
A088669 001 Jun 08, 1984
BAXTER HLTHCARE
EQ 1GM BASE/VIAL
A087569 001
EQ 100MG BASE/VIAL
A086619 001
EQ 250MG BASE/VIAL
A087567 001
EQ 500MG BASE/VIAL
A087568 001
INTL MEDICATION
EQ 100MG BASE/VIAL
A087532 001 Mar 19, 1982
WATSON LABS
EQ 1GM BASE/VIAL
A084748 001
EQ 100MG BASE/VIAL
A084737 002
EQ 100MG BASE/VIAL
A084738 001
EQ 250MG BASE/VIAL
A084737 001
EQ 500MG BASE/VIAL
A084747 001
HYDROCORTISONE VALERATE
CREAM;TOPICAL
HYDROCORTISONE VALERATE
TEVA PHARMS
0.2%
A074489 001 Aug 12, 1998
WESTCORT
RANBAXY
0.2%
N017950 001
OINTMENT;TOPICAL
HYDROCORTISONE VALERATE
FOUGERA PHARMS
0.2%
A075085 001 Jul 31, 2001
WESTCORT
RANBAXY
0.2%
N018726 001 Aug 08, 1983
HYDROCORTISONE; NEOMYCIN SULFATE
CREAM;TOPICAL
NEO-CORT-DOME
BAYER PHARMS 0.5%;EQ 3.5MG BASE/GM
N050237 006 Jun 05, 1984
1%;EQ 3.5MG BASE/GM
N050237 005 Jun 05, 1984
HYDROCORTISONE; NEOMYCIN SULFATE; POLYMYXIN B SULFATE
SOLUTION/DROPS;OTIC
NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE
PHARMAFAIR 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A062394 001 Sep 29, 1982
OTOCORT
WATSON LABS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML A060730 002
SUSPENSION/DROPS;OPHTHALMIC
CORTISPORIN
MONARCH PHARMS 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML N050169 001
NEOMYCIN SULFATE-POLYMYXIN B SULFATE-HYDROCORTISONE
PHARMAFAIR 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A062623 001 Sep 24, 1985
SUSPENSION/DROPS;OTIC
NEOMYCIN SULFATE, POLYMYXIN B SULFATE & HYDROCORTISONE
PHARMAFAIR 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A062617 001 Sep 18, 1985
OTICAIR
PHARMAFAIR 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A062399 001 Nov 18, 1982
OTOBIONE
SCHERING 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A061816 001
OTOCORT
ACTAVIS LABS FL INC 1%;EQ 3.5MG BASE/ML;10,000 UNITS/ML
A062521 001 Jul 11, 1985
HYDROCORTISONE; POLYMYXIN B SULFATE
SOLUTION/DROPS;OTIC
OTOBIOTIC
SCHERING 5MG/ML;EQ 10,000 UNITS BASE/ML
A062302 001
PYOCIDIN
FOREST LABS 5MG/ML;EQ 10,000 UNITS BASE/ML
A061606 001
HYDROCORTISONE; TETRACYCLINE HYDROCHLORIDE
OINTMENT;OPHTHALMIC
ACHROMYCIN
LEDERLE
1.5%;1%
N050272 001
HYDROCORTISONE; UREA
CREAM;TOPICAL
ALPHADERM
BIOGLAN
1%;10%
A086008 001
CALMURID HC
PHARMACIA AND UPJOHN
1%;10%
A083947 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-175(of 337)
HYDROFLUMETHIAZIDE
TABLET;ORAL
DIUCARDIN
WYETH AYERST 50MG A083383 001
HYDROFLUMETHIAZIDE
PAR PHARM 50MG A088850 001 May 31, 1985
WATSON LABS 50MG A088031 001 Apr 06, 1983
50MG A088528 001 Aug 15, 1984
HYDROFLUMETHIAZIDE; RESERPINE
TABLET;ORAL
HYDROFLUMETHIAZIDE AND RESERPINE
USL PHARMA 50MG;0.125MG A088195 001 Oct 26, 1983
WATSON LABS 25MG;0.125MG A088127 001 Mar 22, 1983
50MG;0.125MG A088110 001 Mar 22, 1983
RESERPINE AND HYDROFLUMETHIAZIDE
IVAX PHARMS 50MG;0.125MG A088932 001 Jan 11, 1985
PAR PHARM 50MG;0.125MG A088907 001 Sep 20, 1985
SALUTENSIN
SHIRE 50MG;0.125MG N012359 003
SALUTENSIN-DEMI
SHIRE 25MG;0.125MG N012359 004
HYDROMORPHONE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
PALLADONE
PURDUE PHARMA LP 12MG N021044 001 Sep 24, 2004
16MG N021044 002 Sep 24, 2004
24MG N021044 003 Sep 24, 2004
32MG N021044 004 Sep 24, 2004
INJECTABLE;INJECTION
HYDROMORPHONE HYDROCHLORIDE
WATSON LABS 10MG/ML A074317 001 Aug 23, 1995
TABLET;ORAL
HYDROMORPHONE HYDROCHLORIDE
NESHER PHARMS 2MG A077311 001 Nov 09, 2005
4MG A077311 002 Nov 09, 2005
8MG A077311 003 Nov 09, 2005
HYDROXOCOBALAMIN
INJECTABLE;INJECTION
ALPHAREDISOL
MERCK 1MG/ML A080778 001
CYANOKIT
MERCK SANTE SAS 2.5GM/VIAL (5GM/KIT) N022041 002 Dec 15, 2006
HYDROXOCOBALAMIN
ABRAXIS PHARM 1MG/ML A084921 001
WATSON LABS 1MG/ML A085528 001
HYDROXOMIN
BEL MAR 1MG/ML A084629 001
HYDROXYAMPHETAMINE HYDROBROMIDE
SOLUTION/DROPS;OPHTHALMIC
PAREDRINE
PHARMICS 1% N000004 004
HYDROXYCHLOROQUINE SULFATE
TABLET;ORAL
HYDROXYCHLOROQUINE SULFATE
SANDOZ 200MG A040150 001 Jan 27, 1996
WATSON LABS 200MG A040133 001 Nov 30, 1995
HYDROXYPROGESTERONE CAPROATE
INJECTABLE;INJECTION
DELALUTIN
BRISTOL MYERS SQUIBB 125MG/ML **Federal Register N010347 004
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
125MG/ML **Federal Register N016911 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
250MG/ML **Federal Register N010347 002
determination that product was not
discontinued or withdrawn for safety or
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-176(of 337)
HYDROXYPROGESTERONE CAPROATE
INJECTABLE;INJECTION
DELALUTIN
efficacy reasons**
250MG/ML **Federal Register N016911 002
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
HYDROXYPROGESTERONE CAPROATE
AKORN 125MG/ML N018004 001
WATSON LABS 125MG/ML N017439 001
250MG/ML N017439 002
HYDROXYSTILBAMIDINE ISETHIONATE
INJECTABLE;INJECTION
HYDROXYSTILBAMIDINE ISETHIONATE
SANOFI AVENTIS US 225MG/AMP N009166 001
HYDROXYUREA
CAPSULE;ORAL
HYDROXYUREA
BARR 250MG A075143 002 Sep 21, 2000
BARR LABS INC 250MG A075020 002 Jun 26, 2000
500MG A075020 001 Jul 30, 1998
ROXANE 500MG A074476 001 Aug 18, 1995
TABLET;ORAL
HYDROXYUREA
BARR 1GM A075734 001 Aug 29, 2000
HYDROXYZINE HYDROCHLORIDE
INJECTABLE;INJECTION
HYDROXYZINE
BAXTER HLTHCARE 50MG/ML A085551 002
HYDROXYZINE HYDROCHLORIDE
ALTANA 25MG/ML A087273 001 Apr 20, 1982
50MG/ML A087273 002 Apr 20, 1982
BAXTER HLTHCARE 25MG/ML A085551 001
FRESENIUS KABI USA 25MG/ML A088184 001 Mar 31, 1983
50MG/ML A088185 001 Mar 31, 1983
HOSPIRA 25MG/ML A087416 001
50MG/ML A086821 001
50MG/ML A087546 001
PHARMAFAIR 25MG/ML A088862 001 Feb 14, 1986
25MG/ML A089106 001 Feb 14, 1986
50MG/ML A088881 001 Feb 14, 1986
50MG/ML A089107 001 Feb 14, 1986
SMITH AND NEPHEW 25MG/ML A087592 001
SOLOPAK 25MG/ML A086822 001
25MG/ML A087591 001
50MG/ML A087310 001
50MG/ML A087593 001
50MG/ML A087595 001
50MG/ML A087596 001
WATSON LABS 25MG/ML A085778 001
25MG/ML A087274 001
50MG/ML A085779 001
50MG/ML A087274 002
WYETH AYERST 25MG/ML A086258 001
50MG/ML A086258 002
ORGATRAX
ORGANON USA INC 25MG/ML A087014 001
50MG/ML A087014 002
VISTARIL
PFIZER 25MG/ML N011111 001
50MG/ML N011111 002
SYRUP;ORAL
ATARAX
ROERIG 10MG/5ML N010485 001
HYDROXYZINE HYDROCHLORIDE
ALPHARMA US PHARMS 10MG/5ML A088785 001 Feb 03, 1988
KV PHARM 10MG/5ML A087730 001 Jul 01, 1982
STI PHARMA LLC 10MG/5ML A086880 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-177(of 337)
HYDROXYZINE HYDROCHLORIDE
TABLET;ORAL
ATARAX
PFIZER
10MG
N010392 001
25MG
N010392 004
50MG
N010392 006
100MG
N010392 005
HYDROXYZINE HYDROCHLORIDE
ABLE
10MG
A040559 001 Jul 22, 2004
25MG
A040562 001 Jul 22, 2004
50MG
A040563 001 Jul 22, 2004
ACTAVIS ELIZABETH
10MG
A089071 001 Jul 22, 1986
25MG
A089072 001 Jul 22, 1986
50MG
A089073 001 Jul 22, 1986
HALSEY
10MG
A089366 001 May 02, 1988
25MG
A089117 001 May 02, 1988
50MG
A089396 001 May 02, 1988
IVAX PHARMS
10MG
A087216 001
25MG
A087410 001
50MG
A087411 001
KV PHARM
10MG
A087819 001 Jun 23, 1982
25MG
A087820 001 Jun 23, 1982
50MG
A087821 001 Jun 23, 1982
100MG
A087822 001 Jun 23, 1982
MIKAH PHARMA
10MG
A040600 001 Dec 28, 2004
25MG
A040602 001 Dec 28, 2004
50MG
A040604 001 Dec 28, 2004
MUTUAL PHARM
10MG
A088409 001 Nov 15, 1983
25MG
A087857 001 Apr 18, 1983
50MG
A087860 001 Apr 18, 1983
100MG
A087862 001 Apr 18, 1983
PLIVA
100MG
A081054 001 Sep 25, 1995
PUREPAC PHARM
10MG
A088120 001 Sep 25, 1984
25MG
A088121 001 Sep 25, 1984
50MG
A088122 001 Sep 25, 1984
QUANTUM PHARMICS
10MG
A088540 001 Oct 22, 1985
25MG
A088551 001 Oct 22, 1985
50MG
A088529 001 Oct 22, 1985
SANDOZ
10MG
A087246 002
10MG
A087869 001 Dec 20, 1982
25MG
A085247 001
25MG
A087870 001 Dec 20, 1982
50MG
A087245 001
50MG
A087871 001 Dec 20, 1982
SUPERPHARM
10MG
A088794 001 Dec 05, 1984
25MG
A088795 001 Dec 05, 1984
50MG
A088796 001 Dec 05, 1984
USL PHARMA
10MG
A089121 001 Mar 20, 1986
25MG
A089122 001 Mar 20, 1986
50MG
A089123 001 Mar 20, 1986
VINTAGE
10MG
A087602 001 Jan 22, 1982
25MG
A087603 001 Jan 22, 1982
50MG
A087604 001 Jan 22, 1982
WATSON LABS
10MG
A081149 001 Mar 18, 1994
10MG
A086827 001
25MG
A081150 001 Mar 18, 1994
25MG
A086829 001
50MG
A081151 001 Mar 18, 1994
50MG
A086836 001
HYDROXYZINE PAMOATE
CAPSULE;ORAL
HY-PAM "25"
TEVA
EQ 25MG HCL
A088713 001 Mar 04, 1985
HYDROXYZINE PAMOATE
DURAMED PHARMS BARR
EQ 25MG HCL
A088593 001 Feb 29, 1984
EQ 50MG HCL
A088594 001 Feb 29, 1984
EQ 100MG HCL
A088595 001 Feb 29, 1984
IVAX SUB TEVA PHARMS
EQ 25MG HCL
A087761 001 Mar 05, 1982
EQ 50MG HCL
A087760 001 Mar 05, 1982
PAR PHARM
EQ 25MG HCL
A087656 001 Jun 11, 1982
EQ 25MG HCL
A089145 001 Mar 17, 1986
EQ 50MG HCL
A087657 001 Jun 11, 1982
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-178(of 337)
HYDROXYZINE PAMOATE
CAPSULE;ORAL
HYDROXYZINE PAMOATE
EQ 50MG HCL
A089146 001
Mar 17, 1986
EQ 100MG HCL
A087658 001
Jun 11, 1982
SANDOZ
EQ 25MG HCL
A081127 001
Jun 28, 1991
EQ 50MG HCL
A081128 001
Jun 28, 1991
EQ 100MG HCL
A081129 001
Jun 28, 1991
SUPERPHARM
EQ 25MG HCL
A089031 001
Jan 02, 1987
EQ 50MG HCL
A089032 001
Jan 02, 1987
EQ 100MG HCL
A089033 001
Jan 02, 1987
VANGARD
EQ 25MG HCL
A088392 001
Sep 19, 1983
EQ 50MG HCL
A088393 001
Sep 19, 1983
WATSON LABS
EQ 25MG HYDROCHLORIDE
A081165 001
Jul 31, 1991
EQ 25MG HCL
A086698 001
EQ 25MG HCL
A086840 001
Jul 01, 1982
EQ 50MG HCL
A086695 001
EQ 50MG HCL
A086705 001
Jul 01, 1982
EQ 50MG HCL
A087767 001
Aug 16, 1982
EQ 100MG HCL
A086697 001
EQ 100MG HCL
A086728 001
Oct 05, 1982
EQ 100MG HCL
A087790 001
Aug 16, 1982
VISTARIL
PFIZER
EQ 100MG HCL
N011459 006
SUSPENSION;ORAL
VISTARIL
PFIZER
EQ 25MG HCL/5ML
N011795 001
IBANDRONATE SODIUM
TABLET;ORAL
BONIVA
HOFFMANN LA ROCHE
EQ 2.5MG BASE **Federal Register
N021455 001
May 16, 2003
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
IBUPROFEN
CAPSULE;ORAL
MIDOL
BAYER
200MG **Federal Register determination
A070626 001
Sep 02, 1987
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
200MG **Federal Register determination
A071002 001
Sep 02, 1987
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
SOLUTION;INTRAVENOUS
CALDOLOR
CUMBERLAND PHARMS
400MG/4ML (100MG/ML)
N022348 001
Jun 11, 2009
SUSPENSION;ORAL
CHILDREN'S ADVIL
WYETH CONS
100MG/5ML
N019833 002
Sep 19, 1989
IBU
ABBOTT
100MG/5ML
N019784 001
Dec 18, 1989
MOTRIN
MCNEIL CONSUMER
100MG/5ML
N019842 001
Sep 19, 1989
SUSPENSION/DROPS;ORAL
MOTRIN
MCNEIL
40MG/ML
N020476 001
May 25, 1995
TABLET;ORAL
ACHES-N-PAIN
LEDERLE
200MG
A071065 001
May 28, 1987
CAP-PROFEN
PERRIGO
200MG
A072097 001
Dec 08, 1987
IBU
BASF
400MG
A070083 001
Feb 22, 1985
400MG
N018197 001
600MG
A070088 001
Feb 08, 1985
600MG
A070099 001
Mar 29, 1985
800MG
A070745 001
Jul 23, 1986
IBU-TAB
ALRA
800MG
A071965 001
Aug 11, 1988
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-179(of 337)
IBUPROFEN
TABLET;ORAL
IBUPRIN
PLIVA
200MG A071773 001 Jul 16, 1987
IBUPROFEN
ABBOTT
600MG A070556 001 Jun 14, 1985
800MG A071264 001 Jul 25, 1986
CONTRACT PHARMACAL
200MG A073691 001 Feb 25, 1994
HALSEY
200MG A071027 001 Sep 29, 1987
300MG A071028 001 Mar 23, 1987
400MG A071029 001 Mar 23, 1987
600MG A071030 001 Mar 23, 1987
800MG A072137 001 Feb 05, 1988
IVAX SUB TEVA PHARMS
200MG A071144 001 Jan 20, 1987
200MG A071154 001 Oct 27, 1987
200MG A072040 001 Apr 29, 1988
200MG A072901 001 Dec 19, 1991
200MG A072903 001 Dec 19, 1991
400MG A071145 001 Sep 23, 1986
600MG A071146 001 Sep 23, 1986
800MG A071769 001 May 08, 1987
LEDERLE
400MG A070629 001 Sep 19, 1986
600MG A070630 001 Sep 19, 1986
LEINER
300MG A071266 001 Oct 15, 1986
MCNEIL
400MG A070081 001 Jun 16, 1986
600MG A070476 001 Jun 16, 1986
MUTUAL PHARM
200MG A070493 001 Dec 24, 1985
200MG A070908 001 Sep 26, 1986
200MG A071462 001 Oct 02, 1986
400MG A070079 001 Jul 24, 1985
600MG A070080 001 Jul 24, 1985
800MG A071448 001 Feb 18, 1987
MYLAN
200MG A071870 001 May 05, 1988
400MG A070045 001 Sep 24, 1985
600MG A070057 001 Sep 24, 1985
800MG A071999 001 Dec 03, 1987
NORTHSTAR HLTHCARE
400MG A078132 001 Sep 10, 2007
600MG A078132 002 Sep 10, 2007
800MG A078132 003 Sep 10, 2007
OHM LABS
400MG A070818 001 Dec 26, 1985
PAR PHARM
200MG A071575 001 May 08, 1987
300MG A070328 001 Aug 06, 1985
400MG A070329 001 Aug 06, 1985
600MG A070330 001 Aug 06, 1985
800MG A070986 001 Jul 25, 1986
PERRIGO
200MG A072098 001 Dec 08, 1987
PLIVA
400MG A071666 001 Jun 18, 1987
600MG A071667 001 Jun 18, 1987
800MG A071668 001 Jun 18, 1987
PUREPAC PHARM
200MG A071122 001 Oct 03, 1986
200MG A071664 001 Feb 03, 1987
300MG A071123 001 Sep 19, 1986
400MG A071124 001 Sep 19, 1986
600MG A071125 001 Sep 19, 1986
800MG A071964 001 Feb 01, 1988
SANDOZ
200MG A070733 001 Sep 19, 1986
200MG A071807 001 Feb 25, 1988
200MG A074525 001 Dec 15, 1995
200MG A074533 001 Dec 15, 1995
300MG A070734 001 Jun 12, 1986
400MG A070735 001 Jun 12, 1986
400MG A072064 001 Jan 14, 1988
600MG A070736 001 Jun 12, 1986
600MG A072065 001 Jan 14, 1988
800MG A071938 001 Jan 14, 1988
800MG A072169 001 Dec 11, 1987
SUPERPHARM
600MG A070709 001 Apr 25, 1986
TEVA
200MG A073141 001 May 29, 1992
400MG A073343 001 Jun 30, 1992
600MG A073344 001 Jun 30, 1992
800MG A073345 001 Jun 30, 1992
VINTAGE PHARMS
200MG A072249 001 Jan 10, 1989
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-180(of 337)
IBUPROFEN
TABLET;ORAL
IBUPROFEN
WATSON LABS 200MG A070435 001 Mar 05, 1986
200MG A071765 001 Sep 04, 1987
200MG A071905 001 Mar 08, 1988
300MG A071338 001 Dec 01, 1986
400MG A070038 001 Sep 06, 1985
400MG A070436 001 Aug 21, 1985
600MG A070041 001 Sep 06, 1985
600MG A070437 001 Aug 21, 1985
800MG A071547 001 Jul 02, 1987
800MG A071911 001 Oct 13, 1987
IBUPROHM
OHM LABS 400MG A070469 001 Aug 29, 1985
MEDIPREN
MCNEIL 200MG A070475 001 Feb 06, 1986
200MG A071215 001 Jun 26, 1986
MIDOL
BAYER 200MG A070591 001 Sep 02, 1987
200MG A071001 001 Sep 02, 1987
MOTRIN
MCNEIL CONSUMER 300MG N017463 003
400MG N017463 002
600MG N017463 004
800MG N017463 005 May 22, 1985
MCNEIL PED 100MG N020418 001 Nov 16, 1994
NUPRIN
BRISTOL MYERS 200MG A072035 001 Feb 16, 1988
200MG A072036 001 Feb 16, 1988
MCNEIL 200MG N019012 001 May 18, 1984
200MG N019012 002 Jul 29, 1987
RUFEN
BASF 600MG N018197 002 Mar 05, 1984
TABLET, CHEWABLE;ORAL
MOTRIN
MCNEIL PED 50MG N020135 001 Nov 16, 1994
100MG N020135 002 Nov 16, 1994
IBUPROFEN; OXYCODONE HYDROCHLORIDE
TABLET;ORAL
COMBUNOX
FOREST LABS 400MG;5MG N021378 001 Nov 26, 2004
IDARUBICIN HYDROCHLORIDE
INJECTABLE;INJECTION
IDAMYCIN
PHARMACIA AND UPJOHN 5MG/VIAL N050661 002 Sep 27, 1990
10MG/VIAL N050661 001 Sep 27, 1990
20MG/VIAL N050661 003 Apr 25, 1995
IDARUBICIN HYDROCHLORIDE
SANDOZ 1MG/ML A091293 001 Mar 29, 2011
TEVA PARENTERAL 5MG/VIAL A065037 003 May 01, 2002
10MG/VIAL A065037 002 May 01, 2002
20MG/VIAL A065037 001 May 01, 2002
IDOXURIDINE
OINTMENT;OPHTHALMIC
STOXIL
GLAXOSMITHKLINE 0.5% N015868 001
SOLUTION/DROPS;OPHTHALMIC
STOXIL
GLAXOSMITHKLINE 0.1% N013934 001
IFOSFAMIDE; MESNA
INJECTABLE;INJECTION
IFEX/MESNEX KIT
BAXTER HLTHCARE 1GM/VIAL;100MG/ML N019763 003 Oct 10, 1992
3GM/VIAL;100MG/ML N019763 004 Oct 10, 1992
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-181(of 337)
ILOPROST
SOLUTION;INHALATION
VENTAVIS
ACTELION PHARMS LTD
20MCG/2ML (10MCG/ML)
N021779 001 Dec 29, 2004
IMATINIB MESYLATE
CAPSULE;ORAL
GLEEVEC
NOVARTIS
EQ 50MG BASE
N021335 001 May 10, 2001
EQ 100MG BASE
N021335 002 May 10, 2001
IMIPRAMINE HYDROCHLORIDE
CONCENTRATE;ORAL
IMIPRAMINE HYDROCHLORIDE
NOVARTIS
25MG/ML
A086765 001
INJECTABLE;INJECTION
TOFRANIL
NOVARTIS
12.5MG/ML
N011838 002
TABLET;ORAL
IMIPRAMINE HYDROCHLORIDE
LEDERLE
10MG
A086269 001
25MG
A086267 001
50MG
A086268 001
PAR PHARM
25MG
A089497 001 Jul 14, 1987
PROSAM LABS
10MG
A040753 001 Feb 28, 2008
25MG
A040752 001 Feb 28, 2008
50MG
A040751 001 Feb 28, 2008
ROXANE
10MG
A083799 001
25MG
A083799 002
50MG
A083799 003
SANDOZ
10MG
A085200 001
25MG
A084869 002
50MG
A085133 001
TEVA
10MG
A083729 001
25MG
A083729 004
50MG
A083729 003
USL PHARMA
25MG
A087776 001 Feb 10, 1982
VANGARD
10MG
A088036 001 Nov 03, 1982
25MG
A087619 001 Feb 09, 1982
50MG
A087631 001 Jan 04, 1982
WATSON LABS
10MG
A085220 001
10MG
A085875 001
25MG
A084252 002
25MG
A085878 001
50MG
A085221 001
50MG
A085877 001
WEST WARD
25MG
A088222 001 May 26, 1983
50MG
A088223 001 May 26, 1983
JANIMINE
ABBOTT
10MG
N017895 001
25MG
N017895 002
50MG
N017895 003
PRAMINE
ALRA
10MG
A083827 001
25MG
A083827 002
50MG
A083827 003
PRESAMINE
SANOFI AVENTIS US
10MG
N011836 006
25MG
N011836 003
50MG
N011836 007
INAMRINONE LACTATE
INJECTABLE;INJECTION
AMRINONE LACTATE
BAXTER HLTHCARE CORP
EQ 5MG BASE/ML
A075542 001 May 10, 2000
HOSPIRA
EQ 5MG BASE/ML
A074616 001 Aug 03, 1998
INOCOR
SANOFI AVENTIS US
EQ 5MG BASE/ML
N018700 001 Jul 31, 1984
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DISCONTINUED DRUG PRODUCT LIST 6-182(of 337)
INDAPAMIDE
TABLET;ORAL
INDAPAMIDE
AMERIGEN PHARMS LTD 1.25MG A075201 001 Dec 04, 1998
2.5MG A075201 002 Dec 04, 1998
SANDOZ 1.25MG A074594 001 May 23, 1996
2.5MG A074594 002 May 23, 1996
TEVA 1.25MG A074498 002 Feb 12, 1998
1.25MG A074665 001 Apr 04, 1997
2.5MG A074498 001 Oct 31, 1996
2.5MG A074665 002 Apr 04, 1997
WATSON LABS 1.25MG A074585 001 Sep 26, 1996
2.5MG A074585 002 Sep 26, 1996
LOZOL
SANOFI AVENTIS US 1.25MG **Federal Register determination N018538 002 Apr 29, 1993
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
2.5MG **Federal Register determination N018538 001 Jul 06, 1983
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
INDECAINIDE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
DECABID
LILLY EQ 50MG BASE N019693 001 Dec 29, 1989
EQ 75MG BASE N019693 002 Dec 29, 1989
EQ 100MG BASE N019693 003 Dec 29, 1989
INDINAVIR SULFATE
CAPSULE;ORAL
CRIXIVAN
MERCK SHARP DOHME EQ 100MG BASE N020685 006 Apr 19, 2000
EQ 333MG BASE N020685 005 Dec 17, 1998
INDOCYANINE GREEN
INJECTABLE;INJECTION
IC-GREEN
AKORN 10MG/VIAL N011525 003
40MG/VIAL N011525 004
50MG/VIAL N011525 002
INDOMETHACIN
CAPSULE;ORAL
INDO-LEMMON
TEVA 25MG A070266 001 Nov 07, 1985
50MG A070267 001 Nov 07, 1985
INDOCIN
IROKO PHARMS LLC 25MG N016059 001
50MG N016059 002
INDOMETHACIN
ABLE 25MG A076666 001 Dec 17, 2003
50MG A076666 002 Dec 17, 2003
CYCLE PHARMS LTD 25MG A070353 001 Jun 18, 1985
50MG A070354 001 Jun 18, 1985
DURAMED PHARMS BARR 25MG A070326 001 Oct 18, 1985
50MG A070327 001 Oct 18, 1985
HALSEY 25MG A070782 001 Jun 03, 1987
50MG A070635 001 Jun 03, 1987
IVAX SUB TEVA PHARMS 25MG N018730 001 May 04, 1984
50MG N018730 002 May 04, 1984
MUTUAL PHARM 25MG A070067 001 Oct 03, 1986
25MG A070899 001 Feb 09, 1987
50MG A070068 001 Oct 03, 1986
50MG A070900 001 Feb 09, 1987
MYLAN 50MG N018858 002 Apr 20, 1984
PARKE DAVIS 25MG N018806 001 Nov 23, 1984
50MG N018806 002 Nov 23, 1984
PIONEER PHARMS 25MG A070813 001 Aug 11, 1986
50MG A070592 001 Aug 11, 1986
PLIVA 25MG A071148 001 Mar 18, 1987
50MG A071149 001 Mar 18, 1987
SUPERPHARM 25MG A070487 001 Oct 10, 1986
50MG A070488 001 Oct 10, 1986
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DISCONTINUED DRUG PRODUCT LIST 6-183(of 337)
INDOMETHACIN
CAPSULE;ORAL
INDOMETHACIN
TEVA 25MG A071342 001 Apr 18, 1988
50MG A071343 001 Apr 18, 1988
VINTAGE 25MG N018829 002 Aug 06, 1984
50MG A070651 001 Mar 05, 1986
50MG N018829 001 Aug 06, 1984
WATSON LABS 25MG A070529 001 Oct 18, 1985
25MG A070784 001 Aug 20, 1986
25MG A072996 001 Jul 31, 1991
25MG N018690 001 Jul 31, 1984
50MG A070530 001 Oct 18, 1985
50MG A070785 001 Aug 20, 1986
50MG A071635 001 May 18, 1987
50MG A072997 001 Jul 31, 1991
50MG N018690 002 Jul 31, 1984
CAPSULE, EXTENDED RELEASE;ORAL
INDOCIN SR
IROKO PHARMS 75MG N018185 001 Feb 23, 1982
INDOMETHACIN
ABLE 75MG A076114 001 Feb 06, 2002
INWOOD LABS 75MG A072410 001 Mar 15, 1989
SUPPOSITORY;RECTAL
INDOCIN
IROKO PHARMS 50MG N017814 001 Aug 13, 1984
SUSPENSION;ORAL
INDOMETHACIN
CYCLE PHARMS LTD 25MG/5ML A071412 001 Mar 18, 1987
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT
INJECTABLE;SUBCUTANEOUS
NOVOLOG MIX 50/50
NOVO NORDISK INC 50 UNITS/ML;50 UNITS/ML N021810 001 Aug 26, 2008
NOVOLOG MIX 70/30 PENFILL
NOVO NORDISK INC 210 UNITS/3ML;90 UNITS/3ML (70 N021172 002 Nov 01, 2001
UNITS/ML; 30 UNITS/ML)
210 UNITS/3ML;90 UNITS/3ML (70 N021172 003 Nov 01, 2001
UNITS/ML; 30 UNITS/ML)
INSULIN ASPART RECOMBINANT
INJECTABLE;SUBCUTANEOUS
NOVOLOG INNOLET
NOVO NORDISK INC 300 UNITS/3ML (100 UNITS/ML) N020986 004 Apr 23, 2004
INSULIN DETEMIR RECOMBINANT
INJECTABLE;SUBCUTANEOUS
LEVEMIR INNOLET
NOVO NORDISK INC 300 UNITS/3ML (100 UNITS/ML) N021536 003 Jun 16, 2005
LEVEMIR PENFILL
NOVO NORDISK INC 300 UNITS/3ML (100 UNITS/ML) N021536 004 Jun 16, 2005
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT
INJECTABLE;INJECTION
HUMALOG MIX 50/50 PEN
LILLY 50 UNITS/ML;50 UNITS/ML N021018 003 Dec 22, 1999
HUMALOG MIX 75/25 PEN
LILLY 75 UNITS/ML;25 UNITS/ML N021017 003 Dec 22, 1999
INSULIN LISPRO RECOMBINANT
INJECTABLE;INJECTION
HUMALOG PEN
LILLY 100 UNITS/ML N020563 002 Aug 06, 1998
INSULIN PORK
INJECTABLE;INJECTION
ILETIN I
LILLY 500 UNITS/ML N017931 001
INSULIN
NOVO NORDISK INC 40 UNITS/ML N017926 001
REGULAR INSULIN
NOVO NORDISK INC 100 UNITS/ML N017926 003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-184(of 337)
INSULIN PURIFIED BEEF
INJECTABLE;INJECTION
REGULAR ILETIN II
LILLY
100 UNITS/ML
N018478 001
INSULIN PURIFIED PORK
INJECTABLE;INJECTION
ILETIN II
LILLY
500 UNITS/ML
N018344 002
REGULAR ILETIN II (PORK)
LILLY 100 UNITS/ML
N018344 001
REGULAR PURIFIED PORK INSULIN
NOVO NORDISK INC 100 UNITS/ML
N018381 001
VELOSULIN
NOVO NORDISK INC 100 UNITS/ML
N018193 001
INSULIN PURIFIED PORK; INSULIN SUSP ISOPHANE PURIFIED PORK
INJECTABLE;INJECTION
INSULIN NORDISK MIXTARD (PORK)
NOVO NORDISK INC
30 UNITS/ML;70 UNITS/ML
N018195 001
INSULIN RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN BR
LILLY
100 UNITS/ML
N019529 001 Apr 28, 1986
VELOSULIN BR
NOVO NORDISK INC
100 UNITS/ML
N021028 001 Jul 19, 1999
POWDER;INHALATION
EXUBERA
PFIZER
1MG/INH
N021868 001 Jan 27, 2006
3MG/INH
N021868 002 Jan 27, 2006
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN 50/50
LILLY 50 UNITS/ML;50 UNITS/ML
N020100 001 Apr 29, 1992
INSULIN RECOMBINANT PURIFIED HUMAN
INJECTABLE;INJECTION
NOVOLIN R
NOVO NORDISK INC 100 UNITS/ML N018778 001 Aug 30, 1983
VELOSULIN BR HUMAN
NOVO NORDISK INC 100 UNITS/ML N019450 001 May 30, 1986
INSULIN RECOMBINANT PURIFIED HUMAN; INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED HUMAN
INJECTABLE;INJECTION
MIXTARD HUMAN 70/30
BAYER PHARMS
30 UNITS/ML;70 UNITS/ML
N019585 001 Mar 11, 1988
NOVOLIN 70/30
NOVO NORDISK INC
30 UNITS/ML;70 UNITS/ML
N019441 001 Jul 11, 1986
INSULIN SUSP ISOPHANE BEEF
INJECTABLE;INJECTION
NPH INSULIN
NOVO NORDISK INC
40 UNITS/ML
N017929 001
100 UNITS/ML
N017929 003
INSULIN SUSP ISOPHANE BEEF/PORK
INJECTABLE;INJECTION
NPH ILETIN I (BEEF-PORK)
LILLY
40 UNITS/ML
N017936 001
100 UNITS/ML
N017936 002
INSULIN SUSP ISOPHANE PURIFIED BEEF
INJECTABLE;INJECTION
NPH ILETIN II
LILLY 100 UNITS/ML
N018479 001
INSULIN SUSP ISOPHANE PURIFIED PORK
INJECTABLE;INJECTION
INSULIN INSULATARD NPH NORDISK
NOVO NORDISK INC 100 UNITS/ML
N018194 001
NPH ILETIN II (PORK)
LILLY 100 UNITS/ML
N018345 001
NPH PURIFIED PORK ISOPHANE INSULIN
NOVO NORDISK INC 100 UNITS/ML
N018623 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-185(of 337)
INSULIN SUSP ISOPHANE SEMISYNTHETIC PURIFIED HUMAN
INJECTABLE;INJECTION
INSULATARD NPH HUMAN
NOVO NORDISK INC 100 UNITS/ML N019449 001 May 30, 1986
NOVOLIN N
NOVO NORDISK INC 100 UNITS/ML N019065 001 Jan 23, 1985
INSULIN SUSP PROTAMINE ZINC BEEF/PORK
INJECTABLE;INJECTION
PROTAMINE ZINC & ILETIN I (BEEF-PORK)
LILLY 40 UNITS/ML
N017932 001
100 UNITS/ML
N017932 002
INSULIN SUSP PROTAMINE ZINC PURIFIED BEEF
INJECTABLE;INJECTION
PROTAMINE ZINC AND ILETIN II
LILLY 100 UNITS/ML
N018476 001
PROTAMINE ZINC INSULIN
BRISTOL MYERS SQUIBB 40 UNITS/ML
N017928 001
100 UNITS/ML
N017928 003
INSULIN SUSP PROTAMINE ZINC PURIFIED PORK
INJECTABLE;INJECTION
PROTAMINE ZINC AND ILETIN II (PORK)
LILLY 100 UNITS/ML
N018346 001
INSULIN ZINC SUSP BEEF
INJECTABLE;INJECTION
LENTE INSULIN
NOVO NORDISK INC 40 UNITS/ML
N017998 001
100 UNITS/ML
N017998 003
INSULIN ZINC SUSP EXTENDED BEEF
INJECTABLE;INJECTION
ULTRALENTE INSULIN
NOVO NORDISK INC 100 UNITS/ML
N017997 003
INSULIN ZINC SUSP EXTENDED PURIFIED BEEF
INJECTABLE;INJECTION
ULTRALENTE
NOVO NORDISK INC 100 UNITS/ML
N018385 001
INSULIN ZINC SUSP EXTENDED RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN U
LILLY 40 UNITS/ML
N019571 001 Jun 10, 1987
100 UNITS/ML
N019571 002 Jun 10, 1987
INSULIN ZINC SUSP PROMPT BEEF
INJECTABLE;INJECTION
SEMILENTE INSULIN
NOVO NORDISK INC 100 UNITS/ML
N017996 003
INSULIN ZINC SUSP PROMPT PURIFIED PORK
INJECTABLE;INJECTION
SEMILENTE
NOVO NORDISK INC 100 UNITS/ML
N018382 001
INSULIN ZINC SUSP PURIFIED BEEF
INJECTABLE;INJECTION
LENTE ILETIN II
LILLY 100 UNITS/ML
N018477 001
INSULIN ZINC SUSP PURIFIED BEEF/PORK
INJECTABLE;INJECTION
LENTARD
NOVO NORDISK INC 100 UNITS/ML
N018384 001
INSULIN ZINC SUSP PURIFIED PORK
INJECTABLE;INJECTION
LENTE
NOVO NORDISK INC 100 UNITS/ML
N018383 001
LENTE ILETIN II (PORK)
LILLY 100 UNITS/ML
N018347 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-186(of 337)
INSULIN ZINC SUSP RECOMBINANT HUMAN
INJECTABLE;INJECTION
HUMULIN L
LILLY 100 UNITS/ML N019377 002 Sep 30, 1985
NOVOLIN L
NOVO NORDISK INC 100 UNITS/ML N019965 001 Jun 25, 1991
INSULIN ZINC SUSP SEMISYNTHETIC PURIFIED HUMAN
INJECTABLE;INJECTION
NOVOLIN L
NOVO NORDISK INC 100 UNITS/ML
N018777 001 Aug 30, 1983
INULIN
INJECTABLE;INJECTION
INULIN AND SODIUM CHLORIDE
ISO TEX 100MG/ML
N002282 001
INVERT SUGAR
INJECTABLE;INJECTION
TRAVERT 10% IN PLASTIC CONTAINER
BAXTER HLTHCARE 10GM/100ML
N016717 001
IOBENGUANE SULFATE I-131
INJECTABLE;INJECTION
IOBENGUANE SULFATE I 131
PHARMALUCENCE 2.3mCi/ML
N020084 001 Mar 25, 1994
IOCETAMIC ACID
TABLET;ORAL
CHOLEBRINE
MALLINCKRODT 750MG
N017129 001
IODAMIDE MEGLUMINE
INJECTABLE;INJECTION
RENOVUE-65
BRACCO 65%
N017902 001
RENOVUE-DIP
BRACCO 24%
N017903 001
IODIPAMIDE MEGLUMINE
INJECTABLE;INJECTION
CHOLOGRAFIN MEGLUMINE
BRACCO 10.3%
N009321 007
IODIPAMIDE SODIUM
INJECTABLE;INJECTION
CHOLOGRAFIN SODIUM
BRACCO 20%
N009321 001
IODOHIPPURATE SODIUM I-123
INJECTABLE;INJECTION
NEPHROFLOW
GE HEALTHCARE 1mCi/ML
N018289 001 Dec 28, 1984
IODOHIPPURATE SODIUM I-131
INJECTABLE;INJECTION
HIPPURAN I 131
MALLINCKRODT 0.25mCi/ML
N016666 001
HIPPUTOPE
BRACCO 1-2mCi/VIAL
N015419 002
IODOHIPPURATE SODIUM I 131
PHARMALUCENCE 0.2mCi/ML
N017313 001
IODOXAMATE MEGLUMINE
INJECTABLE;INJECTION
CHOLOVUE
BRACCO 9.9%
N018077 001
40.3%
N018076 001
IOFETAMINE HYDROCHLORIDE I-123
INJECTABLE;INJECTION
SPECTAMINE
IMP 1mCi/ML
N019432 001 Dec 24, 1987
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-187(of 337)
IOHEXOL
INJECTABLE;INJECTION
OMNIPAQUE 210
GE HEALTHCARE 45.3% N018956 006 Jun 30, 1989
SOLUTION;URETHRAL
OMNIPAQUE 70
GE HEALTHCARE 15.1% N018956 007 Jun 01, 1994
IOPAMIDOL
INJECTABLE;INJECTION
IOPAMIDOL
BAXTER HLTHCARE 41% A074629 001 Nov 06, 1996
51% A074629 004 Mar 31, 1998
61% A074629 002 Nov 06, 1996
76% A074629 003 Nov 06, 1996
HOSPIRA 61% A074734 001 Dec 10, 1996
76% A074734 002 Dec 10, 1996
IOPAMIDOL-200
COOK IMAGING 41% A074881 001 Jul 28, 2000
HOSPIRA 41% A074898 001 Dec 30, 1997
IOPAMIDOL-200 IN PLASTIC CONTAINER
HOSPIRA 41% A074636 001 Dec 30, 1997
IOPAMIDOL-250
COOK IMAGING 51% A074881 002 Jul 28, 2000
HOSPIRA 51% A074898 002 Dec 30, 1997
51% A075005 001 Feb 24, 1998
IOPAMIDOL-250 IN PLASTIC CONTAINER
HOSPIRA 51% A074636 002 Dec 30, 1997
IOPAMIDOL-300
ABBVIE 61% A074638 001 Apr 30, 1997
COOK IMAGING 61% A074881 003 Jul 28, 2000
HOSPIRA 61% A074898 003 Dec 30, 1997
61% A075005 002 Feb 24, 1998
IOPAMIDOL-300 IN PLASTIC CONTAINER
HOSPIRA 61% A074636 003 Dec 30, 1997
61% A074637 001 Apr 03, 1997
IOPAMIDOL-370
COOK IMAGING 76% A074881 004 Jul 28, 2000
HOSPIRA 76% A074898 004 Dec 30, 1997
76% A075005 003 Feb 24, 1998
IOPAMIDOL-370 IN PLASTIC CONTAINER
HOSPIRA 76% A074636 004 Dec 30, 1997
ISOVUE-128
BRACCO 26% N018735 005 Oct 21, 1986
ISOVUE-200
BRACCO 41% N020327 001 Oct 12, 1994
IOPANOIC ACID
TABLET;ORAL
TELEPAQUE
GE HEALTHCARE 500MG N008032 001
IOPHENDYLATE
INJECTABLE;INJECTION
PANTOPAQUE
ALCON 100% N005319 001
IOTHALAMATE MEGLUMINE; IOTHALAMATE SODIUM
INJECTABLE;INJECTION
VASCORAY
MALLINCKRODT 52%;26% N016783 001
IOTHALAMATE SODIUM
INJECTABLE;INJECTION
ANGIO-CONRAY
MALLINCKRODT 80% N013319 001
CONRAY 325
MALLINCKRODT 54.3% N017685 001
CONRAY 400
MALLINCKRODT 66.8% N014295 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-188(of 337)
IOTROLAN
INJECTABLE;INTRATHECAL
OSMOVIST 190
BAYER HLTHCARE
40.6%
N019580 001 Dec 07, 1989
OSMOVIST 240
BAYER HLTHCARE
51.3%
N019580 002 Dec 07, 1989
IOVERSOL
INJECTABLE;INJECTION
OPTIRAY 160
MALLINCKRODT
34%
N019710 003 Dec 30, 1988
OPTIRAY 240
MALLINCKRODT
51%
N020923 001 May 28, 1998
OPTIRAY 320
MALLINCKRODT
68%
N020923 002 May 29, 1998
IPODATE CALCIUM
GRANULE;ORAL
ORAGRAFIN CALCIUM
BRACCO
3GM/PACKET
N012968 001
IPODATE SODIUM
CAPSULE;ORAL
BILIVIST
BAYER HLTHCARE
500MG
A087768 001 Aug 11, 1982
ORAGRAFIN SODIUM
BRACCO
500MG
N012967 001
IPRATROPIUM BROMIDE
AEROSOL, METERED;INHALATION
ATROVENT
BOEHRINGER INGELHEIM
0.018MG/INH
N019085 001 Dec 29, 1986
SOLUTION;INHALATION
ATROVENT
BOEHRINGER INGELHEIM
0.02%
N020228 001 Sep 29, 1993
IPRATROPIUM BROMIDE
ACTAVIS MID ATLANTIC
0.02%
A075111 001 Apr 22, 1999
APOTEX INC
0.02%
A075441 001 Mar 28, 2001
PHARMASCIENCE INC
0.02%
A075507 001 Jan 19, 2001
ROXANE
0.02%
A075867 001 Jul 22, 2002
TEVA PHARMS USA
0.02%
A075313 001 Feb 07, 2000
SPRAY, METERED;NASAL
IPRATROPIUM BROMIDE
APOTEX INC
0.021MG/SPRAY
A076156 001 Apr 18, 2003
0.042MG/SPRAY
A076155 001 Apr 18, 2003
IRINOTECAN HYDROCHLORIDE
INJECTABLE;INJECTION
IRINOTECAN HYDROCHLORIDE
SANDOZ
40MG/2ML (20MG/ML)
A077994 001 Feb 27, 2008
100MG/5ML (20MG/ML)
A077994 002 Feb 27, 2008
IRON DEXTRAN
INJECTABLE;INJECTION
IRON DEXTRAN
SANOFI AVENTIS US
EQ 50MG IRON/ML
N010787 002
IRON SUCROSE
INJECTABLE;INTRAVENOUS
VENOFER
LUITPOLD
EQ 65MG BASE/3.25ML (EQ 20MG BASE/ML)
N021135 005 Mar 29, 2013
EQ 75MG BASE/3.75ML (EQ 20MG BASE/ML)
N021135 003 Mar 29, 2005
ISOETHARINE HYDROCHLORIDE
SOLUTION;INHALATION
BETA-2
NEPHRON
1%
A086711 001
BRONKOSOL
SANOFI AVENTIS US
0.25%
N012339 009
1%
N012339 008
ISOETHARINE HYDROCHLORIDE
ALPHARMA US PHARMS
1%
A087101 001
ASTRAZENECA
0.062%
A087937 001 Nov 15, 1982
0.062%
A089614 001 Jun 13, 1991
0.125%
A087938 001 Nov 15, 1982
0.125%
A089615 001 Jun 13, 1991
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-189(of 337)
ISOETHARINE HYDROCHLORIDE
SOLUTION;INHALATION
ISOETHARINE HYDROCHLORIDE
0.167%
A088470 001 Mar 14, 1984
0.167%
A089616 001 Jun 13, 1991
0.2%
A088471 001 Mar 14, 1984
0.2%
A089617 001 Jun 13, 1991
0.25%
A088472 001 Mar 14, 1984
0.25%
A089618 001 Jun 13, 1991
BAXTER HLTHCARE
0.08%
A088144 001 Jul 29, 1983
0.14%
A088145 001 Mar 26, 1984
0.25%
A088146 001 Aug 01, 1983
DEY
0.08%
A088187 001 Dec 03, 1982
0.1%
A087389 001
0.17%
A087390 001
0.25%
A088188 001 Dec 03, 1982
1%
A086763 001
INTL MEDICATION
0.077%
A086651 001
0.08%
A086651 002
0.1%
A086651 003
0.143%
A086651 004
0.167%
A086651 005
0.2%
A086651 006
0.25%
A086651 007
1%
A086651 008
PARKE DAVIS
0.5%
A085997 001
1%
A085889 001
ROXANE
0.1%
A087396 001
0.125%
A087025 001
0.167%
A088226 001 Sep 16, 1983
0.2%
A087324 001
0.25%
A088275 001 Jun 03, 1983
1%
A086899 001
ISOETHARINE HYDROCHLORIDE S/F
DEY
0.08%
A089817 001 Nov 22, 1988
0.1%
A089818 001 Nov 22, 1988
0.17%
A089819 001 Nov 22, 1988
0.25%
A089820 001 Nov 22, 1988
1%
A089252 001 Sep 15, 1986
ISOETHARINE MESYLATE
AEROSOL, METERED;INHALATION
BRONKOMETER
SANOFI AVENTIS US
0.34MG/INH
N012339 007
ISOETHARINE MESYLATE
ALPHARMA US PHARMS
0.34MG/INH
A087858 001 Aug 21, 1984
ISOFLURANE
LIQUID;INHALATION
ISOFLURANE
WATSON LABS INC
99.9%
A074393 001 May 12, 1995
ISOFLUROPHATE
OINTMENT;OPHTHALMIC
FLOROPRYL
MERCK
0.025%
N010656 001
ISONIAZID
INJECTABLE;INJECTION
NYDRAZID
SANDOZ
100MG/ML
N008662 001
RIMIFON
ROCHE
25MG/ML
N008420 002
100MG/ML
N008420 003
SYRUP;ORAL
ISONIAZID
MIKART
50MG/5ML
A081118 001 Jul 21, 1997
LANIAZID
LANNETT
50MG/5ML
A089243 001 Feb 03, 1986
RIMIFON
ROCHE
50MG/5ML
N008420 001
TABLET;ORAL
DOW-ISONIAZID
DOW PHARM
300MG
A080330 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-190(of 337)
ISONIAZID
TABLET;ORAL
HYZYD
MEDPOINTE PHARM HLC
100MG
A080134 003
300MG
A080134 004
INH
NOVARTIS
300MG
A080935 001
ISONIAZID
DURAMED PHARMS BARR
100MG
A088231 001 Mar 17, 1983
300MG
A088119 001 Mar 17, 1983
HALSEY
50MG
A083632 001
HIKMA INTL PHARMS
100MG
A080212 001
300MG
A087425 001
IMPAX LABS
100MG
A080153 001
IVAX SUB TEVA PHARMS
100MG
A080270 001
300MG
A083610 001
LILLY
100MG
N008499 002
300MG
N008499 003
MIKART
100MG
A040090 001 Jun 26, 1997
300MG
A040090 002 Jun 26, 1997
MK LABS
100MG
A080941 001
MUTUAL PHARM
100MG
A080136 001
300MG
A083633 001
NEXGEN PHARMA INC
100MG
A084050 001
PANRAY
50MG
N008428 001
100MG
N008428 002
300MG
N008428 003
PERRIGO
100MG
A083060 001
PHARMAVITE
100MG
A085091 001
PHOENIX LABS NY
50MG
A080368 001
100MG
A080368 002
PUREPAC PHARM
50MG
A080132 003 Jul 14, 1982
100MG
A080132 004 Jul 14, 1982
WATSON LABS
50MG
A080522 001
100MG
A080401 001
100MG
A080523 001
100MG
A085790 001
300MG
A080521 001
300MG
A083178 001
300MG
A085784 001
WHITEWORTH TOWN PLSN
100MG
A080120 002
LANIAZID
LANNETT
50MG
A080140 001
100MG
A080140 002
NYDRAZID
BRISTOL MYERS SQUIBB
100MG
N008392 003
STANOZIDE
EVERYLIFE
100MG
A080126 001
300MG
A080126 002
ISONIAZID; RIFAMPIN
CAPSULE;ORAL
RIFAMPIN AND ISONIAZID
HIKMA INTL PHARMS
150MG;300MG
A065221 001 Jul 29, 2005
ISOPROPAMIDE IODIDE
TABLET;ORAL
DARBID
GLAXOSMITHKLINE
EQ 5MG BASE
N010744 001
ISOPROTERENOL HYDROCHLORIDE
AEROSOL, METERED;INHALATION
ISOPROTERENOL HYDROCHLORIDE
3M
0.12MG/INH
N010375 004
ALPHARMA US PHARMS
0.12MG/INH
A085904 001
ISUPREL
SANOFI AVENTIS US
0.103MG/INH
N011178 001
DISC;INHALATION
NORISODRINE AEROTROL
ABBOTT
0.25%
N016814 001
INJECTABLE;INJECTION
ISOPROTERENOL HYDROCHLORIDE
ABRAXIS PHARM
0.2MG/ML
A083431 001
BAXTER HLTHCARE
0.2MG/ML
A083486 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-191(of 337)
ISOPROTERENOL HYDROCHLORIDE
INJECTABLE;INJECTION
ISOPROTERENOL HYDROCHLORIDE
HOSPIRA
0.02MG/ML
A083283 001
0.2MG/ML
A083346 001
INTL MEDICATION
0.2MG/ML
A083724 001
SOLUTION;INHALATION
AEROLONE
LILLY
0.25%
N007245 001
ISOPROTERENOL HYDROCHLORIDE
ARMOUR PHARM
0.031%
A087935 001 Nov 18, 1982
0.062%
A087936 001 Nov 18, 1982
DEY
0.5%
A086764 001 Jan 04, 1982
PARKE DAVIS
0.25%
A085994 001
0.5%
A085540 001
ISUPREL
SANOFI AVENTIS US
0.5%
N006327 002
1%
N006327 003
VAPO-ISO
FISONS
0.5%
N016813 001
TABLET;RECTAL, SUBLINGUAL
ISUPREL
SANOFI AVENTIS US
10MG
N006328 001
15MG
N006328 002
ISOPROTERENOL HYDROCHLORIDE; PHENYLEPHRINE BITARTRATE
AEROSOL, METERED;INHALATION
DUO-MEDIHALER
3M
0.16MG/INH;0.24MG/INH
N013296 001
ISOPROTERENOL SULFATE
AEROSOL, METERED;INHALATION
MEDIHALER-ISO
3M
0.08MG/INH
N010375 003
POWDER;INHALATION
NORISODRINE
ABBVIE
10%
N006905 003
25%
N006905 002
ISOSORBIDE
SOLUTION;ORAL
ISMOTIC
ALCON
100GM/220ML
N017063 001
ISOSORBIDE DINITRATE
CAPSULE, EXTENDED RELEASE;ORAL
ISORDIL
WYETH AYERST
40MG
N012882 002 Jul 29, 1988
TABLET;ORAL
ISORDIL
VALEANT BERMUDA
10MG
N012093 002 Jul 29, 1988
20MG
N012093 006 Jul 29, 1988
30MG
N012093 005 Jul 29, 1988
ISOSORBIDE DINITRATE
MUTUAL PHARM
5MG
A086166 002 Sep 19, 1986
10MG
A086169 001 Sep 19, 1986
20MG
A086167 001 Sep 19, 1986
30MG
A087564 001 Sep 18, 1986
SUPERPHARM
5MG
A089190 001 Feb 17, 1987
10MG
A089191 001 Feb 17, 1987
20MG
A089192 001 Feb 17, 1987
WATSON LABS
5MG
A086034 001 Jan 06, 1988
10MG
A086032 001 Jan 07, 1988
SORBITRATE
ASTRAZENECA
5MG
N016192 001 Apr 01, 1996
10MG
N016192 002 Apr 01, 1996
20MG
A086405 002 Aug 21, 1990
30MG
A088124 001 Aug 21, 1990
40MG
A088125 001 Aug 21, 1990
TABLET;SUBLINGUAL
ISORDIL
BIOVAIL
2.5MG
N012940 004 Jul 29, 1988
5MG
N012940 003 Jul 29, 1988
10MG **Federal Register determination
N012940 005 Jul 29, 1988
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DISCONTINUED DRUG PRODUCT LIST 6-192(of 337)
ISOSORBIDE DINITRATE
TABLET;SUBLINGUAL
ISORDIL
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
ISOSORBIDE DINITRATE
HIKMA INTL PHARMS 2.5MG A086054 001 Oct 29, 1987
5MG A086055 001 Nov 02, 1987
MUTUAL PHARM 2.5MG A084204 001 Sep 18, 1986
5MG A086168 001 Sep 18, 1986
10MG A087545 001 Sep 18, 1986
SANDOZ 2.5MG A086225 001 Feb 19, 1988
5MG A086222 001 Feb 19, 1988
WATSON LABS 2.5MG **Federal Register determination A086033 001 Feb 26, 1988
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
5MG **Federal Register determination A086031 001 Sep 29, 1987
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
SORBITRATE
ASTRAZENECA 2.5MG N016191 002 Apr 01, 1996
5MG N016191 001 Apr 01, 1996
TABLET, CHEWABLE;ORAL
SORBITRATE
ASTRAZENECA 5MG N016776 002 Apr 01, 1996
10MG N016776 003 Apr 01, 1996
TABLET, EXTENDED RELEASE;ORAL
ISORDIL
WYETH AYERST 40MG N012882 001 Jul 29, 1988
ISOSORBIDE MONONITRATE
TABLET;ORAL
ISMO
PROMIUS PHARMA 20MG N019091 001 Dec 30, 1991
TABLET, EXTENDED RELEASE;ORAL
IMDUR
SCHERING PLOUGH 30MG N020225 001 Aug 12, 1993
60MG N020225 002 Aug 12, 1993
120MG N020225 003 Mar 30, 1995
ISOSORBIDE MONONITRATE
ACTAVIS ELIZABETH 30MG A075306 001 Dec 31, 1998
60MG A075306 002 Dec 31, 1998
ALKERMES GAINESVILLE 60MG A075041 001 Sep 22, 1998
IVAX SUB TEVA PHARMS 30MG A075448 002 Aug 07, 2001
60MG A075448 001 Jun 19, 2000
120MG A075448 003 Aug 07, 2001
SKYEPHARMA AG 60MG A075166 001 Oct 07, 1999
ISOSULFAN BLUE
INJECTABLE;INJECTION
LYMPHAZURIN
COVIDIEN 1% **Federal Register determination N018310 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
ISOTRETINOIN
CAPSULE;ORAL
ACCUTANE
HOFFMANN LA ROCHE 10MG N018662 002 May 07, 1982
20MG N018662 004 Mar 28, 1983
40MG N018662 003 May 07, 1982
ISRADIPINE
CAPSULE;ORAL
DYNACIRC
SMITHKLINE BEECHAM 2.5MG N019546 001 Dec 20, 1990
5MG N019546 002 Dec 20, 1990
TABLET, EXTENDED RELEASE;ORAL
DYNACIRC CR
GLAXOSMITHKLINE LLC 5MG **Federal Register determination N020336 001 Jun 01, 1994
that product was not discontinued or
withdrawn for safety or efficacy
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-193(of 337)
ISRADIPINE
TABLET, EXTENDED RELEASE;ORAL
DYNACIRC CR
reasons**
10MG **Federal Register determination N020336 002 Jun 01, 1994
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
ITRACONAZOLE
INJECTABLE;INJECTION
SPORANOX
JANSSEN PHARMS 10MG/ML N020966 001 Mar 30, 1999
IVERMECTIN
TABLET;ORAL
STROMECTOL
MERCK SHARP DOHME 6MG N050742 001 Nov 22, 1996
KANAMYCIN SULFATE
CAPSULE;ORAL
KANTREX
APOTHECON EQ 500MG BASE A060516 001
EQ 500MG BASE A061911 001
EQ 500MG BASE A062726 001 Mar 06, 1987
INJECTABLE;INJECTION
KANAMYCIN
HIKMA MAPLE EQ 1GM BASE/3ML A062324 003
EQ 75MG BASE/2ML A062324 001
EQ 500MG BASE/2ML A062324 002
KANAMYCIN SULFATE
ABRAXIS PHARM EQ 1GM BASE/3ML A062504 003 Apr 05, 1984
EQ 75MG BASE/2ML A062504 001 Apr 05, 1984
EQ 500MG BASE/2ML A062504 002 Apr 05, 1984
INTL MEDICATION EQ 1GM BASE/3ML A062466 002 Sep 30, 1983
EQ 500MG BASE/2ML A062466 001 Sep 30, 1983
LOCH EQ 1GM BASE/3ML A063025 001 Jul 31, 1992
EQ 75MG BASE/2ML A063021 001 Jul 31, 1992
EQ 500MG BASE/2ML A063022 001 Jul 31, 1992
PHARMAFAIR EQ 1GM BASE/3ML A062669 001 May 07, 1987
EQ 75MG BASE/2ML A062668 001 May 07, 1987
EQ 500MG BASE/2ML A062672 001 May 07, 1987
SOLOPAK EQ 1GM BASE/3ML A062605 002 Feb 26, 1986
EQ 75MG BASE/2ML A062605 003 Feb 26, 1986
EQ 500MG BASE/2ML A062605 001 Feb 26, 1986
WARNER CHILCOTT EQ 1GM BASE/3ML A063092 001 Oct 11, 1989
WATSON LABS EQ 1GM BASE/3ML A062520 003 May 09, 1985
KANTREX
APOTHECON EQ 1GM BASE/3ML A061655 002
EQ 1GM BASE/3ML A061901 002
EQ 1GM BASE/3ML A062564 003 Sep 21, 1984
EQ 75MG BASE/2ML A061655 003
EQ 75MG BASE/2ML A061901 003
EQ 75MG BASE/2ML A062564 001 Sep 21, 1984
EQ 500MG BASE/2ML A061655 001
EQ 500MG BASE/2ML A061901 001
EQ 500MG BASE/2ML A062564 002 Sep 21, 1984
KLEBCIL
KING PHARMS EQ 1GM BASE/3ML A062170 003
EQ 75MG BASE/2ML A062170 001
EQ 500MG BASE/2ML A062170 002
KETOCONAZOLE
CREAM;TOPICAL
NIZORAL
JANSSEN PHARMA 2% N019084 001 Dec 31, 1985
SUSPENSION;ORAL
NIZORAL
JANSSEN PHARMA 100MG/5ML A070767 001 Nov 07, 1986
TABLET;ORAL
KETOCONAZOLE
AAIPHARMA LLC 200MG A075341 001 Jul 27, 1999
APOTEX 200MG A075912 001 Jan 10, 2002
MUTUAL PHARMA 200MG A075314 001 Jun 15, 1999
PLIVA 200MG A075362 001 Jun 15, 1999
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DISCONTINUED DRUG PRODUCT LIST
6-194(of 337)
KETOCONAZOLE
TABLET;ORAL
KETOCONAZOLE
TEVA 200MG
A074971 001
Jun 15, 1999
NIZORAL
JANSSEN PHARMS 200MG
N018533 001
KETOPROFEN
CAPSULE;ORAL
KETOPROFEN
SANDOZ 50MG
A074024 001
Dec 29, 1995
75MG
A074024 002
Dec 29, 1995
TEVA 25MG
A073515 001
Dec 22, 1992
ORUDIS
WYETH AYERST 25MG
N018754 001
Jul 31, 1987
50MG
N018754 002
Jan 09, 1986
75MG
N018754 003
Jan 09, 1986
CAPSULE, EXTENDED RELEASE;ORAL
KETOPROFEN
ALKERMES GAINESVILLE 200MG
A074879 001
Dec 10, 1997
ORUVAIL
WYETH PHARMS INC 100MG
N019816 003
Feb 08, 1995
150MG
N019816 002
Feb 08, 1995
200MG
N019816 001
Sep 24, 1993
FILM;ORAL
NEXCEDE
NOVARTIS 12.5MG
N022470 001
Nov 25, 2009
TABLET;ORAL
ACTRON
BAYER 12.5MG
N020499 001
Oct 06, 1995
KETOPROFEN
PERRIGO 12.5MG
A075364 001
Feb 07, 2002
ORUDIS KT
WYETH CONS 12.5MG **Federal Register determination
N020429 001
Oct 06, 1995
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
KETOROLAC TROMETHAMINE
INJECTABLE;INJECTION
KETOROLAC TROMETHAMINE
AMPHASTAR PHARM 15MG/ML
A076209 001
Jul 21, 2004
30MG/ML
A076209 002
Jul 21, 2004
APOTEX INC 15MG/ML
A075631 002
Jun 29, 2001
30MG/ML
A075626 001
Jul 24, 2001
30MG/ML
A075631 001
Jun 29, 2001
30MG/ML
A077201 001
Oct 14, 2005
APOTHECON 15MG/ML
A075348 001
Nov 28, 2000
30MG/ML
A075348 002
Nov 28, 2000
BEDFORD 15MG/ML **Federal Register
A075222 001
Apr 26, 1999
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
15MG/ML
A075230 002
Oct 25, 1999
30MG/ML **Federal Register
A075222 002
Apr 26, 1999
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
30MG/ML **Federal Register
A075228 001
Apr 26, 1999
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
30MG/ML
A075230 001
Oct 25, 1999
GLAND PHARMA LTD 15MG/ML
A076722 001
Jul 27, 2004
30MG/ML
A076722 002
Jul 27, 2004
HIKMA MAPLE 15MG/ML
A075299 001
Nov 03, 1999
15MG/ML
A075772 001
Jul 21, 2004
30MG/ML
A075299 002
Nov 03, 1999
30MG/ML
A075772 002
Jul 21, 2004
HOSPIRA 15MG/ML
A074801 001
Jun 05, 1997
30MG/ML
A074801 002
Jun 05, 1997
LUITPOLD 15MG/ML
A078145 001
Jan 14, 2008
30MG/ML
A078145 002
Jan 14, 2008
SANDOZ 15MG/ML
A076271 001
Oct 06, 2004
SUN PHARMA GLOBAL 15MG/ML
A078737 001
Oct 06, 2008
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-195(of 337)
KETOROLAC TROMETHAMINE
INJECTABLE;INJECTION
KETOROLAC TROMETHAMINE
30MG/ML A078737 002 Oct 06, 2008
WOCKHARDT 30MG/ML A077943 001 Mar 27, 2007
TORADOL
ROCHE PALO 15MG/ML N019698 001 Nov 30, 1989
30MG/ML N019698 002 Nov 30, 1989
SOLUTION/DROPS;OPHTHALMIC
ACULAR PRESERVATIVE FREE
ALLERGAN 0.5% N020811 001 Nov 03, 1997
KETOROLAC TROMETHAMINE
AKORN 0.45% A203376 001 Feb 10, 2014
TABLET;ORAL
KETOROLAC TROMETHAMINE
CYCLE PHARMS LTD 10MG A074790 001 Jun 26, 1997
WATSON LABS 10MG A074955 001 Sep 19, 1997
TORADOL
ROCHE PALO 10MG N019645 001 Dec 20, 1991
KETOTIFEN FUMARATE
SOLUTION/DROPS;OPHTHALMIC
KETOTIFEN FUMARATE
APOTEX INC EQ 0.025% BASE A077354 001 May 09, 2006
KRYPTON, KR-81M
GAS;INHALATION
MPI KRYPTON 81M GENERATOR
GE HEALTHCARE N/A N018088 001
LABETALOL HYDROCHLORIDE
INJECTABLE;INJECTION
LABETALOL HYDROCHLORIDE
APOTEX INC 5MG/ML A076051 001 Jul 05, 2002
APOTHECON 5MG/ML A075355 001 Nov 29, 1999
HOSPIRA 5MG/ML A075242 001 Sep 30, 1999
NORMODYNE
SCHERING 5MG/ML N018686 001 Aug 01, 1984
TRANDATE
PROMETHEUS LABS 5MG/ML N019425 001 Dec 31, 1985
TABLET;ORAL
LABETALOL HYDROCHLORIDE
APOTHECON 100MG A075223 001 Nov 20, 1998
200MG A075223 002 Nov 20, 1998
300MG A075223 003 Nov 20, 1998
MUTUAL PHARM 100MG A075215 001 Jul 29, 1999
200MG A075215 002 Jul 29, 1999
300MG A075215 003 Jul 29, 1999
TEVA 100MG A074989 001 Sep 30, 1998
200MG A074989 002 Sep 30, 1998
300MG A074989 003 Sep 30, 1998
NORMODYNE
SCHERING 100MG N018687 001 Aug 31, 1987
200MG N018687 002 Aug 01, 1984
300MG N018687 003 Aug 01, 1984
400MG N018687 004 Aug 01, 1984
TRANDATE
CNTY LINE PHARMS 400MG N018716 004 Aug 01, 1984
LACTULOSE
SOLUTION;ORAL
CHRONULAC
SANOFI AVENTIS US 10GM/15ML N017884 001
DUPHALAC
SOLVAY 10GM/15ML A072372 001 Mar 22, 1989
EVALOSE
TEVA PHARMS 10GM/15ML A073497 001 May 28, 1993
LACTULOSE
APOTEX INC 10GM/15ML A075911 001 Feb 21, 2002
MORTON GROVE 10GM/15ML A071841 001 Sep 22, 1988
PACO 10GM/15ML A073160 001 Aug 25, 1992
LAXILOSE
NOSTRUM LABS 10GM/15ML A073686 001 May 28, 1993
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-196(of 337)
LACTULOSE
SOLUTION;ORAL, RECTAL
ACILAC
NOSTRUM LABS 10GM/15ML A073685 001 May 28, 1993
CEPHULAC
SANOFI AVENTIS US 10GM/15ML N017657 001
GENERLAC
MORTON GROVE 10GM/15ML A071842 001 Sep 27, 1988
HEPTALAC
TEVA PHARMS 10GM/15ML A073504 001 May 28, 1993
LACTULOSE
APOTEX INC 10GM/15ML A076645 001 Jul 28, 2003
PACO 10GM/15ML A072029 001 Aug 25, 1992
ROXANE 10GM/15ML A073590 001 May 29, 1992
SOLVAY 10GM/15ML N017906 001
PORTALAC
SOLVAY 10GM/15ML A072374 001 Mar 22, 1989
LAMOTRIGINE
TABLET;ORAL
LAMICTAL
GLAXOSMITHKLINE LLC 50MG N020241 006 Dec 27, 1994
250MG N020241 004 Dec 27, 1994
LAMOTRIGINE
ACTAVIS TOTOWA 25MG A078669 001 Apr 08, 2011
100MG A078669 002 Apr 08, 2011
150MG A078669 003 Apr 08, 2011
200MG A078669 004 Apr 08, 2011
MATRIX LABS LTD 25MG A078443 001 Feb 11, 2009
100MG A078443 002 Feb 11, 2009
150MG A078443 003 Feb 11, 2009
200MG A078443 004 Feb 11, 2009
MYLAN 25MG A077428 001 Jan 27, 2009
100MG A077428 002 Jan 27, 2009
150MG A077428 003 Jan 27, 2009
200MG A077428 004 Jan 27, 2009
PHARMASCIENCE INC 25MG A078310 001 Feb 04, 2009
100MG A078310 002 Feb 04, 2009
150MG A078310 003 Feb 04, 2009
200MG A078310 004 Feb 04, 2009
ROXANE 25MG A077392 001 Jan 27, 2009
100MG A077392 002 Jan 27, 2009
150MG A077392 003 Jan 27, 2009
200MG A077392 004 Jan 27, 2009
SANDOZ 25MG A078645 001 Jan 27, 2009
100MG A078645 002 Jan 27, 2009
150MG A078645 003 Jan 27, 2009
200MG A078645 004 Jan 27, 2009
WOCKHARDT 25MG A078982 001 Jan 27, 2009
100MG A078982 002 Jan 27, 2009
150MG A078982 003 Jan 27, 2009
200MG A078982 004 Jan 27, 2009
TABLET, CHEWABLE;ORAL
LAMICTAL CD
GLAXOSMITHKLINE LLC 100MG N020764 003 Aug 24, 1998
LAMOTRIGINE
SANDOZ 5MG A078409 002 Jan 22, 2009
25MG A078409 003 Jan 22, 2009
LANSOPRAZOLE
FOR SUSPENSION, DELAYED RELEASE;ORAL
PREVACID
TAKEDA PHARMS NA 15MG/PACKET N021281 001 May 03, 2001
30MG/PACKET N021281 002 May 03, 2001
INJECTABLE;INTRAVENOUS
PREVACID IV
TAKEDA PHARMS NA 30MG/VIAL N021566 001 May 27, 2004
TABLET, DELAYED RELEASE, ORALLY DISINTEGRATING;ORAL
LANSOPRAZOLE
ANI PHARMS INC 15MG A078730 001 Oct 15, 2010
30MG A078730 002 Oct 15, 2010
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-197(of 337)
LANSOPRAZOLE; NAPROXEN
CAPSULE, DELAYED REL PELLETS, TABLET;ORAL
PREVACID NAPRAPAC 250 (COPACKAGED)
TAKEDA PHARMS NA 15MG,N/A;N/A,250MG **Federal Register N021507 002 Nov 14, 2003
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
PREVACID NAPRAPAC 375 (COPACKAGED)
TAKEDA PHARMS NA 15MG,N/A;N/A,375MG N021507 003 Nov 14, 2003
PREVACID NAPRAPAC 500 (COPACKAGED)
TAKEDA PHARMS NA 15MG,N/A;N/A,500MG N021507 004 Nov 14, 2003
LANTHANUM CARBONATE
TABLET, CHEWABLE;ORAL
FOSRENOL
SHIRE LLC EQ 250MG BASE N021468 001 Oct 26, 2004
LAPYRIUM CHLORIDE; UNDECOYLIUM CHLORIDE IODINE COMPLEX
SOLUTION;TOPICAL
VIRAC REX
CHESEBROUGH PONDS 0.5%;1.8% N011914 001
LATANOPROST
SOLUTION/DROPS;OPHTHALMIC
LATANOPROST
APOTEX INC 0.005% A077697 001 Mar 22, 2011
LEFLUNOMIDE
TABLET;ORAL
LEFLUNOMIDE
SANDOZ 10MG A077085 001 Sep 13, 2005
10MG A077087 001 Sep 13, 2005
20MG A077085 002 Sep 13, 2005
20MG A077087 002 Sep 13, 2005
LEPIRUDIN RECOMBINANT
INJECTABLE;INJECTION
REFLUDAN
BAYER HLTHCARE 50MG/VIAL N020807 001 Mar 06, 1998
LETROZOLE
TABLET;ORAL
LETROZOLE
ACTAVIS TOTOWA 2.5MG A090292 001 Jul 13, 2011
IMPAX LABS 2.5MG A091638 001 Jun 03, 2011
SYNTHON PHARMS 2.5MG A090196 001 Jun 03, 2011
LEUCOVORIN CALCIUM
FOR SOLUTION;ORAL
LEUCOVORIN CALCIUM
HOSPIRA EQ 60MG BASE/VIAL N008107 003 Jan 30, 1987
INJECTABLE;INJECTION
LEUCOVORIN CALCIUM
ABIC EQ 3MG BASE/ML A089352 001 Jun 01, 1988
EQ 50MG BASE/VIAL A089353 001 Jun 01, 1988
ABRAXIS PHARM EQ 50MG BASE/VIAL A088939 001 Dec 01, 1986
ELKINS SINN EQ 50MG BASE/VIAL A070480 001 Jan 02, 1987
EQ 100MG BASE/VIAL A081224 001 Jun 03, 1994
HOSPIRA EQ 3MG BASE/ML N008107 001
EQ 50MG BASE/VIAL N008107 002
EQ 100MG BASE/VIAL N008107 004 May 23, 1988
EQ 350MG BASE/VIAL N008107 005 Apr 05, 1989
PHARMACHEMIE EQ 350MG BASE/VIAL A040262 001 Dec 15, 1999
PHARMACHEMIE USA EQ 50MG BASE/VIAL A089628 001 Apr 17, 1997
EQ 100MG BASE/VIAL A089915 001 Apr 17, 1997
TEVA PARENTERAL EQ 50MG BASE/VIAL A081278 001 Sep 28, 1993
LEUCOVORIN CALCIUM PRESERVATIVE FREE
HOSPIRA EQ 10MG BASE/ML **Federal Register A040147 001 Jun 25, 1997
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
LUITPOLD EQ 50MG BASE/VIAL A040338 001 Jan 31, 2001
TEVA PARENTERAL EQ 10MG BASE/ML A040332 001 Jun 28, 1999
WELLCOVORIN
GLAXOSMITHKLINE EQ 5MG BASE/ML A087439 001 Oct 19, 1982
EQ 25MG BASE/VIAL A089833 001 Jan 23, 1989
EQ 50MG BASE/VIAL A089465 001 Jan 23, 1989
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-198(of 337)
LEUCOVORIN CALCIUM
INJECTABLE;INJECTION
WELLCOVORIN
EQ 100MG BASE/VIAL A089834 001 Jan 23, 1989
TABLET;ORAL
LEUCOVORIN CALCIUM
COREPHARMA EQ 5MG BASE A074544 001 Aug 28, 1997
EQ 25MG BASE A074544 002 Aug 28, 1997
PAR PHARM EQ 5MG BASE A071600 001 Oct 14, 1987
EQ 25MG BASE A071598 001 Oct 14, 1987
PHARMACHEMIE EQ 5MG BASE A073099 001 Mar 28, 1997
EQ 25MG BASE A073101 001 Mar 28, 1997
SANDOZ EQ 15MG BASE A075327 001 Mar 24, 1999
XANODYNE PHARM EQ 5MG BASE N018459 001 Jan 30, 1986
EQ 10MG BASE A071962 001 Nov 19, 1987
EQ 15MG BASE A071104 001 Mar 04, 1987
WELLCOVORIN
GLAXOSMITHKLINE EQ 5MG BASE N018342 001 Jul 08, 1983
EQ 25MG BASE N018342 002 Jul 08, 1983
LEUPROLIDE ACETATE
IMPLANT;IMPLANTATION
VIADUR
ORTHO MCNEIL JANSSEN EQ 65MG BASE N021088 001 Mar 03, 2000
INJECTABLE;INJECTION
LEUPROLIDE ACETATE
GENZYME 1MG/0.2ML A075721 001 Nov 29, 2001
LUPRON
ABBVIE ENDOCRINE INC 1MG/0.2ML N019010 001 Apr 09, 1985
LUPRON DEPOT
ABBVIE ENDOCRINE INC 3.75MG/VIAL **Federal Register N020011 001 Oct 22, 1990
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
LUPRON DEPOT-PED
ABBVIE ENDOCRINE INC 3.75MG/VIAL,7.5MG/VIAL;3.75MG/VIAL,7.5M N020263 003 Apr 16, 1993
G/VIAL **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
7.5MG/VIAL,7.5MG/VIAL;7.5MG/VIAL,7.5MG/ N020263 004 Apr 16, 1993
VIAL **Federal Register determination
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
LEVALLORPHAN TARTRATE
INJECTABLE;INJECTION
LORFAN
ROCHE 1MG/ML N010423 001
LEVAMISOLE HYDROCHLORIDE
TABLET;ORAL
ERGAMISOL
JANSSEN PHARMA EQ 50MG BASE N020035 001 Jun 18, 1990
LEVETIRACETAM
SOLUTION;ORAL
LEVETIRACETAM
APOTEX INC 100MG/ML A090187 001 Aug 05, 2011
TABLET;ORAL
LEVETIRACETAM
ACTAVIS LABS FL INC 250MG A077408 001 Mar 02, 2009
500MG A077408 002 Mar 02, 2009
750MG A077408 003 Mar 02, 2009
MYLAN 1GM A078731 004 Feb 10, 2009
250MG A078731 001 Feb 10, 2009
500MG A078731 002 Feb 10, 2009
750MG A078731 003 Feb 10, 2009
SANDOZ 1GM A077324 004 Jan 15, 2009
250MG A077324 001 Jan 15, 2009
500MG A077324 002 Jan 15, 2009
750MG A077324 003 Jan 15, 2009
WATSON LABS INC 1GM A078797 001 Jan 15, 2009
250MG A078797 002 Jan 15, 2009
500MG A078797 003 Jan 15, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-199(of 337)
LEVETIRACETAM
TABLET;ORAL
LEVETIRACETAM
750MG
A078797 004
Jan 15, 2009
TABLET, EXTENDED RELEASE;ORAL
LEVETIRACETAM
SANDOZ
500MG
A091668 001
Nov 01, 2012
750MG
A091668 002
Nov 01, 2012
LEVOBETAXOLOL HYDROCHLORIDE
SUSPENSION/DROPS;OPHTHALMIC
BETAXON
ALCON PHARMS LTD
EQ 0.5% BASE
N021114 001
Feb 23, 2000
LEVOBUNOLOL HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
LEVOBUNOLOL HYDROCHLORIDE
APOTEX INC
0.25%
A075473 001
Aug 03, 2000
0.5%
A075475 001
Aug 03, 2000
LEVOBUPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION
CHIROCAINE
PURDUE PHARMA LP
EQ 2.5MG BASE/ML
N020997 001
Aug 05, 1999
EQ 5MG BASE/ML
N020997 002
Aug 05, 1999
EQ 7.5MG BASE/ML
N020997 003
Aug 05, 1999
LEVOCABASTINE HYDROCHLORIDE
SUSPENSION/DROPS;OPHTHALMIC
LIVOSTIN
NOVARTIS
EQ 0.05% BASE
N020219 001
Nov 10, 1993
LEVOCARNITINE
SOLUTION;ORAL
CARNITOR
SIGMA TAU
1GM/10ML
N018948 002
Apr 27, 1988
LEVOCETIRIZINE DIHYDROCHLORIDE
TABLET;ORAL
LEVOCETIRIZINE DIHYDROCHLORIDE
SANDOZ
5MG
A090486 001
Mar 26, 2013
LEVODOPA
CAPSULE;ORAL
BENDOPA
VALEANT PHARM INTL
100MG
N016948 003
250MG
N016948 001
500MG
N016948 002
DOPAR
SHIRE
100MG
N016913 003
250MG
N016913 001
500MG
N016913 002
LARODOPA
ROCHE
100MG
N016912 002
250MG
N016912 001
500MG
N016912 006
TABLET;ORAL
DOPAR
SHIRE
250MG
N016913 004
500MG
N016913 005
LARODOPA
ROCHE
100MG
N016912 005
250MG
N016912 003
500MG
N016912 004
LEVOFLOXACIN
INJECTABLE;INJECTION
LEVOFLOXACIN
AKORN
EQ 500MG/20ML (EQ 25MG/ML)
A091644 001
Jun 20, 2011
EQ 750MG/30ML (EQ 25MG/ML)
A091644 002
Jun 20, 2011
SOLUTION/DROPS;OPHTHALMIC
IQUIX
SANTEN
1.5% **Federal Register determination
N021571 001
Mar 01, 2004
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-200(of 337)
LEVOFLOXACIN
SOLUTION/DROPS;OPHTHALMIC
LEVOFLOXACIN
APOTEX INC
0.5%
A078282 001
Dec 20, 2010
TABLET;ORAL
LEVOFLOXACIN
WATSON LABS INC
250MG
A201484 001
Nov 22, 2013
500MG
A201484 002
Nov 22, 2013
750MG
A201484 003
Nov 22, 2013
LEVOLEUCOVORIN CALCIUM
SOLUTION;IV (INFUSION)
FUSILEV
SPECTRUM PHARMS
EQ 175MG BASE/17.5ML (EQ 10MG BASE/ML)
N020140 002
Apr 29, 2011
**Federal Register determination that
product was not discontinued or
withdrawn for safety or efficacy
reasons**
EQ 250MG BASE/25ML (EQ 10MG BASE/ML)
N020140 003
Apr 29, 2011
**Federal Register determination that
product was not discontinued or
withdrawn for safety or efficacy
reasons**
LEVOMEPROMAZINE
INJECTABLE;INJECTION
LEVOPROME
IMMUNEX
20MG/ML
N015865 001
LEVOMETHADYL ACETATE HYDROCHLORIDE
CONCENTRATE;ORAL
ORLAAM
ROXANE 10MG/ML **Federal Register
N020315 001
Jul 09, 1993
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
LEVONORDEFRIN; MEPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION
ARESTOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN
SOLVAY 0.05MG/ML;2%
A085010 001
CARBOCAINE W/ NEO-COBEFRIN
EASTMAN KODAK 0.05MG/ML;2%
N012125 002
ISOCAINE HYDROCHLORIDE W/ LEVONORDEFRIN
NOVOCOL 0.05MG/ML;2%
A084697 001
MEPIVACAINE HYDROCHLORIDE W/ LEVONORDEFRIN
GRAHAM CHEM 0.05MG/ML;2%
A084850 002
Oct 21, 1983
POLOCAINE W/ LEVONORDEFRIN
DENTSPLY PHARM 0.05MG/ML;2%
A089517 001
Apr 14, 1988
LEVONORDEFRIN; PROCAINE HYDROCHLORIDE; PROPOXYCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
RAVOCAINE AND NOVOCAIN W/ NEO-COBEFRIN
EASTMAN KODAK 0.05MG/ML;2%;0.4%
N008592 007
LEVONORGESTREL
IMPLANT;IMPLANTATION
JADELLE
POPULATION COUNCIL 75MG/IMPLANT **Federal Register
N020544 001
Nov 01, 1996
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
LEVONORGESTREL
WYETH PHARMS INC 75MG/IMPLANT
N020627 001
Aug 15, 1996
NORPLANT
POPULATION COUNCIL 36MG/IMPLANT
N019897 001
Dec 10, 1990
NORPLANT SYSTEM IN PLASTIC CONTAINER
WYETH PHARMS INC
36MG/IMPLANT
N020088 001
Dec 10, 1990
TABLET;ORAL
LEVONORGESTREL
LUPIN LTD
0.75MG
A091328 001
Jan 23, 2013
WATSON LABS
0.75MG
A078666 001
Jun 24, 2009
PLAN B
TEVA BRANDED PHARM
0.75MG
N021045 001
Jul 28, 1999
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-201(of 337)
LEVOPROPOXYPHENE NAPSYLATE ANHYDROUS
CAPSULE;ORAL
NOVRAD
LILLY EQ 50MG BASE N012928 006
EQ 100MG BASE N012928 004
SUSPENSION;ORAL
NOVRAD
LILLY EQ 50MG BASE/5ML N012928 002
LEVORPHANOL TARTRATE
INJECTABLE;INJECTION
LEVO-DROMORAN
VALEANT PHARM INTL 2MG/ML N008719 001 Dec 19, 1991
TABLET;ORAL
LEVO-DROMORAN
VALEANT PHARM INTL 2MG N008720 001 Dec 19, 1991
LEVOTHYROXINE SODIUM
TABLET;ORAL
LEVOLET
VINTAGE 0.025MG N021137 001 Jun 06, 2003
0.05MG N021137 002 Jun 06, 2003
0.075MG N021137 003 Jun 06, 2003
0.088MG N021137 004 Jun 06, 2003
0.1MG N021137 005 Jun 06, 2003
0.112MG N021137 006 Jun 06, 2003
0.125MG N021137 007 Jun 06, 2003
0.137MG N021137 008 Jun 06, 2003
0.15MG N021137 009 Jun 06, 2003
0.175MG N021137 010 Jun 06, 2003
0.2MG N021137 011 Jun 06, 2003
0.3MG N021137 012 Jun 06, 2003
LEVOTHYROXINE SODIUM
MERCK KGAA 0.025MG A076752 001 Jun 16, 2005
0.05MG A076752 002 Jun 16, 2005
0.075MG A076752 003 Jun 16, 2005
0.088MG A076752 004 Jun 16, 2005
0.1MG A076752 005 Jun 16, 2005
0.112MG A076752 006 Jun 16, 2005
0.125MG A076752 007 Jun 16, 2005
0.15MG A076752 008 Jun 16, 2005
0.175MG A076752 009 Jun 16, 2005
0.2MG A076752 010 Jun 16, 2005
0.3MG A076752 011 Jun 16, 2005
LEVOXYL
KING PHARMS R AND D 0.3MG N021301 012 May 25, 2001
NOVOTHYROX
MERCK KGAA 0.025MG N021292 001 May 31, 2002
0.05MG N021292 002 May 31, 2002
0.075MG N021292 003 May 31, 2002
0.088MG N021292 004 May 31, 2002
0.1MG N021292 005 May 31, 2002
0.112MG N021292 006 May 31, 2002
0.125MG N021292 007 May 31, 2002
0.137MG N021292 008 May 31, 2002
0.15MG N021292 009 May 31, 2002
0.175MG N021292 010 May 31, 2002
0.2MG N021292 011 May 31, 2002
0.3MG N021292 012 May 31, 2002
LIDOCAINE
AEROSOL;ORAL
XYLOCAINE
ASTRAZENECA 10% N014394 001
FILM, EXTENDED RELEASE;BUCCAL
DENTIPATCH
NOVEN 23MG/PATCH N020575 001 May 21, 1996
OINTMENT;TOPICAL
ALPHACAINE
CARLISLE 5% A084944 001
5% A084946 001
5% A084947 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-202(of 337)
LIDOCAINE
OINTMENT;TOPICAL
LIDOCAINE
GRAHAM CHEM
5%
A080210 001
XYLOCAINE
ASTRAZENECA
5%
N008048 001
PATCH;TOPICAL
DENTIPATCH
NOVEN
46.1MG/PATCH
N020575 002 May 21, 1996
SOLUTION;TOPICAL
XYLOCAINE
ASTRAZENECA
5%
N014127 001
SUPPOSITORY;RECTAL
XYLOCAINE
ASTRAZENECA
100MG
N013077 001
LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
ALPHACAINE HYDROCHLORIDE
CARLISLE
2%
A084721 001
LIDOCAINE HYDROCHLORIDE
ABBOTT
10%
A087980 001 Feb 02, 1983
20%
A089362 001 May 25, 1988
ABRAXIS PHARM
1%
A080420 001
1%
A086761 001
1.5%
A080420 005
2%
A080420 002
2%
A080420 004
2%
A086761 002
2%
N017508 001
4%
N017508 002
20%
N017508 004
AKORN
1%
A085037 001
2%
A085037 002
BEL MAR
1%
A080710 001
2%
A080760 001
DELL LABS
1%
A083387 001
2%
A083388 001
ELKINS SINN
0.5%
A085131 001
4%
A084626 001
GD SEARLE LLC
1%
A083135 001
2%
A083135 002
GRAHAM CHEM
2%
A080504 001
HIKMA MAPLE
1%
A080407 001
2%
A080407 002
HOSPIRA
1%
A040013 001 Jun 23, 1995
1.5%
A088330 001 May 17, 1984
2%
A088331 001 May 17, 1984
INTL MEDICATION
1%
N017701 002
1GM/VIAL
N018543 001
2%
N017701 001
2GM/VIAL
N018543 002
LUITPOLD
2%
A083198 001
LYPHOMED
1%
A080390 001
2%
A080390 002
MILES
1%
A080414 001
2%
A080414 002
WATSON LABS
1%
A080377 001
1%
A083627 001
2%
A080377 002
2%
A083627 002
WYETH AYERST
1%
A083083 001
2%
A083083 002
LIDOCAINE HYDROCHLORIDE 0.1% AND DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 100MG/100ML
N018461 001
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 200MG/100ML
N018967 001 Mar 30, 1984
LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5%
HOSPIRA 200MG/100ML
A083158 005
LIDOCAINE HYDROCHLORIDE 0.2% IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBOTT 200MG/100ML
N018954 001 Jul 09, 1985
HOSPIRA 200MG/100ML
N018388 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-203(of 337)
LIDOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 400MG/100ML
N018967 002 Mar 30, 1984
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5%
HOSPIRA 400MG/100ML
A083158 006
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 800MG/100ML
N018967 003 Mar 30, 1984
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER
HOSPIRA 1.5%
A088326 001 Jul 31, 1984
10%
A088367 001 Jul 31, 1984
20%
A088368 001 Jul 31, 1984
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE
HIKMA MAPLE 1% A084625 001
2% A084625 002
INTL MEDICATION 4% N017702 002
LIDOCATON
PHARMATON 2% A084727 001 Aug 17, 1983
LIDOPEN
MERIDIAN MEDCL TECHN 10% N017549 001
XYLOCAINE
ASTRAZENECA 1% N010418 005
1.5% N010418 009
2% N010418 007
XYLOCAINE DENTAL
DENTSPLY PHARM 2% N021380 001
XYLOCAINE PRESERVATIVE FREE
FRESENIUS KABI USA 10%
N016801 003
INJECTABLE;SPINAL
XYLOCAINE 1.5% W/ DEXTROSE 7.5%
FRESENIUS KABI USA 1.5%
N016297 001
XYLOCAINE 5% W/ GLUCOSE 7.5%
ASTRAZENECA 5%
N010496 002 Jul 07, 1982
JELLY;TOPICAL
ANESTACON
BANNER PHARMACAPS 2%
A080429 001
LIDOCAINE HYDROCHLORIDE
TEVA PHARMS USA 2%
A081318 001 Apr 29, 1993
SOLUTION;ORAL
LIDOCAINE HYDROCHLORIDE VISCOUS
ACTAVIS MID ATLANTIC 2%
A086578 001
INTL MEDICATION 2%
A086389 001 Feb 02, 1982
SOLUTION;TOPICAL
LARYNGOTRACHEAL ANESTHESIA KIT
KENDALL IL 4%
A087931 001 Jun 10, 1983
LIDOCAINE HYDROCHLORIDE
PACO 4%
A089688 001 Jun 30, 1989
LTA II KIT
HOSPIRA 4%
A088542 001 Jul 31, 1984
PEDIATRIC LTA KIT
ABBOTT 2%
A088572 001 Jul 31, 1984
HOSPIRA 2%
A085995 001
LIDOCAINE HYDROCHLORIDE; OXYTETRACYCLINE
INJECTABLE;INJECTION
TERRAMYCIN
PFIZER
2%;50MG/ML
A060567 001
2%;125MG/ML
A060567 002
LIDOCAINE; PRILOCAINE
DISC;TOPICAL
EMLA
ASTRAZENECA
2.5%;2.5%
N020962 001 Feb 04, 1998
LINCOMYCIN HYDROCHLORIDE
CAPSULE;ORAL
LINCOCIN
PHARMACIA AND UPJOHN
EQ 250MG BASE
N050316 001
EQ 500MG BASE
N050316 002
INJECTABLE;INJECTION
LINCOMYCIN HYDROCHLORIDE
WATSON LABS
EQ 300MG BASE/ML
A063180 001 Apr 16, 1991
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6-204(of 337)
LINDANE
CREAM;TOPICAL
KWELL
REED AND CARNRICK 1%
A084218 001
1%
N006309 001
LOTION;TOPICAL
GAMENE
SOLA BARNES HIND 1%
A084989 001
KWELL
REED AND CARNRICK 1%
A084218 002
1%
N006309 003
SCABENE
STIEFEL 1%
A086769 001
SHAMPOO;TOPICAL
GAMENE
SOLA BARNES HIND 1%
A084988 001
KWELL
REED AND CARNRICK 1%
A084219 001
1%
N010718 001
SCABENE
STIEFEL 1%
A087940 001
Apr 08, 1983
LINEZOLID
TABLET;ORAL
ZYVOX
PHARMACIA AND UPJOHN 400MG **Federal Register determination
N021130 001
Apr 18, 2000
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
LIOTHYRONINE SODIUM
TABLET;ORAL
LIOTHYRONINE SODIUM
WATSON LABS EQ 0.025MG BASE
A085755 001
Jan 25, 1982
EQ 0.05MG BASE
A085753 001
Feb 03, 1982
LIOTRIX (T4;T3)
TABLET;ORAL
EUTHROID-0.5
PARKE DAVIS 0.0075MG;0.0075MG
N016680 001
EUTHROID-1
PARKE DAVIS 0.015MG;0.015MG
N016680 002
EUTHROID-2
PARKE DAVIS 0.03MG;0.03MG
N016680 003
EUTHROID-3
PARKE DAVIS 0.045MG;0.045MG
N016680 004
THYROLAR-5
FOREST LABS 0.0625MG;0.25MG
N016807 006
LISINOPRIL
TABLET;ORAL
LISINOPRIL
SANDOZ 2.5MG
A075903 001
Jul 01, 2002
2.5MG
A075999 001
Jul 01, 2002
5MG
A075903 002
Jul 01, 2002
5MG
A075999 002
Jul 01, 2002
10MG
A075903 003
Jul 01, 2002
10MG
A075999 003
Jul 01, 2002
20MG
A075903 004
Jul 01, 2002
20MG
A075999 004
Jul 01, 2002
30MG
A075903 005
Jul 01, 2002
30MG
A075999 005
Jul 01, 2002
40MG
A075903 006
Jul 01, 2002
40MG
A075999 006
Jul 01, 2002
TEVA 2.5MG
A075783 001
Jul 01, 2002
5MG
A075783 002
Jul 01, 2002
10MG
A075783 003
Jul 01, 2002
20MG
A075783 004
Jul 01, 2002
30MG
A075783 005
Jul 01, 2002
40MG
A075783 006
Jul 01, 2002
PRINIVIL
MERCK 2.5MG
N019558 006
Jan 28, 1994
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6-205(of 337)
LITHIUM CARBONATE
CAPSULE;ORAL
ESKALITH
NOVEN THERAP
300MG
N016860 001
LITHIUM CARBONATE
ABLE
150MG
A076823 001 Jun 29, 2004
300MG
A076121 001 Sep 27, 2001
300MG
A076823 002 Jun 29, 2004
600MG
A076823 003 Jun 29, 2004
APOTEX INC
300MG
A076795 001 Nov 22, 2004
HIKMA PHARMS LLC
600MG
A078763 001 Apr 15, 2008
USL PHARMA
300MG
A072542 001 Feb 01, 1989
WATSON LABS
300MG
A070407 001 Mar 19, 1987
LITHONATE
SOLVAY
300MG
N016782 001
TABLET;ORAL
ESKALITH
JDS PHARMS
300MG
N017971 001
LITHANE
BAYER PHARMS
300MG
N018833 001 Jul 18, 1985
LITHIUM CARBONATE
HIKMA INTL PHARMS
300MG
A078715 001 Dec 28, 2010
PFIZER
300MG
N016834 001
LITHOTABS
SOLVAY
300MG
N016980 001
TABLET, EXTENDED RELEASE;ORAL
ESKALITH CR
JDS PHARMS
450MG
N018152 001 Mar 29, 1982
LITHIUM CARBONATE
ABLE
300MG
A076382 001 Apr 21, 2003
BARR
300MG
A076170 001 Jun 10, 2002
450MG
A076366 001 Aug 21, 2003
LITHIUM CITRATE
SYRUP;ORAL
LITHONATE
SOLVAY
EQ 300MG CARBONATE/5ML
N017672 001
LOMEFLOXACIN HYDROCHLORIDE
TABLET;ORAL
MAXAQUIN
PHARMACIA
EQ 400MG BASE
N020013 001 Feb 21, 1992
LOPERAMIDE HYDROCHLORIDE
CAPSULE;ORAL
IMODIUM
MCNEIL PED
2MG
N017690 001
LOPERAMIDE HYDROCHLORIDE
ROXANE
2MG
A073080 001 Nov 27, 1991
SANDOZ
2MG
A072993 001 Aug 28, 1992
TEVA
2MG
A073122 001 Aug 30, 1991
SOLUTION;ORAL
IMODIUM
JANSSEN PHARMS
1MG/5ML
N019037 001 Jul 31, 1984
LOPERAMIDE HYDROCHLORIDE
ALPHARMA US PHARMS
1MG/5ML
A073187 001 Sep 15, 1992
DURAMED PHARMS BARR
1MG/5ML
A074991 001 Dec 29, 1997
TEVA
1MG/5ML
A073478 001 Jun 23, 1995
WATSON LABS
1MG/5ML
A073062 001 May 28, 1993
TABLET;ORAL
LOPERAMIDE HYDROCHLORIDE
ABLE
2MG
A073528 001 Nov 30, 1993
PERRIGO
2MG
A074194 001 Oct 30, 1992
LORACARBEF
CAPSULE;ORAL
LORABID
KING PHARMS
200MG
N050668 001 Dec 31, 1991
400MG
N050668 002 Apr 05, 1996
FOR SUSPENSION;ORAL
LORABID
KING PHARMS
100MG/5ML
N050667 001 Dec 31, 1991
200MG/5ML
N050667 002 Dec 31, 1991
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DISCONTINUED DRUG PRODUCT LIST 6-206(of 337)
LORATADINE
SYRUP;ORAL
CLARITIN HIVES RELIEF
SCHERING PLOUGH 1MG/ML **Federal Register determination N020641 003 Nov 19, 2003
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
LORATADINE
APOTEX INC 1MG/ML A075565 001 Oct 05, 2004
RANBAXY LABS LTD 1MG/ML A076529 001 Aug 20, 2004
TABLET;ORAL
LORATADINE
PERRIGO 10MG N021512 001 Jun 24, 2004
LORATADINE; PSEUDOEPHEDRINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
LORATADINE AND PSEUDOEPHEDRINE SULFATE
ACTAVIS LABS FL INC 5MG;120MG A076208 001 Jan 28, 2004
LORAZEPAM
INJECTABLE;INJECTION
LORAZEPAM
AKORN 2MG/ML A074974 001 Jul 23, 1998
BEDFORD 2MG/ML A077076 001 Jul 13, 2005
4MG/ML A077076 002 Jul 13, 2005
DAVA PHARMS INC 2MG/ML A074793 001 Mar 16, 2000
4MG/ML A074793 002 Mar 16, 2000
HIKMA MAPLE 2MG/ML A074496 001 Sep 28, 1998
4MG/ML A074496 002 Sep 28, 1998
HOSPIRA 2MG/ML A074280 001 May 27, 1994
2MG/ML A074300 001 Apr 12, 1994
4MG/ML A074280 002 May 27, 1994
4MG/ML A074300 003 Mar 19, 1997
WATSON LABS 2MG/ML A074276 001 Apr 15, 1994
4MG/ML A074276 002 Apr 15, 1994
WATSON LABS INC 1MG/0.5ML A074551 003 Sep 12, 1996
2MG/ML A074535 001 Sep 12, 1996
2MG/ML A074551 001 Sep 12, 1996
4MG/ML A074535 002 Sep 12, 1996
4MG/ML A074551 002 Sep 12, 1996
SOLUTION;ORAL
LORAZEPAM
ROXANE 0.5MG/5ML A074648 001 Mar 18, 1997
TABLET;ORAL
LORAZ
QUANTUM PHARMICS 0.5MG A070200 001 Aug 09, 1985
1MG A070201 001 Aug 09, 1985
2MG A070202 001 Aug 09, 1985
LORAZEPAM
AM THERAP 0.5MG A070727 001 Mar 07, 1986
1MG A070728 001 Mar 07, 1986
2MG A070729 001 Mar 07, 1986
HALSEY 0.5MG A071434 001 Sep 01, 1987
1MG A071435 001 Sep 01, 1987
2MG A071436 001 Sep 01, 1987
MUTUAL PHARM 0.5MG A070472 001 Dec 10, 1985
0.5MG A072553 001 Mar 29, 1991
1MG A070473 001 Dec 10, 1985
1MG A072554 001 Mar 29, 1991
2MG A070474 001 Dec 10, 1985
2MG A072555 001 Mar 29, 1991
PAR PHARM 0.5MG A070675 001 Dec 01, 1986
1MG A070676 001 Dec 01, 1986
2MG A070677 001 Dec 01, 1986
SANDOZ 0.5MG A071193 001 Apr 15, 1988
1MG A071194 001 Apr 15, 1988
2MG A071195 001 Apr 15, 1988
SUPERPHARM 0.5MG A071245 001 Feb 09, 1987
1MG A071246 001 Feb 09, 1987
2MG A071247 001 Feb 09, 1987
USL PHARMA 1MG A070539 001 Dec 22, 1986
2MG A070540 001 Dec 22, 1986
WARNER CHILCOTT 1MG A071038 001 Jan 12, 1988
2MG A071039 001 Jan 12, 1988
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6-207(of 337)
LORAZEPAM
TABLET;ORAL
LORAZEPAM
WATSON LABS
0.5MG
A071086 001
Mar 23, 1987
0.5MG
A071117 001
Jul 24, 1986
1MG
A071087 001
Mar 23, 1987
1MG
A071118 001
Jul 24, 1986
2MG
A071088 001
Mar 23, 1987
2MG
A071110 001
Jul 24, 1986
LOSARTAN POTASSIUM
TABLET;ORAL
LOSARTAN POTASSIUM
WATSON LABS
25MG
A091129 001
Oct 06, 2010
50MG
A091129 002
Oct 06, 2010
100MG
A091129 003
Oct 06, 2010
LOTEPREDNOL ETABONATE
SUSPENSION/DROPS;OPHTHALMIC
LOTEMAX
PHARMOS
0.5%
N020841 001
Mar 09, 1998
LOVASTATIN
TABLET;ORAL
MEVACOR
MERCK
10MG
N019643 002
Mar 28, 1991
20MG
N019643 003
Aug 31, 1987
40MG
N019643 004
Dec 14, 1988
TABLET, EXTENDED RELEASE;ORAL
ALTOPREV
ANDRX LABS LLC
10MG
N021316 001
Jun 26, 2002
LOXAPINE HYDROCHLORIDE
CONCENTRATE;ORAL
LOXITANE C
WATSON LABS
EQ 25MG BASE/ML
N017658 001
INJECTABLE;INJECTION
LOXITANE IM
WATSON LABS
EQ 50MG BASE/ML
N018039 001
LOXAPINE SUCCINATE
CAPSULE;ORAL
LOXITANE
WATSON LABS
EQ 5MG BASE
N017525 001
EQ 10MG BASE
N017525 002
EQ 25MG BASE
N017525 003
EQ 50MG BASE
N017525 004
TABLET;ORAL
LOXITANE
WATSON LABS
EQ 10MG BASE
N017525 006
EQ 25MG BASE
N017525 007
EQ 50MG BASE
N017525 008
LUTROPIN ALFA
INJECTABLE;SUBCUTANEOUS
LUVERIS
EMD SERONO
75 IU/VIAL
N021322 001
Oct 08, 2004
LYPRESSIN
SOLUTION;NASAL
DIAPID
NOVARTIS
0.185MG/ML
N016755 001
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; POTASSIUM PHOSPHATE, MONOBASIC; SODIUM ACETATE; SODIUM
CHLORIDE; SODIUM GLUCONATE; SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
INJECTABLE;INJECTION
ISOLYTE S PH 7.4 IN PLASTIC CONTAINER
B BRAUN 30MG/100ML;37MG/100ML;0.82MG/100ML;370M N019006 001 Apr 04, 1984
G/100ML;530MG/100ML;500MG/100ML;12MG/10
0ML
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DISCONTINUED DRUG PRODUCT LIST 6-208(of 337)
MAGNESIUM CHLORIDE; POTASSIUM CHLORIDE; SODIUM ACETATE; SODIUM CHLORIDE; SODIUM GLUCONATE
INJECTABLE;INJECTION
ISOLYTE S IN PLASTIC CONTAINER
B BRAUN 30MG/100ML;37MG/100ML;370MG/100ML;530MG N018252 001
/100ML;500MG/100ML
SOLUTION;IRRIGATION
PHYSIOSOL IN PLASTIC CONTAINER
HOSPIRA INC 14MG/100ML;37MG/100ML;222MG/100ML;526MG N018406 001
/100ML;502MG/100ML
PHYSIOSOL PH 7.4 IN PLASTIC CONTAINER
HOSPIRA INC 30MG/100ML;37MG/100ML;222MG/100ML;526MG N018406 002 Jul 08, 1982
/100ML;502MG/100ML
SYNOVALYTE IN PLASTIC CONTAINER
BAXTER HLTHCARE 30MG/100ML;37MG/100ML;368MG/100ML;526MG N019326 001 Jan 25, 1985
/100ML;502MG/100ML
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE
TABLET;ORAL
MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM BICARBONATE
SANTARUS 343MG;20MG;750MG N022456 001 Dec 04, 2009
343MG;40MG;750MG N022456 002 Dec 04, 2009
TABLET, CHEWABLE;ORAL
ZEGERID
SANTARUS 700MG;20MG;600MG N021850 001 Mar 24, 2006
700MG;40MG;600MG N021850 002 Mar 24, 2006
MALATHION
LOTION;TOPICAL
MALATHION
MYLAN PHARMS INC 0.5% A078743 001 Mar 06, 2009
MANGAFODIPIR TRISODIUM
INJECTABLE;INJECTION
TESLASCAN
GE HEALTHCARE 37.9MG/ML N020652 001 Nov 26, 1997
MANGANESE CHLORIDE TETRAHYDRATE
FOR SOLUTION;ORAL
LUMENHANCE
BRACCO 3.49MG/GM N020686 001 Dec 19, 1997
MANGANESE SULFATE
INJECTABLE;INJECTION
MANGANESE SULFATE
ABRAXIS PHARM EQ 0.1MG MANGANESE/ML N019228 001 May 05, 1987
MANNITOL
INJECTABLE;INJECTION
MANNITOL 10%
HOSPIRA 10GM/100ML N016269 002
MILES 10GM/100ML N016472 002
MANNITOL 15%
HOSPIRA 15GM/100ML N016269 003
MILES 15GM/100ML N016472 005
MANNITOL 20%
B BRAUN 20GM/100ML N014738 001
HOSPIRA 20GM/100ML N016269 004
MILES 20GM/100ML N016472 004
MANNITOL 25%
ABRAXIS PHARM 12.5GM/50ML A086754 001
ASTRAZENECA 12.5GM/50ML A089239 001 May 06, 1987
12.5GM/50ML A089240 001 May 06, 1987
HOSPIRA 12.5GM/50ML N016269 005
MERCK 12.5GM/50ML N005620 001
WATSON LABS 12.5GM/50ML A087460 001 Jun 27, 1983
MANNITOL 5%
HOSPIRA 5GM/100ML N016269 001
POWDER;INHALATION
ARIDOL KIT
PHARMAXIS LTD N/A,5MG,10MG,20MG,40MG N022368 001 Oct 05, 2010
SOLUTION;IRRIGATION
RESECTISOL
B BRAUN 5GM/100ML N016704 002
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DISCONTINUED DRUG PRODUCT LIST 6-209(of 337)
MANNITOL; SORBITOL
SOLUTION;IRRIGATION
SORBITOL-MANNITOL
HOSPIRA 540MG/100ML;2.7GM/100ML A080224 001
SORBITOL-MANNITOL IN PLASTIC CONTAINER
HOSPIRA 540MG/100ML;2.7GM/100ML N017636 001
MAPROTILINE HYDROCHLORIDE
TABLET;ORAL
LUDIOMIL
NOVARTIS 25MG N017543 001
50MG N017543 002
75MG N017543 003 Sep 30, 1982
MAPROTILINE HYDROCHLORIDE
AM THERAP 25MG A072129 001 Jan 14, 1988
50MG A072130 001 Jan 14, 1988
75MG A072131 001 Jan 14, 1988
WATSON LABS 25MG A071943 001 Dec 30, 1987
25MG A072162 001 Jun 01, 1988
50MG A071944 001 Dec 30, 1987
50MG A072163 001 Jun 01, 1988
75MG A071945 001 Dec 30, 1987
75MG A072164 001 Jun 01, 1988
MASOPROCOL
CREAM;TOPICAL
ACTINEX
UNIV AZ CANCER CTR 10% N019940 001 Sep 04, 1992
MAZINDOL
TABLET;ORAL
MAZANOR
WYETH AYERST 1MG N017980 002
2MG N017980 001
SANOREX
NOVARTIS 1MG **Federal Register determination N017247 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
2MG **Federal Register determination N017247 002
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
MEBENDAZOLE
TABLET, CHEWABLE;ORAL
VERMOX
JANSSEN PHARMS 100MG N017481 001
MEBUTAMATE
TABLET;ORAL
DORMATE
MEDPOINTE PHARM HLC 600MG N017374 001
MECAMYLAMINE HYDROCHLORIDE
TABLET;ORAL
INVERSINE
TARGACEPT 2.5MG N010251 001
MECASERMIN RINFABATE RECOMBINANT
INJECTABLE;SUBCUTANEOUS
IPLEX
INSMED 36MG/0.6ML N021884 001 Dec 12, 2005
MECLIZINE HYDROCHLORIDE
TABLET;ORAL
ANTIVERT
CITRON PHARMA LLC 12.5MG N010721 006
25MG N010721 004
50MG N010721 001 Jan 20, 1982
MECLIZINE HYDROCHLORIDE
ABC HOLDING 12.5MG A085253 001
25MG A085252 001
AMNEAL PHARMS 50MG A201451 003 Feb 23, 2011
ANABOLIC 25MG A085891 001
BUNDY 12.5MG A084382 001
25MG A084872 001
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MECLIZINE HYDROCHLORIDE
TABLET;ORAL
MECLIZINE HYDROCHLORIDE
IVAX SUB TEVA PHARMS 12.5MG A083784 001
12.5MG A084975 001
25MG A084657 001
KV PHARM 12.5MG A085524 001
25MG A085523 001
MYLAN PHARMS INC 50MG A202640 003 Sep 17, 2012
PAR PHARM 50MG A089674 001 Mar 31, 1988
PLIVA 12.5MG A088732 001 Dec 11, 1985
25MG A088734 001 Dec 11, 1985
SUPERPHARM 12.5MG A089113 001 Aug 20, 1985
25MG A089114 001 Aug 20, 1985
UDL 12.5MG A088256 001 Jun 13, 1983
25MG A088257 001 Jun 13, 1983
VANGARD 12.5MG A087877 001 Apr 20, 1982
25MG A087620 001 Jan 04, 1982
WATSON LABS 12.5MG A085195 001
12.5MG A085269 001
25MG A085740 001
TABLET, CHEWABLE;ORAL
ANTIVERT
CITRON PHARMA LLC 25MG N010721 005
MECLIZINE HYDROCHLORIDE
IVAX SUB TEVA PHARMS 25MG A084976 001
NEXGEN PHARMA INC 25MG A086392 001
PLIVA 25MG A088733 001 Dec 11, 1985
MECLOCYCLINE SULFOSALICYLATE
CREAM;TOPICAL
MECLAN
JOHNSON AND JOHNSON 1% N050518 001
MECLOFENAMATE SODIUM
CAPSULE;ORAL
MECLODIUM
QUANTUM PHARMICS EQ 50MG BASE A071380 001 Jul 14, 1987
EQ 100MG BASE A071381 001 Jul 14, 1987
MECLOFENAMATE SODIUM
AM THERAP EQ 50MG BASE A071362 001 Feb 10, 1987
EQ 100MG BASE A071363 001 Feb 10, 1987
BARR EQ 50MG BASE A072848 001 Mar 20, 1989
EQ 100MG BASE A072809 001 Mar 20, 1989
PAR PHARM EQ 50MG BASE A072077 001 Mar 10, 1988
EQ 100MG BASE A072078 001 Mar 10, 1988
SANDOZ EQ 50MG BASE A072262 001 Nov 29, 1988
EQ 100MG BASE A072263 001 Nov 29, 1988
USL PHARMA EQ 50MG BASE A071007 001 Mar 25, 1988
EQ 100MG BASE A071008 001 Mar 25, 1988
VITARINE EQ 50MG BASE A071710 001 Jun 15, 1988
EQ 100MG BASE A071684 001 Jun 15, 1988
WATSON LABS EQ 50MG BASE A070400 001 Nov 25, 1986
EQ 50MG BASE A071468 001 Apr 15, 1987
EQ 50MG BASE A071640 001 Aug 11, 1987
EQ 100MG BASE A070401 001 Nov 25, 1986
EQ 100MG BASE A071469 001 Apr 15, 1987
EQ 100MG BASE A071641 001 Aug 11, 1987
MECLOMEN
PARKE DAVIS EQ 50MG BASE N018006 001
EQ 100MG BASE N018006 002
MEDROXYPROGESTERONE ACETATE
INJECTABLE;INJECTION
DEPO-PROVERA
PHARMACIA AND UPJOHN 100MG/ML **Federal Register N012541 002
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
MEDROXYPROGESTERONE ACETATE
TEVA PHARMS USA 150MG/ML A076552 001 Oct 27, 2004
TABLET;ORAL
AMEN
AMARIN PHARMS 10MG A083242 001
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DISCONTINUED DRUG PRODUCT LIST 6-211(of 337)
MEDROXYPROGESTERONE ACETATE
TABLET;ORAL
CURRETAB
SOLVAY 10MG A085686 001
CYCRIN
ESI 2.5MG A081239 001 Oct 30, 1992
5MG A081240 001 Oct 30, 1992
10MG A089386 001 Sep 09, 1987
MEDROXYPROGESTERONE ACETATE
DURAMED PHARMS BARR 2.5MG A040311 001 Dec 01, 1999
5MG A040311 002 Dec 01, 1999
10MG A040311 003 Dec 01, 1999
USL PHARMA 10MG A088484 001 Jul 26, 1984
MEDRYSONE
SUSPENSION;OPHTHALMIC
HMS
ALLERGAN 1% N016624 003
MEFLOQUINE HYDROCHLORIDE
TABLET;ORAL
LARIAM
ROCHE 250MG N019591 001 May 02, 1989
MEFLOQUINE HYDROCHLORIDE
HIKMA PHARMS LLC 250MG A077699 001 Apr 21, 2010
US ARMY WALTER REED 250MG N019578 001 May 02, 1989
MEGESTROL ACETATE
SUSPENSION;ORAL
MEGESTROL ACETATE
APOTEX INC 40MG/ML A077404 001 Feb 16, 2006
TABLET;ORAL
MEGACE
BRISTOL MYERS SQUIBB 20MG N016979 001
40MG N016979 002
MEGESTROL ACETATE
TEVA 40MG A074745 001 Feb 27, 1998
USL PHARMA 20MG A070646 001 Oct 02, 1987
40MG A070647 001 Oct 02, 1987
MELOXICAM
TABLET;ORAL
MELOXICAM
COREPHARMA 7.5MG A077930 001 Jul 19, 2006
15MG A077930 002 Jul 19, 2006
CR DOUBLE CRANE 7.5MG A078039 001 Dec 14, 2006
15MG A078039 002 Dec 14, 2006
MUTUAL PHARM 7.5MG A077935 001 Jul 19, 2006
15MG A077935 002 Jul 19, 2006
MYLAN 7.5MG A077934 001 Jul 20, 2006
15MG A077934 002 Jul 20, 2006
ROXANE 7.5MG A077925 001 Jul 19, 2006
15MG A077925 002 Jul 19, 2006
YABAO PHARM 7.5MG A077933 001 Jul 19, 2006
15MG A077933 002 Jul 19, 2006
MELPHALAN HYDROCHLORIDE
INJECTABLE;INJECTION
MELPHALAN HYDROCHLORIDE
MYLAN INSTITUTIONAL EQ 50MG BASE/VIAL A090299 001 Oct 27, 2009
MEMANTINE HYDROCHLORIDE
TABLET;ORAL
MEMANTINE
SUN PHARMA GLOBAL 5MG A090058 001 May 05, 2010
10MG A090058 002 May 05, 2010
MEMANTINE HYDROCHLORIDE
DR REDDYS LABS LTD 5MG A090048 001 Apr 14, 2010
10MG A090048 002 Apr 14, 2010
ORCHID HLTHCARE 5MG A090044 001 Mar 12, 2012
10MG A090044 002 Mar 12, 2012
TEVA PHARMS 5MG A090052 001 Oct 25, 2011
10MG A090052 002 Oct 25, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-212(of 337)
MENADIOL SODIUM DIPHOSPHATE
INJECTABLE;INJECTION
KAPPADIONE
LILLY 10MG/ML
N005725 001
SYNKAYVITE
ROCHE 5MG/ML
N003718 004
10MG/ML
N003718 006
37.5MG/ML
N003718 008
TABLET;ORAL
SYNKAYVITE
ROCHE 5MG
N003718 010
MENADIONE
TABLET;ORAL
MENADIONE
LILLY 5MG
N002139 003
MENOTROPINS (FSH;LH)
INJECTABLE;INJECTION
HUMEGON
ORGANON USA INC 75 IU/VIAL;75 IU/VIAL
N020328 001 Sep 01, 1994
150 IU/VIAL;150 IU/VIAL
N020328 002 Sep 01, 1994
MENOTROPINS
FERRING 75 IU/VIAL;75 IU/VIAL
A073598 001 Jan 30, 1997
150 IU/VIAL;150 IU/VIAL
A073599 001 Jan 30, 1997
PERGONAL
SERONO 75 IU/AMP;75 IU/AMP
N017646 001
150 IU/AMP;150 IU/AMP
N017646 002 May 20, 1985
REPRONEX
FERRING 150 IU/VIAL;150 IU/VIAL
N021047 002 Aug 27, 1999
MEPENZOLATE BROMIDE
SOLUTION;ORAL
CANTIL
SANOFI AVENTIS US 25MG/5ML
N010679 004
MEPERIDINE HYDROCHLORIDE
INJECTABLE;INJECTION
DEMEROL
SANOFI AVENTIS US 25MG/ML
N005010 007
50MG/ML
N005010 002
75MG/ML
N005010 009
100MG/ML
N005010 003
MEPERIDINE HYDROCHLORIDE
ABBOTT 25MG/ML
A080388 001
50MG/ML
A080385 001
50MG/ML
A080387 001
75MG/ML
A080389 001
100MG/ML
A080386 001
ASTRAZENECA 25MG/ML
A089781 001 Mar 31, 1989
50MG/ML
A089782 001 Mar 31, 1989
50MG/ML
A089783 001 Mar 31, 1989
50MG/ML
A089784 001 Mar 31, 1989
75MG/ML
A089785 001 Mar 31, 1989
100MG/ML
A089786 001 Mar 31, 1989
100MG/ML
A089787 001 Mar 31, 1989
100MG/ML
A089788 001 Mar 31, 1989
BAXTER HLTHCARE 25MG/ML
A088279 001 Jun 15, 1984
50MG/ML
A088280 001 Jun 15, 1984
75MG/ML
A088281 001 Jun 15, 1984
100MG/ML
A088282 001 Jun 15, 1984
INTL MEDICATION 10MG/ML
A086332 001
PARKE DAVIS 50MG/ML
A080364 002
75MG/ML
A080364 003
100MG/ML
A080364 001
WATSON LABS 50MG/ML
A073444 001 Mar 17, 1992
100MG/ML
A073445 001 Mar 17, 1992
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE
HOSPIRA 10MG/ML A040305 001 Mar 10, 1999
INTL MEDICATION 10MG/ML A081309 001 Aug 30, 1993
MALLINCKRODT 10MG/ML A040163 001 May 12, 1997
WATSON LABS 10MG/ML A073443 001 Mar 17, 1992
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-213(of 337)
MEPERIDINE HYDROCHLORIDE
SYRUP;ORAL
DEMEROL
SANOFI AVENTIS US 50MG/5ML N005010 005
TABLET;ORAL
MEPERIDINE HYDROCHLORIDE
DURAMED PHARMS BARR 50MG A040318 001 Oct 05, 1999
100MG A040318 002 Oct 05, 1999
MUTUAL PHARM 50MG A080448 001
100MG A080448 002
WATSON LABS 50MG A040186 001 Jun 30, 1997
100MG A040186 002 Jun 30, 1997
WYETH AYERST 50MG A080454 001
MEPERIDINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
MEPERGAN
BAXTER HLTHCARE CORP 25MG/ML;25MG/ML N011730 001
MEPHENTERMINE SULFATE
INJECTABLE;INJECTION
WYAMINE SULFATE
BAXTER HLTHCARE CORP EQ 15MG BASE/ML N008248 002
EQ 30MG BASE/ML N008248 001
MEPHENYTOIN
TABLET;ORAL
MESANTOIN
NOVARTIS 100MG **Federal Register determination N006008 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
MEPIVACAINE HYDROCHLORIDE
INJECTABLE;INJECTION
ARESTOCAINE HYDROCHLORIDE
SOLVAY 3% A084777 002 Apr 18, 1982
CARBOCAINE
EASTMAN KODAK 3% N012125 003
MEPIVACAINE HYDROCHLORIDE
GRAHAM CHEM 3% A083559 001
INTL MEDICATION 1% A087509 001 Oct 05, 1982
WATSON LABS 1% A088769 001 Nov 20, 1984
2% A088770 001 Nov 20, 1984
POLOCAINE
DENTSPLY PHARM 3% A088653 001 Aug 21, 1984
MEPREDNISONE
TABLET;ORAL
BETAPAR
SCHERING 4MG N016053 002
MEPROBAMATE
CAPSULE;ORAL
EQUANIL
WYETH AYERST 400MG N012455 002
CAPSULE, EXTENDED RELEASE;ORAL
MEPROSPAN
MEDPOINTE PHARM HLC 200MG N011284 001
400MG N011284 002
TABLET;ORAL
AMOSENE
FERNDALE LABS 400MG A084030 001
BAMATE
ALRA 200MG A080380 001
400MG A080380 002
EQUANIL
WYETH AYERST 200MG N010028 005
400MG N010028 004
MEPRIAM
TEVA 400MG N016069 001
MEPROBAMATE
BARR 600MG A084230 001
ELKINS SINN 200MG N015426 002
400MG N015426 001
HEATHER 400MG N016928 003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-214(of 337)
MEPROBAMATE
TABLET;ORAL
MEPROBAMATE
600MG
A084329 001
IMPAX LABS 200MG
N014322 002
400MG
N014322 001
IVAX SUB TEVA PHARMS 200MG
N015438 001
400MG
N015438 002
600MG
A084181 001
IVC INDS 400MG
A084153 001
LANNETT 200MG
N014882 002
400MG
N014882 001
LEDERLE 400MG
A086299 001
LEE KM 400MG
A089538 001 Nov 25, 1987
MALLARD 400MG
N015072 002
MK LABS 200MG
N014368 004
400MG
N014368 002
MUTUAL PHARM 200MG
A080699 001
400MG
A080699 002
MYLAN 400MG
A083618 001
NEXGEN PHARMA INC 200MG
A084220 001
400MG
A084589 001
PARKE DAVIS 200MG
A084744 001
400MG
A084744 002
PERRIGO 200MG
A084546 001
400MG
A084547 001
PHARMAVITE 400MG
A084438 001
PUREPAC PHARM 200MG
A084804 001
400MG
A084804 002
PVT FORM 400MG
N014601 001
ROXANE 600MG
A084332 001
SANDOZ 200MG
N014547 002
400MG
A080655 001
400MG
N014547 001
SCHERER LABS 400MG
A083343 001
SOLVAY 200MG
A084435 001
STANLABS PHARM 200MG
N014474 002
400MG
N014474 004
TABLICAPS 400MG
A083494 001
TARO 200MG
A200998 001 May 23, 2011
400MG
A200998 002 May 23, 2011
USL PHARMA 200MG
A087825 001 Mar 18, 1982
400MG
A087826 001 Mar 18, 1982
VALEANT PHARM INTL 200MG
N015139 006
400MG
N015139 005
VANGARD 400MG
A088011 001 Jul 14, 1982
WATSON LABS 200MG
A085720 001
400MG
A085721 001
600MG
A084274 001
600MG
A085719 001
WEST WARD 200MG
N015417 003
400MG
N015417 002
WHITEWORTH TOWN PLSN 200MG
A083830 001
400MG
A083442 001
MILTOWN
MEDPOINTE PHARM HLC 200MG
N009698 004
400MG
N009698 002
600MG
A083919 001
NEURAMATE
HALSEY 200MG
N014359 002
400MG
N014359 001
TRANMEP
SOLVAY 400MG
A084369 001
400MG
N016249 001
MEQUINOL; TRETINOIN
SOLUTION;TOPICAL
SOLAGE
AQUA PHARMS 2%;0.01%
N020922 001 Dec 10, 1999
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DISCONTINUED DRUG PRODUCT LIST
6-215(of 337)
MERCAPTOPURINE
TABLET;ORAL
PURINETHOL
TEVA
50MG
N009053 002
MERSALYL SODIUM; THEOPHYLLINE
INJECTABLE;INJECTION
MERSALYL-THEOPHYLLINE
WATSON LABS
100MG/ML;50MG/ML
A084875 001
MESALAMINE
SUPPOSITORY;RECTAL
CANASA
FOREST LABS INC
500MG
N021252 001 Jan 05, 2001
ROWASA
MEDA PHARMS
500MG
N019919 001 Dec 18, 1990
MESORIDAZINE BESYLATE
CONCENTRATE;ORAL
SERENTIL
NOVARTIS
EQ 25MG BASE/ML
N016997 001
INJECTABLE;INJECTION
SERENTIL
NOVARTIS
EQ 25MG BASE/ML
N016775 001
TABLET;ORAL
SERENTIL
NOVARTIS
EQ 10MG BASE
N016774 001
EQ 25MG BASE
N016774 002
EQ 50MG BASE
N016774 003
EQ 100MG BASE
N016774 004
MESTRANOL; NORETHINDRONE
TABLET;ORAL-20
NORINYL
WATSON LABS
0.1MG;2MG
N013625 004
TABLET;ORAL-21
NORETHIN 1/50M-21
WATSON LABS
0.05MG;1MG
A071539 001 Apr 12, 1988
NORETHINDRONE AND MESTRANOL
WATSON LABS
0.05MG;1MG
A070758 001 Jul 01, 1988
NORINYL 1+50 21-DAY
WATSON LABS
0.05MG;1MG
N013625 002
NORINYL 1+80 21-DAY
GD SEARLE LLC
0.08MG;1MG
N016724 001
ORTHO-NOVUM 1/50 21
ORTHO MCNEIL PHARM
0.05MG;1MG
N012728 004
ORTHO-NOVUM 1/80 21
ORTHO MCNEIL PHARM
0.08MG;1MG
N016715 001
ORTHO-NOVUM 10-21
ORTHO MCNEIL PHARM
0.06MG;10MG
N012728 001
ORTHO-NOVUM 2-21
ORTHO MCNEIL PHARM
0.1MG;2MG
N012728 005
TABLET;ORAL-28
NORETHIN 1/50M-28
WATSON LABS
0.05MG;1MG
A071540 001 Apr 12, 1988
NORETHINDRONE AND MESTRANOL
WATSON LABS
0.05MG;1MG
A070759 001 Jul 01, 1988
NORINYL 1+80 28-DAY
GD SEARLE LLC
0.08MG;1MG
N016725 001
ORTHO-NOVUM 1/50 28
ORTHO MCNEIL JANSSEN
0.05MG;1MG
N016709 001
ORTHO-NOVUM 1/80 28
ORTHO MCNEIL PHARM
0.08MG;1MG
N016715 002
MESTRANOL; NORETHYNODREL
TABLET;ORAL
ENOVID
GD SEARLE LLC
0.075MG;5MG
N010976 008
0.15MG;9.85MG
N010976 005
TABLET;ORAL-20
ENOVID
GD SEARLE LLC
0.075MG;5MG
N010976 004
ENOVID-E
GD SEARLE LLC
0.1MG;2.5MG
N010976 006
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-216(of 337)
MESTRANOL; NORETHYNODREL
TABLET;ORAL-21
ENOVID-E 21
GD SEARLE LLC 0.1MG;2.5MG N010976 007
METAPROTERENOL SULFATE
AEROSOL, METERED;INHALATION
ALUPENT
BOEHRINGER INGELHEIM 0.65MG/INH N016402 001
SOLUTION;INHALATION
ALUPENT
BOEHRINGER INGELHEIM 0.4% N018761 002 Oct 10, 1986
0.6% N018761 001 Jun 30, 1983
5% N017659 001
METAPROTERENOL SULFATE
APOTEX INC 0.4% A075402 001 Feb 28, 2001
0.6% A075403 001 Feb 28, 2001
ASTRAZENECA 0.4% A071275 001 Jul 27, 1988
0.6% A071018 001 Jul 27, 1988
DEY 0.33% A071806 001 Aug 05, 1988
0.5% A071805 001 Aug 05, 1988
5% A070805 001 Aug 17, 1987
NEPHRON 0.4% A071855 001 Jul 14, 1988
0.6% A071726 001 Jul 14, 1988
WOCKHARDT 5% A072190 001 Jun 07, 1988
PROMETA
MURO 5% A073340 001 Mar 30, 1992
SYRUP;ORAL
ALUPENT
BOEHRINGER INGELHEIM 10MG/5ML N017571 001
METAPROTERENOL SULFATE
APOTEX INC 10MG/5ML A075235 001 Jan 27, 2000
MORTON GROVE 10MG/5ML A071656 001 Oct 13, 1987
TEVA 10MG/5ML A072761 001 Feb 27, 1992
TEVA PHARMS 10MG/5ML A073034 001 Aug 30, 1991
WOCKHARDT 10MG/5ML A074702 001 Mar 24, 1997
PROMETA
MURO 10MG/5ML A072023 001 Sep 15, 1988
TABLET;ORAL
ALUPENT
BOEHRINGER INGELHEIM 10MG N015874 002
20MG N015874 001
METAPROTERENOL SULFATE
AM THERAP 10MG A072054 001 Jun 23, 1988
20MG A072055 001 Jun 23, 1988
TEVA 10MG A072519 001 Mar 30, 1990
20MG A072520 001 Mar 30, 1990
USL PHARMA 10MG A071013 001 Jan 25, 1988
20MG A071014 001 Jan 25, 1988
WATSON LABS 10MG A073013 001 Jan 31, 1991
20MG A072795 001 Jan 31, 1991
METARAMINOL BITARTRATE
INJECTABLE;INJECTION
ARAMINE
MERCK EQ 10MG BASE/ML N009509 002 Dec 22, 1987
METARAMINOL BITARTRATE
ABRAXIS PHARM EQ 10MG BASE/ML A080431 001
ELKINS SINN EQ 10MG BASE/ML A083363 001
GD SEARLE LLC EQ 10MG BASE/ML A086418 001
EQ 20MG BASE/ML A086418 002
METAXALONE
TABLET;ORAL
SKELAXIN
KING PHARMS 400MG **Federal Register determination N013217 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-217(of 337)
METFORMIN HYDROCHLORIDE
TABLET;ORAL
GLUCOPHAGE
BRISTOL MYERS SQUIBB 625MG N020357 003 Nov 05, 1998
750MG N020357 004 Nov 05, 1998
METFORMIN HYDROCHLORIDE
BARR 1GM A075971 003 Jan 25, 2002
500MG A075971 001 Jan 25, 2002
850MG A075971 002 Jan 25, 2002
IPCA LABS LTD 1GM A078422 003 Aug 06, 2007
500MG A078422 001 Aug 06, 2007
850MG A078422 002 Aug 06, 2007
IVAX SUB TEVA PHARMS 1GM A075975 003 Jan 24, 2002
500MG A075975 001 Jan 24, 2002
625MG A075975 004 Jan 24, 2002
750MG A075975 005 Jan 24, 2002
850MG A075975 002 Jan 24, 2002
TEVA 1GM A076328 003 Dec 16, 2002
500MG A076328 001 Dec 16, 2002
850MG A076328 002 Dec 16, 2002
WATSON LABS 1GM A075979 003 Jan 24, 2002
500MG A075979 001 Jan 24, 2002
850MG A075979 002 Jan 24, 2002
TABLET, EXTENDED RELEASE;ORAL
METFORMIN HYDROCHLORIDE
ACTAVIS ELIZABETH 500MG A076450 001 Oct 01, 2004
750MG A076878 001 Apr 13, 2005
BARR 500MG A076496 001 Nov 25, 2005
IVAX SUB TEVA PHARMS 500MG A076545 001 Dec 01, 2003
MUTUAL PHARM 500MG A077124 001 Dec 21, 2005
RANBAXY LABS LTD 500MG A076413 001 Jun 18, 2004
750MG A077211 001 Jun 29, 2005
SANDOZ 500MG A076223 001 Dec 14, 2004
TORRENT PHARMS LTD 750MG A079226 001 Feb 18, 2010
WATSON LABS INC 500MG A076818 001 Dec 14, 2004
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE
TABLET;ORAL
AVANDAMET
SB PHARMCO 500MG;EQ 1MG BASE **Federal Register N021410 001 Oct 10, 2002
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
METHACYCLINE HYDROCHLORIDE
CAPSULE;ORAL
RONDOMYCIN
MEDPOINTE PHARM HLC EQ 140MG BASE A060641 001
EQ 280MG BASE A060641 002
SYRUP;ORAL
RONDOMYCIN
MEDPOINTE PHARM HLC EQ 70MG BASE/5ML A060641 003
METHADONE HYDROCHLORIDE
SYRUP;ORAL
DOLOPHINE HYDROCHLORIDE
ROXANE 10MG/30ML N006134 004
TABLET;ORAL
METHADONE HYDROCHLORIDE
ROXANE 5MG A088108 001 Mar 08, 1983
10MG A088109 001 Mar 08, 1983
40MG A074081 001 Apr 28, 1995
SANDOZ 5MG A040241 001 May 29, 1998
TABLET, DISPERSIBLE;ORAL
WESTADONE
SANDOZ 2.5MG N017108 001
TABLET, EFFERVESCENT;ORAL
WESTADONE
SANDOZ 5MG N017108 002
10MG N017108 003
40MG N017108 004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-218(of 337)
METHAMPHETAMINE HYDROCHLORIDE
TABLET;ORAL
METHAMPEX
TEVA 10MG
A083889 001
METHAMPHETAMINE HYDROCHLORIDE
ABLE 5MG
A040529 001 Feb 25, 2004
REXAR 5MG
A084931 001
10MG
A084931 002
TEVA 5MG
A086359 001
TABLET, EXTENDED RELEASE;ORAL
DESOXYN
RECORDATI RARE 5MG
N005378 004
10MG
N005378 003
15MG
N005378 005
METHANTHELINE BROMIDE
TABLET;ORAL
BANTHINE
SHIRE 50MG
N007390 001
METHARBITAL
TABLET;ORAL
GEMONIL
ABBVIE 100MG
N008322 001
METHAZOLAMIDE
TABLET;ORAL
METHAZOLAMIDE
APPLIED ANAL 25MG
A040011 001 Jul 17, 1997
50MG
A040011 002 Jul 17, 1997
SANDOZ 25MG
A040102 001 Aug 28, 1996
50MG
A040102 002 Aug 28, 1996
NEPTAZANE
LEDERLE 25MG
N011721 002 Nov 25, 1991
50MG
N011721 001
METHDILAZINE
TABLET, CHEWABLE;ORAL
TACARYL
WESTWOOD SQUIBB 3.6MG
N011950 009
METHDILAZINE HYDROCHLORIDE
SYRUP;ORAL
METHDILAZINE HYDROCHLORIDE
ALPHARMA US PHARMS 4MG/5ML
A087122 001
TACARYL
WESTWOOD SQUIBB 4MG/5ML
N011950 007
TABLET;ORAL
TACARYL
WESTWOOD SQUIBB 8MG
N011950 006
METHICILLIN SODIUM
INJECTABLE;INJECTION
STAPHCILLIN
APOTHECON EQ 3.6GM BASE/VIAL
A061449 002
EQ 3.6GM BASE/VIAL
N050117 002
EQ 5.4GM BASE/VIAL
A061449 003
EQ 5.4GM BASE/VIAL
N050117 003
EQ 900MG BASE/VIAL
A061449 001
EQ 900MG BASE/VIAL
N050117 001
METHIMAZOLE
TABLET;ORAL
METHIMAZOLE
CEDAR PHARMS 15MG
A040619 003 Jul 12, 2005
20MG
A040547 004 Feb 18, 2005
MYLAN 20MG
A040350 003 Jun 07, 2001
TAPAZOLE
KING PHARMS 5MG
N007517 002
10MG
N007517 004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-219(of 337)
METHIXENE HYDROCHLORIDE
TABLET;ORAL
TREST
NOVARTIS 1MG
N013420 001
METHOCARBAMOL
INJECTABLE;INJECTION
METHOCARBAMOL
MARSAM PHARMS LLC 100MG/ML
A089849 001 Dec 27, 1991
WATSON LABS 100MG/ML
A086459 001
TABLET;ORAL
DELAXIN
FERNDALE LABS 500MG
A085454 001
FORBAXIN
FOREST LABS 750MG
A085136 001
METHOCARBAMOL
ABLE 500MG
A040413 001 Mar 17, 2003
750MG
A040413 002 Mar 17, 2003
AM THERAP 500MG
A089417 001 Feb 11, 1987
750MG
A089418 001 Feb 11, 1987
ASCOT 500MG
A087660 001 Oct 27, 1982
750MG
A087661 001 Oct 27, 1982
CLONMEL HLTHCARE 500MG
A085961 001
750MG
A085963 001
HEATHER 500MG
A084675 001
750MG
A084924 001
IMPAX LABS 500MG
A084927 001
750MG
A084928 001
INWOOD LABS 500MG
A085137 001
IVAX SUB TEVA PHARMS 500MG
A084648 001
750MG
A084649 001
KV PHARM 500MG
A085660 001
750MG
A085658 001
MUTUAL PHARM 500MG
A084488 001
750MG
A084486 001
MYLAN 500MG
A084259 001
750MG
A084323 001
NYLOS 750MG
A085033 001
PIONEER PHARMS 500MG
A088731 001 Dec 13, 1985
750MG
A089082 001 Dec 13, 1985
PURACAP PHARM 500MG
A084231 002
750MG
A084471 001
PUREPAC PHARM 500MG
A085718 001
750MG
A085718 002
ROXANE 500MG
A088646 001 Feb 29, 1984
750MG
A088647 001 Feb 29, 1984
SANDOZ 500MG
A087283 001
750MG
A087282 001
SOLVAY 500MG
A084448 001
750MG
A084449 001
SUPERPHARM 500MG
A087589 001 Jan 22, 1982
750MG
A087590 001 Jan 22, 1982
TABLICAPS 500MG
A084846 001
UPSHER SMITH 500MG
A087453 001
750MG
A087454 001
WATSON LABS 500MG
A083605 001
500MG
A085180 001
750MG
A083605 002
750MG
A085192 001
METHOHEXITAL SODIUM
INJECTABLE;INJECTION
BREVITAL SODIUM
PAR STERILE PRODUCTS 5GM/VIAL
N011559 003
METHOTREXATE SODIUM
INJECTABLE;INJECTION
ABITREXATE
ABIC EQ 25MG BASE/ML
A089161 001 Mar 10, 1987
EQ 50MG BASE/VIAL
A089354 001 Jul 17, 1987
EQ 100MG BASE/VIAL
A089355 001 Jul 17, 1987
EQ 250MG BASE/VIAL
A089356 001 Jul 17, 1987
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DISCONTINUED DRUG PRODUCT LIST 6-220(of 337)
METHOTREXATE SODIUM
INJECTABLE;INJECTION
FOLEX
PHARMACIA AND UPJOHN EQ 25MG BASE/VIAL A087695 001 Apr 08, 1983
EQ 50MG BASE/VIAL A087695 002 Apr 08, 1983
EQ 100MG BASE/VIAL A087695 003 Apr 08, 1983
EQ 250MG BASE/VIAL A088954 001 Oct 24, 1985
FOLEX PFS
PHARMACIA AND UPJOHN EQ 25MG BASE/ML A081242 001 Aug 23, 1991
EQ 25MG BASE/ML A089180 001 Jan 03, 1986
METHOTREXATE LPF
HOSPIRA EQ 25MG BASE/ML N011719 007 Mar 31, 1982
METHOTREXATE PRESERVATIVE FREE
FRESENIUS KABI USA EQ 25MG BASE/ML A040265 001 Feb 26, 1999
HOSPIRA EQ 2.5GM BASE/100ML (EQ 25MG BASE/ML) N011719 011 Apr 13, 2005
EQ 20MG BASE/2ML (EQ 10MG BASE/ML) N011719 014 Apr 13, 2005
EQ 500MG BASE/20ML (EQ 25MG BASE/ML) N011719 013 Apr 13, 2005
**Federal Register determination that
product was not discontinued or
withdrawn for safety or efficacy
reasons**
METHOTREXATE SODIUM
ABRAXIS PHARM EQ 2.5MG BASE/ML A089323 001 Jun 13, 1986
EQ 20MG BASE/VIAL A088935 001 Oct 11, 1985
EQ 25MG BASE/ML A089263 001 Jun 13, 1986
EQ 25MG BASE/ML A089322 001 Jun 13, 1986
EQ 50MG BASE/VIAL A088936 001 Oct 11, 1985
EQ 100MG BASE/VIAL A088937 001 Oct 11, 1985
HOSPIRA EQ 2.5MG BASE/ML N011719 004
EQ 20MG BASE/VIAL N011719 001
EQ 25MG BASE/ML N011719 005
EQ 50MG BASE/VIAL N011719 003
EQ 100MG BASE/VIAL N011719 006
NORBROOK EQ 25MG BASE/ML A088648 001 May 09, 1986
PHARMACHEMIE USA EQ 25MG BASE/ML A089158 001 Jul 08, 1988
METHOTREXATE SODIUM PRESERVATIVE FREE
HOSPIRA EQ 1GM BASE/VIAL N011719 009 Apr 07, 1988
MEXATE
BRISTOL EQ 20MG BASE/VIAL A086358 001
EQ 50MG BASE/VIAL A086358 002
EQ 100MG BASE/VIAL A086358 003
EQ 250MG BASE/VIAL A086358 004
MEXATE-AQ
BRISTOL MYERS EQ 25MG BASE/ML A088760 001 Feb 14, 1985
MEXATE-AQ PRESERVED
BRISTOL MYERS SQUIBB EQ 25MG BASE/ML A089887 001 Apr 14, 1989
TABLET;ORAL
METHOTREXATE SODIUM
DURAMED PHARMS BARR EQ 2.5MG BASE A040233 001 Jun 17, 1999
METHOXAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
VASOXYL
GLAXOSMITHKLINE 10MG/ML N006772 002
20MG/ML N006772 001
METHOXSALEN
CAPSULE;ORAL
METHOXSALEN
SANDOZ 10MG A087781 001 Jun 08, 1982
METHSCOPOLAMINE BROMIDE
TABLET;ORAL
METHSCOPOLAMINE BROMIDE
PVT FORM 2.5MG A080970 001
METHYCLOTHIAZIDE
TABLET;ORAL
AQUATENSEN
MEDPOINTE PHARM HLC 5MG N017364 001
ENDURON
ABBVIE 2.5MG **Federal Register determination N012524 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-221(of 337)
METHYCLOTHIAZIDE
TABLET;ORAL
ENDURON
5MG N012524 004
METHYCLOTHIAZIDE
IVAX PHARMS 2.5MG A087913 001 Jun 03, 1982
5MG A087786 001 May 18, 1982
MYLAN 2.5MG A087671 001 Aug 17, 1982
PAR PHARM 2.5MG A089135 001 Feb 12, 1986
5MG A089136 001 Feb 12, 1986
SANDOZ 2.5MG A089835 001 Aug 18, 1988
5MG A089837 001 Aug 18, 1988
USL PHARMA 5MG A088745 001 Mar 21, 1985
WATSON LABS 2.5MG A085487 001 Mar 11, 1982
2.5MG A088750 001 Sep 06, 1984
5MG A085476 001 Mar 11, 1982
5MG A088724 001 Sep 06, 1984
METHYCLOTHIAZIDE; PARGYLINE HYDROCHLORIDE
TABLET;ORAL
EUTRON
ABBOTT 5MG;25MG N016047 001
METHYCLOTHIAZIDE; RESERPINE
TABLET;ORAL
DIUTENSEN-R
MEDPOINTE PHARM HLC 2.5MG;0.1MG N012708 005
METHYL AMINOLEVULINATE HYDROCHLORIDE
CREAM;TOPICAL
METVIXIA
GALDERMA LABS LP EQ 16.8% BASE N021415 001 Jul 27, 2004
METHYLDOPA
SUSPENSION;ORAL
ALDOMET
MERCK 250MG/5ML N018389 001
TABLET;ORAL
ALDOMET
MERCK 125MG N013400 003
250MG N013400 001
500MG N013400 002
METHYLDOPA
ACCORD HLTHCARE 125MG A070070 003 Oct 15, 1985
DURAMED PHARMS BARR 250MG A071006 001 Dec 16, 1986
500MG A071009 001 Dec 16, 1986
HALSEY 125MG A071751 001 Mar 28, 1988
250MG A071752 001 Mar 28, 1988
500MG A071753 001 Mar 28, 1988
MUTUAL PHARM 125MG A070073 001 Oct 09, 1986
250MG A070060 001 Oct 09, 1986
500MG A070074 001 Oct 09, 1986
PAR PHARM 125MG A070535 001 Jan 02, 1987
250MG A070536 001 Jan 02, 1987
500MG A070537 001 Jan 02, 1987
PARKE DAVIS 125MG A070331 001 Apr 15, 1986
250MG A070332 001 Apr 15, 1986
500MG A070333 001 Apr 15, 1986
PLIVA 125MG A072126 001 Jul 07, 1988
250MG A072127 001 Jul 07, 1988
500MG A072128 001 Jul 07, 1988
PUREPAC PHARM 125MG A070749 001 Feb 07, 1986
250MG A070750 001 Feb 07, 1986
500MG A070452 001 Feb 07, 1986
ROXANE 125MG A070192 001 Apr 25, 1986
250MG A070193 001 Apr 25, 1986
500MG A070194 001 Apr 25, 1986
SANDOZ 125MG A071700 001 Mar 02, 1988
250MG N018934 001 Jun 29, 1984
500MG N018934 002 Jun 29, 1984
SUPERPHARM 250MG A070669 001 Jun 23, 1989
500MG A070670 001 Jun 23, 1989
TEVA 125MG A071105 001 Dec 05, 1986
250MG A071106 001 Dec 05, 1986
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-222(of 337)
METHYLDOPA
TABLET;ORAL
METHYLDOPA
500MG A071067 001 Dec 05, 1986
WATSON LABS 125MG A070245 001 Feb 25, 1986
125MG A070260 001 Jun 24, 1985
250MG A070246 001 Feb 25, 1986
250MG A070261 001 Jun 24, 1985
250MG A070703 001 Jun 06, 1986
500MG A070247 001 Feb 25, 1986
500MG A070262 001 Jun 24, 1985
METHYLDOPATE HYDROCHLORIDE
INJECTABLE;INJECTION
ALDOMET
MERCK 50MG/ML N013401 001
METHYLDOPATE HYDROCHLORIDE
ABRAXIS PHARM 50MG/ML A070652 001 Jun 03, 1986
BAXTER HLTHCARE 50MG/ML A070291 001 Jul 01, 1986
HOSPIRA 50MG/ML A070691 001 Jun 19, 1987
50MG/ML A070698 001 Jun 15, 1987
50MG/ML A070699 001 Jun 15, 1987
50MG/ML A070849 001 Jun 19, 1987
MARSAM PHARMS LLC 50MG/ML A071812 001 Dec 22, 1987
SMITH AND NEPHEW 50MG/ML A070841 001 Jan 02, 1987
TEVA PARENTERAL 50MG/ML A072974 001 Nov 22, 1991
METHYLPHENIDATE HYDROCHLORIDE
TABLET;ORAL
METHYLPHENIDATE HYDROCHLORIDE
ABLE 5MG A040404 001 Mar 29, 2001
10MG A040404 002 Mar 29, 2001
20MG A040404 003 Mar 29, 2001
ACTAVIS ELIZABETH 5MG A040321 001 Feb 05, 2002
10MG A040321 002 Feb 05, 2002
20MG A040321 003 Feb 05, 2002
TABLET, EXTENDED RELEASE;ORAL
METADATE ER
UCB INC 10MG A040306 001 Oct 20, 1999
METHYLPHENIDATE HYDROCHLORIDE
ABLE 20MG A076032 001 May 09, 2001
ACTAVIS ELIZABETH 20MG A075450 001 Dec 21, 2001
WATSON LABS 20MG A040410 001 Feb 09, 2001
METHYLPREDNISOLONE
TABLET;ORAL
MEDROL
PHARMACIA AND UPJOHN 24MG N011153 005
METHYLPREDNISOLONE
HEATHER 4MG A085650 001
PAR PHARM 16MG A089207 001 Apr 25, 1988
24MG A089208 001 Apr 25, 1988
32MG A089209 001 Apr 25, 1988
SANDOZ 4MG A087341 001
WATSON LABS 4MG A086161 001 Feb 09, 1982
16MG A086159 001 Feb 09, 1982
METHYLPREDNISOLONE ACETATE
ENEMA;RECTAL
MEDROL
PHARMACIA AND UPJOHN 40MG/BOT N018102 001
INJECTABLE;INJECTION
M-PREDROL
BEL MAR 40MG/ML A086666 001
80MG/ML A087135 001
METHYLPREDNISOLONE ACETATE
AKORN 40MG/ML A086903 001 Oct 20, 1982
80MG/ML A086903 002 Oct 20, 1982
WATSON LABS 20MG/ML A085597 001
20MG/ML A087248 001
40MG/ML A085374 001
40MG/ML A085600 001
80MG/ML A085595 001
80MG/ML A086507 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-223(of 337)
METHYLPREDNISOLONE ACETATE
OINTMENT;TOPICAL
MEDROL ACETATE
PHARMACIA AND UPJOHN 0.25% N012421 001
1% N012421 002
METHYLPREDNISOLONE ACETATE; NEOMYCIN SULFATE
CREAM;TOPICAL
NEO-MEDROL ACETATE
PHARMACIA AND UPJOHN 0.25%;EQ 3.5MG BASE/GM A060611 002
1%;EQ 3.5MG BASE/GM A060611 001
METHYLPREDNISOLONE SODIUM SUCCINATE
INJECTABLE;INJECTION
A-METHAPRED
ABBOTT EQ 1GM BASE/VIAL A089576 001 Feb 22, 1991
EQ 40MG BASE/VIAL A089573 001 Feb 22, 1991
EQ 125MG BASE/VIAL A089574 001 Feb 22, 1991
EQ 500MG BASE/VIAL A089575 001 Feb 22, 1991
HOSPIRA EQ 1GM BASE/VIAL A085852 001
EQ 1GM BASE/VIAL A089174 001 Aug 18, 1987
EQ 40MG BASE/VIAL A085853 001
EQ 125MG BASE/VIAL A085855 001
EQ 500MG BASE/VIAL A085854 001
EQ 500MG BASE/VIAL A089173 001 Aug 18, 1987
METHYLPREDNISOLONE
ELKINS SINN EQ 1GM BASE/VIAL A086906 004
EQ 125MG BASE/VIAL A086906 002
EQ 500MG BASE/VIAL A086906 003
ORGANON USA INC EQ 1GM BASE/VIAL A087535 002 Jun 25, 1982
EQ 500MG BASE/VIAL A087535 001 Jun 25, 1982
METHYLPREDNISOLONE SODIUM SUCCINATE
ABRAXIS PHARM EQ 1GM BASE/VIAL A088679 001 Jun 08, 1984
EQ 1GM BASE/VIAL A089188 001 Mar 28, 1986
EQ 1GM BASE/VIAL A089189 001 Mar 28, 1986
EQ 40MG BASE/VIAL A088676 001 Jun 08, 1984
EQ 40MG BASE/VIAL A089143 001 Mar 28, 1986
EQ 125MG BASE/VIAL A088677 001 Jun 08, 1984
EQ 125MG BASE/VIAL A089144 001 Mar 28, 1986
EQ 500MG BASE/VIAL A088678 001 Jun 08, 1984
EQ 500MG BASE/VIAL A089186 001 Mar 28, 1986
EQ 500MG BASE/VIAL A089187 001 Mar 28, 1986
BEDFORD LABS EQ 1GM BASE/VIAL A040641 004 Feb 21, 2007
EQ 1GM BASE/VIAL A040709 002 Feb 21, 2007
EQ 40MG BASE/VIAL A040662 001 Feb 21, 2007
EQ 125MG BASE/VIAL A040641 002 Feb 21, 2007
EQ 500MG BASE/VIAL A040641 003 Feb 21, 2007
EQ 500MG BASE/VIAL A040709 001 Feb 21, 2007
ELKINS SINN EQ 40MG BASE/VIAL A086906 001
INTL MEDICATION EQ 1GM BASE/VIAL A087852 001 Feb 09, 1983
EQ 40MG BASE/VIAL A087812 001 Feb 09, 1983
EQ 125MG BASE/VIAL A087813 001 Feb 09, 1983
EQ 500MG BASE/VIAL A087851 001 Feb 09, 1983
TEVA PARENTERAL EQ 1GM BASE/VIAL A081268 001 Nov 30, 1992
EQ 125MG BASE/VIAL A081266 001 Nov 30, 1992
EQ 500MG BASE/VIAL A081267 001 Nov 30, 1992
WATSON LABS EQ 1GM BASE/VIAL A088524 001 Jul 24, 1984
EQ 40MG BASE/VIAL A086953 001 Jul 22, 1982
EQ 125MG BASE/VIAL A087030 001 Jul 22, 1982
EQ 500MG BASE/VIAL A088523 001 Jul 24, 1984
METHYLPREDNISOLONE; NEOMYCIN SULFATE
OINTMENT;OPHTHALMIC
NEO-MEDROL
PHARMACIA AND UPJOHN 0.1%;EQ 3.5MG BASE/GM A060645 001
METHYLTESTOSTERONE
CAPSULE;ORAL
METHYLTESTOSTERONE
HEATHER 10MG A084967 001
VIRILON
STAR PHARMS FL 10MG A087750 001 Nov 24, 1982
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-224(of 337)
METHYLTESTOSTERONE
TABLET;BUCCAL
ANDROID 5
VALEANT PHARM INTL 5MG
A087222 001
ORETON
SCHERING 10MG
A080281 001
TABLET;BUCCAL, SUBLINGUAL
METANDREN
NOVARTIS 5MG
N003240 004
10MG
N003240 001
10MG
N003240 005
25MG
N003240 003
METHYLTESTOSTERONE
IMPAX LABS 10MG
A084287 001
LILLY 10MG
A080256 001
25MG
A080256 002
PUREPAC PHARM 10MG
A080308 001
10MG
A080475 001
10MG
A080475 002
25MG
A080475 003
PVT FORM 5MG
A083836 001
TABLICAPS 10MG
A085125 001
USL PHARMA 10MG
A080271 001
TABLET;ORAL
METHYLTESTOSTERONE
INWOOD LABS 10MG
A080839 001
25MG
A080973 001
KV PHARM 10MG
A084312 001
LANNETT 10MG
A087092 001 Nov 05, 1982
25MG
A087111 001 Jan 27, 1983
PARKE DAVIS 10MG
A084244 001
25MG
A084241 001
PUREPAC PHARM 10MG
A080309 001
25MG
A080310 001
PVT FORM 5MG
A080214 001
10MG
A080214 002
25MG
A080214 003
TABLICAPS 10MG
A080313 001
25MG
A085270 001
WATSON LABS 10MG
A080933 001
25MG
A080931 001
WEST WARD 10MG
A084331 001
25MG
A084331 002
25MG
A084642 001
ORETON METHYL
SCHERING 10MG
N003158 001
25MG
N003158 002
METHYPRYLON
CAPSULE;ORAL
NOLUDAR
ROCHE 300MG
N009660 008
ELIXIR;ORAL
NOLUDAR
ROCHE 50MG/5ML
N009660 007
TABLET;ORAL
NOLUDAR
ROCHE 50MG
N009660 002
200MG
N009660 004
METHYSERGIDE MALEATE
TABLET;ORAL
SANSERT
NOVARTIS 2MG
N012516 001
METOCLOPRAMIDE HYDROCHLORIDE
CONCENTRATE;ORAL
METOCLOPRAMIDE INTENSOL
ROXANE EQ 10MG BASE/ML
A072995 001 Jan 30, 1992
INJECTABLE;INJECTION
METOCLOPRAMIDE HYDROCHLORIDE
BEDFORD EQ 5MG BASE/ML A072155 001 Mar 30, 1992
EQ 5MG BASE/ML A072244 001 Mar 30, 1992
EQ 5MG BASE/ML A072247 001 May 18, 1992
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-225(of 337)
METOCLOPRAMIDE HYDROCHLORIDE
INJECTABLE;INJECTION
METOCLOPRAMIDE HYDROCHLORIDE
HOSPIRA EQ 5MG BASE/ML A070505 001 Jun 23, 1989
EQ 5MG BASE/ML A070506 001 Jun 22, 1989
EQ 5MG BASE/ML A070847 001 Nov 07, 1988
EQ 5MG BASE/ML A071291 001 Mar 03, 1989
EQ 5MG BASE/ML A071990 001 Jan 18, 1989
EQ 5MG BASE/ML A073117 001 Jan 17, 1991
EQ 5MG BASE/ML A074147 001 Aug 02, 1996
LYPHOMED EQ 10MG BASE/2ML A070293 001 Jan 24, 1986
NORBROOK EQ 10MG BASE/2ML A070892 001 Aug 26, 1988
SMITH AND NEPHEW EQ 5MG BASE/ML A070623 001 Mar 02, 1987
EQ 10MG BASE/2ML A070622 001 Mar 02, 1987
REGLAN
BAXTER HLTHCARE CORP EQ 10MG BASE/ML N017862 004 May 28, 1987
SOLUTION;ORAL
METOCLOPRAMIDE HYDROCHLORIDE
ACTAVIS MID ATLANTIC EQ 5MG BASE/5ML A071340 001 Aug 18, 1988
MORTON GROVE EQ 5MG BASE/5ML A070949 001 Mar 06, 1987
PACO EQ 5MG BASE/5ML A071665 001 Dec 05, 1988
ROXANE EQ 5MG BASE/5ML A072038 001 Dec 05, 1988
TEVA EQ 5MG BASE/5ML A070819 001 Jul 10, 1987
EQ 5MG BASE/5ML A071315 001 Jun 30, 1993
REGLAN
ROBINS AH EQ 5MG BASE/5ML **Federal Register N018821 001 Mar 25, 1983
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
TABLET;ORAL
CLOPRA
QUANTUM PHARMICS EQ 5MG BASE A072384 001 Jun 02, 1988
EQ 10MG BASE A070294 001 Jul 29, 1985
CLOPRA-"YELLOW"
QUANTUM PHARMICS EQ 10MG BASE A070632 001 Oct 28, 1985
MAXOLON
KING PHARMS EQ 10MG BASE A070106 001 Mar 04, 1986
METOCLOPRAMIDE HYDROCHLORIDE
CLONMEL EQ 10MG BASE A072639 001 May 09, 1991
HALSEY EQ 10MG BASE A070906 001 Oct 28, 1986
INTERPHARM EQ 10MG BASE A071213 001 Sep 24, 1986
MUTUAL PHARM EQ 10MG BASE A070660 001 Feb 10, 1987
EQ 10MG BASE A071536 001 Apr 28, 1993
PAR PHARM EQ 10MG BASE A070342 001 Mar 25, 1986
SANDOZ EQ 5MG BASE A072436 001 Jun 22, 1989
EQ 5MG BASE A074478 001 Oct 05, 1995
EQ 10MG BASE A070850 001 Feb 03, 1987
EQ 10MG BASE A072215 001 Jan 30, 1990
EQ 10MG BASE A074478 002 Oct 05, 1995
SCHERING EQ 10MG BASE A070598 001 Feb 02, 1987
SUPERPHARM EQ 10MG BASE A070926 001 Jun 26, 1987
USL PHARMA EQ 10MG BASE A070339 001 Jul 29, 1985
WATSON LABS EQ 10MG BASE A070363 001 Mar 02, 1987
EQ 10MG BASE A070453 001 Jun 06, 1986
EQ 10MG BASE A070511 001 Jan 22, 1986
EQ 10MG BASE A070645 001 May 11, 1987
TABLET, ORALLY DISINTEGRATING;ORAL
METOZOLV ODT
SALIX PHARMS EQ 10MG BASE **Federal Register N022246 002 Sep 04, 2009
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
REGLAN ODT
MEDA PHARMS EQ 5MG BASE N021793 001 Jun 10, 2005
EQ 10MG BASE N021793 002 Jun 10, 2005
METOCURINE IODIDE
INJECTABLE;INJECTION
METUBINE IODIDE
LILLY 2MG/ML N006632 003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-226(of 337)
METOLAZONE
TABLET;ORAL
DIULO
GD SEARLE LLC 2.5MG
N018535 001
5MG
N018535 002
10MG
N018535 003
METOLAZONE
ROXANE 10MG
A076482 002 Apr 29, 2004
TEVA 2.5MG
A076600 001 Jan 06, 2004
5MG
A076833 001 Mar 01, 2004
10MG
A075543 003 Dec 24, 2003
WATSON LABS 10MG
A076891 001 Jul 21, 2004
MYKROX
UCB INC 0.5MG
N019532 001 Oct 30, 1987
METOPROLOL FUMARATE
TABLET, EXTENDED RELEASE;ORAL
LOPRESSOR
NOVARTIS EQ 100MG TARTRATE
N019786 001 Dec 27, 1989
EQ 200MG TARTRATE
N019786 002 Dec 27, 1989
EQ 300MG TARTRATE
N019786 003 Dec 27, 1989
EQ 400MG TARTRATE
N019786 004 Dec 27, 1989
METOPROLOL SUCCINATE
TABLET, EXTENDED RELEASE;ORAL
METOPROLOL SUCCINATE
NESHER PHARMS EQ 25MG TARTRATE
A077779 001 Mar 20, 2008
EQ 50MG TARTRATE
A077176 001 May 14, 2008
EQ 100MG TARTRATE
A076640 002 May 18, 2007
EQ 200MG TARTRATE
A076640 001 May 18, 2007
SANDOZ EQ 25MG TARTRATE
A076969 001 Jul 31, 2006
EQ 50MG TARTRATE
A076969 002 May 18, 2007
EQ 100MG TARTRATE
A076969 003 Mar 20, 2008
EQ 200MG TARTRATE
A076969 004 Mar 20, 2008
METOPROLOL TARTRATE
INJECTABLE;INJECTION
METOPROLOL TARTRATE
WATSON LABS 1MG/ML
A074032 001 Dec 21, 1993
TABLET;ORAL
METOPROLOL TARTRATE
APOTHECON 50MG
A074258 001 Jan 27, 1994
100MG
A074258 002 Jan 27, 1994
MYLAN 50MG
A073666 001 Dec 21, 1993
100MG
A073666 002 Dec 21, 1993
PRINSTON INC 50MG
A074453 001 Apr 27, 1995
100MG
A074453 002 Apr 27, 1995
PUREPAC PHARM 50MG
A074380 001 Jul 29, 1994
100MG
A074380 002 Jul 29, 1994
TEVA 50MG
A074143 001 Sep 30, 1994
100MG
A074143 002 Sep 30, 1994
TEVA PHARMS 50MG
A074333 001 Jan 27, 1994
100MG
A074333 002 Jan 27, 1994
METRIZAMIDE
INJECTABLE;INJECTION
AMIPAQUE
GE HEALTHCARE 2.5GM/VIAL
N017982 003 Sep 12, 1983
3.75GM/VIAL
N017982 001
6.75GM/VIAL
N017982 002
13.5GM/VIAL
N017982 004 Sep 12, 1983
METRONIDAZOLE
CAPSULE;ORAL
METRONIDAZOLE
ABLE 375MG
A076505 001 Nov 13, 2003
INJECTABLE;INJECTION
METRO I.V.
B BRAUN 500MG/100ML
N018674 001 Aug 31, 1982
METRONIDAZOLE
ABBOTT 500MG/100ML
N018889 001 Nov 18, 1983
ABRAXIS PHARM 500MG/100ML
A070071 001 Dec 03, 1984
HIKMA MAPLE 500MG/100ML
N018907 001 Mar 30, 1984
INTL MEDICATION 500MG/100ML
A070004 001 May 08, 1985
WATSON LABS 500MG/100ML
A070042 001 Dec 20, 1984
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DISCONTINUED DRUG PRODUCT LIST 6-227(of 337)
METRONIDAZOLE
INJECTABLE;INJECTION
METRONIDAZOLE
500MG/100ML A070170 001 Apr 01, 1986
TABLET;ORAL
METROMIDOL
LABS AF 250MG A074523 001 Oct 24, 1996
500MG A074523 002 Oct 24, 1996
METRONIDAZOLE
ABLE 250MG A076519 001 Jun 27, 2003
500MG A076519 002 Jun 27, 2003
HALSEY 250MG A070021 001 Apr 02, 1985
500MG A070593 001 Feb 27, 1986
IVAX SUB TEVA PHARMS 250MG N018517 001
500MG N018517 002 May 05, 1982
LNK 250MG N019029 001 Apr 10, 1984
MUTUAL PHARM 250MG N018818 001 Feb 16, 1983
500MG N018818 002 Feb 16, 1983
PAR PHARM 250MG N018845 001 Aug 18, 1983
500MG N018930 001 Aug 18, 1983
SANDOZ 250MG N018620 001 Mar 04, 1982
250MG N018740 001 Oct 22, 1982
500MG N018620 002 Jun 02, 1983
500MG N018740 002 Oct 22, 1982
SUPERPHARM 250MG A070008 001 Dec 11, 1984
500MG A070009 001 Dec 11, 1984
VIVIMED LABS 250MG A070040 001 Jan 29, 1985
500MG A070039 001 Jan 29, 1985
WATSON LABS 250MG N018599 001 Sep 17, 1982
250MG N018764 001 Sep 17, 1982
500MG N018599 002 Feb 13, 1984
500MG N018764 002 Dec 20, 1982
PROTOSTAT
ORTHO MCNEIL PHARM 250MG N018871 001 Mar 02, 1983
500MG N018871 002 Mar 02, 1983
SATRIC
SAVAGE LABS 250MG A070029 001 Mar 19, 1985
500MG A070731 001 Jun 08, 1987
TABLET, EXTENDED RELEASE;ORAL
METRONIDAZOLE
ABLE 750MG A076462 001 Jun 25, 2003
METRONIDAZOLE HYDROCHLORIDE
INJECTABLE;INJECTION
FLAGYL I.V.
PFIZER EQ 500MG BASE/VIAL N018353 001
METRONIDAZOLE HYDROCHLORIDE
ABRAXIS PHARM EQ 500MG BASE/VIAL A070295 001 Oct 15, 1985
METYRAPONE
TABLET;ORAL
METOPIRONE
HRA PHARMA 250MG N012911 001
MEXILETINE HYDROCHLORIDE
CAPSULE;ORAL
MEXILETINE HYDROCHLORIDE
SANDOZ 150MG A074450 001 May 16, 1996
200MG A074450 002 May 16, 1996
250MG A074450 003 May 16, 1996
WATSON LABS 150MG A074711 001 Feb 26, 1997
150MG A074865 001 Apr 13, 1998
200MG A074711 002 Feb 26, 1997
200MG A074865 002 Apr 13, 1998
250MG A074711 003 Feb 26, 1997
250MG A074865 003 Apr 13, 1998
MEXITIL
BOEHRINGER INGELHEIM 150MG N018873 002 Dec 30, 1985
200MG N018873 003 Dec 30, 1985
250MG N018873 004 Dec 30, 1985
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-228(of 337)
MEZLOCILLIN SODIUM MONOHYDRATE
INJECTABLE;INJECTION
MEZLIN
BAYER PHARMS EQ 1GM BASE/VIAL A062333 001
EQ 1GM BASE/VIAL A062372 005 Jan 13, 1983
EQ 1GM BASE/VIAL N050549 001
EQ 2GM BASE/VIAL A062333 002
EQ 2GM BASE/VIAL A062372 001 May 13, 1982
EQ 2GM BASE/VIAL N050549 002
EQ 3GM BASE/VIAL A062333 003
EQ 3GM BASE/VIAL A062372 002 May 13, 1982
EQ 3GM BASE/VIAL A062697 001 Jan 22, 1987
EQ 3GM BASE/VIAL N050549 003
EQ 4GM BASE/VIAL A062333 004
EQ 4GM BASE/VIAL A062372 003 May 13, 1982
EQ 4GM BASE/VIAL A062697 002 Jan 22, 1987
EQ 4GM BASE/VIAL N050549 004
EQ 20GM BASE/VIAL A062372 004 Mar 02, 1988
EQ 20GM BASE/VIAL N050549 005 Mar 02, 1988
MICONAZOLE
INJECTABLE;INJECTION
MONISTAT
JANSSEN PHARMA 10MG/ML N018040 001
MICONAZOLE NITRATE
CREAM;TOPICAL
MONISTAT-DERM
INSIGHT PHARMS 2% N017494 001
CREAM;VAGINAL
MICONAZOLE NITRATE
TEVA 2% A074136 001 Jan 04, 1995
TEVA PHARMS 2% A074030 001 Oct 30, 1992
CREAM, SUPPOSITORY;TOPICAL, VAGINAL
M-ZOLE 7 DUAL PACK
ACTAVIS MID ATLANTIC 2%,100MG A074586 001 Jul 17, 1997
LOTION;TOPICAL
MONISTAT-DERM
INSIGHT PHARMS 2% N017739 001
TAMPON;VAGINAL
MONISTAT 5
PERSONAL PRODS 100MG N018592 001 Oct 27, 1989
MIDAZOLAM HYDROCHLORIDE
INJECTABLE;INJECTION
MIDAZOLAM HYDROCHLORIDE
APOTEX INC EQ 1MG BASE/ML A075637 001 Oct 31, 2000
EQ 5MG BASE/ML A075637 002 Oct 31, 2000
APOTHECON EQ 1MG BASE/ML A075620 001 Nov 01, 2000
EQ 5MG BASE/ML A075620 002 Nov 01, 2000
EQ 5MG BASE/ML A075641 001 Oct 19, 2000
ASTRAZENECA EQ 5MG BASE/ML A075263 001 Jun 26, 2000
BEDFORD EQ 5MG BASE/ML A075249 001 Jun 23, 2000
BEN VENUE EQ 5MG BASE/ML A075455 001 Jun 20, 2000
HOSPIRA EQ 1MG BASE/ML A075396 001 Jun 20, 2000
EQ 5MG BASE/ML A075396 002 Jun 20, 2000
EQ 5MG BASE/ML A075484 001 Jun 20, 2000
HOSPIRA INC EQ 1MG BASE/ML A075409 002 Jun 20, 2000
EQ 5MG BASE/ML A075409 001 Jun 20, 2000
INTL MEDICATED EQ 1MG BASE/ML A076144 001 Jan 26, 2005
EQ 5MG BASE/ML A076144 002 Jan 26, 2005
INTL MEDICATION EQ 1MG BASE/ML A076020 001 Jul 16, 2004
EQ 5MG BASE/ML A076020 002 Jul 16, 2004
VERSED
HLR EQ 1MG BASE/ML N018654 002 May 26, 1987
EQ 5MG BASE/ML N018654 001 Dec 20, 1985
SYRUP;ORAL
MIDAZOLAM HYDROCHLORIDE
APOTEX INC EQ 2MG BASE/ML A077115 001 Sep 09, 2005
VERSED
ROCHE EQ 2MG BASE/ML N020942 001 Oct 15, 1998
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DISCONTINUED DRUG PRODUCT LIST 6-229(of 337)
MIDODRINE HYDROCHLORIDE
TABLET;ORAL
PROAMATINE
SHIRE LLC 2.5MG N019815 001 Sep 06, 1996
5MG N019815 002 Sep 06, 1996
10MG N019815 003 Mar 20, 2002
MILRINONE LACTATE
INJECTABLE;INJECTION
MILRINONE LACTATE
APOTEX INC EQ 1MG BASE/ML A076427 001 Sep 21, 2004
HIKMA MAPLE EQ 1MG BASE/ML A075852 001 May 28, 2002
HOSPIRA EQ 1MG BASE/ML A075830 001 May 28, 2002
EQ 1MG BASE/ML A075884 001 May 28, 2002
MYLAN INSTITUTIONAL EQ 1MG BASE/ML A076428 001 Jun 16, 2003
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER
APOTEX INC EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A077151 001 Jul 20, 2005
BAXTER HLTHCARE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A076259 001 Aug 08, 2002
HIKMA MAPLE EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) A075510 001 May 28, 2002
PRIMACOR
SANOFI AVENTIS US EQ 1MG BASE/ML N019436 001 Dec 31, 1987
PRIMACOR IN DEXTROSE 5% IN PLASTIC CONTAINER
SANOFI AVENTIS US EQ 10MG BASE/100ML N020343 001 Aug 09, 1994
EQ 15MG BASE/100ML N020343 002 Aug 09, 1994
EQ 20MG BASE/100ML (EQ 0.2MG BASE/ML) N020343 003 Aug 09, 1994
EQ 40MG BASE/200ML (EQ 0.2MG BASE/ML) N020343 004 Aug 09, 1994
MINOCYCLINE HYDROCHLORIDE
CAPSULE;ORAL
DYNACIN
CNTY LINE PHARMS EQ 50MG BASE A063066 001 Aug 14, 1990
MINOCIN
PRECISION DERMAT EQ 75MG BASE N050649 003 Feb 12, 2001
TRIAX PHARMS EQ 50MG BASE N050315 002
EQ 100MG BASE N050315 001
CAPSULE, EXTENDED RELEASE;ORAL
XIMINO
RANBAXY LABS LTD EQ 45MG BASE N201922 001 Jul 11, 2012
EQ 67.5MG BASE N201922 002 Jul 11, 2012
EQ 90MG BASE N201922 003 Jul 11, 2012
EQ 112.5MG BASE N201922 004 Jul 11, 2012
EQ 135MG BASE N201922 005 Jul 11, 2012
INJECTABLE;INJECTION
MINOCIN
LEDERLE EQ 100MG BASE/VIAL A062139 001
SUSPENSION;ORAL
MINOCIN
PRECISION DERMAT EQ 50MG BASE/5ML N050445 001
TABLET;ORAL
MINOCYCLINE HYDROCHLORIDE
TRIAX PHARMS EQ 50MG BASE N050451 003 Aug 10, 1982
EQ 100MG BASE N050451 002 Aug 10, 1982
TABLET, EXTENDED RELEASE;ORAL
MINOCYCLINE HYDROCHLORIDE
LUPIN LTD EQ 55MG BASE A091424 002 Nov 30, 2011
SOLODYN
MEDICIS EQ 45MG BASE N050808 001 May 08, 2006
EQ 90MG BASE N050808 002 May 08, 2006
EQ 135MG BASE N050808 003 May 08, 2006
MINOXIDIL
SOLUTION;TOPICAL
MINOXIDIL (FOR MEN)
APOTEX INC 2% A074924 001 Apr 29, 1998
BAUSCH AND LOMB 2% A074643 001 Apr 09, 1996
COPLEY PHARM 2% A074500 001 May 23, 1996
SIGHT PHARMS 2% A074743 002 Oct 18, 1996
TEVA 2% A074589 001 Apr 05, 1996
MINOXIDIL (FOR WOMEN)
APOTEX INC 2% A074924 002 Apr 29, 1998
SIGHT PHARMS 2% A074743 001 Oct 18, 1996
MINOXIDIL EXTRA STRENGTH (FOR MEN)
APOTEX INC 5% A075839 001 Oct 01, 2001
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DISCONTINUED DRUG PRODUCT LIST 6-230(of 337)
MINOXIDIL
TABLET;ORAL
LONITEN
PHARMACIA AND UPJOHN 2.5MG N018154 001
10MG N018154 003
MINODYL
QUANTUM PHARMICS 2.5MG A072153 001 Jul 13, 1988
10MG A071534 001 Mar 19, 1987
MINOXIDIL
ROYCE LABS 2.5MG A071799 001 Nov 10, 1987
10MG A071796 001 Nov 10, 1987
USL PHARMA 2.5MG A071537 001 Dec 16, 1988
MIRTAZAPINE
TABLET;ORAL
MIRTAZAPINE
ACTAVIS ELIZABETH 15MG A076241 001 Jun 25, 2003
15MG A076308 001 Jun 20, 2003
30MG A076241 002 Jun 25, 2003
30MG A076308 002 Jun 20, 2003
45MG A076241 003 Jun 25, 2003
45MG A076308 003 Jun 20, 2003
IVAX SUB TEVA PHARMS 15MG A076244 001 Dec 22, 2003
30MG A076244 002 Dec 22, 2003
45MG A076244 003 Dec 22, 2003
ROXANE 15MG A076270 001 Jun 19, 2003
30MG A076270 002 Jun 19, 2003
45MG A076270 003 Jun 19, 2003
SANDOZ 15MG A076189 001 Jun 19, 2003
30MG A076189 002 Jun 19, 2003
45MG A076189 003 Jun 19, 2003
TABLET, ORALLY DISINTEGRATING;ORAL
MIRTAZAPINE
ACTAVIS ELIZABETH 15MG A076689 001 Aug 31, 2005
15MG A077959 001 Feb 14, 2011
30MG A076689 002 Aug 31, 2005
30MG A077959 002 Feb 14, 2011
45MG A076689 003 Aug 31, 2005
45MG A077959 003 Feb 14, 2011
MITOMYCIN
INJECTABLE;INJECTION
MITOMYCIN
HOSPIRA 20MG/VIAL A064106 001 Nov 29, 1995
MITOZYTREX
SUPERGEN 5MG/VIAL N050763 001 Nov 14, 2002
MUTAMYCIN
BRISTOL 5MG/VIAL N050450 001
20MG/VIAL N050450 002
BRISTOL MYERS 5MG/VIAL A062336 001
20MG/VIAL A062336 002
40MG/VIAL A062336 003 Mar 10, 1988
MITOXANTRONE HYDROCHLORIDE
INJECTABLE;INJECTION
MITOXANTRONE HYDROCHLORIDE
FRESENIUS KABI ONCOL EQ 20MG BASE/10ML (EQ 2MG BASE/ML) A078606 001 May 14, 2008
EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) A078606 002 May 14, 2008
EQ 30MG BASE/15ML (EQ 2MG BASE/ML) A078606 003 May 14, 2008
NOVANTRONE
EMD SERONO EQ 20MG BASE/10ML (EQ 2MG BASE/ML) N019297 001 Dec 23, 1987
EQ 25MG BASE/12.5ML (EQ 2MG BASE/ML) N019297 002 Dec 23, 1987
EQ 30MG BASE/15ML (EQ 2MG BASE/ML) N019297 003 Dec 23, 1987
MIVACURIUM CHLORIDE
INJECTABLE;INJECTION
MIVACRON
ABBVIE EQ 2MG BASE/ML N020098 001 Jan 22, 1992
MIVACRON IN DEXTROSE 5% IN PLASTIC CONTAINER
ABBVIE EQ 0.5MG BASE/ML N020098 002 Jan 22, 1992
EQ 50MG BASE/100ML N020098 003 Jan 22, 1992
MIVACURIUM CHLORIDE
AGILA SPECLTS EQ 2MG BASE/ML A078562 001 Apr 30, 2009
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DISCONTINUED DRUG PRODUCT LIST 6-231(of 337)
MOLINDONE HYDROCHLORIDE
CAPSULE;ORAL
MOBAN
ENDO PHARMS 5MG **Federal Register determination N017111 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
10MG **Federal Register determination N017111 002
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
25MG **Federal Register determination N017111 003
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
CONCENTRATE;ORAL
MOBAN
ENDO PHARMS 20MG/ML N017938 001
TABLET;ORAL
MOBAN
ENDO PHARMS 5MG **Federal Register determination N017111 004
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
10MG **Federal Register determination N017111 005
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
25MG **Federal Register determination N017111 006
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
50MG **Federal Register determination N017111 007
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
100MG **Federal Register determination N017111 008
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
MOMETASONE FUROATE
OINTMENT;TOPICAL
MOMETASONE FUROATE
TARO 0.1% A076624 001 Dec 03, 2004
MONOBENZONE
CREAM;TOPICAL
BENOQUIN
VALEANT PHARM INTL 20% N008173 003
MONOCTANOIN
LIQUID;PERFUSION, BILIARY
MOCTANIN
ETHITEK 100% N019368 001 Oct 29, 1985
MORICIZINE HYDROCHLORIDE
TABLET;ORAL
ETHMOZINE
SHIRE 200MG N019753 001 Jun 19, 1990
250MG N019753 002 Jun 19, 1990
300MG N019753 003 Jun 19, 1990
MORPHINE SULFATE
INJECTABLE;INJECTION
MORPHINE SULFATE
HOSPIRA 0.5MG/ML N019917 001 Oct 30, 1992
MALLINCKRODT 1MG/ML N020631 001 Jul 03, 1996
2MG/ML N020631 002 Jul 03, 1996
WATSON LABS 0.5MG/ML A073373 001 Sep 30, 1991
0.5MG/ML A073375 001 Sep 30, 1991
1MG/ML A073374 001 Sep 30, 1991
1MG/ML A073376 001 Sep 30, 1991
INJECTABLE, LIPOSOMAL;EPIDURAL
DEPODUR
PACIRA PHARMS INC 10MG/ML (10MG/ML) N021671 001 May 18, 2004
15MG/1.5ML (10MG/ML) N021671 002 May 18, 2004
20MG/2ML (10MG/ML) N021671 003 May 18, 2004
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DISCONTINUED DRUG PRODUCT LIST 6-232(of 337)
MORPHINE SULFATE
TABLET, EXTENDED RELEASE;ORAL
MORPHINE SULFATE
WATSON LABS 100MG A075656 001 Jan 30, 2001
ORAMORPH SR
XANODYNE PHARMS INC 15MG N019977 004 Nov 23, 1994
30MG N019977 001 Aug 15, 1991
60MG N019977 002 Aug 15, 1991
100MG N019977 003 Aug 15, 1991
MOXALACTAM DISODIUM
INJECTABLE;INJECTION
MOXAM
LILLY EQ 1GM BASE/VIAL N050550 003
EQ 2GM BASE/VIAL N050550 004
EQ 10GM BASE/VIAL N050550 008
EQ 250MG BASE/VIAL N050550 001
EQ 500MG BASE/VIAL N050550 002
MYCOPHENOLATE MOFETIL
CAPSULE;ORAL
MYCOPHENOLATE MOFETIL
ZYDUS PHARMS USA INC 250MG A065433 001 May 04, 2009
TABLET;ORAL
MYCOPHENOLATE MOFETIL
DR REDDYS LABS LTD 500MG A090464 001 Sep 13, 2010
ZYDUS PHARMS USA INC 500MG A065477 001 May 04, 2009
NABUMETONE
TABLET;ORAL
NABUMETONE
COPLEY PHARM 750MG A075179 001 Jun 06, 2000
DR REDDYS LABS LTD 500MG A078420 001 Sep 24, 2008
750MG A078420 002 Sep 24, 2008
PROSAM LABS 500MG A079093 001 Feb 27, 2009
750MG A079093 002 Feb 27, 2009
SANDOZ 500MG A075590 001 Feb 25, 2002
750MG A075590 002 Feb 25, 2002
RELAFEN
SMITHKLINE BEECHAM 500MG N019583 001 Dec 24, 1991
750MG N019583 002 Dec 24, 1991
NADOLOL
TABLET;ORAL
CORGARD
KING PHARMS 120MG N018063 003
160MG N018063 004
NADOLOL
IVAX SUB TEVA PHARMS 120MG A074255 002 Jan 24, 1996
160MG A074255 003 Jan 24, 1996
TEVA PHARMS 80MG A074368 001 Aug 31, 1994
120MG A074368 002 Aug 31, 1994
160MG A074368 003 Aug 31, 1994
NAFCILLIN SODIUM
CAPSULE;ORAL
UNIPEN
WYETH AYERST EQ 250MG BASE N050111 001
FOR SOLUTION;ORAL
UNIPEN
WYETH AYERST EQ 250MG BASE/5ML N050199 001
INJECTABLE;INJECTION
NAFCILLIN SODIUM
APOTHECON EQ 1GM BASE/VIAL A061984 002
EQ 2GM BASE/VIAL A061984 003
EQ 4GM BASE/VIAL A061984 005
EQ 500MG BASE/VIAL A061984 001
SANDOZ EQ 500MG BASE/VIAL A062527 001 Aug 02, 1984
WATSON LABS INC EQ 1GM BASE/VIAL A062844 002 Oct 26, 1988
EQ 1.5GM BASE/VIAL A062844 003 Oct 26, 1988
EQ 2GM BASE/VIAL A062844 004 Oct 26, 1988
EQ 4GM BASE/VIAL A062844 005 Oct 26, 1988
EQ 10GM BASE/VIAL A063008 001 Sep 29, 1988
EQ 500MG BASE/VIAL A062844 001 Oct 26, 1988
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DISCONTINUED DRUG PRODUCT LIST 6-233(of 337)
NAFCILLIN SODIUM
INJECTABLE;INJECTION
NALLPEN
GLAXOSMITHKLINE EQ 1GM BASE/VIAL A061999 002
EQ 1GM BASE/VIAL A062755 001 Dec 19, 1986
EQ 2GM BASE/VIAL A061999 003
EQ 2GM BASE/VIAL A062755 002 Dec 19, 1986
EQ 10GM BASE/VIAL A061999 004
EQ 500MG BASE/VIAL A061999 001
UNIPEN
WYETH AYERST EQ 1GM BASE/VIAL A062717 002 Dec 16, 1986
EQ 2GM BASE/VIAL A062717 004 Dec 16, 1986
EQ 2GM BASE/VIAL N050320 003
EQ 4GM BASE/VIAL N050320 004
EQ 10GM BASE/VIAL N050320 005
EQ 20GM BASE/VIAL N050320 006
EQ 500MG BASE/VIAL A062717 001 Dec 16, 1986
EQ 500MG BASE/VIAL N050320 001
UNIPEN IN PLASTIC CONTAINER
WYETH AYERST EQ 1GM BASE/VIAL N050320 002
TABLET;ORAL
UNIPEN
WYETH AYERST EQ 500MG BASE N050462 001
NALBUPHINE HYDROCHLORIDE
INJECTABLE;INJECTION
NALBUPHINE
ABRAXIS PHARM 10MG/ML A070751 001 Jul 02, 1986
20MG/ML A070752 001 Sep 24, 1986
NALBUPHINE HYDROCHLORIDE
ABBOTT 20MG/ML A070917 001 Feb 03, 1989
ABBVIE 1.5MG/ML N020200 001 Mar 12, 1993
ASTRAZENECA 10MG/ML A072070 001 Apr 10, 1989
10MG/ML A072071 001 Apr 10, 1989
10MG/ML A072072 001 Apr 10, 1989
20MG/ML A072073 001 Apr 10, 1989
20MG/ML A072074 001 Apr 10, 1989
20MG/ML A072075 001 Apr 10, 1989
BARR 10MG/ML A074471 001 Mar 19, 1998
20MG/ML A074471 002 Mar 19, 1998
NUBAIN
ENDO PHARMS 10MG/ML N018024 001
20MG/ML N018024 002 May 27, 1982
NALIDIXIC ACID
SUSPENSION;ORAL
NEGGRAM
SANOFI AVENTIS US 250MG/5ML N017430 001
TABLET;ORAL
NALIDIXIC ACID
MUTUAL PHARM 1GM A070272 001 Jun 29, 1988
250MG A070270 001 Jun 29, 1988
500MG A070271 001 Jun 29, 1988
WATSON LABS 1GM A071919 001 Jun 29, 1988
250MG A071936 001 Jun 29, 1988
500MG A072061 001 Jun 29, 1988
NEGGRAM
SANOFI AVENTIS US 1GM N014214 005
250MG N014214 002
500MG N014214 004
NALMEFENE HYDROCHLORIDE
INJECTABLE;INJECTION
REVEX
BAXTER HLTHCARE CORP EQ 0.1MG BASE/ML N020459 001 Apr 17, 1995
EQ 1MG BASE/ML N020459 002 Apr 17, 1995
NALOXONE HYDROCHLORIDE
INJECTABLE;INJECTION
NALOXONE
HIKMA MAPLE 0.4MG/ML A070298 001 Sep 24, 1986
0.4MG/ML A070299 001 Sep 24, 1986
0.4MG/ML A070496 001 Sep 24, 1986
WYETH AYERST 0.02MG/ML A070188 001 Sep 24, 1986
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DISCONTINUED DRUG PRODUCT LIST 6-234(of 337)
NALOXONE HYDROCHLORIDE
INJECTABLE;INJECTION
NALOXONE
0.02MG/ML A070189 001 Sep 24, 1986
0.4MG/ML A070190 001 Sep 24, 1986
0.4MG/ML A070191 001 Sep 24, 1986
NALOXONE HYDROCHLORIDE
ABRAXIS PHARM 0.02MG/ML A070648 001 Nov 17, 1986
0.02MG/ML A070661 001 Nov 17, 1986
0.4MG/ML A070649 001 Nov 17, 1986
1MG/ML A071604 001 Dec 16, 1988
ASTRAZENECA 0.02MG/ML A072081 001 Apr 11, 1989
0.02MG/ML A072082 001 Apr 11, 1989
0.02MG/ML A072083 001 Apr 11, 1989
0.02MG/ML A072084 001 Apr 11, 1989
0.02MG/ML A072085 001 Apr 11, 1989
0.4MG/ML A072086 001 Apr 11, 1989
0.4MG/ML A072087 001 Apr 11, 1989
0.4MG/ML A072088 001 Apr 11, 1989
0.4MG/ML A072089 001 Apr 11, 1989
0.4MG/ML A072090 001 Apr 11, 1989
1MG/ML A072091 001 Apr 11, 1989
1MG/ML A072092 001 Apr 11, 1989
1MG/ML A072093 001 Apr 11, 1989
HIKMA MAPLE 0.02MG/ML A071272 001 May 24, 1988
1MG/ML A071273 001 May 24, 1988
1MG/ML A071274 001 May 24, 1988
1MG/ML A071287 001 May 24, 1988
HOSPIRA 0.02MG/ML A070171 001 Sep 24, 1986
0.02MG/ML A070252 001 Jan 16, 1987
0.02MG/ML A070253 001 Jan 16, 1987
0.4MG/ML A070255 001 Jan 07, 1987
INTL MEDICATION 0.4MG/ML A070417 001 Sep 24, 1986
1MG/ML A072115 001 Apr 27, 1988
MARSAM PHARMS LLC 0.4MG/ML A071811 001 Jul 19, 1988
SMITH AND NEPHEW 0.02MG/ML A071671 001 Nov 17, 1987
0.4MG/ML A071681 001 Nov 17, 1987
0.4MG/ML A071682 001 Nov 17, 1987
SOLOPAK 0.02MG/ML A071672 001 Nov 17, 1987
0.4MG/ML A071683 001 Nov 17, 1987
WATSON LABS 0.4MG/ML A071339 001 Nov 18, 1987
NARCAN
BRISTOL MYERS SQUIBB 0.4MG/ML A071083 001 Jul 28, 1988
1MG/ML A071084 001 Jul 28, 1988
1MG/ML A071311 001 Jul 28, 1988
ENDO PHARMS 0.02MG/ML **Federal Register N016636 002
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
0.4MG/ML **Federal Register N016636 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
1MG/ML **Federal Register determination N016636 003 Jun 14, 1982
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
TARGINIQ
PURDUE PHARMA LP 5MG;10MG N205777 001 Jul 23, 2014
10MG;20MG N205777 002 Jul 23, 2014
20MG;40MG N205777 003 Jul 23, 2014
NALOXONE HYDROCHLORIDE; PENTAZOCINE HYDROCHLORIDE
TABLET;ORAL
TALWIN NX
SANOFI AVENTIS US EQ 0.5MG BASE;EQ 50MG BASE N018733 001 Dec 16, 1982
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DISCONTINUED DRUG PRODUCT LIST 6-235(of 337)
NALTREXONE HYDROCHLORIDE
TABLET;ORAL
NALTREXONE HYDROCHLORIDE
SANDOZ 50MG A075434 001 Mar 08, 2000
NANDROLONE DECANOATE
INJECTABLE;INJECTION
DECA-DURABOLIN
AGI 50MG/ML N013132 001 Jun 12, 1986
100MG/ML N013132 002 Jun 12, 1986
200MG/ML N013132 003 Jun 12, 1986
NANDROLONE DECANOATE
ABRAXIS PHARM 100MG/ML A088290 001 Oct 03, 1983
200MG/ML A088317 001 Oct 14, 1983
AKORN 100MG/ML A087519 001 Sep 28, 1983
WATSON LABS 50MG/ML A086385 001 Jan 13, 1984
50MG/ML A087598 001 Oct 06, 1983
50MG/ML A088554 001 Feb 10, 1986
100MG/ML A086598 001 Jan 13, 1984
100MG/ML A087599 001 Oct 06, 1983
200MG/ML A088128 001 Dec 05, 1983
NANDROLONE PHENPROPIONATE
INJECTABLE;INJECTION
DURABOLIN
ORGANON USA INC 25MG/ML N011891 001
50MG/ML N011891 002
NANDROLONE PHENPROPIONATE
WATSON LABS 25MG/ML A086386 001 Jun 17, 1983
50MG/ML A087488 001 Jun 17, 1983
NAPHAZOLINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
ALBALON
ALLERGAN 0.1% **Federal Register determination A080248 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
NAFAZAIR
BAUSCH AND LOMB 0.1% A040073 001 May 25, 1994
PHARMAFAIR 0.1% A088101 001 Apr 15, 1983
NAPHCON FORTE
ALCON 0.1% A080229 001
OPCON
BAUSCH AND LOMB 0.1% A087506 001
VASOCON
NOVARTIS 0.1% A080235 002 Mar 24, 1983
NAPROXEN
TABLET;ORAL
NAPROXEN
DAVA PHARMS INC 250MG A074105 001 Dec 21, 1993
250MG A074410 001 Apr 28, 1995
375MG A074105 002 Dec 21, 1993
375MG A074410 002 Apr 28, 1995
500MG A074105 003 Dec 21, 1993
500MG A074410 003 Apr 28, 1995
HAMILTON PHARMS 250MG A074110 001 Oct 30, 1992
375MG A074110 002 Oct 30, 1992
500MG A074110 003 Oct 30, 1992
IVAX SUB TEVA PHARMS 250MG A074111 001 Feb 28, 1995
375MG A074111 002 Feb 28, 1995
500MG A074111 003 Feb 28, 1995
PLIVA 250MG A074182 001 Jun 27, 1996
375MG A074182 002 Jun 27, 1996
500MG A074182 003 Jun 27, 1996
PUREPAC PHARM 250MG A074263 001 Dec 21, 1993
375MG A074263 002 Dec 21, 1993
500MG A074263 003 Dec 21, 1993
ROXANE 250MG A074211 001 Feb 28, 1994
375MG A074211 002 Feb 28, 1994
500MG A074211 003 Feb 28, 1994
TEVA 250MG A074129 001 Dec 21, 1993
250MG A074216 001 Apr 11, 1996
375MG A074129 002 Dec 21, 1993
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DISCONTINUED DRUG PRODUCT LIST 6-236(of 337)
NAPROXEN
TABLET;ORAL
NAPROXEN
375MG A074216 002 Apr 11, 1996
500MG A074129 003 Dec 21, 1993
500MG A074216 003 Apr 11, 1996
TEVA PHARMS 250MG A074207 001 Dec 21, 1993
375MG A074207 002 Dec 21, 1993
500MG A074207 003 Dec 21, 1993
WATSON LABS 250MG A074163 001 Feb 10, 1995
250MG A074457 001 May 31, 1995
375MG A074163 002 Feb 10, 1995
375MG A074457 002 May 31, 1995
500MG A074163 003 Feb 10, 1995
500MG A074457 003 May 31, 1995
TABLET, DELAYED RELEASE;ORAL
NAPROXEN
ACTAVIS ELIZABETH 375MG A074936 001 Feb 24, 1998
500MG A074936 002 Feb 24, 1998
NAPROXEN SODIUM
TABLET;ORAL
NAPROXEN SODIUM
ABLE EQ 250MG BASE A076544 001 Aug 22, 2003
EQ 500MG BASE A076544 002 Aug 22, 2003
HAMILTON PHARMS EQ 250MG BASE A074106 001 Aug 31, 1993
EQ 500MG BASE A074106 002 Aug 31, 1993
IVAX SUB TEVA PHARMS EQ 250MG BASE A074230 001 Mar 14, 1995
EQ 500MG BASE A074230 002 Mar 14, 1995
MYLAN EQ 250MG BASE A074367 001 Aug 31, 1994
EQ 500MG BASE A074367 002 Aug 31, 1994
PLIVA EQ 250MG BASE A074242 001 Jun 20, 1996
EQ 500MG BASE A074242 002 Jun 20, 1996
PUREPAC PHARM EQ 250MG BASE A074319 001 Mar 20, 1995
EQ 500MG BASE A074319 002 Mar 20, 1995
ROXANE EQ 250MG BASE A074257 001 Dec 21, 1993
EQ 500MG BASE A074257 002 Dec 21, 1993
SANDOZ EQ 200MG BASE A074646 001 Jan 13, 1997
EQ 250MG BASE A074162 001 Dec 21, 1993
EQ 250MG BASE A074495 001 Dec 05, 1994
EQ 500MG BASE A074162 002 Dec 21, 1993
EQ 500MG BASE A074495 002 Dec 05, 1994
TEVA EQ 250MG BASE A074142 001 Dec 21, 1993
EQ 500MG BASE A074142 002 Dec 21, 1993
TEVA PHARMS EQ 250MG BASE A074289 001 Jan 27, 1994
EQ 500MG BASE A074289 002 Jan 27, 1994
WATSON LABS EQ 250MG BASE A074195 001 Dec 21, 1993
EQ 250MG BASE A074455 001 May 31, 1995
EQ 500MG BASE A074195 002 Dec 21, 1993
EQ 500MG BASE A074455 002 May 31, 1995
NATEGLINIDE
TABLET;ORAL
NATEGLINIDE
TEVA PHARMS 60MG A077467 001 Sep 09, 2009
120MG A077467 002 Sep 09, 2009
NEDOCROMIL SODIUM
AEROSOL, METERED;INHALATION
TILADE
KING PHARMS 1.75MG/INH N019660 001 Dec 30, 1992
SOLUTION;INHALATION
TILADE
SANOFI AVENTIS US 0.5% N020750 001 Oct 01, 1997
NEFAZODONE HYDROCHLORIDE
TABLET;ORAL
NEFAZODONE HYDROCHLORIDE
IVAX SUB TEVA PHARMS 50MG A075763 001 Sep 16, 2003
100MG A075763 002 Sep 16, 2003
150MG A075763 003 Sep 16, 2003
200MG A075763 004 Sep 16, 2003
250MG A075763 005 Sep 16, 2003
MYLAN 100MG A076129 002 Sep 16, 2003
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DISCONTINUED DRUG PRODUCT LIST 6-237(of 337)
NEFAZODONE HYDROCHLORIDE
TABLET;ORAL
NEFAZODONE HYDROCHLORIDE
150MG A076129 003 Sep 16, 2003
200MG A076129 004 Sep 16, 2003
250MG A076129 005 Sep 16, 2003
ROXANE 50MG A076196 001 Sep 16, 2003
100MG A076196 002 Sep 16, 2003
150MG A076196 003 Sep 16, 2003
200MG A076196 004 Sep 16, 2003
250MG A076196 005 Sep 16, 2003
SANDOZ 50MG A076072 001 Sep 16, 2003
50MG A076302 001 Sep 16, 2003
100MG A076072 002 Sep 16, 2003
100MG A076302 002 Sep 16, 2003
150MG A076072 003 Sep 16, 2003
150MG A076302 003 Sep 16, 2003
200MG A076072 004 Sep 16, 2003
200MG A076302 004 Sep 16, 2003
250MG A076072 005 Sep 16, 2003
250MG A076302 005 Sep 16, 2003
WATSON LABS 100MG A076073 002 Sep 16, 2003
150MG A076073 003 Sep 16, 2003
200MG A076073 004 Sep 16, 2003
250MG A076073 005 Sep 16, 2003
SERZONE
BRISTOL MYERS SQUIBB 50MG N020152 001 Dec 22, 1994
100MG N020152 002 Dec 22, 1994
150MG N020152 003 Dec 22, 1994
200MG N020152 004 Dec 22, 1994
250MG N020152 005 Dec 22, 1994
300MG N020152 006 Dec 22, 1994
NELFINAVIR MESYLATE
POWDER;ORAL
VIRACEPT
AGOURON EQ 50MG BASE/SCOOPFUL N020778 001 Mar 14, 1997
NEOMYCIN SULFATE
POWDER;FOR RX COMPOUNDING
NEO-RX
X GEN PHARMS 100% A061579 001
SOLUTION;ORAL
MYCIFRADIN
PHARMACIA AND UPJOHN EQ 87.5MG BASE/5ML N050285 001
TABLET;ORAL
MYCIFRADIN
PHARMACIA AND UPJOHN EQ 350MG BASE A060520 001
NEOBIOTIC
PFIZER EQ 350MG BASE A060475 001
NEOMYCIN SULFATE
BRISTOL MYERS SQUIBB 500MG A060365 001
LANNETT 500MG A060607 001
LILLY 500MG A060385 001
ROXANE 500MG A062173 001
SANDOZ 500MG A061586 001
NEOMYCIN SULFATE; POLYMYXIN B SULFATE
CREAM;TOPICAL
NEOSPORIN
GLAXOSMITHKLINE EQ 3.5MG BASE/GM;10,000 UNITS/GM N050176 002 Jan 14, 1985
OINTMENT;OPHTHALMIC
STATROL
ALCON EQ 3.5MG BASE/GM;10,000 UNITS/GM N050344 002
SOLUTION/DROPS;OPHTHALMIC
STATROL
ALCON EQ 3.5MG BASE/ML;16,250 UNITS/ML A062339 001 Nov 30, 1984
EQ 3.5MG BASE/ML;16,250 UNITS/ML N050456 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-238(of 337)
NEOMYCIN SULFATE; POLYMYXIN B SULFATE; PREDNISOLONE ACETATE
SUSPENSION/DROPS;OPHTHALMIC
POLY-PRED
ALLERGAN EQ 0.35% BASE;10,000 UNITS/ML;0.5%
N050081 002
NEOMYCIN SULFATE; PREDNISOLONE ACETATE
OINTMENT;OPHTHALMIC
NEO-DELTA-CORTEF
PHARMACIA AND UPJOHN EQ 3.5MG BASE/GM;0.25% A061039 002
EQ 3.5MG BASE/GM;0.5% A061039 001
SUSPENSION/DROPS;OPHTHALMIC
NEO-DELTA-CORTEF
PHARMACIA AND UPJOHN EQ 3.5MG BASE/ML;0.25% A061037 001
NEOMYCIN SULFATE; PREDNISOLONE SODIUM PHOSPHATE
OINTMENT;OPHTHALMIC
NEO-HYDELTRASOL
MERCK EQ 3.5MG BASE/GM;EQ 0.25% PHOSPHATE
N050378 001
NEOMYCIN SULFATE; TRIAMCINOLONE ACETONIDE
CREAM;TOPICAL
MYTREX A
SAVAGE LABS EQ 3.5MG BASE/GM;0.1%
A062598 001 Jul 21, 1986
NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE
FOUGERA EQ 3.5MG BASE/GM;0.1%
A062600 001 Jul 21, 1986
PHARMADERM EQ 3.5MG BASE/GM;0.1%
A062595 001 Jul 21, 1986
OINTMENT;TOPICAL
MYTREX A
SAVAGE LABS EQ 3.5MG BASE/GM;0.1%
A062609 001 May 23, 1986
NEOMYCIN SULFATE-TRIAMCINOLONE ACETONIDE
FOUGERA
EQ 3.5MG BASE/GM;0.1%
A062608 001 May 23, 1986
PHARMADERM
EQ 3.5MG BASE/GM;0.1%
A062607 001 May 23, 1986
NETILMICIN SULFATE
INJECTABLE;INJECTION
NETROMYCIN
SCHERING
EQ 10MG BASE/ML
N050544 001 Feb 28, 1983
EQ 25MG BASE/ML
N050544 002 Feb 28, 1983
EQ 100MG BASE/ML
N050544 003 Feb 28, 1983
NIACIN
CAPSULE;ORAL
WAMPOCAP
MEDPOINTE PHARM HLC
500MG
N011073 003
TABLET;ORAL
NIACIN
EVERYLIFE
500MG
A083203 001
HALSEY
500MG
A083453 001
HIKMA PHARMS LLC
500MG
A083718 001
IMPAX LABS
500MG
A083115 001
IVAX SUB TEVA PHARMS
500MG
A083180 001
MK LABS
500MG
A083525 001
PUREPAC PHARM
500MG
A083271 001
SANDOZ
500MG
A083306 001
TABLICAPS
500MG
A084237 001
WATSON LABS
500MG
A083136 001
500MG
A083305 001
500MG
A085172 001
NICOLAR
SANOFI AVENTIS US
500MG
A083823 001
TABLET, EXTENDED RELEASE;ORAL
NIASPAN
ABBVIE
375MG
N020381 001 Jul 28, 1997
NIASPAN TITRATION STARTER PACK
ABBVIE 375MG
N020381 005 Jul 28, 1997
NIACINAMIDE; PYRIDOXINE HYDROCHLORIDE; TYROSINE
SUSPENSION;ORAL
TPN
INTL MINERALS 15MG/5ML;3.75MG/5ML;600MG/5ML
N008378 003
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-239(of 337)
NICARDIPINE HYDROCHLORIDE
CAPSULE;ORAL
NICARDIPINE HYDROCHLORIDE
WATSON LABS 20MG A074670 001 Oct 28, 1996
30MG A074670 002 Oct 28, 1996
CAPSULE, EXTENDED RELEASE;ORAL
CARDENE SR
CHIESI USA INC 30MG N020005 001 Feb 21, 1992
45MG N020005 002 Feb 21, 1992
60MG N020005 003 Feb 21, 1992
NICLOSAMIDE
TABLET, CHEWABLE;ORAL
NICLOCIDE
BAYER PHARMS 500MG N018669 001 May 14, 1982
NICOTINE
FILM, EXTENDED RELEASE;TRANSDERMAL
NICOTROL
MCNEIL CONS 15MG/16HR N020536 001 Jul 03, 1996
PROSTEP
AVEVA 11MG/24HR N019983 003 Dec 23, 1998
22MG/24HR N019983 004 Dec 23, 1998
NICOTINE POLACRILEX
GUM, CHEWING;BUCCAL
NICOTINE POLACRILEX
ACTAVIS LABS NY INC EQ 2MG BASE A076568 001 Jul 29, 2004
EQ 4MG BASE A076569 002 Jul 29, 2004
NIFEDIPINE
CAPSULE;ORAL
ADALAT
BAYER PHARMS 10MG N019478 001 Nov 27, 1985
20MG N019478 002 Sep 17, 1986
NIFEDIPINE
CATALENT 10MG A073250 001 Oct 08, 1991
20MG A074045 001 Apr 30, 1992
CHASE LABS NJ 10MG A072409 001 Jul 04, 1990
20MG A073421 001 Jun 19, 1991
TEVA 10MG A072651 001 Feb 19, 1992
PROCARDIA
PFIZER 20MG N018482 002 Jul 24, 1986
TABLET, EXTENDED RELEASE;ORAL
NIFEDIPINE
MARTEC USA LLC 90MG A075414 003 Mar 23, 2004
MYLAN 30MG A075108 001 Dec 17, 1999
NILUTAMIDE
TABLET;ORAL
NILANDRON
COVIS PHARMA SARL 50MG N020169 001 Sep 19, 1996
NIMODIPINE
CAPSULE;ORAL
NIMOTOP
BAYER PHARMS 30MG **Federal Register determination N018869 001 Dec 28, 1988
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
NISOLDIPINE
TABLET, EXTENDED RELEASE;ORAL
SULAR
SHIONOGI INC 10MG **Federal Register determination N020356 001 Feb 02, 1995
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
20MG **Federal Register determination N020356 002 Feb 02, 1995
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
25.5MG **Federal Register determination N020356 006 Jan 02, 2008
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
30MG **Federal Register determination N020356 003 Feb 02, 1995
that product was not discontinued or
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-240(of 337)
NISOLDIPINE
TABLET, EXTENDED RELEASE;ORAL
SULAR
withdrawn for safety or efficacy
reasons**
40MG **Federal Register determination N020356 004 Feb 02, 1995
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
NITROFURANTOIN
CAPSULE;ORAL
NITROFURANTOIN
WATSON LABS 50MG A084326 001
100MG A084326 002
TABLET;ORAL
FURADANTIN
PROCTER AND GAMBLE 50MG N008693 001
100MG N008693 002
FURALAN
LANNETT 50MG A080017 001
100MG A080017 002
NITROFURANTOIN
ELKINS SINN 50MG A080003 001
100MG A080003 002
IVAX SUB TEVA PHARMS 50MG A080078 002
100MG A080078 001
SANDOZ 50MG A080043 001
100MG A080043 002
WATSON LABS 50MG A080447 001
50MG A085797 001
100MG A080447 002
100MG A085796 001
WHITEWORTH TOWN PLSN 100MG A084085 002
NITROFURANTOIN SODIUM
INJECTABLE;INJECTION
IVADANTIN
PROCTER AND GAMBLE EQ 180MG BASE/VIAL N012402 001
NITROFURANTOIN, MACROCRYSTALLINE
CAPSULE;ORAL
NITROFURANTOIN
MYLAN 100MG A074967 002 Jul 09, 1997
SANDOZ 25MG A074336 001 Jan 25, 1995
50MG A074336 002 Jan 25, 1995
100MG A074336 003 Jan 25, 1995
WATSON LABS 25MG A073696 001 Dec 31, 1992
50MG A073696 002 Dec 31, 1992
100MG A073696 003 Dec 31, 1992
NITROFURANTOIN MACROCRYSTALLINE
WATSON LABS 50MG A070248 001 Jun 24, 1988
100MG A070249 001 Jun 24, 1988
NITROFURANTOIN; NITROFURANTOIN, MACROCRYSTALLINE
CAPSULE;ORAL
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS)
RANBAXY LABS LTD 75MG;25MG A076951 001 Mar 30, 2005
NITROFURAZONE
CREAM;TOPICAL
FURACIN
SHIRE 0.2% A083789 001
DRESSING;TOPICAL
ACTIN-N
SHERWOOD MEDCL 0.2% N017343 001
OINTMENT;TOPICAL
FURACIN
SHIRE 0.2% N005795 001
NITROFURAZONE
AMBIX 0.2% A086077 001
LANNETT 0.2% A084393 001
PERRIGO NEW YORK 0.2% A084968 001
TARO 0.2% A086156 001
WENDT 0.2% A086766 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-241(of 337)
NITROFURAZONE
POWDER;TOPICAL
FURACIN
SHIRE 0.2% A083791 001
SOLUTION;TOPICAL
NITROFURAZONE
PERRIGO NEW YORK 0.2% A085130 001
WENDT 0.2% A087081 001
NITROGLYCERIN
AEROSOL;SUBLINGUAL
NITROLINGUAL
POHL BOSKAMP 0.4MG/SPRAY N018705 001 Oct 31, 1985
FILM, EXTENDED RELEASE;TRANSDERMAL
NITROGLYCERIN
KREMERS URBAN PHARMS 0.2MG/HR A075115 001 Aug 10, 2004
0.4MG/HR A075115 002 Aug 10, 2004
MYLAN TECHNOLOGIES 0.1MG/HR A074992 004 Nov 12, 1999
0.2MG/HR A074992 003 Nov 12, 1999
0.4MG/HR A074992 002 Nov 12, 1999
0.6MG/HR A074992 001 Nov 12, 1999
TRANSDERM-NITRO
NOVARTIS 0.1MG/HR N020144 001 Feb 27, 1996
0.2MG/HR N020144 002 Feb 27, 1996
0.4MG/HR N020144 003 Feb 27, 1996
0.6MG/HR N020144 004 Feb 27, 1996
0.8MG/HR N020144 005 Feb 27, 1996
INJECTABLE;INJECTION
NITRO IV
POHL BOSKAMP 5MG/ML N018672 002 Aug 30, 1983
NITRO-BID
SANOFI AVENTIS US 5MG/ML N018621 001 Jan 05, 1982
10MG/ML A071159 001 Feb 28, 1990
NITROGLYCERIN
ABRAXIS PHARM 5MG/ML A070077 001 Dec 13, 1985
5MG/ML A071203 001 May 08, 1987
HOSPIRA 5MG/ML N018531 001
INTL MEDICATION 5MG/ML A070026 001 Sep 10, 1985
LUITPOLD 5MG/ML A071492 001 May 24, 1988
SMITH AND NEPHEW 5MG/ML A070633 001 Jun 19, 1986
5MG/ML A070634 001 Jun 19, 1986
NITROGLYCERIN IN DEXTROSE 5%
HOSPIRA 0.1MG/ML A074083 001 Oct 26, 1994
NITROL
RORER 0.8MG/ML N018774 001 Jan 19, 1983
NITRONAL
POHL BOSKAMP 1MG/ML N018672 001 Aug 30, 1983
NITROSTAT
PARKE DAVIS 0.8MG/ML N018588 001
5MG/ML A070863 001 Jan 08, 1987
5MG/ML N018588 002 Dec 23, 1983
10MG/ML A070871 001 Jan 08, 1987
10MG/ML A070872 001 Jan 08, 1987
TRIDIL
HOSPIRA 0.5MG/ML N018537 002 Jun 16, 1983
5MG/ML N018537 001
NIZATIDINE
CAPSULE;ORAL
AXID
SMITHKLINE BEECHAM 150MG N019508 001 Apr 12, 1988
300MG N019508 002 Apr 12, 1988
NIZATIDINE
ANI PHARMS INC 150MG A075461 001 Jul 08, 2002
300MG A075461 002 Jul 08, 2002
APOTEX INC 150MG A076383 001 Jan 23, 2003
300MG A076383 002 Jan 23, 2003
MYLAN PHARMS INC 150MG A075934 001 Jul 09, 2002
300MG A075934 002 Jul 09, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-242(of 337)
NONOXYNOL-9
AEROSOL;VAGINAL
DELFEN
PERSONAL PRODS 12.5% N014349 002
NOREPINEPHRINE BITARTRATE
INJECTABLE;INJECTION
NOREPINEPHRINE BITARTRATE
METRICS PHARM EQ 1MG BASE/ML A040522 001 Sep 30, 2004
NOREPINEPHRINE BITARTRATE; PROCAINE HYDROCHLORIDE; PROPOXYCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
RAVOCAINE AND NOVOCAIN W/ LEVOPHED
EASTMAN KODAK EQ 0.033MG BASE/ML;2%;0.4% N008592 003
NORETHINDRONE
TABLET;ORAL
NORLUTIN
PARKE DAVIS 5MG N010895 002
NORETHINDRONE ACETATE
TABLET;ORAL
NORLUTATE
PARKE DAVIS 5MG N012184 002
NORFLOXACIN
SOLUTION/DROPS;OPHTHALMIC
CHIBROXIN
MERCK 0.3% N019757 001 Jun 17, 1991
TABLET;ORAL
NOROXIN
MERCK 400MG N019384 002 Oct 31, 1986
NORGESTREL
TABLET;ORAL
OVRETTE
WYETH PHARMS 0.075MG N017031 001
NORTRIPTYLINE HYDROCHLORIDE
CAPSULE;ORAL
AVENTYL HYDROCHLORIDE
LILLY EQ 10MG BASE N014684 001
EQ 25MG BASE N014684 002
NORTRIPTYLINE HYDROCHLORIDE
SANDOZ EQ 10MG BASE A074054 001 Dec 31, 1992
EQ 10MG BASE A074835 001 Jun 30, 1997
EQ 25MG BASE A074054 002 Dec 31, 1992
EQ 25MG BASE A074835 002 Jun 30, 1997
EQ 50MG BASE A074054 003 Dec 31, 1992
EQ 50MG BASE A074835 003 Jun 30, 1997
EQ 75MG BASE A074054 004 Dec 31, 1992
EQ 75MG BASE A074835 004 Jun 30, 1997
TEVA EQ 10MG BASE A073667 001 Apr 11, 1996
EQ 25MG BASE A073667 002 Apr 11, 1996
EQ 50MG BASE A073667 003 Apr 11, 1996
EQ 75MG BASE A073667 004 Apr 11, 1996
SOLUTION;ORAL
AVENTYL
RANBAXY EQ 10MG BASE/5ML **Federal Register N014685 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
PAMELOR
MALLINCKRODT INC EQ 10MG BASE/5ML N018012 001
NYSTATIN
CREAM;TOPICAL
CANDEX
BAYER PHARMS 100,000 UNITS/GM A061810 001
MYCOSTATIN
DELCOR ASSET CORP 100,000 UNITS/GM A060575 001
MYKINAC
ALPHARMA US PHARMS 100,000 UNITS/GM A062387 001 Jul 29, 1982
NILSTAT
LEDERLE 100,000 UNITS/GM A061445 001
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DISCONTINUED DRUG PRODUCT LIST
6-243(of 337)
NYSTATIN
CREAM;TOPICAL
NYSTATIN
G AND W LABS INC
100,000 UNITS/GM
A061966 001
TARO
100,000 UNITS/GM
A062457 001 Jul 28, 1983
LOTION;TOPICAL
CANDEX
BAYER PHARMS
100,000 UNITS/ML
N050233 001
OINTMENT;TOPICAL
MYCOSTATIN
DELCOR ASSET CORP
100,000 UNITS/GM
A060571 001
MYKINAC
ALPHARMA US PHARMS
100,000 UNITS/GM
A062731 001 Sep 22, 1986
NILSTAT
LEDERLE
100,000 UNITS/GM
A061444 001
PASTILLE;ORAL
MYCOSTATIN
BRISTOL MYERS SQUIBB
200,000 UNITS
N050619 001 Apr 09, 1987
POWDER;ORAL
BARSTATIN 100
BARLAN
100%
A062489 001 Apr 27, 1988
NILSTAT
DAVA PHARMS INC
100%
N050576 001 Dec 22, 1983
NYSTATIN
PADDOCK LLC
100%
A062613 001 Nov 26, 1985
POWDER;TOPICAL
MYCOSTATIN
DELCOR ASSET CORP
100,000 UNITS/GM
A060578 001
NYSTATIN
NESHER PHARMS
100,000 UNITS/GM
A065321 001 Aug 18, 2006
SUPPOSITORY;VAGINAL
NYSERT
WARNER CHILCOTT
100,000 UNITS
N050478 001
SUSPENSION;ORAL
MYCOSTATIN
DELCOR ASSET CORP
100,000 UNITS/ML
A061533 001
NILSTAT
GLENMARK GENERICS
100,000 UNITS/ML
N050299 001
NYSTATIN
ALPHARMA US PHARMS
100,000 UNITS/ML
A062571 001 Oct 29, 1985
MORTON GROVE
100,000 UNITS/ML
A062835 001 Nov 19, 1987
PHARMADERM
100,000 UNITS/ML
A062518 001 Jul 06, 1984
PHARMAFAIR
100,000 UNITS/ML
A062541 001 Jan 16, 1985
ROXANE
100,000 UNITS/ML
A062832 001 Dec 27, 1991
TEVA
100,000 UNITS/ML
A062670 001 Jun 18, 1987
100,000 UNITS/ML
A062776 001 Dec 17, 1987
NYSTEX
SAVAGE LABS
100,000 UNITS/ML
A062519 001 Jul 06, 1984
TABLET;ORAL
MYCOSTATIN
DELCOR ASSET CORP
500,000 UNITS
A060574 001
NILSTAT
LEDERLE
500,000 UNITS
A061151 001
NYSTATIN
QUANTUM PHARMICS
500,000 UNITS
A062525 001 Oct 29, 1984
SANDOZ
500,000 UNITS
A062065 001
USL PHARMA
500,000 UNITS
A062524 001 Nov 26, 1985
WATSON LABS
500,000 UNITS
A062402 001 Dec 16, 1982
TABLET;VAGINAL
KOROSTATIN
HOLLAND RANTOS
100,000 UNITS
A061718 001
MYCOSTATIN
DELCOR ASSET CORP
100,000 UNITS
A060577 001
NILSTAT
LEDERLE
100,000 UNITS
A061325 001
NYSTATIN
FOUGERA
100,000 UNITS
A062459 001 Nov 09, 1983
PHARMADERM
100,000 UNITS
A062460 001 Nov 09, 1983
QUANTUM PHARMICS
100,000 UNITS
A062509 001 Apr 03, 1984
SANDOZ
100,000 UNITS
A061965 001
TEVA
100,000 UNITS
A062502 001 Dec 23, 1983
WATSON LABS
100,000 UNITS
A062176 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-244(of 337)
NYSTATIN; TRIAMCINOLONE ACETONIDE
CREAM;TOPICAL
MYCO-TRIACET II
TEVA 100,000 UNITS/GM;0.1% A061954 002 Sep 20, 1985
MYCOLOG-II
DELCOR ASSET CORP 100,000 UNITS/GM;0.1% A060576 002 May 01, 1985
100,000 UNITS/GM;0.1% A062606 001 May 15, 1985
MYKACET
G AND W LABS INC 100,000 UNITS/GM;0.1% A062367 001 May 28, 1985
MYTREX F
SAVAGE LABS 100,000 UNITS/GM;0.1% A062597 001 Oct 08, 1985
NYSTATIN AND TRIAMCINOLONE ACETONIDE
ALPHARMA US PHARMS 100,000 UNITS/GM;0.1% A063010 001 Dec 20, 1988
PERRIGO NEW YORK 100,000 UNITS/GM;0.1% A062186 002 Jun 06, 1985
PHARMAFAIR 100,000 UNITS/GM;0.1% A062657 001 Jul 30, 1986
TARO 100,000 UNITS/GM;0.1% A062347 001 Mar 30, 1987
NYSTATIN-TRIAMCINOLONE ACETONIDE
PHARMADERM 100,000 UNITS/GM;0.1% A062596 001 Oct 08, 1985
OINTMENT;TOPICAL
MYCO-TRIACET II
TEVA 100,000 UNITS/GM;0.1% A062045 002 Nov 26, 1985
MYCOLOG-II
DELCOR ASSET CORP 100,000 UNITS/GM;0.1% A060572 001 Jun 28, 1985
MYKACET
G AND W LABS INC 100,000 UNITS/GM;0.1% A062733 001 Mar 09, 1987
MYTREX F
SAVAGE LABS 100,000 UNITS/GM;0.1% A062601 001 Oct 09, 1985
NYSTATIN AND TRIAMCINOLONE ACETONIDE
PERRIGO NEW YORK 100,000 UNITS/GM;0.1% A062280 002 Oct 10, 1985
PHARMAFAIR 100,000 UNITS/GM;0.1% A062656 001 Jul 30, 1986
NYSTATIN-TRIAMCINOLONE ACETONIDE
PHARMADERM 100,000 UNITS/GM;0.1% A062603 001 Oct 09, 1985
OFLOXACIN
INJECTABLE;INJECTION
FLOXIN
ORTHO MCNEIL PHARM 20MG/ML N020087 002 Mar 31, 1992
40MG/ML N020087 003 Mar 31, 1992
FLOXIN IN DEXTROSE 5%
ORTHO MCNEIL PHARM 400MG/100ML N020087 001 Mar 31, 1992
FLOXIN IN DEXTROSE 5% IN PLASTIC CONTAINER
ORTHO MCNEIL PHARM 4MG/ML N020087 004 Mar 31, 1992
400MG/100ML N020087 005 Mar 31, 1992
OFLOXACIN
BEDFORD 40MG/ML A075762 001 Jan 16, 2002
SOLUTION/DROPS;OPHTHALMIC
OFLOXACIN
APOTEX INC 0.3% A076513 001 May 14, 2004
SANDOZ 0.3% A076848 001 Nov 25, 2008
TABLET;ORAL
FLOXIN
JANSSEN PHARMS 200MG N019735 001 Dec 28, 1990
300MG N019735 002 Dec 28, 1990
400MG N019735 003 Dec 28, 1990
OFLOXACIN
LARKEN LABS 200MG A076093 001 Sep 02, 2003
300MG A076093 002 Sep 02, 2003
400MG A076093 003 Sep 02, 2003
RANBAXY LABS LTD 200MG A076220 001 Sep 02, 2003
300MG A076220 002 Sep 02, 2003
400MG A076220 003 Sep 02, 2003
OMEPRAZOLE; SODIUM BICARBONATE
FOR SUSPENSION;ORAL
OMEPRAZOLE AND SODIUM BICARBONATE
PAR PHARM 20MG/PACKET;1.68GM/PACKET A079182 001 Apr 19, 2013
40MG/PACKET;1.68GM/PACKET A079182 002 Apr 19, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-245(of 337)
ONDANSETRON
TABLET, ORALLY DISINTEGRATING;ORAL
ONDANSETRON
NESHER PHARMS 4MG A077717 001 Jun 25, 2007
8MG A077717 002 Jun 25, 2007
PAR PHARM 4MG A076506 001 Dec 26, 2006
8MG A076506 002 Dec 26, 2006
16MG A077406 001 Dec 26, 2006
24MG A077406 002 Dec 26, 2006
ONDANSETRON HYDROCHLORIDE
INJECTABLE;INJECTION
ONDANSETRON HYDROCHLORIDE
APOTEX INC EQ 2MG BASE/ML A077368 001 Dec 26, 2006
HOSPIRA EQ 2MG BASE/ML A076695 001 Dec 26, 2006
LANNETT EQ 2MG BASE/ML A090116 001 Apr 14, 2010
LUITPOLD EQ 2MG BASE/ML A077582 001 Dec 26, 2006
PLIVA HRVATSKA DOO EQ 2MG BASE/ML A077544 001 Dec 26, 2006
SAGENT PHARMS EQ 2MG BASE/ML A078180 001 Mar 26, 2007
ONDANSETRON HYDROCHLORIDE AND DEXTROSE IN PLASTIC CONTAINER
BEDFORD LABS EQ 0.64MG BASE/ML A078291 001 Apr 13, 2009
CLARIS LIFESCIENCES EQ 0.64MG BASE/ML A078308 001 Mar 17, 2008
HOSPIRA EQ 0.64MG BASE/ML A076978 001 Feb 26, 2007
EQ 0.64MG BASE/ML A077348 001 Feb 01, 2007
TEVA PHARMS EQ 0.64MG BASE/ML A077480 001 Nov 22, 2006
ONDANSETRON HYDROCHLORIDE AND SODIUM CHLORIDE IN PLASTIC CONTAINER
BAXTER HLTHCARE EQ 0.64MG BASE/ML N021915 002 Dec 27, 2006
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE
APOTEX INC EQ 2MG BASE/ML A077343 001 Dec 26, 2006
HOSPIRA EQ 2MG BASE/ML A076696 001 Dec 26, 2006
LUITPOLD EQ 2MG BASE/ML A077387 001 Dec 26, 2006
ZOFRAN AND DEXTROSE IN PLASTIC CONTAINER
GLAXOSMITHKLINE EQ 0.64MG BASE/ML N020403 001 Jan 31, 1995
TABLET;ORAL
ONDANSETRON HYDROCHLORIDE
HIKMA PHARMS LLC EQ 4MG BASE A077545 001 Sep 06, 2007
EQ 8MG BASE A077545 002 Sep 06, 2007
EQ 24MG BASE A077545 003 Sep 06, 2007
PAR PHARM EQ 4MG BASE A077303 001 Jun 25, 2007
EQ 8MG BASE A077303 002 Jun 25, 2007
EQ 24MG BASE A077303 004 Jun 25, 2007
TARO EQ 4MG BASE A077729 001 Mar 28, 2011
EQ 8MG BASE A077729 002 Mar 28, 2011
EQ 24MG BASE A077729 003 Mar 28, 2011
ORPHENADRINE CITRATE
INJECTABLE;INJECTION
ORPHENADRINE CITRATE
WATSON LABS 30MG/ML A087062 001
TABLET, EXTENDED RELEASE;ORAL
NORFLEX
MEDICIS 100MG N012157 001
ORPHENADRINE CITRATE
ASCOT 100MG A088067 001 Apr 06, 1983
SANDOZ 100MG A085046 001
WATSON LABS 100MG A084303 001
ORPHENADRINE HYDROCHLORIDE
TABLET;ORAL
DISIPAL
3M 50MG N010653 001
OSELTAMIVIR PHOSPHATE
FOR SUSPENSION;ORAL
TAMIFLU
ROCHE EQ 12MG BASE/ML N021246 001 Dec 14, 2000
OXACILLIN SODIUM
CAPSULE;ORAL
BACTOCILL
GLAXOSMITHKLINE EQ 250MG BASE A061336 001
EQ 250MG BASE A062241 001
EQ 500MG BASE A061336 002
EQ 500MG BASE A062241 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-246(of 337)
OXACILLIN SODIUM
CAPSULE;ORAL
OXACILLIN SODIUM
APOTHECON EQ 250MG BASE
A061450 002
EQ 500MG BASE
A061450 001
TEVA EQ 250MG BASE
A062222 001
EQ 500MG BASE
A062222 002
PROSTAPHLIN
APOTHECON EQ 500MG BASE
N050118 002
FOR SOLUTION;ORAL
BACTOCILL
GLAXOSMITHKLINE EQ 250MG BASE/5ML
A062321 001
OXACILLIN SODIUM
APOTHECON EQ 250MG BASE/5ML
A061457 001
TEVA EQ 250MG BASE/5ML
A062252 001
PROSTAPHLIN
APOTHECON EQ 250MG BASE/5ML
N050194 001
INJECTABLE;INJECTION
BACTOCILL
GLAXOSMITHKLINE EQ 1GM BASE/VIAL
A061334 006 Mar 26, 1982
EQ 1GM BASE/VIAL
A062736 001 Dec 19, 1986
EQ 2GM BASE/VIAL
A061334 007 Mar 26, 1982
EQ 2GM BASE/VIAL
A062736 002 Dec 19, 1986
EQ 4GM BASE/VIAL
A061334 008 Mar 26, 1982
EQ 10GM BASE/VIAL
A061334 010
EQ 500MG BASE/VIAL
A061334 009 Mar 26, 1982
OXACILLIN SODIUM
APOTHECON EQ 1GM BASE/VIAL
N050195 003
EQ 2GM BASE/VIAL
N050195 004
EQ 4GM BASE/VIAL
N050195 005
EQ 250MG BASE/VIAL
N050195 001
EQ 500MG BASE/VIAL
N050195 002
ELKINS SINN EQ 1GM BASE/VIAL
A062711 003 Feb 03, 1989
EQ 2GM BASE/VIAL
A062711 004 Feb 03, 1989
EQ 4GM BASE/VIAL
A062711 005 Feb 03, 1989
EQ 10GM BASE/VIAL
A062711 006 Feb 03, 1989
EQ 250MG BASE/VIAL
A062711 001 Feb 03, 1989
EQ 500MG BASE/VIAL
A062711 002 Feb 03, 1989
ISTITUTO BIO ITA SPA EQ 1GM BASE/VIAL
A062798 001 Dec 11, 1995
EQ 2GM BASE/VIAL
A062798 002 Dec 11, 1995
EQ 125MG BASE/VIAL
A062798 003 Dec 11, 1995
EQ 250MG BASE/VIAL
A062798 004 Dec 11, 1995
EQ 500MG BASE/VIAL
A062798 005 Dec 11, 1995
SANDOZ EQ 250MG BASE/VIAL
A061490 001
EQ 500MG BASE/VIAL
A061490 002
WATSON LABS INC EQ 1GM BASE/VIAL
A062856 003 Oct 26, 1988
EQ 2GM BASE/VIAL
A062856 004 Oct 26, 1988
EQ 4GM BASE/VIAL
A062856 005 Oct 26, 1988
EQ 10GM BASE/VIAL
A062984 001 Sep 29, 1988
EQ 250MG BASE/VIAL
A062856 001 Oct 26, 1988
EQ 500MG BASE/VIAL
A062856 002 Oct 26, 1988
OXALIPLATIN
INJECTABLE;IV (INFUSION)
ELOXATIN
SANOFI AVENTIS US 50MG/VIAL
N021492 001 Aug 09, 2002
100MG/VIAL
N021492 002 Aug 09, 2002
OXALIPLATIN
SANDOZ 50MG/VIAL
A090849 001 Apr 28, 2011
100MG/VIAL
A090849 002 Apr 28, 2011
OXAMNIQUINE
CAPSULE;ORAL
VANSIL
PFIZER 250MG
N018069 001
OXANDROLONE
TABLET;ORAL
OXANDROLONE
ROXANE 2.5MG
A077249 001 Jul 10, 2007
10MG
A077249 002 Jul 10, 2007
SANDOZ 2.5MG
A076897 001 Dec 01, 2006
10MG
A076897 002 Dec 01, 2006
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-247(of 337)
OXAPROZIN
TABLET;ORAL
OXAPROZIN
ACTAVIS ELIZABETH 600MG A075843 001 Oct 03, 2001
MYLAN 600MG A075851 001 Aug 17, 2001
MYLAN PHARMS INC 600MG A075847 001 Feb 28, 2001
SANDOZ 600MG A075842 001 Apr 12, 2001
600MG A075850 001 Apr 27, 2001
WATSON LABS 600MG A075848 001 Feb 09, 2001
OXAPROZIN POTASSIUM
TABLET;ORAL
DAYPRO ALTA
GD SEARLE 600MG N020776 001 Oct 17, 2002
OXAZEPAM
CAPSULE;ORAL
OXAZEPAM
AM THERAP 10MG A071955 001 Mar 03, 1988
15MG A071956 001 Mar 03, 1988
30MG A071957 001 Mar 03, 1988
IVAX SUB TEVA PHARMS 10MG A070943 001 Aug 03, 1987
15MG A070944 001 Aug 03, 1987
30MG A070945 001 Aug 03, 1987
MUTUAL PHARM 10MG A071026 002 Aug 10, 1987
15MG A071026 003 Aug 10, 1987
30MG A071026 001 Aug 10, 1987
MYLAN 10MG A071713 001 Oct 20, 1987
15MG A071714 001 Oct 20, 1987
30MG A071715 001 Oct 20, 1987
WATSON LABS 10MG A072952 001 Sep 28, 1990
15MG A072953 001 Sep 28, 1990
30MG A072954 001 Sep 28, 1990
SERAX
ALPHARMA US PHARMS 10MG N015539 002
15MG N015539 004
30MG N015539 006
ZAXOPAM
QUANTUM PHARMICS 10MG A070650 001 Mar 01, 1988
15MG A070640 001 Mar 01, 1988
30MG A070641 001 Mar 01, 1988
TABLET;ORAL
OXAZEPAM
MUTUAL PHARM 15MG A070683 001 Jan 16, 1987
PARKE DAVIS 15MG A071508 001 Feb 02, 1987
WATSON LABS 15MG A071494 001 Apr 21, 1987
SERAX
ALPHARMA US PHARMS 15MG N015539 008
OXCARBAZEPINE
TABLET;ORAL
OXCARBAZEPINE
ANI PHARMS INC 150MG A078005 001 Dec 11, 2007
300MG A078005 002 Dec 11, 2007
600MG A078005 003 Dec 11, 2007
OXPRENOLOL HYDROCHLORIDE
CAPSULE;ORAL
TRASICOR
NOVARTIS 20MG N018166 001 Dec 28, 1983
40MG N018166 002 Dec 28, 1983
80MG N018166 003 Dec 28, 1983
160MG N018166 004 Dec 28, 1983
OXTRIPHYLLINE
SOLUTION;ORAL
CHOLEDYL
PARKE DAVIS 100MG/5ML N009268 012 Nov 27, 1984
OXTRIPHYLLINE
MORTON GROVE 100MG/5ML A088243 001 Dec 05, 1983
SYRUP;ORAL
CHOLEDYL
PARKE DAVIS 50MG/5ML N009268 011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-248(of 337)
OXTRIPHYLLINE
SYRUP;ORAL
OXTRIPHYLLINE PEDIATRIC
MORTON GROVE
50MG/5ML
A088242 001 Dec 05, 1983
TABLET, DELAYED RELEASE;ORAL
CHOLEDYL
PARKE DAVIS
100MG
N009268 003
200MG
N009268 007
OXTRIPHYLLINE
WATSON LABS
100MG
A087866 001 Aug 25, 1983
200MG
A087835 001 Aug 25, 1983
OXYBUTYNIN CHLORIDE
SYRUP;ORAL
DITROPAN
ORTHO MCNEIL JANSSEN
5MG/5ML
N018211 001
OXYBUTYNIN CHLORIDE
APOTEX INC
5MG/5ML
A074997 001 Oct 15, 1997
MIKART
5MG/5ML
A075039 001 Jan 29, 1999
TABLET;ORAL
DITROPAN
JANSSEN PHARMS
5MG
N017577 001
OXYBUTYNIN CHLORIDE
QUANTUM PHARMICS
5MG
A072296 001 Dec 08, 1988
USL PHARMA
5MG
A070746 001 Mar 10, 1988
WATSON LABS
5MG
A072485 001 Apr 19, 1989
OXYCODONE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
ROXICODONE
ROXANE
10MG
N020932 001 Oct 26, 1998
30MG
N020932 002 Oct 26, 1998
OXYMORPHONE HYDROCHLORIDE
INJECTABLE;INJECTION
OPANA
ENDO PHARMS
1.5MG/ML
N011707 001
SUPPOSITORY;RECTAL
NUMORPHAN
ENDO PHARMS
5MG
N011738 004
TABLET, EXTENDED RELEASE;ORAL
OPANA ER
ENDO PHARMS
5MG
N021610 001 Jun 22, 2006
7.5MG
N021610 005 Feb 29, 2008
10MG
N021610 002 Jun 22, 2006
15MG
N021610 006 Feb 29, 2008
20MG
N021610 003 Jun 22, 2006
30MG
N021610 007 Feb 29, 2008
40MG
N021610 004 Jun 22, 2006
OXYPHENBUTAZONE
TABLET;ORAL
OXYPHENBUTAZONE
WATSON LABS
100MG
A088399 001 Sep 17, 1984
TANDEARIL
NOVARTIS
100MG
N012542 004 Sep 03, 1982
OXYPHENCYCLIMINE HYDROCHLORIDE
TABLET;ORAL
DARICON
PFIZER
10MG
N011612 001
OXYPHENONIUM BROMIDE
TABLET;ORAL
ANTRENYL
NOVARTIS
5MG
N008492 002
OXYTETRACYCLINE
TABLET;ORAL
TERRAMYCIN
PFIZER
250MG
N050287 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-249(of 337)
OXYTETRACYCLINE CALCIUM
SYRUP;ORAL
TERRAMYCIN
PFIZER
EQ 125MG BASE/5ML
A060595 001
OXYTETRACYCLINE HYDROCHLORIDE
CAPSULE;ORAL
OXY-KESSO-TETRA
FERRANTE
EQ 250MG BASE
A060179 001
OXYTETRACYCLINE HYDROCHLORIDE
HIKMA PHARMS LLC
EQ 250MG BASE
A060770 001
IMPAX LABS
EQ 250MG BASE
A060760 001
PROTER
EQ 250MG BASE
A060869 001
PUREPAC PHARM
EQ 250MG BASE
A060634 001
TERRAMYCIN
PFIZER
EQ 125MG BASE
N050286 001
EQ 250MG BASE
N050286 002
INJECTABLE;INJECTION
TERRAMYCIN
PFIZER
EQ 250MG BASE/VIAL
A060586 001
EQ 500MG BASE/VIAL
A060586 002
OXYTETRACYCLINE HYDROCHLORIDE; POLYMYXIN B SULFATE
OINTMENT;OTIC
TERRAMYCIN W/ POLYMYXIN
PFIZER EQ 5MG BASE/GM;10,000 UNITS/GM
A061841 001
TABLET;VAGINAL
TERRAMYCIN-POLYMYXIN
PFIZER EQ 100MG BASE;100,000 UNITS
A061009 001
OXYTOCIN
INJECTABLE;INJECTION
OXYTOCIN
TEVA PHARMS USA 10USP UNITS/ML (10USP UNITS/ML)
A077453 001
Jan 24, 2008
100USP UNITS/10ML (10USP UNITS/ML)
A077453 002
Jan 24, 2008
OXYTOCIN 10 USP UNITS IN DEXTROSE 5%
ABBOTT 1USP UNITS/100ML
N019185 004
Mar 29, 1985
2USP UNITS/100ML
N019185 003
Mar 29, 1985
OXYTOCIN 20 USP UNITS IN DEXTROSE 5%
ABBOTT 2USP UNITS/100ML
N019185 002
Mar 29, 1985
OXYTOCIN 5 USP UNITS IN DEXTROSE 5%
ABBOTT
1USP UNITS/100ML
N019185 001
Mar 29, 1985
SYNTOCINON
NOVARTIS
10USP UNITS/ML
N018245 001
SOLUTION;NASAL
SYNTOCINON
RETROPHIN INC
40USP UNITS/ML
N012285 001
PACLITAXEL
INJECTABLE;INJECTION
PACLITAXEL
ACCORD HLTHCARE
6MG/ML
A075436 001
Nov 12, 2004
HOSPIRA
6MG/ML
A076233 001
Aug 01, 2002
MYLAN
6MG/ML
A075278 001
Jan 25, 2002
PLIVA LACHEMA
6MG/ML
A077413 001
Mar 12, 2008
TEVA PHARMS USA
6MG/ML
A075297 001
Jan 25, 2002
PALIPERIDONE
TABLET, EXTENDED RELEASE;ORAL
INVEGA
JANSSEN PHARMS
12MG **Federal Register determination
N021999 004
Dec 19, 2006
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
PALONOSETRON HYDROCHLORIDE
CAPSULE;ORAL
ALOXI
HELSINN HLTHCARE
EQ 0.5MG BASE **Federal Register
N022233 001
Aug 22, 2008
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-250(of 337)
PAMIDRONATE DISODIUM
INJECTABLE;INJECTION
AREDIA
NOVARTIS 30MG/VIAL N020036 001 Oct 31, 1991
60MG/VIAL N020036 003 May 06, 1993
90MG/VIAL N020036 004 May 06, 1993
PAMIDRONATE DISODIUM
AESGEN 30MG/VIAL A075594 001 May 06, 2002
90MG/VIAL A075594 002 May 06, 2002
MN PHARMS 30MG/VIAL A078300 001 Mar 10, 2009
90MG/VIAL A078300 002 Mar 10, 2009
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE)
CAPSULE;ORAL
COTAZYM
ORGANON USA INC 30000USPU;30000USPU;8000USPU N020580 001 Dec 09, 1996
PANCURONIUM BROMIDE
INJECTABLE;INJECTION
PANCURONIUM BROMIDE
ASTRAZENECA 1MG/ML A072210 001 Mar 31, 1988
2MG/ML A072211 001 Mar 31, 1988
2MG/ML A072212 001 Mar 31, 1988
2MG/ML A072213 001 Mar 31, 1988
ELKINS SINN 1MG/ML A072058 001 Mar 23, 1988
2MG/ML A072059 001 Mar 23, 1988
2MG/ML A072060 001 Mar 23, 1988
HOSPIRA 2MG/ML A072321 001 Jan 19, 1989
PAVULON
ORGANON USA INC 1MG/ML N017015 002
2MG/ML N017015 001
PARAMETHADIONE
CAPSULE;ORAL
PARADIONE
ABBVIE 150MG N006800 003
300MG N006800 001
SOLUTION;ORAL
PARADIONE
ABBVIE 300MG/ML N006800 002
PARAMETHASONE ACETATE
TABLET;ORAL
HALDRONE
LILLY 1MG N012772 005
2MG N012772 006
PARGYLINE HYDROCHLORIDE
TABLET;ORAL
EUTONYL
ABBOTT 10MG N013448 002
25MG N013448 003
50MG N013448 004
PAROMOMYCIN SULFATE
CAPSULE;ORAL
HUMATIN
KING PFIZER EQ 250MG BASE A062310 001
PARKEDALE EQ 250MG BASE A060521 001
SYRUP;ORAL
HUMATIN
PARKE DAVIS EQ 125MG BASE/5ML A060522 001
PAROXETINE HYDROCHLORIDE
CAPSULE;ORAL
PAXIL
APOTEX TECHNOLOGIES EQ 10MG BASE **Federal Register N020885 001 Oct 09, 1998
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 20MG BASE **Federal Register N020885 002 Oct 09, 1998
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 30MG BASE **Federal Register N020885 003 Oct 09, 1998
determination that product was not
discontinued or withdrawn for safety or
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-251(of 337)
PAROXETINE HYDROCHLORIDE
CAPSULE;ORAL
PAXIL
efficacy reasons**
EQ 40MG BASE **Federal Register N020885 004 Oct 09, 1998
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
SUSPENSION;ORAL
PAROXETINE HYDROCHLORIDE
APOTEX INC EQ 10MG BASE/5ML A077395 001 Dec 05, 2006
TABLET;ORAL
PAROXETINE HYDROCHLORIDE
ROXANE EQ 10MG BASE A078026 001 Jun 29, 2007
EQ 20MG BASE A078026 002 Jun 29, 2007
EQ 30MG BASE A078026 003 Jun 29, 2007
EQ 40MG BASE A078026 004 Jun 29, 2007
SANDOZ EQ 10MG BASE A075566 001 Mar 08, 2004
EQ 20MG BASE A075566 002 Mar 08, 2004
EQ 30MG BASE A075566 003 Mar 08, 2004
EQ 40MG BASE A075566 004 Mar 08, 2004
TEVA PHARMS EQ 10MG BASE A077082 001 Jun 29, 2007
EQ 20MG BASE A077082 002 Jun 29, 2007
EQ 30MG BASE A077082 003 Jun 29, 2007
EQ 40MG BASE A077082 004 Jun 29, 2007
PAXIL
APOTEX TECHNOLOGIES EQ 50MG BASE N020031 004 Dec 29, 1992
PEGINESATIDE ACETATE
SOLUTION;INTRAVENOUS, SUBCUTANEOUS
OMONTYS
TAKEDA PHARMS USA EQ 10MG BASE/ML (EQ 10MG BASE/ML) N202799 007 Mar 27, 2012
EQ 20MG BASE/2ML (EQ 10MG BASE/ML) N202799 008 Mar 27, 2012
OMONTYS PRESERVATIVE FREE
TAKEDA PHARMS USA EQ 1MG BASE/0.5ML (EQ 1MG BASE/0.5ML) N202799 001 Mar 27, 2012
EQ 2MG BASE/0.5ML (EQ 2MG BASE/0.5ML) N202799 002 Mar 27, 2012
EQ 3MG BASE/0.5ML (EQ 3MG BASE/0.5ML) N202799 003 Mar 27, 2012
EQ 4MG BASE/0.5ML (EQ 4MG BASE/0.5ML) N202799 004 Mar 27, 2012
EQ 5MG BASE/0.5ML (EQ 5MG BASE/0.5ML) N202799 005 Mar 27, 2012
EQ 6MG BASE/0.5ML (EQ 6MG BASE/0.5ML) N202799 006 Mar 27, 2012
PEMIROLAST POTASSIUM
SOLUTION/DROPS;OPHTHALMIC
ALAMAST
SANTEN 0.1% N021079 001 Sep 24, 1999
PEMOLINE
TABLET;ORAL
CYLERT
ABBOTT 18.75MG N016832 001
37.5MG N016832 002
75MG N016832 003
PEMOLINE
ACTAVIS ELIZABETH 18.75MG A075595 001 Feb 28, 2000
37.5MG A075595 002 Feb 28, 2000
75MG A075595 003 Feb 28, 2000
MALLINCKRODT 18.75MG A075726 003 Mar 30, 2001
37.5MG A075726 002 Mar 30, 2001
75MG A075726 001 Mar 30, 2001
SANDOZ 18.75MG A075286 001 Dec 27, 1999
37.5MG A075286 002 Jun 30, 1999
75MG A075286 003 Jun 30, 1999
TEVA PHARMS 18.75MG A075030 003 Feb 22, 2000
37.5MG A075030 001 Jan 29, 1999
75MG A075030 002 Jan 29, 1999
VINTAGE PHARMS 18.75MG A075328 001 Apr 19, 2000
37.5MG A075328 002 Apr 19, 2000
75MG A075328 003 Apr 19, 2000
WATSON LABS 18.75MG A075287 001 Jun 13, 2001
37.5MG A075287 002 Sep 18, 2000
75MG A075287 003 Sep 18, 2000
TABLET, CHEWABLE;ORAL
CYLERT
ABBOTT 37.5MG N017703 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-252(of 337)
PEMOLINE
TABLET, CHEWABLE;ORAL
PEMOLINE
ACTAVIS ELIZABETH 37.5MG
A075678 001
Jul 26, 2000
TEVA PHARMS 37.5MG
A075555 001
Feb 18, 2000
PENBUTOLOL SULFATE
TABLET;ORAL
LEVATOL
AUXILIUM PHARMS LLC 10MG **Federal Register determination
N018976 001
Dec 30, 1987
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
20MG **Federal Register determination
N018976 004
Jan 05, 1989
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
PENICILLAMINE
CAPSULE;ORAL
CUPRIMINE
ATON 125MG
N019853 002
PENICILLIN G BENZATHINE
INJECTABLE;INJECTION
BICILLIN L-A
WYETH AYERST 300,000 UNITS/ML
N050131 001
SUSPENSION;ORAL
BICILLIN
WYETH AYERST 300,000 UNITS/5ML
N050126 002
TABLET;ORAL
BICILLIN
WYETH AYERST 200,000 UNITS
N050128 001
PENICILLIN G POTASSIUM
FOR SOLUTION;ORAL
PENICILLIN
TEVA 200,000 UNITS/5ML
A060307 002
400,000 UNITS/5ML
A060307 004
PENICILLIN G POTASSIUM
MYLAN 200,000 UNITS/5ML
A060752 003
250,000 UNITS/5ML
A060752 002
400,000 UNITS/5ML
A060752 001
PUREPAC PHARM 250,000 UNITS/5ML
A061740 001
400,000 UNITS/5ML
A061740 002
PENICILLIN-2
TEVA 250,000 UNITS/5ML
A060307 003
PENTIDS '200'
APOTHECON 200,000 UNITS/5ML
A062149 001
PENTIDS '400'
APOTHECON 400,000 UNITS/5ML
A062149 002
PFIZERPEN G
PFIZER 400,000 UNITS/5ML
A060587 001
INJECTABLE;INJECTION
PENICILLIN G POTASSIUM
APOTHECON 1,000,000 UNITS/VIAL
A060362 001
5,000,000 UNITS/VIAL
A060362 003
10,000,000 UNITS/VIAL
A060362 004
20,000,000 UNITS/VIAL
A060362 002
CONSOLIDATED PHARM 500,000 UNITS/VIAL
A060806 001
1,000,000 UNITS/VIAL
A060806 002
5,000,000 UNITS/VIAL
A060806 003
10,000,000 UNITS/VIAL
A060806 004
LILLY 200,000 UNITS/VIAL
A060384 004
500,000 UNITS/VIAL
A060384 003
1,000,000 UNITS/VIAL
A060384 002
5,000,000 UNITS/VIAL
A060384 001
20,000,000 UNITS/VIAL
A060384 005
20,000,000 UNITS/VIAL
A060601 001
PARKE DAVIS 1,000,000 UNITS/VIAL
A062003 001
5,000,000 UNITS/VIAL
A062003 002
PFIZER 20,000,000 UNITS/VIAL
A060074 003
SANDOZ 1,000,000 UNITS/VIAL **Federal Register
A065079 001
Aug 30, 2002
determination that product was not
discontinued or withdrawn for safety or
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-253(of 337)
PENICILLIN G POTASSIUM
INJECTABLE;INJECTION
PENICILLIN G POTASSIUM
efficacy reasons**
WATSON LABS INC 1,000,000 UNITS/VIAL
A062991 001
Sep 13, 1988
5,000,000 UNITS/VIAL
A062991 002
Sep 13, 1988
10,000,000 UNITS/VIAL
A062991 003
Sep 13, 1988
20,000,000 UNITS/VIAL
A062991 004
Sep 13, 1988
PFIZERPEN
PFIZER 1,000,000 UNITS/VIAL **Federal Register
A060657 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
TABLET;ORAL
PENICILLIN G POTASSIUM
APOTHECON 250,000 UNITS
A060392 003
IVAX SUB TEVA PHARMS 400,000 UNITS
A060073 004
LILLY 250,000 UNITS
A060403 001
MYLAN 200,000 UNITS
A060781 001
250,000 UNITS
A060781 002
400,000 UNITS
A060781 003
500,000 UNITS
A060781 005
800,000 UNITS
A060781 004
PUREPAC PHARM 200,000 UNITS
A061588 001
250,000 UNITS
A061588 002
400,000 UNITS
A061588 003
TEVA 200,000 UNITS
A060306 001
250,000 UNITS
A060306 002
400,000 UNITS
A060306 003
500,000 UNITS
A060306 004
WYETH AYERST 200,000 UNITS
A060413 001
250,000 UNITS
A060413 002
400,000 UNITS
A060413 003
PENTIDS '200'
APOTHECON 200,000 UNITS
A062155 001
PENTIDS '250'
APOTHECON 250,000 UNITS
A062155 002
PENTIDS '400'
APOTHECON 400,000 UNITS
A060392 004
400,000 UNITS
A062155 003
PENTIDS '800'
APOTHECON 800,000 UNITS
A060392 005
800,000 UNITS
A062155 004
PFIZERPEN G
PFIZER 50,000 UNITS
A060075 001
100,000 UNITS
A060075 002
200,000 UNITS
A060075 003
250,000 UNITS
A060075 004
400,000 UNITS
A060075 005
800,000 UNITS
A060075 006
PENICILLIN G PROCAINE
INJECTABLE;INJECTION
DURACILLIN A.S.
LILLY 300,000 UNITS/ML
A060093 001
PENICILLIN G PROCAINE
CONSOLIDATED PHARM 300,000 UNITS/ML
A060800 001
600,000 UNITS/1.2ML
A060800 002
PARKE DAVIS 300,000 UNITS/ML
A062029 001
PFIZER 300,000 UNITS/VIAL
A060099 001
1,500,000 UNITS/VIAL
A060099 002
PFIZERPEN-AS
PFIZER 300,000 UNITS/ML
A060286 001
600,000 UNITS/ML
A060286 002
PENICILLIN G SODIUM
INJECTABLE;INJECTION
PENICILLIN G SODIUM
BRISTOL MYERS SQUIBB 5,000,000 UNITS/VIAL
A061935 001
COPANOS 5,000,000 UNITS/VIAL
A061051 001
PHARMACIA AND UPJOHN 1,000,000 UNITS/VIAL
A061046 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-254(of 337)
PENICILLIN G SODIUM
INJECTABLE;INTRAMUSCULAR, INTRAVENOUS
PENICILLIN G SODIUM
WATSON LABS INC 5,000,000 UNITS/VIAL
A063014 001 Sep 13, 1988
PENICILLIN V
FOR SUSPENSION;ORAL
V-CILLIN
LILLY 125MG/0.6ML
A060002 001
PENICILLIN V POTASSIUM
FOR SOLUTION;ORAL
BEEPEN-VK
GLAXOSMITHKLINE EQ 125MG BASE/5ML
A062270 001
EQ 250MG BASE/5ML
A062270 002
BETAPEN-VK
APOTHECON EQ 125MG BASE/5ML
A061149 001
EQ 250MG BASE/5ML
A061149 002
LEDERCILLIN VK
LEDERLE EQ 125MG BASE/5ML
A060136 001
EQ 250MG BASE/5ML
A060136 002
PEN-VEE K
WYETH AYERST EQ 125MG BASE/5ML
A060007 001
EQ 250MG BASE/5ML
A060007 002
PENAPAR-VK
PARKE DAVIS EQ 125MG BASE/5ML
A062002 001
EQ 250MG BASE/5ML
A062002 002
PENICILLIN V POTASSIUM
AM ANTIBIOTICS EQ 125MG BASE/5ML
A061529 001
EQ 250MG BASE/5ML
A061529 002
MYLAN EQ 125MG BASE/5ML
A061624 002
EQ 250MG BASE/5ML
A061624 001
PUREPAC PHARM EQ 125MG BASE/5ML
A061758 001
EQ 250MG BASE/5ML
A061758 002
PFIZERPEN VK
PFIZER EQ 125MG BASE/5ML
A061815 001
EQ 250MG BASE/5ML
A061815 002
V-CILLIN K
LILLY EQ 125MG BASE/5ML
A060004 001
EQ 250MG BASE/5ML
A060004 002
VEETIDS
APOTHECON EQ 125MG BASE/5ML
A061410 001
EQ 250MG BASE/5ML
A061410 002
VEETIDS '125'
APOTHECON EQ 125MG BASE/5ML
A061206 001
EQ 125MG BASE/5ML
A062153 001
VEETIDS '250'
APOTHECON EQ 250MG BASE/5ML
A061206 002
EQ 250MG BASE/5ML
A062153 002
TABLET;ORAL
BEEPEN-VK
GLAXOSMITHKLINE EQ 250MG BASE
A062273 001
EQ 500MG BASE
A062273 002
BETAPEN-VK
BRISTOL EQ 250MG BASE
A061150 001
EQ 500MG BASE
A061150 002
LEDERCILLIN VK
LEDERLE EQ 250MG BASE
A060134 001
EQ 500MG BASE
A060134 002
PEN-VEE K
WYETH AYERST EQ 125MG BASE
A060006 001
EQ 250MG BASE
A060006 002
EQ 500MG BASE
A060006 003
PENAPAR-VK
PARKE DAVIS EQ 250MG BASE
A062001 001
EQ 500MG BASE
A062001 002
PENICILLIN V POTASSIUM
AM ANTIBIOTICS EQ 250MG BASE
A061528 001
EQ 500MG BASE
A061528 002
IVAX SUB TEVA PHARMS EQ 125MG BASE
A060518 001
EQ 250MG BASE
A060518 002
EQ 500MG BASE
A060518 003
MYLAN EQ 250MG BASE
A061530 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-255(of 337)
PENICILLIN V POTASSIUM
TABLET;ORAL
PENICILLIN V POTASSIUM
EQ 500MG BASE
A061530 002
PUREPAC PHARM
EQ 125MG BASE
A061571 001
EQ 250MG BASE
A061571 002
EQ 500MG BASE
A061571 003
PFIZERPEN VK
PFIZER
EQ 250MG BASE
A061836 001
EQ 500MG BASE
A061836 002
UTICILLIN VK
PHARMACIA AND UPJOHN
EQ 250MG BASE
A061651 001
EQ 500MG BASE
A061651 002
V-CILLIN K
LILLY
EQ 125MG BASE
A060003 001
EQ 250MG BASE
A060003 002
EQ 500MG BASE
A060003 003
VEETIDS
APOTHECON
EQ 250MG BASE
A061411 001
EQ 500MG BASE
A061411 002
VEETIDS '250'
APOTHECON
EQ 250MG BASE
A061164 001
EQ 250MG BASE
A062156 002
VEETIDS '500'
APOTHECON
EQ 500MG BASE
A061164 002
EQ 500MG BASE
A062156 001
PENTAGASTRIN
INJECTABLE;INJECTION
PEPTAVLON
WYETH AYERST
0.25MG/ML **Federal Register
N017048 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
PENTAMIDINE ISETHIONATE
FOR SOLUTION;INHALATION
NEBUPENT
FRESENIUS KABI USA
600MG/VIAL
N019887 002 Mar 22, 1996
INJECTABLE;INJECTION
PENTACARINAT
ARMOUR PHARM
300MG/VIAL
A073447 001 Apr 28, 1994
PENTAMIDINE ISETHIONATE
BAXTER HLTHCARE
300MG/VIAL
A073617 001 Dec 18, 1995
HOSPIRA
300MG/VIAL
A073479 001 Jun 30, 1992
WATSON LABS
300MG/VIAL
A074303 001 Aug 17, 1995
PENTAZOCINE HYDROCHLORIDE
TABLET;ORAL
TALWIN 50
SANOFI AVENTIS US
EQ 50MG BASE
N016732 001
PENTETATE CALCIUM TRISODIUM
SOLUTION;INHALATION, INTRAVENOUS
PENTETATE CALCIUM TRISODIUM
HAMELN PHARMS EQ 1GM BASE/5ML (EQ 200MG BASE/ML)
N021749 001 Aug 11, 2004
**Federal Register determination that
product was not discontinued or
withdrawn for safety or efficacy
reasons**
PENTETATE CALCIUM TRISODIUM YB-169
INJECTABLE;INJECTION
YTTERBIUM YB 169 DTPA
3M 2mCi/ML
N017518 001
PENTETATE ZINC TRISODIUM
SOLUTION;INHALATION, INTRAVENOUS
PENTETATE ZINC TRISODIUM
HAMELN PHARMS EQ 1GM BASE/5ML (EQ 200MG BASE/ML)
N021751 001 Aug 11, 2004
**Federal Register determination that
product was not discontinued or
withdrawn for safety or efficacy
reasons**
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-256(of 337)
PENTOBARBITAL
ELIXIR;ORAL
NEMBUTAL
OAK PHARMS
18.2MG/5ML
A083244 001
PENTOBARBITAL SODIUM
CAPSULE;ORAL
NEMBUTAL SODIUM
OAK PHARMS
30MG
A084095 001
50MG
A084093 001
100MG
A083245 001
PENTOBARBITAL SODIUM
LANNETT
50MG
A085937 001
100MG
A085915 001
VITARINE
100MG
A083284 001
WHITEWORTH TOWN PLSN
100MG
A083338 001
SODIUM PENTOBARBITAL
ANABOLIC
100MG
A084590 001
ELKINS SINN
100MG
A083368 001
EVERYLIFE
100MG
A083259 001
HALSEY
100MG
A084677 001
IVAX SUB TEVA PHARMS
50MG
A083461 001
100MG
A083461 002
PARKE DAVIS
100MG
A084156 001
PERRIGO
100MG
A084560 001
PUREPAC PHARM
100MG
A083301 001
VALEANT PHARM INTL
100MG
A083264 001
WATSON LABS
100MG
A085791 001
WYETH AYERST
100MG
A083239 001
INJECTABLE;INJECTION
PENTOBARBITAL SODIUM
ELKINS SINN
50MG/ML
A083270 001
SODIUM PENTOBARBITAL
WYETH AYERST
50MG/ML
A083261 001
SUPPOSITORY;RECTAL
NEMBUTAL
OAK PHARMS
30MG
A083247 001 Jan 25, 1982
60MG
A083247 002 Jan 25, 1982
120MG
A083247 003 Jan 25, 1982
200MG
A083247 004 Jan 25, 1982
TABLET;ORAL
PENTOBARBITAL SODIUM
VITARINE
100MG
A083285 001
SODIUM PENTOBARBITAL
NEXGEN PHARMA INC
100MG
A084238 001
PENTOLINIUM TARTRATE
INJECTABLE;INJECTION
ANSOLYSEN
WYETH AYERST
10MG/ML
N009372 001
PENTOXIFYLLINE
TABLET, EXTENDED RELEASE;ORAL
PENTOXIFYLLINE
ACTAVIS ELIZABETH
400MG
A074878 001 Jul 09, 1997
HERITAGE PHARMS INC
400MG
A074877 001 Jul 08, 1997
TEVA
400MG
A075199 001 Sep 03, 1999
WATSON LABS
400MG
A075107 001 Sep 04, 1998
TRENTAL
SANOFI AVENTIS US
400MG
N018631 001 Aug 30, 1984
PERFLUBRON
LIQUID;ORAL
IMAGENT
ALLIANCE PHARM
100%
N020091 001 Aug 13, 1993
PERFLUOROPOLYMETHYLISOPROPYL ETHER; POLYTETRAFLUOROETHYLENE
PASTE;TOPICAL
SKIN EXPOSURE REDUCTION PASTE AGAINST CHEMICAL WARFARE AGENTS
US ARMY 50%;50%
N021084 001 Feb 17, 2000
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-257(of 337)
PERGOLIDE MESYLATE
TABLET;ORAL
PERGOLIDE MESYLATE
IVAX SUB TEVA PHARMS
EQ 0.05MG BASE
A076094 001
Sep 04, 2003
EQ 0.25MG BASE
A076094 002
Sep 04, 2003
EQ 1MG BASE
A076094 003
Sep 04, 2003
PAR PHARM
EQ 0.05MG BASE
A076061 001
Nov 27, 2002
EQ 0.25MG BASE
A076061 002
Nov 27, 2002
EQ 1MG BASE
A076061 003
Nov 27, 2002
PERMAX
VALEANT PHARM INTL
EQ 0.05MG BASE
N019385 001
Dec 30, 1988
EQ 0.25MG BASE
N019385 002
Dec 30, 1988
EQ 1MG BASE
N019385 003
Dec 30, 1988
PERMETHRIN
LOTION;TOPICAL
NIX
GLAXOSMITHKLINE
1%
N019435 001
Mar 31, 1986
PERPHENAZINE
CONCENTRATE;ORAL
PERPHENAZINE
PHARM ASSOC
16MG/5ML
A040360 001
May 25, 2001
TRILAFON
SCHERING
16MG/5ML
N011557 001
INJECTABLE;INJECTION
TRILAFON
SCHERING
5MG/ML
N011213 002
SYRUP;ORAL
TRILAFON
SCHERING
2MG/5ML
N011294 002
TABLET;ORAL
PERPHENAZINE
ANI PHARMS INC
8MG
A089456 001
Sep 10, 1987
TEVA PHARMS USA
2MG
A089707 001
Sep 10, 1987
4MG
A089708 001
Sep 10, 1987
16MG
A089457 001
Sep 10, 1987
TRILAFON
SCHERING
2MG
N010775 001
4MG
N010775 002
8MG
N010775 003
16MG
N010775 004
TABLET, EXTENDED RELEASE;ORAL
TRILAFON
SCHERING
8MG
N011361 002
PHENACEMIDE
TABLET;ORAL
PHENURONE
ABBVIE
500MG **Federal Register determination
N007707 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE
TABLET;ORAL
AZO GANTANOL
ROCHE 100MG;500MG **Federal Register
N013294 001
Sep 10, 1987
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
PHENAZOPYRIDINE HYDROCHLORIDE; SULFAMETHOXAZOLE; TRIMETHOPRIM
TABLET;ORAL
SULFAMETHOXAZOLE AND TRIMETHOPRIM AND PENAZOPYRIDINE HYDROCHLORIDE
ABLE 200MG;800MG;160MG
N021105 001
Jun 26, 2001
PHENAZOPYRIDINE HYDROCHLORIDE; SULFISOXAZOLE
TABLET;ORAL
AZO GANTRISIN
ROCHE 50MG;500MG **Federal Register
N019358 001
Aug 31, 1990
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-258(of 337)
PHENDIMETRAZINE TARTRATE
CAPSULE;ORAL
PHENAZINE
MAST MM
35MG
A086523 001
35MG
A086524 001
35MG
A086525 001
PHENDIMETRAZINE TARTRATE
SANDOZ
35MG
A085633 001
35MG
A085694 001
35MG
A085695 001
35MG
A085702 001
VITARINE
35MG
A085634 001
35MG
A085645 001
35MG
A085670 001
35MG
A086403 001
35MG
A086408 001
35MG
A086410 001
35MG
A087424 001
SPRX-3
SOLVAY
35MG
A085897 001
STATOBEX
TEVA
35MG
A085507 001
X-TROZINE
SHIRE RICHWOOD
35MG
A087394 001 Sep 22, 1982
CAPSULE, EXTENDED RELEASE;ORAL
MELFIAT-105
NUMARK
105MG
A087487 001 Oct 13, 1982
PHENDIMETRAZINE TARTRATE
GRAHAM DM
105MG
A087214 001 May 26, 1982
105MG
A088020 001 Aug 16, 1982
105MG
A088028 001 Aug 16, 1982
105MG
A088062 001 Sep 13, 1982
105MG
A088063 001 Sep 10, 1982
105MG
A088111 001 Oct 18, 1982
SANDOZ
105MG
A087378 001
SPRX-105
NUMARK
105MG
A088024 001 Dec 22, 1982
X-TROZINE L.A.
SHIRE RICHWOOD
105MG
A087371 001 Aug 24, 1982
TABLET;ORAL
ADPHEN
FERNDALE LABS
35MG
A083655 001
ALPHAZINE
SANDOZ
35MG
A085034 001
CAM-METRAZINE
ABC HOLDING
35MG
A085511 001
CAMALL
35MG
A085756 001
TG UNITED LABS
35MG
A083922 001
35MG
A085318 001
35MG
A085320 001
35MG
A085321 001
DI-METREX
PVT FORM
35MG
A085698 001
MELFIAT
NUMARK
35MG
A083790 002
METRA
FOREST PHARMS
35MG
A083754 001
PHENAZINE
MAST MM
35MG
A087305 001
PHENAZINE-35
ABC HOLDING
35MG
A085512 001
PHENDIMETRAZINE TARTRATE
BARR
35MG
A083644 001
35MG
A083684 001
35MG
A083686 001
35MG
A083687 001
35MG
A084831 001
35MG
A084834 001
35MG
A084835 001
FERNDALE LABS
35MG
A086834 001 Sep 15, 1983
INWOOD LABS
35MG
A084740 001
35MG
A084741 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-259(of 337)
PHENDIMETRAZINE TARTRATE
TABLET;ORAL
PHENDIMETRAZINE TARTRATE
35MG
A084742 001
35MG
A084743 001
IVAX PHARMS
35MG
A085611 001
35MG
A085612 001
IVAX SUB TEVA PHARMS
35MG
A083682 001
KV PHARM
35MG
A084138 001
35MG
A084141 001
35MG
A085525 001
MFG CHEMISTS
35MG
A085914 001
NEXGEN PHARMA INC
35MG
A086020 001
NUMARK
35MG
A083790 001
PVT FORM
35MG
A085199 001
35MG
A085697 001
SANDOZ
35MG
A085402 001
35MG
A085497 001
35MG
A085830 001
35MG
A086365 001
35MG
A086370 001
SOLVAY
35MG
A083993 001
TG UNITED LABS
35MG
A085761 001
35MG
A085941 001 Jun 27, 1983
USL PHARMA
35MG
A083805 001
35MG
A084398 001
35MG
A084399 001
VITARINE
35MG
A085519 001
35MG
A086005 001
35MG
A086106 001
WATSON LABS
35MG
A085767 001
35MG
A085768 001
35MG
A085770 001
35MG
A085773 001
PLEGINE
WYETH AYERST
35MG
N012248 001
STATOBEX
TEVA
35MG
A086013 001
STATOBEX-G
TEVA
35MG
A085095 001
X-TROZINE
SHIRE RICHWOOD
35MG
A086550 001
35MG
A086551 001
35MG
A086552 001
35MG
A086553 001
35MG
A086554 001
PHENINDIONE
TABLET;ORAL
HEDULIN
SANOFI AVENTIS US
50MG
N008767 002
PHENMETRAZINE HYDROCHLORIDE
TABLET;ORAL
PRELUDIN
BOEHRINGER INGELHEIM
25MG
N010460 005
TABLET, EXTENDED RELEASE;ORAL
PRELUDIN
BOEHRINGER INGELHEIM
50MG
N011752 004
75MG
N011752 003
PHENPROCOUMON
TABLET;ORAL
LIQUAMAR
ORGANON USA INC
3MG
N011228 001
PHENSUXIMIDE
CAPSULE;ORAL
MILONTIN
PARKE DAVIS
500MG
N008855 004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-260(of 337)
PHENTERMINE HYDROCHLORIDE
CAPSULE;ORAL
FASTIN
GLAXOSMITHKLINE 30MG N017352 001
OBESTIN-30
FERNDALE LABS 30MG A087144 001
OBY-TRIM
SHIRE RICHWOOD 30MG A087764 001 Mar 18, 1982
ONA-MAST
MAST MM 30MG A086511 001
30MG A086516 001
PHENTERMINE HYDROCHLORIDE
ABC HOLDING 30MG A085411 001
ABLE 15MG A040497 001 Mar 13, 2003
30MG A040403 001 Aug 30, 2001
30MG A040427 001 Aug 30, 2001
CAMALL 15MG A086735 001
30MG A087226 001
DURAMED PHARMS BARR 30MG A088948 001 Apr 25, 1986
IVAX PHARMS 30MG A086329 001
MIKAH PHARMA 15MG A040460 001 Jan 14, 2003
30MG A040227 001 Jun 18, 1997
30MG A040448 001 Jan 22, 2003
37.5MG A040228 001 Jun 19, 1997
MUTUAL PHARM 37.5MG A040527 001 Oct 23, 2003
SANDOZ 30MG A087208 001
30MG A087223 001
37.5MG A088414 001 Oct 19, 1983
TEVA 30MG A086911 001
30MG A087126 001
30MG A087777 001 Nov 01, 1985
30MG A088612 001 Apr 04, 1984
30MG A088613 001 Apr 09, 1984
30MG A088614 001 Apr 09, 1984
TG UNITED INC 30MG A040083 001 Mar 07, 1997
TG UNITED LABS 18.75MG A088576 001 May 23, 1984
30MG A085417 001
30MG A086732 002
30MG A087215 001
37.5MG A087915 001 Dec 22, 1983
37.5MG A087918 001 Dec 22, 1983
37.5MG A087930 001 Oct 14, 1983
37.5MG A088610 001 Jun 04, 1984
37.5MG A088611 001 Jun 04, 1984
37.5MG A088625 001 Aug 23, 1984
USL PHARMA 30MG A084487 001 Apr 09, 1982
30MG A088430 001 Mar 27, 1984
30MG A088797 001 Dec 10, 1984
VITARINE 30MG A087202 001
30MG A087235 001
WATSON LABS 30MG A086740 001 Mar 21, 1985
TABLET;ORAL
ONA-MAST
MAST MM 8MG A086260 001
PHENTERMINE HYDROCHLORIDE
ABLE 37.5MG A040402 001 Aug 30, 2001
ACTAVIS ELIZABETH 37.5MG A040276 001 Nov 25, 1998
IVAX PHARMS 8MG A085553 001
SANDOZ 8MG A085671 001
8MG A085689 001
SANDOZ INC 30MG A088605 001 Sep 28, 1987
TG UNITED LABS 8MG A083923 001
8MG A085319 001
37.5MG A087805 001 Dec 06, 1982
37.5MG A088596 001 Apr 04, 1984
USL PHARMA 8MG A083804 001
37.5MG A088910 001 Jul 17, 1985
37.5MG A088917 001 Jul 17, 1985
VITARINE 8MG A086453 001
8MG A086456 001
WATSON LABS 8MG A085739 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-261(of 337)
PHENTERMINE HYDROCHLORIDE
TABLET;ORAL
TORA
SOLVAY 8MG A084035 001
WILPO
SANDOZ 8MG **Federal Register determination N012737 001
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
PHENTERMINE RESIN COMPLEX
CAPSULE, EXTENDED RELEASE;ORAL
IONAMIN
UCB INC EQ 15MG BASE N011613 004
EQ 30MG BASE N011613 002
PHENTERMINE RESIN 30
QUANTUM PHARMICS EQ 30MG BASE A089120 001 Feb 04, 1988
PHENYL AMINOSALICYLATE
POWDER;ORAL
PHENY-PAS-TEBAMIN
PHARM RES ASSOC 50% N011695 002
TABLET;ORAL
PHENY-PAS-TEBAMIN
PHARM RES ASSOC 500MG N011695 003
PHENYLBUTAZONE
CAPSULE;ORAL
AZOLID
SANOFI AVENTIS US 100MG A087260 001
BUTAZOLIDIN
NOVARTIS 100MG N008319 009
PHENYLBUTAZONE
IVAX PHARMS 100MG A088218 001 Jun 24, 1983
MUTUAL PHARM 100MG A088994 001 Dec 04, 1985
SANDOZ 100MG A087774 001 Jun 16, 1982
WATSON LABS 100MG A087756 001 Dec 17, 1982
TABLET;ORAL
AZOLID
SANOFI AVENTIS US 100MG A087091 001
BUTAZOLIDIN
NOVARTIS 100MG N008319 008
PHENYLBUTAZONE
MUTUAL PHARM 100MG A088863 001 Dec 04, 1985
SANDOZ 100MG A084339 001
WATSON LABS 100MG A086151 001
100MG A087674 001 Apr 21, 1982
PHENYLEPHRINE HYDROCHLORIDE; PROMETHAZINE HYDROCHLORIDE
SYRUP;ORAL
PHENERGAN VC
ANI PHARMS 5MG/5ML;6.25MG/5ML N008604 003 Apr 02, 1984
PHERAZINE VC
HALSEY 5MG/5ML;6.25MG/5ML A088868 001 Mar 02, 1987
PROMETHAZINE VC PLAIN
CENCI 5MG/5ML;6.25MG/5ML A088815 001 Nov 22, 1985
WOCKHARDT 5MG/5ML;6.25MG/5ML A088897 001 Jan 04, 1985
PHENYLEPHRINE HYDROCHLORIDE; PYRILAMINE MALEATE
SOLUTION/DROPS;OPHTHALMIC
PREFRIN-A
ALLERGAN 0.12%;0.1% N007953 001
PHENYTOIN
SUSPENSION;ORAL
DILANTIN-30
PARKE DAVIS 30MG/5ML N008762 002
PHENYTOIN
ACTAVIS MID ATLANTIC 125MG/5ML A089892 001 Sep 25, 1992
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DISCONTINUED DRUG PRODUCT LIST 6-262(of 337)
PHENYTOIN SODIUM
CAPSULE;ORAL
DIPHENYLAN SODIUM
LANNETT 30MG PROMPT A080857 001
100MG PROMPT A080857 002
EXTENDED PHENYTOIN SODIUM
ANI PHARMS INC 100MG EXTENDED A040435 001 Jun 20, 2003
100MG EXTENDED A089441 001 Dec 18, 1986
PHENYTEX
WATSON LABS 100MG EXTENDED A088711 001 Dec 21, 1984
PHENYTOIN SODIUM
PHARMERAL 100MG PROMPT A085435 001
WATSON LABS 100MG PROMPT A085894 001
PROMPT PHENYTOIN SODIUM
ANI PHARMS INC 100MG PROMPT A080259 001
WATSON LABS 100MG PROMPT A080905 001
INJECTABLE;INJECTION
DILANTIN
PARKE DAVIS 50MG/ML N010151 001
PHENYTOIN SODIUM
FRESENIUS KABI USA 50MG/ML A089003 001 May 31, 1985
HOSPIRA 50MG/ML A089744 001 Dec 18, 1987
MARSAM PHARMS LLC 50MG/ML A089501 001 Oct 13, 1987
50MG/ML A089779 001 Nov 27, 1992
SMITH AND NEPHEW 50MG/ML A088519 001 Dec 19, 1984
50MG/ML A088521 001 Dec 18, 1984
SOLOPAK 50MG/ML A088520 001 Dec 17, 1984
WARNER CHILCOTT 50MG/ML A089900 001 Mar 30, 1990
WATSON LABS 50MG/ML A085434 001
PHYTONADIONE
INJECTABLE;INJECTION
AQUAMEPHYTON
BIOVAIL TECHNOLOGIES 1MG/0.5ML N012223 002
10MG/ML N012223 001
KONAKION
ROCHE 1MG/0.5ML N011745 001
10MG/ML N011745 003
PHYTONADIONE
GLAXOSMITHKLINE 1MG/0.5ML A084060 001
10MG/ML A084060 002
VITAMIN K1
HOSPIRA 10MG/ML A087956 001 Jul 25, 1983
PILOCARPINE
INSERT, EXTENDED RELEASE;OPHTHALMIC
OCUSERT PILO-20
AKORN 5MG N017431 001
OCUSERT PILO-40
AKORN 11MG N017548 001
PINACIDIL
CAPSULE, EXTENDED RELEASE;ORAL
PINDAC
LEO PHARM 12.5MG N019456 001 Dec 28, 1989
25MG N019456 002 Dec 28, 1989
PINDOLOL
TABLET;ORAL
PINDOLOL
IVAX SUB TEVA PHARMS 5MG A073687 001 Feb 26, 1993
10MG A073687 002 Feb 26, 1993
MYLAN PHARMS INC 5MG A074013 001 Sep 24, 1992
10MG A074018 001 Sep 24, 1992
NOSTRUM LABS 5MG A074474 001 Oct 28, 1996
10MG A074474 002 Oct 28, 1996
PUREPAC PHARM 5MG A074125 001 Apr 28, 1993
10MG A074125 002 Apr 28, 1993
SANDOZ 5MG A073608 001 Mar 29, 1993
10MG A073609 001 Mar 29, 1993
TEVA 5MG A073661 001 Oct 31, 1993
5MG A074123 001 Apr 17, 1997
10MG A073661 002 Oct 31, 1993
10MG A074123 002 Apr 17, 1997
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-263(of 337)
PINDOLOL
TABLET;ORAL
PINDOLOL
WATSON LABS
5MG
A074437 001 Feb 27, 1995
10MG
A074437 002 Feb 27, 1995
VISKEN
NOVARTIS
5MG
N018285 001 Sep 03, 1982
10MG
N018285 002 Sep 03, 1982
PIPECURONIUM BROMIDE
INJECTABLE;INJECTION
ARDUAN
ORGANON USA INC
10MG/VIAL
N019638 001 Jun 26, 1990
PIPERACETAZINE
TABLET;ORAL
QUIDE
DOW PHARM
10MG
N013615 001
25MG
N013615 002
PIPERACILLIN SODIUM
INJECTABLE;INJECTION
PIPRACIL
WYETH PHARMS INC
EQ 2GM BASE/VIAL
A062750 001 Oct 13, 1987
EQ 2GM BASE/VIAL
N050545 002
EQ 3GM BASE/VIAL
A062750 002 Oct 13, 1987
EQ 3GM BASE/VIAL
N050545 003
EQ 4GM BASE/VIAL
A062750 003 Oct 13, 1987
EQ 4GM BASE/VIAL
N050545 004
EQ 40GM BASE/VIAL
N050545 006 Sep 30, 1985
PIPERAZINE CITRATE
SYRUP;ORAL
ANTEPAR
GLAXOSMITHKLINE
EQ 500MG BASE/5ML
N009102 001
BRYREL
SANOFI AVENTIS US
EQ 500MG BASE/5ML
N017796 001
MULTIFUGE
BLULINE
EQ 500MG BASE/5ML
N009452 001
PIPERAZINE CITRATE
ALPHARMA US PHARMS
EQ 500MG BASE/5ML
A080774 001
LANNETT
EQ 500MG BASE/5ML
A080963 001
LUITPOLD
EQ 500MG BASE/5ML
A080671 001
VERMIDOL
SOLVAY
EQ 500MG BASE/5ML
A080992 001
TABLET;ORAL
ANTEPAR
GLAXOSMITHKLINE
EQ 500MG BASE
N009102 003
PIPERAZINE CITRATE
IMPAX LABS
EQ 250MG BASE
A080874 001
PIPERONYL BUTOXIDE; PYRETHRINS
AEROSOL;TOPICAL
RID MOUSSE
BAYER HEALTHCARE LLC
4%;EQ 0.33% BASE
N021043 001 Mar 07, 2000
PIPOBROMAN
TABLET;ORAL
VERCYTE
ABBOTT
10MG
N016245 001
25MG
N016245 002
PIRBUTEROL ACETATE
AEROSOL, METERED;INHALATION
MAXAIR
VALEANT PHARM NORTH
EQ 0.2MG BASE/INH
N019009 001 Dec 30, 1986
PIROXICAM
CAPSULE;ORAL
PIROXICAM
CYCLE PHARMS LTD
10MG
A073651 001 Feb 26, 1993
20MG
A073651 002 Feb 26, 1993
EGIS
10MG
A074808 001 Jul 08, 1997
20MG
A074808 002 Jul 08, 1997
IVAX SUB TEVA PHARMS
10MG
A074148 001 Jun 03, 1996
20MG
A074148 002 Jun 03, 1996
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-264(of 337)
PIROXICAM
CAPSULE;ORAL
PIROXICAM
MUTUAL PHARM 20MG A073536 001 Mar 12, 1993
MYLAN 10MG A074043 001 Sep 22, 1992
20MG A074043 002 Sep 22, 1992
SCS 10MG A074036 001 May 29, 1992
20MG A074036 002 May 29, 1992
TEVA 10MG A073637 001 Jan 28, 1994
20MG A073638 001 Jan 28, 1994
TEVA PHARMS 10MG A074103 001 Aug 28, 1992
20MG A074103 002 Aug 28, 1992
WATSON LABS 10MG A074287 001 May 16, 1996
10MG A074460 001 Sep 29, 1995
20MG A074287 002 May 16, 1996
20MG A074460 002 Sep 29, 1995
PLICAMYCIN
INJECTABLE;INJECTION
MITHRACIN
PFIZER 2.5MG/VIAL N050109 001
POLYESTRADIOL PHOSPHATE
INJECTABLE;INJECTION
ESTRADURIN
WYETH AYERST 40MG/AMP N010753 001
POLYETHYLENE GLYCOL 3350
FOR SOLUTION;ORAL
POLYETHYLENE GLYCOL 3350
PADDOCK LLC 17GM/SCOOPFUL A090567 001 Oct 15, 2009
TEVA PHARMS 17GM/SCOOPFUL A077445 001 May 04, 2006
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE
FOR SOLUTION;ORAL
CLENZ-LYTE
PADDOCK LLC 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A090769 001 Jun 07, 2010
BOT;22.74GM/BOT
SOLUTION;ORAL
OCL
HOSPIRA 6GM/100ML;75MG/100ML;168MG/100ML;146MG/ N019284 001 Apr 30, 1986
100ML;1.29GM/100ML
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE
ANHYDROUS
FOR SOLUTION;ORAL
COLYTE
MEDA PHARMS 120GM/PACKET;1.49GM/PACKET;3.36GM/PACKE N018983 005 Oct 26, 1984
T;2.92GM/PACKET;11.36GM/PACKET
227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC N018983 004 Oct 26, 1984
KET;5.53GM/PACKET;21.5GM/PACKET
240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ N018983 007 Jun 12, 1987
BOT;22.72GM/BOT
360GM/PACKET;4.47GM/PACKET;10.08GM/PACK N018983 006 Oct 26, 1984
ET;8.76GM/PACKET;34.08GM/PACKET
COLYTE-FLAVORED
MEDA PHARMS 227.1GM/BOT;2.82GM/BOT;6.36GM/BOT;5.53G N018983 008 Nov 14, 1991
M/BOT;21.5GM/BOT
240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ N018983 009 Nov 14, 1991
BOT;22.72GM/BOT
POLYETHYLENE GLYCOL 3350 AND ELECTROLYTES
PADDOCK LLC 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ A090712 001 Feb 25, 2010
BOT;22.72GM/BOT
FOR SUSPENSION;ORAL
CO-LAV
VINTAGE PHARMS 240GM/BOT;2.98GM/BOT;6.72GM/BOT;5.84GM/ A073428 001 Jan 28, 1992
BOT;22.72GM/BOT
COLOVAGE
DYNAPHARM 227.1GM/PACKET;2.82GM/PACKET;6.36GM/PAC A071320 001 Apr 20, 1988
KET;5.53GM/PACKET;21.5GM/PACKET
E-Z-EM PREP LYTE
E Z EM 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A071278 001 Nov 21, 1988
BOT;22.74GM/BOT
GLYCOPREP
GOLDLINE 236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/ A072319 001 Dec 23, 1988
BOT;22.74GM/BOT
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-265(of 337)
POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE; SODIUM SULFATE
ANHYDROUS
FOR SUSPENSION;ORAL
GO-EVAC
VINTAGE PHARMS
236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/
A073433 001 Apr 28, 1992
BOT;22.74GM/BOT
PEG-LYTE
SANDOZ
236GM/BOT;2.97GM/BOT;6.74GM/BOT;5.86GM/
A073098 001 Aug 31, 1993
BOT;22.74GM/BOT
POLYMYXIN B SULFATE
INJECTABLE;INJECTION
AEROSPORIN
GLAXOSMITHKLINE
EQ 500,000 U BASE/VIAL
A062036 001
POWDER;FOR RX COMPOUNDING
POLY-RX
X GEN PHARMS
100,000,000 UNITS/BOT
A061578 001
POLYMYXIN B SULFATE
PADDOCK LLC
100,000,000 UNITS/BOT
A062455 001 Jul 27, 1983
POLYTHIAZIDE
TABLET;ORAL
RENESE
PFIZER
1MG
N012845 001
2MG
N012845 002
4MG
N012845 003
POLYTHIAZIDE; PRAZOSIN HYDROCHLORIDE
CAPSULE;ORAL
MINIZIDE
PFIZER
0.5MG;EQ 1MG BASE
N017986 001
0.5MG;EQ 2MG BASE
N017986 002
0.5MG;EQ 5MG BASE
N017986 003
POLYTHIAZIDE; RESERPINE
TABLET;ORAL
RENESE-R
PFIZER
2MG;0.25MG
N013636 001
POTASSIUM AMINOSALICYLATE
CAPSULE;ORAL
PASKALIUM
GLENWOOD
500MG
N009395 004
POWDER;ORAL
POTASSIUM AMINOSALICYLATE
HEXCEL
100%
A080098 001
TABLET;ORAL
PASKALIUM
GLENWOOD
1GM
N009395 003
POTASSIUM CHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
K-LEASE
SAVAGE LABS 8MEQ
A073398 001 Jan 28, 1992
10MEQ
A072427 001 Mar 28, 1990
POTASSIUM CHLORIDE
NESHER PHARMS 10MEQ
A070980 001 Feb 17, 1987
TEVA 8MEQ
A073531 001 Apr 26, 1996
10MEQ
A073532 001 Apr 26, 1996
FOR SUSPENSION, EXTENDED RELEASE;ORAL
MICRO-K LS
KV PHARM
20MEQ/PACKET
N019561 003 Aug 26, 1988
INJECTABLE;INJECTION
POTASSIUM CHLORIDE
ABRAXIS PHARM
2MEQ/ML
A080204 001
2MEQ/ML
A084290 001
2MEQ/ML
A086713 001
2MEQ/ML
A086714 001
2MEQ/ML
A087787 001 Apr 20, 1982
2MEQ/ML
A087885 001 Feb 03, 1983
AKORN
2MEQ/ML
A088286 001 Sep 05, 1985
BAXTER HLTHCARE
2MEQ/ML
A080203 001
FRESENIUS KABI USA
2MEQ/ML
A087817 001 Oct 20, 1982
GD SEARLE LLC
1MEQ/ML
A086219 001
2MEQ/ML
A086219 002
2MEQ/ML
A086220 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-266(of 337)
POTASSIUM CHLORIDE
INJECTABLE;INJECTION
POTASSIUM CHLORIDE
3MEQ/ML A086219 003
3MEQ/ML A086220 001
4MEQ/ML A086219 004
HOSPIRA
1MEQ/ML A080205 003
1MEQ/ML A083345 003
1.5MEQ/ML A083345 001
2MEQ/ML A083345 002
2.4MEQ/ML A080205 004
3.2MEQ/ML A080205 005
INTL MEDICATION
2MEQ/ML A083163 001
LILLY
2MEQ/ML N007865 002
LUITPOLD
2MEQ/ML A080221 001
2MEQ/ML A080736 001
2MEQ/ML A087584 001
2MEQ/ML A087585 001
MILES
1MEQ/ML A080195 002
2MEQ/ML A080195 001
3MEQ/ML A080195 003
4MEQ/ML A080195 004
PHARMA SERVE NY
2MEQ/ML A086297 001
2MEQ/ML A087362 001 Mar 08, 1983
WATSON LABS
2MEQ/ML A086208 001
2MEQ/ML A089163 001 Mar 10, 1988
2MEQ/ML A089421 001 Jan 02, 1987
3MEQ/ML A086210 001
TABLET, EXTENDED RELEASE;ORAL
K+10
FUTURE PAK
10MEQ A070999 001 Oct 22, 1987
K+8
FUTURE PAK
8MEQ A070998 001 Jan 25, 1993
KAON CL
SAVAGE LABS
6.7MEQ N017046 001
KAON CL-10
SAVAGE LABS
10MEQ N017046 002
KLOTRIX
APOTHECON
10MEQ N017850 001
POTASSIUM CHLORIDE
COPLEY PHARM
8MEQ A070618 001 Sep 09, 1987
NESHER PHARMS
20MEQ A076044 001 Apr 05, 2002
SCHERING
10MEQ N019439 002 Jun 13, 1986
20MEQ N019439 001 Jun 13, 1986
SLOW-K
NOVARTIS
8MEQ N017476 002
TEN-K
NOVARTIS
10MEQ N019381 001 Apr 16, 1986
POTASSIUM CHLORIDE; SODIUM CHLORIDE
INJECTABLE;INJECTION
POTASSIUM CHLORIDE 0.037% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 37MG/100ML;900MG/100ML N019708 001 Sep 29, 1989
POTASSIUM CHLORIDE 0.075% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 75MG/100ML;900MG/100ML N019708 002 Sep 29, 1989
POTASSIUM CHLORIDE 0.11% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 110MG/100ML;900MG/100ML N019708 003 Sep 29, 1989
POTASSIUM CHLORIDE 0.22% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 220MG/100ML;900MG/100ML N019708 005 Sep 29, 1989
POTASSIUM CHLORIDE 0.3% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
B BRAUN 300MG/100ML;900MG/100ML N019708 006 Sep 29, 1989
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER
B BRAUN 75MG/100ML;900MG/100ML N018722 001 Nov 09, 1982
BAXTER HLTHCARE 75MG/100ML;900MG/100ML N017648 004
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER
B BRAUN 150MG/100ML;900MG/100ML N018722 002 Nov 09, 1982
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.22% IN PLASTIC CONTAINER
B BRAUN 220MG/100ML;900MG/100ML N018722 003 Nov 09, 1982
SODIUM CHLORIDE 0.9% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER
B BRAUN 300MG/100ML;900MG/100ML N018722 004 Nov 09, 1982
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-267(of 337)
POTASSIUM CHLORIDE; SODIUM CHLORIDE; TROMETHAMINE
INJECTABLE;INJECTION
THAM-E
HOSPIRA 370MG/VIAL;1.75GM/VIAL;36GM/VIAL N013025 001
POTASSIUM CITRATE
FOR SOLUTION;ORAL
POTASSIUM CITRATE
UT SW MEDCTR 10MEQ/PACKET **Federal Register N019647 002 Oct 13, 1988
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
20MEQ/PACKET **Federal Register N019647 001 Oct 13, 1988
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
POTASSIUM IODIDE
SOLUTION;ORAL
POTASSIUM IODIDE
ROXANE 1GM/ML N018551 001 Feb 19, 1982
TABLET;ORAL
THYRO-BLOCK
MEDPOINTE PHARM HLC 130MG N018307 001
POTASSIUM PERCHLORATE
CAPSULE;ORAL
PERCHLORACAP
MALLINCKRODT 200MG N017551 001
POVIDONE-IODINE
SOLUTION;TOPICAL
E-Z PREP
CLINIPAD 10% N019382 001 Jul 25, 1989
SPONGE;TOPICAL
E-Z PREP
CLINIPAD 5% N019382 002 Jul 25, 1989
E-Z PREP 220
CLINIPAD 5% N019382 003 Jul 25, 1989
PRALIDOXIME CHLORIDE
INJECTABLE;INJECTION
PRALIDOXIME CHLORIDE
BAXTER HLTHCARE CORP 300MG/ML N018799 001 Dec 13, 1982
TABLET;ORAL
PROTOPAM CHLORIDE
WYETH AYERST 500MG N014122 002
PRAMIPEXOLE DIHYDROCHLORIDE
TABLET;ORAL
MIRAPEX
BOEHRINGER INGELHEIM 1.25MG N020667 004 Jul 01, 1997
PRAMIPEXOLE DIHYDROCHLORIDE
WATSON LABS 0.125MG A078551 001 Oct 08, 2010
0.25MG A078551 002 Oct 08, 2010
0.5MG A078551 003 Oct 08, 2010
1MG A078551 004 Oct 08, 2010
1.5MG A078551 005 Oct 08, 2010
PRAMLINTIDE ACETATE
INJECTABLE;SUBCUTANEOUS
SYMLIN
ASTRAZENECA AB EQ 3MG BASE/5ML (EQ 600MCG BASE/ML) N021332 001 Mar 16, 2005
PRAVASTATIN SODIUM
TABLET;ORAL
PRAVACHOL
BRISTOL MYERS SQUIBB 10MG N019898 002 Oct 31, 1991
PRAVASTATIN SODIUM
PLIVA HRVATSKA DOO 10MG A077730 001 Nov 21, 2006
20MG A077730 002 Nov 21, 2006
30MG A077730 003 Nov 21, 2006
40MG A077730 005 Nov 21, 2006
RANBAXY LABS LTD 10MG A076445 001 Apr 23, 2007
20MG A076445 002 Apr 23, 2007
40MG A076445 003 Apr 23, 2007
80MG A076445 004 Apr 23, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-268(of 337)
PRAZEPAM
CAPSULE;ORAL
CENTRAX
PARKE DAVIS 5MG N018144 001
10MG N018144 002
20MG N018144 003 May 10, 1982
PRAZEPAM
USL PHARMA 5MG A070427 001 Nov 06, 1987
10MG A070428 001 Nov 06, 1987
TABLET;ORAL
CENTRAX
PARKE DAVIS 10MG N017415 001
PRAZOSIN HYDROCHLORIDE
CAPSULE;ORAL
PRAZOSIN HYDROCHLORIDE
AM THERAP EQ 1MG BASE A072782 001 May 16, 1989
EQ 2MG BASE A072783 001 May 16, 1989
EQ 5MG BASE A072784 001 May 16, 1989
DAVA PHARMS INC EQ 1MG BASE A072705 001 May 16, 1989
EQ 2MG BASE A072706 001 May 16, 1989
EQ 5MG BASE A072707 001 May 16, 1989
PUREPAC PHARM EQ 1MG BASE A072991 001 May 16, 1989
EQ 2MG BASE A072921 001 May 16, 1989
EQ 5MG BASE A072992 001 May 16, 1989
SANDOZ EQ 1MG BASE A072576 001 May 16, 1989
EQ 2MG BASE A072577 001 May 16, 1989
EQ 5MG BASE A072578 001 May 16, 1989
WATSON LABS EQ 1MG BASE A072352 001 May 16, 1989
EQ 2MG BASE A072333 001 May 16, 1989
EQ 5MG BASE A072609 001 May 16, 1989
TABLET, EXTENDED RELEASE;ORAL
MINIPRESS XL
PFIZER 2.5MG N019775 001 Jan 29, 1992
5MG N019775 002 Jan 29, 1992
PREDNISOLONE
CREAM;TOPICAL
METI-DERM
SCHERING 0.5% N010209 002
SYRUP;ORAL
PREDNISOLONE
APOTEX INC 5MG/5ML A040570 001 Aug 25, 2005
15MG/5ML A040571 001 Aug 25, 2005
IVAX SUB TEVA PHARMS 15MG/5ML A040287 001 May 28, 1999
NESHER PHARMS 5MG/5ML A040423 001 Oct 22, 2001
15MG/5ML A040364 001 Apr 10, 2002
TEVA PHARMS 15MG/5ML A040322 001 Jan 19, 2000
WE PHARMS 15MG/5ML A040192 001 May 28, 1998
PRELONE
MURO 5MG/5ML A089654 001 Jan 17, 1989
TABLET;ORAL
CORTALONE
HALSEY 1MG A080304 003
2.5MG A080304 002
5MG A080304 001
DELTA-CORTEF
PHARMACIA AND UPJOHN 5MG N009987 004
FERNISOLONE-P
FERNDALE LABS 5MG A083941 001
PREDNISOLONE
BARR 5MG A084426 002
BUNDY 5MG A083675 001
ELKINS SINN 5MG A080625 001
EVERYLIFE 1MG A084439 001
2.5MG A084439 002
5MG A084439 003
FERRANTE 2.5MG A080562 001
5MG A080562 002
HEATHER 5MG A080326 001
IMPAX LABS 5MG A080780 001
INWOOD LABS 5MG A080748 001
IVAX SUB TEVA PHARMS 5MG A080378 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-269(of 337)
PREDNISOLONE
TABLET;ORAL
PREDNISOLONE
LANNETT
5MG
A080531 002
MARSHALL PHARMA
5MG
A080307 001
PANRAY
1MG
A080351 001
5MG
A080351 002
PERRIGO
5MG
A084542 001
PHOENIX LABS NY
5MG
A080322 001
PUREPAC PHARM
5MG
A080325 001
PVT FORM
5MG
A080211 001
ROXANE
5MG
A080327 002
SANDOZ
5MG
A080339 001
5MG
A084773 001
SPERTI
1MG
A080358 001
2.5MG
A080358 002
5MG
A080358 003
SUPERPHARM
5MG
A088892 001 Feb 26, 1985
TABLICAPS
5MG
A085170 001
TEVA
5MG
A080398 001
UDL
5MG
A087987 001 Jan 18, 1983
VALEANT PHARM INTL
5MG
A080236 001
VITARINE
5MG
A080534 001
WATSON LABS
5MG
A085085 002
5MG
A085415 001
5MG
A085416 001
WEST WARD
5MG
A080324 001
WHITEWORTH TOWN PLSN
5MG
A080342 001
STERANE
PFIZER
5MG
N009996 001
PREDNISOLONE ACETATE
INJECTABLE;INJECTION
METICORTELONE
SCHERING
25MG/ML
N010255 002
PREDNISOLONE ACETATE
AKORN
25MG/ML
A083032 001
50MG/ML
A084492 001
BEL MAR
25MG/ML
A083738 001
50MG/ML
A083738 002
CENT PHARMS
25MG/ML
A084717 001
50MG/ML
A084717 002
WATSON LABS
25MG/ML
A083398 001
25MG/ML
A083654 001
40MG/ML
A083767 001
50MG/ML
A083764 001
50MG/ML
A085781 001
STERANE
PFIZER
25MG/ML
N011446 001
SUSPENSION;ORAL
FLO-PRED
TARO
EQ 5MG BASE/5ML
N022067 001 Jan 17, 2008
SUSPENSION/DROPS;OPHTHALMIC
ECONOPRED
ALCON
0.125%
N017468 001
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM
OINTMENT;OPHTHALMIC
CETAPRED
ALCON
0.25%;10%
A087771 001 Aug 06, 1993
METIMYD
SCHERING
0.5%;10%
N010210 002 Sep 09, 1984
PREDSULFAIR
PHARMAFAIR
0.5%;10%
A088032 001 Apr 15, 1983
VASOCIDIN
NOVARTIS
0.5%;10%
A088791 001 Oct 05, 1984
SUSPENSION;OPHTHALMIC
ISOPTO CETAPRED
ALCON
0.25%;10%
A087547 001
SUSPENSION/DROPS;OPHTHALMIC
METIMYD
SCHERING
0.5%;10%
N010210 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-270(of 337)
PREDNISOLONE ACETATE; SULFACETAMIDE SODIUM
SUSPENSION/DROPS;OPHTHALMIC
PREDAMIDE
AKORN
0.5%;10%
A088059 001 Jul 29, 1983
PREDSULFAIR
PHARMAFAIR
0.5%;10%
A088007 001 Apr 19, 1983
PREDSULFAIR II
PHARMAFAIR
0.2%;10%
A088837 001 Dec 24, 1985
SULPHRIN
BAUSCH AND LOMB
0.5%;10%
A088089 001 Dec 28, 1982
PREDNISOLONE SODIUM PHOSPHATE
INJECTABLE;INJECTION
HYDELTRASOL
MERCK
EQ 20MG PHOSPHATE/ML
N011583 002
PREDNISOLONE SODIUM PHOSPHATE
WATSON LABS EQ 20MG PHOSPHATE/ML
A080517 001
OINTMENT;OPHTHALMIC, OTIC
HYDELTRASOL
MERCK EQ 0.25% PHOSPHATE
N011028 001
SOLUTION;ORAL
PREDNISOLONE SODIUM PHOSPHATE
MEDICIS PHARMS
EQ 15MG BASE/5ML
A075250 001 Jul 12, 2002
NESHER PHARMS
EQ 5MG BASE/5ML
A076982 001 May 24, 2005
EQ 15MG BASE/5ML
A076988 001 May 24, 2005
PHARM ASSOC
EQ 5MG BASE/5ML
A076123 001 Dec 23, 2002
VINTAGE PHARMS
EQ 5MG BASE/5ML
A078416 001 Oct 31, 2007
WE PHARMS
EQ 5MG BASE/5ML
A075181 001 Dec 23, 2002
SOLUTION/DROPS;OPHTHALMIC
INFLAMASE FORTE
NOVARTIS
EQ 0.9% PHOSPHATE
A080751 002
INFLAMASE MILD
NOVARTIS
EQ 0.11% PHOSPHATE
A080751 001
METRETON
SCHERING
EQ 0.5% PHOSPHATE
A083834 001
PREDAIR
PHARMAFAIR
EQ 0.11% PHOSPHATE
A088415 001 Feb 29, 1984
PREDAIR FORTE
PHARMAFAIR
EQ 0.9% PHOSPHATE
A088165 001 Mar 28, 1983
PREDNISOLONE SODIUM PHOSPHATE
AKORN
EQ 0.11% PHOSPHATE
A083358 001
EQ 0.9% PHOSPHATE
A083358 002
ALCON PHARMS LTD
EQ 0.11% PHOSPHATE
A081043 001 Oct 24, 1991
EQ 0.9% PHOSPHATE
A081044 001 Oct 24, 1991
BAUSCH AND LOMB
EQ 0.11% PHOSPHATE
A040065 001 Jul 29, 1994
SOLA BARNES HIND
EQ 0.11% PHOSPHATE
A084171 001
EQ 0.9% PHOSPHATE
A084168 001
EQ 0.9% PHOSPHATE
A084169 001
EQ 0.9% PHOSPHATE
A084172 001
PREDNISOLONE SODIUM PHOSPHATE; SULFACETAMIDE SODIUM
SOLUTION/DROPS;OPHTHALMIC
SULSTER
AKORN
EQ 0.23% PHOSPHATE;10%
A074511 001 Jul 30, 1996
VASOCIDIN
NOVARTIS
EQ 0.23% PHOSPHATE;10%
N018988 001 Aug 26, 1988
PREDNISOLONE TEBUTATE
INJECTABLE;INJECTION
HYDELTRA-TBA
MERCK
20MG/ML
N010562 001
PREDNISOLONE TEBUTATE
WATSON LABS
20MG/ML
A083362 001 Feb 17, 1984
PREDNISONE
SOLUTION;ORAL
PREDNISONE
WOCKHARDT
5MG/5ML
A089726 001 Aug 02, 1988
SYRUP;ORAL
LIQUID PRED
MURO
5MG/5ML
A087611 002 Sep 07, 1982
TABLET;ORAL
CORTAN
HALSEY
20MG
A087480 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-271(of 337)
PREDNISONE
TABLET;ORAL
DELTA-DOME
BAYER PHARMS 5MG
A080293 001
DELTASONE
PHARMACIA AND UPJOHN 2.5MG
N009986 005
5MG
N009986 002
10MG
N009986 006
20MG
N009986 007
50MG
N009986 008
FERNISONE
FERNDALE LABS 5MG
A083364 001
METICORTEN
SCHERING 1MG
N009766 002
5MG
N009766 001
ORASONE
SOLVAY 1MG
A083009 001
5MG
A083009 002
10MG
A083009 003
20MG
A083009 004
50MG
A085999 001
PARACORT
PARKE DAVIS 5MG
N010962 002
PREDNICEN-M
SCHWARZ PHARMA 5MG
A084655 001
PREDNISONE
AM THERAP 5MG
A089387 001 Nov 06, 1986
10MG
A089388 001 Nov 06, 1986
20MG
A089389 001 Nov 06, 1986
AMNEAL PHARMS NY 5MG
A089597 001 Oct 05, 1987
10MG
A089598 001 Oct 05, 1987
20MG
A089599 001 Oct 05, 1987
BUNDY 5MG
A083676 001
DURAMED PHARMS BARR 5MG
A088394 001 Oct 04, 1983
10MG
A088395 001 Oct 04, 1983
20MG
A088396 001 Oct 04, 1983
ELKINS SINN 5MG
A080491 001
20MG
A085811 001
EVERYLIFE 1MG
A084440 001
2.5MG
A084440 002
5MG
A084440 003
FERRANTE 2.5MG
A080563 001
5MG
A080563 002
HALSEY 5MG
A080300 001
HEATHER 5MG
A080320 001
10MG
A084341 001
20MG
A084417 001
20MG
A085543 001
50MG
A086946 001
IMPAX LABS 5MG
A080782 001
INWOOD LABS 1MG
A080328 001
2.5MG
A080306 001
5MG
A080279 001
IVAX SUB TEVA PHARMS 5MG
A080283 001
10MG
A084133 001
20MG
A084134 001
KV PHARM 5MG
A084236 001
LANNETT 5MG
A080514 001
20MG
A084275 001
LEDERLE 5MG
A086968 001
MARSHALL PHARMA 5MG
A080301 001
MUTUAL PHARM 5MG
A080701 001
10MG
A086595 001
20MG
A084634 001
50MG
A086596 001
NYLOS 5MG
A085115 001
PANRAY 1MG
A080350 001
2.5MG
A080350 002
5MG
A080350 003
PERRIGO 5MG
A083059 001
PHARMAVITE 5MG
A084662 002
PHOENIX LABS NY 5MG
A080321 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-272(of 337)
PREDNISONE
TABLET;ORAL
PREDNISONE
20MG
A083807 001
PUREPAC PHARM
5MG
A080353 001
10MG
A086062 001
20MG
A086061 001
PVT FORM
20MG
A085151 001
REXALL
5MG
A080232 001
ROXANE
20MG
N017109 001
25MG
A087833 001 May 04, 1982
SANDOZ
5MG
A080336 002
5MG
A084774 001
10MG
A089983 001 Jan 12, 1989
20MG
A085813 001
50MG
A089984 001 Jan 12, 1989
SCHERER LABS
5MG
A080371 001
SPERTI
1MG
A080359 001
2.5MG
A080359 002
5MG
A080359 003
SUPERPHARM
5MG
A088865 001 Oct 25, 1984
10MG
A088866 001 Oct 25, 1984
20MG
A088867 001 Oct 25, 1984
TEVA
5MG
A080397 001
UDL
5MG
A087984 001 Jan 18, 1983
10MG
A087985 001 Jan 18, 1983
20MG
A087986 001 Jan 18, 1983
UPSHER SMITH
5MG
A087471 001
20MG
A087470 001
VALEANT PHARM INTL
5MG
A080237 001
VANGARD
5MG
A087682 001 Jan 15, 1982
20MG
A087701 001 Jan 15, 1982
VITARINE
5MG
A080334 001
5MG
A080506 001
WATSON LABS
5MG
A085084 002
10MG
A087773 001 Jul 13, 1982
20MG
A086813 001
50MG
A086867 001
50MG
A087772 001 Jul 13, 1982
WHITEWORTH TOWN PLSN
2.5MG
A084913 001
5MG
A080343 001
10MG
A089028 001 Jul 24, 1986
20MG
A084913 002
SERVISONE
LEDERLE
5MG
A080223 001
PRILOCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
CITANEST
ASTRAZENECA
1%
N014763 004
2%
N014763 005
3%
N014763 003
CITANEST PLAIN
ASTRAZENECA
4%
N014763 007
CITANEST PLAIN DENTAL
DENTSPLY PHARM
4%
N021382 001
PRIMIDONE
SUSPENSION;ORAL
MYSOLINE
NURO PHARMA
250MG/5ML
N010401 001
TABLET;ORAL
PRIMIDONE
DR REDDYS LABS LTD
50MG
A040862 001 Oct 03, 2008
250MG
A040862 002 Oct 03, 2008
HIKMA PHARMS LLC
50MG
A040667 001 Jul 27, 2006
WATSON LABS
250MG
A085052 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-273(of 337)
PROBENECID
TABLET;ORAL
BENEMID
MERCK
500MG
N007898 004
PROBENECID
IVAX SUB TEVA PHARMS
500MG
A083740 001 May 09, 1984
LEDERLE
500MG
A086917 001
WATSON LABS
500MG
A086150 002 Apr 23, 1982
PROBUCOL
TABLET;ORAL
LORELCO
SANOFI AVENTIS US
250MG
N017535 001
500MG
N017535 002 Jul 06, 1988
PROCAINAMIDE HYDROCHLORIDE
CAPSULE;ORAL
PROCAINAMIDE HYDROCHLORIDE
ASCOT
250MG
A087542 001 Jan 08, 1982
375MG
A087697 001 Mar 01, 1983
500MG
A087543 001 Jan 08, 1982
IVAX SUB TEVA PHARMS
250MG
A084604 001
375MG
A084595 001
500MG
A084606 001
LANNETT
250MG
A083693 001
500MG
A084696 001
LEDERLE
250MG
A086942 001
375MG
A086952 001
500MG
A086943 001
ROXANE
250MG
A088989 001 Apr 26, 1985
500MG
A088990 001 Apr 26, 1985
SANDOZ
250MG
A089219 001 Jul 01, 1986
375MG
A089220 001 Jul 01, 1986
500MG
A089221 001 Jul 01, 1986
VANGARD
250MG
A087643 001 Jun 01, 1982
500MG
A087875 001 Jun 01, 1982
WATSON LABS
250MG
A083287 001
250MG
A083795 001
250MG
A085167 001
375MG
A084403 001
375MG
A087020 001
500MG
A084280 001
500MG
A084357 001
500MG
A087021 001
PROCAN
PARKE DAVIS
250MG
A085804 001
375MG
A087502 001
500MG
A085079 001
PROCAPAN
PANRAY
250MG
A083553 002
PRONESTYL
APOTHECON
250MG
N007335 001
375MG
N007335 004
500MG
N007335 003
INJECTABLE;INJECTION
PROCAINAMIDE HYDROCHLORIDE
ABRAXIS PHARM
100MG/ML
A089415 001 Nov 17, 1986
500MG/ML
A089416 001 Nov 17, 1986
HIKMA MAPLE
100MG/ML
A089029 001 Apr 17, 1986
500MG/ML
A089030 001 Apr 17, 1986
HOSPIRA
500MG/ML
A089537 001 Aug 25, 1987
INTL MEDICATION
100MG/ML
A088636 001 Jul 31, 1984
500MG/ML
A088637 001 Jul 31, 1984
PHARMAFAIR
100MG/ML
A088824 001 Nov 20, 1985
500MG/ML
A088830 001 Nov 20, 1985
SMITH AND NEPHEW
100MG/ML
A088530 001 Mar 04, 1985
500MG/ML
A088531 001 Mar 04, 1985
SOLOPAK
500MG/ML
A088532 001 Mar 04, 1985
WARNER CHILCOTT
100MG/ML
A089528 001 May 03, 1988
500MG/ML
A089529 001 May 03, 1988
WATSON LABS
100MG/ML
A087079 001
500MG/ML
A087080 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-274(of 337)
PROCAINAMIDE HYDROCHLORIDE
INJECTABLE;INJECTION
PRONESTYL
APOTHECON 100MG/ML
N007335 002
500MG/ML
N007335 005
TABLET;ORAL
PRONESTYL
APOTHECON 250MG
N017371 001
375MG
N017371 002
500MG
N017371 003
TABLET, EXTENDED RELEASE;ORAL
PROCAINAMIDE HYDROCHLORIDE
ANI PHARMS INC 1GM
A040111 001 Dec 13, 1996
250MG
A088958 001 Dec 02, 1985
500MG
A088959 001 Dec 02, 1985
500MG
A088974 001 Jul 22, 1985
750MG
A089438 001 Mar 23, 1987
INWOOD LABS 500MG
A089840 001 Mar 06, 1989
SANDOZ 250MG
A089369 001 Aug 14, 1987
500MG
A089284 001 Jun 23, 1986
500MG
A089370 001 Jan 09, 1987
750MG
A089371 001 Aug 14, 1987
WATSON LABS 1GM
A089520 001 Jan 15, 1987
250MG
A088533 001 Dec 03, 1984
250MG
A089026 001 Oct 22, 1985
500MG
A088534 001 Dec 03, 1984
500MG
A089027 001 Oct 22, 1985
750MG
A088535 001 Nov 03, 1984
750MG
A089042 001 Oct 22, 1985
PROCAN SR
PARKE DAVIS 250MG
A086468 001
PARKEDALE 1GM
A088489 001 Jan 16, 1985
500MG
A086065 001
750MG
A087510 001 Apr 01, 1982
PROCANBID
KING PHARMS 1GM
N020545 002 Jan 31, 1996
500MG
N020545 001 Jan 31, 1996
PRONESTYL-SR
APOTHECON 500MG
A087361 001
PROCAINE HYDROCHLORIDE
INJECTABLE;INJECTION
NOVOCAIN
HOSPIRA 1%
A085362 003
2%
A085362 004
10%
A086797 001
PROCAINE HYDROCHLORIDE
ABRAXIS PHARM 1%
A080384 002
1%
A080421 001
2%
A080384 003
2%
A080421 002
BEL MAR 1%
A080711 001
2%
A080756 001
ELKINS SINN 1%
A083315 001
2%
A083315 002
GD SEARLE LLC 1%
A086202 001
2%
A086202 002
HOSPIRA 1%
A080416 001
2%
A080416 002
MILES 1%
A080415 001
2%
A080415 002
WATSON LABS 1%
A080658 001
1%
A083535 001
2%
A080658 002
2%
A083535 002
PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE
INJECTABLE;INJECTION
ACHROMYCIN
LEDERLE 40MG/VIAL;100MG/VIAL
N050276 001
40MG/VIAL;250MG/VIAL
N050276 003
TETRACYN
PFIZER 40MG/VIAL;100MG/VIAL
A060285 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-275(of 337)
PROCAINE HYDROCHLORIDE; TETRACYCLINE HYDROCHLORIDE
INJECTABLE;INJECTION
TETRACYN
40MG/VIAL;250MG/VIAL
A060285 003
PROCAINE MERETHOXYLLINE; THEOPHYLLINE
INJECTABLE;INJECTION
DICURIN PROCAINE
LILLY
100MG/ML;50MG/ML
N008869 001
PROCHLORPERAZINE
SUPPOSITORY;RECTAL
COMPAZINE
GLAXOSMITHKLINE
2.5MG
N011127 003
5MG
N011127 001
25MG
N011127 002
PROCHLORPERAZINE
ABLE
2.5MG
A040407 001 Jul 11, 2001
5MG
A040407 002 Jul 11, 2001
25MG
A040407 003 Jul 11, 2001
PROCHLORPERAZINE EDISYLATE
CONCENTRATE;ORAL
COMPAZINE
GLAXOSMITHKLINE
EQ 10MG BASE/ML
N011276 001
PROCHLORPERAZINE
ALPHARMA US PHARMS
EQ 10MG BASE/ML
A087153 001 Jun 08, 1982
PROCHLORPERAZINE EDISYLATE
MORTON GROVE
EQ 10MG BASE/ML
A088598 001 Oct 25, 1984
INJECTABLE;INJECTION
COMPAZINE
GLAXOSMITHKLINE
EQ 5MG BASE/ML
N010742 002
PROCHLORPERAZINE
BAXTER HLTHCARE
EQ 5MG BASE/ML
A087759 001 Oct 01, 1982
PROCHLORPERAZINE EDISYLATE
HIKMA MAPLE
EQ 5MG BASE/ML
A089523 001 May 03, 1988
HOSPIRA
EQ 5MG BASE/ML
A089703 001 Apr 07, 1988
MARSAM PHARMS LLC
EQ 5MG BASE/ML
A089675 001 Dec 05, 1988
SMITH AND NEPHEW
EQ 5MG BASE/ML
A089251 001 Dec 04, 1986
TEVA PARENTERAL
EQ 5MG BASE/ML
A040505 001 May 30, 2003
WATSON LABS
EQ 5MG BASE/ML
A089530 001 Jul 08, 1987
EQ 5MG BASE/ML
A089605 001 Jul 08, 1987
EQ 5MG BASE/ML
A089606 001 Jul 08, 1987
WYETH AYERST
EQ 5MG BASE/ML
A086348 001
SYRUP;ORAL
COMPAZINE
GLAXOSMITHKLINE
EQ 5MG BASE/5ML
N011188 001
PROCHLORPERAZINE EDISYLATE
ALPHARMA US PHARMS
EQ 5MG BASE/5ML
A087154 001 Sep 01, 1982
MORTON GROVE
EQ 5MG BASE/5ML
A088597 001 Oct 25, 1984
PROCHLORPERAZINE MALEATE
CAPSULE, EXTENDED RELEASE;ORAL
COMPAZINE
GLAXOSMITHKLINE
EQ 10MG BASE
N011000 001
EQ 10MG BASE
N021019 001 Oct 06, 1999
EQ 15MG BASE
N011000 002
EQ 15MG BASE
N021019 002 Oct 06, 1999
EQ 30MG BASE
N011000 003
EQ 75MG BASE
N011000 004
TABLET;ORAL
COMPAZINE
GLAXOSMITHKLINE
EQ 5MG BASE
N010571 001
EQ 10MG BASE
N010571 002
EQ 25MG BASE
N010571 003
PROCHLORPERAZINE
WATSON LABS
EQ 5MG BASE
A085580 001
EQ 10MG BASE
A085178 001
EQ 25MG BASE
A085579 001
PROCHLORPERAZINE MALEATE
DURAMED PHARMS BARR
EQ 5MG BASE
A040207 001 May 01, 1997
EQ 5MG BASE
A089484 001 Jan 20, 1987
EQ 10MG BASE
A040207 002 May 01, 1997
EQ 10MG BASE
A089485 001 Jan 20, 1987
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-276(of 337)
PROCHLORPERAZINE MALEATE
TABLET;ORAL
PROCHLORPERAZINE MALEATE
EQ 25MG BASE A089486 001 Jan 20, 1987
IVAX SUB TEVA PHARMS
EQ 5MG BASE A040162 001 Jan 20, 1998
EQ 10MG BASE A040162 002 Jan 20, 1998
SANDOZ
EQ 25MG BASE A040101 003 Jul 19, 1996
PROCYCLIDINE HYDROCHLORIDE
TABLET;ORAL
KEMADRIN
MONARCH PHARMS
2MG N009818 005
5MG N009818 003
PROGESTERONE
CAPSULE;ORAL
PROMETRIUM
ABBVIE INC
300MG N019781 003 Oct 15, 1999
INJECTABLE;INJECTION
PROGESTERONE
LILLY
25MG/ML N009238 002
50MG/ML N009238 001
INSERT, EXTENDED RELEASE;INTRAUTERINE
PROGESTASERT
ALZA
38MG N017553 001
PROMAZINE HYDROCHLORIDE
CONCENTRATE;ORAL
SPARINE
WYETH AYERST
30MG/ML N010942 001
100MG/ML N010942 004
INJECTABLE;INJECTION
PROMAZINE HYDROCHLORIDE
WATSON LABS
25MG/ML A084510 001
50MG/ML A084517 001
SPARINE
BAXTER HLTHCARE CORP
25MG/ML N010349 008
50MG/ML N010349 006
SYRUP;ORAL
SPARINE
WYETH AYERST
10MG/5ML N010942 003
TABLET;ORAL
SPARINE
WYETH AYERST
10MG N010348 006
25MG N010348 001
50MG N010348 002
100MG N010348 003
200MG N010348 004
PROMETHAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
PHENERGAN
WYETH AYERST
25MG/ML N008857 002
50MG/ML N008857 003
PROMETHAZINE HYDROCHLORIDE
ABBOTT
25MG/ML A084223 001
50MG/ML A084222 001
AKORN
25MG/ML A083955 002
50MG/ML A083955 001
BEDFORD LABS
25MG/ML A040524 001 Mar 17, 2004
50MG/ML A040524 002 Mar 17, 2004
HOSPIRA
25MG/ML A040372 001 Jun 08, 2000
50MG/ML A040372 002 Jun 08, 2000
50MG/ML A083838 002
LUITPOLD
25MG/ML A040515 001 Mar 19, 2003
MARSAM PHARMS LLC
25MG/ML A089463 001 May 02, 1988
50MG/ML A089477 001 May 02, 1988
MYLAN INSTITUTIONAL
25MG/ML A040471 001 Nov 21, 2002
SANDOZ
25MG/ML A040593 001 Nov 08, 2006
50MG/ML A040593 002 Nov 08, 2006
TEVA PHARMS USA
25MG/ML A040454 001 Aug 22, 2002
50MG/ML A040454 002 Aug 22, 2002
WATSON LABS
25MG/ML A083532 001
25MG/ML A084591 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-277(of 337)
PROMETHAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
PROMETHAZINE HYDROCHLORIDE
50MG/ML A080629 002
50MG/ML A083532 002
WOCKHARDT 25MG/ML A040785 001 Sep 26, 2008
50MG/ML A040785 002 Sep 26, 2008
ZIPAN-25
ALTANA 25MG/ML A083997 001
ZIPAN-50
ALTANA 50MG/ML A083997 002
SUPPOSITORY;RECTAL
PHENERGAN
DELCOR ASSET CORP 50MG N011689 001
SHIONOGI INC 12.5MG N010926 002
25MG N010926 001
PROMETHACON
POLYMEDICA 25MG A084901 001
50MG A084902 001
PROMETHAZINE HYDROCHLORIDE
ABLE 12.5MG A040504 001 Apr 11, 2003
25MG A040504 002 Apr 11, 2003
50MG A040449 001 Feb 27, 2003
SYRUP;ORAL
MYMETHAZINE FORTIS
USL PHARMA 25MG/5ML A087996 001 Jan 18, 1983
PROMETH FORTIS
ALPHARMA US PHARMS 25MG/5ML A084772 001
PROMETH PLAIN
ACTAVIS MID ATLANTIC 6.25MG/5ML A085953 001
PROMETHAZINE
CENCI 6.25MG/5ML A089013 001 Sep 20, 1985
PROMETHAZINE HYDROCHLORIDE
KV PHARM 6.25MG/5ML A085388 001
25MG/5ML A085385 001
PHARM ASSOC 6.25MG/5ML A087518 001
WHITEWORTH TOWN PLSN 6.25MG/5ML A086395 001
PROMETHAZINE HYDROCHLORIDE PLAIN
ANI PHARMS 6.25MG/5ML N008381 004 Apr 18, 1984
25MG/5ML **Federal Register N008381 003
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
TABLET;ORAL
PHENERGAN
DELCOR ASSET CORP 12.5MG N007935 002
25MG N007935 003
50MG N007935 004
PROMETHAZINE HYDROCHLORIDE
ABBOTT 12.5MG A084160 001
25MG A084166 001
50MG A084539 001
ABLE 12.5MG A040558 001 Jul 01, 2004
25MG A040558 002 Jul 01, 2004
50MG A040558 003 Jul 01, 2004
IMPAX LABS 25MG A084214 002 Jul 07, 1982
IVAX SUB TEVA PHARMS 12.5MG A083604 001
25MG A083603 001
50MG A083613 001
LANNETT 12.5MG A080949 001
25MG A080949 002
50MG A080949 003
MUTUAL PHARM 12.5MG A084555 001
25MG A084554 001
50MG A084557 001
PVT FORM 12.5MG A083214 001
25MG A083658 001
SANDOZ 12.5MG A084176 002 May 22, 2009
12.5MG A084233 001
25MG A085146 001
50MG A085146 002
TABLICAPS 12.5MG A084080 001
25MG A084027 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-278(of 337)
PROMETHAZINE HYDROCHLORIDE
TABLET;ORAL
PROMETHAZINE HYDROCHLORIDE
TEVA 25MG A089109 001 Sep 10, 1985
WATSON LABS 12.5MG A083401 001
12.5MG A083712 001
12.5MG A085986 001
25MG A083204 001
25MG A085684 001
50MG A083403 001
50MG A085664 001
REMSED
BRISTOL MYERS SQUIBB 25MG A083176 002
50MG A083176 001
PROPAFENONE HYDROCHLORIDE
TABLET;ORAL
PROPAFENONE HYDROCHLORIDE
NESHER PHARMS 150MG A076193 001 Feb 07, 2002
225MG A076193 002 Feb 07, 2002
300MG A076193 003 Feb 07, 2002
PROPANTHELINE BROMIDE
INJECTABLE;INJECTION
PRO-BANTHINE
GD SEARLE LLC 30MG/VIAL N008843 001
TABLET;ORAL
PRO-BANTHINE
SHIRE 7.5MG **Federal Register determination N008732 003
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
15MG N008732 002
PROPANTHELINE BROMIDE
ASCOT 15MG A087663 001 Oct 25, 1982
HEATHER 15MG A085780 001
IMPAX LABS 15MG A084541 002
MYLAN 15MG A083706 001
PAR PHARM 15MG A088377 001 Dec 08, 1983
PVT FORM 15MG A080977 001
ROXANE 7.5MG A080927 001
SANDOZ 15MG A080928 001
TABLICAPS 15MG A084428 001
WATSON LABS 15MG A083029 002
15MG A083151 001
PROPARACAINE HYDROCHLORIDE
SOLUTION/DROPS;OPHTHALMIC
KAINAIR
PHARMAFAIR 0.5% A088087 001 Jun 07, 1983
OPHTHAINE
APOTHECON 0.5% N008883 001
OPHTHETIC
ALLERGAN 0.5% N012583 001
PARACAINE
OPTOPICS 0.5% A087681 001 Aug 05, 1982
PROPARACAINE HYDROCHLORIDE
SOLA BARNES HIND 0.5% A084144 001
0.5% A084151 001
PROPIOLACTONE
SOLUTION;IRRIGATION
BETAPRONE
FOREST LABS N/A N011657 001
PROPIOMAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
LARGON
HIKMA MAPLE 20MG/ML N012382 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-279(of 337)
PROPOFOL
INJECTABLE;INJECTION
DIPRIVAN
FRESENIUS KABI USA
10MG/ML
N019627 001 Oct 02, 1989
PROPOFOL
EUROHLTH INTL
10MG/ML
A074848 001 Apr 19, 2005
TEVA PARENTERAL
10MG/ML
A075392 001 Sep 19, 2000
PROPOXYPHENE HYDROCHLORIDE
CAPSULE;ORAL
DARVON
XANODYNE PHARM
32MG
N010997 001
65MG
N010997 003
DOLENE
HERITAGE PHARMS INC
65MG
A080530 001
KESSO-GESIC
MK LABS
65MG
A083544 001
PROPHENE 65
HALSEY
65MG
A083538 002
PROPOXYPHENE HYDROCHLORIDE
ALRA
65MG
A083184 001
IMPAX LABS
65MG
A083317 001
IVAX SUB TEVA PHARMS
32MG
A083597 001
MUTUAL PHARM
65MG
A083186 001
MYLAN
32MG
A083528 001
65MG
A040569 001 Dec 16, 2004
65MG
A083299 001
NEXGEN PHARMA INC
65MG
A083185 001
PAR PHARM
65MG
A080269 001
PUREPAC PHARM
65MG
A083278 001
PVT FORM
65MG
A083113 001
ROXANE
32MG
A083089 001
65MG
A083089 002
SANDOZ
32MG
A084014 001
65MG
A083125 002
65MG
A083688 001
65MG
A083870 002
65MG
A086495 001
TEVA
65MG
A088615 001 Oct 22, 1984
VALEANT PHARM INTL
65MG
A080783 001
VINTAGE PHARMS
65MG
A040908 001 Jul 17, 2009
WATSON LABS
65MG
A080908 002
65MG
A085190 001
WEST WARD
65MG
A083501 001
WHITEWORTH TOWN PLSN
65MG
A084551 001
PROPOXYPHENE HYDROCHLORIDE 65
WARNER CHILCOTT 65MG
A083786 001
PROPOXYPHENE NAPSYLATE
SUSPENSION;ORAL
DARVON-N
AAIPHARMA LLC 50MG/5ML
N016861 001
TABLET;ORAL
DARVON-N
XANODYNE PHARM 100MG
N016862 002
PROPRANOLOL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
PROPRANOLOL HYDROCHLORIDE
INWOOD LABS 60MG
A072499 001 Apr 11, 1989
80MG
A072500 001 Apr 11, 1989
120MG
A072501 001 Apr 11, 1989
160MG
A072502 001 Apr 11, 1989
CONCENTRATE;ORAL
PROPRANOLOL HYDROCHLORIDE INTENSOL
ROXANE
80MG/ML
A071388 001 May 15, 1987
INJECTABLE;INJECTION
PROPRANOLOL HYDROCHLORIDE
SMITH AND NEPHEW
1MG/ML
A070135 001 Apr 15, 1986
1MG/ML
A070137 001 Apr 15, 1986
SOLOPAK
1MG/ML
A070136 001 Apr 15, 1986
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-280(of 337)
PROPRANOLOL HYDROCHLORIDE
SOLUTION;ORAL
PROPRANOLOL HYDROCHLORIDE
MORTON GROVE 20MG/5ML A071984 001 Mar 03, 1989
40MG/5ML A071985 001 Mar 03, 1989
SUSPENSION;ORAL
INDERAL
WYETH AYERST 10MG/ML N019536 001 Dec 12, 1986
TABLET;ORAL
INDERAL
WYETH PHARMS INC 10MG N016418 001
20MG N016418 003
40MG N016418 002
60MG N016418 009 Oct 18, 1982
80MG **Federal Register determination N016418 004
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
90MG **Federal Register determination N016418 010 Oct 18, 1982
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
PROPRANOLOL HYDROCHLORIDE
ANI PHARMS INC 90MG A071977 001 Apr 06, 1988
DAVA PHARMS INC 10MG A070125 001 Jul 30, 1985
20MG A070126 001 Jul 30, 1985
40MG A070127 001 Jul 30, 1985
60MG A071495 001 Dec 31, 1987
80MG A070128 001 Jul 30, 1985
90MG A071496 001 Dec 31, 1987
DURAMED PHARMS BARR 10MG A070306 001 Sep 09, 1985
20MG A070307 001 Sep 09, 1985
40MG A070308 001 Sep 09, 1985
60MG A070309 001 Oct 01, 1986
80MG A070310 001 Sep 09, 1985
90MG A071327 001 Oct 01, 1986
INTERPHARM 10MG A071368 001 May 05, 1987
20MG A071369 001 May 05, 1987
40MG A071370 001 May 05, 1987
80MG A071371 001 May 05, 1987
IVAX SUB TEVA PHARMS 10MG A072063 001 Jul 29, 1988
20MG A072066 001 Jul 29, 1988
40MG A072067 001 Jul 29, 1988
60MG A072068 001 Jul 29, 1988
80MG A072069 001 Jul 29, 1988
LEDERLE 10MG A072117 001 Jun 23, 1988
20MG A072118 001 Jun 23, 1988
40MG A072119 001 Jun 23, 1988
80MG A072120 001 Jun 23, 1988
MUTUAL PHARM 10MG A070319 001 Oct 22, 1985
20MG A070320 001 Oct 22, 1985
40MG A070103 001 Oct 22, 1985
60MG A070321 001 Sep 24, 1986
80MG A070322 001 Aug 04, 1986
MYLAN 60MG A072275 001 Jun 09, 1989
PAR PHARM 90MG A071288 001 Oct 22, 1986
PUREPAC PHARM 10MG A070814 001 Nov 03, 1986
20MG A070815 001 Nov 03, 1986
40MG A070816 001 Nov 03, 1986
60MG A070817 001 Nov 03, 1986
80MG A070757 001 Nov 03, 1986
ROXANE 10MG A070516 001 Jul 07, 1986
20MG A070517 001 Jul 07, 1986
40MG A070518 001 Jul 07, 1986
60MG A070519 001 Sep 24, 1986
80MG A070520 001 Jul 07, 1986
90MG A070521 001 Sep 24, 1986
SANDOZ 10MG A070663 001 Jun 13, 1986
10MG A071658 001 Jul 05, 1988
20MG A070664 001 Jun 13, 1986
20MG A071687 001 Jul 05, 1988
40MG A070665 001 Jun 13, 1986
40MG A071688 001 Jul 05, 1988
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-281(of 337)
PROPRANOLOL HYDROCHLORIDE
TABLET;ORAL
PROPRANOLOL HYDROCHLORIDE
60MG
A070666 001 Oct 10, 1986
60MG
A072197 001 Jul 05, 1988
80MG
A070667 001 Jun 13, 1986
80MG
A071689 001 Jul 05, 1988
90MG
A072198 001 Jul 05, 1988
SCHERING 10MG
A070120 001 Aug 06, 1985
20MG
A070121 001 Aug 06, 1985
40MG
A070122 001 Aug 06, 1985
60MG
A070123 001 Oct 29, 1986
80MG
A070124 001 Aug 06, 1985
SUPERPHARM 10MG
A071515 001 Jun 08, 1988
20MG
A071516 001 Jun 08, 1988
40MG
A071517 001 Jun 08, 1988
80MG
A071518 001 Jun 08, 1988
TEVA 10MG
A070232 001 Oct 07, 1987
20MG
A070233 001 Jun 23, 1986
40MG
A070234 001 Jun 23, 1986
WARNER CHILCOTT 10MG
A070438 001 Sep 15, 1986
20MG
A070439 001 Sep 15, 1986
40MG
A070440 001 Sep 15, 1986
60MG
A070441 001 Sep 24, 1986
80MG
A070442 001 Sep 15, 1986
WATSON LABS 10MG
A070140 001 Jul 30, 1985
10MG
A070378 001 Mar 19, 1987
10MG
A070548 001 Jul 10, 1986
20MG
A070141 001 Jul 30, 1985
20MG
A070379 001 Mar 19, 1987
20MG
A070549 001 Apr 11, 1986
40MG
A070142 001 Jul 30, 1985
40MG
A070380 001 Mar 19, 1987
40MG
A070550 001 Apr 11, 1986
60MG
A070143 001 Jan 15, 1987
60MG
A070381 001 Mar 19, 1987
60MG
A071098 001 Oct 06, 1986
60MG
A071791 001 Jul 15, 1987
80MG
A070144 001 Jul 30, 1985
80MG
A070382 001 Mar 19, 1987
80MG
A070551 001 Jul 10, 1986
90MG
A071183 001 Oct 06, 1986
90MG
A071792 001 Jul 15, 1987
PROPYLIODONE
SUSPENSION;INTRATRACHEAL
DIONOSIL AQUEOUS
GLAXOSMITHKLINE 50%
N009309 001
DIONOSIL OILY
GLAXOSMITHKLINE 60%
N009309 002
PROPYLTHIOURACIL
TABLET;ORAL
PROPYLTHIOURACIL
ABBOTT 50MG
A084075 001
ANABOLIC 50MG
A080285 001
ANI PHARMS INC 50MG
A080215 001
HALSEY 50MG
A080015 001
HIKMA PHARMS LLC 50MG
A080154 001
IMPAX LABS 50MG
A080159 001
LANNETT 50MG
A080016 001
LILLY 50MG
N006213 001
MUTUAL PHARM 50MG
A083982 001
PERRIGO 50MG
A084543 001
TABLICAPS 50MG
A080840 001
WATSON LABS 50MG
A080932 001
50MG
A085201 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-282(of 337)
PROTAMINE SULFATE
INJECTABLE;INJECTION
PROTAMINE SULFATE
HIKMA MAPLE 10MG/ML A089474 001 Nov 05, 1986
10MG/ML A089475 001 Nov 05, 1986
LILLY 10MG/ML N006460 002
PHARMACIA AND UPJOHN 50MG/VIAL N007413 001
250MG/VIAL N007413 002 Aug 02, 1984
PROTEIN HYDROLYSATE
INJECTABLE;INJECTION
AMINOSOL 5%
ABBVIE 5% N005932 012 Jan 31, 1985
HYPROTIGEN 5%
B BRAUN 5% N006170 003 Jan 10, 1984
PROTIRELIN
INJECTABLE;INJECTION
THYPINONE
ABBOTT 0.5MG/ML N017638 001
THYREL TRH
FERRING 0.5MG/ML N018087 001
PROTOKYLOL HYDROCHLORIDE
TABLET;ORAL
VENTAIRE
SANOFI AVENTIS US 2MG A083459 001
PROTRIPTYLINE HYDROCHLORIDE
TABLET;ORAL
VIVACTIL
TEVA WOMENS 5MG N016012 001
10MG N016012 002
PSEUDOEPHEDRINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
NOVAFED
SANOFI AVENTIS US 120MG N017603 001
SUDAFED 12 HOUR
GLAXOSMITHKLINE 120MG **Federal Register determination N017941 002
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
ACTIFED
GLAXOSMITHKLINE 120MG;5MG N018996 001 Jun 17, 1985
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES
KV PHARM 120MG;5MG A071798 001 Mar 16, 1989
SYRUP;ORAL
ACTAHIST
CENCI 30MG/5ML;1.25MG/5ML A088344 001 Feb 09, 1984
HISTAFED
CENCI 30MG/5ML;1.25MG/5ML A088283 001 Apr 20, 1984
MYFED
USL PHARMA 30MG/5ML;1.25MG/5ML A088116 001 Mar 04, 1983
TRILITRON
NEWTRON PHARMS 30MG/5ML;1.25MG/5ML A088474 001 Feb 12, 1985
TABLET;ORAL
ALLERFED
PVT FORM 60MG;2.5MG A088860 001 Jan 31, 1985
CORPHED
SANDOZ 60MG;2.5MG A088602 001 Apr 11, 1985
PSEUDOEPHEDRINE HYDROCHLORIDE AND TRIPROLIDINE HYDROCHLORIDE
SANDOZ 60MG;2.5MG A088193 001 May 17, 1983
TRILITRON
NEWTRON PHARMS 60MG;2.5MG A088515 001 Jan 09, 1985
TRIPHED
TEVA 60MG;2.5MG A088630 001 May 17, 1984
TRIPROLIDINE AND PSEUDOEPHEDRINE
WATSON LABS 60MG;2.5MG A088318 002 Jan 13, 1984
WEST WARD 60MG;2.5MG A088117 001 Apr 19, 1983
TRIPROLIDINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE
IVAX SUB TEVA PHARMS 60MG;2.5MG A085273 001 Dec 12, 1984
SUPERPHARM 60MG;2.5MG A088578 001 Feb 21, 1985
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-283(of 337)
PSEUDOEPHEDRINE HYDROCHLORIDE; TRIPROLIDINE HYDROCHLORIDE
TABLET, EXTENDED RELEASE;ORAL
TRIPROLIDINE AND PSEUDOEPHEDRINE HYDROCHLORIDES
KV PHARM 120MG;5MG
A072758 001 Nov 25, 1991
PSEUDOEPHEDRINE POLISTIREX
SUSPENSION, EXTENDED RELEASE;ORAL
PSEUDO-12
UCB INC
EQ 60MG HCL/5ML
N019401 001 Jun 19, 1987
PYRIDOSTIGMINE BROMIDE
TABLET;ORAL
PYRIDOSTIGMINE BROMIDE
BARR
30MG
A040512 002 Jul 20, 2005
60MG
A040512 001 Oct 08, 2003
COREPHARMA
60MG
A040457 001 Dec 26, 2002
SOLVAY
30MG
A089572 001 Nov 27, 1990
US ARMY
30MG
N020414 001 Feb 05, 2003
PYRIDOXINE HYDROCHLORIDE
INJECTABLE;INJECTION
HEXA-BETALIN
LILLY
100MG/ML
A080854 001
PYRIDOXINE HYDROCHLORIDE
AKORN
100MG/ML
A087967 001 Oct 01, 1982
BEL MAR
100MG/ML
A080761 001
DELL LABS
50MG/ML
A083771 001
100MG/ML
A083772 001
ELKINS SINN
100MG/ML
A080581 001
LUITPOLD
100MG/ML
A080669 001
WATSON LABS
100MG/ML
A080572 001
100MG/ML
A083760 001
PYRILAMINE MALEATE
TABLET;ORAL
PYRILAMINE MALEATE
IMPAX LABS
25MG
A080808 001
WATSON LABS
25MG
A085231 001
PYRIMETHAMINE; SULFADOXINE
TABLET;ORAL
FANSIDAR
ROCHE
25MG;500MG
N018557 001
PYRITHIONE ZINC
LOTION;TOPICAL
HEAD & SHOULDERS CONDITIONER
WARNER CHILCOTT
0.3%
N019412 002 Mar 10, 1986
PYRVINIUM PAMOATE
SUSPENSION;ORAL
POVAN
PARKE DAVIS
EQ 50MG BASE/5ML
N011964 001
TABLET;ORAL
POVAN
PARKE DAVIS
EQ 50MG BASE
N012485 002
QUAZEPAM
TABLET;ORAL
DORAL
SCIECURE PHARMA INC
7.5MG
N018708 003 Feb 26, 1987
QUETIAPINE FUMARATE
TABLET;ORAL
SEROQUEL
ASTRAZENECA
EQ 150MG BASE
N020639 004 Dec 20, 1998
QUINAPRIL HYDROCHLORIDE
TABLET;ORAL
QUINAPRIL HYDROCHLORIDE
ACTAVIS ELIZABETH
EQ 5MG BASE
A076459 001 Dec 22, 2004
EQ 10MG BASE
A076459 002 Dec 22, 2004
EQ 20MG BASE
A076459 003 Dec 22, 2004
EQ 40MG BASE
A076459 004 Dec 22, 2004
APOTEX INC
EQ 5MG BASE
A076240 001 Jan 26, 2006
EQ 10MG BASE
A076240 002 Jan 26, 2006
EQ 20MG BASE
A076240 003 Jan 26, 2006
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-284(of 337)
QUINAPRIL HYDROCHLORIDE
TABLET;ORAL
QUINAPRIL HYDROCHLORIDE
EQ 40MG BASE
A076240 004 Jan 26, 2006
MYLAN
EQ 5MG BASE
A076036 001 Jan 28, 2005
EQ 10MG BASE
A076036 002 Jan 28, 2005
EQ 20MG BASE
A076036 003 Jan 28, 2005
EQ 40MG BASE
A076036 004 Jan 28, 2005
SANDOZ
EQ 5MG BASE
A076803 001 Mar 02, 2005
EQ 10MG BASE
A076803 002 Mar 02, 2005
EQ 20MG BASE
A076803 003 Mar 02, 2005
EQ 40MG BASE
A076803 004 Mar 02, 2005
QUINESTROL
TABLET;ORAL
ESTROVIS
PARKE DAVIS
0.1MG
N016768 002
0.2MG
N016768 003
QUINETHAZONE
TABLET;ORAL
HYDROMOX
LEDERLE
50MG
N013264 001
QUINETHAZONE; RESERPINE
TABLET;ORAL
HYDROMOX R
LEDERLE
50MG;0.125MG
N013927 001
QUINIDINE GLUCONATE
TABLET;ORAL
QUINACT
BAYER HLTHCARE
266MG
A085978 001
400MG
A086099 001
TABLET, EXTENDED RELEASE;ORAL
DURAQUIN
WARNER CHILCOTT
330MG
N017917 001
QUINAGLUTE
BAYER HLTHCARE
324MG
N016647 001
QUINALAN
LANNETT
324MG
A088081 001 Feb 10, 1986
QUINATIME
WATSON LABS
324MG
A087448 001
QUINIDINE GLUCONATE
ASCOT
324MG
A088582 001 Jun 17, 1985
HALSEY
324MG
A089476 001 Apr 10, 1987
ROXANE
324MG
A088431 001 Jan 06, 1984
SANDOZ
324MG
A089894 001 Dec 15, 1988
SUPERPHARM
324MG
A089164 001 Nov 21, 1985
WATSON LABS
324MG
A087785 001 Jan 24, 1983
324MG
A087810 001 Sep 29, 1982
QUINIDINE POLYGALACTURONATE
TABLET;ORAL
CARDIOQUIN
PHARM RES ASSOC
275MG
N011642 002
QUINIDINE SULFATE
CAPSULE;ORAL
CIN-QUIN
SOLVAY
200MG
A085296 001
300MG
A085297 001
QUINIDINE SULFATE
LILLY
200MG
A085103 001
TABLET;ORAL
CIN-QUIN
SOLVAY
100MG
A085299 001
200MG
A084932 001
300MG
A085298 001
QUINIDINE SULFATE
BARR
200MG
A084177 001
CONTRACT PHARMACAL
200MG
A083808 001
DAVA PHARMS INC
200MG
A087011 001
ELKINS SINN
200MG
A083622 001
EVERYLIFE
200MG
A083439 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-285(of 337)
QUINIDINE SULFATE
TABLET;ORAL
QUINIDINE SULFATE
HALSEY
200MG
A083583 001
HIKMA PHARMS LLC
200MG
A083862 001
IMPAX LABS
200MG
A083347 001
IVAX SUB TEVA PHARMS
200MG
A084549 001
KING PHARMS
200MG
A085175 001
KV PHARM
200MG
A085276 001
LANNETT
200MG
A083743 001
LEDERLE
200MG
A086176 001
LILLY
200MG
A085038 001
MUTUAL PHARM
100MG
A081029 001
Apr 14, 1989
PERRIGO
200MG
A085322 001
PHARMAVITE
200MG
A084627 001
PUREPAC PHARM
200MG
A084003 001
ROXANE
200MG
A083640 001
300MG
A085632 001
SANDOZ
200MG
A084631 001
200MG
A084914 001
300MG
A089839 001
Sep 29, 1988
SCHERER LABS
200MG
A085068 001
SUPERPHARM
200MG
A088973 001
Apr 10, 1985
USL PHARMA
200MG
A087837 001
Apr 14, 1982
VALEANT PHARM INTL
200MG
A083393 001
VANGARD
200MG
A087909 001
Jul 13, 1982
VINTAGE PHARMS
200MG
A083963 001
WARNER CHILCOTT
200MG
A083879 001
WATSON LABS
100MG
A085584 001
200MG
A085140 002
WHITEWORTH TOWN PLSN
200MG
A085444 001
QUINORA
KEY PHARMS
200MG
A083576 001
SCHERING
300MG
A085222 001
TABLET, EXTENDED RELEASE;ORAL
QUINIDEX
WYETH PHARMS INC
300MG
N012796 002
RABEPRAZOLE SODIUM
TABLET, DELAYED RELEASE;ORAL
ACIPHEX
EISAI INC
10MG **Federal Register determination
N020973 001
May 29, 2002
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
RAMIPRIL
CAPSULE;ORAL
RAMIPRIL
ACTAVIS ELIZABETH
1.25MG
A077513 001
Jun 18, 2008
2.5MG
A077513 002
Jun 18, 2008
5MG
A077513 003
Jun 18, 2008
10MG
A077513 004
Jun 18, 2008
CIPLA
1.25MG
A077004 001
Aug 07, 2008
2.5MG
A077004 002
Aug 07, 2008
5MG
A077004 003
Aug 07, 2008
10MG
A077004 004
Aug 07, 2008
RANBAXY LABS LTD
5MG
A078849 001
Mar 06, 2009
10MG
A078849 002
Mar 06, 2009
TABLET;ORAL
ALTACE
KING PFIZER
1.25MG
N022021 001
Feb 27, 2007
2.5MG
N022021 002
Feb 27, 2007
5MG
N022021 003
Feb 27, 2007
10MG
N022021 004
Feb 27, 2007
RANITIDINE BISMUTH CITRATE
TABLET;ORAL
TRITEC
GLAXOSMITHKLINE
400MG
N020559 001
Aug 08, 1996
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-286(of 337)
RANITIDINE HYDROCHLORIDE
CAPSULE;ORAL
RANITIDINE HYDROCHLORIDE
MYLAN EQ 150MG BASE A075564 001 Oct 27, 2000
EQ 300MG BASE A075564 002 Oct 27, 2000
TEVA EQ 150MG BASE A075557 001 Oct 31, 2003
EQ 300MG BASE A075557 002 Oct 31, 2003
ZANTAC 150
GLAXOSMITHKLINE EQ 150MG BASE N020095 001 Mar 08, 1994
ZANTAC 300
GLAXOSMITHKLINE EQ 300MG BASE N020095 002 Mar 08, 1994
GRANULE, EFFERVESCENT;ORAL
ZANTAC 150
GLAXO GRP LTD EQ 150MG BASE/PACKET N020251 002 Mar 31, 1994
INJECTABLE;INJECTION
RANITIDINE HYDROCHLORIDE
BEDFORD EQ 25MG BASE/ML A074764 001 Nov 19, 2004
ZANTAC IN PLASTIC CONTAINER
COVIS INJECTABLES EQ 1MG BASE/ML N019593 002 Sep 27, 1991
EQ 50MG BASE/100ML N019593 001 Dec 17, 1986
SYRUP;ORAL
RANITIDINE HYDROCHLORIDE
APOTEX INC EQ 15MG BASE/ML A077602 001 Sep 17, 2007
RANBAXY EQ 15MG BASE/ML A078448 001 Dec 13, 2007
TABLET;ORAL
RANITIDINE HYDROCHLORIDE
BOEHRINGER INGELHEIM EQ 150MG BASE A074662 001 Aug 29, 1997
EQ 300MG BASE A074662 002 Aug 29, 1997
MYLAN EQ 150MG BASE A074552 001 Jul 30, 1998
EQ 300MG BASE A074552 002 Jul 30, 1998
RANBAXY EQ 75MG BASE A075132 001 Jan 14, 2000
EQ 75MG BASE A075254 001 Jan 14, 2000
EQ 150MG BASE A075000 001 Jan 30, 1998
EQ 150MG BASE A075439 001 Apr 19, 2000
EQ 300MG BASE A075000 002 Jan 30, 1998
EQ 300MG BASE A075439 002 Apr 19, 2000
SANDOZ EQ 75MG BASE A075519 001 Sep 26, 2002
WATSON LABS EQ 75MG BASE A075212 001 Jan 14, 2000
EQ 150MG BASE A074864 001 Oct 20, 1997
EQ 300MG BASE A074864 002 Oct 20, 1997
WATSON LABS INC EQ 150MG BASE A077426 001 Dec 19, 2005
EQ 300MG BASE A077426 002 Dec 19, 2005
WOCKHARDT EQ 150MG BASE A078653 001 Nov 26, 2007
EQ 150MG BASE A078701 001 Nov 12, 2009
EQ 300MG BASE A078701 002 Dec 11, 2009
TABLET, EFFERVESCENT;ORAL
ZANTAC 150
GLAXO GRP LTD EQ 150MG BASE N020251 001 Mar 31, 1994
ZANTAC 25
GLAXO GRP LTD EQ 25MG BASE N020251 003 Apr 01, 2004
ZANTAC 75
BOEHRINGER INGELHEIM EQ 75MG BASE **Federal Register N020745 001 Feb 26, 1998
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
RAPACURONIUM BROMIDE
INJECTABLE;INJECTION
RAPLON
ORGANON USA INC 100MG/VIAL N020984 001 Aug 18, 1999
200MG/VIAL N020984 002 Aug 18, 1999
RASAGILINE MESYLATE
TABLET;ORAL
RASAGILINE MESYLATE
WATSON LABS INC EQ 0.5MG BASE A201823 001 Jul 01, 2013
EQ 1MG BASE A201823 002 Jul 01, 2013
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-287(of 337)
RAUWOLFIA SERPENTINA ROOT
TABLET;ORAL
HIWOLFIA
BOWMAN PHARMS
50MG N009276 003
50MG N009276 005
100MG N009276 004
HYSERPIN
PHYS PRODS VA
50MG N010581 001
KOGLUCOID
PANRAY
50MG N009278 001
100MG N009278 002
RAUDIXIN
APOTHECON
50MG N008842 001
100MG N008842 002
RAUSERPIN
FERNDALE LABS
50MG N009926 002
100MG N009926 004
RAUVAL
PAL PAK
50MG N009108 002
100MG N009108 004
RAUWOLFIA SERPENTINA
BUNDY
50MG N009477 001
100MG N009477 002
HALSEY
50MG A080498 001
100MG A080498 002
IMPAX LABS
50MG N009273 001
100MG N009273 002
IVAX SUB TEVA PHARMS
50MG N011521 001
100MG N011521 002
PUREPAC PHARM
50MG A080842 001
100MG A080842 002
PVT FORM
50MG A080583 001
100MG A080583 002
SOLVAY
50MG A080500 001
100MG A080500 002
TABLICAPS
50MG A083867 001
100MG A083444 001
VALEANT PHARM INTL
50MG N009668 001
100MG N009668 002
WATSON LABS
50MG A080907 001
100MG A080914 001
WOLFINA
FOREST PHARMS
50MG N009255 008
100MG N009255 006
RESCINNAMINE
CAPSULE;ORAL
CINNASIL
PANRAY
0.5MG A084736 001
TABLET;ORAL
MODERIL
PFIZER
0.25MG N010686 003
0.5MG N010686 006
RESERPINE
ELIXIR;ORAL
SERPASIL
NOVARTIS
0.2MG/4ML N009115 005
INJECTABLE;INJECTION
SANDRIL
LILLY
2.5MG/ML N010012 001
SERPASIL
NOVARTIS
2.5MG/ML N009434 002
TABLET;ORAL
HISERPIA
BOWMAN PHARMS
0.1MG N009631 002
0.25MG N009631 004
RAU-SED
BRISTOL MYERS SQUIBB
0.1MG N009357 001
0.25MG N009357 004
0.5MG N009357 006
1MG N009357 008
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-288(of 337)
RESERPINE
TABLET;ORAL
RESERPINE
BARR 0.25MG
A080721 002
BELL PHARMA 0.1MG
A083058 001
0.25MG
A083058 002
BUNDY 0.1MG
N009663 001
0.25MG
N009663 003
CYCLE PHARMS LTD 0.1MG
N009859 001
0.25MG
N009859 002
ELKINS SINN 0.1MG
A083145 001
0.25MG
A083145 002
EVERYLIFE 0.1MG
N010441 001
0.25MG
N010441 002
0.5MG
N010441 003
1MG
N010441 004
HALSEY 0.1MG
A080457 002
0.25MG
A080457 001
1MG
A080457 003
HIKMA PHARMS LLC 0.1MG
A080975 001
0.25MG
A080975 002
1MG
A080975 003
IMPAX LABS 0.1MG
N009627 001
0.25MG
N009627 002
IVAX SUB TEVA PHARMS 0.1MG
N011185 001
0.25MG
N011185 002
MARSHALL PHARMA 0.1MG
A080492 001
0.25MG
A080492 002
MK LABS 0.1MG
A080525 002
0.25MG
A080525 001
MYLAN 1MG
A084974 001
PHARMAVITE 0.25MG
A084663 001
PUREPAC PHARM 0.1MG
A080753 002
0.25MG
A080753 001
PVT FORM 0.1MG
A086117 001
0.25MG
A080582 001
0.25MG
A085775 001
1MG
A080582 002
REXALL 0.25MG
A080637 001
SOLVAY 0.25MG
A080446 001
TABLICAPS 0.25MG
A085207 001
TEVA 0.1MG
A089020 001 Mar 07, 1985
0.25MG
A089019 001 Mar 07, 1985
VALEANT PHARM INTL 0.1MG
N009667 001
0.25MG
N009667 002
WATSON LABS 0.1MG
A080679 001
0.25MG
A080393 001
0.25MG
A085401 001
1MG
A080749 001
WHITEWORTH TOWN PLSN 0.1MG
A080723 001
0.25MG
A080723 002
1MG
A080723 003
SANDRIL
LILLY 0.1MG
N009376 004
0.25MG
N009376 001
SERPALAN
LANNETT 0.1MG
N010124 001
0.25MG
N010124 002
SERPANRAY
PANRAY 0.1MG
N009391 001
0.25MG
N009391 002
1MG
N009391 004
SERPASIL
NOVARTIS 0.1MG
N009115 001
0.25MG
N009115 003
1MG
N009115 004
SERPATE
VALE 0.1MG
N009453 001
0.25MG
N009453 002
SERPIVITE
VITARINE 0.25MG
N009645 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-289(of 337)
RESERPINE; TRICHLORMETHIAZIDE
TABLET;ORAL
METATENSIN #2
SANOFI AVENTIS US 0.1MG;2MG N012972 001
METATENSIN #4
SANOFI AVENTIS US 0.1MG;4MG N012972 002
NAQUIVAL
SCHERING 0.1MG;4MG N012265 003
TRICHLORMETHIAZIDE W/ RESERPINE
WATSON LABS 0.1MG;4MG A085248 001
RIBAVIRIN
TABLET;ORAL
COPEGUS
ROCHE 400MG N021511 002 Jun 21, 2005
RIMANTADINE HYDROCHLORIDE
SYRUP;ORAL
FLUMADINE
FOREST LABS 50MG/5ML N019650 001 Sep 17, 1993
TABLET;ORAL
RIMANTADINE HYDROCHLORIDE
ACTAVIS ELIZABETH 100MG A076375 001 Jan 14, 2003
COREPHARMA 100MG A075916 001 Nov 02, 2001
RISEDRONATE SODIUM
TABLET;ORAL
ACTONEL
WARNER CHILCOTT LLC 75MG **Federal Register determination N020835 004 Apr 16, 2007
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
RISPERIDONE
TABLET;ORAL
RISPERDAL
JANSSEN PHARMS 5MG N020272 005 Dec 29, 1993
RISPERIDONE
CADISTA PHARMS 0.25MG A078828 001 Mar 23, 2009
0.5MG A078828 002 Mar 23, 2009
1MG A078828 003 Mar 23, 2009
2MG A078828 004 Mar 23, 2009
3MG A078828 005 Mar 23, 2009
4MG A078828 006 Mar 23, 2009
RATIOPHARM 0.25MG A077784 001 Jun 08, 2010
0.5MG A077784 002 Jun 08, 2010
1MG A077784 003 Jun 08, 2010
2MG A077784 004 Jun 08, 2010
3MG A077784 005 Jun 08, 2010
4MG A077784 006 Jun 08, 2010
SYNTHON PHARMS 0.25MG A078187 001 Oct 22, 2009
0.5MG A078187 002 Oct 22, 2009
1MG A078187 003 Oct 22, 2009
2MG A078187 004 Oct 22, 2009
3MG A078187 005 Oct 22, 2009
4MG A078187 006 Oct 22, 2009
WATSON LABS 0.25MG A077860 001 Dec 05, 2008
0.5MG A077860 002 Dec 05, 2008
1MG A077860 003 Dec 05, 2008
2MG A077860 004 Dec 05, 2008
3MG A077860 005 Dec 05, 2008
4MG A077860 006 Dec 05, 2008
WEST WARD PHARMS 0.25MG A078740 001 May 29, 2009
0.5MG A078740 002 May 29, 2009
1MG A078740 003 May 29, 2009
2MG A078740 004 May 29, 2009
3MG A078740 005 May 29, 2009
4MG A078740 006 May 29, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-290(of 337)
RITODRINE HYDROCHLORIDE
INJECTABLE;INJECTION
RITODRINE HYDROCHLORIDE
ABRAXIS PHARM 10MG/ML A071188 001 Jul 23, 1987
15MG/ML A071189 001 Jul 23, 1987
HOSPIRA 10MG/ML A071618 001 Feb 28, 1991
15MG/ML A071619 001 Feb 28, 1991
RITODRINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA 30MG/100ML A071438 001 Jan 22, 1991
YUTOPAR
ASTRAZENECA 10MG/ML N018580 001
15MG/ML N018580 002
TABLET;ORAL
YUTOPAR
ASTRAZENECA 10MG N018555 001
RITONAVIR
CAPSULE;ORAL
NORVIR
ABBOTT 100MG N020680 001 Mar 01, 1996
RIVASTIGMINE TARTRATE
SOLUTION;ORAL
EXELON
NOVARTIS EQ 2MG BASE/ML N021025 001 Apr 21, 2000
ROCURONIUM BROMIDE
INJECTABLE;INJECTION
ZEMURON
ORGANON USA INC 50MG/5ML (10MG/ML) **Federal Register N020214 001 Mar 17, 1994
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
10MG/ML (10MG/ML) **Federal Register N020214 002 Mar 17, 1994
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
100MG/10ML (10MG/ML) **Federal Register N020214 003 Mar 17, 1994
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
ROFECOXIB
SUSPENSION;ORAL
VIOXX
MERCK 12.5MG/5ML N021052 001 May 20, 1999
25MG/5ML N021052 002 May 20, 1999
TABLET;ORAL
VIOXX
MERCK 12.5MG N021042 001 May 20, 1999
25MG N021042 002 May 20, 1999
50MG N021042 003 Feb 25, 2000
ROPINIROLE HYDROCHLORIDE
TABLET;ORAL
ROPINIROLE HYDROCHLORIDE
COREPHARMA EQ 0.25MG BASE A078230 001 May 20, 2008
EQ 0.5MG BASE A078230 002 May 20, 2008
EQ 1MG BASE A078230 003 May 20, 2008
EQ 2MG BASE A078230 004 May 20, 2008
EQ 3MG BASE A078230 005 May 20, 2008
EQ 4MG BASE A078230 006 May 20, 2008
EQ 5MG BASE A078230 007 May 20, 2008
TABLET, EXTENDED RELEASE;ORAL
REQUIP XL
GLAXOSMITHKLINE LLC EQ 3MG BASE N022008 002 Jun 13, 2008
ROSE BENGAL SODIUM I-131
INJECTABLE;INJECTION
ROBENGATOPE
BRACCO 0.5mCi/VIAL N016224 001
1mCi/VIAL N016224 002
2mCi/VIAL N016224 003
SODIUM ROSE BENGAL I 131
SORIN 0.5mCi/ML N017318 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-291(of 337)
RUFINAMIDE
TABLET;ORAL
BANZEL
EISAI INC 100MG **Federal Register determination N021911 001 Nov 14, 2008
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
SAFFLOWER OIL
INJECTABLE;INJECTION
LIPOSYN 10%
ABBOTT 10% (10GM/100ML) N018203 001
LIPOSYN 20%
ABBOTT 20% (20GM/100ML) N018614 001
SAFFLOWER OIL; SOYBEAN OIL
INJECTABLE;INJECTION
LIPOSYN II 10%
HOSPIRA 5%;5% (5GM/100ML) N018997 001 Aug 27, 1984
LIPOSYN II 20%
HOSPIRA 10%;10% (10GM/100ML) N018991 001 Aug 27, 1984
SALMETEROL XINAFOATE
AEROSOL, METERED;INHALATION
SEREVENT
GLAXOSMITHKLINE EQ 0.021MG BASE/INH N020236 001 Feb 04, 1994
SAQUINAVIR
CAPSULE;ORAL
FORTOVASE
HOFFMANN LA ROCHE 200MG N020828 001 Nov 07, 1997
SARALASIN ACETATE
INJECTABLE;INJECTION
SARENIN
PROCTER AND GAMBLE EQ 0.6MG BASE/ML N018009 001
SECOBARBITAL SODIUM
CAPSULE;ORAL
SECOBARBITAL SODIUM
ANABOLIC 100MG A084422 001
BARR 100MG A084225 001
EVERYLIFE 100MG A085895 001
HALSEY 100MG A084676 001
IVAX PHARMS 100MG A085869 001
KV PHARM 100MG A085285 001
LANNETT 50MG A085909 001
100MG A085903 001
PARKE DAVIS 100MG A084762 001
PERRIGO 100MG A084561 001
PUREPAC PHARM 100MG A085867 001
VALEANT PHARM INTL 100MG A085477 001
VITARINE 100MG A085898 001
100MG A086273 001
WATSON LABS 100MG A085792 001
WEST WARD 100MG A084926 001
WHITEWORTH TOWN PLSN 100MG A085798 001
WYETH AYERST 100MG A086390 001
INJECTABLE;INJECTION
SECOBARBITAL SODIUM
ELKINS SINN 100MG/VIAL A083281 001
WYETH AYERST 50MG/ML A083262 001
SECONAL SODIUM
LILLY 50MG/ML N007392 002
SUPPOSITORY;RECTAL
SECONAL SODIUM
LILLY 30MG A086530 001
60MG A086530 002
120MG A086530 003
200MG A086530 004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-292(of 337)
SECRETIN
INJECTABLE;INJECTION
SECRETIN-FERRING
FERRING
75CU/VIAL
N018290 001
SECRETIN SYNTHETIC PORCINE
FOR SOLUTION;INTRAVENOUS
SECREFLO
CHIRHOCLIN
16MCG/VIAL
N021136 001
Apr 04, 2002
SELEGILINE HYDROCHLORIDE
CAPSULE;ORAL
SELEGILINE HYDROCHLORIDE
LANNETT HOLDINGS INC
5MG
A075145 001
Sep 15, 2003
TABLET;ORAL
SELEGILINE HYDROCHLORIDE
DAVA PHARMS INC
5MG
A074641 001
Aug 02, 1996
IVAX SUB TEVA PHARMS
5MG
A074756 001
Nov 25, 1998
SIEGFRIED
5MG
A074672 001
Apr 01, 1997
SOMERSET
5MG
N019334 001
Jun 05, 1989
TEVA
5MG
A074537 001
Aug 02, 1996
5MG
A074744 001
Jan 27, 1997
VINTAGE PHARMS LLC
5MG
A074565 001
Aug 02, 1996
SELENIUM SULFIDE
LOTION/SHAMPOO;TOPICAL
EXSEL
ALLERGAN HERBERT
2.5%
A083892 001
SELENIUM SULFIDE
ACTAVIS MID ATLANTIC
2.5%
A084394 001
G AND W LABS INC
2.5%
A086209 001
IVAX PHARMS
2.5%
A085777 001
SELENOMETHIONINE SE-75
INJECTABLE;INJECTION
SELENOMETHIONINE SE 75
GE HEALTHCARE
250uCi/ML
N017257 001
MALLINCKRODT
100uCi/ML
N017098 001
PHARMALUCENCE
500uCi/ML
N017322 001
SETHOTOPE
BRACCO
85-550uCi/ML
N017047 001
SERACTIDE ACETATE
INJECTABLE;INJECTION
ACTHAR GEL-SYNTHETIC
ARMOUR PHARM
40 UNITS/ML
N017861 001
80 UNITS/ML
N017861 002
SERMORELIN ACETATE
INJECTABLE;INJECTION
GEREF
EMD SERONO
EQ 0.05MG BASE/AMP **Federal Register
N019863 001
Dec 28, 1990
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EMD SERONO INC
EQ 0.5MG BASE/VIAL **Federal Register
N020443 001
Sep 26, 1997
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 1MG BASE/VIAL **Federal Register
N020443 002
Sep 26, 1997
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
SERTRALINE HYDROCHLORIDE
CONCENTRATE;ORAL
SERTRALINE HYDROCHLORIDE
RANBAXY LABS LTD
EQ 20MG BASE/ML
A078053 001
Feb 05, 2007
ROXANE
EQ 20MG BASE/ML
A076934 001
Jun 30, 2006
TABLET;ORAL
SERTRALINE HYDROCHLORIDE
ACTAVIS ELIZABETH
EQ 25MG BASE
A077345 001
Feb 06, 2007
EQ 50MG BASE
A077345 002
Feb 06, 2007
EQ 100MG BASE
A077345 003
Feb 06, 2007
CIPLA LTD
EQ 25MG BASE
A077162 001
Feb 06, 2007
EQ 50MG BASE
A077162 002
Feb 06, 2007
EQ 100MG BASE
A077162 003
Feb 06, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-293(of 337)
SERTRALINE HYDROCHLORIDE
TABLET;ORAL
SERTRALINE HYDROCHLORIDE
DR REDDYS LABS LTD EQ 25MG BASE A076442 001 Apr 30, 2007
EQ 50MG BASE A076442 002 Apr 30, 2007
EQ 100MG BASE A076442 003 Apr 30, 2007
IVAX SUB TEVA PHARMS EQ 25MG BASE A075719 003 Jun 30, 2006
EQ 50MG BASE A075719 001 Jun 30, 2006
EQ 100MG BASE A075719 002 Jun 30, 2006
MUTUAL PHARM EQ 25MG BASE A077818 001 Feb 06, 2007
EQ 50MG BASE A077818 002 Feb 06, 2007
EQ 100MG BASE A077818 003 Feb 06, 2007
MYLAN PHARMS INC EQ 25MG BASE A076540 001 Mar 20, 2007
EQ 50MG BASE A076540 002 Mar 20, 2007
EQ 100MG BASE A076540 003 Mar 20, 2007
PLIVA HRVATSKA DOO EQ 25MG BASE A077299 001 Feb 06, 2007
EQ 50MG BASE A077299 002 Feb 06, 2007
EQ 100MG BASE A077299 003 Feb 06, 2007
ROXANE EQ 25MG BASE A076881 001 Feb 06, 2007
EQ 50MG BASE A076881 002 Feb 06, 2007
EQ 100MG BASE A076881 003 Feb 06, 2007
SANDOZ EQ 25MG BASE A077713 001 Feb 06, 2007
EQ 50MG BASE A077713 002 Feb 06, 2007
EQ 100MG BASE A077713 003 Feb 06, 2007
WATSON LABS EQ 25MG BASE A077663 001 Feb 06, 2007
EQ 50MG BASE A077663 002 Feb 06, 2007
EQ 100MG BASE A077663 003 Feb 06, 2007
ZOLOFT
PFIZER EQ 150MG BASE N019839 003 Dec 30, 1991
EQ 200MG BASE N019839 004 Dec 30, 1991
SEVELAMER HYDROCHLORIDE
CAPSULE;ORAL
RENAGEL
GENZYME 403MG N020926 001 Oct 30, 1998
SIBUTRAMINE HYDROCHLORIDE
CAPSULE;ORAL
MERIDIA
ABBOTT 5MG N020632 001 Nov 22, 1997
10MG N020632 002 Nov 22, 1997
15MG N020632 003 Nov 22, 1997
SILVER SULFADIAZINE
DRESSING;TOPICAL
SILDAFLO
FRANKLIN PHARMS 1% N019608 001 Nov 30, 1989
SIMETHICONE-CELLULOSE
SUSPENSION;ORAL
SONORX
BRACCO 7.5MG/ML N020773 001 Oct 29, 1998
SIMVASTATIN
TABLET;ORAL
SIMVASTATIN
SANDOZ INC 5MG A077766 001 Dec 20, 2006
10MG A077766 002 Dec 20, 2006
20MG A077766 003 Dec 20, 2006
40MG A077766 004 Dec 20, 2006
80MG A077766 005 Dec 20, 2006
TABLET, ORALLY DISINTEGRATING;ORAL
SIMVASTATIN
SYNTHON PHARMS 10MG N021961 001 Oct 09, 2007
20MG N021961 002 Oct 09, 2007
40MG N021961 003 Oct 09, 2007
80MG N021961 004 Oct 09, 2007
SIMVASTATIN; SITAGLIPTIN PHOSPHATE
TABLET;ORAL
JUVISYNC
MERCK SHARP DOHME 10MG;EQ 50MG BASE N202343 004 Sep 18, 2012
10MG;EQ 100MG BASE N202343 001 Oct 07, 2011
20MG;EQ 50MG BASE N202343 005 Sep 18, 2012
20MG;EQ 100MG BASE N202343 002 Oct 07, 2011
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-294(of 337)
SIMVASTATIN; SITAGLIPTIN PHOSPHATE
TABLET;ORAL
JUVISYNC
40MG;EQ 50MG BASE N202343 006 Sep 18, 2012
40MG;EQ 100MG BASE N202343 003 Oct 07, 2011
SIROLIMUS
TABLET;ORAL
RAPAMUNE
PF PRISM CV 5MG **Federal Register determination N021110 003 Feb 23, 2004
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
SODIUM BENZOATE; SODIUM PHENYLACETATE
SOLUTION;ORAL
UCEPHAN
B BRAUN 100MG/ML;100MG/ML N019530 001 Dec 23, 1987
SODIUM BICARBONATE
INJECTABLE;INJECTION
SODIUM BICARBONATE IN PLASTIC CONTAINER
ABBOTT 0.9MEQ/ML N019443 001 Jun 03, 1986
1MEQ/ML N019443 002 Jun 03, 1986
SODIUM BICARBONATE; TARTARIC ACID
GRANULE, EFFERVESCENT;ORAL
BAROS
MALLINCKRODT INC 460MG/GM;420MG/GM N018509 001 Aug 07, 1985
SODIUM CHLORIDE
INJECTABLE;INJECTION
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ABRAXIS PHARM 9MG/ML A088909 001 Feb 07, 1985
SODIUM CHLORIDE
ABBOTT 20GM/100ML N017013 001
B BRAUN 20GM/100ML N017038 001
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
B BRAUN 450MG/100ML N018184 001
MILES 450MG/100ML N018503 001
SODIUM CHLORIDE 0.9%
MEDEFIL INC 18MG/2ML (9MG/ML) N202832 002 Jan 06, 2012
22.5MG/2.5ML (9MG/ML) N202832 003 Jan 06, 2012
27MG/3ML (9MG/ML) N202832 004 Jan 06, 2012
45MG/5ML (9MG/ML) N202832 005 Jan 06, 2012
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER
ABBOTT 9MG/ML N019218 001 Jul 13, 1984
MEDEFIL INC 9MG/ML (9MG/ML) N202832 001 Jan 06, 2012
MILES 900MG/100ML N018502 001
SODIUM CHLORIDE 23.4% IN PLASTIC CONTAINER
ABRAXIS PHARM 234MG/ML N019329 001 Apr 22, 1987
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER
B BRAUN 3GM/100ML N019635 003 Mar 09, 1988
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER
B BRAUN 5GM/100ML N019635 004 Mar 09, 1988
SOLUTION;IRRIGATION
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER
BAXTER HLTHCARE 450MG/100ML N017864 001
450MG/100ML N018497 001 Feb 19, 1982
HOSPIRA 450MG/100ML N017670 001
450MG/100ML N018380 001
SODIUM CHLORIDE IN PLASTIC CONTAINER
MILES 900MG/100ML N018247 001
SODIUM CHROMATE CR-51
INJECTABLE;INJECTION
CHROMITOPE SODIUM
BRACCO 2mCi/VIAL N013993 002
200uCi/ML N013993 001
SODIUM CHROMATE CR 51
MALLINCKRODT 100uCi/ML N016708 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-295(of 337)
SODIUM FLUORIDE F-18
INJECTABLE;INTRAVENOUS
FLUORINE F-18
GE HEALTHCARE 2mCi/ML **Federal Register N017042 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
SODIUM FLUORIDE F 18
NIH NCI DCTD 10-200mCi/ML N022494 001 Jan 26, 2011
SODIUM IODIDE I-123
CAPSULE;ORAL
SODIUM IODIDE I 123
CARDINAL HLTH 414 400uCi N018671 003 May 27, 1982
GE HEALTHCARE 100uCi N017630 001
SOLUTION;ORAL
SODIUM IODIDE I 123
GE HEALTHCARE 2mCi/ML N017630 002
SODIUM IODIDE I-131
CAPSULE;ORAL
IODOTOPE
BRACCO 1-130mCi N010929 001
1-150mCi N010929 003
SODIUM IODIDE I 131
CIS 50uCi N017316 001
100uCi N017316 002
MALLINCKRODT 0.8-100mCi N016515 002
15-100uCi N016517 002
SODIUM IODIDE I-131
JUBILANT DRAXIMAGE 2-200mCi N021305 004 Nov 18, 2004
SOLUTION;ORAL
HICON
JUBILANT DRAXIMAGE 1-250mCi/0.25ML N021305 002 Jan 24, 2003
1-500mCi/0.5ML N021305 003 Jan 24, 2003
1-1000mCi/ML N021305 005 Apr 04, 2006
IODOTOPE
BRACCO 7-106mCi/BOT N010929 002
SODIUM IODIDE I 131
CIS 50mCi/ML N017315 001
SODIUM LACTATE
INJECTABLE;INJECTION
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER
B BRAUN 1.87GM/100ML N018186 001
HOSPIRA 1.87GM/100ML N018249 001
SODIUM MONOFLUOROPHOSPHATE
GEL;DENTAL
EXTRA-STRENGTH AIM
CHESEBROUGH PONDS 1.2% N019518 002 Aug 06, 1986
PASTE;DENTAL
EXTRA-STRENGTH AIM
CHESEBROUGH PONDS 1.2% N019518 001 Jun 03, 1987
SODIUM NITROPRUSSIDE
INJECTABLE;INJECTION
NIPRIDE
ROCHE 50MG/VIAL N017546 001
NITROPRESS
ABBOTT 50MG/VIAL A071555 001 Nov 16, 1987
ABBVIE 50MG/VIAL N018450 001
HOSPIRA 50MG/VIAL A070566 001 Jun 09, 1986
SODIUM NITROPRUSSIDE
ABRAXIS PHARM 50MG/VIAL A070031 001 Jan 17, 1985
BAXTER HLTHCARE 50MG/VIAL N018581 001 Jul 28, 1982
TEVA PARENTERAL 25MG/ML A073465 001 Mar 30, 1992
SODIUM PHOSPHATE P-32
SOLUTION;INJECTION, ORAL
PHOSPHOTOPE
BRACCO 1-8mCi/VIAL N010927 001
SODIUM PHOSPHATE P 32
MALLINCKRODT 0.67mCi/ML N011777 001
1.5mCi/VIAL N011777 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-296(of 337)
SODIUM PHOSPHATE, DIBASIC ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
TABLET;ORAL
VISICOL
SALIX PHARMS 0.398GM;1.102GM N021097 001 Sep 21, 2000
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE
TABLET;ORAL
MONOBASIC SODIUM PHOSPHATE AND DIBASIC SODIUM PHOSPHATE
NOVEL LABS INC 0.398GM;1.102GM A079247 001 Dec 30, 2011
SODIUM POLYSTYRENE SULFONATE
POWDER;ORAL, RECTAL
SODIUM POLYSTYRENE SULFONATE
CITRUSPHRMA 454GM/BOT A040909 001 Dec 03, 2008
WOCKHARDT 453.6GM/BOT A088786 001 Sep 11, 1984
SUSPENSION;ORAL, RECTAL
SODIUM POLYSTYRENE SULFONATE
MORTON GROVE 15GM/60ML A088717 001 Sep 11, 1984
ROXANE 15GM/60ML A088453 001 Nov 17, 1983
SODIUM SUCCINATE
INJECTABLE;INJECTION
SODIUM SUCCINATE
ELKINS SINN 30% A080516 001
SODIUM TETRADECYL SULFATE
INJECTABLE;INJECTION
SOTRADECOL
ELKINS SINN 1% **Federal Register determination N005970 004
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
3% **Federal Register determination N005970 005
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
SODIUM THIOSULFATE
INJECTABLE;INJECTION
SODIUM THIOSULFATE
US ARMY 250MG/ML N020166 001 Feb 14, 1992
SOMATREM
INJECTABLE;INJECTION
PROTROPIN
GENENTECH 5MG/VIAL N019107 001 Oct 17, 1985
10MG/VIAL N019107 002 Oct 24, 1989
SOMATROPIN
INJECTABLE;INJECTION
ASELLACRIN 10
SERONO 10 IU/VIAL N017726 001
ASELLACRIN 2
SERONO 2 IU/VIAL N017726 002 Jul 21, 1983
CRESCORMON
GENENTECH 4 IU/VIAL N017992 001
SOMATROPIN RECOMBINANT
INJECTABLE;INJECTION
ACCRETROPIN
EMERGENT 5MG/ML (5MG/ML) N021538 001 Jan 23, 2008
BIO-TROPIN
FERRING 4.8MG/VIAL N019774 001 May 25, 1995
HUMATROPE
LILLY 2MG/VIAL N019640 001 Jun 23, 1987
NORDITROPIN
NOVO NORDISK INC 4MG/VIAL N019721 001 May 08, 1995
5MG/1.5ML N021148 001 Jun 20, 2000
8MG/VIAL N019721 002 May 08, 1995
10MG/1.5ML N021148 002 Jun 20, 2000
15MG/1.5ML N021148 003 Jun 20, 2000
NORDITROPIN NORDIFLEX
NOVO NORDISK INC 5MG/1.5ML N021148 004 Oct 01, 2004
10MG/1.5ML N021148 005 Oct 01, 2004
15MG/1.5ML N021148 006 Oct 01, 2004
NUTROPIN DEPOT
GENENTECH 13.5MG/VIAL N021075 001 Dec 22, 1999
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-297(of 337)
SOMATROPIN RECOMBINANT
INJECTABLE;INJECTION
NUTROPIN DEPOT
18MG/VIAL
N021075 002 Dec 22, 1999
22.5MG/VIAL
N021075 003 Dec 22, 1999
SAIZEN
EMD SERONO 4MG/VIAL
N019764 005 Jan 16, 2007
6MG/VIAL
N019764 001 Oct 08, 1996
SEROSTIM
EMD SERONO 8.8MG/VIAL
N020604 004 Sep 06, 2001
ZORBTIVE
EMD SERONO 4MG/VIAL
N021597 001 Dec 01, 2003
5MG/VIAL
N021597 002 Dec 01, 2003
6MG/VIAL
N021597 003 Dec 01, 2003
INJECTABLE;SUBCUTANEOUS
SEROSTIM LQ
EMD SERONO 6MG/0.5ML (6MG/0.5ML)
N020604 005 Feb 11, 2005
SORBITOL
SOLUTION;IRRIGATION
SORBITOL 3% IN PLASTIC CONTAINER
BAXTER HLTHCARE 3GM/100ML
N018512 001 May 27, 1982
SOTALOL HYDROCHLORIDE
TABLET;ORAL
BETAPACE
BAYER HLTHCARE 320MG
N019865 004 Oct 30, 1992
BETAPACE AF
COVIS PHARMA SARL 40MG
N021151 006 Apr 02, 2003
60MG
N021151 007 Apr 02, 2003
100MG
N021151 005 Mar 14, 2003
SOTALOL HYDROCHLORIDE
MUTUAL PHARM 80MG
A075515 001 Oct 15, 2001
80MG
A076576 001 Apr 08, 2004
120MG
A075515 004 Oct 15, 2001
120MG
A076576 002 Apr 08, 2004
160MG
A075515 002 Oct 15, 2001
160MG
A076576 003 Apr 08, 2004
240MG
A075515 003 Oct 15, 2001
WATSON LABS 80MG
A075238 001 Jul 13, 2000
120MG
A075238 002 Jul 13, 2000
160MG
A075238 003 Jul 13, 2000
240MG
A075238 004 Jul 13, 2000
SOYBEAN OIL
INJECTABLE;INJECTION
LIPOSYN III 10%
HOSPIRA 10%
N018969 001 Sep 24, 1984
LIPOSYN III 20%
HOSPIRA 20%
N018970 001 Sep 25, 1984
LIPOSYN III 30%
HOSPIRA 30%
N020181 001 Jan 13, 1998
SOYACAL 10%
ALPHA THERA 10%
N018465 001 Jun 29, 1983
SOYACAL 20%
ALPHA THERA 20%
N018786 001 Jun 29, 1983
TRAVAMULSION 10%
BAXTER HLTHCARE 10%
N018660 001 Feb 26, 1982
TRAVAMULSION 20%
BAXTER HLTHCARE 20%
N018758 001 Feb 15, 1983
SPARFLOXACIN
TABLET;ORAL
ZAGAM
MYLAN 200MG
N020677 001 Dec 19, 1996
SPECTINOMYCIN HYDROCHLORIDE
INJECTABLE;INJECTION
TROBICIN
PFIZER EQ 2GM BASE/VIAL
N050347 001
EQ 4GM BASE/VIAL
N050347 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-298(of 337)
SPIRAPRIL HYDROCHLORIDE
TABLET;ORAL
RENORMAX
SCHERING
3MG
N020240 001 Dec 29, 1994
6MG
N020240 002 Dec 29, 1994
12MG
N020240 003 Dec 29, 1994
24MG
N020240 004 Dec 29, 1994
SPIRONOLACTONE
TABLET;ORAL
SPIRONOLACTONE
ASCOT
25MG
A087687 001 Oct 20, 1982
IVAX PHARMS
25MG
A087108 001
LEDERLE
25MG
A087634 001
MUTUAL PHARM
25MG
A087265 001
MYLAN
25MG
A087086 001
PUREPAC PHARM
25MG
A087998 001 Oct 14, 1983
25MG
A088053 001 Aug 25, 1983
SUPERPHARM
25MG
A089364 001 Nov 07, 1986
UPSHER SMITH
25MG
A087554 001
VANGARD
25MG
A087648 001 Feb 01, 1982
WARNER CHILCOTT
25MG
A087952 001 Nov 18, 1982
WATSON LABS
25MG
A086898 002 Mar 02, 1982
25MG
A087078 001
STANOZOLOL
TABLET;ORAL
WINSTROL
LUNDBECK INC
2MG
N012885 001 May 14, 1984
STAVUDINE
CAPSULE;ORAL
ZERIT
BRISTOL MYERS SQUIBB 5MG
N020412 001 Jun 24, 1994
CAPSULE, EXTENDED RELEASE;ORAL
ZERIT XR
BRISTOL MYERS SQUIBB 37.5MG
N021453 001 Dec 31, 2002
50MG
N021453 002 Dec 31, 2002
75MG
N021453 003 Dec 31, 2002
100MG
N021453 004 Dec 31, 2002
STERILE WATER FOR INJECTION
LIQUID;N/A
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER
ABRAXIS PHARM 100%
A089099 001 Dec 29, 1987
100%
A089100 001 Dec 29, 1987
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER
B BRAUN 100%
N019077 001 Mar 02, 1984
STERILE WATER FOR IRRIGATION
LIQUID;IRRIGATION
STERILE WATER IN PLASTIC CONTAINER
MILES
100%
N018246 001
STREPTOMYCIN SULFATE
INJECTABLE;INJECTION
STREPTOMYCIN SULFATE
COPANOS
EQ 500MG BASE/ML
A060684 001
LILLY
EQ 1GM BASE/VIAL
A060107 001
EQ 1GM BASE/2ML
A060404 001
EQ 5GM BASE/VIAL
A060107 002
PFIZER
EQ 1GM BASE/VIAL
A060076 001
EQ 1GM BASE/2.5ML
A060111 001
EQ 5GM BASE/VIAL
A060076 002
SUCCINYLCHOLINE CHLORIDE
INJECTABLE;INJECTION
ANECTINE
SANDOZ
1GM/VIAL
N008453 004
50MG/ML
N008453 003
500MG/VIAL
N008453 001
QUELICIN PRESERVATIVE FREE
HOSPIRA
50MG/ML
N008845 002
SUCCINYLCHOLINE CHLORIDE
INTL MEDICATION
100MG/VIAL
A085400 001 Feb 04, 1982
ORGANON USA INC
20MG/ML
A080997 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-299(of 337)
SUCCINYLCHOLINE CHLORIDE
INJECTABLE;INJECTION
SUCOSTRIN
APOTHECON 20MG/ML
N008847 001
100MG/ML
N008847 003
SUFENTANIL CITRATE
INJECTABLE;INJECTION
SUFENTANIL CITRATE
WATSON LABS EQ 0.05MG BASE/ML
A074406 001 Dec 15, 1995
SULFACETAMIDE SODIUM
OINTMENT;OPHTHALMIC
BLEPH-10
ALLERGAN 10%
A084015 001
SODIUM SULAMYD
SCHERING 10%
N005963 002
SULFAIR 10
PHARMAFAIR 10%
A088000 001 Dec 22, 1982
SOLUTION/DROPS;OPHTHALMIC
BLEPH-30
ALLERGAN 30%
A080028 002
ISOPTO CETAMIDE
ALCON 15%
A080020 002
OCUSULF-10
MIZA PHARMS USA 10%
A080660 001
OCUSULF-30
MIZA PHARMS USA 30%
A080660 002
SODIUM SULAMYD
SCHERING 10%
N005963 001
30%
N005963 003
SODIUM SULFACETAMIDE
AKORN 10%
A083021 001
15%
A083021 002
30%
A083021 003
SOLA BARNES HIND 10%
A084143 001
10%
A084145 001
30%
A084146 001
30%
A084147 001
SULF-10
NOVARTIS 10%
A080025 001
SULF-15
NOVARTIS 15%
A089047 001 Oct 31, 1995
SULFACEL-15
OPTOPICS 15%
A080024 001
SULFACETAMIDE SODIUM
AKORN 10%
A040215 001 May 25, 1999
30%
A040216 001 May 25, 1999
ALCON PHARMS LTD 30%
A089068 001 May 05, 1987
PHARMAFAIR 10%
A088947 001 May 17, 1985
SULFAIR 10
PHARMAFAIR 10%
A087949 001 Dec 13, 1982
SULFAIR FORTE
PHARMAFAIR 30%
A088385 001 Oct 13, 1983
SULFAIR-15
PHARMAFAIR 15%
A088186 001 May 25, 1983
SULTEN-10
BAUSCH AND LOMB 10%
A087818 001 Feb 03, 1983
SULFACYTINE
TABLET;ORAL
RENOQUID
GLENWOOD 250MG
N017569 001
SULFADIAZINE
TABLET;ORAL
SULFADIAZINE
ABBVIE 300MG
N004125 005
EVERYLIFE 500MG
A080088 001
IMPAX LABS 500MG
A080081 001
LANNETT 500MG
A080084 001
LEDERLE 500MG
N004054 001
LILLY 500MG
N004122 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-300(of 337)
SULFADIAZINE SODIUM
INJECTABLE;INJECTION
SULFADIAZINE SODIUM
LEDERLE
250MG/ML
N004054 002
SULFADIAZINE; SULFAMERAZINE
SUSPENSION;ORAL
SULFONAMIDES DUPLEX
LILLY
250MG/5ML;250MG/5ML
N006317 007
SULFAMETER
TABLET;ORAL
SULLA
BAYER HLTHCARE
500MG
N016000 002
SULFAMETHIZOLE
TABLET;ORAL
MICROSUL
FOREST PHARMS
1GM
A086012 001
PROKLAR
FOREST PHARMS
500MG
A080273 001
THIOSULFIL
WYETH AYERST
250MG
N008565 001
500MG
N008565 004
SULFAMETHOXAZOLE
SUSPENSION;ORAL
GANTANOL
ROCHE
500MG/5ML
N013664 002
TABLET;ORAL
GANTANOL
ROCHE
500MG
N012715 002
GANTANOL-DS
ROCHE
1GM
N012715 003
SULFAMETHOXAZOLE
ASCOT
500MG
A087662 001 Oct 20, 1982
BARR
500MG
A087189 001 Jul 25, 1983
HEATHER
500MG
A086163 001
SANDOZ
500MG
A085844 001
WATSON LABS
1GM
A086000 001
500MG
A085053 001
UROBAK
SHIONOGI
500MG
A087307 001
SULFAMETHOXAZOLE; TRIMETHOPRIM
INJECTABLE;INJECTION
BACTRIM
MUTUAL PHARM
80MG/ML;16MG/ML
N018374 001
SEPTRA
MONARCH PHARMS
80MG/ML;16MG/ML
N018452 001
SULFAMETHOXAZOLE AND TRIMETHOPRIM
ABRAXIS PHARM
80MG/ML;16MG/ML
A070223 001 Dec 29, 1987
BEDFORD
80MG/ML;16MG/ML
A072383 001 Apr 29, 1992
HIKMA MAPLE
80MG/ML;16MG/ML
A070627 001 Dec 29, 1987
80MG/ML;16MG/ML
A070628 001 Dec 29, 1987
HOSPIRA
80MG/ML;16MG/ML
A073199 001 Sep 11, 1992
WATSON LABS
80MG/ML;16MG/ML
A071556 001 Dec 29, 1987
SUSPENSION;ORAL
BACTRIM
MUTUAL PHARM
200MG/5ML;40MG/5ML
N017560 001
BACTRIM PEDIATRIC
MUTUAL PHARM
200MG/5ML;40MG/5ML
N017560 002
SEPTRA
MONARCH PHARMS
200MG/5ML;40MG/5ML
N017598 001
SEPTRA GRAPE
MONARCH PHARMS
200MG/5ML;40MG/5ML
N017598 002 Feb 12, 1986
SULFAMETHOXAZOLE AND TRIMETHOPRIM
TEVA
200MG/5ML;40MG/5ML
A070028 001 Jun 02, 1987
200MG/5ML;40MG/5ML
N018812 001 Jan 28, 1983
200MG/5ML;40MG/5ML
N018812 002 Jun 10, 1983
TEVA PHARMS
200MG/5ML;40MG/5ML
A077612 001 Nov 13, 2006
SULFATRIM
STI PHARMA LLC
200MG/5ML;40MG/5ML
N018615 002 Jan 07, 1983
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-301(of 337)
SULFAMETHOXAZOLE; TRIMETHOPRIM
SUSPENSION;ORAL
SULMEPRIM
USL PHARMA 200MG/5ML;40MG/5ML A070063 001 Aug 01, 1986
SULMEPRIM PEDIATRIC
USL PHARMA 200MG/5ML;40MG/5ML A070064 001 Aug 01, 1986
TRIMETH/SULFA
ALPHARMA US PHARMS 200MG/5ML;40MG/5ML A072289 001 May 23, 1988
200MG/5ML;40MG/5ML A072398 001 May 23, 1988
NASKA 200MG/5ML;40MG/5ML A072399 001 May 23, 1988
TABLET;ORAL
COTRIM
TEVA 400MG;80MG A070034 001 May 16, 1985
COTRIM D.S.
TEVA 800MG;160MG A070048 001 Mar 18, 1985
SULFAMETHOPRIM
NOVEL LABS INC 400MG;80MG A070022 001 Feb 15, 1985
SULFAMETHOPRIM-DS
NOVEL LABS INC 800MG;160MG A070032 001 Feb 15, 1985
SULFAMETHOXAZOLE AND TRIMETHOPRIM
HEATHER 400MG;80MG N018946 001 Aug 10, 1984
800MG;160MG N018946 002 Aug 10, 1984
INTERPHARM 400MG;80MG A071299 001 Oct 27, 1987
800MG;160MG A071300 001 Oct 27, 1987
MARTEC USA LLC 400MG;80MG A072408 001 Dec 07, 1988
MUTUAL PHARM 400MG;80MG A070006 001 Nov 14, 1984
400MG;80MG A071016 001 Aug 25, 1986
PLIVA 400MG;80MG A070215 001 Sep 10, 1985
800MG;160MG A070216 001 Sep 10, 1985
ROXANE 400MG;80MG A072768 001 Aug 30, 1991
SANDOZ 400MG;80MG A070889 001 Nov 13, 1986
400MG;80MG N018598 003 May 19, 1982
800MG;160MG A070890 001 Nov 13, 1986
TEVA 400MG;80MG N018242 001
800MG;160MG N018242 002
USL PHARMA 400MG;80MG A070203 001 Nov 08, 1985
800MG;160MG A070204 001 Nov 08, 1985
WATSON LABS 400MG;80MG A070002 001 Nov 07, 1984
400MG;80MG N018852 001 May 09, 1983
800MG;160MG A070000 001 Nov 07, 1984
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH
MARTEC USA LLC 800MG;160MG A072417 001 Dec 07, 1988
MUTUAL PHARM 800MG;160MG A070007 001 Nov 14, 1984
ROXANE 800MG;160MG A072769 001 Aug 30, 1991
SANDOZ 800MG;160MG N018598 004 May 19, 1982
WATSON LABS 800MG;160MG N018854 001 May 09, 1983
SULFATRIM-DS
SUPERPHARM 800MG;160MG A070066 001 Jun 24, 1985
SULFATRIM-SS
SUPERPHARM 400MG;80MG A070065 002 Jun 24, 1985
UROPLUS DS
SHIONOGI 800MG;160MG A071816 001 Sep 28, 1987
UROPLUS SS
SHIONOGI 400MG;80MG A071815 001 Sep 28, 1987
SULFANILAMIDE
CREAM;VAGINAL
SULFANILAMIDE
TEVA 15% A088718 001 Sep 19, 1985
SUPPOSITORY;VAGINAL
AVC
MEDA PHARMS 1.05GM N006530 004 Jan 27, 1987
SULFAPHENAZOLE
SUSPENSION;ORAL
SULFABID
PHARM RES ASSOC 500MG/5ML N013093 001
TABLET;ORAL
SULFABID
PURDUE FREDERICK 500MG N013092 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-302(of 337)
SULFAPYRIDINE
TABLET;ORAL
SULFAPYRIDINE
LILLY 500MG N000159 001
SULFASALAZINE
SUSPENSION;ORAL
AZULFIDINE
PHARMACIA AND UPJOHN 250MG/5ML N018605 001
TABLET;ORAL
S.A.S.-500
SOLVAY 500MG A083450 001
SULFASALAZINE
HERITAGE PHARMS INC 500MG A080197 001
MUTUAL PHARM 500MG A089590 001 Oct 19, 1987
SANDOZ 500MG A086184 001
SUPERPHARM 500MG A089339 001 Oct 26, 1987
WATSON LABS 500MG A084964 001
500MG A087197 001
TABLET, DELAYED RELEASE;ORAL
SULFASALAZINE
WATSON LABS 500MG A088052 001 May 24, 1983
SULFINPYRAZONE
CAPSULE;ORAL
ANTURANE
NOVARTIS 200MG **Federal Register determination N011556 004
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
SULFINPYRAZONE
BARR 200MG A087666 001 Sep 17, 1982
IVAX PHARMS 200MG A087770 001 Nov 19, 1982
PAR PHARM 200MG A088934 001 Sep 06, 1985
VANGARD 200MG A088666 001 Feb 17, 1984
TABLET;ORAL
ANTURANE
NOVARTIS 100MG **Federal Register determination N011556 003
that product was not discontinued or
withdrawn for safety or efficacy
reasons**
SULFINPYRAZONE
BARR 100MG A087665 001 Sep 17, 1982
IVAX PHARMS 100MG A087769 001 Jun 01, 1982
PAR PHARM 100MG A088933 001 Sep 06, 1985
WATSON LABS 100MG A087667 001 May 26, 1982
SULFISOXAZOLE
TABLET;ORAL
GANTRISIN
ROCHE 500MG N006525 001
SOSOL
MK LABS 500MG A080036 001
SOXAZOLE
ALRA 500MG A080366 001
SULFALAR
PARKE DAVIS 500MG A084955 001
SULFISOXAZOLE
BARR 500MG A084031 001
HEATHER 500MG A080189 001
IMPAX LABS 500MG A080109 001
IVAX SUB TEVA PHARMS 500MG A080142 001
LANNETT 500MG A080085 001
LEDERLE 500MG A087649 001
PHARMERAL 500MG A084385 001
PUREPAC PHARM 500MG A080087 001
ROXANE 500MG A080082 001
SANDOZ 500MG A085628 001
VALEANT PHARM INTL 500MG A080268 002
VITARINE 500MG A087332 001
WATSON LABS 500MG A085534 001
WEST WARD 500MG A080379 001
SULSOXIN
SOLVAY 500MG A080040 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-303(of 337)
SULFISOXAZOLE ACETYL
EMULSION;ORAL
LIPO GANTRISIN
ROCHE
EQ 1GM BASE/5ML
N009182 009
SUSPENSION;ORAL
GANTRISIN PEDIATRIC
ROCHE
EQ 500MG BASE/5ML
N009182 004
SYRUP;ORAL
GANTRISIN
ROCHE
EQ 500MG BASE/5ML
N009182 002
SULFISOXAZOLE DIOLAMINE
INJECTABLE;INJECTION
GANTRISIN
ROCHE
EQ 400MG BASE/ML
N006917 001
OINTMENT;OPHTHALMIC
GANTRISIN
ROCHE
EQ 4% BASE
N008414 002
SOLUTION/DROPS;OPHTHALMIC
GANTRISIN
ROCHE
EQ 4% BASE
N007757 002
SULFISOXAZOLE DIOLAMINE
SOLA BARNES HIND
EQ 4% BASE
A084148 001
SULFOXONE SODIUM
TABLET, DELAYED RELEASE;ORAL
DIASONE SODIUM
ABBVIE
165MG
N006044 003
SULFUR
POWDER;TOPICAL
BENSULFOID
POYTHRESS
33.32%
N002918 001
SULINDAC
TABLET;ORAL
CLINORIL
MERCK
150MG
N017911 001
SULINDAC
SANDOZ
150MG
A072712 001 Aug 30, 1991
200MG
A072713 001 Aug 30, 1991
TEVA
150MG
A072972 001 Feb 28, 1992
200MG
A072973 001 Feb 28, 1992
SUMATRIPTAN
SPRAY;NASAL
IMITREX
GLAXOSMITHKLINE
10MG/SPRAY
N020626 002 Aug 26, 1997
SUMATRIPTAN SUCCINATE
INJECTABLE;SUBCUTANEOUS
SUMATRIPTAN SUCCINATE
FRESENIUS KABI USA
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A079240 002 Sep 18, 2009
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
A079240 001 Sep 18, 2009
SANDOZ
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
A078067 002 Feb 06, 2009
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A078067 001 Feb 06, 2009
TEVA PARENTERAL
EQ 4MG BASE/0.5ML (EQ 8MG BASE/ML)
A078318 001 Feb 06, 2009
EQ 6MG BASE/0.5ML (EQ 12MG BASE/ML)
A078318 002 Feb 06, 2009
TABLET;ORAL
SUMATRIPTAN SUCCINATE
MYLAN
EQ 25MG BASE
A077163 001 Nov 02, 2009
EQ 50MG BASE
A077163 002 Nov 02, 2009
EQ 100MG BASE
A077163 003 Nov 02, 2009
ROXANE
EQ 25MG BASE
A078241 001 Aug 10, 2009
EQ 50MG BASE
A078241 002 Aug 10, 2009
EQ 100MG BASE
A078241 003 Aug 10, 2009
TEVA
EQ 25MG BASE
A076840 001 Feb 09, 2009
EQ 50MG BASE
A076840 002 Feb 09, 2009
EQ 100MG BASE
A076840 003 Feb 09, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-304(of 337)
SUPROFEN
SOLUTION/DROPS;OPHTHALMIC
PROFENAL
ALCON 1% N019387 001 Dec 23, 1988
SUTILAINS
OINTMENT;TOPICAL
TRAVASE
ABBOTT 82,000 UNITS/GM **Federal Register N012828 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
TACRINE HYDROCHLORIDE
CAPSULE;ORAL
COGNEX
SHIONOGI INC EQ 10MG BASE N020070 001 Sep 09, 1993
EQ 20MG BASE N020070 002 Sep 09, 1993
EQ 30MG BASE N020070 003 Sep 09, 1993
EQ 40MG BASE N020070 004 Sep 09, 1993
TACROLIMUS
CAPSULE;ORAL
TACROLIMUS
WATSON LABS EQ 5MG BASE A090402 001 Jul 01, 2010
TALBUTAL
TABLET;ORAL
LOTUSATE
SANOFI AVENTIS US 120MG N009410 005
TAMOXIFEN CITRATE
TABLET;ORAL
NOLVADEX
ASTRAZENECA EQ 10MG BASE N017970 001
EQ 20MG BASE N017970 002 Mar 21, 1994
TAMOXIFEN CITRATE
AEGIS PHARMS EQ 10MG BASE A076398 001 Mar 31, 2003
EQ 20MG BASE A076398 002 Mar 31, 2003
IVAX SUB TEVA PHARMS EQ 10MG BASE A075740 001 Feb 20, 2003
EQ 20MG BASE A075740 002 Feb 20, 2003
PHARMACHEMIE EQ 10MG BASE A074539 001 Mar 31, 2003
ROXANE EQ 10MG BASE A076027 001 Feb 20, 2003
EQ 20MG BASE A076027 002 Feb 20, 2003
TEVA EQ 10MG BASE A074504 001 Apr 28, 2003
EQ 20MG BASE A074504 002 Apr 28, 2003
TECHNETIUM TC-99M ALBUMIN AGGREGATED
INJECTABLE;INJECTION
TC 99M-LUNGAGGREGATE
GE HEALTHCARE 5mCi/ML N017848 001
TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT
INJECTABLE;INJECTION
A-N STANNOUS AGGREGATED ALBUMIN
SYNCOR PHARMS N/A N017916 001
AN-MAA
PHARMALUCENCE N/A N017792 001
LUNGAGGREGATE REAGENT
GE HEALTHCARE N/A N017838 001
MACROTEC
BRACCO N/A N017833 001
TECHNESCAN MAA
MALLINCKRODT N/A N017842 001
TECHNETIUM TC 99M MAA
GE HEALTHCARE N/A N017773 001
TECHNETIUM TC-99M ALBUMIN COLLOID KIT
INJECTABLE;INJECTION
MICROLITE
PHARMALUCENCE N/A N018263 001 Mar 25, 1983
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-305(of 337)
TECHNETIUM TC-99M ALBUMIN KIT
INJECTABLE;INJECTION
TECHNETIUM TC 99M HSA
GE HEALTHCARE N/A
N017775 001
TECHNETIUM TC-99M ALBUMIN MICROSPHERES KIT
INJECTABLE;INJECTION
INSTANT MICROSPHERES
3M N/A
N017832 001
TECHNETIUM TC-99M APCITIDE
INJECTABLE;INJECTION
ACUTECT
CIS BIO INTL SA N/A
N020887 001 Sep 14, 1998
TECHNETIUM TC-99M DEPREOTIDE
INJECTABLE;INJECTION
NEO TECT KIT
CIS BIO INTL SA N/A
N021012 001 Aug 03, 1999
TECHNETIUM TC-99M ETIDRONATE KIT
INJECTABLE;INJECTION
CINTICHEM TECHNETIUM 99M HEDSPA
GE HEALTHCARE N/A
N017653 001
MPI STANNOUS DIPHOSPHONATE
GE HEALTHCARE N/A
N017667 001
OSTEOSCAN
MALLINCKRODT N/A
N017454 001
TECHNETIUM TC 99M DIPHOSPHONATE-TIN KIT
GE HEALTHCARE N/A
N017562 001
TECHNETIUM TC-99M FERPENTETATE KIT
INJECTABLE;INJECTION
RENOTEC
BRACCO N/A
N017045 001
TECHNETIUM TC-99M GLUCEPTATE KIT
INJECTABLE;INJECTION
GLUCOSCAN
BRISTOL MYERS SQUIBB N/A
N017907 001
TECHNESCAN GLUCEPTATE
DRAXIMAGE N/A
N018272 001 Jan 27, 1982
TECHNETIUM TC-99M LIDOFENIN KIT
INJECTABLE;INJECTION
TECHNESCAN HIDA
DRAXIMAGE N/A
N018489 001 Oct 31, 1986
TECHNETIUM TC-99M MEDRONATE
INJECTABLE;INJECTION
DRAXIMAGE MDP-10
JUBILANT DRAXIMAGE N/A
N018035 001
TECHNETIUM TC-99M MEDRONATE KIT
INJECTABLE;INJECTION
AMERSCAN MDP KIT
GE HEALTHCARE N/A
N018335 001 Aug 05, 1982
OSTEOLITE
PHARMALUCENCE N/A
N017972 001
TECHNETIUM TC 99M MPI MDP
GE HEALTHCARE N/A
N018141 001
N/A
N018141 002 Jun 12, 1989
TECHNETIUM TC-99M PENTETATE KIT
INJECTABLE;INJECTION
MPI DTPA KIT - CHELATE
GE HEALTHCARE N/A
N017255 001
TECHNETIUM TC-99M PENTETATE KIT
GE HEALTHCARE N/A
N017264 002
TECHNETIUM TC-99M POLYPHOSPHATE KIT
INJECTABLE;INJECTION
SODIUM POLYPHOSPHATE-TIN KIT
GE HEALTHCARE N/A
N017664 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-306(of 337)
TECHNETIUM TC-99M PYRO/TRIMETA PHOSPHATES KIT
INJECTABLE;INJECTION
PYROLITE
PHARMALUCENCE N/A
N017684 001
TECHNETIUM TC-99M PYROPHOSPHATE KIT
INJECTABLE;INJECTION
PHOSPHOTEC
BRACCO N/A
N017680 001
TECHNETIUM TC-99M RED BLOOD CELL KIT
INJECTABLE;INJECTION
RBC-SCAN
CADEMA N/A
N020063 001 Jun 11, 1992
TECHNETIUM TC-99M SESTAMIBI KIT
INJECTABLE;INJECTION
MIRALUMA
LANTHEUS MEDCL N/A
N019785 003 May 23, 1997
TECHNETIUM TC-99M SODIUM PERTECHNETATE
SOLUTION;INJECTION, ORAL
SODIUM PERTECHNETATE TC 99M
GE HEALTHCARE 2-100mCi/ML **Federal Register notice
N017471 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
MALLINCKRODT 10-60mCi/ML **Federal Register
N017725 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
PHARMALUCENCE 12mCi/ML
N017321 001
24mCi/ML
N017321 002
48mCi/ML
N017321 003
TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
SOLUTION;INJECTION, ORAL
MINITEC
BRACCO 0.22-2.22 CI/GENERATOR
N017339 001
SOLUTION;INTRAVENOUS
TECHNELITE
LANTHEUS MEDCL 0.0083-2.7 CI/GENERATOR
N017771 001
ULTRA-TECHNEKOW FM
MALLINCKRODT 0.25-3 CI/GENERATOR
N017243 002
SOLUTION;INTRAVENOUS, ORAL
TECHNETIUM TC 99M GENERATOR
GE HEALTHCARE 830-16600mCi/GENERATOR
N017693 001
TECHNETIUM TC-99M SULFUR COLLOID
SOLUTION;INJECTION, ORAL
TECHNETIUM TC 99M SULFUR COLLOID
GE HEALTHCARE 4mCi/ML
N017456 001
SOLUTION;ORAL
TECHNETIUM TC 99M SULFUR COLLOID
MALLINCKRODT 3mCi/ML
N017724 001
TECHNETIUM TC-99M SULFUR COLLOID KIT
SOLUTION;INJECTION, ORAL
TECHNECOLL
MALLINCKRODT N/A
N017059 001
TECHNETIUM TC 99M TSC
GE HEALTHCARE N/A
N017784 001
TESULOID
BRACCO N/A
N016923 001
TECHNETIUM TC-99M TEBOROXIME KIT
INJECTABLE;INJECTION
CARDIOTEC
BRACCO N/A
N019928 001 Dec 19, 1990
TEGASEROD MALEATE
TABLET;ORAL
ZELNORM
NOVARTIS EQ 2MG BASE
N021200 001 Jul 24, 2002
EQ 6MG BASE
N021200 002 Jul 24, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-307(of 337)
TELBIVUDINE
SOLUTION;ORAL
TYZEKA
NOVARTIS 100MG/5ML N022154 001 Apr 28, 2009
TEMAZEPAM
CAPSULE;ORAL
TEMAZ
QUANTUM PHARMICS 15MG A070564 001 Oct 15, 1985
30MG A070547 001 Oct 15, 1985
TEMAZEPAM
DURAMED PHARMS BARR 15MG A071708 001 Sep 29, 1988
30MG A071709 001 Sep 29, 1988
MUTUAL PHARM 15MG A071174 001 Jul 10, 1986
30MG A071175 001 Jul 10, 1986
USL PHARMA 15MG A070489 001 Jul 07, 1986
30MG A070490 001 Jul 07, 1986
WATSON LABS 15MG A070383 001 Mar 23, 1987
15MG A071446 001 May 21, 1993
30MG A070384 001 Mar 23, 1987
30MG A071447 001 May 21, 1993
TERAZOSIN HYDROCHLORIDE
CAPSULE;ORAL
HYTRIN
ABBOTT EQ 1MG BASE **Federal Register N020347 001 Dec 14, 1994
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 2MG BASE **Federal Register N020347 002 Dec 14, 1994
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 5MG BASE **Federal Register N020347 003 Dec 14, 1994
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 10MG BASE **Federal Register N020347 004 Dec 14, 1994
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
TERAZOSIN HYDROCHLORIDE
MYLAN TECHNOLOGIES EQ 1MG BASE A075384 001 Dec 01, 2000
EQ 2MG BASE A075384 002 Dec 01, 2000
EQ 5MG BASE A075384 003 Dec 01, 2000
EQ 10MG BASE A075384 004 Dec 01, 2000
RANBAXY LABS LTD EQ 1MG BASE A076021 001 Aug 22, 2002
EQ 2MG BASE A076021 002 Aug 22, 2002
EQ 5MG BASE A076021 003 Aug 22, 2002
EQ 10MG BASE A076021 004 Aug 22, 2002
SANDOZ EQ 1MG BASE A075667 001 Jul 28, 2000
EQ 2MG BASE A075667 002 Jul 28, 2000
EQ 5MG BASE A075667 003 Jul 28, 2000
EQ 10MG BASE A075667 004 Jul 28, 2000
TABLET;ORAL
HYTRIN
ABBOTT EQ 1MG BASE N019057 001 Aug 07, 1987
EQ 2MG BASE N019057 002 Aug 07, 1987
EQ 5MG BASE N019057 003 Aug 07, 1987
EQ 10MG BASE N019057 004 Aug 07, 1987
TERAZOSIN HYDROCHLORIDE
IVAX SUB TEVA PHARMS EQ 1MG BASE A074530 001 Apr 21, 2000
EQ 2MG BASE A074530 002 Apr 21, 2000
EQ 5MG BASE A074530 003 Apr 21, 2000
EQ 10MG BASE A074530 004 Apr 21, 2000
SANDOZ EQ 1MG BASE A074315 001 Dec 31, 1998
EQ 1MG BASE A074657 001 Apr 28, 2000
EQ 2MG BASE A074315 002 Dec 31, 1998
EQ 2MG BASE A074657 002 Apr 28, 2000
EQ 5MG BASE A074315 003 Dec 31, 1998
EQ 5MG BASE A074657 003 Apr 28, 2000
EQ 10MG BASE A074315 004 Dec 31, 1998
EQ 10MG BASE A074657 004 Apr 28, 2000
TEVA EQ 1MG BASE A074446 001 May 18, 2000
EQ 2MG BASE A074446 002 May 18, 2000
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-308(of 337)
TERAZOSIN HYDROCHLORIDE
TABLET;ORAL
TERAZOSIN HYDROCHLORIDE
EQ 5MG BASE
A074446 003 May 18, 2000
EQ 10MG BASE
A074446 004 May 18, 2000
TERBINAFINE
GEL;TOPICAL
LAMISIL
NOVARTIS
1%
N020846 001 Apr 29, 1998
TERBINAFINE HYDROCHLORIDE
CREAM;TOPICAL
LAMISIL
NOVARTIS
1%
N020192 001 Dec 30, 1992
SOLUTION;TOPICAL
LAMISIL
NOVARTIS
1%
N020749 001 Oct 17, 1997
TABLET;ORAL
TERBINAFINE HYDROCHLORIDE
GEDEON RICHTER USA
EQ 250MG BASE
A077065 001 Jul 02, 2007
MYLAN
EQ 250MG BASE
A077136 001 Jul 02, 2007
ROXANE
EQ 250MG BASE
A077223 001 Jul 02, 2007
TERBUTALINE SULFATE
AEROSOL, METERED;INHALATION
BRETHAIRE
NOVARTIS
0.2MG/INH
N018762 001 Aug 17, 1984
BRICANYL
SANOFI AVENTIS US
0.2MG/INH
N018000 001 Mar 19, 1985
INJECTABLE;INJECTION
BRETHINE
AAIPHARMA LLC
1MG/ML
N018571 001
BRICANYL
SANOFI AVENTIS US
1MG/ML
N017466 001
TERBUTALINE SULFATE
TEVA PHARMS USA
1MG/ML
A076853 001 Jul 20, 2004
TABLET;ORAL
BRETHINE
LEHIGH VALLEY
2.5MG
N017849 001
5MG
N017849 002
BRICANYL
SANOFI AVENTIS US
2.5MG
N017618 001
5MG
N017618 002
TERCONAZOLE
SUPPOSITORY;VAGINAL
TERCONAZOLE
FOUGERA PHARMS
80MG
A076850 001 Jul 12, 2006
TARO
80MG
A077553 001 Mar 09, 2007
TERIPARATIDE ACETATE
INJECTABLE;INJECTION
PARATHAR
SANOFI AVENTIS US
200 UNITS/VIAL
N019498 001 Dec 23, 1987
TERIPARATIDE RECOMBINANT HUMAN
INJECTABLE;SUBCUTANEOUS
FORTEO
LILLY
0.75MG/3ML (0.25MG/ML)
N021318 001 Nov 26, 2002
TESAMORELIN ACETATE
POWDER;SUBCUTANEOUS
EGRIFTA
THERATECHNOLOGIES
EQ 2MG BASE/VIAL
N022505 002 Nov 29, 2011
TESTOLACTONE
INJECTABLE;INJECTION
TESLAC
BRISTOL MYERS SQUIBB
100MG/ML
N016119 001
TABLET;ORAL
TESLAC
BRISTOL MYERS SQUIBB
50MG
N016118 001
250MG
N016118 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-309(of 337)
TESTOSTERONE
FILM, EXTENDED RELEASE;TRANSDERMAL
ANDRODERM
ACTAVIS LABS UT INC
2.5MG/24HR
N020489 001 Sep 29, 1995
5MG/24HR
N020489 002 May 02, 1997
TESTODERM
ALZA
4MG/24HR
N019762 001 Oct 12, 1993
6MG/24HR
N019762 002 Oct 12, 1993
TESTODERM TTS
ALZA
5MG/24HR
N020791 001 Dec 18, 1997
GEL;TRANSDERMAL
TESTOSTERONE
PAR PHARM
1% (2.5GM/PACKET)
A076744 001 May 23, 2007
1% (5GM/PACKET)
A076744 002 May 23, 2007
WATSON LABS
1% (2.5GM/PACKET)
A076737 001 Jan 27, 2006
1% (5GM/PACKET)
A076737 002 Jan 27, 2006
INJECTABLE;INJECTION
TESTOSTERONE
WATSON LABS
25MG/ML
A086420 001 May 10, 1983
50MG/ML
A086419 001 Aug 23, 1983
100MG/ML
A086417 001 Jul 07, 1983
TESTOSTERONE CYPIONATE
INJECTABLE;INJECTION
DEPO-TESTOSTERONE
PHARMACIA AND UPJOHN
50MG/ML
A085635 001
TESTOSTERONE CYPIONATE
WATSON LABS
100MG/ML
A084401 001
100MG/ML
A086029 001
200MG/ML
A084401 002
TESTOSTERONE ENANTHATE
INJECTABLE;INJECTION
DELATESTRYL
ENDO PHARMS
200MG/ML
N009165 001
TESTOSTERONE ENANTHATE
WATSON LABS
100MG/ML
A083667 001
100MG/ML
A085599 001
200MG/ML
A083667 002
TESTOSTERONE PROPIONATE
INJECTABLE;INJECTION
TESTOSTERONE PROPIONATE
BEL MAR
25MG/ML
A080741 001
50MG/ML
A080742 001
100MG/ML
A080743 001
ELKINS SINN
25MG/ML
A080276 001
LILLY
50MG/ML
A080254 002
WATSON LABS
25MG/ML
A080188 001
25MG/ML
A085490 001
50MG/ML
A080188 002
50MG/ML
A085490 002
100MG/ML
A080188 003
100MG/ML
A083595 003
TETRACYCLINE HYDROCHLORIDE
CAPSULE;ORAL
BRISTACYCLINE
BRISTOL
250MG
A061658 001
250MG
A061888 001
500MG
A061658 002
500MG
A061888 002
CYCLOPAR
WARNER CHILCOTT
250MG
A061725 001
250MG
A062175 001
250MG
A062332 001
500MG
A061725 002
500MG
A062332 002
PANMYCIN
PHARMACIA AND UPJOHN
250MG
A060347 001
RETET
SOLVAY
250MG
A061443 001
500MG
A061443 002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-310(of 337)
TETRACYCLINE HYDROCHLORIDE
CAPSULE;ORAL
ROBITET
WYETH AYERST 250MG
A061734 001
500MG
A061734 002
SUMYCIN
APOTHECON 100MG
A060429 002
125MG
A060429 004
250MG
A060429 001
500MG
A060429 003
TETRACHEL
ANGUS 250MG
A060343 001
500MG
A060343 003
TETRACYCLINE HYDROCHLORIDE
ABBOTT 250MG
A061802 001
500MG
A061802 002
ELKINS SINN 250MG
A060059 001
FERRANTE 125MG
A060173 001
250MG
A060173 002
HEATHER 250MG
A061148 001
500MG
A061148 002
HIKMA PHARMS LLC 250MG
A060768 001
500MG
A060768 002
LABS ATRAL 250MG
A062752 001 Aug 12, 1988
500MG
A062752 002 Aug 12, 1988
MAST MM 250MG
A062085 001
MUTUAL PHARM 250MG
A060736 001
500MG
A060736 002
MYLAN 250MG
A060783 001
500MG
A060783 002
PUREPAC PHARM 250MG
A060290 001
500MG
A060290 002
PVT FORM 250MG
A062686 001 Jul 24, 1986
500MG
A062686 002 Jul 24, 1986
ROXANE 500MG
A061214 002
SANDOZ 250MG
A061471 001
SUPERPHARM 250MG
A062540 001 Mar 21, 1985
500MG
A062540 002 Mar 21, 1985
VALEANT PHARM INTL 250MG
A060471 001
500MG
A060471 002
WARNER CHILCOTT 250MG
A062300 001
500MG
A062300 002
WATSON LABS 250MG
A062103 001
250MG
A062343 001
500MG
A062103 002
500MG
A062343 002
WYETH AYERST 250MG
A061685 001
500MG
A061685 002
TETRACYN
PFIPHARMECS 250MG
A060082 003
500MG
A060082 004
FIBER, EXTENDED RELEASE;PERIODONTAL
ACTISITE
SCHIFF AND CO 12.7MG/FIBER
N050653 001 Mar 25, 1994
FOR SOLUTION;TOPICAL
TOPICYCLINE
SHIRE 2.2MG/ML
N050493 001
INJECTABLE;INJECTION
ACHROMYCIN
LEDERLE 250MG/VIAL
N050273 002
500MG/VIAL
N050273 003
TETRACYN
PFIZER 250MG/VIAL
A060096 001
500MG/VIAL
A060096 002
OINTMENT;OPHTHALMIC
ACHROMYCIN
STORZ 10MG/GM
N050266 001
SUSPENSION;ORAL
ACHROMYCIN V
LEDERLE 125MG/5ML
N050263 002
SUMYCIN
PAR PHARM 125MG/5ML
A060400 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-311(of 337)
TETRACYCLINE HYDROCHLORIDE
SUSPENSION;ORAL
TETRACYCLINE HYDROCHLORIDE
ALPHARMA US PHARMS
125MG/5ML
A060633 001
FERRANTE
125MG/5ML
A060174 001
PROTER
125MG/5ML
A060446 001
PUREPAC PHARM
125MG/5ML
A060291 001
TETRACYN
PFIPHARMECS
125MG/5ML
A060095 001
TETRAMED
IVAX SUB TEVA PHARMS
125MG/5ML
A061468 001
SUSPENSION/DROPS;OPHTHALMIC
ACHROMYCIN
STORZ
1%
N050268 001
TABLET;ORAL
PANMYCIN
PHARMACIA AND UPJOHN
250MG
A061705 001
500MG
A061705 002
SUMYCIN
PAR PHARM
50MG
A061147 003
100MG
A061147 002
250MG
A061147 001
500MG
A061147 004
TETRACYCLINE PHOSPHATE COMPLEX
CAPSULE;ORAL
TETREX
BRISTOL
EQ 100MG HCL
A061653 001
EQ 250MG HCL
A061653 002
EQ 250MG HCL
A061889 002
EQ 250MG HCL
N050212 002
EQ 500MG HCL
A061653 003
EQ 500MG HCL
A061889 001
EQ 500MG HCL
N050212 003
THALLOUS CHLORIDE TL-201
INJECTABLE;INJECTION
THALLOUS CHLORIDE TL 201
BRACCO
1mCi/ML
N018548 001 Dec 30, 1982
TRACE LIFE
1mCi/ML
A075569 001 Nov 21, 2001
INJECTABLE;INTRAVENOUS
THALLOUS CHLORIDE TL 201
MALLINCKRODT
2mCi/ML
A077698 001 Nov 09, 2006
THEOPHYLLINE
CAPSULE;ORAL
BRONKODYL
SANOFI AVENTIS US
100MG
A085264 001
200MG
A085264 002
ELIXOPHYLLIN
FOREST LABS
100MG
A085545 001 Jul 31, 1984
200MG
A083921 001 Jul 31, 1984
SOMOPHYLLIN-T
FISONS
100MG
A087155 001 Feb 25, 1985
200MG
A087155 002 Feb 25, 1985
250MG
A087155 003 Feb 25, 1985
THEOPHYLLINE
KV PHARM
100MG
A085263 001
200MG
A085263 002
SCHERER RP
100MG
A084731 002 Nov 07, 1986
200MG
A084731 001 Nov 07, 1986
250MG
A084731 003 Nov 07, 1986
CAPSULE, EXTENDED RELEASE;ORAL
AEROLATE III
FLEMING PHARMS
65MG
A085075 003 Nov 24, 1986
AEROLATE JR
FLEMING PHARMS
130MG
A085075 002 Nov 24, 1986
AEROLATE SR
FLEMING PHARMS
260MG
A085075 001 Nov 24, 1986
ELIXOPHYLLIN SR
FOREST LABS
125MG
A086826 001 Jan 29, 1985
250MG
A086826 002 Jan 29, 1985
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-312(of 337)
THEOPHYLLINE
CAPSULE, EXTENDED RELEASE;ORAL
SLO-BID
SANOFI AVENTIS US 50MG A088269 001 Jan 31, 1985
75MG A089539 001 May 10, 1989
100MG A087892 001 Jan 31, 1985
125MG A089540 001 May 10, 1989
200MG A087893 001 Jan 31, 1985
300MG A087894 001 Jan 31, 1985
SLO-PHYLLIN
SANOFI AVENTIS US 60MG A085206 001 May 24, 1982
125MG A085203 001 May 24, 1982
250MG A085205 001 May 24, 1982
SOMOPHYLLIN-CRT
GRAHAM DM 50MG A087763 001 Feb 27, 1985
100MG A087194 001
200MG A088382 001 Feb 27, 1985
250MG A087193 001
300MG A088383 001 Feb 27, 1985
THEO-DUR
SCHERING 50MG A088022 001 Sep 10, 1985
75MG A088015 001 Sep 10, 1985
125MG A088016 001 Sep 10, 1985
200MG A087995 001 Sep 10, 1985
THEOBID
WHITBY 260MG A085983 001 Mar 20, 1985
THEOBID JR.
WHITBY 130MG A087854 001 Mar 20, 1985
THEOCLEAR L.A.-130
SCHWARZ PHARMA 130MG A086569 001 May 27, 1982
THEOCLEAR L.A.-260
SCHWARZ PHARMA 260MG A086569 002 May 27, 1982
THEOPHYL-SR
ORTHO MCNEIL PHARM 125MG A086480 001 Feb 08, 1985
250MG A086471 001 Feb 08, 1985
THEOPHYLLINE
CENT PHARMS 125MG A088654 001 Feb 12, 1985
250MG A088689 001 Feb 12, 1985
HOSPIRA 100MG A089976 001 Jan 04, 1995
200MG A089977 001 Jan 04, 1995
300MG A089932 001 Jan 04, 1995
INWOOD LABS 100MG A040052 001 Feb 14, 1994
125MG A040052 002 Feb 14, 1994
200MG A040052 003 Feb 14, 1994
300MG A040052 004 Feb 14, 1994
SANDOZ 260MG A087462 001 May 11, 1982
THEOPHYLLINE-SR
SCHERER RP 300MG A088255 001 Jun 12, 1986
THEOVENT
SCHERING 125MG A087010 001 Jan 31, 1985
250MG A087910 001 Jan 31, 1985
ELIXIR;ORAL
ELIXOMIN
CENCI 80MG/15ML A088303 001 Jan 25, 1984
LANOPHYLLIN
LANNETT 80MG/15ML A084578 001
THEOLIXIR
PANRAY 80MG/15ML A084559 001
THEOPHYL-225
ORTHO MCNEIL PHARM 112.5MG/15ML A086485 001
THEOPHYLLINE
ALPHARMA US PHARMS 80MG/15ML A089223 001 May 27, 1988
CENCI 80MG/15ML A087679 001 Apr 15, 1982
HALSEY 80MG/15ML A085169 001
PERRIGO 80MG/15ML A085952 001
PHARM ASSOC 80MG/15ML A086720 001
PRECISION DOSE 80MG/15ML A085863 001
ROXANE 80MG/15ML A084739 001
TARO 80MG/15ML A089626 001 Oct 28, 1988
WOCKHARDT 80MG/15ML A086748 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-313(of 337)
THEOPHYLLINE
INJECTABLE;INJECTION
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 40MG/100ML N019083 001 Nov 07, 1984
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 80MG/100ML N019083 002 Nov 07, 1984
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 160MG/100ML N019083 003 Nov 07, 1984
THEOPHYLLINE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 200MG/100ML N019212 001 Nov 07, 1984
200MG/100ML N019826 004 Aug 14, 1992
THEOPHYLLINE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER
B BRAUN 4MG/ML N019212 003 Nov 07, 1984
400MG/100ML N019212 002 Nov 07, 1984
400MG/100ML N019826 005 Aug 14, 1992
THEOPHYLLINE AND DEXTROSE 5% IN PLASTIC CONTAINER
BAXTER HLTHCARE 4MG/ML N018649 007 Jul 26, 1982
40MG/100ML N018649 001 Jul 26, 1982
80MG/100ML N018649 002 Jul 26, 1982
160MG/100ML N018649 003 Jul 26, 1982
200MG/100ML N018649 004 Jul 26, 1982
320MG/100ML N018649 006 Nov 13, 1985
400MG/100ML N018649 005 Jul 26, 1982
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER
HOSPIRA INC 80MG/100ML N019211 002 Dec 14, 1984
200MG/100ML N019211 004 Dec 14, 1984
400MG/100ML N019211 005 Dec 14, 1984
SOLUTION;ORAL
AEROLATE
FLEMING PHARMS 150MG/15ML A089141 001 Dec 03, 1986
THEOLAIR
3M 80MG/15ML A086107 001
THEOPHYLLINE
ROXANE 80MG/15ML A087449 001 Sep 15, 1983
SUSPENSION;ORAL
ELIXICON
FOREST LABS 100MG/5ML A085502 001
SYRUP;ORAL
ACCURBRON
SANOFI AVENTIS US 150MG/15ML A088746 001 Nov 22, 1985
AQUAPHYLLIN
FERNDALE LABS 80MG/15ML A087917 001 Jan 18, 1983
SLO-PHYLLIN
SANOFI AVENTIS US 80MG/15ML A085187 001
THEOCLEAR-80
CENT PHARMS 80MG/15ML A087095 001 Mar 01, 1982
THEOPHYLLINE
ALPHARMA US PHARMS 80MG/15ML A086001 001
150MG/15ML A086545 001
TABLET;ORAL
QUIBRON-T
MONARCH PHARMS 300MG A088656 001 Aug 22, 1985
SLO-PHYLLIN
SANOFI AVENTIS US 100MG A085202 001
200MG A085204 001
THEOCLEAR-100
CENT PHARMS 100MG A085353 002
THEOCLEAR-200
CENT PHARMS 200MG A085353 001
THEOPHYL-225
ORTHO MCNEIL PHARM 225MG A084726 001
TABLET, CHEWABLE;ORAL
THEOPHYL
ORTHO MCNEIL PHARM 100MG A086506 001 Sep 12, 1985
TABLET, EXTENDED RELEASE;ORAL
DURAPHYL
FOREST LABS 100MG A088503 001 Apr 03, 1985
200MG A088504 001 Apr 03, 1985
300MG A088505 001 Apr 03, 1985
LABID
WARNER CHILCOTT 250MG A087225 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-314(of 337)
THEOPHYLLINE
TABLET, EXTENDED RELEASE;ORAL
QUIBRON-T/SR
MONARCH PHARMS
300MG
A087563 001 Jun 21, 1983
SUSTAIRE
ROERIG
100MG
A085665 001
300MG
A085665 002
T-PHYL
PHARM RES ASSOC
200MG
A088253 001 Aug 17, 1983
THEO-DUR
SCHERING
100MG
A085328 001
200MG
A086998 001
300MG
A085328 002
450MG
A089131 001 Jun 25, 1986
THEOCHRON
SUN PHARM INDS INC
300MG
A087400 002 Jan 11, 1983
THEOLAIR-SR
3M
200MG
A088369 001 Jul 16, 1987
250MG
A086363 002 Jul 16, 1987
300MG
A088364 001 Jul 16, 1987
500MG
A089132 001 Jul 16, 1987
THEOPHYLLINE
ABLE
300MG
A040548 001 Apr 30, 2004
400MG
A040543 001 Apr 27, 2004
450MG
A040546 001 Apr 30, 2004
600MG
A040539 001 Apr 27, 2004
INWOOD LABS
450MG
A040034 001 Apr 28, 1995
UNI-DUR
SCHERING
400MG
A089822 001 Jan 04, 1995
600MG
A089823 001 Jan 04, 1995
THEOPHYLLINE SODIUM GLYCINATE
ELIXIR;ORAL
SYNOPHYLATE
CENT PHARMS
EQ 165MG BASE/15ML
N006333 008
TABLET;ORAL
ASBRON
NOVARTIS
EQ 150MG BASE
A085148 001
THIABENDAZOLE
SUSPENSION;ORAL
MINTEZOL
MERCK SHARP DOHME
500MG/5ML
N016097 001
TABLET, CHEWABLE;ORAL
MINTEZOL
MERCK SHARP DOHME
500MG
N016096 001
THIAMINE HYDROCHLORIDE
INJECTABLE;INJECTION
BETALIN S
LILLY
100MG/ML
A080853 001
THIAMINE HYDROCHLORIDE
ABRAXIS PHARM
100MG/ML
A080509 001
AKORN
100MG/ML
A087968 001 Oct 01, 1982
BEL MAR
100MG/ML
A080718 001
200MG/ML
A080712 001
DELL LABS
100MG/ML
A083775 001
HIKMA MAPLE
100MG/ML
A080575 001
HOSPIRA
100MG/ML
A040079 001 May 03, 1996
LUITPOLD
100MG/ML
A080667 001
PARKE DAVIS
100MG/ML
A080770 001
WATSON LABS
100MG/ML
A080571 001
100MG/ML
A083534 001
200MG/ML
A080571 002
200MG/ML
A083534 002
WYETH AYERST
100MG/ML
A080553 001
THIAMYLAL SODIUM
INJECTABLE;INJECTION
SURITAL
PARKEDALE
1GM/VIAL
N007600 003
5GM/VIAL
N007600 005
10GM/VIAL
N007600 009
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DISCONTINUED DRUG PRODUCT LIST 6-315(of 337)
THIETHYLPERAZINE MALATE
INJECTABLE;INJECTION
TORECAN
NOVARTIS 5MG/ML N012754 002
THIETHYLPERAZINE MALEATE
SUPPOSITORY;RECTAL
TORECAN
NOVARTIS 10MG N013247 001
TABLET;ORAL
TORECAN
NOVARTIS 10MG N012753 001
THIOPENTAL SODIUM
SUSPENSION;RECTAL
PENTOTHAL
ABBOTT 400MG/GM N011679 001
THIORIDAZINE
SUSPENSION;ORAL
MELLARIL-S
NOVARTIS EQ 25MG HCL/5ML N017923 001
EQ 100MG HCL/5ML N017923 002
THIORIDAZINE HYDROCHLORIDE
CONCENTRATE;ORAL
MELLARIL
NOVARTIS 30MG/ML N011808 012
100MG/ML N011808 018
THIORIDAZINE HYDROCHLORIDE
ACTAVIS MID ATLANTIC 100MG/ML A088229 001 Aug 23, 1983
ALPHARMA US PHARMS 30MG/ML A087766 001 Apr 26, 1983
ANI PHARMS INC 100MG/ML A089603 001 Nov 09, 1987
HI TECH PHARMA 30MG/ML A040125 001 Aug 16, 1996
100MG/ML A040126 001 Aug 16, 1996
PHARM ASSOC 30MG/ML A040187 001 Aug 28, 1997
100MG/ML A040213 001 May 29, 1998
SANDOZ 30MG/ML A088307 001 Nov 23, 1983
100MG/ML A088308 001 Nov 23, 1983
TEVA PHARMS 30MG/ML A089602 001 Nov 09, 1987
WOCKHARDT 30MG/ML A088258 001 Jul 25, 1983
100MG/ML A088227 001 Jul 05, 1983
THIORIDAZINE HYDROCHLORIDE INTENSOL
ROXANE 30MG/ML A088941 001 Dec 16, 1985
100MG/ML A088942 001 Dec 16, 1985
TABLET;ORAL
MELLARIL
NOVARTIS 10MG N011808 003
15MG N011808 016
25MG N011808 006
50MG N011808 011
100MG N011808 009
150MG N011808 017
200MG N011808 015
THIORIDAZINE HYDROCHLORIDE
ANI PHARMS INC 10MG A088270 001 Apr 14, 1983
10MG A088493 001 May 17, 1985
15MG A088271 001 Apr 14, 1983
25MG A088272 001 Apr 14, 1983
50MG A088194 001 Apr 14, 1983
100MG A088273 001 Oct 03, 1983
100MG A088456 001 May 17, 1985
MUTUAL PHARM 10MG A088375 001 Nov 18, 1983
15MG A088461 001 Nov 18, 1983
25MG A087264 001 Nov 18, 1983
50MG A088370 001 Nov 18, 1983
100MG A088379 001 Nov 16, 1983
150MG A088737 001 Sep 26, 1984
200MG A088738 001 Oct 16, 1984
MYLAN 10MG A088332 001 Jun 27, 1983
25MG A088333 001 Jun 27, 1983
50MG A088334 001 Jun 27, 1983
100MG A088335 001 Nov 18, 1983
PAR PHARM 10MG A088351 001 Dec 05, 1983
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DISCONTINUED DRUG PRODUCT LIST
6-316(of 337)
THIORIDAZINE HYDROCHLORIDE
TABLET;ORAL
THIORIDAZINE HYDROCHLORIDE
15MG
A088352 001 Dec 05, 1983
25MG
A088336 001 Dec 05, 1983
50MG
A088322 001 Dec 05, 1983
100MG
A088480 001 Dec 29, 1983
150MG
A089764 001 Feb 09, 1988
200MG
A089765 001 Feb 09, 1988
ROXANE 10MG
A088663 001 Mar 15, 1984
25MG
A088664 001 Mar 15, 1984
50MG
A088665 001 Mar 15, 1984
100MG
A089048 001 Feb 26, 1985
SANDOZ 10MG
A088131 001 Aug 30, 1983
15MG
A088132 001 Aug 30, 1983
25MG
A088133 001 Aug 30, 1983
50MG
A088134 001 Aug 30, 1983
100MG
A088135 001 Nov 20, 1984
150MG
A088136 001 Sep 17, 1986
200MG
A088137 001 Sep 17, 1986
SUPERPHARM 10MG
A089103 001 Jul 02, 1985
25MG
A089104 001 Jul 02, 1985
50MG
A089105 001 Jul 02, 1985
WATSON LABS 10MG
A088412 001 Sep 12, 1983
10MG
A088476 001 Nov 08, 1983
10MG
A088561 001 May 11, 1984
15MG
A088345 001 Jul 28, 1983
15MG
A088477 001 Nov 08, 1983
15MG
A088562 001 May 11, 1984
25MG
A088296 001 Jul 28, 1983
25MG
A088478 001 Nov 08, 1983
25MG
A088567 001 May 11, 1984
25MG
A088755 001 Jul 24, 1984
50MG
A088323 001 Jul 28, 1983
50MG
A088479 001 Nov 08, 1983
50MG
A088563 001 May 11, 1984
100MG
A088284 001 Aug 25, 1983
100MG
A088564 001 May 11, 1984
100MG
A088736 001 Jul 24, 1984
150MG
A088410 001 Mar 05, 1984
150MG
A088869 001 Jun 28, 1985
200MG
A088381 001 Mar 14, 1984
200MG
A088872 001 Apr 26, 1985
WEST WARD 10MG
A088658 001 Mar 26, 1984
15MG
A088659 001 Mar 26, 1984
25MG
A088660 001 Mar 26, 1984
50MG
A088661 001 Mar 26, 1984
THIOTEPA
INJECTABLE;INJECTION
THIOPLEX
IMMUNEX 15MG/VIAL
N020058 001 Dec 22, 1994
THIOTEPA
FRESENIUS KABI USA 15MG/VIAL
A075698 001 Sep 20, 2001
IMMUNEX 15MG/VIAL
N011683 001
TEVA PARENTERAL 15MG/VIAL
A075730 001 Apr 20, 2001
30MG/VIAL
A075730 002 Apr 20, 2001
THIOTHIXENE
CAPSULE;ORAL
NAVANE
PFIZER 20MG
N016584 005
THIOTHIXENE
AM THERAP 1MG
A071884 001 Aug 12, 1987
2MG
A071885 001 Aug 12, 1987
5MG
A071886 001 Aug 12, 1987
10MG
A071887 001 Aug 12, 1987
20MG
A072200 001 Dec 17, 1987
WATSON LABS 1MG
A070600 001 Jun 05, 1987
2MG
A070601 001 Jun 05, 1987
2MG
A071626 001 Jun 25, 1987
5MG
A070602 001 Jun 05, 1987
5MG
A071627 001 Jun 25, 1987
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-317(of 337)
THIOTHIXENE
CAPSULE;ORAL
THIOTHIXENE
10MG A070603 001 Jun 05, 1987
10MG A071628 001 Jun 25, 1987
THIOTHIXENE HYDROCHLORIDE
CONCENTRATE;ORAL
NAVANE
PFIZER EQ 5MG BASE/ML N016758 001
THIOTHIXENE HYDROCHLORIDE
ALPHARMA US PHARMS EQ 5MG BASE/ML A070969 001 Oct 16, 1987
PACO EQ 1MG BASE/ML A071917 001 Sep 20, 1989
EQ 5MG BASE/ML A071939 001 Dec 16, 1988
TEVA EQ 5MG BASE/ML A071184 001 Jun 22, 1987
TEVA PHARMS EQ 5MG BASE/ML A071554 001 Oct 16, 1987
THIOTHIXENE HYDROCHLORIDE INTENSOL
CYCLE PHARMS LTD EQ 5MG BASE/ML A073494 001 Jun 30, 1992
INJECTABLE;INJECTION
NAVANE
PFIZER EQ 2MG BASE/ML N016904 001
EQ 10MG BASE/VIAL N016904 002
THYROGLOBULIN
TABLET;ORAL
PROLOID
PARKE DAVIS 16MG N002245 009
32MG N002245 005
65MG N002245 002
100MG N002245 008
130MG N002245 010
200MG N002245 007
325MG N002245 004
THYROGLOBULIN
IMPAX LABS 64.8MG A080151 001
THYROTROPIN
INJECTABLE;INJECTION
THYTROPAR
SANOFI AVENTIS US 10 IU/VIAL N008682 001
TIAGABINE HYDROCHLORIDE
TABLET;ORAL
GABITRIL
CEPHALON 6MG N020646 006 Nov 29, 2005
8MG N020646 007 Nov 29, 2005
10MG N020646 008 Nov 29, 2005
20MG N020646 004 Sep 30, 1997
TICARCILLIN DISODIUM
INJECTABLE;INJECTION
TICAR
GLAXOSMITHKLINE EQ 1GM BASE/VIAL N050497 001
EQ 3GM BASE/VIAL A062690 001 Dec 19, 1986
EQ 3GM BASE/VIAL N050497 002
EQ 6GM BASE/VIAL N050497 003
EQ 20GM BASE/VIAL N050497 004
EQ 30GM BASE/VIAL N050497 005 Apr 04, 1984
TICLOPIDINE HYDROCHLORIDE
TABLET;ORAL
TICLID
ROCHE PALO 125MG N019979 001 Mar 24, 1993
250MG N019979 002 Oct 31, 1991
TICLOPIDINE HYDROCHLORIDE
ACTAVIS ELIZABETH 250MG A075253 001 Aug 20, 1999
MYLAN 250MG A075161 001 Sep 13, 1999
250MG A075316 001 Nov 02, 1999
SANDOZ 250MG A075318 001 Aug 20, 1999
250MG A075326 001 Aug 20, 1999
WATSON LABS 250MG A075309 001 Apr 26, 2000
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DISCONTINUED DRUG PRODUCT LIST 6-318(of 337)
TILUDRONATE DISODIUM
TABLET;ORAL
SKELID
SANOFI AVENTIS US EQ 200MG BASE N020707 001 Mar 07, 1997
TIMOLOL MALEATE
SOLUTION/DROPS;OPHTHALMIC
TIMOLOL MALEATE
AKORN EQ 0.25% BASE A074465 001 Mar 25, 1997
EQ 0.25% BASE A074515 001 Mar 25, 1997
APOTEX INC EQ 0.25% BASE A075411 001 Sep 08, 2000
EQ 0.5% BASE A075412 001 Sep 08, 2000
FOUGERA EQ 0.25% BASE A074667 001 Mar 25, 1997
EQ 0.5% BASE A074668 001 Mar 25, 1997
TABLET;ORAL
BLOCADREN
MERCK 5MG N018017 001
10MG N018017 002
20MG N018017 004
TIMOLOL MALEATE
QUANTUM PHARMICS 5MG A072466 001 May 19, 1989
10MG A072467 001 May 19, 1989
20MG A072468 001 May 19, 1989
SANDOZ 5MG A072550 001 Apr 13, 1989
10MG A072551 001 Apr 13, 1989
20MG A072552 001 Apr 13, 1989
TEVA 5MG A072648 001 Jun 16, 1993
10MG A072649 001 Jun 16, 1993
20MG A072650 001 Jun 16, 1993
USL PHARMA 5MG A072001 001 Apr 11, 1989
10MG A072002 001 Apr 11, 1989
20MG A072003 001 Apr 11, 1989
WATSON LABS 5MG A072269 001 Apr 11, 1989
5MG A072917 001 Jul 31, 1991
10MG A072270 001 Apr 11, 1989
10MG A072918 001 Jul 31, 1991
20MG A072271 001 Apr 11, 1989
20MG A072919 001 Jul 31, 1991
TINZAPARIN SODIUM
INJECTABLE;INJECTION
INNOHEP
LEO PHARMA AS 20,000 IU/ML N020484 001 Jul 14, 2000
TIOCONAZOLE
CREAM;TOPICAL
TZ-3
PFIZER 1% N018682 001 Feb 18, 1983
TIROFIBAN HYDROCHLORIDE
INJECTABLE;INJECTION
AGGRASTAT
MEDICURE EQ 12.5MG BASE/50ML (EQ 0.25MG BASE/ML) N020912 001 May 14, 1998
EQ 25MG BASE/500ML (EQ 0.05MG BASE/ML) N020913 001 May 14, 1998
TIZANIDINE HYDROCHLORIDE
TABLET;ORAL
TIZANIDINE HYDROCHLORIDE
ACTAVIS ELIZABETH EQ 2MG BASE A076283 001 Jul 12, 2002
EQ 4MG BASE A076283 002 Jul 12, 2002
BARR EQ 2MG BASE A076371 001 Apr 09, 2003
EQ 4MG BASE A076371 002 Apr 09, 2003
IVAX SUB TEVA PHARMS EQ 2MG BASE A076321 001 Sep 30, 2004
EQ 4MG BASE A076321 002 Sep 30, 2004
MYLAN PHARMS INC EQ 2MG BASE A076282 001 Dec 16, 2003
EQ 4MG BASE A076282 002 Dec 16, 2003
ZANAFLEX
ACORDA EQ 2MG BASE **Federal Register N020397 002 Feb 04, 2000
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-319(of 337)
TOBRAMYCIN
SOLUTION/DROPS;OPHTHALMIC
TOBRAMYCIN
ALCON PHARMS LTD 0.3% A063176 001 May 25, 1994
APOTEX INC 0.3% A065087 001 Feb 25, 2002
TOBRAMYCIN SULFATE
INJECTABLE;INJECTION
NEBCIN
LILLY EQ 1.2GM BASE/VIAL N050519 001
EQ 10MG BASE/ML A062008 004
EQ 10MG BASE/ML A062707 001 Apr 29, 1987
EQ 10MG BASE/ML N050477 005
EQ 40MG BASE/ML A062008 001
TOBRAMYCIN SULFATE
APOTHECON EQ 10MG BASE/ML A064021 001 May 31, 1994
EQ 40MG BASE/ML A064021 002 May 31, 1994
EQ 40MG BASE/ML A064026 001 May 31, 1994
ASTRAZENECA EQ 10MG BASE/ML A063119 001 Oct 31, 1994
EQ 40MG BASE/ML A063120 001 Oct 31, 1994
EQ 40MG BASE/ML A063121 001 Oct 31, 1994
EQ 40MG BASE/ML A063122 001 Oct 31, 1994
HIKMA MAPLE EQ 10MG BASE/ML A063113 001 Apr 26, 1991
EQ 10MG BASE/ML A063128 001 Nov 27, 1991
EQ 40MG BASE/ML A063118 001 Jul 29, 1991
EQ 40MG BASE/ML A063127 001 Nov 27, 1991
HOSPIRA EQ 10MG BASE/ML A063080 001 Apr 30, 1991
EQ 40MG BASE/ML A063161 001 May 29, 1991
WATSON LABS INC EQ 10MG BASE/ML A062945 001 Aug 09, 1989
EQ 40MG BASE/ML A062945 002 Aug 09, 1989
TOCAINIDE HYDROCHLORIDE
TABLET;ORAL
TONOCARD
ASTRAZENECA 400MG N018257 001 Nov 09, 1984
600MG N018257 002 Nov 09, 1984
TOLAZAMIDE
TABLET;ORAL
TOLAZAMIDE
BARR 100MG A070162 001 Jan 14, 1986
250MG A070163 001 Jan 14, 1986
500MG A070164 001 Jan 14, 1986
DURAMED PHARMS BARR 100MG A070165 001 Jan 10, 1986
250MG A070166 001 Jan 10, 1986
500MG A070167 001 Jan 10, 1986
INTERPHARM 250MG A071270 001 Sep 23, 1986
500MG A071271 001 Sep 23, 1986
IVAX SUB TEVA PHARMS 100MG N018894 001 Nov 02, 1984
250MG N018894 002 Nov 02, 1984
500MG N018894 003 Nov 02, 1984
MUTUAL PHARM 100MG A071357 001 Jul 16, 1987
250MG A071358 001 Jul 16, 1987
500MG A071359 001 Jul 16, 1987
PAR PHARM 100MG A070159 001 Jan 06, 1986
250MG A070160 001 Jan 06, 1986
500MG A070161 001 Jan 06, 1986
SANDOZ 100MG A071633 001 Dec 09, 1987
250MG A070289 001 Mar 13, 1986
500MG A070290 001 Mar 13, 1986
SUPERPHARM 250MG A070763 001 Jun 16, 1986
500MG A070764 001 Jun 16, 1986
USL PHARMA 100MG A071355 001 Jan 11, 1988
250MG A070168 001 Apr 02, 1986
500MG A070169 001 Apr 02, 1986
WATSON LABS 100MG A070242 001 Aug 01, 1986
100MG A070513 001 Jan 09, 1986
250MG A070243 001 Aug 01, 1986
250MG A070514 001 Jan 09, 1986
500MG A070244 001 Aug 01, 1986
500MG A070515 001 Jan 09, 1986
TOLINASE
PHARMACIA AND UPJOHN 100MG **Federal Register determination N015500 002
that product was not discontinued or
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-320(of 337)
TOLAZAMIDE
TABLET;ORAL
TOLINASE
withdrawn for safety or efficacy
reasons**
250MG
N015500 004
500MG
N015500 005
TOLAZOLINE HYDROCHLORIDE
INJECTABLE;INJECTION
PRISCOLINE
NOVARTIS
25MG/ML
N006403 005 Feb 22, 1985
TOLBUTAMIDE
TABLET;ORAL
ORINASE
PHARMACIA AND UPJOHN
250MG
N010670 002
500MG
N010670 001
TOLBUTAMIDE
ALRA
500MG
A086141 001
ASCOT
500MG
A087541 001 Mar 01, 1983
BARR
500MG
A087121 001
DAVA PHARMS INC
500MG
A086926 001
IVAX PHARMS
500MG
A087093 001
PARKE DAVIS
500MG
A086047 001
PUREPAC PHARM
500MG
A088950 001 Jun 17, 1985
SANDOZ
500MG
A086574 001
500MG
N012678 001
SUPERPHARM
500MG
A088893 001 Nov 19, 1984
VANGARD
500MG
A087876 001 Apr 20, 1982
WATSON LABS
250MG
A089110 001 May 29, 1987
500MG
A086109 001
500MG
A087318 001
500MG
A089111 001 May 29, 1987
TOLBUTAMIDE SODIUM
INJECTABLE;INJECTION
ORINASE DIAGNOSTIC
PHARMACIA AND UPJOHN
EQ 1GM BASE/VIAL
N012095 001
TOLCAPONE
TABLET;ORAL
TASMAR
VALEANT PHARMS LLC
200MG
N020697 002 Jan 29, 1998
TOLMETIN SODIUM
CAPSULE;ORAL
TOLECTIN DS
ORTHO MCNEIL JANSSEN
EQ 400MG BASE
N018084 001
TOLMETIN SODIUM
ACTAVIS ELIZABETH
EQ 400MG BASE
A073308 001 Jan 24, 1992
IVAX SUB TEVA PHARMS
EQ 400MG BASE
A073392 001 Jan 24, 1992
MUTUAL PHARM
EQ 400MG BASE
A073311 001 Nov 27, 1991
SANDOZ
EQ 400MG BASE
A073462 001 Apr 30, 1992
TEVA
EQ 400MG BASE
A073519 001 May 29, 1992
TABLET;ORAL
TOLECTIN
ORTHO MCNEIL JANSSEN
EQ 200MG BASE
N017628 001
TOLECTIN 600
ORTHO MCNEIL JANSSEN
EQ 600MG BASE
N017628 002 Mar 08, 1989
TOLMETIN SODIUM
ACTAVIS ELIZABETH
EQ 600MG BASE
A073527 001 Jun 30, 1992
IVAX SUB TEVA PHARMS
EQ 600MG BASE
A074399 001 Mar 28, 1996
SANDOZ
EQ 200MG BASE
A073588 001 Jul 31, 1992
EQ 600MG BASE
A074002 001 Sep 27, 1993
TEVA
EQ 600MG BASE
A074729 001 Feb 27, 1997
TOLVAPTAN
TABLET;ORAL
SAMSCA
OTSUKA AMERICA PHARM
60MG
N022275 003 May 19, 2009
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-321(of 337)
TOPIRAMATE
CAPSULE;ORAL
TOPAMAX SPRINKLE
JANSSEN PHARMS 50MG N020844 003 Oct 26, 1998
TOPIRAMATE
BARR 15MG A076448 001 Apr 15, 2009
25MG A076448 002 Apr 15, 2009
SANDOZ 15MG A079206 001 Oct 14, 2009
25MG A079206 002 Oct 14, 2009
TABLET;ORAL
TOPAMAX
JANSSEN PHARMS 300MG N020505 003 Dec 24, 1996
400MG N020505 006 Dec 24, 1996
TOPIRAMATE
BARR 25MG A076315 001 Mar 27, 2009
100MG A076315 002 Mar 27, 2009
200MG A076315 003 Mar 27, 2009
PLIVA HRVATSKA DOO 25MG A077905 001 Mar 30, 2009
50MG A077905 002 Mar 30, 2009
100MG A077905 003 Mar 30, 2009
200MG A077905 004 Mar 30, 2009
ROXANE 25MG A076306 001 Mar 27, 2009
50MG A076306 002 Mar 27, 2009
100MG A076306 003 Mar 27, 2009
200MG A076306 004 Mar 27, 2009
WATSON LABS 25MG A077643 001 Mar 27, 2009
50MG A077643 002 Mar 27, 2009
100MG A077643 003 Mar 27, 2009
200MG A077643 004 Mar 27, 2009
TOPOTECAN HYDROCHLORIDE
INJECTABLE;INJECTION
TOPOTECAN HYDROCHLORIDE
FRESENIUS KABI ONCOL EQ 4MG BASE/VIAL A091376 001 Nov 29, 2010
SOLUTION;INTRAVENOUS
TOPOTECAN
SANDOZ INC EQ 1MG BASE/ML (EQ 1MG BASE/ML) N200199 001 Feb 25, 2011
EQ 3MG BASE/3ML (EQ 1MG BASE/ML) N200199 002 Feb 25, 2011
EQ 4MG BASE/4ML (EQ 1MG BASE/ML) N200199 003 Feb 25, 2011
TORSEMIDE
INJECTABLE;INJECTION
DEMADEX
ROCHE 50MG/5ML (10MG/ML) N020137 002 Aug 23, 1993
20MG/2ML (10MG/ML) N020137 001 Aug 23, 1993
TRAMADOL HYDROCHLORIDE
TABLET;ORAL
TRAMADOL HYDROCHLORIDE
ACTAVIS ELIZABETH 50MG A075960 001 Jun 19, 2002
ASTA 50MG A075974 001 Jul 12, 2002
IVAX SUB TEVA PHARMS 50MG A075963 001 Jul 03, 2002
SANDOZ 50MG A075968 001 Jun 25, 2002
WATSON LABS 50MG A075962 001 Jun 24, 2002
ULTRAM
JANSSEN PHARMS 100MG N020281 001 Mar 03, 1995
TABLET, EXTENDED RELEASE;ORAL
RYZOLT
PURDUE PHARMA 100MG N021745 001 Dec 30, 2008
200MG N021745 002 Dec 30, 2008
300MG N021745 003 Dec 30, 2008
TABLET, ORALLY DISINTEGRATING;ORAL
RYBIX ODT
SHIONOGI INC 50MG N021693 001 May 05, 2005
TRANDOLAPRIL
TABLET;ORAL
TRANDOLAPRIL
CIPLA 1MG A077307 002 Jun 12, 2007
2MG A077307 001 Jun 12, 2007
4MG A077307 003 Jun 12, 2007
COREPHARMA 1MG A077256 001 Jun 12, 2007
2MG A077256 002 Jun 12, 2007
4MG A077256 003 Jun 12, 2007
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-322(of 337)
TRANDOLAPRIL
TABLET;ORAL
TRANDOLAPRIL
DR REDDYS LABS LTD 1MG A078493 001 Aug 25, 2008
2MG A078493 002 Aug 25, 2008
4MG A078493 003 Aug 25, 2008
TRANEXAMIC ACID
INJECTABLE;INJECTION
TRANEXAMIC ACID
FRESENIUS KABI USA 100MG/ML A091596 001 Mar 02, 2012
TABLET;ORAL
CYKLOKAPRON
PHARMACIA AND UPJOHN 500MG N019280 001 Dec 30, 1986
TRAVOPROST
SOLUTION/DROPS;OPHTHALMIC
TRAVATAN
ALCON PHARMS LTD 0.004% N021257 001 Mar 16, 2001
TRAZODONE HYDROCHLORIDE
TABLET;ORAL
DESYREL
APOTHECON 50MG N018207 001
100MG N018207 002
150MG N018207 003 Mar 25, 1985
300MG N018207 004 Nov 07, 1988
TRAZODONE HYDROCHLORIDE
AM THERAP 50MG A071139 001 Oct 29, 1986
100MG A071140 001 Oct 29, 1986
MYLAN 50MG A071405 001 Feb 27, 1991
100MG A071406 001 Feb 27, 1991
QUANTUM PHARMICS 100MG A070921 001 Dec 01, 1986
SANDOZ 50MG A072484 001 Apr 30, 1990
100MG A072483 001 Apr 30, 1990
TEVA 150MG A074357 001 Apr 30, 1997
USL PHARMA 50MG A070491 001 Apr 29, 1987
100MG A070492 001 Apr 29, 1987
WATSON LABS 50MG A070857 001 Oct 10, 1986
50MG A071112 001 Nov 17, 1986
100MG A070858 001 Oct 10, 1986
100MG A071113 001 Nov 17, 1986
TRIALODINE
QUANTUM PHARMICS 50MG A070942 001 Dec 01, 1986
TRETINOIN
CAPSULE;ORAL
VESANOID
ROCHE 10MG N020438 001 Nov 22, 1995
SOLUTION;TOPICAL
TRETINOIN
TEVA PHARMS 0.05% A074873 001 Jun 19, 1998
WOCKHARDT 0.05% A075260 001 Jan 25, 1999
SWAB;TOPICAL
RETIN-A
VALEANT INTL 0.05% N016921 002
TRIAMCINOLONE
TABLET;ORAL
ARISTOCORT
ASTELLAS 1MG N011161 009
2MG N011161 004
4MG N011161 007
8MG N011161 011
16MG N011161 010
KENACORT
DELCOR ASSET CORP 1MG N011283 003
2MG N011283 008
4MG N011283 006
8MG N011283 010
TRIAMCINOLONE
BARR 2MG A084286 001
2MG A084318 001
4MG A084267 001
4MG A084319 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-323(of 337)
TRIAMCINOLONE
TABLET;ORAL
TRIAMCINOLONE
8MG
A084268 001
8MG
A084320 001
IMPAX LABS
4MG
A084340 001
IVAX SUB TEVA PHARMS
4MG
A083750 001
MYLAN
2MG
A084406 001
PUREPAC PHARM
2MG
A084020 002
4MG
A084020 003
ROXANE
2MG
A084708 001
4MG
A084709 001
8MG
A084707 001
SANDOZ
4MG
A085601 001
TEVA
4MG
A084775 001
WATSON LABS
4MG
A084270 001
4MG
A085834 001
TRIAMCINOLONE ACETONIDE
AEROSOL, METERED;INHALATION
AZMACORT
ABBVIE
0.1MG/INH
N018117 001 Apr 23, 1982
AEROSOL, METERED;NASAL
NASACORT
SANOFI AVENTIS US
0.055MG/INH
N019798 001 Jul 11, 1991
CREAM;TOPICAL
ARISTOCORT
ASTELLAS
0.025%
A083017 003
0.1%
A083016 004
0.5%
A083015 002
ARISTOCORT A
ASTELLAS
0.025%
A083017 004
0.025%
A088818 001 Oct 16, 1984
0.1%
A083016 005
0.1%
A088819 001 Oct 16, 1984
0.5%
A083015 003
0.5%
A088820 001 Oct 16, 1984
FLUTEX
IVAX PHARMS
0.025%
A085539 001
0.1%
A085539 002
0.5%
A085539 003
KENALOG
DELCOR ASSET CORP
0.025%
N011601 003
0.1%
N011601 006
0.5%
A083943 001
KENALOG-H
DELCOR ASSET CORP
0.1%
A086240 001
TRIACET
TEVA
0.025%
A084908 001
0.1%
A084908 002
0.5%
A084908 003
TRIACORT
SOLVAY
0.1%
A087113 001
TRIAMCINOLONE ACETONIDE
ACTAVIS MID ATLANTIC
0.1%
A087798 001 Jun 04, 1982
ALPHARMA US PHARMS
0.025%
A087797 001 Jun 07, 1982
AMBIX
0.025%
A087932 001 May 09, 1983
G AND W LABS
0.025%
A089797 001 May 31, 1991
0.1%
A089798 001 May 31, 1991
MORTON GROVE
0.025%
A088094 001 Sep 01, 1983
0.1%
A088095 001 Sep 01, 1983
0.5%
A088096 001 Sep 01, 1983
PHARMADERM
0.025%
A087990 001 Jul 07, 1983
0.1%
A087991 001 Jul 07, 1983
0.5%
A087992 001 Jul 07, 1983
PHARMAFAIR
0.025%
A087921 001 Aug 10, 1982
0.1%
A087912 001 Aug 10, 1982
0.5%
A087922 001 Aug 10, 1982
TARO
0.025%
A040038 001 Oct 26, 1994
0.025%
A086277 001
0.1%
A086276 001
0.5%
A086275 001
TOPIDERM
0.025%
A089274 001 Feb 21, 1989
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-324(of 337)
TRIAMCINOLONE ACETONIDE
CREAM;TOPICAL
TRIAMCINOLONE ACETONIDE
0.1% A089275 001 Feb 21, 1989
0.5% A089276 001 Feb 21, 1989
TRIATEX
IVAX PHARMS 0.025% A087430 001 Nov 01, 1988
0.1% A087429 001 Nov 01, 1988
0.5% A087428 001 Nov 01, 1988
TRYMEX
SAVAGE LABS 0.025% A088196 001 Mar 25, 1983
0.1% A088197 001 Mar 25, 1983
0.5% A088198 001 Mar 25, 1983
GEL;TOPICAL
ARISTOGEL
ASTELLAS 0.1% A083380 001
INJECTABLE;INJECTION
TRIAMCINOLONE ACETONIDE
PARNELL 3MG/ML N019503 001 Oct 16, 1987
SANDOZ 10MG/ML A090166 001 May 27, 2009
SANDOZ CANADA INC 40MG/ML A090164 001 Jun 01, 2009
WATSON LABS 40MG/ML A085825 001
INJECTABLE;INTRA-ARTICULAR, INTRAMUSCULAR, INTRAVITREAL
TRIVARIS
ALLERGAN 8MG/0.1ML (8MG/0.1ML) N022220 001 Jun 16, 2008
LOTION;TOPICAL
KENALOG
DELCOR ASSET CORP 0.025% A084343 001
0.025% N011602 003
0.1% A084343 002
0.1% N011602 001
TRIAMCINOLONE ACETONIDE
ALPHARMA US PHARMS 0.025% A087191 001 Sep 08, 1982
0.1% A087192 001 Sep 08, 1982
G AND W LABS INC 0.1% A089129 001 Aug 14, 1986
OINTMENT;TOPICAL
ARISTOCORT
ASTELLAS 0.1% A080750 004
0.5% A080745 002
ARISTOCORT A
ASTELLAS 0.1% A080750 003
0.1% A088780 001 Oct 01, 1984
0.5% A080745 003
0.5% A088781 001 Oct 05, 1984
FLUTEX
IVAX PHARMS 0.025% A087375 001 Nov 01, 1988
0.1% A087377 001 Nov 01, 1988
0.5% A087376 001 Nov 01, 1988
KENALOG
DELCOR ASSET CORP 0.025% N011600 003
0.1% N011600 001
0.5% A083944 001
TRIAMCINOLONE ACETONIDE
ACTAVIS MID ATLANTIC 0.1% A087799 001 Jun 07, 1982
ALPHARMA US PHARMS 0.5% A089913 001 Dec 23, 1988
G AND W LABS 0.025% A089795 001 Dec 23, 1988
0.1% A089796 001 Dec 23, 1988
MORTON GROVE 0.025% A088090 001 Sep 01, 1983
0.1% A088091 001 Sep 01, 1983
0.5% A088092 001 Sep 01, 1983
PHARMADERM 0.025% A088692 001 Aug 02, 1984
0.1% A088690 001 Aug 02, 1984
TARO 0.025% A040040 001 Sep 30, 1994
0.025% A040374 001 Jun 05, 2001
0.1% A087902 001 Dec 27, 1982
0.5% A040386 001 Jun 05, 2001
TRYMEX
SAVAGE LABS 0.025% A088693 001 Aug 02, 1984
0.1% A088691 001 Aug 02, 1984
PASTE;DENTAL
KENALOG IN ORABASE
DELCOR ASSET CORP 0.1% N012097 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-325(of 337)
TRIAMCINOLONE ACETONIDE
PASTE;DENTAL
ORALONE
TARO 0.1%
A071383 001
Jul 06, 1987
SPRAY, METERED;NASAL
ALLERNAZE
LUPIN ATLANTIS 0.05MG/SPRAY
N020120 001
Feb 04, 2000
NASACORT HFA
SANOFI AVENTIS US 0.055MG/SPRAY
N020784 001
Apr 07, 2004
TRIAMCINOLONE DIACETATE
INJECTABLE;INJECTION
ARISTOCORT
SANDOZ 25MG/ML
N011685 003
40MG/ML **Federal Register
N012802 001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
TRIAMCINOLONE DIACETATE
AKORN 25MG/ML
A085122 001
40MG/ML
A086394 001
WATSON LABS 40MG/ML
A084072 001
40MG/ML
A085529 001
SYRUP;ORAL
ARISTOCORT
ASTELLAS 2MG/5ML
N011960 004
KENACORT
DELCOR ASSET CORP EQ 4MG BASE/5ML
N012515 001
TRIAZOLAM
TABLET;ORAL
HALCION
PHARMACIA AND UPJOHN 0.5MG
N017892 002
Nov 15, 1982
TRIAZOLAM
WATSON LABS 0.125MG
A074445 001
Oct 20, 1995
0.25MG
A074445 002
Oct 20, 1995
TRICHLORMETHIAZIDE
TABLET;ORAL
METAHYDRIN
SANOFI AVENTIS US 2MG
N012594 001
Jun 16, 1988
4MG
N012594 002
Jun 16, 1988
NAQUA
SCHERING 2MG
N012265 001
4MG
N012265 002
TRICHLOREX
LANNETT 4MG
A083436 001
4MG
A085630 001
TRICHLORMAS
MAST MM 4MG
A086259 001
TRICHLORMETHIAZIDE
IMPAX LABS 4MG
A083967 001
PAR PHARM 2MG
A087007 001
4MG
A087005 001
SANDOZ 4MG
A086171 001
TG UNITED LABS 4MG
A085568 001
WATSON LABS 2MG
A083847 001
2MG
A086458 001
4MG
A083462 001
4MG
A083855 001
4MG
A085962 001
TRICLOFOS SODIUM
SOLUTION;ORAL
TRICLOS
SANOFI AVENTIS US 1.5GM/15ML
N016830 001
TABLET;ORAL
TRICLOS
SANOFI AVENTIS US 750MG
N016809 002
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DISCONTINUED DRUG PRODUCT LIST
6-326(of 337)
TRIDIHEXETHYL CHLORIDE
INJECTABLE;INJECTION
PATHILON
LEDERLE
10MG/ML
N009729 001
TABLET;ORAL
PATHILON
LEDERLE
25MG
N009489 005
TRIFLUOPERAZINE HYDROCHLORIDE
CONCENTRATE;ORAL
STELAZINE
GLAXOSMITHKLINE
EQ 10MG BASE/ML
N011552 006
TRIFLUOPERAZINE HYDROCHLORIDE
SANDOZ
EQ 10MG BASE/ML
A085787 001 Apr 15, 1982
WOCKHARDT
EQ 10MG BASE/ML
A088143 001 Jul 26, 1983
INJECTABLE;INJECTION
STELAZINE
GLAXOSMITHKLINE
EQ 2MG BASE/ML
N011552 005
TABLET;ORAL
STELAZINE
GLAXOSMITHKLINE
EQ 1MG BASE
N011552 001
EQ 2MG BASE
N011552 002
EQ 5MG BASE
N011552 003
EQ 10MG BASE
N011552 004
TRIFLUOPERAZINE HYDROCHLORIDE
DURAMED PHARMS BARR
EQ 1MG BASE
A088967 001 Apr 23, 1985
EQ 2MG BASE
A088968 001 Apr 23, 1985
EQ 5MG BASE
A088969 001 Apr 23, 1985
EQ 10MG BASE
A088970 001 Apr 23, 1985
IVAX PHARMS
EQ 1MG BASE
A087612 001 Nov 19, 1982
EQ 2MG BASE
A087613 001 Nov 19, 1982
EQ 5MG BASE
A087328 001 Nov 19, 1982
EQ 10MG BASE
A087614 001 Nov 19, 1982
SANDOZ
EQ 1MG BASE
A040153 001 Oct 25, 1996
EQ 2MG BASE
A040153 002 Oct 25, 1996
EQ 5MG BASE
A040153 003 Oct 25, 1996
EQ 10MG BASE
A040153 004 Oct 25, 1996
WATSON LABS
EQ 1MG BASE
A085975 001 Jun 23, 1988
EQ 2MG BASE
A085976 001 Jun 23, 1988
EQ 5MG BASE
A085973 001 Jun 23, 1988
EQ 10MG BASE
A088710 001 Jun 23, 1988
TRIFLUPROMAZINE
SUSPENSION;ORAL
VESPRIN
APOTHECON
EQ 50MG HCL/5ML
N011491 004
TRIFLUPROMAZINE HYDROCHLORIDE
INJECTABLE;INJECTION
VESPRIN
APOTHECON
3MG/ML
N011325 005
10MG/ML
N011325 004
20MG/ML
N011325 001
TABLET;ORAL
VESPRIN
BRISTOL MYERS SQUIBB
10MG
N011123 001
25MG
N011123 002
50MG
N011123 003
TRIHEXYPHENIDYL HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
ARTANE
LEDERLE 5MG
N006773 010
5MG
N012947 001
ELIXIR;ORAL
ARTANE
LEDERLE 2MG/5ML
N006773 009
TRIHEXYPHENIDYL HYDROCHLORIDE
PHARM VENTURES 2MG/5ML
A089514 001 Apr 07, 1989
TABLET;ORAL
ARTANE
LEDERLE 2MG
N006773 005
5MG
N006773 003
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DISCONTINUED DRUG PRODUCT LIST
6-327(of 337)
TRIHEXYPHENIDYL HYDROCHLORIDE
TABLET;ORAL
TREMIN
SCHERING 2MG
A080381 001
5MG
A080381 003
TRIHEXYPHENIDYL HYDROCHLORIDE
HIKMA PHARMS LLC 2MG
A040337 002 Feb 16, 2000
5MG
A040337 001 Feb 16, 2000
NYLOS 5MG
A085622 001
VANGARD 2MG
A088035 001 Jul 30, 1982
WATSON LABS 2MG
A040184 001 Feb 06, 1998
2MG
A085117 001
5MG
A040184 002 Feb 06, 1998
5MG
A085105 001
TRILOSTANE
CAPSULE;ORAL
MODRASTANE
BIOENVISION 30MG
N018719 002 Dec 31, 1984
60MG
N018719 001 Dec 31, 1984
TRIMEPRAZINE TARTRATE
CAPSULE, EXTENDED RELEASE;ORAL
TEMARIL
ALLERGAN HERBERT
EQ 5MG BASE
N011316 004
SYRUP;ORAL
TEMARIL
ALLERGAN HERBERT
EQ 2.5MG BASE/5ML
N011316 003
TRIMEPRAZINE TARTRATE
ALPHARMA US PHARMS
EQ 2.5MG BASE/5ML
A085015 001 Feb 18, 1982
MORTON GROVE
EQ 2.5MG BASE/5ML
A088285 001 Apr 11, 1985
TABLET;ORAL
TEMARIL
ALLERGAN HERBERT
EQ 2.5MG BASE
N011316 001
TRIMETHADIONE
CAPSULE;ORAL
TRIDIONE
ABBVIE
300MG
N005856 005
SOLUTION;ORAL
TRIDIONE
ABBVIE
200MG/5ML
N005856 002
TRIMETHAPHAN CAMSYLATE
INJECTABLE;INJECTION
ARFONAD
ROCHE
50MG/ML
N008983 001
TRIMETHOBENZAMIDE HYDROCHLORIDE
INJECTABLE;INJECTION
TRIMETHOBENZAMIDE HYDROCHLORIDE
HOSPIRA
100MG/ML
A088804 001 Apr 03, 1987
SMITH AND NEPHEW
100MG/ML
A088960 001 Apr 04, 1986
100MG/ML
A089043 001 Apr 04, 1986
SOLOPAK
100MG/ML
A089094 001 Apr 04, 1986
WATSON LABS
100MG/ML
A086577 001 Oct 19, 1982
100MG/ML
A087939 001 Dec 28, 1982
TRIMETHOPRIM
TABLET;ORAL
PROLOPRIM
MONARCH PHARMS
100MG
N017943 001
200MG
N017943 003 Jul 14, 1982
TRIMETHOPRIM
MUTUAL PHARM
100MG
A070494 001 Jan 22, 1986
200MG
A070495 001 Sep 24, 1986
TEVA
200MG
A071259 001 Jun 18, 1987
TRIMPEX
ROCHE
100MG
N017952 001
TRIMPEX 200
ROCHE
200MG
N017952 002 Nov 09, 1982
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-328(of 337)
TRIMETHOPRIM HYDROCHLORIDE
SOLUTION;ORAL
PRIMSOL
FSC
EQ 25MG BASE/5ML
A074374 001 Jun 23, 1995
TRIMETREXATE GLUCURONATE
INJECTABLE;INJECTION
NEUTREXIN
MEDIMMUNE ONCOLOGY
EQ 25MG BASE/VIAL
N020326 001 Dec 17, 1993
EQ 200MG BASE/VIAL
N020326 002 Jul 31, 1998
TRIMIPRAMINE MALEATE
CAPSULE;ORAL
TRIMIPRAMINE MALEATE
USL PHARMA
EQ 25MG BASE
A071283 001 Dec 08, 1987
EQ 50MG BASE
A071284 001 Dec 08, 1987
EQ 100MG BASE
A071285 001 Dec 08, 1987
TRIOXSALEN
TABLET;ORAL
TRISORALEN
VALEANT PHARM INTL
5MG
N012697 001
TRIPELENNAMINE CITRATE
ELIXIR;ORAL
PBZ
NOVARTIS
EQ 25MG HCL/5ML
N005914 004
TRIPELENNAMINE HYDROCHLORIDE
TABLET;ORAL
PBZ
NOVARTIS
25MG
A083149 001
50MG
N005914 002
TRIPELENNAMINE HYDROCHLORIDE
ANABOLIC
50MG
A083037 001
BARR
50MG
A080744 001
HEATHER
50MG
A083989 001
IMPAX LABS
50MG
A080785 001
LANNETT
50MG
A083557 001
NYLOS
50MG
A085412 001
PARKE DAVIS
25MG
A083625 001
50MG
A083626 001
WATSON LABS
50MG
A080713 001
50MG
A080790 001
50MG
A085188 001
TABLET, EXTENDED RELEASE;ORAL
PBZ-SR
NOVARTIS
50MG
N010533 002
100MG
N010533 001
TRIPLE SULFA (SULFABENZAMIDE;SULFACETAMIDE;SULFATHIAZOLE)
CREAM;VAGINAL
GYNE-SULF
G AND W LABS
2.86%;3.42%;3.7%
A088607 001 Jun 09, 1986
SULTRIN
ORTHO MCNEIL PHARM
2.86%;3.42%;3.7%
N005794 001
TRIPLE SULFA
ALPHARMA US PHARMS
2.86%;3.42%;3.7%
A087864 001 Sep 01, 1982
FOUGERA
2.86%;3.42%;3.7%
A086424 001
PERRIGO NEW YORK
2.86%;3.42%;3.7%
A087285 001 Nov 15, 1982
TRYSUL
SAVAGE LABS
2.86%;3.42%;3.7%
A087887 001 Jul 23, 1982
VAGILIA
TEVA
3.42%;3.42%;3.42%
A088821 001 Nov 09, 1987
TABLET;VAGINAL
SULTRIN
ORTHO MCNEIL PHARM
143.75MG;172.5MG;184MG
N005794 002
TRIPLE SULFA
FOUGERA
172.5MG;172.5MG;172.5MG
A088463 001 Jan 03, 1985
PHARMADERM
172.5MG;172.5MG;172.5MG
A088462 001 Jan 03, 1985
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-329(of 337)
TRIPROLIDINE HYDROCHLORIDE
SYRUP;ORAL
ACTIDIL
GLAXOSMITHKLINE
1.25MG/5ML
N011496 002 Jul 01, 1983
MYIDYL
USL PHARMA
1.25MG/5ML
A087963 001 Jan 18, 1983
TRIPROLIDINE HYDROCHLORIDE
ALPHARMA US PHARMS
1.25MG/5ML
A085940 001
HALSEY
1.25MG/5ML
A088735 001 Jan 17, 1985
PHARM ASSOC
1.25MG/5ML
A087514 001 Feb 10, 1982
TABLET;ORAL
ACTIDIL
GLAXOSMITHKLINE
2.5MG
N011110 002 Jul 01, 1983
TRIPROLIDINE HYDROCHLORIDE
VITARINE
2.5MG
A085610 001
WATSON LABS
2.5MG
A085094 001
TRISULFAPYRIMIDINES (SULFADIAZINE;SULFAMERAZINE;SULFAMETHAZINE)
SUSPENSION;ORAL
LANTRISUL
LANNETT
167MG/5ML;167MG/5ML;167MG/5ML
A080123 002
NEOTRIZINE
LILLY
167MG/5ML;167MG/5ML;167MG/5ML
N006317 012
SULFALOID
FOREST PHARMS
167MG/5ML;167MG/5ML;167MG/5ML
A080100 001
SULFOSE
WYETH AYERST
167MG/5ML;167MG/5ML;167MG/5ML
A080013 002
TERFONYL
BRISTOL MYERS SQUIBB
167MG/5ML;167MG/5ML;167MG/5ML
N006904 002
TRIPLE SULFA
ALPHARMA US PHARMS
167MG/ML;167MG/ML;167MG/ML
A080280 001
TRIPLE SULFAS
LEDERLE
167MG/5ML;167MG/5ML;167MG/5ML
N006920 003
TABLET;ORAL
NEOTRIZINE
LILLY
167MG;167MG;167MG
N006317 011
SULFA-TRIPLE #2
IMPAX LABS
167MG;167MG;167MG
A080079 001
SULFALOID
FOREST PHARMS
167MG;167MG;167MG
A080099 001
SULFOSE
WYETH AYERST
167MG;167MG;167MG
A080013 001
TERFONYL
BRISTOL MYERS SQUIBB
167MG;167MG;167MG
N006904 001
TRIPLE SULFA
PUREPAC PHARM
167MG;167MG;167MG
A080086 001
TRIPLE SULFAS
LEDERLE
167MG;167MG;167MG
N006920 002
TRIPLE SULFOID
PAL PAK
167MG;167MG;167MG
A080094 001
TROGLITAZONE
TABLET;ORAL
PRELAY
SANKYO
200MG
N020719 001 Jan 29, 1997
300MG
N020719 003 Aug 04, 1997
400MG
N020719 002 Jan 29, 1997
REZULIN
PFIZER PHARMS
200MG
N020720 001 Jan 29, 1997
300MG
N020720 003 Aug 04, 1997
400MG
N020720 002 Jan 29, 1997
TROLAMINE POLYPEPTIDE OLEATE CONDENSATE
SOLUTION/DROPS;OTIC
CERUMENEX
PHARM RES ASSOC 10%
N011340 002
TROLEANDOMYCIN
CAPSULE;ORAL
TAO
PFIZER EQ 250MG BASE
N050336 002
SUSPENSION;ORAL
TAO
PFIZER EQ 125MG BASE/5ML
N050332 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-330(of 337)
TROPICAMIDE
SOLUTION/DROPS;OPHTHALMIC
MYDRIACYL
ALCON
0.5%
N012111 002
1%
N012111 004
MYDRIAFAIR
PHARMAFAIR
0.5%
A088274 001 Sep 16, 1983
1%
A088230 001 Sep 16, 1983
TROPICAMIDE
AKORN
1%
A088447 001 Aug 28, 1985
ALCON PHARMS LTD
1%
A089172 001 Dec 28, 1990
MIZA PHARMS USA
0.5%
A087636 001 Jul 30, 1982
1%
A087637 001 Aug 09, 1982
WATSON LABS
0.5%
A089171 001 Dec 28, 1990
TROVAFLOXACIN MESYLATE
TABLET;ORAL
TROVAN
PFIZER
EQ 100MG BASE
N020759 001 Dec 18, 1997
EQ 200MG BASE
N020759 002 Dec 18, 1997
TUBOCURARINE CHLORIDE
INJECTABLE;INJECTION
TUBOCURARINE CHLORIDE
BRISTOL MYERS SQUIBB
3MG/ML
N005657 001
HOSPIRA
3MG/ML
N006095 001
LILLY
3MG/ML
N006325 001
TYROPANOATE SODIUM
CAPSULE;ORAL
BILOPAQUE
GE HEALTHCARE
750MG
N013731 001
URACIL MUSTARD
CAPSULE;ORAL
URACIL MUSTARD
SHIRE
1MG
N012892 001
UREA
INJECTABLE;INJECTION
STERILE UREA
HOSPIRA
40GM/VIAL
N017698 001
UREAPHIL
HOSPIRA
40GM/VIAL
N012154 001
UREA C-13
FOR SOLUTION;ORAL
BREATHTEK UBT FOR H-PYLORI
OTSUKA AMERICA
EQ 75MG/POUCH
N020586 002 May 10, 2001
HELICOSOL
METABOLIC SOLUTIONS
125MG/VIAL
N021092 001 Dec 17, 1999
MERETEK UBT KIT (W/ PRANACTIN)
OTSUKA AMERICA
125MG/VIAL
N020586 001 Sep 17, 1996
PYLORI-CHEK BREATH TEST
DXS DEVICES
100MG/VIAL
N020900 001 Feb 04, 1999
UROFOLLITROPIN
INJECTABLE;INTRAMUSCULAR
METRODIN
SERONO
75 IU/AMP
N019415 002 Sep 18, 1986
150 IU/AMP
N019415 003 Sep 18, 1986
INJECTABLE;SUBCUTANEOUS
FERTINEX
SERONO
75 IU/AMP
N019415 005 Aug 23, 1996
150 IU/AMP
N019415 004 Aug 23, 1996
UROKINASE
INJECTABLE;INJECTION
KINLYTIC
MICROBIX BIOSYSTEMS
5,000 IU/VIAL
N021846 003
9,000 IU/VIAL
N021846 002
250,000 IU/VIAL
N021846 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-331(of 337)
URSODIOL
CAPSULE;ORAL
ACTIGALL
WATSON PHARMS 150MG N019594 001 Dec 31, 1987
TABLET;ORAL
URSODIOL
TEVA PHARMS USA 250MG A079184 001 May 13, 2009
500MG A079184 002 May 13, 2009
VALDECOXIB
TABLET;ORAL
BEXTRA
GD SEARLE 10MG N021341 002 Nov 16, 2001
20MG N021341 003 Nov 16, 2001
VALPROIC ACID
CAPSULE;ORAL
VALPROIC ACID
PAR PHARM 250MG A070431 001 Feb 28, 1986
SCHERER RP 250MG A070195 001 Jul 02, 1987
USL PHARMA 250MG A070631 001 Jun 11, 1987
CAPSULE, DELAYED RELEASE;ORAL
STAVZOR
BANNER PHARMACAPS 125MG N022152 001 Jul 29, 2008
250MG N022152 002 Jul 29, 2008
500MG N022152 003 Jul 29, 2008
SYRUP;ORAL
VALPROIC ACID
APOTEX INC 250MG/5ML A077105 001 Jul 29, 2005
VALSARTAN
CAPSULE;ORAL
DIOVAN
NOVARTIS 80MG N020665 001 Dec 23, 1996
160MG N020665 002 Dec 23, 1996
VANCOMYCIN HYDROCHLORIDE
FOR SOLUTION;ORAL
VANCOCIN HYDROCHLORIDE
ANI PHARMS INC EQ 250MG BASE/5ML A061667 002 Jul 13, 1983
EQ 500MG BASE/6ML A061667 001
VANCOLED
LEDERLE EQ 250MG BASE/5ML A063321 002 Oct 15, 1993
EQ 500MG BASE/6ML A063321 003 Oct 15, 1993
INJECTABLE;INJECTION
VANCOCIN HYDROCHLORIDE
ANI PHARMS INC EQ 1GM BASE/VIAL A060180 002 Mar 21, 1986
EQ 1GM BASE/VIAL A062476 002 Mar 21, 1986
EQ 1GM BASE/VIAL A062716 002 Mar 13, 1987
EQ 1GM BASE/VIAL A062812 002 Nov 17, 1987
EQ 10GM BASE/VIAL A062812 003 Nov 17, 1987
EQ 500MG BASE/VIAL A060180 001
EQ 500MG BASE/VIAL A062476 001 Mar 15, 1984
EQ 500MG BASE/VIAL A062716 001 Mar 13, 1987
EQ 500MG BASE/VIAL A062812 001 Nov 17, 1987
VANCOLED
HIKMA MAPLE EQ 1GM BASE/VIAL A062682 002 Mar 30, 1988
EQ 2GM BASE/VIAL A062682 003 May 11, 1988
EQ 5GM BASE/VIAL A062682 004 May 11, 1988
EQ 10GM BASE/VIAL A062682 005 May 11, 1988
EQ 500MG BASE/VIAL A062682 001 Jul 22, 1986
VANCOMYCIN HYDROCHLORIDE
HIKMA MAPLE EQ 1GM BASE/VIAL A062879 002 Aug 02, 1988
EQ 500MG BASE/VIAL A062879 001 Aug 02, 1988
VANCOR
PHARMACIA AND UPJOHN EQ 1GM BASE/VIAL A062956 002 Aug 01, 1988
EQ 500MG BASE/VIAL A062956 001 Aug 01, 1988
VASOPRESSIN TANNATE
INJECTABLE;INJECTION
PITRESSIN TANNATE
PARKE DAVIS 5PRESSOR UNITS/ML N003402 001
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-332(of 337)
VECURONIUM BROMIDE
INJECTABLE;INJECTION
NORCURON
ORGANON USA INC 10MG/VIAL N018776 002 Apr 30, 1984
20MG/VIAL N018776 003 Jan 03, 1992
VECURONIUM BROMIDE
HIKMA MAPLE 10MG/VIAL A075218 001 Aug 23, 1999
20MG/VIAL A075218 002 Aug 23, 1999
HOSPIRA 4MG/VIAL A075558 001 Sep 11, 2001
WATSON LABS 10MG/VIAL A074334 001 Aug 31, 1995
20MG/VIAL A074334 002 Aug 31, 1995
VELAGLUCERASE ALFA
POWDER;IV (INFUSION)
VPRIV
SHIRE HUMAN GENETIC 200 UNITS/VIAL N022575 002 Feb 26, 2010
VENLAFAXINE HYDROCHLORIDE
CAPSULE, EXTENDED RELEASE;ORAL
EFFEXOR XR
WYETH PHARMS INC EQ 100MG BASE N020699 003 Oct 20, 1997
TABLET;ORAL
EFFEXOR
WYETH PHARMS INC EQ 12.5MG BASE **Federal Register N020151 001 Dec 28, 1993
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 25MG BASE **Federal Register N020151 002 Dec 28, 1993
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 37.5MG BASE **Federal Register N020151 006 Dec 28, 1993
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 50MG BASE **Federal Register N020151 003 Dec 28, 1993
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 75MG BASE **Federal Register N020151 004 Dec 28, 1993
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
EQ 100MG BASE **Federal Register N020151 005 Dec 28, 1993
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
VENLAFAXINE HYDROCHLORIDE
PLIVA HRVATSKA DOO EQ 25MG BASE A078517 001 Jun 13, 2008
EQ 37.5MG BASE A078517 002 Jun 13, 2008
EQ 50MG BASE A078517 003 Jun 13, 2008
EQ 75MG BASE A078517 004 Jun 13, 2008
EQ 100MG BASE A078517 005 Jun 13, 2008
SANDOZ EQ 25MG BASE A077515 001 Jun 13, 2008
EQ 37.5MG BASE A077515 002 Jun 13, 2008
EQ 50MG BASE A077515 003 Jun 13, 2008
EQ 75MG BASE A077515 004 Jun 13, 2008
EQ 100MG BASE A077515 005 Jun 13, 2008
VERAPAMIL HYDROCHLORIDE
INJECTABLE;INJECTION
CALAN
GD SEARLE LLC 2.5MG/ML N018925 001 Mar 30, 1984
2.5MG/ML N019038 001 Mar 30, 1984
ISOPTIN
FSC 2.5MG/ML N018485 001
VERAPAMIL HYDROCHLORIDE
ABRAXIS PHARM 2.5MG/ML A070348 001 May 01, 1986
BEDFORD 2.5MG/ML A072888 001 Jul 28, 1995
HOSPIRA 2.5MG/ML A070577 001 Feb 02, 1987
2.5MG/ML A070739 001 May 06, 1987
2.5MG/ML A070740 001 May 06, 1987
INTL MEDICATION 2.5MG/ML A070451 001 Dec 16, 1985
LUITPOLD 2.5MG/ML A070225 001 Nov 12, 1985
2.5MG/ML A070617 001 Nov 12, 1985
MARSAM PHARMS LLC 2.5MG/ML A072233 001 Feb 26, 1993
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST 6-333(of 337)
VERAPAMIL HYDROCHLORIDE
INJECTABLE;INJECTION
VERAPAMIL HYDROCHLORIDE
2.5MG/ML A073485 001 Sep 27, 1993
SMITH AND NEPHEW 2.5MG/ML A070696 001 Jul 31, 1987
2.5MG/ML A070697 001 Jul 31, 1987
SOLOPAK 2.5MG/ML A070695 001 Jul 31, 1987
TABLET;ORAL
CALAN
GD SEARLE LLC 160MG N018817 004 Feb 23, 1988
ISOPTIN
FSC 40MG N018593 003 Nov 23, 1987
80MG N018593 001 Mar 08, 1982
120MG N018593 002 Mar 08, 1982
VERAPAMIL HYDROCHLORIDE
ACTAVIS ELIZABETH 80MG A071019 001 Sep 24, 1986
120MG A070468 001 Sep 24, 1986
MUTUAL PHARM 80MG A070482 001 Sep 24, 1986
80MG A071489 002 Jan 13, 1988
120MG A070483 001 Sep 24, 1986
120MG A071489 001 Jan 13, 1988
PLIVA 40MG A072751 001 Feb 23, 1996
80MG A072124 001 Jan 26, 1989
120MG A072125 001 Jan 26, 1989
SANDOZ 40MG A073168 001 Jul 31, 1992
80MG A071423 001 May 24, 1988
120MG A071424 001 May 25, 1988
WARNER CHILCOTT 80MG A070340 001 Sep 24, 1986
120MG A070341 001 Sep 24, 1986
WATSON LABS 40MG A072799 001 Apr 28, 1989
40MG A072923 001 Jun 29, 1993
80MG A070855 001 Sep 24, 1986
80MG A071366 001 Oct 01, 1986
120MG A070856 001 Sep 24, 1986
120MG A071367 001 Oct 01, 1986
TABLET, EXTENDED RELEASE;ORAL
VERAPAMIL HYDROCHLORIDE
PLIVA 240MG A072922 001 Mar 01, 1996
VERATRUM VIRIDE ROOT
TABLET;ORAL
VERTAVIS
MEDPOINTE PHARM HLC 130CSR UNIT N005691 002
VIDARABINE
INJECTABLE;INJECTION
VIRA-A
PARKEDALE EQ 187.4MG BASE/ML N050523 001
OINTMENT;OPHTHALMIC
VIRA-A
PARKEDALE 3% N050486 001
VINBLASTINE SULFATE
INJECTABLE;INJECTION
VELBAN
LILLY 10MG/VIAL N012665 001
VINBLASTINE SULFATE
ABRAXIS PHARM 10MG/VIAL A089011 001 Nov 18, 1985
HOSPIRA 10MG/VIAL A089565 001 Aug 18, 1987
VINCRISTINE SULFATE
INJECTABLE;INJECTION
ONCOVIN
LILLY 1MG/VIAL N014103 001
1MG/ML N014103 003 Mar 07, 1984
5MG/VIAL N014103 002
VINCASAR PFS
TEVA PARENTERAL 1MG/ML A071426 001 Jul 17, 1987
VINCREX
BRISTOL MYERS SQUIBB 5MG/VIAL A070867 001 Jul 12, 1988
VINCRISTINE SULFATE
ABIC 1MG/ML A070873 001 Feb 19, 1987
ABRAXIS PHARM 1MG/ML A070411 001 Sep 10, 1986
FRESENIUS KABI USA 1MG/ML A076296 001 Dec 20, 2002
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-334(of 337)
VINCRISTINE SULFATE
INJECTABLE;INJECTION
VINCRISTINE SULFATE
1MG/ML
A076401 001 Oct 28, 2003
HOSPIRA 1MG/VIAL
A071559 001 Apr 11, 1988
2MG/VIAL
A071560 001 Apr 11, 1988
5MG/VIAL
A071561 001 Apr 11, 1988
VINORELBINE TARTRATE
INJECTABLE;INJECTION
VINORELBINE TARTRATE
EBEWE PHARMA EQ 10MG BASE/ML
A078408 001 Feb 13, 2008
VIOMYCIN SULFATE
INJECTABLE;INJECTION
VIOCIN SULFATE
PFIZER EQ 1GM BASE/VIAL
A061086 001
EQ 5GM BASE/VIAL
A061086 002
VITAMIN A
CAPSULE;ORAL
AQUASOL A
ASTRAZENECA 25,000USP UNITS
A083080 002
50,000USP UNITS
A083080 001
VITAMIN A
BANNER PHARMACAPS 50,000USP UNITS
A083973 001
CHASE CHEM 50,000 IU
A083351 001
EVERYLIFE 50,000 IU
A083134 001
IMPAX LABS 50,000USP UNITS
A080952 001
WEST WARD 50,000USP UNITS
A080985 001
VITAMIN A PALMITATE
CAPSULE;ORAL
AFAXIN
STERLING WINTHROP EQ 50,000 UNITS BASE
A083187 001
ALPHALIN
LILLY EQ 50,000 UNITS BASE
A080883 001
DEL-VI-A
DEL RAY LABS EQ 50,000 UNITS BASE
A080830 001
VI-DOM-A
BAYER PHARMS EQ 50,000 UNITS BASE
A080972 001
VITAMIN A
BANNER PHARMACAPS EQ 50,000 UNITS BASE
A080702 001
BRISTOL MYERS SQUIBB EQ 50,000 UNITS BASE
A080860 001
CHASE CHEM EQ 50,000 UNITS BASE
A080746 001
EQ 50,000 UNITS BASE
A083207 001
ELKINS SINN EQ 50,000 UNITS BASE
A085479 001
EVERYLIFE EQ 50,000 UNITS BASE
A080943 001
EQ 50,000 UNITS BASE
A083114 001
IMPAX LABS EQ 50,000 UNITS BASE
A080953 001
EQ 50,000 UNITS BASE
A080955 001
IVAX SUB TEVA PHARMS EQ 50,000 UNITS BASE
A083035 001
EQ 50,000 UNITS BASE
A083190 001
MK LABS EQ 25,000 UNITS BASE
A083457 002
EQ 50,000 UNITS BASE
A083457 001
WEST WARD EQ 50,000 UNITS BASE
A080967 001
WHARTON LABS EQ 50,000 UNITS BASE
A083665 001
VITAMIN A PALMITATE
ARCUM EQ 50,000 UNITS BASE
A083311 001
EQ 50,000 UNITS BASE
A083321 001
BANNER PHARMACAPS EQ 50,000 UNITS BASE
A083948 001
EQ 50,000 UNITS BASE
A083981 001
VITAMIN A SOLUBILIZED
TEVA EQ 50,000 UNITS BASE
A080921 001
INJECTABLE;INJECTION
VITAMIN A PALMITATE
BEL MAR EQ 50,000 UNITS BASE/ML
A080819 001
WARFARIN POTASSIUM
TABLET;ORAL
ATHROMBIN-K
PHARM RES ASSOC 2MG
N011771 007
5MG
N011771 004
10MG
N011771 005
25MG
N011771 006
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-335(of 337)
WARFARIN SODIUM
INJECTABLE;INJECTION
COUMADIN
BRISTOL MYERS SQUIBB 5MG/VIAL
N009218 024 Feb 07, 1995
50MG/VIAL
N009218 020
75MG/VIAL
N009218 012
TABLET;ORAL
ATHROMBIN
PHARM RES ASSOC 5MG
N011771 003
10MG
N011771 002
25MG
N011771 001
PANWARFIN
ABBOTT 2MG
N017020 001
2.5MG
N017020 002
5MG
N017020 003
7.5MG
N017020 004
10MG
N017020 005
WARFARIN SODIUM
SANDOZ 1MG
A040196 001 Sep 30, 1997
2MG
A040196 002 Sep 30, 1997
2.5MG
A040196 003 Sep 30, 1997
3MG
A040196 008 Jul 26, 2000
4MG
A040196 004 Sep 30, 1997
5MG
A040196 005 Sep 30, 1997
6MG
A040196 009 Jul 26, 2000
7.5MG
A040196 006 Sep 30, 1997
10MG
A040196 007 Sep 30, 1997
USL PHARMA 2MG
A088719 001 Jun 27, 1985
2.5MG
A088720 001 Aug 06, 1985
5MG
A088721 001 Jul 02, 1985
WATSON LABS 2MG
A086123 001 Aug 17, 1982
2.5MG
A086120 001 Aug 17, 1982
5MG
A086119 001 Aug 17, 1982
7.5MG
A086118 001 Aug 17, 1982
10MG
A086122 001 Aug 17, 1982
XENON XE-127
GAS;INHALATION
XENON XE 127
MALLINCKRODT 5mCi/VIAL
N018536 001 Oct 01, 1982
10mCi/VIAL
N018536 002 Oct 01, 1982
XENON XE-133
GAS;INHALATION
XENON XE 133
GE HEALTHCARE 1 CI/AMP
N017256 002
10mCi/VIAL
N017687 002
20mCi/VIAL
N017687 003
GEN ELECTRIC 5-100 CI/CYLINDER
N017550 001
0.25-5 CI/AMP
N017550 003
MALLINCKRODT 10mCi/VIAL
N018327 001 Mar 09, 1982
20mCi/VIAL
N018327 002 Mar 09, 1982
XENON XE 133-V.S.S.
GE HEALTHCARE 10mCi/VIAL
N017687 001
INJECTABLE;INJECTION
XENON XE 133
GE HEALTHCARE 1.3-1.7 CI/AMP
N017256 001
LANTHEUS MEDCL 6.3mCi/ML
N017283 001
SOLUTION;INHALATION, INJECTION
XENEISOL
MALLINCKRODT 18-25mCi/AMP
N017262 002
XYLOSE
POWDER;ORAL
XYLO-PFAN
SAVAGE LABS 25GM/BOT
N017605 001
XYLOSE
LYNE 25GM/BOT
N018856 001 Mar 26, 1987
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-336(of 337)
ZALCITABINE
TABLET;ORAL
HIVID
ROCHE 0.375MG
N020199 001
Jun 19, 1992
0.75MG
N020199 002
Jun 19, 1992
ZALEPLON
CAPSULE;ORAL
ZALEPLON
SANDOZ 5MG
A078095 001
Jun 06, 2008
10MG
A078095 002
Jun 06, 2008
ZICONOTIDE ACETATE
INJECTABLE;INTRATHECAL
PRIALT
JAZZ PHARMS INTL 200MCG/2ML (100MCG/ML)
N021060 003
Dec 28, 2004
ZIDOVUDINE
INJECTABLE;INJECTION
ZIDOVUDINE
LIAONING CHENGDA 10MG/ML
A204538 001
Nov 26, 2013
TABLET;ORAL
RETROVIR
VIIV HLTHCARE 200MG
N020518 001
Dec 19, 1995
300MG
N020518 002
Oct 04, 1996
ZIDOVUDINE
AUROBINDO PHARMA 60MG
N022294 001
Jul 23, 2009
MATRIX LABS LTD 100MG
N200732 001
Feb 23, 2011
RANBAXY LABS LTD 300MG
A077327 001
Sep 19, 2005
ZILEUTON
TABLET;ORAL
ZYFLO
CHIESI USA INC 300MG
N020471 001
Dec 09, 1996
ZINC SULFATE
INJECTABLE;INJECTION
ZINC SULFATE
ABRAXIS PHARM EQ 1MG ZINC/ML
N019229 002
May 05, 1987
ZOLEDRONIC ACID
INJECTABLE;IV (INFUSION)
ZOMETA
NOVARTIS EQ 4MG BASE/VIAL **Federal Register
N021223 001
Aug 20, 2001
determination that product was not
discontinued or withdrawn for safety or
efficacy reasons**
ZOLPIDEM TARTRATE
TABLET;ORAL
ZOLPIDEM TARTRATE
DR REDDYS LABS LTD 5MG
A077985 001
Apr 23, 2007
10MG
A077985 002
Apr 23, 2007
MUTUAL PHARMA 5MG
A077288 001
Apr 23, 2007
10MG
A077288 002
Apr 23, 2007
MYLAN PHARMS INC 5MG
A078016 001
Apr 23, 2007
10MG
A078016 002
Apr 23, 2007
SYNTHON PHARMS 5MG
A077540 001
Apr 23, 2007
10MG
A077540 002
Apr 23, 2007
VIVIMED LABS 5MG
A076062 001
Apr 23, 2007
10MG
A076062 002
Apr 23, 2007
WATSON LABS 5MG
A077773 001
Apr 23, 2007
10MG
A077773 002
Apr 23, 2007
TABLET, ORALLY DISINTEGRATING;ORAL
TOVALT ODT
BIOVAIL LABS INTL 5MG
N021412 001
Apr 25, 2007
10MG
N021412 002
Apr 25, 2007
ZONISAMIDE
CAPSULE;ORAL
ZONISAMIDE
ANI PHARMS INC 25MG
A077639 001
Dec 22, 2005
25MG
A077641 003
Dec 22, 2005
50MG
A077639 002
Dec 22, 2005
50MG
A077641 002
Dec 22, 2005
100MG
A077639 003
Dec 22, 2005
100MG
A077641 001
Dec 22, 2005
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
DISCONTINUED DRUG PRODUCT LIST
6-337(of 337)
ZONISAMIDE
CAPSULE;ORAL
ZONISAMIDE
COREPHARMA 25MG
A077876 001 Feb 21, 2007
50MG
A077876 002 Feb 21, 2007
100MG
A077876 003 Feb 21, 2007
DR REDDYS LABS LTD 25MG
A077645 002 Sep 29, 2006
50MG
A077645 003 Sep 29, 2006
100MG
A077645 001 Dec 22, 2005
MUTUAL PHARM 25MG
A077635 001 Dec 22, 2005
50MG
A077635 002 Dec 22, 2005
100MG
A077635 003 Dec 22, 2005
ROXANE 25MG
A077648 001 Dec 22, 2005
50MG
A077648 002 Dec 22, 2005
100MG
A077648 003 Dec 22, 2005
SANDOZ 25MG
A077644 001 Dec 22, 2005
50MG
A077644 002 Dec 22, 2005
100MG
A077644 003 Dec 22, 2005
WATSON LABS 25MG
A077650 001 Apr 20, 2006
50MG
A077650 002 Apr 20, 2006
100MG
A077650 003 Apr 20, 2006
35TH EDITION - 2015 - APPROVED DRUG PRODUCTS LIST
7-1
ORPHAN PRODUCT DESIGNATIONS AND APPROVALS LIST
The list of List of Orphan Designations and Approvals is available at:
http://www.fda.gov/ForIndustry/DevelopingProductsforRareDiseasesConditions/default.htm
35TH EDITION - 2015 - APPROVED DRUG PRODUCTS LIST
8-1
DRUG PRODUCTS WHICH MUST DEMONSTRATE IN VIVO BIOAVAILABILITY
ONLY IF PRODUCT FAILS TO ACHIEVE ADEQUATE DISSOLUTION
ACETAMINOPHEN;ASPIRIN;BUTALBITAL ASPIRIN;CAFFEINE;CARISOPRODOL;
CAPSULE OR TABLET; ORAL CODEINE PHOSPHATE
160-165MG;160-165MG;50MG TABLET; ORAL
325MG;325MG;50MG 160MG;32MG;200MG;16MG
ACETAMINOPHEN;ASPIRIN;BUTALBITAL; ASPIRIN;CARISOPRODOL
CAFFEINE TABLET; ORAL
CAPSULE OR TABLET; ORAL 325MG;200MG
160-165MG;160-165MG;50MG;40MG
325MG;325MG;50MG;40MG
ASPIRIN;CARISOPRODOL;
CODEINE PHOSPHATE
ACETAMINOPHEN;BUTALBITAL TABLET; ORAL
CAPSULE OR TABLET; ORAL 325MG;200MG;16MG
325MG;50MG
ASPIRIN;MEPROBAMATE
ACETAMINOPHEN;BUTALBITAL;CAFFEINE TABLET; ORAL
CAPSULE OR TABLET; ORAL 325MG;200MG
325MG;50MG;40MG
ASPIRIN;METHOCARBAMOL
AMINOPHYLLINE TABLET; ORAL
TABLET; ORAL 325MG;400MG
100MG;200MG
CHLOROTHIAZIDE
ASPIRIN;BUTALBITAL TABLET; ORAL
CAPSULE OR TABLET; ORAL 250MG
325MG;50MG
650MG;50MG
HYDROXYZINE HYDROCHLORIDE
TABLET; ORAL
ASPIRIN;BUTALBITAL;CAFFEINE 10MG;25MG;
CAPSULE OR TABLET; ORAL 50MG;100MG
325MG;50MG;40MG
650MG;50MG;40MG
PREDNISONE
TABLET; ORAL
ASPIRIN;CAFFEINE;CARISOPRODOL 1MG;2.5MG;5MG;10MG;
TABLET; ORAL 20MG;25MG;50MG
160MG;32MG;200MG
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 1
APPENDIX A - PRODUCT NAME INDEX
** 8 **
8-MOP, METHOXSALEN
** A **
A-HYDROCORT, HYDROCORTISONE SODIUM SUCCINATE
A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE
ABACAVIR SULFATE, ABACAVIR SULFATE
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE, ABACAVIR SULFATE
ABELCET, AMPHOTERICIN B
ABILIFY, ARIPIPRAZOLE
ABILIFY MAINTENA KIT, ARIPIPRAZOLE
ABLAVAR, GADOFOSVESET TRISODIUM
ABRAXANE, PACLITAXEL
ABREVA, DOCOSANOL (OTC)
ABSORICA, ISOTRETINOIN
ABSTRAL, FENTANYL CITRATE
ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM
ACANYA, BENZOYL PEROXIDE
ACARBOSE, ACARBOSE
ACCOLATE, ZAFIRLUKAST
ACCUNEB, ALBUTEROL SULFATE
ACCUPRIL, QUINAPRIL HYDROCHLORIDE
ACCURETIC, HYDROCHLOROTHIAZIDE
ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE
ACEON, PERINDOPRIL ERBUMINE
ACEPHEN, ACETAMINOPHEN (OTC)
ACETADOTE, ACETYLCYSTEINE
ACETAMINOPHEN, ACETAMINOPHEN (OTC)
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC)
ACETASOL HC, ACETIC ACID, GLACIAL
ACETAZOLAMIDE, ACETAZOLAMIDE
ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM
ACETAZOLAMIDE SODIUM , ACETAZOLAMIDE SODIUM
ACETIC ACID, ACETIC ACID, GLACIAL
ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL
ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE, ACETIC ACID, GLACIAL
ACETYLCYSTEINE, ACETYLCYSTEINE
ACHROMYCIN V, TETRACYCLINE HYDROCHLORIDE
ACIPHEX, RABEPRAZOLE SODIUM
ACIPHEX SPRINKLE, RABEPRAZOLE SODIUM
ACITRETIN, ACITRETIN
ACOVA, ARGATROBAN
ACTHREL, CORTICORELIN OVINE TRIFLUTATE
ACTICLATE, DOXYCYCLINE HYCLATE
ACTIGALL, URSODIOL
ACTIQ, FENTANYL CITRATE
ACTIVELLA, ESTRADIOL
ACTONEL, RISEDRONATE SODIUM
ACTOPLUS MET, METFORMIN HYDROCHLORIDE
ACTOPLUS MET XR, METFORMIN HYDROCHLORIDE
ACTOS, PIOGLITAZONE HYDROCHLORIDE
ACULAR, KETOROLAC TROMETHAMINE
ACULAR LS, KETOROLAC TROMETHAMINE
ACUVAIL, KETOROLAC TROMETHAMINE
ACYCLOVIR, ACYCLOVIR
ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE, ACYCLOVIR SODIUM
ACYCLOVIR SODIUM, ACYCLOVIR SODIUM
ACZONE, DAPSONE
ADAGEN, PEGADEMASE BOVINE
ADALAT CC, NIFEDIPINE
ADAPALENE, ADAPALENE
ADASUVE, LOXAPINE
ADCIRCA, TADALAFIL
ADDERALL XR 10, AMPHETAMINE ASPARTATE
ADDERALL XR 15, AMPHETAMINE ASPARTATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 2
APPENDIX A - PRODUCT NAME INDEX
** A **
ADDERALL XR 20, AMPHETAMINE ASPARTATE
ADDERALL XR 25, AMPHETAMINE ASPARTATE
ADDERALL XR 30, AMPHETAMINE ASPARTATE
ADDERALL XR 5, AMPHETAMINE ASPARTATE
ADEFOVIR DIPIVOXIL, ADEFOVIR DIPIVOXIL
ADEMPAS, RIOCIGUAT
ADENOCARD, ADENOSINE
ADENOSCAN, ADENOSINE
ADENOSINE, ADENOSINE
ADIPEX-P, PHENTERMINE HYDROCHLORIDE
ADRENACLICK, EPINEPHRINE
ADRENALIN, EPINEPHRINE HYDROCHLORIDE
ADREVIEW, IOBENGUANE SULFATE I-123
ADVAIR DISKUS 100/50, FLUTICASONE PROPIONATE
ADVAIR DISKUS 250/50, FLUTICASONE PROPIONATE
ADVAIR DISKUS 500/50, FLUTICASONE PROPIONATE
ADVAIR HFA, FLUTICASONE PROPIONATE
ADVICOR, LOVASTATIN
ADVIL, IBUPROFEN (OTC)
ADVIL, IBUPROFEN SODIUM (OTC)
ADVIL ALLERGY AND CONGESTION RELIEF, CHLORPHENIRAMINE MALEATE (OTC)
ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)
ADVIL COLD AND SINUS, IBUPROFEN (OTC)
ADVIL CONGESTION RELIEF, IBUPROFEN (OTC)
ADVIL LIQUI-GELS, IBUPROFEN (OTC)
ADVIL MIGRAINE LIQUI-GELS, IBUPROFEN (OTC)
ADVIL PM, DIPHENHYDRAMINE CITRATE (OTC)
ADVIL PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)
AEROSPAN HFA, FLUNISOLIDE
AFEDITAB CR, NIFEDIPINE
AFINITOR, EVEROLIMUS
AFINITOR DISPERZ, EVEROLIMUS
AFREZZA, INSULIN RECOMBINANT HUMAN
AFRINOL, PSEUDOEPHEDRINE SULFATE (OTC)
AGGRASTAT, TIROFIBAN HYDROCHLORIDE
AGGRENOX, ASPIRIN
AGRYLIN, ANAGRELIDE HYDROCHLORIDE
AK-FLUOR 10%, FLUORESCEIN SODIUM
AK-FLUOR 25%, FLUORESCEIN SODIUM
AKBETA, LEVOBUNOLOL HYDROCHLORIDE
AKINETON, BIPERIDEN HYDROCHLORIDE
AKNE-MYCIN, ERYTHROMYCIN
AKPENTOLATE, CYCLOPENTOLATE HYDROCHLORIDE
AKTEN, LIDOCAINE HYDROCHLORIDE
AKTOB, TOBRAMYCIN
AKYNZEO, NETUPITANT
ALA-CORT, HYDROCORTISONE
ALA-SCALP, HYDROCORTISONE
ALAVERT, LORATADINE (OTC)
ALAWAY, KETOTIFEN FUMARATE (OTC)
ALBENZA, ALBENDAZOLE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE
ALCAINE, PROPARACAINE HYDROCHLORIDE
ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE
ALCOHOL 10% AND DEXTROSE 5%, ALCOHOL
ALCOHOL 5% AND DEXTROSE 5%, ALCOHOL
ALDACTAZIDE, HYDROCHLOROTHIAZIDE
ALDACTONE, SPIRONOLACTONE
ALDARA, IMIQUIMOD
ALENDRONATE SODIUM, ALENDRONATE SODIUM
ALEVE, NAPROXEN SODIUM (OTC)
ALEVE PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)
ALEVE-D SINUS & COLD, NAPROXEN SODIUM (OTC)
ALFENTA, ALFENTANIL HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 3
APPENDIX A - PRODUCT NAME INDEX
** A **
ALFENTANIL, ALFENTANIL HYDROCHLORIDE
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
ALIMTA, PEMETREXED DISODIUM
ALINIA, NITAZOXANIDE
ALKERAN, MELPHALAN
ALKERAN, MELPHALAN HYDROCHLORIDE
ALLEGRA, FEXOFENADINE HYDROCHLORIDE
ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE (OTC)
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE (OTC)
ALLI, ORLISTAT (OTC)
ALLOPURINOL, ALLOPURINOL
ALLOPURINOL SODIUM, ALLOPURINOL SODIUM
ALOCRIL, NEDOCROMIL SODIUM
ALOMIDE, LODOXAMIDE TROMETHAMINE
ALOPRIM, ALLOPURINOL SODIUM
ALORA, ESTRADIOL
ALOXI, PALONOSETRON HYDROCHLORIDE
ALPHAGAN P, BRIMONIDINE TARTRATE
ALPRAZOLAM, ALPRAZOLAM
ALPROSTADIL, ALPROSTADIL
ALREX, LOTEPREDNOL ETABONATE
ALSUMA, SUMATRIPTAN SUCCINATE
ALTABAX, RETAPAMULIN
ALTACE, RAMIPRIL
ALTAVERA, ETHINYL ESTRADIOL
ALTOPREV, LOVASTATIN
ALVESCO, CICLESONIDE
ALYACEN 1/35, ETHINYL ESTRADIOL
ALYACEN 7/7/7, ETHINYL ESTRADIOL
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
AMARYL, GLIMEPIRIDE
AMBIEN, ZOLPIDEM TARTRATE
AMBIEN CR, ZOLPIDEM TARTRATE
AMBISOME, AMPHOTERICIN B
AMCINONIDE, AMCINONIDE
AMERGE, NARATRIPTAN HYDROCHLORIDE
AMICAR, AMINOCAPROIC ACID
AMIDATE, ETOMIDATE
AMIFOSTINE, AMIFOSTINE
AMIKACIN SULFATE, AMIKACIN SULFATE
AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE
AMINO ACIDS, AMINO ACIDS
AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER, GLYCINE
AMINOCAPROIC, AMINOCAPROIC ACID
AMINOCAPROIC ACID, AMINOCAPROIC ACID
AMINOCAPROIC ACID IN PLASTIC CONTAINER, AMINOCAPROIC ACID
AMINOPHYLLINE, AMINOPHYLLINE
AMINOSYN 10%, AMINO ACIDS
AMINOSYN 10% (PH6), AMINO ACIDS
AMINOSYN 3.5%, AMINO ACIDS
AMINOSYN 3.5% M, AMINO ACIDS
AMINOSYN 5%, AMINO ACIDS
AMINOSYN 7%, AMINO ACIDS
AMINOSYN 7% (PH6), AMINO ACIDS
AMINOSYN 7% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN 8.5%, AMINO ACIDS
AMINOSYN 8.5% (PH6), AMINO ACIDS
AMINOSYN 8.5% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN II 10%, AMINO ACIDS
AMINOSYN II 10% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 10% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN II 15% IN PLASTIC CONTAINER, AMINO ACIDS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 4
APPENDIX A - PRODUCT NAME INDEX
** A **
AMINOSYN II 7%, AMINO ACIDS
AMINOSYN II 8.5%, AMINO ACIDS
AMINOSYN II 8.5% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN-HBC 7%, AMINO ACIDS
AMINOSYN-HF 8%, AMINO ACIDS
AMINOSYN-PF 10%, AMINO ACIDS
AMINOSYN-PF 7%, AMINO ACIDS
AMINOSYN-RF 5.2%, AMINO ACIDS
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMITIZA, LUBIPROSTONE
AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE
AMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDE, AMLODIPINE
AMMONIA N 13, AMMONIA N-13
AMMONIUM CHLORIDE IN PLASTIC CONTAINER, AMMONIUM CHLORIDE
AMMONIUM LACTATE, AMMONIUM LACTATE
AMMONUL, SODIUM BENZOATE
AMNESTEEM, ISOTRETINOIN
AMOXAPINE, AMOXAPINE
AMOXICILLIN, AMOXICILLIN
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN PEDIATRIC, AMOXICILLIN
AMOXIL, AMOXICILLIN
AMPHADASE, HYALURONIDASE
AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF, AMPHETAMINE
AMPHETAMINE SULFATE, AMPHETAMINE SULFATE
AMPHOTEC, AMPHOTERICIN B
AMPHOTERICIN B, AMPHOTERICIN B
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
AMPICILLIN SODIUM, AMPICILLIN SODIUM
AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE
AMPYRA, DALFAMPRIDINE
AMRINONE LACTATE, INAMRINONE LACTATE
AMRIX, CYCLOBENZAPRINE HYDROCHLORIDE
AMTURNIDE, ALISKIREN HEMIFUMARATE
AMYVID, FLORBETAPIR F-18
AN-DTPA, TECHNETIUM TC-99M PENTETATE KIT
AN-SULFUR COLLOID, TECHNETIUM TC-99M SULFUR COLLOID KIT
ANADROL-50, OXYMETHOLONE
ANAFRANIL, CLOMIPRAMINE HYDROCHLORIDE
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
ANAPROX, NAPROXEN SODIUM
ANAPROX DS, NAPROXEN SODIUM
ANASTROZOLE, ANASTROZOLE
ANCEF IN PLASTIC CONTAINER, CEFAZOLIN SODIUM
ANCOBON, FLUCYTOSINE
ANDRODERM, TESTOSTERONE
ANDROGEL, TESTOSTERONE
ANDROID 10, METHYLTESTOSTERONE
ANDROID 25, METHYLTESTOSTERONE
ANECTINE, SUCCINYLCHOLINE CHLORIDE
ANEXSIA 5/325, ACETAMINOPHEN
ANEXSIA 7.5/325, ACETAMINOPHEN
ANGELIQ, DROSPIRENONE
ANGIOMAX, BIVALIRUDIN
ANORO ELLIPTA, UMECLIDINIUM BROMIDE
ANSAID, FLURBIPROFEN
ANTABUSE, DISULFIRAM
ANTARA (MICRONIZED), FENOFIBRATE
ANTHELIOS 20, AVOBENZONE (OTC)
ANTHELIOS 40, AVOBENZONE (OTC)
ANTHELIOS SX, AVOBENZONE (OTC)
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 5
APPENDIX A - PRODUCT NAME INDEX
** A **
ANTIZOL, FOMEPIZOLE
ANUSOL HC, HYDROCORTISONE
ANZEMET, DOLASETRON MESYLATE
APIDRA, INSULIN GLULISINE RECOMBINANT
APIDRA SOLOSTAR, INSULIN GLULISINE RECOMBINANT
APLENZIN, BUPROPION HYDROBROMIDE
APOKYN, APOMORPHINE HYDROCHLORIDE
APRACLONIDINE HYDROCHLORIDE, APRACLONIDINE HYDROCHLORIDE
APREPITANT, APREPITANT
APRISO, MESALAMINE
APTIOM, ESLICARBAZEPINE ACETATE
APTIVUS, TIPRANAVIR
AQUASOL A, VITAMIN A PALMITATE
ARALEN, CHLOROQUINE PHOSPHATE
ARANELLE, ETHINYL ESTRADIOL
ARAVA, LEFLUNOMIDE
ARCAPTA NEOHALER, INDACATEROL MALEATE
ARESTIN, MINOCYCLINE HYDROCHLORIDE
ARGATROBAN, ARGATROBAN
ARGATROBAN IN 0.9% SODIUM CHLORIDE, ARGATROBAN
ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN
ARICEPT, DONEPEZIL HYDROCHLORIDE
ARICEPT ODT, DONEPEZIL HYDROCHLORIDE
ARIMIDEX, ANASTROZOLE
ARISTOSPAN, TRIAMCINOLONE HEXACETONIDE
ARIXTRA, FONDAPARINUX SODIUM
ARNUITY ELLIPTA, FLUTICASONE FUROATE
AROMASIN, EXEMESTANE
ARRANON, NELARABINE
ARTHROTEC, DICLOFENAC SODIUM
ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, ARTICAINE HYDROCHLORIDE
ASACOL, MESALAMINE
ASACOL HD, MESALAMINE
ASCLERA, POLIDOCANOL
ASMANEX HFA, MOMETASONE FUROATE
ASMANEX TWISTHALER, MOMETASONE FUROATE
ASPIRIN, ASPIRIN (OTC)
ASPIRIN AND DIPYRIDAMOLE, ASPIRIN
ASTAGRAF XL, TACROLIMUS
ASTELIN, AZELASTINE HYDROCHLORIDE
ASTEPRO, AZELASTINE HYDROCHLORIDE
ASTRAMORPH PF, MORPHINE SULFATE
ATACAND, CANDESARTAN CILEXETIL
ATACAND HCT, CANDESARTAN CILEXETIL
ATAZANAVIR SULFATE, ATAZANAVIR SULFATE
ATELVIA, RISEDRONATE SODIUM
ATENOLOL, ATENOLOL
ATENOLOL AND CHLORTHALIDONE, ATENOLOL
ATIVAN, LORAZEPAM
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
ATOVAQUONE, ATOVAQUONE
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE
ATRACURIUM BESYLATE, ATRACURIUM BESYLATE
ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE
ATRALIN, TRETINOIN
ATRIDOX, DOXYCYCLINE HYCLATE
ATRIPLA, EFAVIRENZ
ATROPEN, ATROPINE
ATROPINE SULFATE, ATROPINE SULFATE
ATROPINE SULFATE ANSYR PLASTIC SYRINGE, ATROPINE SULFATE
ATROVENT, IPRATROPIUM BROMIDE
ATROVENT HFA, IPRATROPIUM BROMIDE
AUBAGIO, TERIFLUNOMIDE
AUGMENTIN '125', AMOXICILLIN
AUGMENTIN '200', AMOXICILLIN
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 6
APPENDIX A - PRODUCT NAME INDEX
** A **
AUGMENTIN '250', AMOXICILLIN
AUGMENTIN '400', AMOXICILLIN
AUGMENTIN '500', AMOXICILLIN
AUGMENTIN '875', AMOXICILLIN
AUGMENTIN ES-600, AMOXICILLIN
AUGMENTIN XR, AMOXICILLIN
AUVI-Q, EPINEPHRINE
AVAGARD, ALCOHOL (OTC)
AVAGE, TAZAROTENE
AVALIDE, HYDROCHLOROTHIAZIDE
AVANDAMET, METFORMIN HYDROCHLORIDE
AVANDARYL, GLIMEPIRIDE
AVANDIA, ROSIGLITAZONE MALEATE
AVAPRO, IRBESARTAN
AVC, SULFANILAMIDE
AVEED, TESTOSTERONE UNDECANOATE
AVELOX, MOXIFLOXACIN HYDROCHLORIDE
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, MOXIFLOXACIN HYDROCHLORIDE
AVIANE-28, ETHINYL ESTRADIOL
AVINZA, MORPHINE SULFATE
AVITA, TRETINOIN
AVODART, DUTASTERIDE
AXERT, ALMOTRIPTAN MALATE
AXID, NIZATIDINE
AXID AR, NIZATIDINE (OTC)
AXIRON, TESTOSTERONE
AYGESTIN, NORETHINDRONE ACETATE
AZACITIDINE, AZACITIDINE
AZACTAM, AZTREONAM
AZACTAM IN PLASTIC CONTAINER, AZTREONAM
AZASAN, AZATHIOPRINE
AZASITE, AZITHROMYCIN
AZATHIOPRINE, AZATHIOPRINE
AZATHIOPRINE SODIUM, AZATHIOPRINE SODIUM
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
AZELEX, AZELAIC ACID
AZILECT, RASAGILINE MESYLATE
AZITHROMYCIN, AZITHROMYCIN
AZOPT, BRINZOLAMIDE
AZOR, AMLODIPINE BESYLATE
AZTREONAM, AZTREONAM
AZULFIDINE, SULFASALAZINE
AZULFIDINE EN-TABS, SULFASALAZINE
** B **
BACIIM, BACITRACIN
BACITRACIN, BACITRACIN
BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC
BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE, BACITRACIN
BACLOFEN, BACLOFEN
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
BACTOCILL IN PLASTIC CONTAINER, OXACILLIN SODIUM
BACTRIM, SULFAMETHOXAZOLE
BACTRIM DS, SULFAMETHOXAZOLE
BACTROBAN, MUPIROCIN
BACTROBAN, MUPIROCIN CALCIUM
BAL, DIMERCAPROL
BALANCED SALT, CALCIUM CHLORIDE
BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM
BALZIVA-28, ETHINYL ESTRADIOL
BANZEL, RUFINAMIDE
BARACLUDE, ENTECAVIR
BECONASE AQ, BECLOMETHASONE DIPROPIONATE MONOHYDRATE
BELEODAQ, BELINOSTAT
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 7
APPENDIX A - PRODUCT NAME INDEX
** B **
BELSOMRA, SUVOREXANT
BELVIQ, LORCASERIN HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE
BENICAR, OLMESARTAN MEDOXOMIL
BENICAR HCT, HYDROCHLOROTHIAZIDE
BENTYL, DICYCLOMINE HYDROCHLORIDE
BENTYL PRESERVATIVE FREE, DICYCLOMINE HYDROCHLORIDE
BENZACLIN, BENZOYL PEROXIDE
BENZAMYCIN, BENZOYL PEROXIDE
BENZAMYCIN PAK, BENZOYL PEROXIDE
BENZONATATE, BENZONATATE
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
BEPREVE, BEPOTASTINE BESILATE
BESIVANCE, BESIFLOXACIN HYDROCHLORIDE
BETA-VAL, BETAMETHASONE VALERATE
BETADINE, POVIDONE-IODINE
BETAGAN, LEVOBUNOLOL HYDROCHLORIDE
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
BETAPACE, SOTALOL HYDROCHLORIDE
BETAPACE AF, SOTALOL HYDROCHLORIDE
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
BETHKIS, TOBRAMYCIN
BETIMOL, TIMOLOL
BETOPTIC, BETAXOLOL HYDROCHLORIDE
BETOPTIC S, BETAXOLOL HYDROCHLORIDE
BEYAZ, DROSPIRENONE
BIAXIN, CLARITHROMYCIN
BIAXIN XL, CLARITHROMYCIN
BICALUTAMIDE, BICALUTAMIDE
BICILLIN C-R, PENICILLIN G BENZATHINE
BICILLIN C-R 900/300, PENICILLIN G BENZATHINE
BICILLIN L-A, PENICILLIN G BENZATHINE
BICNU, CARMUSTINE
BIDIL, HYDRALAZINE HYDROCHLORIDE
BILTRICIDE, PRAZIQUANTEL
BIMATOPROST, BIMATOPROST
BINOSTO, ALENDRONATE SODIUM
BIOSCRUB, CHLORHEXIDINE GLUCONATE (OTC)
BISOPROLOL FUMARATE, BISOPROLOL FUMARATE
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE
BLEOMYCIN SULFATE, BLEOMYCIN SULFATE
BLEPH-10, SULFACETAMIDE SODIUM
BLEPHAMIDE, PREDNISOLONE ACETATE
BLEPHAMIDE S.O.P., PREDNISOLONE ACETATE
BLOXIVERZ, NEOSTIGMINE METHYLSULFATE
BONIVA, IBANDRONATE SODIUM
BONTRIL, PHENDIMETRAZINE TARTRATE
BONTRIL PDM, PHENDIMETRAZINE TARTRATE
BOSULIF, BOSUTINIB MONOHYDRATE
BRANCHAMIN 4% IN PLASTIC CONTAINER, AMINO ACIDS
BRAVELLE, UROFOLLITROPIN
BREO ELLIPTA, FLUTICASONE FUROATE
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER, BRETYLIUM TOSYLATE
BREVIBLOC, ESMOLOL HYDROCHLORIDE
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE
BREVIBLOC IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE
BREVICON 28-DAY, ETHINYL ESTRADIOL
BREVITAL SODIUM, METHOHEXITAL SODIUM
BRIAN CARE, CHLORHEXIDINE GLUCONATE (OTC)
BRIELLYN, ETHINYL ESTRADIOL
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 8
APPENDIX A - PRODUCT NAME INDEX
** B **
BRILINTA, TICAGRELOR
BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE
BRINTELLIX, VORTIOXETINE HYDROBROMIDE
BRISDELLE, PAROXETINE MESYLATE
BROMDAY, BROMFENAC SODIUM
BROMFED-DM, BROMPHENIRAMINE MALEATE
BROMFENAC SODIUM, BROMFENAC SODIUM
BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE,
BRONCHO SALINE, SODIUM CHLORIDE (OTC)
BROVANA, ARFORMOTEROL TARTRATE
BSS, CALCIUM CHLORIDE
BSS PLUS, CALCIUM CHLORIDE
BUDESONIDE, BUDESONIDE
BUMETANIDE, BUMETANIDE
BUNAVAIL, BUPRENORPHINE HYDROCHLORIDE
BUPHENYL, SODIUM PHENYLBUTYRATE
BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
BUPRENEX, BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE , BUPRENORPHINE HYDROCHLORIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
BUSULFEX, BUSULFAN
BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN
BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN
BUTAPAP, ACETAMINOPHEN
BUTISOL SODIUM, BUTABARBITAL SODIUM
BUTOCONAZOLE NITRATE, BUTOCONAZOLE NITRATE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE
BUTRANS, BUPRENORPHINE
BYDUREON, EXENATIDE SYNTHETIC
BYETTA, EXENATIDE SYNTHETIC
BYSTOLIC, NEBIVOLOL HYDROCHLORIDE
** C **
C-SOLVE-2, ERYTHROMYCIN
CABERGOLINE, CABERGOLINE
CADUET, AMLODIPINE BESYLATE
CAFCIT, CAFFEINE CITRATE
CAFERGOT, CAFFEINE
CAFFEINE CITRATE, CAFFEINE CITRATE
CALAN, VERAPAMIL HYDROCHLORIDE
CALAN SR, VERAPAMIL HYDROCHLORIDE
CALCIJEX, CALCITRIOL
CALCIPOTRIENE, CALCIPOTRIENE
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CALCITONIN-SALMON, CALCITONIN SALMON
CALCITRIOL, CALCITRIOL
CALCIUM ACETATE, CALCIUM ACETATE
CALCIUM CARBONATE, FAMOTIDINE AND MAGNESIUM HYDROXIDE, CALCIUM CARBONATE (OTC)
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
CALCIUM DISODIUM VERSENATE, EDETATE CALCIUM DISODIUM
CALDOLOR, IBUPROFEN
CAMBIA, DICLOFENAC POTASSIUM
CAMILA, NORETHINDRONE
CAMPRAL, ACAMPROSATE CALCIUM
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 9
APPENDIX A - PRODUCT NAME INDEX
** C **
CAMPTOSAR, IRINOTECAN HYDROCHLORIDE
CANASA, MESALAMINE
CANCIDAS, CASPOFUNGIN ACETATE
CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL
CANTIL, MEPENZOLATE BROMIDE
CAPASTAT SULFATE, CAPREOMYCIN SULFATE
CAPECITABINE, CAPECITABINE
CAPEX, FLUOCINOLONE ACETONIDE
CAPITAL AND CODEINE, ACETAMINOPHEN
CAPITAL SOLEIL 15, AVOBENZONE (OTC)
CAPOTEN, CAPTOPRIL
CAPRELSA, VANDETANIB
CAPTOPRIL, CAPTOPRIL
CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL
CARAC, FLUOROURACIL
CARAFATE, SUCRALFATE
CARBAGLU, CARGLUMIC ACID
CARBAMAZEPINE, CARBAMAZEPINE
CARBATROL, CARBAMAZEPINE
CARBIDOPA, CARBIDOPA
CARBIDOPA AND LEVODOPA, CARBIDOPA
CARBIDOPA, LEVODOPA AND ENTACAPONE, CARBIDOPA
CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE
CARBOCAINE, MEPIVACAINE HYDROCHLORIDE
CARBOPLATIN, CARBOPLATIN
CARDENE, NICARDIPINE HYDROCHLORIDE
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDIOGEN-82, RUBIDIUM CHLORIDE RB-82
CARDIOLITE, TECHNETIUM TC-99M SESTAMIBI KIT
CARDIOPLEGIC IN PLASTIC CONTAINER, CALCIUM CHLORIDE
CARDIZEM, DILTIAZEM HYDROCHLORIDE
CARDIZEM CD, DILTIAZEM HYDROCHLORIDE
CARDIZEM LA, DILTIAZEM HYDROCHLORIDE
CARDURA, DOXAZOSIN MESYLATE
CARDURA XL, DOXAZOSIN MESYLATE
CARISOPRODOL, CARISOPRODOL
CARISOPRODOL AND ASPIRIN, ASPIRIN
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN
CARNITOR, LEVOCARNITINE
CARNITOR SF, LEVOCARNITINE
CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE
CARTIA XT, DILTIAZEM HYDROCHLORIDE
CARVEDILOL, CARVEDILOL
CASODEX, BICALUTAMIDE
CATAFLAM, DICLOFENAC POTASSIUM
CATAPRES, CLONIDINE HYDROCHLORIDE
CATAPRES-TTS-1, CLONIDINE
CATAPRES-TTS-2, CLONIDINE
CATAPRES-TTS-3, CLONIDINE
CAVERJECT, ALPROSTADIL
CAVERJECT IMPULSE, ALPROSTADIL
CAYSTON, AZTREONAM
CEDAX, CEFTIBUTEN DIHYDRATE
CEFACLOR, CEFACLOR
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFAZOLIN AND DEXTROSE, CEFAZOLIN SODIUM
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFDINIR, CEFDINIR
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER, CEFEPIME HYDROCHLORIDE
CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE
CEFEPIME IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 10
APPENDIX A - PRODUCT NAME INDEX
** C **
CEFOTAXIME, CEFOTAXIME SODIUM
CEFOTAXIME SODIUM, CEFOTAXIME SODIUM
CEFOTETAN, CEFOTETAN DISODIUM
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER, CEFOTETAN DISODIUM
CEFOXITIN, CEFOXITIN SODIUM
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER, CEFOXITIN SODIUM
CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL
CEFPROZIL, CEFPROZIL
CEFTAZIDIME, CEFTAZIDIME
CEFTAZIDIME IN DEXTROSE CONTAINER, CEFTAZIDIME
CEFTIN, CEFUROXIME AXETIL
CEFTRIAXONE, CEFTRIAXONE SODIUM
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE SODIUM
CEFTRIAXONE IN PLASTIC CONTAINER, CEFTRIAXONE SODIUM
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER, CEFUROXIME SODIUM
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CEFUROXIME SODIUM, CEFUROXIME SODIUM
CELEBREX, CELECOXIB
CELECOXIB, CELECOXIB
CELESTONE SOLUSPAN, BETAMETHASONE ACETATE
CELEXA, CITALOPRAM HYDROBROMIDE
CELLCEPT, MYCOPHENOLATE MOFETIL
CELLCEPT, MYCOPHENOLATE MOFETIL HYDROCHLORIDE
CELONTIN, METHSUXIMIDE
CENESTIN, ESTROGENS, CONJUGATED SYNTHETIC A
CENTANY, MUPIROCIN
CEPHALEXIN, CEPHALEXIN
CERDELGA, ELIGLUSTAT TARTRATE
CEREBYX, FOSPHENYTOIN SODIUM
CERETEC, TECHNETIUM TC-99M EXAMETAZIME KIT
CEREZYME, IMIGLUCERASE
CERUBIDINE, DAUNORUBICIN HYDROCHLORIDE
CERVIDIL, DINOPROSTONE
CESAMET, NABILONE
CETAMIDE, SULFACETAMIDE SODIUM
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CETRAXAL, CIPROFLOXACIN HYDROCHLORIDE
CETROTIDE, CETRORELIX
CEVIMELINE, CEVIMELINE HYDROCHLORIDE
CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE
CHANTIX, VARENICLINE TARTRATE
CHEMET, SUCCIMER
CHENODIOL, CHENODIOL
CHG SCRUB, CHLORHEXIDINE GLUCONATE (OTC)
CHILDREN'S ADVIL, IBUPROFEN (OTC)
CHILDREN'S ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)
CHILDREN'S ADVIL COLD, IBUPROFEN (OTC)
CHILDREN'S ADVIL-FLAVORED, IBUPROFEN (OTC)
CHILDREN'S ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CLARITIN, LORATADINE (OTC)
CHILDREN'S ELIXSURE, IBUPROFEN (OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S IBUPROFEN, IBUPROFEN (OTC)
CHILDREN'S MOTRIN, IBUPROFEN (OTC)
CHILDREN'S MOTRIN COLD, IBUPROFEN (OTC)
CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 11
APPENDIX A - PRODUCT NAME INDEX
** C **
CHIRHOSTIM, SECRETIN SYNTHETIC HUMAN
CHLOR-TRIMETON, CHLORPHENIRAMINE MALEATE (OTC)
CHLORAMPHENICOL SODIUM SUCCINATE, CHLORAMPHENICOL SODIUM SUCCINATE
CHLORAPREP ONE-STEP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP ONE-STEP FREPP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP ONE-STEP SEPP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP SINGLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP TRIPLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP WITH TINT, CHLORHEXIDINE GLUCONATE (OTC)
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC)
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE
CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE
CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
CHLOROTHIAZIDE, CHLOROTHIAZIDE
CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM
CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE (OTC)
CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE
CHLORPROPAMIDE, CHLORPROPAMIDE
CHLORTHALIDONE, CHLORTHALIDONE
CHLORZOXAZONE, CHLORZOXAZONE
CHOLAC, LACTULOSE
CHOLEDYL SA, OXTRIPHYLLINE
CHOLESTYRAMINE, CHOLESTYRAMINE
CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE
CHOLETEC, TECHNETIUM TC-99M MEBROFENIN KIT
CHOLINE C-11, CHOLINE C-11
CHOLOGRAFIN MEGLUMINE, IODIPAMIDE MEGLUMINE
CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC
CHROMIC CHLORIDE IN PLASTIC CONTAINER, CHROMIC CHLORIDE
CIALIS, TADALAFIL
CICLOPIROX, CICLOPIROX
CIDA-STAT, CHLORHEXIDINE GLUCONATE (OTC)
CIDOFOVIR, CIDOFOVIR
CILOSTAZOL, CILOSTAZOL
CILOXAN, CIPROFLOXACIN HYDROCHLORIDE
CIMETIDINE, CIMETIDINE (OTC)
CIMETIDINE, CIMETIDINE
CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE
CIPRO, CIPROFLOXACIN
CIPRO, CIPROFLOXACIN HYDROCHLORIDE
CIPRO HC, CIPROFLOXACIN HYDROCHLORIDE
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPRODEX, CIPROFLOXACIN
CIPROFLOXACIN, CIPROFLOXACIN
CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIS-MDP, TECHNETIUM TC-99M MEDRONATE KIT
CIS-PYRO, TECHNETIUM TC-99M PYROPHOSPHATE KIT
CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE
CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE
CISPLATIN, CISPLATIN
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CITANEST FORTE DENTAL, EPINEPHRINE BITARTRATE
CLADRIBINE, CLADRIBINE
CLAFORAN, CEFOTAXIME SODIUM
CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER, CEFOTAXIME SODIUM
CLARAVIS, ISOTRETINOIN
CLARINEX, DESLORATADINE
CLARINEX D 24 HOUR, DESLORATADINE
CLARINEX-D 12 HOUR, DESLORATADINE
CLARITHROMYCIN, CLARITHROMYCIN
CLARITIN, LORATADINE (OTC)
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 12
APPENDIX A - PRODUCT NAME INDEX
** C **
CLARITIN HIVES RELIEF, LORATADINE (OTC)
CLARITIN HIVES RELIEF REDITAB, LORATADINE (OTC)
CLARITIN REDITABS, LORATADINE (OTC)
CLARITIN-D, LORATADINE (OTC)
CLARITIN-D 24 HOUR, LORATADINE (OTC)
CLEMASTINE FUMARATE, CLEMASTINE FUMARATE (OTC)
CLEMASTINE FUMARATE, CLEMASTINE FUMARATE
CLEOCIN, CLINDAMYCIN PALMITATE HYDROCHLORIDE
CLEOCIN, CLINDAMYCIN PHOSPHATE
CLEOCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLEOCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE
CLEOCIN T, CLINDAMYCIN PHOSPHATE
CLEVIPREX, CLEVIDIPINE
CLIMARA, ESTRADIOL
CLIMARA PRO, ESTRADIOL
CLINDA-DERM, CLINDAMYCIN PHOSPHATE
CLINDAGEL, CLINDAMYCIN PHOSPHATE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE
CLINDESSE, CLINDAMYCIN PHOSPHATE
CLINDETS, CLINDAMYCIN PHOSPHATE
CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX E 2.75/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 2.75/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 4.25/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 4.25/20 SULFITE-FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 4.25/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 4.25/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 5/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 5/15 SULFITE-FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 5/20 SULFITE-FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 5/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 5/35 SULFITE-FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER,
CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS
CLINOLIPID 20%, OLIVE OIL
CLINORIL, SULINDAC
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE
CLOBEX, CLOBETASOL PROPIONATE
CLODERM, CLOCORTOLONE PIVALATE
CLOLAR, CLOFARABINE
CLOMID, CLOMIPHENE CITRATE
CLOMIPHENE CITRATE, CLOMIPHENE CITRATE
CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE
CLONAZEPAM, CLONAZEPAM
CLONIDINE, CLONIDINE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
CLONIDINE HYDROCHLORIDE , CLONIDINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 13
APPENDIX A - PRODUCT NAME INDEX
** C **
CLOPIDOGREL, CLOPIDOGREL
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM
CLORPRES, CHLORTHALIDONE
CLOTRIMAZOLE, CLOTRIMAZOLE (OTC)
CLOTRIMAZOLE, CLOTRIMAZOLE
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CLOZAPINE, CLOZAPINE
CLOZARIL, CLOZAPINE
COARTEM, ARTEMETHER
CODEINE SULFATE, CODEINE SULFATE
COGENTIN, BENZTROPINE MESYLATE
COL-PROBENECID, COLCHICINE
COLAZAL, BALSALAZIDE DISODIUM
COLCRYS, COLCHICINE
COLESTID, COLESTIPOL HYDROCHLORIDE
COLESTIPOL HYDROCHLORIDE, COLESTIPOL HYDROCHLORIDE
COLGATE TOTAL, SODIUM FLUORIDE (OTC)
COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM
COLOCORT, HYDROCORTISONE
COLY-MYCIN M, COLISTIMETHATE SODIUM
COLY-MYCIN S, COLISTIN SULFATE
COLYTE, POLYETHYLENE GLYCOL 3350
COLYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350
COMBIGAN, BRIMONIDINE TARTRATE
COMBIPATCH, ESTRADIOL
COMBIVENT, ALBUTEROL SULFATE
COMBIVENT RESPIMAT, ALBUTEROL SULFATE
COMBIVIR, LAMIVUDINE
COMETRIQ, CABOZANTINIB S-MALATE
COMMIT, NICOTINE POLACRILEX (OTC)
COMPLERA, EMTRICITABINE
COMPRO, PROCHLORPERAZINE
COMTAN, ENTACAPONE
CONCERTA, METHYLPHENIDATE HYDROCHLORIDE
CONDYLOX, PODOFILOX
CONRAY, IOTHALAMATE MEGLUMINE
CONRAY 30, IOTHALAMATE MEGLUMINE
CONRAY 43, IOTHALAMATE MEGLUMINE
CONSTILAC, LACTULOSE
CONSTULOSE, LACTULOSE
CONTRAVE, BUPROPION HYDROCHLORIDE
CONZIP, TRAMADOL HYDROCHLORIDE
COPAXONE, GLATIRAMER ACETATE
COPEGUS, RIBAVIRIN
CORDARONE, AMIODARONE HYDROCHLORIDE
CORDRAN, FLURANDRENOLIDE
CORDRAN SP, FLURANDRENOLIDE
COREG, CARVEDILOL
COREG CR, CARVEDILOL PHOSPHATE
CORGARD, NADOLOL
CORLOPAM, FENOLDOPAM MESYLATE
CORMAX, CLOBETASOL PROPIONATE
CORTEF, HYDROCORTISONE
CORTENEMA, HYDROCORTISONE
CORTIFOAM, HYDROCORTISONE ACETATE
CORTISONE ACETATE, CORTISONE ACETATE
CORTISPORIN, BACITRACIN ZINC
CORTISPORIN, HYDROCORTISONE
CORTISPORIN, HYDROCORTISONE ACETATE
CORTROSYN, COSYNTROPIN
CORVERT, IBUTILIDE FUMARATE
CORZIDE, BENDROFLUMETHIAZIDE
COSMEGEN, DACTINOMYCIN
COSOPT, DORZOLAMIDE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 14
APPENDIX A - PRODUCT NAME INDEX
** C **
COSOPT PF, DORZOLAMIDE HYDROCHLORIDE
COSYNTROPIN, COSYNTROPIN
COUMADIN, WARFARIN SODIUM
COVERA-HS, VERAPAMIL HYDROCHLORIDE
COZAAR, LOSARTAN POTASSIUM
CREON, PANCRELIPASE (AMYLASE
CRESTOR, ROSUVASTATIN CALCIUM
CRINONE, PROGESTERONE
CRIXIVAN, INDINAVIR SULFATE
CROLOM, CROMOLYN SODIUM
CROMOLYN SODIUM, CROMOLYN SODIUM (OTC)
CROMOLYN SODIUM, CROMOLYN SODIUM
CROTAN, CROTAMITON
CRYSELLE, ETHINYL ESTRADIOL
CUBICIN, DAPTOMYCIN
CUPRIC CHLORIDE IN PLASTIC CONTAINER, CUPRIC CHLORIDE
CUPRIMINE, PENICILLAMINE
CUROSURF, PORACTANT ALFA
CUTIVATE, FLUTICASONE PROPIONATE
CUVPOSA, GLYCOPYRROLATE
CYANOCOBALAMIN, CYANOCOBALAMIN
CYANOKIT, HYDROXOCOBALAMIN
CYCLAFEM 1/35, ETHINYL ESTRADIOL
CYCLAFEM 7/7/7, ETHINYL ESTRADIOL
CYCLESSA, DESOGESTREL
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE
CYCLOMYDRIL, CYCLOPENTOLATE HYDROCHLORIDE
CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE
CYCLOSET, BROMOCRIPTINE MESYLATE
CYCLOSPORINE, CYCLOSPORINE
CYKLOKAPRON, TRANEXAMIC ACID
CYMBALTA, DULOXETINE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
CYSTADANE, BETAINE HYDROCHLORIDE
CYSTAGON, CYSTEAMINE BITARTRATE
CYSTARAN, CYSTEAMINE HYDROCHLORIDE
CYSTO-CONRAY II, IOTHALAMATE MEGLUMINE
CYSTOGRAFIN, DIATRIZOATE MEGLUMINE
CYSTOGRAFIN DILUTE, DIATRIZOATE MEGLUMINE
CYSVIEW KIT, HEXAMINOLEVULINATE HYDROCHLORIDE
CYTARABINE, CYTARABINE
CYTOMEL, LIOTHYRONINE SODIUM
CYTOSAR-U, CYTARABINE
CYTOTEC, MISOPROSTOL
CYTOVENE, GANCICLOVIR SODIUM
CYTOXAN (LYOPHILIZED), CYCLOPHOSPHAMIDE
** D **
D.H.E. 45, DIHYDROERGOTAMINE MESYLATE
DACARBAZINE, DACARBAZINE
DACOGEN, DECITABINE
DACTINOMYCIN, DACTINOMYCIN
DALIRESP, ROFLUMILAST
DALVANCE, DALBAVANCIN HYDROCHLORIDE
DANAZOL, DANAZOL
DANTRIUM, DANTROLENE SODIUM
DANTROLENE SODIUM, DANTROLENE SODIUM
DAPSONE, DAPSONE
DAPTOMYCIN, DAPTOMYCIN
DARAPRIM, PYRIMETHAMINE
DASETTA 1/35, ETHINYL ESTRADIOL
DASETTA 7/7/7, ETHINYL ESTRADIOL
DATSCAN, IOFLUPANE I-123
DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 15
APPENDIX A - PRODUCT NAME INDEX
** D **
DAUNOXOME, DAUNORUBICIN CITRATE
DAYPRO, OXAPROZIN
DAYSEE, ETHINYL ESTRADIOL
DAYTRANA, METHYLPHENIDATE
DDAVP, DESMOPRESSIN ACETATE
DDAVP (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE
DECITABINE, DECITABINE
DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE
DEFINITY, PERFLUTREN
DELATESTRYL, TESTOSTERONE ENANTHATE
DELESTROGEN, ESTRADIOL VALERATE
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELSYM, DEXTROMETHORPHAN POLISTIREX (OTC)
DELZICOL, MESALAMINE
DEMADEX, TORSEMIDE
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE
DEMEROL, MEPERIDINE HYDROCHLORIDE
DEMSER, METYROSINE
DENAVIR, PENCICLOVIR SODIUM
DENDRID, IDOXURIDINE
DEPACON, VALPROATE SODIUM
DEPAKENE, VALPROIC ACID
DEPAKOTE, DIVALPROEX SODIUM
DEPAKOTE ER, DIVALPROEX SODIUM
DEPEN, PENICILLAMINE
DEPO-ESTRADIOL, ESTRADIOL CYPIONATE
DEPO-MEDROL, METHYLPREDNISOLONE ACETATE
DEPO-PROVERA, MEDROXYPROGESTERONE ACETATE
DEPO-SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE
DEPO-TESTOSTERONE, TESTOSTERONE CYPIONATE
DEPOCYT, CYTARABINE
DERMA-SMOOTHE/FS, FLUOCINOLONE ACETONIDE
DERMABET, BETAMETHASONE VALERATE
DERMATOP, PREDNICARBATE
DERMATOP E EMOLLIENT, PREDNICARBATE
DERMOTIC, FLUOCINOLONE ACETONIDE
DESFERAL, DEFEROXAMINE MESYLATE
DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE
DESLORATADINE, DESLORATADINE
DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR, DESLORATADINE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE
DESOGEN, DESOGESTREL
DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL
DESONATE, DESONIDE
DESONIDE, DESONIDE
DESOWEN, DESONIDE
DESOXIMETASONE, DESOXIMETASONE
DESOXYN, METHAMPHETAMINE HYDROCHLORIDE
DESVENLAFAXINE, DESVENLAFAXINE
DESVENLAFAXINE, DESVENLAFAXINE FUMARATE
DETROL, TOLTERODINE TARTRATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 16
APPENDIX A - PRODUCT NAME INDEX
** D **
DETROL LA, TOLTERODINE TARTRATE
DEXAMETHASONE, DEXAMETHASONE
DEXAMETHASONE INTENSOL, DEXAMETHASONE
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DEXASPORIN, DEXAMETHASONE
DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE, DEXBROMPHENIRAMINE MALEATE (OTC)
DEXCHLORPHENIRAMINE MALEATE, DEXCHLORPHENIRAMINE MALEATE
DEXEDRINE, DEXTROAMPHETAMINE SULFATE
DEXFERRUM, IRON DEXTRAN
DEXILANT, DEXLANSOPRAZOLE
DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE
DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
DEXTROMETHORPHAN POLISTIREX, DEXTROMETHORPHAN POLISTIREX (OTC)
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 25%, DEXTROSE
DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND ELECTROLYTE NO 75 IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K), DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K), DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K), DEXTROSE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 17
APPENDIX A - PRODUCT NAME INDEX
** D **
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER,
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC CONTAINER,
DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 60% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE
DIABETA, GLYBURIDE
DIABINESE, CHLORPROPAMIDE
DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIAMOX, ACETAZOLAMIDE
DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIASTAT, DIAZEPAM
DIASTAT ACUDIAL, DIAZEPAM
DIAZEPAM, DIAZEPAM
DIAZEPAM INTENSOL, DIAZEPAM
DIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDE
DICLEGIS, DOXYLAMINE SUCCINATE
DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DICLOFENAC SODIUM , DICLOFENAC SODIUM
DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM
DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE), DICYCLOMINE HYDROCHLORIDE
DIDANOSINE, DIDANOSINE
DIDREX, BENZPHETAMINE HYDROCHLORIDE
DIDRONEL, ETIDRONATE DISODIUM
DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE
DIFFERIN, ADAPALENE
DIFICID, FIDAXOMICIN
DIFLORASONE DIACETATE, DIFLORASONE DIACETATE
DIFLUCAN, FLUCONAZOLE
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
DIFLUCAN IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
DIFLUNISAL, DIFLUNISAL
DIGOXIN, DIGOXIN
DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE
DILACOR XR, DILTIAZEM HYDROCHLORIDE
DILANTIN, PHENYTOIN
DILANTIN, PHENYTOIN SODIUM
DILANTIN-125, PHENYTOIN
DILATRATE-SR, ISOSORBIDE DINITRATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 18
APPENDIX A - PRODUCT NAME INDEX
** D **
DILAUDID, HYDROMORPHONE HYDROCHLORIDE
DILAUDID-HP, HYDROMORPHONE HYDROCHLORIDE
DILT-CD, DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DILTZAC, DILTIAZEM HYDROCHLORIDE
DIMENHYDRINATE, DIMENHYDRINATE
DIMETHYL SULFOXIDE, DIMETHYL SULFOXIDE
DIOVAN, VALSARTAN
DIOVAN HCT, HYDROCHLOROTHIAZIDE
DIPENTUM, OLSALAZINE SODIUM
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE
DIPRIVAN, PROPOFOL
DIPROLENE, BETAMETHASONE DIPROPIONATE
DIPROLENE AF, BETAMETHASONE DIPROPIONATE
DIPYRIDAMOLE, DIPYRIDAMOLE
DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE
DISULFIRAM, DISULFIRAM
DISULFIRAM , DISULFIRAM
DITROPAN XL, OXYBUTYNIN CHLORIDE
DIURIL, CHLOROTHIAZIDE
DIURIL, CHLOROTHIAZIDE SODIUM
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DIVIGEL, ESTRADIOL
DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE
DOCEFREZ, DOCETAXEL
DOCETAXEL, DOCETAXEL
DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%, DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE
DOPRAM, DOXAPRAM HYDROCHLORIDE
DORAL, QUAZEPAM
DORIBAX, DORIPENEM
DORYX, DOXYCYCLINE HYCLATE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DOTAREM, GADOTERATE MEGLUMINE
DOVONEX, CALCIPOTRIENE
DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
DOXERCALCIFEROL, DOXERCALCIFEROL
DOXIL (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE
DOXTERIC, DOXYCYCLINE HYCLATE
DOXY 100, DOXYCYCLINE HYCLATE
DOXY 200, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
DOXYCYCLINE, DOXYCYCLINE HYCLATE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC)
DRAXIMAGE MDP-25, TECHNETIUM TC-99M MEDRONATE
DRISDOL, ERGOCALCIFEROL
DRONABINOL, DRONABINOL
DROPERIDOL, DROPERIDOL
DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE
DROXIA, HYDROXYUREA
DTIC-DOME, DACARBAZINE
DTPA, TECHNETIUM TC-99M PENTETATE KIT
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 19
APPENDIX A - PRODUCT NAME INDEX
** D **
DUAC, BENZOYL PEROXIDE
DUAVEE, BAZEDOXIFENE ACETATE
DUETACT, GLIMEPIRIDE
DUEXIS, FAMOTIDINE
DULERA, FORMOTEROL FUMARATE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
DUODOTE, ATROPINE
DUONEB, ALBUTEROL SULFATE
DURACLON, CLONIDINE HYDROCHLORIDE
DURAGESIC-100, FENTANYL
DURAGESIC-12, FENTANYL
DURAGESIC-25, FENTANYL
DURAGESIC-50, FENTANYL
DURAGESIC-75, FENTANYL
DURAMORPH PF, MORPHINE SULFATE
DURAPREP, IODINE POVACRYLEX (OTC)
DUREZOL, DIFLUPREDNATE
DUTASTERIDE, DUTASTERIDE
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE
DUTOPROL, HYDROCHLOROTHIAZIDE
DYAZIDE, HYDROCHLOROTHIAZIDE
DYLOJECT, DICLOFENAC SODIUM
DYMISTA, AZELASTINE HYDROCHLORIDE
DYNA-HEX, CHLORHEXIDINE GLUCONATE (OTC)
DYNACIN, MINOCYCLINE HYDROCHLORIDE
DYRENIUM, TRIAMTERENE
** E **
E-Z SCRUB 201, POVIDONE-IODINE (OTC)
E-Z SCRUB 241, POVIDONE-IODINE (OTC)
E.E.S., ERYTHROMYCIN ETHYLSUCCINATE
E.E.S. 200, ERYTHROMYCIN ETHYLSUCCINATE
E.E.S. 400, ERYTHROMYCIN ETHYLSUCCINATE
EC-NAPROSYN, NAPROXEN
ECONAZOLE NITRATE, ECONAZOLE NITRATE
ECOZA, ECONAZOLE NITRATE
EDARBI, AZILSARTAN KAMEDOXOMIL
EDARBYCLOR, AZILSARTAN KAMEDOXOMIL
EDECRIN, ETHACRYNATE SODIUM
EDECRIN, ETHACRYNIC ACID
EDEX, ALPROSTADIL
EDLUAR, ZOLPIDEM TARTRATE
EDURANT, RILPIVIRINE HYDROCHLORIDE
EFFEXOR XR, VENLAFAXINE HYDROCHLORIDE
EFFIENT, PRASUGREL HYDROCHLORIDE
EFUDEX, FLUOROURACIL
EGRIFTA, TESAMORELIN ACETATE
ELDEPRYL, SELEGILINE HYDROCHLORIDE
ELELYSO, TALIGLUCERASE ALFA
ELESTAT, EPINASTINE HYDROCHLORIDE
ELESTRIN, ESTRADIOL
ELIDEL, PIMECROLIMUS
ELIGARD, LEUPROLIDE ACETATE
ELIMITE, PERMETHRIN
ELINEST, ETHINYL ESTRADIOL
ELIPHOS, CALCIUM ACETATE
ELIQUIS, APIXABAN
ELIXOPHYLLIN, THEOPHYLLINE
ELLA, ULIPRISTAL ACETATE
ELLENCE, EPIRUBICIN HYDROCHLORIDE
ELLIOTTS B SOLUTION, CALCIUM CHLORIDE
ELMIRON, PENTOSAN POLYSULFATE SODIUM
ELOCON, MOMETASONE FUROATE
ELOXATIN, OXALIPLATIN
EMADINE, EMEDASTINE DIFUMARATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 20
APPENDIX A - PRODUCT NAME INDEX
** E **
EMBEDA, MORPHINE SULFATE
EMBELINE, CLOBETASOL PROPIONATE
EMBELINE E, CLOBETASOL PROPIONATE
EMCYT, ESTRAMUSTINE PHOSPHATE SODIUM
EMEND, APREPITANT
EMEND, FOSAPREPITANT DIMEGLUMINE
EMLA, LIDOCAINE
EMOQUETTE, DESOGESTREL
EMSAM, SELEGILINE
EMTRIVA, EMTRICITABINE
ENABLEX, DARIFENACIN HYDROBROMIDE
ENALAPRIL MALEATE, ENALAPRIL MALEATE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
ENALAPRILAT, ENALAPRILAT
ENDOMETRIN, PROGESTERONE
ENDOSOL EXTRA, CALCIUM CHLORIDE
ENFLURANE, ENFLURANE
ENJUVIA, ESTROGENS, CONJUGATED SYNTHETIC B
ENLON, EDROPHONIUM CHLORIDE
ENLON-PLUS, ATROPINE SULFATE
ENOXAPARIN SODIUM, ENOXAPARIN SODIUM
ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM
ENPRESSE-28, ETHINYL ESTRADIOL
ENSKYCE, DESOGESTREL
ENTACAPONE, ENTACAPONE
ENTECAVIR, ENTECAVIR
ENTEREG, ALVIMOPAN
ENTOCORT EC, BUDESONIDE
ENULOSE, LACTULOSE
EOVIST, GADOXETATE DISODIUM
EPANED KIT, ENALAPRIL MALEATE
EPANOVA, OMEGA-3-CARBOXYLIC ACIDS
EPIDUO, ADAPALENE
EPIFOAM, HYDROCORTISONE ACETATE
EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE
EPINEPHRINE, EPINEPHRINE HYDROCHLORIDE
EPIPEN, EPINEPHRINE
EPIPEN JR., EPINEPHRINE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
EPITOL, CARBAMAZEPINE
EPIVIR, LAMIVUDINE
EPIVIR-HBV, LAMIVUDINE
EPLERENONE, EPLERENONE
EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM
EPROSARTAN MESYLATE, EPROSARTAN MESYLATE
EPZICOM, ABACAVIR SULFATE
EQUETRO, CARBAMAZEPINE
ERAXIS, ANIDULAFUNGIN
ERGOCALCIFEROL, ERGOCALCIFEROL
ERGOLOID MESYLATES, ERGOLOID MESYLATES
ERGOMAR, ERGOTAMINE TARTRATE
ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE
ERIVEDGE, VISMODEGIB
ERLOTINIB HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE
ERRIN, NORETHINDRONE
ERTACZO, SERTACONAZOLE NITRATE
ERY-TAB, ERYTHROMYCIN
ERYC, ERYTHROMYCIN
ERYGEL, ERYTHROMYCIN
ERYPED, ERYTHROMYCIN ETHYLSUCCINATE
ERYTHRA-DERM, ERYTHROMYCIN
ERYTHRO-STATIN, ERYTHROMYCIN
ERYTHROCIN, ERYTHROMYCIN LACTOBIONATE
ERYTHROCIN STEARATE, ERYTHROMYCIN STEARATE
ERYTHROMYCIN, ERYTHROMYCIN
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 21
APPENDIX A - PRODUCT NAME INDEX
** E **
ERYTHROMYCIN AND BENZOYL PEROXIDE, BENZOYL PEROXIDE
ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL, ERYTHROMYCIN ETHYLSUCCINATE
ESBRIET, PIRFENIDONE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE
ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM
ESOMEPRAZOLE STRONTIUM, ESOMEPRAZOLE STRONTIUM
ESTARYLLA, ETHINYL ESTRADIOL
ESTAZOLAM, ESTAZOLAM
ESTRACE, ESTRADIOL
ESTRADERM, ESTRADIOL
ESTRADIOL, ESTRADIOL
ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL
ESTRADIOL AND NORGESTIMATE, ESTRADIOL
ESTRADIOL VALERATE, ESTRADIOL VALERATE
ESTRASORB, ESTRADIOL HEMIHYDRATE
ESTRING, ESTRADIOL
ESTROGEL, ESTRADIOL
ESTROPIPATE, ESTROPIPATE
ESTROSTEP FE, ETHINYL ESTRADIOL
ESZOPICLONE, ESZOPICLONE
ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE
ETHAMOLIN, ETHANOLAMINE OLEATE
ETHOSUXIMIDE, ETHOSUXIMIDE
ETHRANE, ENFLURANE
ETHYOL, AMIFOSTINE
ETIDRONATE DISODIUM, ETIDRONATE DISODIUM
ETODOLAC, ETODOLAC
ETOMIDATE, ETOMIDATE
ETOPOPHOS PRESERVATIVE FREE, ETOPOSIDE PHOSPHATE
ETOPOSIDE, ETOPOSIDE
EURAX, CROTAMITON
EVAMIST, ESTRADIOL
EVISTA, RALOXIFENE HYDROCHLORIDE
EVOCLIN, CLINDAMYCIN PHOSPHATE
EVOXAC, CEVIMELINE HYDROCHLORIDE
EVZIO, NALOXONE HYDROCHLORIDE
EXALGO, HYDROMORPHONE HYDROCHLORIDE
EXCEDRIN (MIGRAINE), ACETAMINOPHEN (OTC)
EXELDERM, SULCONAZOLE NITRATE
EXELON, RIVASTIGMINE
EXELON, RIVASTIGMINE TARTRATE
EXEMESTANE, EXEMESTANE
EXFORGE, AMLODIPINE BESYLATE
EXFORGE HCT, AMLODIPINE BESYLATE
EXIDINE, CHLORHEXIDINE GLUCONATE (OTC)
EXJADE, DEFERASIROX
EXPAREL, BUPIVACAINE
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
EXTINA, KETOCONAZOLE
EXTRANEAL, ICODEXTRIN
** F **
FABIOR, TAZAROTENE
FACTIVE, GEMIFLOXACIN MESYLATE
FALLBACK SOLO, LEVONORGESTREL (OTC)
FALMINA, ETHINYL ESTRADIOL
FAMCICLOVIR, FAMCICLOVIR
FAMOTIDINE, FAMOTIDINE (OTC)
FAMOTIDINE, FAMOTIDINE
FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE
FAMVIR, FAMCICLOVIR
FANAPT, ILOPERIDONE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 22
APPENDIX A - PRODUCT NAME INDEX
** F **
FARESTON, TOREMIFENE CITRATE
FARXIGA, DAPAGLIFLOZIN
FASLODEX, FULVESTRANT
FAZACLO ODT, CLOZAPINE
FELBAMATE, FELBAMATE
FELBATOL, FELBAMATE
FELDENE, PIROXICAM
FELODIPINE, FELODIPINE
FEMARA, LETROZOLE
FEMCON FE, ETHINYL ESTRADIOL
FEMHRT, ETHINYL ESTRADIOL
FEMRING, ESTRADIOL ACETATE
FEMSTAT 3, BUTOCONAZOLE NITRATE (OTC)
FEMTRACE, ESTRADIOL ACETATE
FENOFIBRATE, FENOFIBRATE
FENOFIBRATE (MICRONIZED), FENOFIBRATE
FENOFIBRIC ACID, CHOLINE FENOFIBRATE
FENOGLIDE, FENOFIBRATE
FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE
FENOPROFEN CALCIUM, FENOPROFEN CALCIUM
FENTANYL CITRATE, FENTANYL CITRATE
FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE
FENTANYL-100, FENTANYL
FENTANYL-12, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-37, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-62, FENTANYL
FENTANYL-75, FENTANYL
FENTANYL-87, FENTANYL
FENTORA, FENTANYL CITRATE
FERAHEME, FERUMOXYTOL
FERRIC CITRATE, FERRIC CITRATE
FERRIPROX, DEFERIPRONE
FERRLECIT, SODIUM FERRIC GLUCONATE COMPLEX
FETZIMA, LEVOMILNACIPRAN HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
FIBRICOR, FENOFIBRIC ACID
FINACEA, AZELAIC ACID
FINASTERIDE, FINASTERIDE
FIORICET W/ CODEINE, ACETAMINOPHEN
FIORINAL, ASPIRIN
FIORINAL W/CODEINE, ASPIRIN
FIRAZYR, ICATIBANT ACETATE
FIRMAGON, DEGARELIX ACETATE
FLAGYL, METRONIDAZOLE
FLAGYL ER, METRONIDAZOLE
FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE
FLAREX, FLUOROMETHOLONE ACETATE
FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE
FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE
FLECAINIDE ACETATE, FLECAINIDE ACETATE
FLECTOR, DICLOFENAC EPOLAMINE
FLO-PRED, PREDNISOLONE ACETATE
FLOLAN, EPOPROSTENOL SODIUM
FLOMAX, TAMSULOSIN HYDROCHLORIDE
FLONASE, FLUTICASONE PROPIONATE
FLONASE ALLERGY RELIEF, FLUTICASONE PROPIONATE (OTC)
FLOVENT DISKUS 100, FLUTICASONE PROPIONATE
FLOVENT DISKUS 250, FLUTICASONE PROPIONATE
FLOVENT DISKUS 50, FLUTICASONE PROPIONATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 23
APPENDIX A - PRODUCT NAME INDEX
** F **
FLOVENT HFA, FLUTICASONE PROPIONATE
FLOXIN OTIC, OFLOXACIN
FLOXURIDINE, FLOXURIDINE
FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUCONAZOLE, FLUCONAZOLE
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUCYTOSINE, FLUCYTOSINE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE
FLUMADINE, RIMANTADINE HYDROCHLORIDE
FLUMAZENIL, FLUMAZENIL
FLUNISOLIDE, FLUNISOLIDE
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
FLUOCINONIDE, FLUOCINONIDE
FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE
FLUORESCITE, FLUORESCEIN SODIUM
FLUOROPLEX, FLUOROURACIL
FLUOROURACIL, FLUOROURACIL
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUOXYMESTERONE, FLUOXYMESTERONE
FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE
FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE
FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE
FLURBIPROFEN, FLURBIPROFEN
FLURBIPROFEN SODIUM, FLURBIPROFEN SODIUM
FLUTAMIDE, FLUTAMIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
FLUVASTATIN SODIUM, FLUVASTATIN SODIUM
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
FML, FLUOROMETHOLONE
FML FORTE, FLUOROMETHOLONE
FOAMCOAT, ALUMINUM HYDROXIDE (OTC)
FOCALIN, DEXMETHYLPHENIDATE HYDROCHLORIDE
FOCALIN XR, DEXMETHYLPHENIDATE HYDROCHLORIDE
FOLIC ACID, FOLIC ACID
FOLLISTIM AQ, FOLLITROPIN ALFA/BETA
FOLOTYN, PRALATREXATE
FOMEPIZOLE, FOMEPIZOLE
FONDAPARINUX SODIUM, FONDAPARINUX SODIUM
FORADIL, FORMOTEROL FUMARATE
FORANE, ISOFLURANE
FORFIVO XL, BUPROPION HYDROCHLORIDE
FORTAMET, METFORMIN HYDROCHLORIDE
FORTAZ, CEFTAZIDIME
FORTAZ IN PLASTIC CONTAINER, CEFTAZIDIME SODIUM
FORTEO, TERIPARATIDE RECOMBINANT HUMAN
FORTESTA, TESTOSTERONE
FORTICAL, CALCITONIN SALMON RECOMBINANT
FOSAMAX, ALENDRONATE SODIUM
FOSAMAX PLUS D, ALENDRONATE SODIUM
FOSCARNET SODIUM, FOSCARNET SODIUM
FOSCAVIR, FOSCARNET SODIUM
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
FOSRENOL, LANTHANUM CARBONATE
FRAGMIN, DALTEPARIN SODIUM
FREAMINE HBC 6.9%, AMINO ACIDS
FREAMINE III 10%, AMINO ACIDS
FREAMINE III 3% W/ ELECTROLYTES, AMINO ACIDS
FREAMINE III 8.5%, AMINO ACIDS
FREAMINE III 8.5% W/ ELECTROLYTES, AMINO ACIDS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 24
APPENDIX A - PRODUCT NAME INDEX
** F **
FROVA, FROVATRIPTAN SUCCINATE
FROVATRIPTAN SUCCINATE, FROVATRIPTAN SUCCINATE
FULYZAQ, CROFELEMER
FURADANTIN, NITROFURANTOIN
FUROSEMIDE, FUROSEMIDE
FUSILEV, LEVOLEUCOVORIN CALCIUM
FUZEON, ENFUVIRTIDE
FYCOMPA, PERAMPANEL
** G **
GABAPENTIN, GABAPENTIN
GABITRIL, TIAGABINE HYDROCHLORIDE
GABLOFEN, BACLOFEN
GADAVIST, GADOBUTROL
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67
GALZIN, ZINC ACETATE
GANCICLOVIR, GANCICLOVIR SODIUM
GANIRELIX ACETATE, GANIRELIX ACETATE
GASTROCROM, CROMOLYN SODIUM
GASTROGRAFIN, DIATRIZOATE MEGLUMINE
GATIFLOXACIN, GATIFLOXACIN
GATTEX KIT, TEDUGLUTIDE RECOMBINANT
GAVISCON, ALUMINUM HYDROXIDE (OTC)
GELNIQUE, OXYBUTYNIN CHLORIDE
GELNIQUE 3%, OXYBUTYNIN
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GEMFIBROZIL, GEMFIBROZIL
GEMZAR, GEMCITABINE HYDROCHLORIDE
GEN-XENE, CLORAZEPATE DIPOTASSIUM
GENERLAC, LACTULOSE
GENGRAF, CYCLOSPORINE
GENOPTIC, GENTAMICIN SULFATE
GENOTROPIN, SOMATROPIN RECOMBINANT
GENOTROPIN PRESERVATIVE FREE, SOMATROPIN RECOMBINANT
GENTAK, GENTAMICIN SULFATE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE
GEODON, ZIPRASIDONE HYDROCHLORIDE
GEODON, ZIPRASIDONE MESYLATE
GIAZO, BALSALAZIDE DISODIUM
GILDAGIA, ETHINYL ESTRADIOL
GILDESS 1.5/30, ETHINYL ESTRADIOL
GILDESS 1/20, ETHINYL ESTRADIOL
GILDESS 24 FE, ETHINYL ESTRADIOL
GILDESS FE 1.5/30, ETHINYL ESTRADIOL
GILDESS FE 1/20, ETHINYL ESTRADIOL
GILENYA, FINGOLIMOD
GILOTRIF, AFATINIB DIMALEATE
GLEEVEC, IMATINIB MESYLATE
GLEOSTINE, LOMUSTINE
GLIADEL, CARMUSTINE
GLIMEPIRIDE, GLIMEPIRIDE
GLIPIZIDE, GLIPIZIDE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
GLOFIL-125, IOTHALAMATE SODIUM I-125
GLUCAGEN, GLUCAGON HYDROCHLORIDE RECOMBINANT
GLUCAGON, GLUCAGON RECOMBINANT
GLUCOPHAGE, METFORMIN HYDROCHLORIDE
GLUCOPHAGE XR, METFORMIN HYDROCHLORIDE
GLUCOTROL, GLIPIZIDE
GLUCOTROL XL, GLIPIZIDE
GLUCOVANCE, GLYBURIDE
GLUMETZA, METFORMIN HYDROCHLORIDE
GLYBURIDE, GLYBURIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 25
APPENDIX A - PRODUCT NAME INDEX
** G **
GLYBURIDE (MICRONIZED), GLYBURIDE
GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE
GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE
GLYCOLAX, POLYETHYLENE GLYCOL 3350 (OTC)
GLYCOLAX, POLYETHYLENE GLYCOL 3350
GLYCOPYRROLATE, GLYCOPYRROLATE
GLYDO, LIDOCAINE HYDROCHLORIDE
GLYNASE, GLYBURIDE
GLYSET, MIGLITOL
GOLYTELY, POLYETHYLENE GLYCOL 3350
GONAL-F, FOLLITROPIN ALFA/BETA
GONAL-F RFF, FOLLITROPIN ALFA/BETA
GONAL-F RFF REDI-JECT, FOLLITROPIN ALFA/BETA
GRALISE, GABAPENTIN
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE
GRANISTERON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
GRIFULVIN V, GRISEOFULVIN, MICROSIZE
GRIS-PEG, GRISEOFULVIN, ULTRAMICROSIZE
GRISEOFULVIN, GRISEOFULVIN, MICROSIZE
GRISEOFULVIN, ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE
GRISEOFULVIN,ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE
GUAIFENESIN, GUAIFENESIN (OTC)
GUANABENZ ACETATE, GUANABENZ ACETATE
GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE
GUANIDINE HYDROCHLORIDE, GUANIDINE HYDROCHLORIDE
GYNE-LOTRIMIN, CLOTRIMAZOLE (OTC)
GYNE-LOTRIMIN 3, CLOTRIMAZOLE (OTC)
GYNE-LOTRIMIN 3 COMBINATION PACK, CLOTRIMAZOLE (OTC)
GYNE-LOTRIMIN COMBINATION PACK, CLOTRIMAZOLE (OTC)
** H **
H.P. ACTHAR GEL, CORTICOTROPIN
HABITROL, NICOTINE (OTC)
HALAVEN, ERIBULIN MESYLATE
HALCION, TRIAZOLAM
HALDOL, HALOPERIDOL DECANOATE
HALDOL, HALOPERIDOL LACTATE
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
HALOG, HALCINONIDE
HALOPERIDOL, HALOPERIDOL
HALOPERIDOL, HALOPERIDOL LACTATE
HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE
HARVONI, LEDIPASVIR
HEATHER, NORETHINDRONE
HECTOROL, DOXERCALCIFEROL
HEMABATE, CARBOPROST TROMETHAMINE
HEMANGEOL, PROPRANOLOL HYDROCHLORIDE
HEPARIN SODIUM, HEPARIN SODIUM
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM
HEPATAMINE 8%, AMINO ACIDS
HEPATOLITE, TECHNETIUM TC-99M DISOFENIN KIT
HEPSERA, ADEFOVIR DIPIVOXIL
HERPLEX, IDOXURIDINE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 26
APPENDIX A - PRODUCT NAME INDEX
** H **
HETLIOZ, TASIMELTEON
HEXABRIX, IOXAGLATE MEGLUMINE
HEXALEN, ALTRETAMINE
HIBICLENS, CHLORHEXIDINE GLUCONATE (OTC)
HIBISTAT, CHLORHEXIDINE GLUCONATE (OTC)
HICON, SODIUM IODIDE I-131
HIPREX, METHENAMINE HIPPURATE
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, HOMATROPINE METHYLBROMIDE
HORIZANT, GABAPENTIN ENACARBIL
HUMALOG, INSULIN LISPRO RECOMBINANT
HUMALOG KWIKPEN, INSULIN LISPRO RECOMBINANT
HUMALOG MIX 50/50, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 50/50 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 75/25, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 75/25 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMATROPE, SOMATROPIN RECOMBINANT
HUMULIN 70/30, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN 70/30 PEN, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC)
HUMULIN R, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN R, INSULIN RECOMBINANT HUMAN
HUMULIN R PEN, INSULIN RECOMBINANT HUMAN (OTC)
HYCAMTIN, TOPOTECAN HYDROCHLORIDE
HYDERGINE, ERGOLOID MESYLATES
HYDRA-ZIDE, HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDREA, HYDROXYUREA
HYDRO-RX, HYDROCORTISONE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE
HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE
HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE, HYDROCODONE BITARTRATE
HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE,
HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE ,
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX, CHLORPHENIRAMINE POLISTIREX
HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX, CHLORPHENIRAMINE POLISTIREX
HYDROCORTISONE, HYDROCORTISONE
HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE
HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL
HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE
HYDROCORTISONE IN ABSORBASE, HYDROCORTISONE
HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
HYDROXOCOBALAMIN, HYDROXOCOBALAMIN
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
HYDROXYUREA, HYDROXYUREA
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE
HYLENEX RECOMBINANT, HYALURONIDASE RECOMBINANT HUMAN
HYSINGLA, HYDROCODONE BITARTRATE
HYZAAR, HYDROCHLOROTHIAZIDE
** I **
IBANDRONATE SODIUM, IBANDRONATE SODIUM
IBU-TAB, IBUPROFEN
IBU-TAB 200, IBUPROFEN (OTC)
IBUPROFEN, IBUPROFEN (OTC)
IBUPROFEN, IBUPROFEN
IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC)
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)
IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE, IBUPROFEN (OTC)
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)
IBUPROHM, IBUPROFEN (OTC)
IBUPROHM COLD AND SINUS, IBUPROFEN (OTC)
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 27
APPENDIX A - PRODUCT NAME INDEX
** I **
IBUTILIDE FUMARATE, IBUTILIDE FUMARATE
IC-GREEN, INDOCYANINE GREEN
ICLUSIG, PONATINIB HYDROCHLORIDE
IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE
IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE
IDARUBICIN HYDROCHLORIDE PFS, IDARUBICIN HYDROCHLORIDE
IDKIT:HP, CITRIC ACID
IFEX, IFOSFAMIDE
IFOSFAMIDE, IFOSFAMIDE
IFOSFAMIDE/MESNA KIT, IFOSFAMIDE
ILEVRO, NEPAFENAC
ILUVIEN, FLUOCINOLONE ACETONIDE
IMBRUVICA, IBRUTINIB
IMIPENEM AND CILASTATIN, CILASTATIN SODIUM
IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE
IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE
IMIQUIMOD, IMIQUIMOD
IMITREX, SUMATRIPTAN
IMITREX, SUMATRIPTAN SUCCINATE
IMITREX STATDOSE, SUMATRIPTAN SUCCINATE
IMODIUM, LOPERAMIDE HYDROCHLORIDE
IMODIUM A-D, LOPERAMIDE HYDROCHLORIDE (OTC)
IMODIUM A-D EZ CHEWS, LOPERAMIDE HYDROCHLORIDE (OTC)
IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE (OTC)
IMPAVIDO, MILTEFOSINE
IMPLANON, ETONOGESTREL
IMURAN, AZATHIOPRINE
INAPSINE, DROPERIDOL
INCIVEK, TELAPREVIR
INCRELEX, MECASERMIN RECOMBINANT
INCRUSE ELLIPTA , UMECLIDINIUM BROMIDE
INDAPAMIDE, INDAPAMIDE
INDERAL LA, PROPRANOLOL HYDROCHLORIDE
INDERIDE-40/25, HYDROCHLOROTHIAZIDE
INDICLOR, INDIUM IN-111 CHLORIDE
INDIUM IN 111 CHLORIDE, INDIUM IN-111 CHLORIDE
INDIUM IN-111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE
INDOCIN, INDOMETHACIN
INDOCIN, INDOMETHACIN SODIUM
INDOCYANINE GREEN, INDOCYANINE GREEN
INDOMETHACIN, INDOMETHACIN
INDOMETHACIN SODIUM, INDOMETHACIN SODIUM
INFANTS' FEVERALL, ACETAMINOPHEN (OTC)
INFASURF PRESERVATIVE FREE, CALFACTANT
INFED, IRON DEXTRAN
INFUMORPH, MORPHINE SULFATE
INFUVITE ADULT, ALPHA-TOCOPHEROL ACETATE
INFUVITE PEDIATRIC, ASCORBIC ACID
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), ASCORBIC ACID
INJECTAFER, FERRIC CARBOXYMALTOSE
INLYTA, AXITINIB
INNOPRAN XL, PROPRANOLOL HYDROCHLORIDE
INOMAX, NITRIC OXIDE
INSPRA, EPLERENONE
INTEGRILIN, EPTIFIBATIDE
INTELENCE, ETRAVIRINE
INTERMEZZO, ZOLPIDEM TARTRATE
INTRALIPID 10%, SOYBEAN OIL
INTRALIPID 20%, SOYBEAN OIL
INTRALIPID 30%, SOYBEAN OIL
INTROVALE, ETHINYL ESTRADIOL
INTUNIV, GUANFACINE HYDROCHLORIDE
INVANZ, ERTAPENEM SODIUM
INVEGA, PALIPERIDONE
INVEGA SUSTENNA, PALIPERIDONE PALMITATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 28
APPENDIX A - PRODUCT NAME INDEX
** I **
INVIRASE, SAQUINAVIR MESYLATE
INVOKAMET, CANAGLIFLOZIN
INVOKANA, CANAGLIFLOZIN
IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
IOPAMIDOL-250, IOPAMIDOL
IOPAMIDOL-300, IOPAMIDOL
IOPAMIDOL-370, IOPAMIDOL
IOPIDINE, APRACLONIDINE HYDROCHLORIDE
IOSAT, POTASSIUM IODIDE (OTC)
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
IPRIVASK, DESIRUDIN RECOMBINANT
IRBESARTAN, IRBESARTAN
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
ISENTRESS, RALTEGRAVIR POTASSIUM
ISOCAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE
ISOFLURANE, ISOFLURANE
ISOLYTE E IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE S IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
ISOLYTE S PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
ISONIAZID, ISONIAZID
ISOPTO CARPINE, PILOCARPINE HYDROCHLORIDE
ISORDIL, ISOSORBIDE DINITRATE
ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
ISOSULFAN BLUE, ISOSULFAN BLUE
ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER, GENTAMICIN SULFATE
ISOVUE-200, IOPAMIDOL
ISOVUE-250, IOPAMIDOL
ISOVUE-300, IOPAMIDOL
ISOVUE-370, IOPAMIDOL
ISOVUE-M 200, IOPAMIDOL
ISOVUE-M 300, IOPAMIDOL
ISRADIPINE, ISRADIPINE
ISTALOL, TIMOLOL MALEATE
ISTODAX, ROMIDEPSIN
ISUPREL, ISOPROTERENOL HYDROCHLORIDE
ITRACONAZOLE, ITRACONAZOLE
IVERMECTIN, IVERMECTIN
IVY BLOCK, BENTOQUATAM (OTC)
IXEMPRA KIT, IXABEPILONE
IZBA, TRAVOPROST
** J **
JAKAFI, RUXOLITINIB PHOSPHATE
JALYN, DUTASTERIDE
JANTOVEN, WARFARIN SODIUM
JANUMET, METFORMIN HYDROCHLORIDE
JANUMET XR, METFORMIN HYDROCHLORIDE
JANUVIA, SITAGLIPTIN PHOSPHATE
JARDIANCE, EMPAGLIFLOZIN
JEANATOPE, ALBUMIN IODINATED I-125 SERUM
JENCYCLA, NORETHINDRONE
JENTADUETO, LINAGLIPTIN
JEVTANA KIT, CABAZITAXEL
JUBLIA, EFINACONAZOLE
JUNEL 1.5/30, ETHINYL ESTRADIOL
JUNEL 1/20, ETHINYL ESTRADIOL
JUNEL FE 1.5/30, ETHINYL ESTRADIOL
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 29
APPENDIX A - PRODUCT NAME INDEX
** J **
JUNEL FE 1/20, ETHINYL ESTRADIOL
JUNIOR STRENGTH ADVIL, IBUPROFEN (OTC)
JUNIOR STRENGTH IBUPROFEN, IBUPROFEN (OTC)
JUNIOR STRENGTH MOTRIN, IBUPROFEN (OTC)
JUXTAPID, LOMITAPIDE MESYLATE
** K **
K-TAB, POTASSIUM CHLORIDE
KABIVEN IN PLASTIC CONTAINER, AMINO ACIDS
KADIAN, MORPHINE SULFATE
KALETRA, LOPINAVIR
KALEXATE, SODIUM POLYSTYRENE SULFONATE
KALYDECO, IVACAFTOR
KANAMYCIN SULFATE, KANAMYCIN SULFATE
KAPVAY, CLONIDINE HYDROCHLORIDE
KARBINAL ER, CARBINOXAMINE MALEATE
KARIVA, DESOGESTREL
KAYEXALATE, SODIUM POLYSTYRENE SULFONATE
KAZANO, ALOGLIPTIN BENZOATE
KEFLEX, CEPHALEXIN
KEFZOL, CEFAZOLIN SODIUM
KELNOR, ETHINYL ESTRADIOL
KENALOG, TRIAMCINOLONE ACETONIDE
KENALOG-10, TRIAMCINOLONE ACETONIDE
KENALOG-40, TRIAMCINOLONE ACETONIDE
KEPPRA, LEVETIRACETAM
KEPPRA XR, LEVETIRACETAM
KERYDIN, TAVABOROLE
KETALAR, KETAMINE HYDROCHLORIDE
KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE
KETEK, TELITHROMYCIN
KETOCONAZOLE, KETOCONAZOLE
KETOPROFEN, KETOPROFEN
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC)
KETOZOLE, KETOCONAZOLE
KHEDEZLA, DESVENLAFAXINE
KINEVAC, SINCALIDE
KIONEX, SODIUM POLYSTYRENE SULFONATE
KITABIS PAK, TOBRAMYCIN
KLARON, SULFACETAMIDE SODIUM
KLONOPIN, CLONAZEPAM
KLOR-CON, POTASSIUM CHLORIDE
KLOR-CON M10, POTASSIUM CHLORIDE
KLOR-CON M15, POTASSIUM CHLORIDE
KLOR-CON M20, POTASSIUM CHLORIDE
KOMBIGLYZE XR, METFORMIN HYDROCHLORIDE
KORLYM, MIFEPRISTONE
KURVELO, ETHINYL ESTRADIOL
KUVAN, SAPROPTERIN DIHYDROCHLORIDE
KYNAMRO, MIPOMERSEN SODIUM
KYPROLIS, CARFILZOMIB
** L **
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
LABETALOL HYDROCLORIDE, LABETALOL HYDROCHLORIDE
LAC-HYDRIN, AMMONIUM LACTATE
LACRISERT, HYDROXYPROPYL CELLULOSE
LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LACTULOSE, LACTULOSE
LAMICTAL, LAMOTRIGINE
LAMICTAL CD, LAMOTRIGINE
LAMICTAL ODT, LAMOTRIGINE
LAMICTAL XR, LAMOTRIGINE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 30
APPENDIX A - PRODUCT NAME INDEX
** L **
LAMISIL, TERBINAFINE HYDROCHLORIDE (OTC)
LAMISIL, TERBINAFINE HYDROCHLORIDE
LAMISIL AT, TERBINAFINE (OTC)
LAMISIL AT, TERBINAFINE HYDROCHLORIDE (OTC)
LAMIVUDINE, LAMIVUDINE
LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE
LAMOTRIGINE, LAMOTRIGINE
LAMPRENE, CLOFAZIMINE
LANIAZID, ISONIAZID
LANORINAL, ASPIRIN
LANOXIN, DIGOXIN
LANOXIN PEDIATRIC, DIGOXIN
LANSOPRAZOLE, LANSOPRAZOLE (OTC)
LANSOPRAZOLE, LANSOPRAZOLE
LANSOPRAZOLE , LANSOPRAZOLE
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN, AMOXICILLIN
LANTUS, INSULIN GLARGINE RECOMBINANT
LANTUS SOLOSTAR, INSULIN GLARGINE RECOMBINANT
LARIN 1.5/30, ETHINYL ESTRADIOL
LARIN 1/20, ETHINYL ESTRADIOL
LARIN FE 1.5/30, ETHINYL ESTRADIOL
LARIN FE 1/20, ETHINYL ESTRADIOL
LAROTID, AMOXICILLIN
LARYNG-O-JET KIT, LIDOCAINE HYDROCHLORIDE
LASIX, FUROSEMIDE
LASTACAFT, ALCAFTADINE
LATANOPROST, LATANOPROST
LATISSE, BIMATOPROST
LATUDA, LURASIDONE HYDROCHLORIDE
LAX-LYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350
LAZANDA, FENTANYL CITRATE
LEFLUNOMIDE, LEFLUNOMIDE
LESCOL, FLUVASTATIN SODIUM
LESCOL XL, FLUVASTATIN SODIUM
LESSINA-28, ETHINYL ESTRADIOL
LETAIRIS, AMBRISENTAN
LETROZOLE, LETROZOLE
LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM
LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM
LEUKERAN, CHLORAMBUCIL
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE
LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE
LEVAQUIN, LEVOFLOXACIN
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
LEVEMIR, INSULIN DETEMIR RECOMBINANT
LEVEMIR FLEXPEN, INSULIN DETEMIR RECOMBINANT
LEVEMIR FLEXTOUCH, INSULIN DETEMIR RECOMBINANT
LEVETIRACETAM, LEVETIRACETAM
LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM
LEVITRA, VARDENAFIL HYDROCHLORIDE
LEVO-T, LEVOTHYROXINE SODIUM **
LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE
LEVOCARNITINE, LEVOCARNITINE
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOFLOXACIN, LEVOFLOXACIN
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
LEVONEST, ETHINYL ESTRADIOL
LEVONORGESTREL, LEVONORGESTREL (OTC)
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
LEVOPHED, NOREPINEPHRINE BITARTRATE
LEVORA 0.15/30-28, ETHINYL ESTRADIOL
LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE
LEVOTHROID, LEVOTHYROXINE SODIUM **
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 31
APPENDIX A - PRODUCT NAME INDEX
** L **
LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM
LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM **
LEVOXYL, LEVOTHYROXINE SODIUM **
LEVULAN, AMINOLEVULINIC ACID HYDROCHLORIDE
LEXAPRO, ESCITALOPRAM OXALATE
LEXISCAN, REGADENOSON
LEXIVA, FOSAMPRENAVIR CALCIUM
LIALDA, MESALAMINE
LIBRIUM, CHLORDIAZEPOXIDE HYDROCHLORIDE
LIDEX, FLUOCINONIDE
LIDOCAINE, LIDOCAINE
LIDOCAINE AND PRILOCAINE, LIDOCAINE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE VISCOUS, LIDOCAINE HYDROCHLORIDE
LIDOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE
LIDODERM, LIDOCAINE
LIGNOSPAN FORTE, EPINEPHRINE BITARTRATE
LIGNOSPAN STANDARD, EPINEPHRINE BITARTRATE
LINCOCIN, LINCOMYCIN HYDROCHLORIDE
LINDANE, LINDANE
LINEZOLID, LINEZOLID
LINZESS, LINACLOTIDE
LIORESAL, BACLOFEN
LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM
LIPIODOL, ETHIODIZED OIL
LIPITOR, ATORVASTATIN CALCIUM
LIPOFEN, FENOFIBRATE
LIPTRUZET, ATORVASTATIN CALCIUM
LISINOPRIL, LISINOPRIL
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LITHIUM CARBONATE, LITHIUM CARBONATE
LITHIUM CITRATE, LITHIUM CITRATE
LITHOBID, LITHIUM CARBONATE
LITHOSTAT, ACETOHYDROXAMIC ACID
LIVALO, PITAVASTATIN CALCIUM
LO LOESTRIN FE, ETHINYL ESTRADIOL
LO MINASTRIN FE, ETHINYL ESTRADIOL
LO/OVRAL-28, ETHINYL ESTRADIOL
LOCOID, HYDROCORTISONE BUTYRATE
LOCOID LIPOCREAM, HYDROCORTISONE BUTYRATE
LODOSYN, CARBIDOPA
LOESTRIN 21 1.5/30, ETHINYL ESTRADIOL
LOESTRIN 21 1/20, ETHINYL ESTRADIOL
LOESTRIN 24 FE, ETHINYL ESTRADIOL
LOESTRIN FE 1.5/30, ETHINYL ESTRADIOL
LOESTRIN FE 1/20, ETHINYL ESTRADIOL
LOMOTIL, ATROPINE SULFATE
LONOX, ATROPINE SULFATE
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC)
LOPID, GEMFIBROZIL
LOPRESSOR, METOPROLOL TARTRATE
LOPRESSOR HCT, HYDROCHLOROTHIAZIDE
LOPROX, CICLOPIROX
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 32
APPENDIX A - PRODUCT NAME INDEX
** L **
LOPURIN, ALLOPURINOL
LORATADINE, LORATADINE (OTC)
LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC)
LORATADINE REDIDOSE, LORATADINE (OTC)
LORAZEPAM, LORAZEPAM
LORAZEPAM INTENSOL, LORAZEPAM
LORAZEPAM PRESERVATIVE FREE, LORAZEPAM
LORYNA, DROSPIRENONE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSEASONIQUE, ETHINYL ESTRADIOL
LOTEMAX, LOTEPREDNOL ETABONATE
LOTENSIN, BENAZEPRIL HYDROCHLORIDE
LOTENSIN HCT, BENAZEPRIL HYDROCHLORIDE
LOTREL, AMLODIPINE BESYLATE
LOTRIMIN ULTRA, BUTENAFINE HYDROCHLORIDE (OTC)
LOTRISONE, BETAMETHASONE DIPROPIONATE
LOTRONEX, ALOSETRON HYDROCHLORIDE
LOVASTATIN, LOVASTATIN
LOVAZA, OMEGA-3-ACID ETHYL ESTERS
LOVENOX, ENOXAPARIN SODIUM
LOVENOX (PRESERVATIVE FREE), ENOXAPARIN SODIUM
LOXAPINE SUCCINATE, LOXAPINE SUCCINATE
LTA II KIT, LIDOCAINE HYDROCHLORIDE
LUFYLLIN, DYPHYLLINE
LUMASON, SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES
LUMIGAN, BIMATOPROST
LUNESTA, ESZOPICLONE
LUPANETA PACK, LEUPROLIDE ACETATE
LUPRON DEPOT, LEUPROLIDE ACETATE
LUPRON DEPOT-PED, LEUPROLIDE ACETATE
LUVOX, FLUVOXAMINE MALEATE
LUVOX CR, FLUVOXAMINE MALEATE
LUXIQ, BETAMETHASONE VALERATE
LUZU, LULICONAZOLE
LYMPHOSEEK KIT, TECHNETIUM TC-99M TILMANOCEPT
LYRICA, PREGABALIN
LYSODREN, MITOTANE
LYSTEDA, TRANEXAMIC ACID
** M **
M-ZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
M.V.I. ADULT, ASCORBIC ACID
M.V.I. ADULT (PHARMACY BULK PACKAGE), ASCORBIC ACID
M.V.I. PEDIATRIC, ASCORBIC ACID
M.V.I.-12 (WITHOUT VITAMIN K), ASCORBIC ACID
MACROBID, NITROFURANTOIN
MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE
MACUGEN, PEGAPTANIB SODIUM
MAFENIDE ACETATE, MAFENIDE ACETATE
MAGNESIUM SULFATE, MAGNESIUM SULFATE
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE
MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE
MAGNEVIST, GADOPENTETATE DIMEGLUMINE
MAKENA, HYDROXYPROGESTERONE CAPROATE
MALARONE, ATOVAQUONE
MALARONE PEDIATRIC, ATOVAQUONE
MALATHION, MALATHION
MANGANESE CHLORIDE IN PLASTIC CONTAINER, MANGANESE CHLORIDE
MANNITOL 10%, MANNITOL
MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER, MANNITOL
MANNITOL 15%, MANNITOL
MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%, MANNITOL
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 33
APPENDIX A - PRODUCT NAME INDEX
** M **
MANNITOL 20%, MANNITOL
MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 25%, MANNITOL
MANNITOL 5%, MANNITOL
MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%, MANNITOL
MAPROTILINE HYDROCHLORIDE, MAPROTILINE HYDROCHLORIDE
MARCAINE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
MARINOL, DRONABINOL
MARLISSA, ETHINYL ESTRADIOL
MARPLAN, ISOCARBOXAZID
MARQIBO KIT, VINCRISTINE SULFATE
MATULANE, PROCARBAZINE HYDROCHLORIDE
MAVIK, TRANDOLAPRIL
MAXAIR, PIRBUTEROL ACETATE
MAXALT, RIZATRIPTAN BENZOATE
MAXALT-MLT, RIZATRIPTAN BENZOATE
MAXIDEX, DEXAMETHASONE
MAXIPIME, CEFEPIME HYDROCHLORIDE
MAXITROL, DEXAMETHASONE
MAXZIDE, HYDROCHLOROTHIAZIDE
MAXZIDE-25, HYDROCHLOROTHIAZIDE
MD-76R, DIATRIZOATE MEGLUMINE
MD-GASTROVIEW, DIATRIZOATE MEGLUMINE
MDP-BRACCO, TECHNETIUM TC-99M MEDRONATE KIT
MEBENDAZOLE, MEBENDAZOLE
MECAMYLAMINE HYDROCHLORIDE, MECAMYLAMINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM
MEDROL, METHYLPREDNISOLONE
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE
MEFENAMIC ACID, MEFENAMIC ACID
MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE
MEFOXIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM
MEGACE, MEGESTROL ACETATE
MEGACE ES, MEGESTROL ACETATE
MEGATOPE, ALBUMIN IODINATED I-131 SERUM
MEGESTROL ACETATE, MEGESTROL ACETATE
MEKINIST, TRAMETINIB DIMETHYL SULFOXIDE
MELOXICAM, MELOXICAM
MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE
MEMBRANEBLUE, TRYPAN BLUE
MEN'S ROGAINE, MINOXIDIL (OTC)
MENEST, ESTROGENS, ESTERIFIED
MENOPUR, MENOTROPINS (FSH
MENOSTAR, ESTRADIOL
MENTAX, BUTENAFINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE
MEPHYTON, PHYTONADIONE
MEPIVACAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE
MEPROBAMATE, MEPROBAMATE
MEPRON, ATOVAQUONE
MERCAPTOPURINE, MERCAPTOPURINE
MEROPENEM, MEROPENEM
MERREM, MEROPENEM
MESALAMINE, MESALAMINE
MESNA, MESNA
MESNEX, MESNA
MESTINON, PYRIDOSTIGMINE BROMIDE
METADATE CD, METHYLPHENIDATE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 34
APPENDIX A - PRODUCT NAME INDEX
** M **
METADATE ER, METHYLPHENIDATE HYDROCHLORIDE
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
METARAMINOL BITARTRATE, METARAMINOL BITARTRATE
METASTRON, STRONTIUM CHLORIDE SR-89
METAXALONE, METAXALONE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDE INTENSOL, METHADONE HYDROCHLORIDE
METHADOSE, METHADONE HYDROCHLORIDE
METHAMPHETAMINE HYDROCHLORIDE, METHAMPHETAMINE HYDROCHLORIDE
METHAZOLAMIDE, METHAZOLAMIDE
METHENAMINE HIPPURATE, METHENAMINE HIPPURATE
METHERGINE, METHYLERGONOVINE MALEATE
METHIMAZOLE, METHIMAZOLE
METHOCARBAMOL, METHOCARBAMOL
METHOCARBAMOL AND ASPIRIN, ASPIRIN
METHOTREXATE PRESERVATIVE FREE, METHOTREXATE SODIUM
METHOTREXATE SODIUM, METHOTREXATE SODIUM
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
METHOXSALEN, METHOXSALEN
METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE
METHYCLOTHIAZIDE, METHYCLOTHIAZIDE
METHYLDOPA, METHYLDOPA
METHYLDOPA AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
METHYLDOPATE HYDROCHLORIDE, METHYLDOPATE HYDROCHLORIDE
METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE
METHYLIN, METHYLPHENIDATE HYDROCHLORIDE
METHYLIN ER, METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
METHYLPREDNISOLONE, METHYLPREDNISOLONE
METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE
METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE
METHYLTESTOSTERONE, METHYLTESTOSTERONE
METIPRANOLOL, METIPRANOLOL HYDROCHLORIDE
METOCLOPRAMIDE, METOCLOPRAMIDE HYDROCHLORIDE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
METOLAZONE, METOLAZONE
METOPIRONE, METYRAPONE
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
METOZOLV ODT, METOCLOPRAMIDE HYDROCHLORIDE
METRO I.V. IN PLASTIC CONTAINER, METRONIDAZOLE
METROCREAM, METRONIDAZOLE
METROGEL, METRONIDAZOLE
METROGEL-VAGINAL, METRONIDAZOLE
METROLOTION, METRONIDAZOLE
METRONIDAZOLE, METRONIDAZOLE
METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE
MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE
MIACALCIN, CALCITONIN SALMON
MICARDIS, TELMISARTAN
MICARDIS HCT, HYDROCHLOROTHIAZIDE
MICONAZOLE 3, MICONAZOLE NITRATE (OTC)
MICONAZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MICONAZOLE 7, MICONAZOLE NITRATE (OTC)
MICONAZOLE 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)
MICONAZOLE NITRATE, MICONAZOLE NITRATE
MICONAZOLE NITRATE COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MICORT-HC, HYDROCORTISONE ACETATE
MICRO-K, POTASSIUM CHLORIDE
MICRO-K 10, POTASSIUM CHLORIDE
MICROGESTIN 1.5/30, ETHINYL ESTRADIOL
MICROGESTIN 1/20, ETHINYL ESTRADIOL
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 35
APPENDIX A - PRODUCT NAME INDEX
** M **
MICROGESTIN FE 1.5/30, ETHINYL ESTRADIOL
MICROGESTIN FE 1/20, ETHINYL ESTRADIOL
MICRONOR, NORETHINDRONE
MICROZIDE, HYDROCHLOROTHIAZIDE
MIDAMOR, AMILORIDE HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE
MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE
MIDOL LIQUID GELS, IBUPROFEN (OTC)
MIDOZALAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MIFEPREX, MIFEPRISTONE
MIGERGOT, CAFFEINE
MIGRANAL, DIHYDROERGOTAMINE MESYLATE
MILRINONE LACTATE, MILRINONE LACTATE
MILRINONE LACTATE IN DEXTROSE 5%, MILRINONE LACTATE
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE
MILRINONE LACTATE IN PLASTIC CONTAINER, MILRINONE LACTATE
MINASTRIN 24 FE, ETHINYL ESTRADIOL
MINIPRESS, PRAZOSIN HYDROCHLORIDE
MINIRIN, DESMOPRESSIN ACETATE
MINITRAN, NITROGLYCERIN
MINIVELLE, ESTRADIOL
MINOCIN, MINOCYCLINE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MINOXIDIL, MINOXIDIL (OTC)
MINOXIDIL, MINOXIDIL
MINOXIDIL (FOR MEN), MINOXIDIL (OTC)
MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)
MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)
MIOCHOL-E, ACETYLCHOLINE CHLORIDE
MIOSTAT, CARBACHOL
MIRALAX, POLYETHYLENE GLYCOL 3350 (OTC)
MIRAPEX, PRAMIPEXOLE DIHYDROCHLORIDE
MIRAPEX ER, PRAMIPEXOLE DIHYDROCHLORIDE
MIRENA, LEVONORGESTREL
MIRTAZAPINE, MIRTAZAPINE
MIRVASO, BRIMONIDINE TARTRATE
MISOPROSTOL, MISOPROSTOL
MITIGARE, COLCHICINE
MITOMYCIN, MITOMYCIN
MITOSOL, MITOMYCIN
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
MOBIC, MELOXICAM
MODAFINIL, MODAFINIL
MODICON 28, ETHINYL ESTRADIOL
MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
MOEXIPRIL HYDROCHLORIDE AND HYDROCHOLROTHIAZIDE, HYDROCHLOROTHIAZIDE
MOMETASONE FUROATE, MOMETASONE FUROATE
MONISTAT 1 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MONISTAT 3, MICONAZOLE NITRATE (OTC)
MONISTAT 3, MICONAZOLE NITRATE
MONISTAT 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MONISTAT 3 COMBINATION PACK (PREFILLED), MICONAZOLE NITRATE (OTC)
MONISTAT 7, MICONAZOLE NITRATE (OTC)
MONISTAT 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MONISTAT-3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MONO-LINYAH, ETHINYL ESTRADIOL
MONODOX, DOXYCYCLINE
MONOKET, ISOSORBIDE MONONITRATE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MONUROL, FOSFOMYCIN TROMETHAMINE
MORPHINE SULFATE, MORPHINE SULFATE
MOTOFEN, ATROPINE SULFATE
MOTRIN IB, IBUPROFEN (OTC)
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 36
APPENDIX A - PRODUCT NAME INDEX
** M **
MOTRIN MIGRAINE PAIN, IBUPROFEN (OTC)
MOVANTIK, NALOXEGOL OXALATE
MOVIPREP, ASCORBIC ACID
MOXATAG, AMOXICILLIN
MOXEZA, MOXIFLOXACIN HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE
MOZOBIL, PLERIXAFOR
MPI DMSA KIDNEY REAGENT, TECHNETIUM TC-99M SUCCIMER KIT
MPI INDIUM DTPA IN 111, INDIUM IN-111 PENTETATE DISODIUM
MS CONTIN, MORPHINE SULFATE
MUCINEX, GUAIFENESIN (OTC)
MUCINEX D, GUAIFENESIN (OTC)
MUCINEX DM, DEXTROMETHORPHAN HYDROBROMIDE (OTC)
MULTAQ, DRONEDARONE HYDROCHLORIDE
MULTIHANCE, GADOBENATE DIMEGLUMINE
MULTIHANCE MULTIPACK, GADOBENATE DIMEGLUMINE
MUPIROCIN, MUPIROCIN
MUPIROCIN, MUPIROCIN CALCIUM
MUSE, ALPROSTADIL
MUSTARGEN, MECHLORETHAMINE HYDROCHLORIDE
MYAMBUTOL, ETHAMBUTOL HYDROCHLORIDE
MYCAMINE, MICAFUNGIN SODIUM
MYCELEX-7, CLOTRIMAZOLE (OTC)
MYCELEX-7 COMBINATION PACK, CLOTRIMAZOLE (OTC)
MYCOBUTIN, RIFABUTIN
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
MYCOPHENOLIC ACID, MYCOPHENOLIC ACID
MYDRIACYL, TROPICAMIDE
MYFORTIC, MYCOPHENOLIC ACID
MYLERAN, BUSULFAN
MYORISAN, ISOTRETINOIN
MYOVIEW, TECHNETIUM TC-99M TETROFOSMIN KIT
MYOVIEW 30ML, TECHNETIUM TC-99M TETROFOSMIN KIT
MYRBETRIQ, MIRABEGRON
MYSOLINE, PRIMIDONE
MYZILRA, ETHINYL ESTRADIOL
** N **
NABUMETONE, NABUMETONE
NADOLOL, NADOLOL
NADOLOL AND BENDROFLUMETHIAZIDE, BENDROFLUMETHIAZIDE
NAFCILLIN SODIUM, NAFCILLIN SODIUM
NAFTIN, NAFTIFINE HYDROCHLORIDE
NALBUPHINE HYDROCHLORIDE, NALBUPHINE HYDROCHLORIDE
NALFON, FENOPROFEN CALCIUM
NALLPEN IN PLASTIC CONTAINER, NAFCILLIN SODIUM
NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
NAMENDA, MEMANTINE HYDROCHLORIDE
NAMENDA XR, MEMANTINE HYDROCHLORIDE
NAMZARIC, DONEPEZIL HYDROCHLORIDE
NANDROLONE DECANOATE, NANDROLONE DECANOATE
NAPHAZOLINE HYDROCHLORIDE, NAPHAZOLINE HYDROCHLORIDE
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE (OTC)
NAPHCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)
NAPRELAN, NAPROXEN SODIUM
NAPROSYN, NAPROXEN
NAPROXEN, NAPROXEN
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
NAPROXEN SODIUM, NAPROXEN SODIUM
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC)
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
NARDIL, PHENELZINE SULFATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 37
APPENDIX A - PRODUCT NAME INDEX
** N **
NAROPIN, ROPIVACAINE HYDROCHLORIDE
NASACORT ALLERGY 24 HOUR, TRIAMCINOLONE ACETONIDE (OTC)
NASCOBAL, CYANOCOBALAMIN
NASONEX, MOMETASONE FUROATE MONOHYDRATE
NATACYN, NATAMYCIN
NATAZIA, DIENOGEST
NATEGLINIDE, NATEGLINIDE
NATESTO, TESTOSTERONE
NATRECOR, NESIRITIDE RECOMBINANT
NATROBA, SPINOSAD
NAVANE, THIOTHIXENE
NAVELBINE, VINORELBINE TARTRATE
NAVSTEL, CALCIUM CHLORIDE
NEBUPENT, PENTAMIDINE ISETHIONATE
NEDOCROMIL SODIUM, NEDOCROMIL SODIUM
NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE
NEMBUTAL SODIUM, PENTOBARBITAL SODIUM
NEO-FRADIN, NEOMYCIN SULFATE
NEO-SYNALAR, FLUOCINOLONE ACETONIDE
NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC
NEOMYCIN SULFATE, NEOMYCIN SULFATE
NEOPAP, ACETAMINOPHEN (OTC)
NEOPROFEN, IBUPROFEN LYSINE
NEORAL, CYCLOSPORINE
NEOSPORIN, GRAMICIDIN
NEOSPORIN G.U. IRRIGANT, NEOMYCIN SULFATE
NEPHRAMINE 5.4%, AMINO ACIDS
NESACAINE, CHLOROPROCAINE HYDROCHLORIDE
NESACAINE-MPF, CHLOROPROCAINE HYDROCHLORIDE
NESINA, ALOGLIPTIN BENZOATE
NEUPRO, ROTIGOTINE
NEURACEQ, FLORBETABEN F-18
NEUROLITE, TECHNETIUM TC-99M BICISATE KIT
NEURONTIN, GABAPENTIN
NEVANAC, NEPAFENAC
NEVIRAPINE, NEVIRAPINE
NEXAVAR, SORAFENIB TOSYLATE
NEXIUM, ESOMEPRAZOLE MAGNESIUM
NEXIUM 24HR, ESOMEPRAZOLE MAGNESIUM (OTC)
NEXIUM IV, ESOMEPRAZOLE SODIUM
NEXPLANON, ETONOGESTREL
NEXTERONE, AMIODARONE HYDROCHLORIDE
NIACIN, NIACIN
NIACOR, NIACIN
NIASPAN, NIACIN
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
NICODERM CQ, NICOTINE (OTC)
NICORETTE, NICOTINE POLACRILEX (OTC)
NICORETTE (MINT), NICOTINE POLACRILEX (OTC)
NICOTINE, NICOTINE (OTC)
NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)
NICOTROL, NICOTINE
NIFEDIPINE, NIFEDIPINE
NIKKI, DROSPIRENONE
NILANDRON, NILUTAMIDE
NIMBEX, CISATRACURIUM BESYLATE
NIMBEX PRESERVATIVE FREE, CISATRACURIUM BESYLATE
NIMODIPINE, NIMODIPINE
NIPENT, PENTOSTATIN
NISOLDIPINE, NISOLDIPINE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 38
APPENDIX A - PRODUCT NAME INDEX
** N **
NITHIODOTE, SODIUM NITRITE
NITRO-DUR, NITROGLYCERIN
NITROFURANTOIN, NITROFURANTOIN
NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN
NITROGLYCERIN, NITROGLYCERIN
NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN
NITROLINGUAL PUMPSPRAY, NITROGLYCERIN
NITROMIST, NITROGLYCERIN
NITROPRESS, SODIUM NITROPRUSSIDE
NITROSTAT, NITROGLYCERIN
NIX, PERMETHRIN (OTC)
NIZATIDINE, NIZATIDINE
NIZORAL, KETOCONAZOLE
NIZORAL A-D, KETOCONAZOLE (OTC)
NOR-QD, NORETHINDRONE
NORCO, ACETAMINOPHEN
NORDETTE-28, ETHINYL ESTRADIOL
NORDITROPIN FLEXPRO, SOMATROPIN RECOMBINANT
NORDITROPIN NORDIFLEX, SOMATROPIN RECOMBINANT
NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE
NORETHINDRONE, NORETHINDRONE
NORETHINDRONE ACETATE, NORETHINDRONE ACETATE
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11), ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
NORFLEX, ORPHENADRINE CITRATE
NORGESIC, ASPIRIN
NORGESIC FORTE, ASPIRIN
NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
NORINYL 1+35 21-DAY, ETHINYL ESTRADIOL
NORINYL 1+35 28-DAY, ETHINYL ESTRADIOL
NORINYL 1+50 28-DAY, MESTRANOL
NORITATE, METRONIDAZOLE
NORMOCARB HF 25, MAGNESIUM CHLORIDE
NORMOCARB HF 35, MAGNESIUM CHLORIDE
NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
NORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
NORPACE, DISOPYRAMIDE PHOSPHATE
NORPACE CR, DISOPYRAMIDE PHOSPHATE
NORPRAMIN, DESIPRAMINE HYDROCHLORIDE
NORTHERA, DROXIDOPA
NORTREL 0.5/35-28, ETHINYL ESTRADIOL
NORTREL 1/35-21, ETHINYL ESTRADIOL
NORTREL 1/35-28, ETHINYL ESTRADIOL
NORTREL 7/7/7, ETHINYL ESTRADIOL
NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE
NORVASC, AMLODIPINE BESYLATE
NORVIR, RITONAVIR
NOVOLIN 70/30, INSULIN RECOMBINANT HUMAN (OTC)
NOVOLIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC)
NOVOLIN R, INSULIN RECOMBINANT HUMAN (OTC)
NOVOLOG, INSULIN ASPART RECOMBINANT
NOVOLOG FLEXPEN, INSULIN ASPART RECOMBINANT
NOVOLOG FLEXTOUCH, INSULIN ASPART RECOMBINANT
NOVOLOG MIX 70/30, INSULIN ASPART PROTAMINE RECOMBINANT
NOVOLOG MIX 70/30 FLEXPEN, INSULIN ASPART PROTAMINE RECOMBINANT
NOVOLOG PENFILL, INSULIN ASPART RECOMBINANT
NOXAFIL, POSACONAZOLE
NUCYNTA, TAPENTADOL HYDROCHLORIDE
NUCYNTA ER, TAPENTADOL HYDROCHLORIDE
NUEDEXTA, DEXTROMETHORPHAN HYDROBROMIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 39
APPENDIX A - PRODUCT NAME INDEX
** N **
NULYTELY, POLYETHYLENE GLYCOL 3350
NULYTELY-FLAVORED, POLYETHYLENE GLYCOL 3350
NUTRACORT, HYDROCORTISONE
NUTRESTORE, GLUTAMINE
NUTRILIPID 10%, SOYBEAN OIL
NUTRILIPID 20%, SOYBEAN OIL
NUTROPIN, SOMATROPIN RECOMBINANT
NUTROPIN AQ, SOMATROPIN RECOMBINANT
NUTROPIN AQ PEN, SOMATROPIN RECOMBINANT
NUVARING, ETHINYL ESTRADIOL
NUVIGIL, ARMODAFINIL
NYMALIZE, NIMODIPINE
NYSTATIN, NYSTATIN
NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN
NYSTOP, NYSTATIN
** O **
OBREDON, GUAIFENESIN
OCTOCAINE, EPINEPHRINE
OCTREOSCAN, INDIUM IN-111 PENTETREOTIDE KIT
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE
OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE
OCUCLEAR, OXYMETAZOLINE HYDROCHLORIDE (OTC)
OCUFEN, FLURBIPROFEN SODIUM
OCUFLOX, OFLOXACIN
OCUPRESS, CARTEOLOL HYDROCHLORIDE
OFEV, NINTEDANIB
OFIRMEV, ACETAMINOPHEN
OFLOXACIN, OFLOXACIN
OGEN .625, ESTROPIPATE
OGEN 1.25, ESTROPIPATE
OGEN 2.5, ESTROPIPATE
OGEN 5, ESTROPIPATE
OGESTREL 0.5/50-28, ETHINYL ESTRADIOL
OLANZAPINE, OLANZAPINE
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
OLAPARIB, OLAPARIB
OLEPTRO, TRAZODONE HYDROCHLORIDE
OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE
OLUX, CLOBETASOL PROPIONATE
OLUX E, CLOBETASOL PROPIONATE
OLYSIO, SIMEPREVIR SODIUM
OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS
OMEPRAZOLE, OMEPRAZOLE (OTC)
OMEPRAZOLE, OMEPRAZOLE
OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN, AMOXICILLIN
OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE
OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC)
OMIDRIA, KETOROLAC TROMETHAMINE
OMNARIS, CICLESONIDE
OMNIPAQUE 140, IOHEXOL
OMNIPAQUE 180, IOHEXOL
OMNIPAQUE 240, IOHEXOL
OMNIPAQUE 300, IOHEXOL
OMNIPAQUE 350, IOHEXOL
OMNIPRED, PREDNISOLONE ACETATE
OMNISCAN, GADODIAMIDE
OMNITROPE, SOMATROPIN RECOMBINANT
OMTRYG, OMEGA-3-ACID ETHYL ESTERS
ONDANSETRON, ONDANSETRON
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONEXTON, BENZOYL PEROXIDE
ONFI, CLOBAZAM
ONGLYZA, SAXAGLIPTIN HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 40
APPENDIX A - PRODUCT NAME INDEX
** O **
ONMEL, ITRACONAZOLE
OPANA, OXYMORPHONE HYDROCHLORIDE
OPANA ER, OXYMORPHONE HYDROCHLORIDE
OPCICON ONE-STEP, LEVONORGESTREL (OTC)
OPCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)
OPSUMIT, MACITENTAN
OPTIMARK, GADOVERSETAMIDE
OPTIMARK IN PLASTIC CONTAINER, GADOVERSETAMIDE
OPTIPRANOLOL, METIPRANOLOL HYDROCHLORIDE
OPTIRAY 240, IOVERSOL
OPTIRAY 300, IOVERSOL
OPTIRAY 320, IOVERSOL
OPTIRAY 350, IOVERSOL
OPTISON, ALBUMIN HUMAN
OPTIVAR, AZELASTINE HYDROCHLORIDE
ORABLOC, ARTICAINE HYDROCHLORIDE
ORACEA, DOXYCYCLINE
ORAP, PIMOZIDE
ORAPRED, PREDNISOLONE SODIUM PHOSPHATE
ORAPRED ODT, PREDNISOLONE SODIUM PHOSPHATE
ORAQIX, LIDOCAINE
ORAVERSE, PHENTOLAMINE MESYLATE
ORAVIG, MICONAZOLE
ORBACTIV, ORITAVANCIN DIPHOSPHATE
ORENITRAM, TREPROSTINIL DIOLAMINE
ORETIC, HYDROCHLOROTHIAZIDE
ORFADIN, NITISINONE
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE, ASPIRIN
ORSYTHIA, ETHINYL ESTRADIOL
ORTHO CYCLEN-28, ETHINYL ESTRADIOL
ORTHO EVRA, ETHINYL ESTRADIOL
ORTHO TRI-CYCLEN, ETHINYL ESTRADIOL
ORTHO TRI-CYCLEN LO, ETHINYL ESTRADIOL
ORTHO-CEPT, DESOGESTREL
ORTHO-NOVUM 1/35-28, ETHINYL ESTRADIOL
ORTHO-NOVUM 7/7/7-28, ETHINYL ESTRADIOL
ORVATEN, MIDODRINE HYDROCHLORIDE
OSENI, ALOGLIPTIN BENZOATE
OSMITROL 10% IN WATER, MANNITOL
OSMITROL 10% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 15% IN WATER, MANNITOL
OSMITROL 15% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 20% IN WATER, MANNITOL
OSMITROL 20% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 5% IN WATER, MANNITOL
OSMITROL 5% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMOPREP, SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
OSPHENA, OSPEMIFENE
OTEZLA, APREMILAST
OTICAIR, HYDROCORTISONE
OTREXUP, METHOTREXATE
OVCON-35, ETHINYL ESTRADIOL
OVIDE, MALATHION
OVIDREL, CHORIOGONADOTROPIN ALFA
OXACILLIN SODIUM, OXACILLIN SODIUM
OXALIPLATIN, OXALIPLATIN
OXANDRIN, OXANDROLONE
OXANDROLONE, OXANDROLONE
OXAPROZIN, OXAPROZIN
OXAZEPAM, OXAZEPAM
OXCARBAZEPINE, OXCARBAZEPINE
OXECTA, OXYCODONE HYDROCHLORIDE
OXILAN-300, IOXILAN
OXILAN-350, IOXILAN
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 41
APPENDIX A - PRODUCT NAME INDEX
** O **
OXISTAT, OXICONAZOLE NITRATE
OXSORALEN, METHOXSALEN
OXSORALEN-ULTRA, METHOXSALEN
OXTELLAR XR, OXCARBAZEPINE
OXYBUTYNIN, OXYBUTYNIN
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
OXYCET, ACETAMINOPHEN
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE AND ASPIRIN, ASPIRIN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN
OXYCONTIN, OXYCODONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
OXYTOCIN, OXYTOCIN
OXYTROL, OXYBUTYNIN
OXYTROL FOR WOMEN, OXYBUTYNIN (OTC)
OZURDEX, DEXAMETHASONE
** P **
PACERONE, AMIODARONE HYDROCHLORIDE
PACLITAXEL, PACLITAXEL
PAMELOR, NORTRIPTYLINE HYDROCHLORIDE
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PAMINE, METHSCOPOLAMINE BROMIDE
PAMINE FORTE, METHSCOPOLAMINE BROMIDE
PANCREAZE, PANCRELIPASE (AMYLASE
PANCURONIUM BROMIDE, PANCURONIUM BROMIDE
PANDEL, HYDROCORTISONE PROBUTATE
PANRETIN, ALITRETINOIN
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PARAFON FORTE DSC, CHLORZOXAZONE
PARAGARD T 380A, COPPER
PAREMYD, HYDROXYAMPHETAMINE HYDROBROMIDE
PARICALCITOL, PARICALCITOL
PARLODEL, BROMOCRIPTINE MESYLATE
PARNATE, TRANYLCYPROMINE SULFATE
PAROEX, CHLORHEXIDINE GLUCONATE
PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE
PAROXETINE, PAROXETINE HYDROCHLORIDE
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PASER, AMINOSALICYLIC ACID
PATADAY, OLOPATADINE HYDROCHLORIDE
PATANASE, OLOPATADINE HYDROCHLORIDE
PATANOL, OLOPATADINE HYDROCHLORIDE
PAXIL, PAROXETINE HYDROCHLORIDE
PAXIL CR, PAROXETINE HYDROCHLORIDE
PCE, ERYTHROMYCIN
PEDIAMYCIN, ERYTHROMYCIN ETHYLSUCCINATE
PEDIAMYCIN 400, ERYTHROMYCIN ETHYLSUCCINATE
PEDIAPRED, PREDNISOLONE SODIUM PHOSPHATE
PEDIATRIC ADVIL, IBUPROFEN (OTC)
PEDIOTIC, HYDROCORTISONE
PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350
PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL, BISACODYL
PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE, POLYETHYLENE GLYCOL 3350
PEGANONE, ETHOTOIN
PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER, PENICILLIN G POTASSIUM
PENICILLIN G PROCAINE, PENICILLIN G PROCAINE
PENICILLIN G SODIUM, PENICILLIN G SODIUM
PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM
PENICILLIN-VK, PENICILLIN V POTASSIUM
PENLAC, CICLOPIROX
PENNSAID, DICLOFENAC SODIUM
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 42
APPENDIX A - PRODUCT NAME INDEX
** P **
PENTAM, PENTAMIDINE ISETHIONATE
PENTASA, MESALAMINE
PENTOLAIR, CYCLOPENTOLATE HYDROCHLORIDE
PENTOSTATIN, PENTOSTATIN
PENTOXIFYLLINE, PENTOXIFYLLINE
PENTOXIL, PENTOXIFYLLINE
PEPCID, FAMOTIDINE
PEPCID AC, FAMOTIDINE (OTC)
PEPCID AC , FAMOTIDINE (OTC)
PEPCID COMPLETE, CALCIUM CARBONATE (OTC)
PERCOCET, ACETAMINOPHEN
PERCODAN, ASPIRIN
PERFOROMIST, FORMOTEROL FUMARATE
PERIDEX, CHLORHEXIDINE GLUCONATE
PERIKABIVEN IN PLASTIC CONTAINER, AMINO ACIDS
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
PERIOCHIP, CHLORHEXIDINE GLUCONATE
PERIOGARD, CHLORHEXIDINE GLUCONATE
PERMAPEN, PENICILLIN G BENZATHINE
PERMETHRIN, PERMETHRIN (OTC)
PERMETHRIN, PERMETHRIN
PERPHENAZINE, PERPHENAZINE
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
PERSANTINE, DIPYRIDAMOLE
PERTZYE, PANCRELIPASE (AMYLASE
PEXEVA, PAROXETINE MESYLATE
PFIZERPEN, PENICILLIN G POTASSIUM
PHARMASEAL SCRUB CARE, CHLORHEXIDINE GLUCONATE (OTC)
PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE
PHENELZINE SULFATE, PHENELZINE SULFATE
PHENOXYBENZAMINE HYDROCHLORIDE, PHENOXYBENZAMINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PHENTERMINE RESIN COMPLEX, PHENTERMINE RESIN COMPLEX
PHENTOLAMINE MESYLATE, PHENTOLAMINE MESYLATE
PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
PHENYTEK, PHENYTOIN SODIUM
PHENYTOIN, PHENYTOIN
PHENYTOIN SODIUM, PHENYTOIN SODIUM
PHILITH, ETHINYL ESTRADIOL
PHISOHEX, HEXACHLOROPHENE
PHOSLO GELCAPS, CALCIUM ACETATE
PHOSLYRA, CALCIUM ACETATE
PHOSPHOLINE IODIDE, ECHOTHIOPHATE IODIDE
PHOTOFRIN, PORFIMER SODIUM
PHYSIOLYTE IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PHYTONADIONE, PHYTONADIONE
PICATO, INGENOL MEBUTATE
PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE
PILOPINE HS, PILOCARPINE HYDROCHLORIDE
PIMTREA, DESOGESTREL
PINDOLOL, PINDOLOL
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE, GLIMEPIRIDE
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
PIPERACILLIN, PIPERACILLIN SODIUM
PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM
PIRMELLA 1/35, ETHINYL ESTRADIOL
PIRMELLA 7/7/7, ETHINYL ESTRADIOL
PIROXICAM, PIROXICAM
PITOCIN, OXYTOCIN
PLAN B, LEVONORGESTREL (OTC)
PLAN B, LEVONORGESTREL
PLAN B ONE-STEP, LEVONORGESTREL (OTC)
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 43
APPENDIX A - PRODUCT NAME INDEX
** P **
PLAQUENIL, HYDROXYCHLOROQUINE SULFATE
PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
PLASMA-LYTE 56 IN PLASTIC CONTAINER, MAGNESIUM ACETATE TETRAHYDRATE
PLASMA-LYTE A IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PLASMA-LYTE R IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PLAVIX, CLOPIDOGREL BISULFATE
PLEGISOL IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PLENDIL, FELODIPINE
PLETAL, CILOSTAZOL
PLIAGLIS, LIDOCAINE
PODOFILOX, PODOFILOX
POLOCAINE, MEPIVACAINE HYDROCHLORIDE
POLOCAINE-MPF, MEPIVACAINE HYDROCHLORIDE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
POLYMYCIN B SULFATE, POLYMYXIN B SULFATE
POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
POLYTRIM, POLYMYXIN B SULFATE
POMALYST, POMALIDOMIDE
PONSTEL, MEFENAMIC ACID
PORTIA-28, ETHINYL ESTRADIOL
POTASSIUM ACETATE IN PLASTIC CONTAINER, POTASSIUM ACETATE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 44
APPENDIX A - PRODUCT NAME INDEX
** P **
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CITRATE, POTASSIUM CITRATE
POTIGA, EZOGABINE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 45
APPENDIX A - PRODUCT NAME INDEX
** P **
POVIDONE IODINE, POVIDONE-IODINE (OTC)
PRADAXA, DABIGATRAN ETEXILATE MESYLATE
PRALIDOXIME CHLORIDE, PRALIDOXIME CHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PRAMOSONE, HYDROCORTISONE ACETATE
PRANDIMET, METFORMIN HYDROCHLORIDE
PRANDIN, REPAGLINIDE
PRAVACHOL, PRAVASTATIN SODIUM
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE
PRE-OP, HEXACHLOROPHENE
PRE-OP II, HEXACHLOROPHENE
PRE-PEN, BENZYLPENICILLOYL POLYLYSINE
PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE
PRECOSE, ACARBOSE
PRED FORTE, PREDNISOLONE ACETATE
PRED MILD, PREDNISOLONE ACETATE
PRED-G, GENTAMICIN SULFATE
PREDNICARBATE, PREDNICARBATE
PREDNISOLONE, PREDNISOLONE
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PREDNISONE, PREDNISONE
PREDNISONE INTENSOL, PREDNISONE
PREGABALIN, PREGABALIN
PREGNYL, GONADOTROPIN, CHORIONIC
PRELONE, PREDNISOLONE
PREMARIN, ESTROGENS, CONJUGATED
PREMASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS
PREMASOL 6% IN PLASTIC CONTAINER, AMINO ACIDS
PREMPHASE 14/14, ESTROGENS, CONJUGATED
PREMPRO, ESTROGENS, CONJUGATED
PREPIDIL, DINOPROSTONE
PREPOPIK, CITRIC ACID
PREVACID, LANSOPRAZOLE
PREVACID 24 HR, LANSOPRAZOLE (OTC)
PREVALITE, CHOLESTYRAMINE
PREVANTICS MAXI SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
PREVANTICS SWAB, CHLORHEXIDINE GLUCONATE (OTC)
PREVANTICS SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
PREVIFEM, ETHINYL ESTRADIOL
PREVPAC, AMOXICILLIN
PREZISTA, DARUNAVIR ETHANOLATE
PRIALT, ZICONOTIDE ACETATE
PRIFTIN, RIFAPENTINE
PRILOCAINE HYDROCHLORIDE, PRILOCAINE HYDROCHLORIDE
PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, EPINEPHRINE BITARTRATE
PRILOSEC, OMEPRAZOLE
PRILOSEC, OMEPRAZOLE MAGNESIUM
PRILOSEC OTC, OMEPRAZOLE MAGNESIUM (OTC)
PRIMAQUINE, PRIMAQUINE PHOSPHATE
PRIMAQUINE PHOSPHATE, PRIMAQUINE PHOSPHATE
PRIMAXIN, CILASTATIN SODIUM
PRIMIDONE, PRIMIDONE
PRIMSOL, TRIMETHOPRIM HYDROCHLORIDE
PRINIVIL, LISINOPRIL
PRINZIDE, HYDROCHLOROTHIAZIDE
PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 46
APPENDIX A - PRODUCT NAME INDEX
** P **
PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISTIQ, DESVENLAFAXINE SUCCINATE
PROAIR HFA, ALBUTEROL SULFATE
PROBALAN, PROBENECID
PROBENECID, PROBENECID
PROBENECID AND COLCHICINE, COLCHICINE
PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE
PROCALAMINE, AMINO ACIDS
PROCARDIA, NIFEDIPINE
PROCARDIA XL, NIFEDIPINE
PROCHLORPERAZINE, PROCHLORPERAZINE
PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE
PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE
PROCOMP, PROCHLORPERAZINE MALEATE
PROCTOFOAM HC, HYDROCORTISONE ACETATE
PROCYSBI, CYSTEAMINE BITARTRATE
PROFEN, IBUPROFEN (OTC)
PROFERDEX, IRON DEXTRAN
PROGESTERONE, PROGESTERONE
PROGLYCEM, DIAZOXIDE
PROGRAF, TACROLIMUS
PROHANCE, GADOTERIDOL
PROHANCE MULTIPACK, GADOTERIDOL
PROLENSA, BROMFENAC SODIUM
PROMACTA, ELTROMBOPAG OLAMINE
PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE PHOSPHATE
PROMETH VC PLAIN, PHENYLEPHRINE HYDROCHLORIDE
PROMETH VC W/ CODEINE, CODEINE PHOSPHATE
PROMETHAZINE DM, DEXTROMETHORPHAN HYDROBROMIDE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE
PROMETHAZINE PLAIN, PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE
PROMETHAZINE WITH CODEINE, CODEINE PHOSPHATE
PROMETHEGAN, PROMETHAZINE HYDROCHLORIDE
PROMETRIUM, PROGESTERONE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
PROPANTHELINE BROMIDE, PROPANTHELINE BROMIDE
PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE
PROPECIA, FINASTERIDE
PROPOFOL, PROPOFOL
PROPOXYPHENE HYDROCHLORIDE, PROPOXYPHENE HYDROCHLORIDE
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
PROPYLTHIOURACIL, PROPYLTHIOURACIL
PROSCAR, FINASTERIDE
PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS
PROSTIN E2, DINOPROSTONE
PROSTIN VR PEDIATRIC, ALPROSTADIL
PROTAMINE SULFATE, PROTAMINE SULFATE
PROTONIX, PANTOPRAZOLE SODIUM
PROTONIX IV, PANTOPRAZOLE SODIUM
PROTOPAM CHLORIDE, PRALIDOXIME CHLORIDE
PROTOPIC, TACROLIMUS
PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE
PROVENTIL-HFA, ALBUTEROL SULFATE
PROVERA, MEDROXYPROGESTERONE ACETATE
PROVIGIL, MODAFINIL
PROVOCHOLINE, METHACHOLINE CHLORIDE
PROZAC, FLUOXETINE HYDROCHLORIDE
PROZAC WEEKLY, FLUOXETINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 47
APPENDIX A - PRODUCT NAME INDEX
** P **
PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)
PULMICORT FLEXHALER, BUDESONIDE
PULMICORT RESPULES, BUDESONIDE
PULMOLITE, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT
PUR-WASH, PURIFIED WATER (OTC)
PURIXAN, MERCAPTOPURINE
PYLERA, BISMUTH SUBCITRATE POTASSIUM
PYRAZINAMIDE, PYRAZINAMIDE
PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE
PYRIDOXINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE
PYTEST, UREA, C-14
PYTEST KIT, UREA, C-14
** Q **
QNASL, BECLOMETHASONE DIPROPIONATE
QOLIANA, BRIMONIDINE TARTRATE
QSYMIA, PHENTERMINE HYDROCHLORIDE
QUADRAMET, SAMARIUM SM-153 LEXIDRONAM PENTASODIUM
QUALAQUIN, QUININE SULFATE
QUARTETTE, ETHINYL ESTRADIOL
QUASENSE, ETHINYL ESTRADIOL
QUDEXY XR, TOPIRAMATE
QUELICIN, SUCCINYLCHOLINE CHLORIDE
QUELICIN PRESERVATIVE FREE, SUCCINYLCHOLINE CHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
QUILLIVANT XR, METHYLPHENIDATE HYDROCHLORIDE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
QUINARETIC, HYDROCHLOROTHIAZIDE
QUINIDINE GLUCONATE, QUINIDINE GLUCONATE
QUINIDINE SULFATE, QUINIDINE SULFATE
QUININE SULFATE, QUININE SULFATE
QUIXIN, LEVOFLOXACIN
QUTENZA, CAPSAICIN
QVAR 40, BECLOMETHASONE DIPROPIONATE
QVAR 80, BECLOMETHASONE DIPROPIONATE
** R **
R-GENE 10, ARGININE HYDROCHLORIDE
RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM
RADIOGARDASE (PRUSSIAN BLUE), FERRIC HEXACYANOFERRATE(II)
RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE
RAMELTEON, RAMELTEON
RAMIPRIL, RAMIPRIL
RANEXA, RANOLAZINE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RANOLAZINE, RANOLAZINE
RAPAFLO, SILODOSIN
RAPAMUNE, SIROLIMUS
RAPIVAB, PERAMIVIR
RASAGILINE MESYLATE, RASAGILINE MESYLATE
RASUVO, METHOTREXATE
RAVICTI, GLYCEROL PHENYLBUTYRATE
RAYOS, PREDNISONE
RAZADYNE, GALANTAMINE HYDROBROMIDE
RAZADYNE ER, GALANTAMINE HYDROBROMIDE
REBETOL, RIBAVIRIN
RECLAST, ZOLEDRONIC ACID
RECTIV, NITROGLYCERIN
REGITINE, PHENTOLAMINE MESYLATE
REGLAN, METOCLOPRAMIDE HYDROCHLORIDE
REGONOL, PYRIDOSTIGMINE BROMIDE
RELENZA, ZANAMIVIR
RELISTOR, METHYLNALTREXONE BROMIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 48
APPENDIX A - PRODUCT NAME INDEX
** R **
RELPAX, ELETRIPTAN HYDROBROMIDE
REMERON, MIRTAZAPINE
REMERON SOLTAB, MIRTAZAPINE
REMODULIN, TREPROSTINIL
RENACIDIN, CITRIC ACID
RENAGEL, SEVELAMER HYDROCHLORIDE
RENOGRAFIN-76, DIATRIZOATE MEGLUMINE
RENOVA, TRETINOIN
RENVELA, SEVELAMER CARBONATE
REPAGLINIDE, REPAGLINIDE
REPREXAIN, HYDROCODONE BITARTRATE
REPRONEX, MENOTROPINS (FSH
REQUIP, ROPINIROLE HYDROCHLORIDE
REQUIP XL, ROPINIROLE HYDROCHLORIDE
RESCRIPTOR, DELAVIRDINE MESYLATE
RESCULA, UNOPROSTONE ISOPROPYL
RESECTISOL IN PLASTIC CONTAINER, MANNITOL
RESERPINE, RESERPINE
RESTASIS, CYCLOSPORINE
RESTORIL, TEMAZEPAM
RETIN-A, TRETINOIN
RETIN-A MICRO, TRETINOIN
RETIN-A-MICRO, TRETINOIN
RETISERT, FLUOCINOLONE ACETONIDE
RETROVIR, ZIDOVUDINE
REVATIO, SILDENAFIL CITRATE
REVIA, NALTREXONE HYDROCHLORIDE
REVLIMID, LENALIDOMIDE
REVONTO, DANTROLENE SODIUM
REYATAZ, ATAZANAVIR SULFATE
REZIRA, HYDROCODONE BITARTRATE
RHINOCORT, BUDESONIDE
RIBASPHERE, RIBAVIRIN
RIBAVARIN, RIBAVIRIN
RIBAVIRIN, RIBAVIRIN
RIDAURA, AURANOFIN
RIFABUTIN, RIFABUTIN
RIFADIN, RIFAMPIN
RIFAMATE, ISONIAZID
RIFAMPIN, RIFAMPIN
RIFATER, ISONIAZID
RILUTEK, RILUZOLE
RILUZOLE, RILUZOLE
RIMACTANE, RIFAMPIN
RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE
RIMSO-50, DIMETHYL SULFOXIDE
RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
RIOMET, METFORMIN HYDROCHLORIDE
RISEDRONATE SODIUM, RISEDRONATE SODIUM
RISPERDAL, RISPERIDONE
RISPERDAL CONSTA, RISPERIDONE
RISPERIDONE, RISPERIDONE
RITALIN, METHYLPHENIDATE HYDROCHLORIDE
RITALIN LA, METHYLPHENIDATE HYDROCHLORIDE
RITALIN-SR, METHYLPHENIDATE HYDROCHLORIDE
RITONAVIR, RITONAVIR
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
ROBAXIN, METHOCARBAMOL
ROBAXIN-750, METHOCARBAMOL
ROBINUL, GLYCOPYRROLATE
ROBINUL FORTE, GLYCOPYRROLATE
ROCALTROL, CALCITRIOL
ROCEPHIN, CEFTRIAXONE SODIUM
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 49
APPENDIX A - PRODUCT NAME INDEX
** R **
ROGAINE (FOR MEN), MINOXIDIL (OTC)
ROGAINE (FOR WOMEN), MINOXIDIL (OTC)
ROGAINE EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE
ROSIGLITAZONE MALEATE, ROSIGLITAZONE MALEATE
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
ROWASA, MESALAMINE
ROXICET, ACETAMINOPHEN
ROXICODONE, OXYCODONE HYDROCHLORIDE
ROZEREM, RAMELTEON
RYANODEX, DANTROLENE SODIUM
RYTHMOL, PROPAFENONE HYDROCHLORIDE
RYTHMOL SR, PROPAFENONE HYDROCHLORIDE
** S **
SABRIL, VIGABATRIN
SAFYRAL, DROSPIRENONE
SAIZEN, SOMATROPIN RECOMBINANT
SALAGEN, PILOCARPINE HYDROCHLORIDE
SALONPAS, MENTHOL (OTC)
SALURON, HYDROFLUMETHIAZIDE
SAMSCA, TOLVAPTAN
SANCTURA, TROSPIUM CHLORIDE
SANCTURA XR, TROSPIUM CHLORIDE
SANCUSO, GRANISETRON
SANDIMMUNE, CYCLOSPORINE
SANDOSTATIN, OCTREOTIDE ACETATE
SANDOSTATIN LAR, OCTREOTIDE ACETATE
SAPHRIS, ASENAPINE MALEATE
SARAFEM, FLUOXETINE HYDROCHLORIDE
SAVELLA, MILNACIPRAN HYDROCHLORIDE
SAXENDA, LIRAGLUTIDE RECOMBINANT
SCANDONEST L, LEVONORDEFRIN
SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE
SCANLUX-300, IOPAMIDOL
SCANLUX-370, IOPAMIDOL
SCLEROSOL, TALC
SEASONALE, ETHINYL ESTRADIOL
SEASONIQUE, ETHINYL ESTRADIOL
SECONAL SODIUM, SECOBARBITAL SODIUM
SECTRAL, ACEBUTOLOL HYDROCHLORIDE
SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE
SELENIUM SULFIDE, SELENIUM SULFIDE
SELFEMRA, FLUOXETINE HYDROCHLORIDE
SELSUN, SELENIUM SULFIDE
SELZENTRY, MARAVIROC
SEMPREX-D, ACRIVASTINE
SENSIPAR, CINACALCET HYDROCHLORIDE
SENSORCAINE, BUPIVACAINE HYDROCHLORIDE
SEPTOCAINE, ARTICAINE HYDROCHLORIDE
SEPTRA, SULFAMETHOXAZOLE
SEPTRA DS, SULFAMETHOXAZOLE
SEREVENT, SALMETEROL XINAFOATE
SEROMYCIN, CYCLOSERINE
SEROPHENE, CLOMIPHENE CITRATE
SEROQUEL, QUETIAPINE FUMARATE
SEROQUEL XR, QUETIAPINE FUMARATE
SEROSTIM, SOMATROPIN RECOMBINANT
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SETLAKIN, ETHINYL ESTRADIOL
SEVOFLURANE, SEVOFLURANE
SFROWASA, MESALAMINE
SHADE UVAGUARD, AVOBENZONE (OTC)
SIGNIFOR, PASIREOTIDE DIASPARTATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 50
APPENDIX A - PRODUCT NAME INDEX
** S **
SIGNIFOR LAR, PASIREOTIDE PAMOATE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
SILENOR, DOXEPIN HYDROCHLORIDE
SILVADENE, SILVER SULFADIAZINE
SIMBRINZA, BRIMONIDINE TARTRATE
SIMCOR, NIACIN
SIMVASTATIN, SIMVASTATIN
SINE-AID IB, IBUPROFEN (OTC)
SINEMET, CARBIDOPA
SINEMET CR, CARBIDOPA
SINGULAIR, MONTELUKAST SODIUM
SINOGRAFIN, DIATRIZOATE MEGLUMINE
SIROLIMUS, SIROLIMUS
SIRTURO, BEDAQUILINE FUMARATE
SITAVIG, ACYCLOVIR
SIVEXTRO, TEDIZOLID PHOSPHATE
SKELAXIN, METAXALONE
SKLICE, IVERMECTIN
SKYLA, LEVONORGESTREL
SODIUM ACETATE IN PLASTIC CONTAINER, SODIUM ACETATE ANHYDROUS
SODIUM BICARBONATE, SODIUM BICARBONATE
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% , SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE, SODIUM FERRIC GLUCONATE COMPLEX
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
SODIUM IODIDE I 123, SODIUM IODIDE I-123
SODIUM IODIDE I 131, SODIUM IODIDE I-131
SODIUM IODIDE I-131, SODIUM IODIDE I-131
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE
SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE
SODIUM LACTATE IN PLASTIC CONTAINER, SODIUM LACTATE
SODIUM NITRITE, SODIUM NITRITE
SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE
SODIUM PHOSPHATES IN PLASTIC CONTAINER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
SODIUM THIOSULFATE, SODIUM THIOSULFATE
SOJOURN, SEVOFLURANE
SOLARAZE, DICLOFENAC SODIUM
SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE
SOLODYN, MINOCYCLINE HYDROCHLORIDE
SOLTAMOX, TAMOXIFEN CITRATE
SOLU-CORTEF, HYDROCORTISONE SODIUM SUCCINATE
SOLU-MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATE
SOMA, CARISOPRODOL
SOMA COMPOUND, ASPIRIN
SOMA COMPOUND W/ CODEINE, ASPIRIN
SOMATULINE DEPOT, LANREOTIDE ACETATE
SOMAVERT, PEGVISOMANT
SONATA, ZALEPLON
SOOLANTRA, IVERMECTIN
SORBITOL 3% IN PLASTIC CONTAINER, SORBITOL
SORBITOL 3.3% IN PLASTIC CONTAINER, SORBITOL
SORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOL
SORIATANE, ACITRETIN
SORILUX, CALCIPOTRIENE
SORINE, SOTALOL HYDROCHLORIDE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
SOTRADECOL, SODIUM TETRADECYL SULFATE
SOTRET, ISOTRETINOIN
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 51
APPENDIX A - PRODUCT NAME INDEX
** S **
SOTYLIZE, SOTALOL HYDROCHLORIDE
SOVALDI, SOFOSBUVIR
SPECTRACEF, CEFDITOREN PIVOXIL
SPIRIVA, TIOTROPIUM BROMIDE
SPIRIVA RESPIMAT, TIOTROPIUM BROMIDE
SPIRONOLACTONE, SPIRONOLACTONE
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
SPORANOX, ITRACONAZOLE
SPRINTEC, ETHINYL ESTRADIOL
SPRIX, KETOROLAC TROMETHAMINE
SPRYCEL, DASATINIB
SPS, SODIUM POLYSTYRENE SULFONATE
SSD, SILVER SULFADIAZINE
SSD AF, SILVER SULFADIAZINE
STALEVO 100, CARBIDOPA
STALEVO 125, CARBIDOPA
STALEVO 150, CARBIDOPA
STALEVO 200, CARBIDOPA
STALEVO 50, CARBIDOPA
STALEVO 75, CARBIDOPA
STARLIX, NATEGLINIDE
STAVUDINE, STAVUDINE
STAXYN, VARDENAFIL HYDROCHLORIDE
STENDRA, AVANAFIL
STERILE WATER, STERILE WATER FOR IRRIGATION
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION
STIE-CORT, HYDROCORTISONE
STIMATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE
STIVARGA, REGORAFENIB
STRATTERA, ATOMOXETINE HYDROCHLORIDE
STREPTOMYCIN SULFATE, STREPTOMYCIN SULFATE
STRIANT, TESTOSTERONE
STRIBILD, COBICISTAT
STRIVERDI RESPIMAT, OLODATEROL HYDROCHLORIDE
STROMECTOL, IVERMECTIN
STRONTIUM CHLORIDE SR-89, STRONTIUM CHLORIDE SR-89
SUBLIMAZE PRESERVATIVE FREE, FENTANYL CITRATE
SUBOXONE, BUPRENORPHINE HYDROCHLORIDE
SUBSYS, FENTANYL
SUCLEAR, MAGNESIUM SULFATE
SUCRAID, SACROSIDASE
SUCRALFATE, SUCRALFATE
SUDAFED 12 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)
SUDAFED 24 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)
SUFENTA PRESERVATIVE FREE, SUFENTANIL CITRATE
SUFENTANIL CITRATE, SUFENTANIL CITRATE
SULAR, NISOLDIPINE
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
SULFADIAZINE, SULFADIAZINE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE
SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH, SULFAMETHOXAZOLE
SULFAMYLON, MAFENIDE ACETATE
SULFASALAZINE, SULFASALAZINE
SULFATRIM PEDIATRIC, SULFAMETHOXAZOLE
SULINDAC, SULINDAC
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
SUMAVEL DOSEPRO, SUMATRIPTAN SUCCINATE
SUNITINIB MALATE, SUNITINIB MALATE
SUPPRELIN LA, HISTRELIN ACETATE
SUPRANE, DESFLURANE
SUPRAX, CEFIXIME
SUPRENZA, PHENTERMINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 52
APPENDIX A - PRODUCT NAME INDEX
** S **
SUPREP BOWEL PREP KIT, MAGNESIUM SULFATE ANHYDROUS
SURFAXIN, LUCINACTANT
SURMONTIL, TRIMIPRAMINE MALEATE
SURVANTA, BERACTANT
SUSTIVA, EFAVIRENZ
SUTENT, SUNITINIB MALATE
SYEDA, DROSPIRENONE
SYMBICORT, BUDESONIDE
SYMBYAX, FLUOXETINE HYDROCHLORIDE
SYMLIN, PRAMLINTIDE ACETATE
SYNACORT, HYDROCORTISONE
SYNALAR, FLUOCINOLONE ACETONIDE
SYNALGOS-DC, ASPIRIN
SYNAREL, NAFARELIN ACETATE
SYNERA, LIDOCAINE
SYNERCID, DALFOPRISTIN
SYNRIBO, OMACETAXINE MEPESUCCINATE
SYNTHROID, LEVOTHYROXINE SODIUM **
SYPRINE, TRIENTINE HYDROCHLORIDE
** T **
TAB-PROFEN, IBUPROFEN (OTC)
TACLONEX, BETAMETHASONE DIPROPIONATE
TACROLIMUS, TACROLIMUS
TAFINLAR, DABRAFENIB MESYLATE
TAGAMET HB, CIMETIDINE (OTC)
TALC, TALC
TALWIN, PENTAZOCINE LACTATE
TAMIFLU, OSELTAMIVIR PHOSPHATE
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TAPAZOLE, METHIMAZOLE
TARCEVA, ERLOTINIB HYDROCHLORIDE
TARGRETIN, BEXAROTENE
TARKA, TRANDOLAPRIL
TASIGNA, NILOTINIB HYDROCHLORIDE MONOHYDRATE
TASMAR, TOLCAPONE
TAVIST-1, CLEMASTINE FUMARATE (OTC)
TAXOL, PACLITAXEL
TAXOTERE, DOCETAXEL
TAZICEF, CEFTAZIDIME
TAZORAC, TAZAROTENE
TAZTIA XT, DILTIAZEM HYDROCHLORIDE
TECFIDERA, DIMETHYL FUMARATE
TECHNELITE, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
TECHNESCAN, TECHNETIUM TC-99M OXIDRONATE KIT
TECHNESCAN MAG3, TECHNETIUM TC-99M MERTIATIDE KIT
TECHNESCAN PYP KIT, TECHNETIUM TC-99M PYROPHOSPHATE KIT
TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT
TECHNETIUM TC 99M GENERATOR, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT
TECHNETIUM TC-99M MEBROFENIN, TECHNETIUM TC-99M MEBROFENIN KIT
TECHNETIUM TC-99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT
TEFLARO, CEFTAROLINE FOSAMIL
TEGRETOL, CARBAMAZEPINE
TEGRETOL-XR, CARBAMAZEPINE
TEKAMLO, ALISKIREN HEMIFUMARATE
TEKTURNA, ALISKIREN HEMIFUMARATE
TEKTURNA HCT, ALISKIREN HEMIFUMARATE
TELMISARTAN, TELMISARTAN
TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE
TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
TEMAZEPAM, TEMAZEPAM
TEMODAR, TEMOZOLOMIDE
TEMOVATE, CLOBETASOL PROPIONATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 53
APPENDIX A - PRODUCT NAME INDEX
** T **
TEMOVATE E, CLOBETASOL PROPIONATE
TEMOZOLOMIDE, TEMOZOLOMIDE
TENEX, GUANFACINE HYDROCHLORIDE
TENORETIC 100, ATENOLOL
TENORETIC 50, ATENOLOL
TENORMIN, ATENOLOL
TENSILON, EDROPHONIUM CHLORIDE
TENSILON PRESERVATIVE FREE, EDROPHONIUM CHLORIDE
TENUATE, DIETHYLPROPION HYDROCHLORIDE
TENUATE DOSPAN, DIETHYLPROPION HYDROCHLORIDE
TERAZOL 3, TERCONAZOLE
TERAZOL 7, TERCONAZOLE
TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE (OTC)
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TERBUTALINE SULFATE, TERBUTALINE SULFATE
TERCONAZOLE, TERCONAZOLE
TERIL, CARBAMAZEPINE
TERRAMYCIN W/ POLYMYXIN B SULFATE, OXYTETRACYCLINE HYDROCHLORIDE
TESSALON, BENZONATATE
TESTIM, TESTOSTERONE
TESTOPEL, TESTOSTERONE
TESTOSTERONE, TESTOSTERONE
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE
TESTRED, METHYLTESTOSTERONE
TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE
TEV-TROPIN, SOMATROPIN RECOMBINANT
TEVETEN, EPROSARTAN MESYLATE
TEVETEN HCT, EPROSARTAN MESYLATE
TEXACORT, HYDROCORTISONE
THALITONE, CHLORTHALIDONE
THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201
THALOMID, THALIDOMIDE
THAM, TROMETHAMINE
THEO-24, THEOPHYLLINE
THEOCHRON, THEOPHYLLINE
THEOLAIR, THEOPHYLLINE
THEOPHYLLINE, THEOPHYLLINE
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THERMAZENE, SILVER SULFADIAZINE
THEROXIDIL, MINOXIDIL (OTC)
THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE
THIOGUANINE, THIOGUANINE
THIOLA, TIOPRONIN
THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE
THIOTEPA, THIOTEPA
THIOTHIXENE, THIOTHIXENE
THRIVE, NICOTINE POLACRILEX (OTC)
THYROGEN, THYROTROPIN ALFA
THYROLAR-0.25, LIOTRIX (T4
THYROLAR-0.5, LIOTRIX (T4
THYROLAR-1, LIOTRIX (T4
THYROLAR-2, LIOTRIX (T4
THYROLAR-3, LIOTRIX (T4
THYROSAFE, POTASSIUM IODIDE (OTC)
THYROSHIELD, POTASSIUM IODIDE (OTC)
TIAGABINE HYDROCHLORIDE, TIAGABINE HYDROCHLORIDE
TIAZAC, DILTIAZEM HYDROCHLORIDE
TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE
TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 54
APPENDIX A - PRODUCT NAME INDEX
** T **
TIKOSYN, DOFETILIDE
TIMENTIN, CLAVULANATE POTASSIUM
TIMENTIN IN PLASTIC CONTAINER, CLAVULANATE POTASSIUM
TIMOLOL MALEATE, TIMOLOL MALEATE
TIMOPTIC, TIMOLOL MALEATE
TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE
TIMOPTIC-XE, TIMOLOL MALEATE
TINDAMAX, TINIDAZOLE
TINIDAZOLE, TINIDAZOLE
TIOCONAZOLE, TIOCONAZOLE (OTC)
TIROSINT, LEVOTHYROXINE SODIUM
TIS-U-SOL, MAGNESIUM SULFATE
TIS-U-SOL IN PLASTIC CONTAINER, MAGNESIUM SULFATE
TIVICAY, DOLUTEGRAVIR SODIUM
TIVORBEX, INDOMETHACIN
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TOBI, TOBRAMYCIN
TOBI PODHALER, TOBRAMYCIN
TOBRADEX, DEXAMETHASONE
TOBRADEX ST, DEXAMETHASONE
TOBRAMYCIN, TOBRAMYCIN
TOBRAMYCIN AND DEXAMETHASONE, DEXAMETHASONE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
TOBRAMYCIN SULFATE (PHARMACY BULK), TOBRAMYCIN SULFATE
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, TOBRAMYCIN SULFATE
TOBREX, TOBRAMYCIN
TODAY, NONOXYNOL-9 (OTC)
TOFRANIL, IMIPRAMINE HYDROCHLORIDE
TOFRANIL-PM, IMIPRAMINE PAMOATE
TOLAZAMIDE, TOLAZAMIDE
TOLBUTAMIDE, TOLBUTAMIDE
TOLMETIN SODIUM, TOLMETIN SODIUM
TOLTERODINE TARTRATE, TOLTERODINE TARTRATE
TOPAMAX, TOPIRAMATE
TOPICORT, DESOXIMETASONE
TOPIRAMATE, TOPIRAMATE
TOPIRAMATE , TOPIRAMATE
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
TOPROL-XL, METOPROLOL SUCCINATE
TORISEL, TEMSIROLIMUS
TORSEMIDE, TORSEMIDE
TOTECT, DEXRAZOXANE HYDROCHLORIDE
TOVIAZ, FESOTERODINE FUMARATE
TPN ELECTROLYTES IN PLASTIC CONTAINER, CALCIUM CHLORIDE
TRACLEER, BOSENTAN
TRADJENTA, LINAGLIPTIN
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRANDATE, LABETALOL HYDROCHLORIDE
TRANDOLAPRIL, TRANDOLAPRIL
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE, TRANDOLAPRIL
TRANEXAMIC ACID, TRANEXAMIC ACID
TRANSDERM SCOP, SCOPOLAMINE
TRANXENE, CLORAZEPATE DIPOTASSIUM
TRANYLCYPROMINE SULFATE, TRANYLCYPROMINE SULFATE
TRAVASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 5.5% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 8.5% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS
TRAVATAN Z, TRAVOPROST
TRAVOPROST, TRAVOPROST
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TREANDA, BENDAMUSTINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 55
APPENDIX A - PRODUCT NAME INDEX
** T **
TRECATOR, ETHIONAMIDE
TRELSTAR, TRIPTORELIN PAMOATE
TRETINOIN, TRETINOIN
TREXALL, METHOTREXATE SODIUM
TREXIMET, NAPROXEN SODIUM
TREZIX, ACETAMINOPHEN
TRI-ESTARYLLA, ETHINYL ESTRADIOL
TRI-LEGEST 21, ETHINYL ESTRADIOL
TRI-LEGEST FE, ETHINYL ESTRADIOL
TRI-LINYAH, ETHINYL ESTRADIOL
TRI-LUMA, FLUOCINOLONE ACETONIDE
TRI-NORINYL 28-DAY, ETHINYL ESTRADIOL
TRI-PREVIFEM, ETHINYL ESTRADIOL
TRI-SPRINTEC, ETHINYL ESTRADIOL
TRIACIN-C, CODEINE PHOSPHATE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
TRIAMCINOLONE ACETONIDE IN ABSORBASE, TRIAMCINOLONE ACETONIDE
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
TRIAZOLAM, TRIAZOLAM
TRIBENZOR, AMLODIPINE BESYLATE
TRICOR, FENOFIBRATE
TRIDERM, TRIAMCINOLONE ACETONIDE
TRIDIONE, TRIMETHADIONE
TRIESENCE, TRIAMCINOLONE ACETONIDE
TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE
TRIFLURIDINE, TRIFLURIDINE
TRIGLIDE, FENOFIBRATE
TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE
TRILEPTAL, OXCARBAZEPINE
TRILIPIX, CHOLINE FENOFIBRATE
TRILYTE, POLYETHYLENE GLYCOL 3350
TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE
TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE, TRIMETHOBENZAMIDE HYDROCHLORIDE
TRIMETHOPRIM, TRIMETHOPRIM
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE
TRIOSTAT, LIOTHYRONINE SODIUM
TRISENOX, ARSENIC TRIOXIDE
TRIUMEQ, ABACAVIR SULFATE
TRIVAGIZOLE 3, CLOTRIMAZOLE (OTC)
TRIVORA-28, ETHINYL ESTRADIOL
TRIZIVIR, ABACAVIR SULFATE
TROKENDI XR, TOPIRAMATE
TROPHAMINE, AMINO ACIDS
TROPHAMINE 10%, AMINO ACIDS
TROPICACYL, TROPICAMIDE
TROPICAMIDE, TROPICAMIDE
TROSPIUM CHLORIDE, TROSPIUM CHLORIDE
TRUSOPT, DORZOLAMIDE HYDROCHLORIDE
TRUVADA, EMTRICITABINE
TUDORZA PRESSAIR, ACLIDINIUM BROMIDE
TUSSICAPS, CHLORPHENIRAMINE POLISTIREX
TUSSIGON, HOMATROPINE METHYLBROMIDE
TUSSIONEX PENNKINETIC, CHLORPHENIRAMINE POLISTIREX
TWINJECT 0.15, EPINEPHRINE
TWINJECT 0.3, EPINEPHRINE
TWYNSTA, AMLODIPINE BESYLATE
TYBOST, COBICISTAT
TYGACIL, TIGECYCLINE
TYKERB, LAPATINIB DITOSYLATE
TYLENOL , ACETAMINOPHEN (OTC)
TYLENOL W/ CODEINE NO. 3, ACETAMINOPHEN
TYLENOL W/ CODEINE NO. 4, ACETAMINOPHEN
TYVASO, TREPROSTINIL
TYZEKA, TELBIVUDINE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 56
APPENDIX A - PRODUCT NAME INDEX
** T **
TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE
** U **
U-CORT, HYDROCORTISONE ACETATE
UCERIS, BUDESONIDE
ULESFIA, BENZYL ALCOHOL
ULORIC, FEBUXOSTAT
ULTANE, SEVOFLURANE
ULTIVA, REMIFENTANIL HYDROCHLORIDE
ULTRA-TECHNEKOW FM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
ULTRACET, ACETAMINOPHEN
ULTRAM, TRAMADOL HYDROCHLORIDE
ULTRAM ER, TRAMADOL HYDROCHLORIDE
ULTRATAG, TECHNETIUM TC-99M RED BLOOD CELL KIT
ULTRAVATE, HALOBETASOL PROPIONATE
ULTRAVIST (PHARMACY BULK), IOPROMIDE
ULTRAVIST 150, IOPROMIDE
ULTRAVIST 240, IOPROMIDE
ULTRAVIST 300, IOPROMIDE
ULTRAVIST 300 IN PLASTIC CONTAINER, IOPROMIDE
ULTRAVIST 370, IOPROMIDE
ULTRESA, PANCRELIPASE (AMYLASE
UNASYN, AMPICILLIN SODIUM
UNIPHYL, THEOPHYLLINE
UNIRETIC, HYDROCHLOROTHIAZIDE
UNISOM, DOXYLAMINE SUCCINATE (OTC)
UNITHROID, LEVOTHYROXINE SODIUM **
UNIVASC, MOEXIPRIL HYDROCHLORIDE
URECHOLINE, BETHANECHOL CHLORIDE
UREX, METHENAMINE HIPPURATE
UROCIT-K, POTASSIUM CITRATE
UROXATRAL, ALFUZOSIN HYDROCHLORIDE
URSO 250, URSODIOL
URSO FORTE, URSODIOL
URSODIOL, URSODIOL
UVADEX, METHOXSALEN
** V **
VAGIFEM, ESTRADIOL
VAGISTAT-1, TIOCONAZOLE (OTC)
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VALCHLOR, MECHLORETHAMINE HYDROCHLORIDE
VALCYTE, VALGANCICLOVIR HYDROCHLORIDE
VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE
VALIUM, DIAZEPAM
VALNAC, BETAMETHASONE VALERATE
VALPROATE SODIUM, VALPROATE SODIUM
VALPROIC ACID, VALPROIC ACID
VALSARTAN, VALSARTAN
VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
VALSTAR PRESERVATIVE FREE, VALRUBICIN
VALTREX, VALACYCLOVIR HYDROCHLORIDE
VALTROPIN, SOMATROPIN RECOMBINANT
VANCOCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VANDAZOLE, METRONIDAZOLE
VANIQA, EFLORNITHINE HYDROCHLORIDE
VANOS, FLUOCINONIDE
VANTAS, HISTRELIN ACETATE
VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER, CONIVAPTAN HYDROCHLORIDE
VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE
VARITHENA, POLIDOCANOL
VASCEPA, ICOSAPENT ETHYL
VASERETIC, ENALAPRIL MALEATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 57
APPENDIX A - PRODUCT NAME INDEX
** V **
VASOSTRICT, VASOPRESSIN
VASOTEC, ENALAPRIL MALEATE
VAZCULEP, PHENYLEPHRINE HYDROCHLORIDE
VECTICAL, CALCITRIOL
VECURONIUM BROMIDE, VECURONIUM BROMIDE
VELCADE, BORTEZOMIB
VELETRI, EPOPROSTENOL SODIUM
VELIVET, DESOGESTREL
VELPHORO, SUCROFERRIC OXYHYDROXIDE
VELTIN, CLINDAMYCIN PHOSPHATE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
VENOFER, IRON SUCROSE
VENTAVIS, ILOPROST
VENTOLIN HFA, ALBUTEROL SULFATE
VERAMYST, FLUTICASONE FUROATE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
VERDESO, DESONIDE
VEREGEN, SINECATECHINS
VERELAN, VERAPAMIL HYDROCHLORIDE
VERELAN PM, VERAPAMIL HYDROCHLORIDE
VERSACLOZ, CLOZAPINE
VESICARE, SOLIFENACIN SUCCINATE
VEXOL, RIMEXOLONE
VFEND, VORICONAZOLE
VIAGRA, SILDENAFIL CITRATE
VIBATIV, TELAVANCIN HYDROCHLORIDE
VIBISONE, CYANOCOBALAMIN
VIBRAMYCIN, DOXYCYCLINE
VIBRAMYCIN, DOXYCYCLINE CALCIUM
VIBRAMYCIN, DOXYCYCLINE HYCLATE
VICOPROFEN, HYDROCODONE BITARTRATE
VICTOZA, LIRAGLUTIDE RECOMBINANT
VICTRELIS, BOCEPREVIR
VIDAZA, AZACITIDINE
VIDEX, DIDANOSINE
VIDEX EC, DIDANOSINE
VIEKIRA PAK (COPACKAGED), DASABUVIR SODIUM
VIGAMOX, MOXIFLOXACIN HYDROCHLORIDE
VIIBRYD, VILAZODONE HYDROCHLORIDE
VIMOVO, ESOMEPRAZOLE MAGNESIUM
VIMPAT, LACOSAMIDE
VINBLASTINE SULFATE, VINBLASTINE SULFATE
VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE
VINORELBINE, VINORELBINE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
VIOKACE, PANCRELIPASE (AMYLASE
VIORELE, DESOGESTREL
VIRACEPT, NELFINAVIR MESYLATE
VIRAMUNE, NEVIRAPINE
VIRAMUNE XR, NEVIRAPINE
VIRAZOLE, RIBAVIRIN
VIREAD, TENOFOVIR DISOPROXIL FUMARATE
VIROPTIC, TRIFLURIDINE
VISINE L.R., OXYMETAZOLINE HYDROCHLORIDE (OTC)
VISINE-A, NAPHAZOLINE HYDROCHLORIDE (OTC)
VISIONBLUE, TRYPAN BLUE
VISIPAQUE 270, IODIXANOL
VISIPAQUE 320, IODIXANOL
VISTARIL, HYDROXYZINE PAMOATE
VISTIDE, CIDOFOVIR
VISUDYNE, VERTEPORFIN
VITAMIN D, ERGOCALCIFEROL
VITAMIN K1, PHYTONADIONE
VITEKTA, ELVITEGRAVIR
VITRASE, HYALURONIDASE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 58
APPENDIX A - PRODUCT NAME INDEX
** V **
VITUZ, CHLORPHENIRAMINE MALEATE
VIVACTIL, PROTRIPTYLINE HYDROCHLORIDE
VIVELLE, ESTRADIOL
VIVELLE-DOT, ESTRADIOL
VIVITROL, NALTREXONE
VIZAMYL, FLUTEMETAMOL F-18
VOGELXO, TESTOSTERONE
VOLTAREN, DICLOFENAC SODIUM
VOLTAREN-XR, DICLOFENAC SODIUM
VORICONAZOLE, VORICONAZOLE
VOSOL, ACETIC ACID, GLACIAL
VOSOL HC, ACETIC ACID, GLACIAL
VOSPIRE ER, ALBUTEROL SULFATE
VOTRIENT, PAZOPANIB HYDROCHLORIDE
VPRIV, VELAGLUCERASE ALFA
VUMON, TENIPOSIDE
VUSION, MICONAZOLE NITRATE
VYFEMLA, ETHINYL ESTRADIOL
VYTORIN, EZETIMIBE
VYVANSE, LISDEXAMFETAMINE DIMESYLATE
** W **
WARFARIN SODIUM, WARFARIN SODIUM
WELCHOL, COLESEVELAM HYDROCHLORIDE
WELLBUTRIN, BUPROPION HYDROCHLORIDE
WELLBUTRIN SR, BUPROPION HYDROCHLORIDE
WELLBUTRIN XL, BUPROPION HYDROCHLORIDE
WERA, ETHINYL ESTRADIOL
WOMEN'S ROGAINE, MINOXIDIL (OTC)
** X **
XALATAN, LATANOPROST
XALKORI, CRIZOTINIB
XANAX, ALPRAZOLAM
XANAX XR, ALPRAZOLAM
XARELTO, RIVAROXABAN
XARTEMIS XR, ACETAMINOPHEN
XELJANZ, TOFACITINIB CITRATE
XELODA, CAPECITABINE
XENAZINE, TETRABENAZINE
XENICAL, ORLISTAT
XENON XE 133, XENON XE-133
XERESE, ACYCLOVIR
XIFAXAN, RIFAXIMIN
XIGDUO XR, DAPAGLIFLOZIN
XOFIGO, RADIUM RA-223 DICHLORIDE
XOLEGEL, KETOCONAZOLE
XOPENEX, LEVALBUTEROL HYDROCHLORIDE
XOPENEX HFA, LEVALBUTEROL TARTRATE
XTANDI, ENZALUTAMIDE
XTORO, FINAFLOXACIN
XULANE, ETHINYL ESTRADIOL
XYLOCAINE, LIDOCAINE HYDROCHLORIDE
XYLOCAINE 4% PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
XYLOCAINE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
XYLOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE
XYLOCAINE W/ EPINEPHRINE, EPINEPHRINE
XYREM, SODIUM OXYBATE
XYZAL, LEVOCETIRIZINE DIHYDROCHLORIDE
** Y **
YAELA, DROSPIRENONE
YASMIN, DROSPIRENONE
YAZ, DROSPIRENONE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 59
APPENDIX A - PRODUCT NAME INDEX
** Z **
ZADITOR, KETOTIFEN FUMARATE (OTC)
ZAFIRLUKAST, ZAFIRLUKAST
ZALEPLON, ZALEPLON
ZANAFLEX, TIZANIDINE HYDROCHLORIDE
ZANOSAR, STREPTOZOCIN
ZANTAC, RANITIDINE HYDROCHLORIDE
ZANTAC 150, RANITIDINE HYDROCHLORIDE (OTC)
ZANTAC 150, RANITIDINE HYDROCHLORIDE
ZANTAC 300, RANITIDINE HYDROCHLORIDE
ZANTAC 75, RANITIDINE HYDROCHLORIDE (OTC)
ZARONTIN, ETHOSUXIMIDE
ZAROXOLYN, METOLAZONE
ZAVESCA, MIGLUSTAT
ZEBETA, BISOPROLOL FUMARATE
ZECUITY, SUMATRIPTAN SUCCINATE
ZEGERID, OMEPRAZOLE
ZEGERID OTC, OMEPRAZOLE (OTC)
ZELAPAR, SELEGILINE HYDROCHLORIDE
ZELBORAF, VEMURAFENIB
ZEMPLAR, PARICALCITOL
ZENATANE, ISOTRETINOIN
ZENPEP, PANCRELIPASE (AMYLASE
ZERBAXA, CEFTOLOZANE SULFATE
ZERIT, STAVUDINE
ZESTORETIC, HYDROCHLOROTHIAZIDE
ZESTRIL, LISINOPRIL
ZETIA, EZETIMIBE
ZETONNA, CICLESONIDE
ZIAC, BISOPROLOL FUMARATE
ZIAGEN, ABACAVIR SULFATE
ZIANA, CLINDAMYCIN PHOSPHATE
ZIDOVUDINE, ZIDOVUDINE
ZINACEF, CEFUROXIME SODIUM
ZINACEF IN PLASTIC CONTAINER, CEFUROXIME SODIUM
ZINC CHLORIDE IN PLASTIC CONTAINER, ZINC CHLORIDE
ZINECARD, DEXRAZOXANE HYDROCHLORIDE
ZINGO, LIDOCAINE HYDROCHLORIDE
ZIOPTAN, TAFLUPROST
ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE
ZIPSOR, DICLOFENAC POTASSIUM
ZIRGAN, GANCICLOVIR
ZITHROMAX, AZITHROMYCIN
ZMAX, AZITHROMYCIN
ZOCOR, SIMVASTATIN
ZOFRAN, ONDANSETRON HYDROCHLORIDE
ZOFRAN ODT, ONDANSETRON
ZOFRAN PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ZOHYDRO ER, HYDROCODONE BITARTRATE
ZOLADEX, GOSERELIN ACETATE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
ZOLINZA, VORINOSTAT
ZOLMITRIPTAN, ZOLMITRIPTAN
ZOLOFT, SERTRALINE HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ZOLPIMIST, ZOLPIDEM TARTRATE
ZOMETA, ZOLEDRONIC ACID
ZOMIG, ZOLMITRIPTAN
ZOMIG-ZMT, ZOLMITRIPTAN
ZONALON, DOXEPIN HYDROCHLORIDE
ZONEGRAN, ZONISAMIDE
ZONISAMIDE, ZONISAMIDE
ZONTIVITY, VORAPAXAR SULFATE
ZORBTIVE, SOMATROPIN RECOMBINANT
ZORTRESS, EVEROLIMUS
ZORVOLEX, DICLOFENAC
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST A - 60
APPENDIX A - PRODUCT NAME INDEX
** Z **
ZOSYN, PIPERACILLIN SODIUM
ZOSYN IN PLASTIC CONTAINER, PIPERACILLIN SODIUM
ZOVIA 1/35E-28, ETHINYL ESTRADIOL
ZOVIA 1/50E-28, ETHINYL ESTRADIOL
ZOVIRAX, ACYCLOVIR
ZUBSOLV, BUPRENORPHINE HYDROCHLORIDE
ZUPLENZ, ONDANSETRON
ZUTRIPRO, CHLORPHENIRAMINE MALEATE
ZYBAN, BUPROPION HYDROCHLORIDE
ZYCLARA, IMIQUIMOD
ZYDELIG, IDELALISIB
ZYFLO, ZILEUTON
ZYFLO CR, ZILEUTON
ZYKADIA, CERITINIB
ZYLET, LOTEPREDNOL ETABONATE
ZYLOPRIM, ALLOPURINOL
ZYMAR, GATIFLOXACIN
ZYMAXID, GATIFLOXACIN
ZYPREXA, OLANZAPINE
ZYPREXA RELPREVV, OLANZAPINE PAMOATE
ZYPREXA ZYDIS, OLANZAPINE
ZYRTEC, CETIRIZINE HYDROCHLORIDE
ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
ZYRTEC-D 12 HOUR, CETIRIZINE HYDROCHLORIDE (OTC)
ZYTIGA, ABIRATERONE ACETATE
ZYVOX, LINEZOLID
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 1
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** 3 **
3M
* 3M CO
PERIDEX, CHLORHEXIDINE GLUCONATE
* 3M HEALTH CARE INC
AVAGARD, ALCOHOL (OTC)
DURAPREP, IODINE POVACRYLEX (OTC)
* 3M PHARMACEUTICALS INC
PROVENTIL-HFA, ALBUTEROL SULFATE
** A **
AAIPHARMA LLC
* AAIPHARMA LLC
AZASAN, AZATHIOPRINE
ABBVIE
* ABBVIE INC
ADVICOR, LOVASTATIN
AKINETON, BIPERIDEN HYDROCHLORIDE
ANDROGEL, TESTOSTERONE
BIAXIN XL, CLARITHROMYCIN
BIAXIN, CLARITHROMYCIN
CALCIJEX, CALCITRIOL
CREON, PANCRELIPASE (AMYLASE
CYCLOSPORINE, CYCLOSPORINE
DEPACON, VALPROATE SODIUM
DEPAKENE, VALPROIC ACID
DEPAKOTE ER, DIVALPROEX SODIUM
DEPAKOTE, DIVALPROEX SODIUM
GENGRAF, CYCLOSPORINE
K-TAB, POTASSIUM CHLORIDE
KALETRA, LOPINAVIR
MARINOL, DRONABINOL
MAVIK, TRANDOLAPRIL
NIASPAN, NIACIN
NIMBEX PRESERVATIVE FREE, CISATRACURIUM BESYLATE
NIMBEX, CISATRACURIUM BESYLATE
NORVIR, RITONAVIR
ORETIC, HYDROCHLOROTHIAZIDE
SIMCOR, NIACIN
SURVANTA, BERACTANT
SYNTHROID, LEVOTHYROXINE SODIUM **
TARKA, TRANDOLAPRIL
TEVETEN HCT, EPROSARTAN MESYLATE
TEVETEN, EPROSARTAN MESYLATE
TRICOR, FENOFIBRATE
TRIDIONE, TRIMETHADIONE
TRILIPIX, CHOLINE FENOFIBRATE
ULTANE, SEVOFLURANE
VICOPROFEN, HYDROCODONE BITARTRATE
ZEMPLAR, PARICALCITOL
ABBVIE ENDOCRINE
* ABBVIE ENDOCRINE INC
LUPANETA PACK, LEUPROLIDE ACETATE
ABBVIE ENDOCRINE INC
* ABBVIE ENDOCRINE INC
LUPRON DEPOT, LEUPROLIDE ACETATE
LUPRON DEPOT-PED, LEUPROLIDE ACETATE
ABBVIE INC
* ABBVIE INC
PROMETRIUM, PROGESTERONE
VIEKIRA PAK (COPACKAGED), DASABUVIR SODIUM
ABRAXIS BIOSCIENCE
* ABRAXIS BIOSCIENCE LLC
ABRAXANE, PACLITAXEL
ABRAXIS PHARM
* ABRAXIS PHARMACEUTICAL PRODUCTS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 2
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
* ABRAXIS PHARMACEUTICAL PRODUCTS
CLINDAMYCIN PHOSPHATE IN DEXTROSE 5%, CLINDAMYCIN PHOSPHATE
ACADEMIC PHARMS
* ACADEMIC PHARMACEUTICALS INC
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
ACCELRX LABS
* ACCELRX LABS LLC
CARISOPRODOL, CARISOPRODOL
ACCORD HLTHCARE
* ACCORD HEALTHCARE INC
ALLOPURINOL, ALLOPURINOL
AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ANASTROZOLE, ANASTROZOLE
BICALUTAMIDE, BICALUTAMIDE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
CARBIDOPA AND LEVODOPA, CARBIDOPA
CLONAZEPAM, CLONAZEPAM
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DOCETAXEL, DOCETAXEL
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
ETOPOSIDE, ETOPOSIDE
FINASTERIDE, FINASTERIDE
FLUOROURACIL, FLUOROURACIL
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GLIMEPIRIDE, GLIMEPIRIDE
GLIPIZIDE, GLIPIZIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
LISINOPRIL, LISINOPRIL
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
METHYLDOPA, METHYLDOPA
MITOMYCIN, MITOMYCIN
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
TACROLIMUS, TACROLIMUS
TOPIRAMATE, TOPIRAMATE
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
ACCORD HLTHCARE INC
* ACCORD HEALTHCARE INC USA
FINASTERIDE, FINASTERIDE
RAMIPRIL, RAMIPRIL
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
ACELLA PHARMS LLC
* ACELLA PHARMACEUTICALS LLC
GABAPENTIN, GABAPENTIN
ACI HEALTHCARE LTD
* ACI HEALTHCARE LTD
GABAPENTIN, GABAPENTIN
ACIC FINE CHEMS
* ACIC FINE CHEMICALS INC
TRANEXAMIC ACID, TRANEXAMIC ACID
ACORDA
* ACORDA THERAPEUTICS INC
AMPYRA, DALFAMPRIDINE
QUTENZA, CAPSAICIN
ZANAFLEX, TIZANIDINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 3
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
ACS DOBFAR
* ACS DOBFAR SPA
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE
CEFOXITIN, CEFOXITIN SODIUM
CEFTAZIDIME, CEFTAZIDIME
CEFTRIAXONE, CEFTRIAXONE SODIUM
IMIPENEM AND CILASTATIN, CILASTATIN SODIUM
KEFZOL, CEFAZOLIN SODIUM
MEROPENEM, MEROPENEM
ACS DOBFAR INFO SA
* ACS DOBFAR INFO SA
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
FLUCANAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
ZOLEDRONIC ACID, ZOLEDRONIC ACID
ACS DOBFAR SPA
* ACS DOBFAR SPA
AMPICILLIN SODIUM, AMPICILLIN SODIUM
ACTAVIS
* ACTAVIS SOUTHATLANTIC LLC
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
ACTAVIS ELIZABETH
* ACTAVIS ELIZABETH LLC
ALPRAZOLAM, ALPRAZOLAM
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
CARBIDOPA AND LEVODOPA, CARBIDOPA
CLONAZEPAM, CLONAZEPAM
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
GABAPENTIN, GABAPENTIN
GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE
GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
INDAPAMIDE, INDAPAMIDE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LOVASTATIN, LOVASTATIN
MORPHINE SULFATE, MORPHINE SULFATE
NIFEDIPINE, NIFEDIPINE
OXAZEPAM, OXAZEPAM
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
PROPYLTHIOURACIL, PROPYLTHIOURACIL
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SPIRONOLACTONE, SPIRONOLACTONE
TEMAZEPAM, TEMAZEPAM
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ACTAVIS GRP PTC
* ACTAVIS GROUP PTC EHF
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 4
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
* ACTAVIS GROUP PTC EHF
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
ACTAVIS INC
* ACTAVIS INC
DOCETAXEL, DOCETAXEL
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
ACTAVIS LABS FL INC
* ACTAVIS LABORATORIES FL INC
ALPRAZOLAM, ALPRAZOLAM
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CABERGOLINE, CABERGOLINE
CARTIA XT, DILTIAZEM HYDROCHLORIDE
CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN
CLARITHROMYCIN, CLARITHROMYCIN
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
FLUTAMIDE, FLUTAMIDE
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GLIMEPIRIDE, GLIMEPIRIDE
HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
KETOPROFEN, KETOPROFEN
LEVETIRACETAM, LEVETIRACETAM
LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC)
LORATADINE, LORATADINE (OTC)
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
MIRTAZAPINE, MIRTAZAPINE
NAPROXEN SODIUM, NAPROXEN SODIUM
NORCO, ACETAMINOPHEN
OMEPRAZOLE, OMEPRAZOLE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TAZTIA XT, DILTIAZEM HYDROCHLORIDE
TRANEXAMIC ACID, TRANEXAMIC ACID
TROSPIUM CHLORIDE, TROSPIUM CHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ACTAVIS LABS NY INC
* ACTAVIS LABORATORIES NY INC
NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)
ACTAVIS LABS UT INC
* ACTAVIS LABORATORIES UT INC
ANDRODERM, TESTOSTERONE
ACTAVIS MID ATLANTIC
* ACTAVIS MID ATLANTIC LLC
ACETASOL HC, ACETIC ACID, GLACIAL
ACYCLOVIR, ACYCLOVIR
ADAPALENE, ADAPALENE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 5
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
* ACTAVIS MID ATLANTIC LLC
CICLOPIROX, CICLOPIROX
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CLOTRIMAZOLE, CLOTRIMAZOLE (OTC)
CONSTULOSE, LACTULOSE
ENULOSE, LACTULOSE
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
GRISEOFULVIN, GRISEOFULVIN, MICROSIZE
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE
HYDROCORTISONE, HYDROCORTISONE
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
LEVETIRACETAM, LEVETIRACETAM
M-ZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MICONAZOLE 7, MICONAZOLE NITRATE (OTC)
MICONAZOLE NITRATE, MICONAZOLE NITRATE
MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)
MINOXIDIL (FOR MEN), MINOXIDIL (OTC)
MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)
NYSTATIN, NYSTATIN
PERMETHRIN, PERMETHRIN
PERMETHRIN, PERMETHRIN (OTC)
PROMETH VC PLAIN, PHENYLEPHRINE HYDROCHLORIDE
PROMETH VC W/ CODEINE, CODEINE PHOSPHATE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
VALNAC, BETAMETHASONE VALERATE
ACTAVIS TOTOWA
* ACTAVIS TOTOWA LLC
BICALUTAMIDE, BICALUTAMIDE
CARBOPLATIN, CARBOPLATIN
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
FINASTERIDE, FINASTERIDE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
OXALIPLATIN, OXALIPLATIN
PACLITAXEL, PACLITAXEL
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
REPAGLINIDE, REPAGLINIDE
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
ACTELION PHARMS LTD
* ACTELION PHARMACEUTICALS LTD
OPSUMIT, MACITENTAN
TRACLEER, BOSENTAN
VALCHLOR, MECHLORETHAMINE HYDROCHLORIDE
VELETRI, EPOPROSTENOL SODIUM
VENTAVIS, ILOPROST
ZAVESCA, MIGLUSTAT
ACTIENT PHARMS
* ACTIENT PHARMACEUTICALS LLC
TESTOPEL, TESTOSTERONE
THEO-24, THEOPHYLLINE
ACTIVIS TOTOWA LLC
* ACTIVIS TOTOWA LLC
TOPIRAMATE, TOPIRAMATE
ACURA PHARMS INC
* ACURA PHARMACEUTICALS INC
OXECTA, OXYCODONE HYDROCHLORIDE
AEGERION
* AEGERION PHARMACEUTICALS INC
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 6
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
* AEGERION PHARMACEUTICALS INC
JUXTAPID, LOMITAPIDE MESYLATE
AGILA SPECLTS
* AGILA SPECIALTIES PRIVATE LTD
ADENOSINE, ADENOSINE
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
AMPICILLIN SODIUM, AMPICILLIN SODIUM
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DOXYCYCLINE, DOXYCYCLINE HYCLATE
ETOMIDATE, ETOMIDATE
FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE
FLUMAZENIL, FLUMAZENIL
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE
HALOPERIDOL, HALOPERIDOL LACTATE
IBANDRONATE SODIUM, IBANDRONATE SODIUM
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
MESNA, MESNA
NAFCILLIN SODIUM, NAFCILLIN SODIUM
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXACILLIN SODIUM, OXACILLIN SODIUM
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM
RIFAMPIN, RIFAMPIN
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VECURONIUM BROMIDE, VECURONIUM BROMIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
AGOURON
* AGOURON PHARMACEUTICALS INC
VIRACEPT, NELFINAVIR MESYLATE
AJANTA PHARMA
* AJANTA PHARMA LTD
LEVETIRACETAM, LEVETIRACETAM
AJANTA PHARMA LTD
* AJANTA PHARMA LTD
RISPERIDONE, RISPERIDONE
AKORN
* AKORN INC
ADENOSINE, ADENOSINE
AK-FLUOR 10%, FLUORESCEIN SODIUM
AK-FLUOR 25%, FLUORESCEIN SODIUM
AKBETA, LEVOBUNOLOL HYDROCHLORIDE
AKPENTOLATE, CYCLOPENTOLATE HYDROCHLORIDE
AKTEN, LIDOCAINE HYDROCHLORIDE
AKTOB, TOBRAMYCIN
ALFENTA, ALFENTANIL HYDROCHLORIDE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
ATROPINE SULFATE, ATROPINE SULFATE
BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC
BAL, DIMERCAPROL
BALANCED SALT, CALCIUM CHLORIDE
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE
CALCITRIOL, CALCITRIOL
CAPASTAT SULFATE, CAPREOMYCIN SULFATE
CARBOPLATIN, CARBOPLATIN
CROMOLYN SODIUM, CROMOLYN SODIUM
DICLOFENAC SODIUM, DICLOFENAC SODIUM
ENDOSOL EXTRA, CALCIUM CHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 7
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
* AKORN INC
ERYTHROMYCIN, ERYTHROMYCIN
GENTAK, GENTAMICIN SULFATE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
IC-GREEN, INDOCYANINE GREEN
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC)
LATANOPROST, LATANOPROST
LEVOFLOXACIN, LEVOFLOXACIN
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LORAZEPAM, LORAZEPAM
NEDOCROMIL SODIUM, NEDOCROMIL SODIUM
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC
OFLOXACIN, OFLOXACIN
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
PAREMYD, HYDROXYAMPHETAMINE HYDROBROMIDE
SUBLIMAZE PRESERVATIVE FREE, FENTANYL CITRATE
SUFENTA PRESERVATIVE FREE, SUFENTANIL CITRATE
TERBUTALINE SULFATE, TERBUTALINE SULFATE
TIMOLOL MALEATE, TIMOLOL MALEATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
TROPICACYL, TROPICAMIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
AKORN INC
* AKORN INC
APRACLONIDINE HYDROCHLORIDE, APRACLONIDINE HYDROCHLORIDE
CEFTRIAXONE, CEFTRIAXONE SODIUM
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE
DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DRONABINOL, DRONABINOL
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
INAPSINE, DROPERIDOL
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE (OTC)
NAPHAZOLINE HYDROCHLORIDE, NAPHAZOLINE HYDROCHLORIDE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE
TOBRAMYCIN, TOBRAMYCIN
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
ALARA PHARM
* ALARA PHARMACEUTICAL CORPORATION
LEVO-T, LEVOTHYROXINE SODIUM **
ALCON
* ALCON INC
TRIESENCE, TRIAMCINOLONE ACETONIDE
* ALCON LABORATORIES INC
ALCAINE, PROPARACAINE HYDROCHLORIDE
ALOMIDE, LODOXAMIDE TROMETHAMINE
BETOPTIC S, BETAXOLOL HYDROCHLORIDE
BETOPTIC, BETAXOLOL HYDROCHLORIDE
BSS PLUS, CALCIUM CHLORIDE
BSS, CALCIUM CHLORIDE
CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE
CETAMIDE, SULFACETAMIDE SODIUM
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 8
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
* ALCON LABORATORIES INC
CROMOLYN SODIUM, CROMOLYN SODIUM
CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE
CYCLOMYDRIL, CYCLOPENTOLATE HYDROCHLORIDE
DENDRID, IDOXURIDINE
EMADINE, EMEDASTINE DIFUMARATE
FLAREX, FLUOROMETHOLONE ACETATE
IOPIDINE, APRACLONIDINE HYDROCHLORIDE
MAXIDEX, DEXAMETHASONE
MAXITROL, DEXAMETHASONE
MIOSTAT, CARBACHOL
MYDRIACYL, TROPICAMIDE
NAPHCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)
NATACYN, NATAMYCIN
OMNIPRED, PREDNISOLONE ACETATE
PATANOL, OLOPATADINE HYDROCHLORIDE
PILOPINE HS, PILOCARPINE HYDROCHLORIDE
TOBRADEX, DEXAMETHASONE
TOBREX, TOBRAMYCIN
VEXOL, RIMEXOLONE
ALCON LABS INC
* ALCON LABORATORIES INC
CYCLOGYL, CYCLOPENTOLATE HYDROCHLORIDE
IZBA, TRAVOPROST
ALCON PHARMA
* ALCON RESEARCH LTD
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
ZADITOR, KETOTIFEN FUMARATE (OTC)
ALCON PHARMS LTD
* ALCON PHARMACEUTICALS LTD
AZOPT, BRINZOLAMIDE
BETADINE, POVIDONE-IODINE
BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE
CILOXAN, CIPROFLOXACIN HYDROCHLORIDE
CIPRO HC, CIPROFLOXACIN HYDROCHLORIDE
CIPRODEX, CIPROFLOXACIN
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
DUREZOL, DIFLUPREDNATE
FLUORESCITE, FLUORESCEIN SODIUM
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
KETOTIFEN FUMARATE, KETOTIFEN FUMARATE (OTC)
MOXEZA, MOXIFLOXACIN HYDROCHLORIDE
NAVSTEL, CALCIUM CHLORIDE
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE
NEVANAC, NEPAFENAC
OFLOXACIN, OFLOXACIN
PATADAY, OLOPATADINE HYDROCHLORIDE
PATANASE, OLOPATADINE HYDROCHLORIDE
QOLIANA, BRIMONIDINE TARTRATE
SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
TOBRADEX ST, DEXAMETHASONE
TRAVATAN Z, TRAVOPROST
TRIFLURIDINE, TRIFLURIDINE
VIGAMOX, MOXIFLOXACIN HYDROCHLORIDE
ALCON RES
* ALCON RESEARCH LTD
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
ISOPTO CARPINE, PILOCARPINE HYDROCHLORIDE
LATANOPROST, LATANOPROST
ALCON RES LTD
* ALCON RESEARCH LTD
GENTAMICIN SULFATE, GENTAMICIN SULFATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 9
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
* ALCON RESEARCH LTD
ILEVRO, NEPAFENAC
LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE
METIPRANOLOL, METIPRANOLOL HYDROCHLORIDE
SIMBRINZA, BRIMONIDINE TARTRATE
TIMOLOL MALEATE, TIMOLOL MALEATE
XTORO, FINAFLOXACIN
ALEMBIC LTD
* ALEMBIC LTD
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LITHIUM CARBONATE, LITHIUM CARBONATE
METRONIDAZOLE, METRONIDAZOLE
MODAFINIL, MODAFINIL
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
THEOPHYLLINE, THEOPHYLLINE
VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
ALEMBIC PHARMS LTD
* ALEMBIC PHARMACEUTICALS LTD
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
DESVENLAFAXINE, DESVENLAFAXINE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
FAMOTIDINE, FAMOTIDINE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
LAMOTRIGINE, LAMOTRIGINE
LEFLUNOMIDE, LEFLUNOMIDE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MEPROBAMATE, MEPROBAMATE
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONIDAZOLE, METRONIDAZOLE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
TELMISARTAN, TELMISARTAN
VALSARTAN, VALSARTAN
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ALIMERA SCIENCES INC
* ALIMERA SCIENCES INC
ILUVIEN, FLUOCINOLONE ACETONIDE
ALKEM
* ALKEM LABORATORIES LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
GABAPENTIN, GABAPENTIN
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
ALKEM LABS LTD
* ALKEM LABORATORIES LTD
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CEPHALEXIN, CEPHALEXIN
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
LAMOTRIGINE, LAMOTRIGINE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
ALKERMES
* ALKERMES INC
VIVITROL, NALTREXONE
ALKERMES GAINESVILLE
* ALKERMES GAINESVILLE LLC
VERELAN PM, VERAPAMIL HYDROCHLORIDE
VERELAN, VERAPAMIL HYDROCHLORIDE
ALKOPHARMA USA
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 10
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
* ALKOPHARMA USA INC
AMPHOTEC, AMPHOTERICIN B
ALLEGIANCE HLTHCARE
* ALLEGIANCE HEALTHCARE CORP
POVIDONE IODINE, POVIDONE-IODINE (OTC)
ALLERGAN
* ALLERGAN
ACULAR LS, KETOROLAC TROMETHAMINE
ALPHAGAN P, BRIMONIDINE TARTRATE
BLEPH-10, SULFACETAMIDE SODIUM
GENOPTIC, GENTAMICIN SULFATE
ZYMAXID, GATIFLOXACIN
* ALLERGAN INC
ACULAR, KETOROLAC TROMETHAMINE
ACUVAIL, KETOROLAC TROMETHAMINE
ACZONE, DAPSONE
ALOCRIL, NEDOCROMIL SODIUM
ALPHAGAN P, BRIMONIDINE TARTRATE
AVAGE, TAZAROTENE
AZELEX, AZELAIC ACID
COMBIGAN, BRIMONIDINE TARTRATE
ELESTAT, EPINASTINE HYDROCHLORIDE
LASTACAFT, ALCAFTADINE
LATISSE, BIMATOPROST
LUMIGAN, BIMATOPROST
OCUFLOX, OFLOXACIN
OZURDEX, DEXAMETHASONE
POLYTRIM, POLYMYXIN B SULFATE
RESTASIS, CYCLOSPORINE
SANCTURA XR, TROSPIUM CHLORIDE
SANCTURA, TROSPIUM CHLORIDE
TAZORAC, TAZAROTENE
ZYMAR, GATIFLOXACIN
* ALLERGAN PHARMACEUTICAL
BETAGAN, LEVOBUNOLOL HYDROCHLORIDE
BLEPHAMIDE S.O.P., PREDNISOLONE ACETATE
BLEPHAMIDE, PREDNISOLONE ACETATE
FML FORTE, FLUOROMETHOLONE
FML, FLUOROMETHOLONE
HERPLEX, IDOXURIDINE
OCUFEN, FLURBIPROFEN SODIUM
PRED FORTE, PREDNISOLONE ACETATE
PRED MILD, PREDNISOLONE ACETATE
PRED-G, GENTAMICIN SULFATE
ALLERQUEST
* ALLERQUEST LLC
PRE-PEN, BENZYLPENICILLOYL POLYLYSINE
ALLIED PHARMA INC
* ALLIED PHARMA INC
CLARITHROMYCIN, CLARITHROMYCIN
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
ALLOS
* ALLOS THERAPEUTICS INC
FOLOTYN, PRALATREXATE
ALMATICA PHARMA INC
* ALMATICA PHARMA INC
NAPRELAN, NAPROXEN SODIUM
ALPHARMA
* ALPHARMA USPD INC
PREDNISOLONE, PREDNISOLONE
VALPROIC ACID, VALPROIC ACID
ALPHARMA PHARMS
* ALPHARMA PHARMACEUTICALS LLC
EMBEDA, MORPHINE SULFATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 11
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
ALRA
* ALRA LABORATORIES INC
CHOLAC, LACTULOSE
CONSTILAC, LACTULOSE
GEN-XENE, CLORAZEPATE DIPOTASSIUM
IBU-TAB 200, IBUPROFEN (OTC)
IBU-TAB, IBUPROFEN
ALTAIRE PHARMS INC
* ALTAIRE PHARMACEUTICALS INC
NAPHAZOLINE HYDROCHLORIDE AND PHENIRAMINE MALEATE, NAPHAZOLINE HYDROCHLORIDE (OTC)
OFLOXACIN, OFLOXACIN
ALVOGEN
* ALVOGEN INC
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
ALVOGEN INC
* ALVOGEN INC
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
EXEMESTANE, EXEMESTANE
MACROBID, NITROFURANTOIN
MACRODANTIN, NITROFURANTOIN, MACROCRYSTALLINE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PRIMAQUINE PHOSPHATE, PRIMAQUINE PHOSPHATE
ALVOGEN PINE BROOK
* ALVOGEN PINE BROOK INC
DISULFIRAM , DISULFIRAM
AM ANTIBIOTICS
* AMERICAN ANTIBIOTICS INC
AMOXICILLIN, AMOXICILLIN
AMAG PHARMS INC
* AMAG PHARMACEUTICALS INC
FERAHEME, FERUMOXYTOL
AMARIN PHARMS
* AMARIN PHARMACEUTICALS IRELAND LTD
VASCEPA, ICOSAPENT ETHYL
AMEDRA PHARMS
* AMEDRA PHARMACEUTICALS LLC
ADRENACLICK, EPINEPHRINE
ALBENZA, ALBENDAZOLE
DARAPRIM, PYRIMETHAMINE
DEXEDRINE, DEXTROAMPHETAMINE SULFATE
HYDROCORTISONE, HYDROCORTISONE
TWINJECT 0.15, EPINEPHRINE
TWINJECT 0.3, EPINEPHRINE
AMEDRA PHARMS LLC
* AMEDRA PHARMACEUTICALS LLC
MEBENDAZOLE, MEBENDAZOLE
AMERIGEN PHARMS LTD
* AMERIGEN PHARMACEUTICALS LTD
CARBIDOPA, CARBIDOPA
AMGEN
* AMGEN INC
SENSIPAR, CINACALCET HYDROCHLORIDE
AMNEAL PHARM
* AMNEAL PHARMACEUTICAL
ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE
FLECAINIDE ACETATE, FLECAINIDE ACETATE
FOLIC ACID, FOLIC ACID
GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
PRIMIDONE, PRIMIDONE
AMNEAL PHARMS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 12
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
* AMNEAL PHARMACEUTICALS
ACYCLOVIR, ACYCLOVIR
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ATOVAQUONE, ATOVAQUONE
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE , BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
CALCIUM ACETATE, CALCIUM ACETATE
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE
CLOPIDOGREL, CLOPIDOGREL
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FELBAMATE, FELBAMATE
GABAPENTIN, GABAPENTIN
IBUPROFEN, IBUPROFEN (OTC)
INDOMETHACIN, INDOMETHACIN
LEVETIRACETAM, LEVETIRACETAM
LORAZEPAM, LORAZEPAM
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
METAXALONE, METAXALONE
NITROFURANTOIN, NITROFURANTOIN
NIZATIDINE, NIZATIDINE
NORETHINDRONE ACETATE, NORETHINDRONE ACETATE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXCARBAZEPINE, OXCARBAZEPINE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
PROMETHAZINE HYDROCHLORIDE AND PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
SPIRONOLACTONE, SPIRONOLACTONE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
WARFARIN SODIUM, WARFARIN SODIUM
* AMNEAL PHARMACEUTICALS LLC
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
* AMNEAL PHARMACEUTICALS OF NEW YORK LLC
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
AMNEAL PHARMS CO
* AMNEAL PHARMACEUTICALS CO GMBH
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
AMNEAL PHARMS LLC
* AMNEAL PHARMACEUTICALS LLC
ACTIVELLA, ESTRADIOL
AZATHIOPRINE, AZATHIOPRINE
AMNEAL PHARMS NY
* AMNEAL PHARMACEUTICALS NY LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
ALPRAZOLAM, ALPRAZOLAM
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
GABAPENTIN, GABAPENTIN
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 13
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
* AMNEAL PHARMACEUTICALS NY LLC
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NAPROXEN SODIUM, NAPROXEN SODIUM
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
NAPROXEN, NAPROXEN
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
REPREXAIN, HYDROCODONE BITARTRATE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
AMPHASTAR PHARM
* AMPHASTAR PHARMACEUTICAL INC
AMPHADASE, HYALURONIDASE
ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM
AMPHASTAR PHARMS INC
* AMPHASTAR PHARMACEUTICALS INC
CORTROSYN, COSYNTROPIN
AMPOLGEN
* AMPOLGEN PHARMACEUTICALS LLC
SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE
ANACOR PHARMS INC
* ANACOR PHARMACEUTICALS INC
KERYDIN, TAVABOROLE
ANBEX
* ANBEX INC
IOSAT, POTASSIUM IODIDE (OTC)
ANCHEN PHARMS
* ANCHEN PHARMACEUTICALS INC
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CLONIDINE HYDROCHLORIDE , CLONIDINE HYDROCHLORIDE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE, DUTASTERIDE
FENOFIBRIC ACID, CHOLINE FENOFIBRATE
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRETINOIN, TRETINOIN
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
* ANCHEN PHARMACEUTICALS TAIWAN INC
DIVALPROEX SODIUM, DIVALPROEX SODIUM
* ANCHEN PHARMACEUTICALS, INC
ALPRAZOLAM, ALPRAZOLAM
CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ANDRX LABS LLC
* ANDRX LABS LLC
ALTOPREV, LOVASTATIN
FORTAMET, METFORMIN HYDROCHLORIDE
ANGELINI PHARMA
* ANGELINI PHARMA INC
OLEPTRO, TRAZODONE HYDROCHLORIDE
ANI PHARMS
* ANI PHARMACEUTICALS INC
CORTENEMA, HYDROCORTISONE
LACTULOSE, LACTULOSE
LUVOX, FLUVOXAMINE MALEATE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
REGLAN, METOCLOPRAMIDE HYDROCHLORIDE
ANI PHARMS INC
* ANI PHARMACEUTICALS INC
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 14
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
* ANI PHARMACEUTICALS INC
ALPRAZOLAM, ALPRAZOLAM
CHLORPROPAMIDE, CHLORPROPAMIDE
CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE
ETODOLAC, ETODOLAC
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
GUANABENZ ACETATE, GUANABENZ ACETATE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
LITHOBID, LITHIUM CARBONATE
METHAZOLAMIDE, METHAZOLAMIDE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
NIZATIDINE, NIZATIDINE
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
VALPROIC ACID, VALPROIC ACID
VANCOCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
ANTARES PHARMA INC
* ANTARES PHARMA INC
OTREXUP, METHOTREXATE
ANTIBIOTICE
* ANTIBIOTICE SA
AMPICILLIN SODIUM, AMPICILLIN SODIUM
NAFCILLIN SODIUM, NAFCILLIN SODIUM
ANTIBIOTICOS BRASIL
* ANTIBIOTICOS DO BRASIL LTDA
CEFOXITIN, CEFOXITIN SODIUM
APGDI
* ASTELLAS PHARMA GLOBAL DEVELOPMENT INC
MYRBETRIQ, MIRABEGRON
APOPHARMA INC
* APOPHARMA INC
FERRIPROX, DEFERIPRONE
APOTEX
* APOTEX CORP
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
* APOTEX INC
ALENDRONATE SODIUM, ALENDRONATE SODIUM
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
CAPTOPRIL, CAPTOPRIL
CARBIDOPA AND LEVODOPA, CARBIDOPA
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CIMETIDINE, CIMETIDINE
CIMETIDINE, CIMETIDINE (OTC)
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CYCLOSPORINE, CYCLOSPORINE
DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM
DILT-CD, DILTIAZEM HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
ENALAPRIL MALEATE, ENALAPRIL MALEATE
EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE
EPLERENONE, EPLERENONE
ETODOLAC, ETODOLAC
FAMCICLOVIR, FAMCICLOVIR
FAMOTIDINE, FAMOTIDINE
FLUCONAZOLE, FLUCONAZOLE
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
GEMFIBROZIL, GEMFIBROZIL
GLIPIZIDE, GLIPIZIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LAMIVUDINE, LAMIVUDINE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 15
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
* APOTEX INC
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
OMEPRAZOLE, OMEPRAZOLE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PENTOXIFYLLINE, PENTOXIFYLLINE
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
RAMIPRIL, RAMIPRIL
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE
TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TROSPIUM CHLORIDE, TROSPIUM CHLORIDE
APOTEX CORP
* APOTEX CORP
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AZITHROMYCIN, AZITHROMYCIN
CABERGOLINE, CABERGOLINE
CLARITHROMYCIN, CLARITHROMYCIN
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
RILUZOLE, RILUZOLE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
TOLTERODINE TARTRATE, TOLTERODINE TARTRATE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE
APOTEX INC
* APOTEX INC
ABACAVIR SULFATE, ABACAVIR SULFATE
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
ALPRAZOLAM, ALPRAZOLAM
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
ANASTROZOLE, ANASTROZOLE
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE
BIMATOPROST, BIMATOPROST
BROMFENAC SODIUM, BROMFENAC SODIUM
CALCITONIN-SALMON, CALCITONIN SALMON
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL
CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL
CARBAMAZEPINE, CARBAMAZEPINE
CARBIDOPA AND LEVODOPA, CARBIDOPA
CEFPROZIL, CEFPROZIL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CEVIMELINE, CEVIMELINE HYDROCHLORIDE
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FENOFIBRATE (MICRONIZED), FENOFIBRATE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IBANDRONATE SODIUM, IBANDRONATE SODIUM
IMIQUIMOD, IMIQUIMOD
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 16
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
* APOTEX INC
IRBESARTAN, IRBESARTAN
LAMIVUDINE, LAMIVUDINE
LAMOTRIGINE, LAMOTRIGINE
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
LEVOFLOXACIN, LEVOFLOXACIN
LOVASTATIN, LOVASTATIN
MILRINONE LACTATE IN DEXTROSE 5%, MILRINONE LACTATE
MODAFINIL, MODAFINIL
MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MYCOPHENOLIC ACID, MYCOPHENOLIC ACID
NABUMETONE, NABUMETONE
NEVIRAPINE, NEVIRAPINE
OFLOXACIN, OFLOXACIN
OLANZAPINE, OLANZAPINE
OLOPATADINE HYDROCHLORIDE, OLOPATADINE HYDROCHLORIDE
OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS
OXCARBAZEPINE, OXCARBAZEPINE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
RASAGILINE MESYLATE, RASAGILINE MESYLATE
RISEDRONATE SODIUM, RISEDRONATE SODIUM
RISPERIDONE, RISPERIDONE
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRANEXAMIC ACID, TRANEXAMIC ACID
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
ZOLMITRIPTAN, ZOLMITRIPTAN
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
* APOTEX INC ETOBICOKE SITE
ACYCLOVIR, ACYCLOVIR
ALLOPURINOL, ALLOPURINOL
BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CARBAMAZEPINE, CARBAMAZEPINE
CARVEDILOL, CARVEDILOL
CILOSTAZOL, CILOSTAZOL
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DILTZAC, DILTIAZEM HYDROCHLORIDE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
ETODOLAC, ETODOLAC
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GABAPENTIN, GABAPENTIN
LEFLUNOMIDE, LEFLUNOMIDE
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LORATADINE, LORATADINE (OTC)
MELOXICAM, MELOXICAM
MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
OXAPROZIN, OXAPROZIN
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 17
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
* APOTEX INC ETOBICOKE SITE
SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
TORSEMIDE, TORSEMIDE
ZONISAMIDE, ZONISAMIDE
* APOTEX INC RICHMOND HILL
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
BUDESONIDE, BUDESONIDE
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE
FLUNISOLIDE, FLUNISOLIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
RISPERIDONE, RISPERIDONE
* APOTEX INC.
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
APOTEX TECHNOLOGIES
* APOTEX TECHNOLOGIES INC
PAXIL CR, PAROXETINE HYDROCHLORIDE
PAXIL, PAROXETINE HYDROCHLORIDE
APOTHECON
* APOTHECON INC DIV BRISTOL MYERS SQUIBB
KENALOG-10, TRIAMCINOLONE ACETONIDE
KENALOG-40, TRIAMCINOLONE ACETONIDE
APP PHARMS
* APP PHARMACEUTICALS LLC
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
APTALIS PHARMA US
* APTALIS PHARMA US INC
BENTYL, DICYCLOMINE HYDROCHLORIDE
APTALIS PHARMATECH
* APTALIS PHARMATECH INC
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
AQUA PHARMS
* AQUA PHARMACEUTICALS
CORDRAN SP, FLURANDRENOLIDE
CORDRAN, FLURANDRENOLIDE
MONODOX, DOXYCYCLINE
VERDESO, DESONIDE
* AQUA PHARMACEUTICALS LLC
FLUOROPLEX, FLUOROURACIL
XOLEGEL, KETOCONAZOLE
AQUA PHARMS LLC
* AQUA PHARMACEUTICALS LLC
ACTICLATE, DOXYCYCLINE HYCLATE
ARBOR PHARMS IRELAND
* ARBOR PHARMACEUTICALS IRELAND LTD
EDARBI, AZILSARTAN KAMEDOXOMIL
EDARBYCLOR, AZILSARTAN KAMEDOXOMIL
ARBOR PHARMS LLC
* ARBOR PHARMACEUTICALS LLC
AMPHETAMINE SULFATE, AMPHETAMINE SULFATE
BIDIL, HYDRALAZINE HYDROCHLORIDE
E.E.S. 200, ERYTHROMYCIN ETHYLSUCCINATE
E.E.S. 400, ERYTHROMYCIN ETHYLSUCCINATE
E.E.S., ERYTHROMYCIN ETHYLSUCCINATE
ERY-TAB, ERYTHROMYCIN
ERYPED, ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROCIN STEARATE, ERYTHROMYCIN STEARATE
ERYTHROMYCIN ETHYLSUCCINATE, ERYTHROMYCIN ETHYLSUCCINATE
ERYTHROMYCIN, ERYTHROMYCIN
GLIADEL, CARMUSTINE
NYMALIZE, NIMODIPINE
PCE, ERYTHROMYCIN
PEDIAMYCIN 400, ERYTHROMYCIN ETHYLSUCCINATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 18
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
* ARBOR PHARMACEUTICALS LLC
PEDIAMYCIN, ERYTHROMYCIN ETHYLSUCCINATE
SOTYLIZE, SOTALOL HYDROCHLORIDE
ARCO PHARMS LLC
* ARCO PHARMACEUTICALS LLC
THYROSHIELD, POTASSIUM IODIDE (OTC)
AREVA PHARMS
* AREVA PHARMACEUTICALS INC
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
ARIAD
* ARIAD PHARMACEUTICALS INC
ICLUSIG, PONATINIB HYDROCHLORIDE
ASCEND THERAPS US
* ASCEND THERAPEUTICS US LLC
ESTROGEL, ESTRADIOL
ASPEN GLOBAL
* ASPEN GLOBAL INC
MYLERAN, BUSULFAN
ASPEN GLOBAL INC
* ASPEN GLOBAL INC
LEUKERAN, CHLORAMBUCIL
THIOGUANINE, THIOGUANINE
ASTELLAS
* ASTELLAS PHARMA US INC
ADENOCARD, ADENOSINE
ADENOSCAN, ADENOSINE
AMBISOME, AMPHOTERICIN B
ASTAGRAF XL, TACROLIMUS
LEXISCAN, REGADENOSON
MYCAMINE, MICAFUNGIN SODIUM
PROGRAF, TACROLIMUS
PROTOPIC, TACROLIMUS
VESICARE, SOLIFENACIN SUCCINATE
XTANDI, ENZALUTAMIDE
ASTRAZENECA
* ASTRAZENECA LP
ENTOCORT EC, BUDESONIDE
PULMICORT FLEXHALER, BUDESONIDE
SEROQUEL, QUETIAPINE FUMARATE
SYMBICORT, BUDESONIDE
TENORMIN, ATENOLOL
* ASTRAZENECA PHARMACEUTICALS LP
ATACAND HCT, CANDESARTAN CILEXETIL
ATACAND, CANDESARTAN CILEXETIL
FASLODEX, FULVESTRANT
PLENDIL, FELODIPINE
SEROQUEL XR, QUETIAPINE FUMARATE
TENORETIC 100, ATENOLOL
TENORETIC 50, ATENOLOL
ZOMIG, ZOLMITRIPTAN
ZOMIG-ZMT, ZOLMITRIPTAN
* ASTRAZENECA UK LTD
ACCOLATE, ZAFIRLUKAST
ARIMIDEX, ANASTROZOLE
CASODEX, BICALUTAMIDE
MERREM, MEROPENEM
ZESTORETIC, HYDROCHLOROTHIAZIDE
ZESTRIL, LISINOPRIL
ZOLADEX, GOSERELIN ACETATE
ASTRAZENECA AB
* ASTRAZENECA AB
BYDUREON, EXENATIDE SYNTHETIC
BYETTA, EXENATIDE SYNTHETIC
FARXIGA, DAPAGLIFLOZIN
KOMBIGLYZE XR, METFORMIN HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 19
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
* ASTRAZENECA AB
ONGLYZA, SAXAGLIPTIN HYDROCHLORIDE
SYMLIN, PRAMLINTIDE ACETATE
XIGDUO XR, DAPAGLIFLOZIN
ASTRAZENECA LP
* ASTRAZENECA LP
BRILINTA, TICAGRELOR
NEXIUM 24HR, ESOMEPRAZOLE MAGNESIUM (OTC)
ASTRAZENECA PHARMS
* ASTRAZENECA PHARMACEUTICALS LP
EPANOVA, OMEGA-3-CARBOXYLIC ACIDS
MOVANTIK, NALOXEGOL OXALATE
NEXIUM IV, ESOMEPRAZOLE SODIUM
NEXIUM, ESOMEPRAZOLE MAGNESIUM
OLAPARIB, OLAPARIB
PRILOSEC OTC, OMEPRAZOLE MAGNESIUM (OTC)
PRILOSEC, OMEPRAZOLE
PRILOSEC, OMEPRAZOLE MAGNESIUM
PULMICORT RESPULES, BUDESONIDE
RHINOCORT, BUDESONIDE
TOPROL-XL, METOPROLOL SUCCINATE
ATLAS PHARMS LLC
* ATLAS PHARMACEUTICALS LLC
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
ATON
* ATON PHARMA INC
CUPRIMINE, PENICILLAMINE
EDECRIN, ETHACRYNATE SODIUM
EDECRIN, ETHACRYNIC ACID
LACRISERT, HYDROXYPROPYL CELLULOSE
LODOSYN, CARBIDOPA
SYPRINE, TRIENTINE HYDROCHLORIDE
TIMOPTIC IN OCUDOSE, TIMOLOL MALEATE
TIMOPTIC, TIMOLOL MALEATE
ATON PHARMA VPNA
* ATON PHARMA DIV VALEANT PHARMACEUTICALS NORTH AMERICA LLC
DEMSER, METYROSINE
AUROBINDO
* AUROBINDO PHARMA LTD
AMOXICILLIN, AMOXICILLIN
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLARITHROMYCIN, CLARITHROMYCIN
DIDANOSINE, DIDANOSINE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
NEVIRAPINE, NEVIRAPINE
ZIDOVUDINE, ZIDOVUDINE
AUROBINDO PHARM
* AUROBINDO PHARMA USA INC
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
GABAPENTIN, GABAPENTIN
LEVETIRACETAM, LEVETIRACETAM
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
AUROBINDO PHARMA
* AUROBINDO PHARMA
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
* AUROBINDO PHARMA LTD
ALENDRONATE SODIUM, ALENDRONATE SODIUM
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMPICILLIN SODIUM, AMPICILLIN SODIUM
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 20
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
* AUROBINDO PHARMA LTD
ATENOLOL, ATENOLOL
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BISOPROLOL FUMARATE, BISOPROLOL FUMARATE
CARISOPRODOL, CARISOPRODOL
CARVEDILOL, CARVEDILOL
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFDINIR, CEFDINIR
CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL
CEFPROZIL, CEFPROZIL
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DIDANOSINE, DIDANOSINE
FINASTERIDE, FINASTERIDE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE
GLYBURIDE, GLYBURIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MELOXICAM, MELOXICAM
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON, ONDANSETRON
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
RIBAVARIN, RIBAVIRIN
RIBAVIRIN, RIBAVIRIN
RISPERIDONE, RISPERIDONE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
STAVUDINE, STAVUDINE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
TORSEMIDE, TORSEMIDE
TRANDOLAPRIL, TRANDOLAPRIL
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZALEPLON, ZALEPLON
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
AUROBINDO PHARMA LTD
* AUROBINDO PHARMA LIMITED
DIVALPROEX SODIUM, DIVALPROEX SODIUM
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
LEVOFLOXACIN, LEVOFLOXACIN
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
* AUROBINDO PHARMA LTD
ABACAVIR SULFATE, ABACAVIR SULFATE
ACYCLOVIR SODIUM, ACYCLOVIR SODIUM
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 21
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
* AUROBINDO PHARMA LTD
AMOXICILLIN, AMOXICILLIN
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL
CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FAMCICLOVIR, FAMCICLOVIR
FELODIPINE, FELODIPINE
FINASTERIDE, FINASTERIDE
GABAPENTIN, GABAPENTIN
GLIMEPIRIDE, GLIMEPIRIDE
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE
LAMIVUDINE, LAMIVUDINE
LEVOFLOXACIN, LEVOFLOXACIN
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MODAFINIL, MODAFINIL
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE
NAFCILLIN SODIUM, NAFCILLIN SODIUM
NAPROXEN SODIUM, NAPROXEN SODIUM
OLANZAPINE, OLANZAPINE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXACILLIN SODIUM, OXACILLIN SODIUM
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RAMIPRIL, RAMIPRIL
REPAGLINIDE, REPAGLINIDE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
VALSARTAN, VALSARTAN
* AUROBINDO PHARMA LTD INC
CEFPROZIL, CEFPROZIL
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CEPHALEXIN, CEPHALEXIN
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
MIRTAZAPINE, MIRTAZAPINE
ZIDOVUDINE, ZIDOVUDINE
AUROBINDO PHARMA USA
* AUROBINDO PHARMA USA INC
ALPRAZOLAM, ALPRAZOLAM
NAPROXEN, NAPROXEN
AUROLIFE PHARMA LLC
* AUROLIFE PHARMA LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
GLYCOPYRROLATE, GLYCOPYRROLATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 22
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** A **
* AUROLIFE PHARMA LLC
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
AUSTARPHARMA LLC
* AUSTARPHARMA LLC
ALENDRONATE SODIUM, ALENDRONATE SODIUM
METHOCARBAMOL, METHOCARBAMOL
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
AUXILIUM PHARMS
* AUXILIUM PHARMACEUTICALS INC
TESTIM, TESTOSTERONE
AUXILIUM PHARMS LLC
* AUXILIUM PHARMACEUTICALS LLC
DILATRATE-SR, ISOSORBIDE DINITRATE
EDEX, ALPROSTADIL
ROBAXIN, METHOCARBAMOL
ROBAXIN-750, METHOCARBAMOL
SEMPREX-D, ACRIVASTINE
STRIANT, TESTOSTERONE
AVACOR PRODS
* AVACOR PRODUCTS LLC
MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)
AVANIR PHARMS
* AVANIR PHARMACEUTICALS INC
NUEDEXTA, DEXTROMETHORPHAN HYDROBROMIDE
AVANTHI INC
* AVANTHI INC
CHLORPHENIRAMINE MALEATE, CHLORPHENIRAMINE MALEATE (OTC)
DEXBROMPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE SULFATE, DEXBROMPHENIRAMINE MALEATE
DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE
INDOMETHACIN, INDOMETHACIN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
AVEMA PHARMA
* AVEMA PHARMA SOLUTIONS
IBUPROFEN, IBUPROFEN (OTC)
AVENT
* AVENT INC
PYTEST KIT, UREA, C-14
PYTEST, UREA, C-14
AVEVA
* AVEVA DRUG DELIVERY SYSTEMS INC
CLONIDINE, CLONIDINE
FENTANYL-100, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
NICOTINE, NICOTINE (OTC)
AVID RADIOPHARMS INC
* AVID RADIOPHARMACEUTICALS INC
AMYVID, FLORBETAPIR F-18
** B **
B BRAUN
* B BRAUN MEDICAL INC
ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL
ALCOHOL 10% AND DEXTROSE 5%, ALCOHOL
ALCOHOL 5% AND DEXTROSE 5%, ALCOHOL
AMINO ACIDS, AMINO ACIDS
BALANCED SALT, CALCIUM CHLORIDE
BRETYLIUM TOSYLATE IN DEXTROSE 5% IN PLASTIC CONTAINER, BRETYLIUM TOSYLATE
CEFAZOLIN AND DEXTROSE, CEFAZOLIN SODIUM
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 23
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** B **
* B BRAUN MEDICAL INC
CEFEPIME AND DEXTROSE IN DUPLEX CONTAINER, CEFEPIME HYDROCHLORIDE
CEFOTETAN AND DEXTROSE IN DUPLEX CONTAINER, CEFOTETAN DISODIUM
CEFOXITIN AND DEXTROSE IN DUPLEX CONTAINER, CEFOXITIN SODIUM
CEFTAZIDIME IN DEXTROSE CONTAINER, CEFTAZIDIME
CEFTRIAXONE AND DEXTROSE IN DUPLEX CONTAINER, CEFTRIAXONE SODIUM
CEFUROXIME AND DEXTROSE IN DUPLEX CONTAINER, CEFUROXIME SODIUM
DEXTROSE 10% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% IN HALF-STRENGTH LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM
DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN ACETATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% IN LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE CONCENTRATE W/ DEXTROSE 30% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE CONCENTRATE W/ DEXTROSE 50% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE LM/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE LM/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIALYTE LM/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE AND DEXTROSE 5%, DOPAMINE HYDROCHLORIDE
FREAMINE HBC 6.9%, AMINO ACIDS
FREAMINE III 10%, AMINO ACIDS
FREAMINE III 3% W/ ELECTROLYTES, AMINO ACIDS
FREAMINE III 8.5% W/ ELECTROLYTES, AMINO ACIDS
FREAMINE III 8.5%, AMINO ACIDS
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE
GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPATAMINE 8%, AMINO ACIDS
ISOLYTE E IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ISOLYTE H IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE M IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE P IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE R IN DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ISOLYTE S IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
ISOLYTE S IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
ISOLYTE S PH 7.4 IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 10% W/ DEXTROSE 5% IN DISTILLED WATER, MANNITOL
MANNITOL 10%, MANNITOL
MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 15% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.45%, MANNITOL
MANNITOL 15%, MANNITOL
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 24
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** B **
* B BRAUN MEDICAL INC
MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 20%, MANNITOL
MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 5% W/ DEXTROSE 5% IN SODIUM CHLORIDE 0.12%, MANNITOL
MANNITOL 5%, MANNITOL
METRO I.V. IN PLASTIC CONTAINER, METRONIDAZOLE
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE
NEPHRAMINE 5.4%, AMINO ACIDS
NUTRILIPID 10%, SOYBEAN OIL
NUTRILIPID 20%, SOYBEAN OIL
PHYSIOLYTE IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC
POTASSIUM CHLORIDE 0.037% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.075% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.11% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.15% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.22% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 3.3% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.11% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER,
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 25
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** B **
* B BRAUN MEDICAL INC
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 0.3% IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PROCALAMINE, AMINO ACIDS
RESECTISOL IN PLASTIC CONTAINER, MANNITOL
RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM LACTATE 1/6 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE
SORBITOL 3.3% IN PLASTIC CONTAINER, SORBITOL
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION
THEOPHYLLINE 0.04% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.08% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.16% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
THEOPHYLLINE 0.32% AND DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
TROPHAMINE 10%, AMINO ACIDS
TROPHAMINE, AMINO ACIDS
BAJAJ MEDICAL LLC
* BAJAJ MECICAL LLC
DYNA-HEX, CHLORHEXIDINE GLUCONATE (OTC)
BANNER PHARMACAPS
* BANNER PHARMACAPS INC
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
BENZONATATE, BENZONATATE
CALCITRIOL, CALCITRIOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
ETHOSUXIMIDE, ETHOSUXIMIDE
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)
IBUPROFEN, IBUPROFEN (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
MIDOL LIQUID GELS, IBUPROFEN (OTC)
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
NIMODIPINE, NIMODIPINE
PARICALCITOL, PARICALCITOL
PROGESTERONE, PROGESTERONE
VALPROIC ACID, VALPROIC ACID
VITAMIN D, ERGOCALCIFEROL
ZONISAMIDE, ZONISAMIDE
BARR
* BARR LABORATORIES INC
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
ARANELLE, ETHINYL ESTRADIOL
ASPIRIN AND DIPYRIDAMOLE, ASPIRIN
BALZIVA-28, ETHINYL ESTRADIOL
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
CAMILA, NORETHINDRONE
CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE
CHLORZOXAZONE, CHLORZOXAZONE
CLONAZEPAM, CLONAZEPAM
CLONIDINE, CLONIDINE
DANAZOL, DANAZOL
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
DIAZEPAM, DIAZEPAM
DIDANOSINE, DIDANOSINE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 26
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** B **
* BARR LABORATORIES INC
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
DIPYRIDAMOLE, DIPYRIDAMOLE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE
DUTASTERIDE, DUTASTERIDE
ERRIN, NORETHINDRONE
ERYTHROMYCIN ETHYLSUCCINATE AND SULFISOXAZOLE ACETYL, ERYTHROMYCIN ETHYLSUCCINATE
ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL
ESTRADIOL AND NORGESTIMATE, ESTRADIOL
ESTROPIPATE, ESTROPIPATE
ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FLECAINIDE ACETATE, FLECAINIDE ACETATE
FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
HYDROXYUREA, HYDROXYUREA
HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE
ISONIAZID, ISONIAZID
JUNEL 1.5/30, ETHINYL ESTRADIOL
JUNEL 1/20, ETHINYL ESTRADIOL
JUNEL FE 1.5/30, ETHINYL ESTRADIOL
JUNEL FE 1/20, ETHINYL ESTRADIOL
KARIVA, DESOGESTREL
KELNOR, ETHINYL ESTRADIOL
LEFLUNOMIDE, LEFLUNOMIDE
LESSINA-28, ETHINYL ESTRADIOL
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE
MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE
MEGESTROL ACETATE, MEGESTROL ACETATE
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHOTREXATE SODIUM, METHOTREXATE SODIUM
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
NIACIN, NIACIN
NORETHINDRONE ACETATE, NORETHINDRONE ACETATE
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
NORTREL 0.5/35-28, ETHINYL ESTRADIOL
NORTREL 1/35-21, ETHINYL ESTRADIOL
NORTREL 1/35-28, ETHINYL ESTRADIOL
NORTREL 7/7/7, ETHINYL ESTRADIOL
ONDANSETRON, ONDANSETRON
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PORTIA-28, ETHINYL ESTRADIOL
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
SPRINTEC, ETHINYL ESTRADIOL
TEMOZOLOMIDE, TEMOZOLOMIDE
TREXALL, METHOTREXATE SODIUM
TRI-LEGEST 21, ETHINYL ESTRADIOL
TRI-LEGEST FE, ETHINYL ESTRADIOL
TRI-SPRINTEC, ETHINYL ESTRADIOL
WARFARIN SODIUM, WARFARIN SODIUM
* BARR PHARMACEUTICALS
LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM
BARR LABS DIV TEVA
* BARR LABORATORIES INC SUB TEVA PHARMACEUTICALS USA
ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM
BUDESONIDE, BUDESONIDE
OXYBUTYNIN, OXYBUTYNIN
BARR LABS INC
* BARR LABORATORIES INC
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 27
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** B **
* BARR LABORATORIES INC
ACITRETIN, ACITRETIN
DEXTROAMP SACCHARATE,AMP ASPARTATE,DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
ESTRADIOL, ESTRADIOL
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
NIMODIPINE, NIMODIPINE
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
OLANZAPINE, OLANZAPINE
OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN
TRETINOIN, TRETINOIN
BAUSCH AND LOMB
* BAUSCH AND LOMB INC
ALAWAY, KETOTIFEN FUMARATE (OTC)
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALREX, LOTEPREDNOL ETABONATE
BESIVANCE, BESIFLOXACIN HYDROCHLORIDE
CARTEOLOL HYDROCHLORIDE, CARTEOLOL HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
FLURBIPROFEN SODIUM, FLURBIPROFEN SODIUM
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
ISTALOL, TIMOLOL MALEATE
LATANOPROST, LATANOPROST
LOTEMAX, LOTEPREDNOL ETABONATE
MIOCHOL-E, ACETYLCHOLINE CHLORIDE
OFLOXACIN, OFLOXACIN
OPCON-A, NAPHAZOLINE HYDROCHLORIDE (OTC)
PROLENSA, BROMFENAC SODIUM
RETISERT, FLUOCINOLONE ACETONIDE
TIMOLOL MALEATE, TIMOLOL MALEATE
VITRASE, HYALURONIDASE
ZIRGAN, GANCICLOVIR
ZYLET, LOTEPREDNOL ETABONATE
* BAUSCH AND LOMB PHARMACEUTICALS INC
ACETIC ACID 2% IN AQUEOUS ALUMINUM ACETATE, ACETIC ACID, GLACIAL
BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC
BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE
CROLOM, CROMOLYN SODIUM
CROMOLYN SODIUM, CROMOLYN SODIUM
CROMOLYN SODIUM, CROMOLYN SODIUM (OTC)
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DEXASPORIN, DEXAMETHASONE
ERYTHROMYCIN, ERYTHROMYCIN
FLUNISOLIDE, FLUNISOLIDE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE
NEOMYCIN AND POLYMYXIN B SULFATES, BACITRACIN ZINC AND HYDROCORTISONE, BACITRACIN ZINC
OFLOXACIN, OFLOXACIN
OPTIPRANOLOL, METIPRANOLOL HYDROCHLORIDE
OTICAIR, HYDROCORTISONE
PENTOLAIR, CYCLOPENTOLATE HYDROCHLORIDE
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PROPARACAINE HYDROCHLORIDE, PROPARACAINE HYDROCHLORIDE
SULFACETAMIDE SODIUM AND PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
TIMOLOL MALEATE, TIMOLOL MALEATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 28
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** B **
* BAUSCH AND LOMB PHARMACEUTICALS INC
TOBRAMYCIN AND DEXAMETHASONE, DEXAMETHASONE
TOBRAMYCIN, TOBRAMYCIN
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
TROPICAMIDE, TROPICAMIDE
BAUSCH AND LOMB INC
* BAUSCH AND LOMB INC
BEPREVE, BEPOTASTINE BESILATE
BROMDAY, BROMFENAC SODIUM
LOTEMAX, LOTEPREDNOL ETABONATE
BAXTER HLTHCARE
* BAXTER HEALTHCARE CORP
ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL
AMINOACETIC ACID 1.5% IN PLASTIC CONTAINER, GLYCINE
ANCEF IN PLASTIC CONTAINER, CEFAZOLIN SODIUM
BACTOCILL IN PLASTIC CONTAINER, OXACILLIN SODIUM
BRANCHAMIN 4% IN PLASTIC CONTAINER, AMINO ACIDS
BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE
BREVIBLOC IN PLASTIC CONTAINER, ESMOLOL HYDROCHLORIDE
BREVIBLOC, ESMOLOL HYDROCHLORIDE
CARDIOPLEGIC IN PLASTIC CONTAINER, CALCIUM CHLORIDE
CEFEPIME IN PLASTIC CONTAINER, CEFEPIME HYDROCHLORIDE
CEFTRIAXONE IN PLASTIC CONTAINER, CEFTRIAXONE SODIUM
CLINIMIX 2.75/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 2.75/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 2.75/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 4.25/5 SULFITE FREE IN DEXTROSE 5% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/10 SULFITE FREE IN DEXTROSE 10% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/15 SULFITE FREE IN DEXTROSE 15% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/20 SULFITE FREE IN DEXTROSE 20% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/25 SULFITE FREE IN DEXTROSE 25% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX 5/35 SULFITE FREE IN DEXTROSE 35% IN PLASTIC CONTAINER, AMINO ACIDS
CLINIMIX E 2.75/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC
CLINIMIX E 2.75/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC
CLINIMIX E 2.75/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 4.25/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC
CLINIMIX E 4.25/20 SULFITE-FREE W/ ELECT IN DEXTROSE 20% W/ CALCIUM IN PLASTIC
CLINIMIX E 4.25/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC
CLINIMIX E 4.25/5 SULFITE-FREE W/ ELECT IN DEXTROSE 5% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 5/10 SULFITE-FREE W/ ELECT IN DEXTROSE 10% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 5/15 SULFITE-FREE W/ ELECT IN DEXTROSE 15% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 5/20 SULFITE-FREE W/ ELECT IN 20% DEXTROSE W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 5/25 SULFITE-FREE W/ ELECT IN DEXTROSE 25% W/ CALCIUM IN PLASTIC CONTAINER,
CLINIMIX E 5/35 SULFITE-FREE W/ ELECT IN DEXTROSE 35% W/ CALCIUM IN PLASTIC CONTAINER,
CLINISOL 15% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS
CLINOLIPID 20%, OLIVE OIL
CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE
CYTOXAN (LYOPHILIZED), CYCLOPHOSPHAMIDE
DEXTROSE 10% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 2.5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND ELECTROLYTE NO 75 IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND ELECTROLYTE NO.48 IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.075% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.15% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.224% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND POTASSIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN SODIUM CHLORIDE 0.2% IN PLASTIC CONTAINER, DEXTROSE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 29
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** B **
* BAXTER HEALTHCARE CORP
DEXTROSE 5% IN SODIUM CHLORIDE 0.33% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 10MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 15MEQ (K), DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ (K), DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 20MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 30MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 40MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ (K), DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.2% AND POTASSIUM CHLORIDE 5MEQ, DEXTROSE
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 15MEQ IN PLASTIC CONTAINER,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER,
DEXTROSE 5%, SODIUM CHLORIDE 0.33% AND POTASSIUM CHLORIDE 5MEQ IN PLASTIC CONTAINER,
DEXTROSE 5%, SODIUM CHLORIDE 0.45% AND POTASSIUM CHLORIDE 20MEQ (K) IN PLASTIC
DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 60% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE
DIANEAL 137 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL 137 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL 137 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL LOW CALCIUM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-1 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DIANEAL PD-2 W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE
ETHRANE, ENFLURANE
EXTRANEAL, ICODEXTRIN
FAMOTIDINE PRESERVATIVE FREE IN PLASTIC CONTAINER, FAMOTIDINE
FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FORANE, ISOFLURANE
HEPARIN SODIUM 1,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN
HEPARIN SODIUM 2,000 UNITS AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN
IFEX, IFOSFAMIDE
ISOTONIC GENTAMICIN SULFATE IN PLASTIC CONTAINER, GENTAMICIN SULFATE
LACTATED RINGER'S AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LIDOCAINE HYDROCHLORIDE 0.2% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
LIDOCAINE HYDROCHLORIDE 0.4% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
LIDOCAINE HYDROCHLORIDE 0.8% AND DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
MESNEX, MESNA
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE
NALLPEN IN PLASTIC CONTAINER, NAFCILLIN SODIUM
NEXTERONE, AMIODARONE HYDROCHLORIDE
NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN
OSMITROL 10% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 10% IN WATER, MANNITOL
OSMITROL 15% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 15% IN WATER, MANNITOL
OSMITROL 20% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 20% IN WATER, MANNITOL
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 30
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** B **
* BAXTER HEALTHCARE CORP
OSMITROL 5% IN WATER IN PLASTIC CONTAINER, MANNITOL
OSMITROL 5% IN WATER, MANNITOL
PENICILLIN G POTASSIUM IN PLASTIC CONTAINER, PENICILLIN G POTASSIUM
PLASMA-LYTE 148 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
PLASMA-LYTE 148 IN WATER IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PLASMA-LYTE 56 AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
PLASMA-LYTE 56 IN PLASTIC CONTAINER, MAGNESIUM ACETATE TETRAHYDRATE
PLASMA-LYTE A IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PLASMA-LYTE M AND DEXTROSE 5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PLASMA-LYTE R IN PLASTIC CONTAINER, CALCIUM CHLORIDE
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 0.15% IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 0.224% IN SODIUM CHLORIDE 0.9%, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 0.3% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PREMASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS
PREMASOL 6% IN PLASTIC CONTAINER, AMINO ACIDS
RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
SEVOFLURANE, SEVOFLURANE
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN STERILE PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 3% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 5% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM LACTATE 0.167 MOLAR IN PLASTIC CONTAINER, SODIUM LACTATE
SORBITOL 3% IN PLASTIC CONTAINER, SORBITOL
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION
STERILE WATER, STERILE WATER FOR IRRIGATION
SUPRANE, DESFLURANE
TIS-U-SOL IN PLASTIC CONTAINER, MAGNESIUM SULFATE
TIS-U-SOL, MAGNESIUM SULFATE
TRAVASOL 10% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 3.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 5.5% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 5.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 8.5% IN PLASTIC CONTAINER, AMINO ACIDS
TRAVASOL 8.5% SULFITE FREE W/ ELECTROLYTES IN PLASTIC CONTAINER, AMINO ACIDS
VANCOCIN HYDROCHLORIDE IN PLASTIC CONTAINER, VANCOMYCIN HYDROCHLORIDE
* BAXTER HEALTHCARE INTERNATI0NAL SPECIALTY THERAPIES DIV
PROSOL 20% SULFITE FREE IN PLASTIC CONTAINER, AMINO ACIDS
BAXTER HLTHCARE CORP
* BAXTER HEALTHCARE CORP ANESTHESIA AND CRITICAL CARE
PROTOPAM CHLORIDE, PRALIDOXIME CHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 31
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** B **
* BAXTER HEALTHCARE CORP ANESTHESIA CRITICAL CARE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
REGLAN, METOCLOPRAMIDE HYDROCHLORIDE
BAYER
* BAYER HEALTHCARE LLC
ALEVE, NAPROXEN SODIUM (OTC)
ALEVE-D SINUS & COLD, NAPROXEN SODIUM (OTC)
FEMSTAT 3, BUTOCONAZOLE NITRATE (OTC)
BAYER HEALTHCARE LLC
* BAYER HEALTHCARE LLC
CLARITIN HIVES RELIEF REDITAB, LORATADINE (OTC)
CLARITIN HIVES RELIEF, LORATADINE (OTC)
CLARITIN REDITABS, LORATADINE (OTC)
CLARITIN, LORATADINE (OTC)
GYNE-LOTRIMIN 3 COMBINATION PACK, CLOTRIMAZOLE (OTC)
GYNE-LOTRIMIN 3, CLOTRIMAZOLE (OTC)
MYCELEX-7 COMBINATION PACK, CLOTRIMAZOLE (OTC)
MYCELEX-7, CLOTRIMAZOLE (OTC)
OXYTROL FOR WOMEN, OXYBUTYNIN (OTC)
BAYER HLTHCARE
* BAYER HEALTHCARE CONSUMER CARE
ALEVE PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)
* BAYER HEALTHCARE PHARMACEUTICALS INC
ADALAT CC, NIFEDIPINE
ADEMPAS, RIOCIGUAT
ANGELIQ, DROSPIRENONE
AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER, MOXIFLOXACIN HYDROCHLORIDE
AVELOX, MOXIFLOXACIN HYDROCHLORIDE
BETAPACE, SOTALOL HYDROCHLORIDE
BEYAZ, DROSPIRENONE
BILTRICIDE, PRAZIQUANTEL
CIPRO IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPRO, CIPROFLOXACIN
CIPRO, CIPROFLOXACIN HYDROCHLORIDE
CLIMARA PRO, ESTRADIOL
CLIMARA, ESTRADIOL
DESONATE, DESONIDE
DTIC-DOME, DACARBAZINE
EOVIST, GADOXETATE DISODIUM
FINACEA, AZELAIC ACID
GADAVIST, GADOBUTROL
LEVITRA, VARDENAFIL HYDROCHLORIDE
MAGNEVIST, GADOPENTETATE DIMEGLUMINE
MENOSTAR, ESTRADIOL
MIRENA, LEVONORGESTREL
NATAZIA, DIENOGEST
NEXAVAR, SORAFENIB TOSYLATE
PRECOSE, ACARBOSE
SAFYRAL, DROSPIRENONE
SKYLA, LEVONORGESTREL
STAXYN, VARDENAFIL HYDROCHLORIDE
STIVARGA, REGORAFENIB
ULTRAVIST (PHARMACY BULK), IOPROMIDE
ULTRAVIST 150, IOPROMIDE
ULTRAVIST 240, IOPROMIDE
ULTRAVIST 300 IN PLASTIC CONTAINER, IOPROMIDE
ULTRAVIST 300, IOPROMIDE
ULTRAVIST 370, IOPROMIDE
XOFIGO, RADIUM RA-223 DICHLORIDE
YASMIN, DROSPIRENONE
YAZ, DROSPIRENONE
BAYSHORE PHARMS LLC
* BAYSHORE PHARMACEUTICALS LLC
METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE
PRIMAQUINE PHOSPHATE, PRIMAQUINE PHOSPHATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 32
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** B **
BD RX
* BD RX INC
DIPHENHYDRAMINE HYDROCHLORIDE PRESERVATIVE FREE, DIPHENHYDRAMINE HYDROCHLORIDE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
BECTON DICKINSON
* BECTON DICKINSON AND CO
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC)
E-Z SCRUB 201, POVIDONE-IODINE (OTC)
E-Z SCRUB 241, POVIDONE-IODINE (OTC)
BEDFORD
* BEDFORD LABORATORIES DIV BEN VENUE LABORATORIES INC
ACYCLOVIR SODIUM, ACYCLOVIR SODIUM
ADENOSINE, ADENOSINE
BUMETANIDE, BUMETANIDE
BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CEFTRIAXONE, CEFTRIAXONE SODIUM
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIPYRIDAMOLE, DIPYRIDAMOLE
DOXAPRAM HYDROCHLORIDE, DOXAPRAM HYDROCHLORIDE
ENALAPRILAT, ENALAPRILAT
ETOMIDATE, ETOMIDATE
FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MILRINONE LACTATE, MILRINONE LACTATE
MITOMYCIN, MITOMYCIN
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
RIFAMPIN, RIFAMPIN
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBUTALINE SULFATE, TERBUTALINE SULFATE
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
VALPROATE SODIUM, VALPROATE SODIUM
VECURONIUM BROMIDE, VECURONIUM BROMIDE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
BEDFORD LABS
* BEDFORD LABORATORIES
DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE
FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUMAZENIL, FLUMAZENIL
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LORAZEPAM PRESERVATIVE FREE, LORAZEPAM
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
BELCHER PHARMS
* BELCHER PHARMACEUTICALS LLC
CEPHALEXIN, CEPHALEXIN
DESLORATADINE, DESLORATADINE
BELCHER PHARMS LLC
* BELCHER PHARMACEUTICALS LLC
EPINEPHRINE, EPINEPHRINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 33
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** B **
BEXIMCO USA
* BEXIMCO PHARMACEUTICALS USA INC
CARVEDILOL, CARVEDILOL
BICON PHARM
* BICON PHARMACEUTICAL INC
FOLIC ACID, FOLIC ACID
BIO NUCLEONICS
* BIO NUCLEONICS INC
STRONTIUM CHLORIDE SR-89, STRONTIUM CHLORIDE SR-89
BIO PHARM INC
* BIO PHARM INC
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
BIOALLIANCE PHARMA
* BIOALLIANCE PHARMA
ORAVIG, MICONAZOLE
BIOCODEX INC
* BIOCODEX INC
TOTECT, DEXRAZOXANE HYDROCHLORIDE
BIOCRYST
* BIOCRYST PHARMACEUTICALS INC
RAPIVAB, PERAMIVIR
BIODELIVERY SCI INTL
* BIODELIVERY SCIENCES INTERNATIONAL INC
BUNAVAIL, BUPRENORPHINE HYDROCHLORIDE
BIOGEN IDEC INC
* BIOGEN IDEC INC
TECFIDERA, DIMETHYL FUMARATE
BIOKEY
* BIOKEY INC
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
CILOSTAZOL, CILOSTAZOL
BIOMARIN PHARM
* BIOMARIN PHARMACEUTICAL INC
KUVAN, SAPROPTERIN DIHYDROCHLORIDE
BIOMEDCL RES FDN
* BIOMEDICAL RESEARCH FOUNDATION NORTHWEST LOUISANA
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
BLAIREX
* BLAIREX LABORATORIES INC
BRONCHO SALINE, SODIUM CHLORIDE (OTC)
BLU CARIBE
* BLU CARIBE INC
GEMFIBROZIL, GEMFIBROZIL
SIMVASTATIN, SIMVASTATIN
BLU CARIBE INC
* BLU CARIBE INC
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
BOEHRINGER INGELHEIM
* BOEHRINGER INGELHEIM
CATAPRES, CLONIDINE HYDROCHLORIDE
CATAPRES-TTS-1, CLONIDINE
CATAPRES-TTS-2, CLONIDINE
CATAPRES-TTS-3, CLONIDINE
GILOTRIF, AFATINIB DIMALEATE
MICARDIS HCT, HYDROCHLOROTHIAZIDE
MICARDIS, TELMISARTAN
MIRAPEX, PRAMIPEXOLE DIHYDROCHLORIDE
ZANTAC 150, RANITIDINE HYDROCHLORIDE (OTC)
ZANTAC 75, RANITIDINE HYDROCHLORIDE (OTC)
* BOEHRINGER INGELHEIM PHARMACEUTICALS INC
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 34
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** B **
* BOEHRINGER INGELHEIM PHARMACEUTICALS INC
AGGRENOX, ASPIRIN
APTIVUS, TIPRANAVIR
ATROVENT HFA, IPRATROPIUM BROMIDE
ATROVENT, IPRATROPIUM BROMIDE
COMBIVENT RESPIMAT, ALBUTEROL SULFATE
COMBIVENT, ALBUTEROL SULFATE
FLOMAX, TAMSULOSIN HYDROCHLORIDE
JARDIANCE, EMPAGLIFLOZIN
JENTADUETO, LINAGLIPTIN
MIRAPEX ER, PRAMIPEXOLE DIHYDROCHLORIDE
MOBIC, MELOXICAM
OFEV, NINTEDANIB
PERSANTINE, DIPYRIDAMOLE
PRADAXA, DABIGATRAN ETEXILATE MESYLATE
SPIRIVA RESPIMAT, TIOTROPIUM BROMIDE
SPIRIVA, TIOTROPIUM BROMIDE
STRIVERDI RESPIMAT, OLODATEROL HYDROCHLORIDE
TRADJENTA, LINAGLIPTIN
TWYNSTA, AMLODIPINE BESYLATE
VIRAMUNE XR, NEVIRAPINE
VIRAMUNE, NEVIRAPINE
BRACCO
* BRACCO DIAGNOSTICS INC
CARDIOGEN-82, RUBIDIUM CHLORIDE RB-82
CHOLETEC, TECHNETIUM TC-99M MEBROFENIN KIT
CHOLOGRAFIN MEGLUMINE, IODIPAMIDE MEGLUMINE
CYSTOGRAFIN DILUTE, DIATRIZOATE MEGLUMINE
CYSTOGRAFIN, DIATRIZOATE MEGLUMINE
GASTROGRAFIN, DIATRIZOATE MEGLUMINE
ISOVUE-200, IOPAMIDOL
ISOVUE-250, IOPAMIDOL
ISOVUE-300, IOPAMIDOL
ISOVUE-370, IOPAMIDOL
ISOVUE-M 200, IOPAMIDOL
ISOVUE-M 300, IOPAMIDOL
KINEVAC, SINCALIDE
LUMASON, SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES
MDP-BRACCO, TECHNETIUM TC-99M MEDRONATE KIT
MULTIHANCE MULTIPACK, GADOBENATE DIMEGLUMINE
MULTIHANCE, GADOBENATE DIMEGLUMINE
PROHANCE MULTIPACK, GADOTERIDOL
PROHANCE, GADOTERIDOL
RENOGRAFIN-76, DIATRIZOATE MEGLUMINE
SINOGRAFIN, DIATRIZOATE MEGLUMINE
BRAINTREE
* BRAINTREE LABORATORIES INC
AXID, NIZATIDINE
GOLYTELY, POLYETHYLENE GLYCOL 3350
NULYTELY, POLYETHYLENE GLYCOL 3350
NULYTELY-FLAVORED, POLYETHYLENE GLYCOL 3350
BRAINTREE LABS
* BRAINTREE LABORATORIES INC
SUCLEAR, MAGNESIUM SULFATE
SUPREP BOWEL PREP KIT, MAGNESIUM SULFATE ANHYDROUS
BRECKENRIDGE PHARM
* BRECKENRIDGE PHARMACEUTICAL INC
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CILOSTAZOL, CILOSTAZOL
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE
ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL
LEVETIRACETAM, LEVETIRACETAM
MEFENAMIC ACID, MEFENAMIC ACID
MELOXICAM, MELOXICAM
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 35
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** B **
* BRECKENRIDGE PHARMACEUTICAL INC
METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE
OXCARBAZEPINE, OXCARBAZEPINE
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
BRIGHAM WOMENS
* BRIGHAM AND WOMENS HOSP
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
BRIGHAM WOMENS HOSP
* BRIGHAM AND WOMENS HOSP INC
AMMONIA N 13, AMMONIA N-13
BRISTOL MYERS SQUIBB
* BRISTOL MYERS SQUIBB
AZACTAM, AZTREONAM
BARACLUDE, ENTECAVIR
GLUCOVANCE, GLYBURIDE
LYSODREN, MITOTANE
MEGACE, MEGESTROL ACETATE
PRAVACHOL, PRAVASTATIN SODIUM
* BRISTOL MYERS SQUIBB CO
AZACTAM IN PLASTIC CONTAINER, AZTREONAM
DROXIA, HYDROXYUREA
GLUCOPHAGE XR, METFORMIN HYDROCHLORIDE
HYDREA, HYDROXYUREA
IXEMPRA KIT, IXABEPILONE
REYATAZ, ATAZANAVIR SULFATE
SPRYCEL, DASATINIB
SUSTIVA, EFAVIRENZ
VIDEX EC, DIDANOSINE
* BRISTOL MYERS SQUIBB CO PHARMACEUTICAL RESEARCH INSTITUTE
ELIQUIS, APIXABAN
ETOPOPHOS PRESERVATIVE FREE, ETOPOSIDE PHOSPHATE
GLUCOPHAGE, METFORMIN HYDROCHLORIDE
VIDEX, DIDANOSINE
ZERIT, STAVUDINE
* BRISTOL MYERS SQUIBB PHARMA CO
COUMADIN, WARFARIN SODIUM
BRYAN
* BRYAN CORP
SCLEROSOL, TALC
TALC, TALC
** C **
CADENCE PHARMS
* CADENCE PHARMACEUTICALS INC
OFIRMEV, ACETAMINOPHEN
CADILA PHARMS LTD
* CADILA PHARMACEUTICALS LTD
ACYCLOVIR, ACYCLOVIR
FOLIC ACID, FOLIC ACID
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
OFLOXACIN, OFLOXACIN
CADISTA PHARMS
* CADISTA PHARMACEUTICALS INC
ALENDRONATE SODIUM, ALENDRONATE SODIUM
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
LAMOTRIGINE, LAMOTRIGINE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
OXCARBAZEPINE, OXCARBAZEPINE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 36
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** C **
CARACO
* CARACO PHARMACEUTICAL LABORATORIES LTD
BACLOFEN, BACLOFEN
FLUMADINE, RIMANTADINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
SYNALGOS-DC, ASPIRIN
CARDINAL HEALTH 414
* CARDINAL HEALTH 414 LLC
TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT
* CARDINAL HEALTH 414 LLC CARDINAL HEALTH NUCLEAR PHARMACY SERVICES
AMMONIA N 13, AMMONIA N-13
CARDINAL HLTH 414
* CARDINAL HEALTH 414
SODIUM IODIDE I 123, SODIUM IODIDE I-123
CAREFUSION
* CAREFUSION 213 LLC
CHLORAPREP ONE-STEP FREPP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP ONE-STEP SEPP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP ONE-STEP, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP SINGLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP TRIPLE SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
CHLORAPREP WITH TINT, CHLORHEXIDINE GLUCONATE (OTC)
PHARMASEAL SCRUB CARE, CHLORHEXIDINE GLUCONATE (OTC)
CARLSBAD
* CARLSBAD TECHNOLOGY INC
ACYCLOVIR, ACYCLOVIR
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
FAMOTIDINE, FAMOTIDINE
GLIMEPIRIDE, GLIMEPIRIDE
LOVASTATIN, LOVASTATIN
MELOXICAM, MELOXICAM
MODAFINIL, MODAFINIL
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
CAROLINA MEDCL
* CAROLINA MEDICAL PRODUCTS CO
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
HYDROCORTISONE IN ABSORBASE, HYDROCORTISONE
ISONIAZID, ISONIAZID
SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
SPS, SODIUM POLYSTYRENE SULFONATE
TRIAMCINOLONE ACETONIDE IN ABSORBASE, TRIAMCINOLONE ACETONIDE
CATALENT
* CATALENT PHARMA SOLUTIONS LLC
VALPROIC ACID, VALPROIC ACID
CEDAR PHARMS
* CEDAR PHARMACEUTICALS LLC
METHIMAZOLE, METHIMAZOLE
SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
CELGENE
* CELGENE CORP
ISTODAX, ROMIDEPSIN
POMALYST, POMALIDOMIDE
REVLIMID, LENALIDOMIDE
THALOMID, THALIDOMIDE
VIDAZA, AZACITIDINE
CELGENE CORP
* CELGENE CORP
OTEZLA, APREMILAST
CEPHALON
* CEPHALON INC
ACTIQ, FENTANYL CITRATE
FENTORA, FENTANYL CITRATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 37
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** C **
* CEPHALON INC
GABITRIL, TIAGABINE HYDROCHLORIDE
NUVIGIL, ARMODAFINIL
PROVIGIL, MODAFINIL
TREANDA, BENDAMUSTINE HYDROCHLORIDE
TRISENOX, ARSENIC TRIOXIDE
CEREXA
* CEREXA INC
TEFLARO, CEFTAROLINE FOSAMIL
CHARTWELL LIFE SCI
* CHARTWELL LIFE SCIENCE LLC
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
CHATTEM
* CHATTEM INC
SELSUN, SELENIUM SULFIDE
UNISOM, DOXYLAMINE SUCCINATE (OTC)
CHEMISCH FBRK KRSSLR
* CHEMISCHE FABRIK KREUSSLER & CO. GMBH
ASCLERA, POLIDOCANOL
CHIESI USA INC
* CHIESI USA INC
BETHKIS, TOBRAMYCIN
CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER, NICARDIPINE HYDROCHLORIDE
CARDENE, NICARDIPINE HYDROCHLORIDE
CUROSURF, PORACTANT ALFA
ZYFLO CR, ZILEUTON
ZYFLO, ZILEUTON
CHILDRENS HOSP MI
* CHILDRENS HOSP MICHIGAN
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
CHIRHOCLIN
* CHIRHOCLIN INC
CHIRHOSTIM, SECRETIN SYNTHETIC HUMAN
CIPHER PHARMS INC
* CIPHER PHARMACEUTICALS INC
CONZIP, TRAMADOL HYDROCHLORIDE
LIPOFEN, FENOFIBRATE
CIPLA
* CIPLA LTD
NEVIRAPINE, NEVIRAPINE
RISPERIDONE, RISPERIDONE
ZIDOVUDINE, ZIDOVUDINE
CIPLA LTD
* CIPLA LTD
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE
ALENDRONATE SODIUM, ALENDRONATE SODIUM
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ANASTROZOLE, ANASTROZOLE
CARBOPLATIN, CARBOPLATIN
CARVEDILOL, CARVEDILOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CICLOPIROX, CICLOPIROX
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
FAMCICLOVIR, FAMCICLOVIR
FINASTERIDE, FINASTERIDE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 38
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** C **
* CIPLA LTD
IRBESARTAN, IRBESARTAN
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LAMOTRIGINE, LAMOTRIGINE
LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE
LEVOFLOXACIN, LEVOFLOXACIN
MELOXICAM, MELOXICAM
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
STAVUDINE, STAVUDINE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
ZALEPLON, ZALEPLON
ZIDOVUDINE, ZIDOVUDINE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
CITIUS PHARMS
* CITIUS PHARMACEUTICALS LLC
SUPRENZA, PHENTERMINE HYDROCHLORIDE
CITRON PHARMA LLC
* CITRON PHARMA LLC
CORTISPORIN, HYDROCORTISONE
THALITONE, CHLORTHALIDONE
CLARIS LIFESCIENCES
* CLARIS LIFESCIENCES LIMITED
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
* CLARIS LIFESCIENCES LTD
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPROFLOXACIN, CIPROFLOXACIN
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
FUROSEMIDE, FUROSEMIDE
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
LEVOFLOXACIN, LEVOFLOXACIN
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE
NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE
CLINIGEN HLTHCARE
* CLINIGEN HEALTHCARE LTD
ETHYOL, AMIFOSTINE
FOSCAVIR, FOSCARNET SODIUM
CLOVER PHARMS
* CLOVER PHARMACEUTICALS CORP
AMICAR, AMINOCAPROIC ACID
CNTY LINE PHARMS
* COUNTY LINE PHARMACEUTICALS LLC
DYNACIN, MINOCYCLINE HYDROCHLORIDE
LIDEX, FLUOCINONIDE
LOPROX, CICLOPIROX
TRANDATE, LABETALOL HYDROCHLORIDE
UREX, METHENAMINE HIPPURATE
COASTAL PHARMS
* COASTAL PHARMACEUTICALS
BROMFENAC SODIUM, BROMFENAC SODIUM
LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM
METHAMPHETAMINE HYDROCHLORIDE, METHAMPHETAMINE HYDROCHLORIDE
NYSTATIN, NYSTATIN
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE AND ASPIRIN, ASPIRIN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
COLGATE
* COLGATE ORAL PHARMACEUTICALS INC
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 39
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** C **
* COLGATE ORAL PHARMACEUTICALS INC
PERIOGARD, CHLORHEXIDINE GLUCONATE
COLGATE PALMOLIVE
* COLGATE PALMOLIVE
COLGATE TOTAL, SODIUM FLUORIDE (OTC)
CONCORDIA LABS INC
* CONCORDIA LABORATORIES INC
PHOTOFRIN, PORFIMER SODIUM
CONCORDIA PHARMS INC
* CONCORDIA PHARMACEUTICALS INC
KAPVAY, CLONIDINE HYDROCHLORIDE
ORAPRED ODT, PREDNISOLONE SODIUM PHOSPHATE
ORAPRED, PREDNISOLONE SODIUM PHOSPHATE
CONTRACT PHARMACAL
* CONTRACT PHARMACAL CORP
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CIMETIDINE, CIMETIDINE (OTC)
FOLIC ACID, FOLIC ACID
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
PREDNISONE, PREDNISONE
PROFEN, IBUPROFEN (OTC)
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
CORCEPT THERAP
* CORCEPT THERAPEUTICS INC
KORLYM, MIFEPRISTONE
CORDEN PHARMA
* CORDEN PHARMA LATINA SPA
GLEOSTINE, LOMUSTINE
COREPHARMA
* COREPHARMA LLC
ALPRAZOLAM, ALPRAZOLAM
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE
GLYBURIDE, GLYBURIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE
LEVOCARNITINE, LEVOCARNITINE
METHENAMINE HIPPURATE, METHENAMINE HIPPURATE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
PHENYTOIN, PHENYTOIN
PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE
POTASSIUM CITRATE, POTASSIUM CITRATE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
URSODIOL, URSODIOL
COVIS INJECTABLES
* COVIS INJECTABLES SARL
FORTAZ IN PLASTIC CONTAINER, CEFTAZIDIME SODIUM
FORTAZ, CEFTAZIDIME
LANOXIN PEDIATRIC, DIGOXIN
LANOXIN, DIGOXIN
ZANTAC, RANITIDINE HYDROCHLORIDE
ZINACEF IN PLASTIC CONTAINER, CEFUROXIME SODIUM
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 40
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** C **
* COVIS INJECTABLES SARL
ZINACEF, CEFUROXIME SODIUM
COVIS PHARMA
* COVIS PHARMA SARL
LANOXIN, DIGOXIN
PARNATE, TRANYLCYPROMINE SULFATE
COVIS PHARMA SARL
* COVIS PHARMA SARL
BETAPACE AF, SOTALOL HYDROCHLORIDE
DIBENZYLINE, PHENOXYBENZAMINE HYDROCHLORIDE
DUTOPROL, HYDROCHLOROTHIAZIDE
DYRENIUM, TRIAMTERENE
KAYEXALATE, SODIUM POLYSTYRENE SULFONATE
NILANDRON, NILUTAMIDE
RILUTEK, RILUZOLE
UROXATRAL, ALFUZOSIN HYDROCHLORIDE
CPDC
* CENTRE FOR PROBE DEVELOPMENT AND COMMERCIALIZATION
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
CPPI CV
* CP PHARMACEUTICALS INTERNATIONAL CV
SUTENT, SUNITINIB MALATE
CRANFORD PHARMS LLC
* CRANFORD PHARMACEUTICALS LLC
INDERAL LA, PROPRANOLOL HYDROCHLORIDE
CREALTA PHARMS LLC
* CREALTA PHARMACEUTICALS LLC
MIGERGOT, CAFFEINE
OXANDRIN, OXANDROLONE
CROWN LABS
* CROWN LABORATORIES INC
ALA-CORT, HYDROCORTISONE
ALA-SCALP, HYDROCORTISONE
TRIDERM, TRIAMCINOLONE ACETONIDE
CSL BEHRING
* CSL BEHRING LLC
STIMATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE
CSPC OUYI PHARM CO
* CSPC OUYI PHARMACEUTICAL CO LTD
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
CUBIST
* CUBIST PHARMACEUTICALS INC
CUBICIN, DAPTOMYCIN
CUBIST PHARMS
* CUBIST PHARMACEUTICALS INC
DIFICID, FIDAXOMICIN
ENTEREG, ALVIMOPAN
ZERBAXA, CEFTOLOZANE SULFATE
CUBIST PHARMS INC
* CUBIST PHARMACEUTICALS INC
SIVEXTRO, TEDIZOLID PHOSPHATE
CUMBERLAND PHARMS
* CUMBERLAND PHARMACEUTICALS INC
ACETADOTE, ACETYLCYSTEINE
CALDOLOR, IBUPROFEN
LACTULOSE, LACTULOSE
VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER, CONIVAPTAN HYDROCHLORIDE
CYPRESS BIOSCIENCE
* CYPRESS BIOSCIENCE INC
SAVELLA, MILNACIPRAN HYDROCHLORIDE
CYPRESS PHARM
* CYPRESS PHARMACEUTICAL INC
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 41
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** C **
* CYPRESS PHARMACEUTICAL INC
CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
ELIPHOS, CALCIUM ACETATE
REZIRA, HYDROCODONE BITARTRATE
VITUZ, CHLORPHENIRAMINE MALEATE
ZUTRIPRO, CHLORPHENIRAMINE MALEATE
** D **
DAIICHI
* DAIICHI PHARMACEUTICAL CORP
FLOXIN OTIC, OFLOXACIN
DAIICHI SANKYO
* DAIICHI SANKYO INC
AZOR, AMLODIPINE BESYLATE
BENICAR HCT, HYDROCHLOROTHIAZIDE
BENICAR, OLMESARTAN MEDOXOMIL
EVOXAC, CEVIMELINE HYDROCHLORIDE
TRIBENZOR, AMLODIPINE BESYLATE
WELCHOL, COLESEVELAM HYDROCHLORIDE
DANCO LABS LLC
* DANCO LABORATORIES LLC
MIFEPREX, MIFEPRISTONE
DARA BIOSCIENCES
* DARA BIOSCIENCES INC
SOLTAMOX, TAMOXIFEN CITRATE
DAVA INTL INC
* DAVA INTERNATIONAL INC
ALPRAZOLAM, ALPRAZOLAM
DAVA PHARMS INC
* DAVA PHARMACEUTICALS INC
ACYCLOVIR, ACYCLOVIR
AMOXICILLIN, AMOXICILLIN
AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE
ATENOLOL, ATENOLOL
CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
GEMFIBROZIL, GEMFIBROZIL
GLYBURIDE (MICRONIZED), GLYBURIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
METHOTREXATE SODIUM, METHOTREXATE SODIUM
MORPHINE SULFATE, MORPHINE SULFATE
PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM
PROPYLTHIOURACIL, PROPYLTHIOURACIL
PYRAZINAMIDE, PYRAZINAMIDE
SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE
VOSPIRE ER, ALBUTEROL SULFATE
DAVIS AND GECK
* DAVIS AND GECK DIV AMERICAN CYANAMID CO
PRE-OP II, HEXACHLOROPHENE
PRE-OP, HEXACHLOROPHENE
DELCOR ASSET
* DELCOR ASSET CORP
EVOCLIN, CLINDAMYCIN PHOSPHATE
LUXIQ, BETAMETHASONE VALERATE
OLUX E, CLOBETASOL PROPIONATE
OLUX, CLOBETASOL PROPIONATE
VUSION, MICONAZOLE NITRATE
ZOVIRAX, ACYCLOVIR
DELCOR ASSET CORP
* DELCOR ASSET CORP
ERYGEL, ERYTHROMYCIN
EXTINA, KETOCONAZOLE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 42
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** D **
DENCO ASSET
* DENCO ASSET LLC
DENAVIR, PENCICLOVIR SODIUM
DENTSPLY PHARM
* DENTSPLY PHARMACEUTICAL INC
CITANEST FORTE DENTAL, EPINEPHRINE BITARTRATE
ORAQIX, LIDOCAINE
DEPOMED INC
* DEPOMED INC
CAMBIA, DICLOFENAC POTASSIUM
GRALISE, GABAPENTIN
LAZANDA, FENTANYL CITRATE
ZIPSOR, DICLOFENAC POTASSIUM
DEPROCO
* DEPROCO INC
LIGNOSPAN FORTE, EPINEPHRINE BITARTRATE
LIGNOSPAN STANDARD, EPINEPHRINE BITARTRATE
SCANDONEST L, LEVONORDEFRIN
SCANDONEST PLAIN, MEPIVACAINE HYDROCHLORIDE
SEPTOCAINE, ARTICAINE HYDROCHLORIDE
DEXCEL LTD
* DEXCEL LTD
DICLOFENAC SODIUM, DICLOFENAC SODIUM
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
DEXCEL PHARMA
* DEXCEL PHARMA TECHNOLOGIES LTD
OMEPRAZOLE, OMEPRAZOLE (OTC)
PERIOCHIP, CHLORHEXIDINE GLUCONATE
DIALYSIS SUPS
* DIALYSIS SUPPLIES INC
NORMOCARB HF 25, MAGNESIUM CHLORIDE
NORMOCARB HF 35, MAGNESIUM CHLORIDE
DIGESTIVE CARE INC
* DIGESTIVE CARE INC
PERTZYE, PANCRELIPASE (AMYLASE
DISCOVERY LABS
* DISCOVERY LABORATORIES INC
SURFAXIN, LUCINACTANT
DORADO PHARMA
* DORADO PHARMA LLC
KETOPROFEN, KETOPROFEN
DORC
* DORC INTERNATIONAL BV
MEMBRANEBLUE, TRYPAN BLUE
VISIONBLUE, TRYPAN BLUE
DOUGLAS PHARMS
* DOUGLAS PHARMACEUTICALS AMERICA LTD
MYORISAN, ISOTRETINOIN
DOW PHARM
* DOW PHARMACEUTICAL SCIENCES
ACANYA, BENZOYL PEROXIDE
AKNE-MYCIN, ERYTHROMYCIN
ATRALIN, TRETINOIN
JUBLIA, EFINACONAZOLE
NUTRACORT, HYDROCORTISONE
ONEXTON, BENZOYL PEROXIDE
OXSORALEN-ULTRA, METHOXSALEN
DR REDDYS LA
* DR REDDYS LABORATORIES LOUISIANA LLC
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
LOPURIN, ALLOPURINOL
SSD AF, SILVER SULFADIAZINE
SSD, SILVER SULFADIAZINE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 43
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** D **
DR REDDYS LABS INC
* DR REDDYS LABORATORIES INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
AMOXIL, AMOXICILLIN
AUGMENTIN '125', AMOXICILLIN
AUGMENTIN '200', AMOXICILLIN
AUGMENTIN '250', AMOXICILLIN
AUGMENTIN '400', AMOXICILLIN
AUGMENTIN '500', AMOXICILLIN
AUGMENTIN '875', AMOXICILLIN
AUGMENTIN ES-600, AMOXICILLIN
AUGMENTIN XR, AMOXICILLIN
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
FINASTERIDE, FINASTERIDE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
HABITROL, NICOTINE (OTC)
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
LAROTID, AMOXICILLIN
LEVOFLOXACIN, LEVOFLOXACIN
MELOXICAM, MELOXICAM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC)
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
SIMVASTATIN, SIMVASTATIN
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE
DR REDDYS LABS LTD
* DR REDDYS LABORATORIES LIMITED
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
* DR REDDYS LABORATORIES LTD
ALENDRONATE SODIUM, ALENDRONATE SODIUM
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ANASTROZOLE, ANASTROZOLE
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
AZACITIDINE, AZACITIDINE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL
CARVEDILOL, CARVEDILOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DECITABINE, DECITABINE
DESLORATADINE AND PSEUDOEPHEDRINE SULFATE 24 HOUR, DESLORATADINE
DESLORATADINE, DESLORATADINE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DOCETAXEL, DOCETAXEL
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
ESZOPICLONE, ESZOPICLONE
FAMOTIDINE, FAMOTIDINE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 44
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** D **
* DR REDDYS LABORATORIES LTD
FAMOTIDINE, FAMOTIDINE (OTC)
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE
FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FINASTERIDE, FINASTERIDE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FONDAPARINUX SODIUM, FONDAPARINUX SODIUM
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GLIMEPIRIDE, GLIMEPIRIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IBANDRONATE SODIUM, IBANDRONATE SODIUM
IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC)
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LAMOTRIGINE, LAMOTRIGINE
LANSOPRAZOLE, LANSOPRAZOLE
LANSOPRAZOLE, LANSOPRAZOLE (OTC)
LATANOPROST, LATANOPROST
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NAPROXEN AND ESOMEPRAZOLE MAGNESIUM, ESOMEPRAZOLE MAGNESIUM
NAPROXEN SODIUM, NAPROXEN SODIUM
NATEGLINIDE, NATEGLINIDE
NIZATIDINE, NIZATIDINE
OFLOXACIN, OFLOXACIN
OLANZAPINE, OLANZAPINE
OMEPRAZOLE MAGNESIUM, OMEPRAZOLE MAGNESIUM (OTC)
OMEPRAZOLE, OMEPRAZOLE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXAPROZIN, OXAPROZIN
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PARICALCITOL, PARICALCITOL
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM
RAMIPRIL, RAMIPRIL
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
RISPERIDONE, RISPERIDONE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
SIROLIMUS, SIROLIMUS
TACROLIMUS, TACROLIMUS
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
ZAFIRLUKAST, ZAFIRLUKAST
ZENATANE, ISOTRETINOIN
ZOLEDRONIC ACID, ZOLEDRONIC ACID
DR REDDYS LABS SA
* DR REDDYS LABORATORIES SA
FENOFIBRATE (MICRONIZED), FENOFIBRATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 45
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** D **
DRAXIMAGE
* DRAXIMAGE INC
DTPA, TECHNETIUM TC-99M PENTETATE KIT
TECHNETIUM TC 99M ALBUMIN AGGREGATED KIT, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT
TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT
DUCHESNAY
* DUCHESNAY INC
DICLEGIS, DOXYLAMINE SUCCINATE
DURAMED PHARMS BARR
* DURAMED PHARMACEUTICALS INC SUB BARR LABORATORIES INC
AVIANE-28, ETHINYL ESTRADIOL
CRYSELLE, ETHINYL ESTRADIOL
DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL
DIAMOX, ACETAZOLAMIDE
ENPRESSE-28, ETHINYL ESTRADIOL
METHYLPREDNISOLONE, METHYLPREDNISOLONE
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
VELIVET, DESOGESTREL
DURAMED RES
* DURAMED RESEARCH INC
AYGESTIN, NORETHINDRONE ACETATE
DURATA THERAPS INTL
* DURATA THERAPEUTICS INTERNATIONAL BV
DALVANCE, DALBAVANCIN HYDROCHLORIDE
DUSA
* DUSA PHARMACEUTICALS INC
LEVULAN, AMINOLEVULINIC ACID HYDROCHLORIDE
REDDYS
* DOCTOR REDDYS LABORATORIES LTD
DESLORATADINE, DESLORATADINE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
** E **
EAGLE PHARMS
* EAGLE PHARMACEUTICALS INC
ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN
DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM
RYANODEX, DANTROLENE SODIUM
EASTMAN KODAK
* EASTMAN KODAK CO
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE
EBEWE PHARMA
* EBEWE PHARMA GES MBH NFG KG
CARBOPLATIN, CARBOPLATIN
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
OXALIPLATIN, OXALIPLATIN
PACLITAXEL, PACLITAXEL
ECLAT PHARMS LLC
* ECLAT PHARMACEUTICALS LLC
BLOXIVERZ, NEOSTIGMINE METHYLSULFATE
VAZCULEP, PHENYLEPHRINE HYDROCHLORIDE
ECOLAB
* ECOLAB INC
CHG SCRUB, CHLORHEXIDINE GLUCONATE (OTC)
CIDA-STAT, CHLORHEXIDINE GLUCONATE (OTC)
ECR
* ECR PHARMACEUTICALS
DEXAMETHASONE, DEXAMETHASONE
ECR PHARMA
* ECR PHARMA
TUSSICAPS, CHLORPHENIRAMINE POLISTIREX
EDENBRIDGE PHARMS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 46
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** E **
* EDENBRIDGE PHARMACEUTICALS LLC
IVERMECTIN, IVERMECTIN
EDGEMONT PHARMS LLC
* EDGEMONT PHARMACEUTICALS LLC
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FORFIVO XL, BUPROPION HYDROCHLORIDE
EDISON THERAPS LLC
* EDISON THERAPEUTICS LLC
METHERGINE, METHYLERGONOVINE MALEATE
EI INC
* EI INC
THEROXIDIL, MINOXIDIL (OTC)
EISAI INC
* EISAI INC
ACIPHEX SPRINKLE, RABEPRAZOLE SODIUM
ACIPHEX, RABEPRAZOLE SODIUM
ARICEPT ODT, DONEPEZIL HYDROCHLORIDE
ARICEPT, DONEPEZIL HYDROCHLORIDE
BANZEL, RUFINAMIDE
BELVIQ, LORCASERIN HYDROCHLORIDE
DACOGEN, DECITABINE
FRAGMIN, DALTEPARIN SODIUM
FYCOMPA, PERAMPANEL
HALAVEN, ERIBULIN MESYLATE
HEXALEN, ALTRETAMINE
PANRETIN, ALITRETINOIN
SALAGEN, PILOCARPINE HYDROCHLORIDE
ZONEGRAN, ZONISAMIDE
ELAN PHARMA INTL LTD
* ELAN PHARMA INTERNATIONAL LTD
CLINDESSE, CLINDAMYCIN PHOSPHATE
EVAMIST, ESTRADIOL
ELI LILLY AND CO
* ELI LILLY AND CO
AXIRON, TESTOSTERONE
EFFIENT, PRASUGREL HYDROCHLORIDE
PROZAC, FLUOXETINE HYDROCHLORIDE
SARAFEM, FLUOXETINE HYDROCHLORIDE
ELI LILLY CO
* ELI LILLY CO
ADCIRCA, TADALAFIL
ZYPREXA RELPREVV, OLANZAPINE PAMOATE
ELITE LABS
* ELITE LABORATORIES INC
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
ELITE LABS INC
* ELITE LABORATORIES INC
PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE
EMCURE PHARMS
* EMCURE PHARMACEUTICALS LTD
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
EMCURE PHARMS INDIA
* EMCURE PHARMACEUTICALS LTD INDIA
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
EMCURE PHARMS LTD
* EMCURE PHARMACEUTICALS LTD
ACARBOSE, ACARBOSE
ACETAZOLAMIDE SODIUM , ACETAZOLAMIDE SODIUM
ADENOSINE, ADENOSINE
AMIKACIN SULFATE, AMIKACIN SULFATE
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
BICNU, CARMUSTINE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 47
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** E **
* EMCURE PHARMACEUTICALS LTD
CIDOFOVIR, CIDOFOVIR
COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM
ETOMIDATE, ETOMIDATE
FUROSEMIDE, FUROSEMIDE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
IBANDRONATE SODIUM, IBANDRONATE SODIUM
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LEVOFLOXACIN, LEVOFLOXACIN
METOCLOPRAMIDE, METOCLOPRAMIDE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE
RIFAMPIN, RIFAMPIN
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
TRANEXAMIC ACID, TRANEXAMIC ACID
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
EMCURE PHARMS USA
* EMCURE PHARMACEUTICALS USA INC
DIFLUNISAL, DIFLUNISAL
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE
METHIMAZOLE, METHIMAZOLE
NIFEDIPINE, NIFEDIPINE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
EMCURE USA
* EMCURE PHARMACEUTICALS USA INC
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
EMD SERONO
* EMD SERONO INC
GONAL-F RFF REDI-JECT, FOLLITROPIN ALFA/BETA
GONAL-F RFF, FOLLITROPIN ALFA/BETA
GONAL-F, FOLLITROPIN ALFA/BETA
OVIDREL, CHORIOGONADOTROPIN ALFA
SAIZEN, SOMATROPIN RECOMBINANT
SEROPHENE, CLOMIPHENE CITRATE
SEROSTIM, SOMATROPIN RECOMBINANT
ZORBTIVE, SOMATROPIN RECOMBINANT
EMD SERONO INC
* EMD SERONO INC
CETROTIDE, CETRORELIX
EMMAUS MEDCL
* EMMAUS MEDICAL INC
NUTRESTORE, GLUTAMINE
ENDO PHARM
* ENDO PHARMACEUTICAL SOLUTIONS INC
SUPPRELIN LA, HISTRELIN ACETATE
VALSTAR PRESERVATIVE FREE, VALRUBICIN
VANTAS, HISTRELIN ACETATE
ENDO PHARMS
* ENDO PHARMACEUTICALS INC
DELATESTRYL, TESTOSTERONE ENANTHATE
FORTESTA, TESTOSTERONE
FROVA, FROVATRIPTAN SUCCINATE
OPANA ER, OXYMORPHONE HYDROCHLORIDE
OPANA, OXYMORPHONE HYDROCHLORIDE
PERCODAN, ASPIRIN
ENDO PHARMS INC
* ENDO PHARMACEUTICALS INC
AVEED, TESTOSTERONE UNDECANOATE
VALGANCICLOVIR HYDROCHLORIDE, VALGANCICLOVIR HYDROCHLORIDE
ENDO VENTURES LTD
* ENDO VENTURES LTD
NATESTO, TESTOSTERONE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 48
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** E **
* ENDO VENTURES LTD IRELAND
SUMAVEL DOSEPRO, SUMATRIPTAN SUCCINATE
EPIC PHARMA
* EPIC PHARMA INC
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
* EPIC PHARMA LLC
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE
SULINDAC, SULINDAC
TRANDOLAPRIL, TRANDOLAPRIL
URSODIOL, URSODIOL
EPIC PHARMA INC
* EPIC PHARMA INC
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
EPIC PHARMA LLC
* EPIC PHARMA LLC
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE
SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
ERGOJECT
* ERGOJECT LLC
METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE
ESSENTIAL ISOTOPES
* ESSENTIAL ISOTOPES LLC
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
ETHYPHARM
* ETHYPHARM
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
EURAND
* EURAND AMERICA INC
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
EUROHLTH INTL
* EUROHEALTH INTERNATIONAL SARL
ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM
ALLOPURINOL SODIUM, ALLOPURINOL SODIUM
ALPROSTADIL, ALPROSTADIL
AMIKACIN SULFATE, AMIKACIN SULFATE
AMRINONE LACTATE, INAMRINONE LACTATE
ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE
ATRACURIUM BESYLATE, ATRACURIUM BESYLATE
AZATHIOPRINE SODIUM, AZATHIOPRINE SODIUM
AZTREONAM, AZTREONAM
BLEOMYCIN SULFATE, BLEOMYCIN SULFATE
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
CAFCIT, CAFFEINE CITRATE
CARBOPLATIN, CARBOPLATIN
CERUBIDINE, DAUNORUBICIN HYDROCHLORIDE
CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE
CISPLATIN, CISPLATIN
CLADRIBINE, CLADRIBINE
CYCLOSPORINE, CYCLOSPORINE
CYTARABINE, CYTARABINE
DACARBAZINE, DACARBAZINE
DACTINOMYCIN, DACTINOMYCIN
DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE
DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE
DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE
DICYCLOMINE HYDROCHLORIDE (PRESERVATIVE-FREE), DICYCLOMINE HYDROCHLORIDE
DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 49
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** E **
* EUROHEALTH INTERNATIONAL SARL
DOXYCYCLINE, DOXYCYCLINE HYCLATE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE
ETOPOSIDE, ETOPOSIDE
FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE
FLOXURIDINE, FLOXURIDINE
FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE
HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE
HALOPERIDOL, HALOPERIDOL LACTATE
IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE
IFOSFAMIDE, IFOSFAMIDE
INDOMETHACIN SODIUM, INDOMETHACIN SODIUM
KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM
LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM
LEVOCARNITINE, LEVOCARNITINE
MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE
MESNA, MESNA
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
METHOTREXATE SODIUM, METHOTREXATE SODIUM
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
PACLITAXEL, PACLITAXEL
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PENTOSTATIN, PENTOSTATIN
PHENTOLAMINE MESYLATE, PHENTOLAMINE MESYLATE
POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
THIOTEPA, THIOTEPA
TORSEMIDE, TORSEMIDE
VINBLASTINE SULFATE, VINBLASTINE SULFATE
EXALENZ BIOSCIENCE
* EXALENZ BIOSCIENCE LTD
IDKIT:HP, CITRIC ACID
EXCELLIUM
* EXCELLIUM PHARMACEUTICAL INC
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
FOLIC ACID, FOLIC ACID
FUROSEMIDE, FUROSEMIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE
LORAZEPAM, LORAZEPAM
EXELA PHARMA SCIENCE
* EXELA PHARMA SCIENCES
CAFFEINE CITRATE, CAFFEINE CITRATE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
EXELA PHARMA SCS LLC
* EXELA PHARMA SCIENCES LLC
CAFFEINE CITRATE, CAFFEINE CITRATE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
MAGNESIUM SULFATE, MAGNESIUM SULFATE
EXELIXIS
* EXELIXIS INC
COMETRIQ, CABOZANTINIB S-MALATE
FOUGERA
* E FOUGERA DIV ALTANA INC
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 50
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** E **
* E FOUGERA DIV ALTANA INC
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
FLUOCINONIDE, FLUOCINONIDE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
HYDROCORTISONE, HYDROCORTISONE
LIDOCAINE, LIDOCAINE
NITROGLYCERIN, NITROGLYCERIN
NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN
NYSTATIN, NYSTATIN
LILLY
* ELI LILLY AND CO
ALIMTA, PEMETREXED DISODIUM
CIALIS, TADALAFIL
CYMBALTA, DULOXETINE HYDROCHLORIDE
EVISTA, RALOXIFENE HYDROCHLORIDE
FORTEO, TERIPARATIDE RECOMBINANT HUMAN
GEMZAR, GEMCITABINE HYDROCHLORIDE
GLUCAGON, GLUCAGON RECOMBINANT
HUMALOG KWIKPEN, INSULIN LISPRO RECOMBINANT
HUMALOG MIX 50/50 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 50/50, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 75/25 KWIKPEN, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG MIX 75/25, INSULIN LISPRO PROTAMINE RECOMBINANT
HUMALOG, INSULIN LISPRO RECOMBINANT
HUMATROPE, SOMATROPIN RECOMBINANT
HUMULIN 70/30 PEN, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN 70/30, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC)
HUMULIN R PEN, INSULIN RECOMBINANT HUMAN (OTC)
HUMULIN R, INSULIN RECOMBINANT HUMAN
HUMULIN R, INSULIN RECOMBINANT HUMAN (OTC)
PROZAC WEEKLY, FLUOXETINE HYDROCHLORIDE
QUINIDINE GLUCONATE, QUINIDINE GLUCONATE
STRATTERA, ATOMOXETINE HYDROCHLORIDE
SYMBYAX, FLUOXETINE HYDROCHLORIDE
ZYPREXA ZYDIS, OLANZAPINE
ZYPREXA, OLANZAPINE
** F **
FALCON PHARMS
* FALCON PHARMACEUTICALS LTD
LEVOBUNOLOL HYDROCHLORIDE, LEVOBUNOLOL HYDROCHLORIDE
MAXITROL, DEXAMETHASONE
TOBREX, TOBRAMYCIN
TRIMETHOPRIM SULFATE AND POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
FAMY CARE LTD
* FAMY CARE LTD
DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL
LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
LEVONORGESTREL, LEVONORGESTREL (OTC)
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
NORETHINDRONE, NORETHINDRONE
FDC LTD
* FDC LTD
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
OFLOXACIN, OFLOXACIN
TIMOLOL MALEATE, TIMOLOL MALEATE
FEINSTEIN
* FEINSTEIN INSTITUTE MEDICAL RESEARCH
AMMONIA N 13, AMMONIA N-13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
FERA PHARMS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 51
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** F **
* FERA PHARMACEUTICALS LLC
OFLOXACIN, OFLOXACIN
TOBRAMYCIN, TOBRAMYCIN
FERNDALE LABS
* FERNDALE LABORATORIES INC
HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE
FERRING
* FERRING PHARMACEUTICALS INC
ACTHREL, CORTICORELIN OVINE TRIFLUTATE
BRAVELLE, UROFOLLITROPIN
CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
ENDOMETRIN, PROGESTERONE
FIRMAGON, DEGARELIX ACETATE
MENOPUR, MENOTROPINS (FSH
MINIRIN, DESMOPRESSIN ACETATE
REPRONEX, MENOTROPINS (FSH
TEV-TROPIN, SOMATROPIN RECOMBINANT
FERRING CONTROLLED
* FERRING CONTROLLED THERAPEUTICS LTD
CERVIDIL, DINOPROSTONE
FERRING PHARMS AS
* FERRING PHARMACEUTICALS AS
LYSTEDA, TRANEXAMIC ACID
PREPOPIK, CITRIC ACID
FERRING PHARMS INC
* FERRING PHARMACEUTICALS INC
DDAVP (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE
DDAVP, DESMOPRESSIN ACETATE
FOREST LABS
* FOREST LABORATORIES INC
BYSTOLIC, NEBIVOLOL HYDROCHLORIDE
CAMPRAL, ACAMPROSATE CALCIUM
CELEXA, CITALOPRAM HYDROBROMIDE
LEXAPRO, ESCITALOPRAM OXALATE
NAMENDA XR, MEMANTINE HYDROCHLORIDE
NAMENDA, MEMANTINE HYDROCHLORIDE
THYROLAR-0.25, LIOTRIX (T4
THYROLAR-0.5, LIOTRIX (T4
THYROLAR-1, LIOTRIX (T4
THYROLAR-2, LIOTRIX (T4
THYROLAR-3, LIOTRIX (T4
FOREST LABS INC
* FOREST LABORATORIES INC
BENTYL PRESERVATIVE FREE, DICYCLOMINE HYDROCHLORIDE
BENTYL, DICYCLOMINE HYDROCHLORIDE
CANASA, MESALAMINE
CARAFATE, SUCRALFATE
FETZIMA, LEVOMILNACIPRAN HYDROCHLORIDE
LINZESS, LINACLOTIDE
NAMZARIC, DONEPEZIL HYDROCHLORIDE
PYLERA, BISMUTH SUBCITRATE POTASSIUM
RECTIV, NITROGLYCERIN
SAPHRIS, ASENAPINE MALEATE
TUDORZA PRESSAIR, ACLIDINIUM BROMIDE
ULTRESA, PANCRELIPASE (AMYLASE
URSO 250, URSODIOL
URSO FORTE, URSODIOL
VIIBRYD, VILAZODONE HYDROCHLORIDE
VIOKACE, PANCRELIPASE (AMYLASE
ZENPEP, PANCRELIPASE (AMYLASE
FOREST RES INST INC
* FOREST RESEARCH INSTITUTE INC
DALIRESP, ROFLUMILAST
FOUGERA PHARMS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 52
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** F **
* FOUGERA PHARMACEUTICALS INC
ADAPALENE, ADAPALENE
ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE
AMCINONIDE, AMCINONIDE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
C-SOLVE-2, ERYTHROMYCIN
CALCIPOTRIENE, CALCIPOTRIENE
CICLOPIROX, CICLOPIROX
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CLOTRIMAZOLE, CLOTRIMAZOLE
CUTIVATE, FLUTICASONE PROPIONATE
DESONIDE, DESONIDE
DESOXIMETASONE, DESOXIMETASONE
DIFLORASONE DIACETATE, DIFLORASONE DIACETATE
ECONAZOLE NITRATE, ECONAZOLE NITRATE
ERYTHROMYCIN, ERYTHROMYCIN
FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE
FLUOCINONIDE, FLUOCINONIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
HYDROCORTISONE, HYDROCORTISONE
IMIQUIMOD, IMIQUIMOD
KETOCONAZOLE, KETOCONAZOLE
LIDOCAINE AND PRILOCAINE, LIDOCAINE
METRONIDAZOLE, METRONIDAZOLE
MOMETASONE FUROATE, MOMETASONE FUROATE
MUPIROCIN, MUPIROCIN
NYSTATIN, NYSTATIN
OXISTAT, OXICONAZOLE NITRATE
PAMINE FORTE, METHSCOPOLAMINE BROMIDE
PAMINE, METHSCOPOLAMINE BROMIDE
PANDEL, HYDROCORTISONE PROBUTATE
PREDNICARBATE, PREDNICARBATE
SOLARAZE, DICLOFENAC SODIUM
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
TEMOVATE E, CLOBETASOL PROPIONATE
TEMOVATE, CLOBETASOL PROPIONATE
TERCONAZOLE, TERCONAZOLE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
TYZINE, TETRAHYDROZOLINE HYDROCHLORIDE
ZONALON, DOXEPIN HYDROCHLORIDE
FOUGERA PHARMS INC
* FOUGERA PHARMACEUTICALS INC
FLUOCINONIDE, FLUOCINONIDE
TACROLIMUS, TACROLIMUS
FRESENIUS
* FRESENIUS KABI DEUTSCHLAND GMBH
INTRALIPID 10%, SOYBEAN OIL
INTRALIPID 20%, SOYBEAN OIL
INTRALIPID 30%, SOYBEAN OIL
FRESENIUS KABI
* FRESENIUS KABI AUSTRIA GMBH
LACTULOSE, LACTULOSE
FRESENIUS KABI ONCOL
* FRESENIUS KABI ONCOLOGY PLC
ANASTROZOLE, ANASTROZOLE
BICALUTAMIDE, BICALUTAMIDE
CARBOPLATIN, CARBOPLATIN
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LETROZOLE, LETROZOLE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 53
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** F **
* FRESENIUS KABI ONCOLOGY PLC
OXALIPLATIN, OXALIPLATIN
PACLITAXEL, PACLITAXEL
FRESENIUS KABI USA
* FRESENIUS KABI USA LLC
ACYCLOVIR SODIUM, ACYCLOVIR SODIUM
ADENOSINE, ADENOSINE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
ASTRAMORPH PF, MORPHINE SULFATE
AZITHROMYCIN, AZITHROMYCIN
AZTREONAM, AZTREONAM
BACITRACIN, BACITRACIN
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
BLEOMYCIN SULFATE, BLEOMYCIN SULFATE
CAFFEINE CITRATE, CAFFEINE CITRATE
CALCITRIOL, CALCITRIOL
CARBOPLATIN, CARBOPLATIN
CEFOTETAN, CEFOTETAN DISODIUM
CEFTRIAXONE, CEFTRIAXONE SODIUM
CHLORAMPHENICOL SODIUM SUCCINATE, CHLORAMPHENICOL SODIUM SUCCINATE
CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM
CHORIONIC GONADOTROPIN, GONADOTROPIN, CHORIONIC
CISPLATIN, CISPLATIN
CLADRIBINE, CLADRIBINE
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM
CYTARABINE, CYTARABINE
DACARBAZINE, DACARBAZINE
DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE
DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DIMENHYDRINATE, DIMENHYDRINATE
DIPRIVAN, PROPOFOL
DIPYRIDAMOLE, DIPYRIDAMOLE
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
DOXY 100, DOXYCYCLINE HYCLATE
DOXY 200, DOXYCYCLINE HYCLATE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE
ETOPOSIDE, ETOPOSIDE
FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE
FLOXURIDINE, FLOXURIDINE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
FLUMAZENIL, FLUMAZENIL
FLUOROURACIL, FLUOROURACIL
FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE
FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE
FOLIC ACID, FOLIC ACID
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
FUROSEMIDE, FUROSEMIDE
GANCICLOVIR, GANCICLOVIR SODIUM
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
GRANISETRON HYDROCHLORIDE PRESERVATIVE FREE, GRANISETRON HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE
HALOPERIDOL, HALOPERIDOL LACTATE
HEPARIN SODIUM IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM
HEPARIN SODIUM, HEPARIN SODIUM
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 54
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** F **
* FRESENIUS KABI USA LLC
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE
IFOSFAMIDE, IFOSFAMIDE
INDOMETHACIN, INDOMETHACIN
IOPAMIDOL-250, IOPAMIDOL
IOPAMIDOL-300, IOPAMIDOL
IOPAMIDOL-370, IOPAMIDOL
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
KABIVEN IN PLASTIC CONTAINER, AMINO ACIDS
KANAMYCIN SULFATE, KANAMYCIN SULFATE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
MAGNESIUM SULFATE, MAGNESIUM SULFATE
MANNITOL 25%, MANNITOL
MESNA, MESNA
METARAMINOL BITARTRATE, METARAMINOL BITARTRATE
METHOTREXATE PRESERVATIVE FREE, METHOTREXATE SODIUM
METHOTREXATE SODIUM, METHOTREXATE SODIUM
METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MILRINONE LACTATE, MILRINONE LACTATE
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
NAROPIN, ROPIVACAINE HYDROCHLORIDE
NEBUPENT, PENTAMIDINE ISETHIONATE
NESACAINE, CHLOROPROCAINE HYDROCHLORIDE
NESACAINE-MPF, CHLOROPROCAINE HYDROCHLORIDE
OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXALIPLATIN, OXALIPLATIN
OXYTOCIN, OXYTOCIN
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PENTAM, PENTAMIDINE ISETHIONATE
PERIKABIVEN IN PLASTIC CONTAINER, AMINO ACIDS
POLOCAINE, MEPIVACAINE HYDROCHLORIDE
POLOCAINE-MPF, MEPIVACAINE HYDROCHLORIDE
POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
POTASSIUM CHLORIDE IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PROGESTERONE, PROGESTERONE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
PROTAMINE SULFATE, PROTAMINE SULFATE
PYRIDOXINE HYDROCHLORIDE, PYRIDOXINE HYDROCHLORIDE
RIFAMPIN, RIFAMPIN
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
SENSORCAINE, BUPIVACAINE HYDROCHLORIDE
SENSORCAINE, BUPIVACAINE HYDROCHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBUTALINE SULFATE, TERBUTALINE SULFATE
THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE
TOBRAMYCIN SULFATE (PHARMACY BULK), TOBRAMYCIN SULFATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VALPROATE SODIUM, VALPROATE SODIUM
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 55
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** F **
* FRESENIUS KABI USA LLC
VIBISONE, CYANOCOBALAMIN
VINBLASTINE SULFATE, VINBLASTINE SULFATE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
XYLOCAINE 4% PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
XYLOCAINE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
XYLOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE
XYLOCAINE W/ EPINEPHRINE, EPINEPHRINE
XYLOCAINE, LIDOCAINE HYDROCHLORIDE
FRESENIUS MEDCL
* FRESENIUS MEDICAL CARE NORTH AMERICA
CALCITRIOL, CALCITRIOL
DELFLEX W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 1.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM
DELFLEX W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 2.5% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM
DELFLEX W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX W/ DEXTROSE 4.25% LOW MAGNESIUM LOW CALCIUM IN PLASTIC CONTAINER, CALCIUM
DELFLEX-LM W/ DEXTROSE 1.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX-LM W/ DEXTROSE 2.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX-LM W/ DEXTROSE 3.5% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DELFLEX-LM W/ DEXTROSE 4.25% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PHOSLO GELCAPS, CALCIUM ACETATE
PHOSLYRA, CALCIUM ACETATE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
FSC
* FSC LABORATORIES INC
PRIMSOL, TRIMETHOPRIM HYDROCHLORIDE
** G **
G AND W LABS
* G AND W LABORATORIES INC
ACEPHEN, ACETAMINOPHEN (OTC)
CICLOPIROX, CICLOPIROX
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
INDOMETHACIN, INDOMETHACIN
METRONIDAZOLE, METRONIDAZOLE
MICONAZOLE 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)
MOMETASONE FUROATE, MOMETASONE FUROATE
PROCHLORPERAZINE, PROCHLORPERAZINE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROMETHEGAN, PROMETHAZINE HYDROCHLORIDE
G AND W LABS INC
* G AND W LABORATORIES INC
CALCIPOTRIENE, CALCIPOTRIENE
CICLOPIROX, CICLOPIROX
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
FLUOCINONIDE, FLUOCINONIDE
METRONIDAZOLE, METRONIDAZOLE
MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)
GALDERMA LABS
* GALDERMA LABORATORIES INC
CLOBEX, CLOBETASOL PROPIONATE
GALDERMA LABS LP
* GALDERMA LABORATORIES L P
CLOBEX, CLOBETASOL PROPIONATE
* GALDERMA LABORATORIES LP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 56
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** G **
* GALDERMA LABORATORIES LP
CAPEX, FLUOCINOLONE ACETONIDE
CLOBEX, CLOBETASOL PROPIONATE
DESOWEN, DESONIDE
DIFFERIN, ADAPALENE
EPIDUO, ADAPALENE
METROCREAM, METRONIDAZOLE
METROGEL, METRONIDAZOLE
METROLOTION, METRONIDAZOLE
MIRVASO, BRIMONIDINE TARTRATE
ORACEA, DOXYCYCLINE
PLIAGLIS, LIDOCAINE
SOOLANTRA, IVERMECTIN
TRI-LUMA, FLUOCINOLONE ACETONIDE
VECTICAL, CALCITRIOL
GALEN (UK)
* GALEN LTD
DAUNOXOME, DAUNORUBICIN CITRATE
GALEN SPECIALTY
* GALEN SPECIALTY PHARMA US LLC
SYNERA, LIDOCAINE
GALENA BIOPHARMA
* GALENA BIOPHARMA
ABSTRAL, FENTANYL CITRATE
GALENA BIOPHARMA INC
* GALENA BIOPHARMA INC
ZUPLENZ, ONDANSETRON
GAMBRO RENAL PRODS
* GAMBRO RENAL PRODUCTS
PRISMASOL B22GK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL B22GK 4/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL B22GK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 0/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 2/0 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 2/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 4/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BGK 4/2.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BK 0/0/1.2 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
PRISMASOL BK 0/3.5 IN PLASTIC CONTAINER, CALCIUM CHLORIDE
GASTROENTERO
* GASTROENTERO LOGIC LLC
OMEPRAZOLE AND CLARITHROMYCIN AND AMOXICILLIN, AMOXICILLIN
GATE PHARMS
* GATE PHARMACEUTICALS
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
GAVIS PHARMS
* GAVIS PHARMACEUTICALS LLC
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
NYSTATIN, NYSTATIN
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
QUINARETIC, HYDROCHLOROTHIAZIDE
TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE
GAVIS PHARMS LLC
* GAVIS PHARMACEUTICALS LLC
EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE
GD SEARLE
* GD SEARLE LLC
CELEBREX, CELECOXIB
DAYPRO, OXAPROZIN
GD SEARLE LLC
* GD SEARLE LLC
ALDACTAZIDE, HYDROCHLOROTHIAZIDE
ALDACTONE, SPIRONOLACTONE
ARTHROTEC, DICLOFENAC SODIUM
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 57
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** G **
* GD SEARLE LLC
CALAN, VERAPAMIL HYDROCHLORIDE
COVERA-HS, VERAPAMIL HYDROCHLORIDE
CYTOTEC, MISOPROSTOL
FLAGYL ER, METRONIDAZOLE
FLAGYL, METRONIDAZOLE
INSPRA, EPLERENONE
LOMOTIL, ATROPINE SULFATE
NORPACE CR, DISOPYRAMIDE PHOSPHATE
NORPACE, DISOPYRAMIDE PHOSPHATE
SYNAREL, NAFARELIN ACETATE
GE HEALTHCARE
* GE HEALTHCARE
ADREVIEW, IOBENGUANE SULFATE I-123
CERETEC, TECHNETIUM TC-99M EXAMETAZIME KIT
INDICLOR, INDIUM IN-111 CHLORIDE
INDIUM IN-111 OXYQUINOLINE, INDIUM IN-111 OXYQUINOLINE
METASTRON, STRONTIUM CHLORIDE SR-89
MPI DMSA KIDNEY REAGENT, TECHNETIUM TC-99M SUCCIMER KIT
MPI INDIUM DTPA IN 111, INDIUM IN-111 PENTETATE DISODIUM
MYOVIEW 30ML, TECHNETIUM TC-99M TETROFOSMIN KIT
MYOVIEW, TECHNETIUM TC-99M TETROFOSMIN KIT
OMNIPAQUE 140, IOHEXOL
OMNIPAQUE 180, IOHEXOL
OMNIPAQUE 240, IOHEXOL
OMNIPAQUE 300, IOHEXOL
OMNIPAQUE 350, IOHEXOL
OMNISCAN, GADODIAMIDE
OPTISON, ALBUMIN HUMAN
TECHNETIUM TC 99M GENERATOR, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201
VISIPAQUE 270, IODIXANOL
VISIPAQUE 320, IODIXANOL
VIZAMYL, FLUTEMETAMOL F-18
GE HLTHCARE INC
* GE HEALTHCARE INC
DATSCAN, IOFLUPANE I-123
GEDEON RICHTER USA
* GEDEON RICHTER USA INC
FINASTERIDE, FINASTERIDE
GENENTECH
* GENENTECH INC
ERIVEDGE, VISMODEGIB
NUTROPIN AQ PEN, SOMATROPIN RECOMBINANT
NUTROPIN AQ, SOMATROPIN RECOMBINANT
NUTROPIN, SOMATROPIN RECOMBINANT
GENZYME
* GENZYME CORP
CEREZYME, IMIGLUCERASE
CLOLAR, CLOFARABINE
MOZOBIL, PLERIXAFOR
RENAGEL, SEVELAMER HYDROCHLORIDE
RENVELA, SEVELAMER CARBONATE
THYROGEN, THYROTROPIN ALFA
GENZYME CORP
* GENZYME CORP
CERDELGA, ELIGLUSTAT TARTRATE
HECTOROL, DOXERCALCIFEROL
KYNAMRO, MIPOMERSEN SODIUM
GILEAD
* GILEAD SCIENCES INC
ATRIPLA, EFAVIRENZ
CAYSTON, AZTREONAM
EMTRIVA, EMTRICITABINE
HEPSERA, ADEFOVIR DIPIVOXIL
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 58
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** G **
* GILEAD SCIENCES INC
LETAIRIS, AMBRISENTAN
RANEXA, RANOLAZINE
TRUVADA, EMTRICITABINE
GILEAD SCIENCES INC
* GILEAD SCIENCES INC
COMPLERA, EMTRICITABINE
HARVONI, LEDIPASVIR
SOVALDI, SOFOSBUVIR
STRIBILD, COBICISTAT
TYBOST, COBICISTAT
VIREAD, TENOFOVIR DISOPROXIL FUMARATE
VISTIDE, CIDOFOVIR
VITEKTA, ELVITEGRAVIR
ZYDELIG, IDELALISIB
GLAND PHARMA LTD
* GLAND PHARMA LTD
ADENOSINE, ADENOSINE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AZITHROMYCIN, AZITHROMYCIN
HALOPERIDOL, HALOPERIDOL LACTATE
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MILRINONE LACTATE, MILRINONE LACTATE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
GLAXO GRP ENGLAND
* GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
INCRUSE ELLIPTA , UMECLIDINIUM BROMIDE
GLAXO GRP LTD
* GLAXO GROUP LTD DBA GLAXOSMITHKLINE
ALTABAX, RETAPAMULIN
FLOVENT HFA, FLUTICASONE PROPIONATE
* GLAXO GROUP LTD ENGLAND DBA GLAXOSMITHKLINE
ADVAIR DISKUS 100/50, FLUTICASONE PROPIONATE
ADVAIR DISKUS 250/50, FLUTICASONE PROPIONATE
ADVAIR DISKUS 500/50, FLUTICASONE PROPIONATE
ADVAIR HFA, FLUTICASONE PROPIONATE
BREO ELLIPTA, FLUTICASONE FUROATE
FLOVENT DISKUS 100, FLUTICASONE PROPIONATE
FLOVENT DISKUS 250, FLUTICASONE PROPIONATE
FLOVENT DISKUS 50, FLUTICASONE PROPIONATE
ZANTAC 150, RANITIDINE HYDROCHLORIDE
ZANTAC 300, RANITIDINE HYDROCHLORIDE
ZANTAC, RANITIDINE HYDROCHLORIDE
GLAXO WELLCOME
* GLAXOSMITHKLINE
HYCAMTIN, TOPOTECAN HYDROCHLORIDE
GLAXOSMITHKLINE
* GLAXOSMITHKLINE
ABREVA, DOCOSANOL (OTC)
ALKERAN, MELPHALAN
ALKERAN, MELPHALAN HYDROCHLORIDE
AVODART, DUTASTERIDE
BACTROBAN, MUPIROCIN
BACTROBAN, MUPIROCIN CALCIUM
BECONASE AQ, BECLOMETHASONE DIPROPIONATE MONOHYDRATE
CEFTIN, CEFUROXIME AXETIL
EPIVIR-HBV, LAMIVUDINE
FLONASE, FLUTICASONE PROPIONATE
HYCAMTIN, TOPOTECAN HYDROCHLORIDE
IMITREX STATDOSE, SUMATRIPTAN SUCCINATE
IMITREX, SUMATRIPTAN
IMITREX, SUMATRIPTAN SUCCINATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 59
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** G **
* GLAXOSMITHKLINE
JALYN, DUTASTERIDE
MALARONE PEDIATRIC, ATOVAQUONE
MALARONE, ATOVAQUONE
NICORETTE (MINT), NICOTINE POLACRILEX (OTC)
NICORETTE, NICOTINE POLACRILEX (OTC)
POTIGA, EZOGABINE
PROMACTA, ELTROMBOPAG OLAMINE
RELENZA, ZANAMIVIR
TAFINLAR, DABRAFENIB MESYLATE
TIMENTIN IN PLASTIC CONTAINER, CLAVULANATE POTASSIUM
TIMENTIN, CLAVULANATE POTASSIUM
VALTREX, VALACYCLOVIR HYDROCHLORIDE
VERAMYST, FLUTICASONE FUROATE
VOTRIENT, PAZOPANIB HYDROCHLORIDE
WELLBUTRIN SR, BUPROPION HYDROCHLORIDE
WELLBUTRIN, BUPROPION HYDROCHLORIDE
ZOFRAN ODT, ONDANSETRON
ZOFRAN PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ZOFRAN, ONDANSETRON HYDROCHLORIDE
ZYBAN, BUPROPION HYDROCHLORIDE
* GLAXOSMITHKLINE INTELLECTUAL PROPERTY DEVELOPMENT LTD ENGLAND
ANORO ELLIPTA, UMECLIDINIUM BROMIDE
ARNUITY ELLIPTA, FLUTICASONE FUROATE
* GLAXOSMITHKLINE INTELLECTUAL PROPERTY LTD ENGLAND
SEREVENT, SALMETEROL XINAFOATE
VENTOLIN HFA, ALBUTEROL SULFATE
* GLAXOSMITHKLINE INTELLECTUAL PROPERTY NO 2 LTD ENGLAND
TIMENTIN, CLAVULANATE POTASSIUM
GLAXOSMITHKLINE CONS
* GLAXOSMITHKLINE CONSUMER HEALTHCARE
ALLI, ORLISTAT (OTC)
COMMIT, NICOTINE POLACRILEX (OTC)
FLONASE ALLERGY RELIEF, FLUTICASONE PROPIONATE (OTC)
NICORETTE, NICOTINE POLACRILEX (OTC)
GLAXOSMITHKLINE LLC
* GLAXOSMITHKLINE LLC
AMERGE, NARATRIPTAN HYDROCHLORIDE
DYAZIDE, HYDROCHLOROTHIAZIDE
FLOLAN, EPOPROSTENOL SODIUM
INNOPRAN XL, PROPRANOLOL HYDROCHLORIDE
LAMICTAL CD, LAMOTRIGINE
LAMICTAL ODT, LAMOTRIGINE
LAMICTAL XR, LAMOTRIGINE
LAMICTAL, LAMOTRIGINE
MEKINIST, TRAMETINIB DIMETHYL SULFOXIDE
MEPRON, ATOVAQUONE
REQUIP XL, ROPINIROLE HYDROCHLORIDE
REQUIP, ROPINIROLE HYDROCHLORIDE
RYTHMOL SR, PROPAFENONE HYDROCHLORIDE
RYTHMOL, PROPAFENONE HYDROCHLORIDE
GLENMARK GENERICS
* GLENMARK GENERICS INC USA
ADAPALENE, ADAPALENE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CALCIPOTRIENE, CALCIPOTRIENE
IMIQUIMOD, IMIQUIMOD
MOMETASONE FUROATE, MOMETASONE FUROATE
MUPIROCIN, MUPIROCIN CALCIUM
NIZATIDINE, NIZATIDINE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
ZONISAMIDE, ZONISAMIDE
* GLENMARK GENERICS LIMITED
BRIELLYN, ETHINYL ESTRADIOL
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 60
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** G **
* GLENMARK GENERICS LIMITED
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
* GLENMARK GENERICS LTD
ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM
ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE
ALYACEN 1/35, ETHINYL ESTRADIOL
ALYACEN 7/7/7, ETHINYL ESTRADIOL
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE
CARVEDILOL, CARVEDILOL
CICLOPIROX, CICLOPIROX
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
DESOXIMETASONE, DESOXIMETASONE
ESZOPICLONE, ESZOPICLONE
FELODIPINE, FELODIPINE
FLUCONAZOLE, FLUCONAZOLE
FLUOCINONIDE, FLUOCINONIDE
GABAPENTIN, GABAPENTIN
HEATHER, NORETHINDRONE
HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE
LAMOTRIGINE, LAMOTRIGINE
LEVOFLOXACIN, LEVOFLOXACIN
LITHIUM CARBONATE, LITHIUM CARBONATE
MARLISSA, ETHINYL ESTRADIOL
MELOXICAM, MELOXICAM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE
MOMETASONE FUROATE, MOMETASONE FUROATE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
NAPROXEN SODIUM, NAPROXEN SODIUM
NAPROXEN, NAPROXEN
NORETHINDRONE, NORETHINDRONE
NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
OMEPRAZOLE, OMEPRAZOLE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON, ONDANSETRON
OXCARBAZEPINE, OXCARBAZEPINE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
RILUZOLE, RILUZOLE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
TELMISARTAN, TELMISARTAN
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
THEOPHYLLINE, THEOPHYLLINE
TOPIRAMATE, TOPIRAMATE
TRANDOLAPRIL AND VERAPAMIL HYDROCHLORIDE, TRANDOLAPRIL
TROSPIUM CHLORIDE, TROSPIUM CHLORIDE
URSODIOL, URSODIOL
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
VIORELE, DESOGESTREL
ZOLMITRIPTAN, ZOLMITRIPTAN
* GLENMARK GENERICS LTD INDIA
INDOMETHACIN, INDOMETHACIN
LITHIUM CARBONATE, LITHIUM CARBONATE
NORETHINDRONE ACETATE, NORETHINDRONE ACETATE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
GLENMARK PHARMS
* GLENMARK PHARMACEUTICALS INC USA
CICLOPIROX, CICLOPIROX
CLOTRIMAZOLE, CLOTRIMAZOLE
MUPIROCIN, MUPIROCIN
* GLENMARK PHARMACEUTICALS LTD
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
GLENMARK PHARMS LTD
* GLENMARK PHARMACEUTICALS LTD
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 61
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** G **
* GLENMARK PHARMACEUTICALS LTD
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
GLOBAL ISOTOPES LLC
* GLOBAL ISOTOPES LLC DBA ZEVACOR MOLECULAR
AMMONIA N 13, AMMONIA N-13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
GRANULES INDIA
* GRANULES INDIA LTD
IBUPROFEN, IBUPROFEN (OTC)
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
GUARDIAN DRUG
* GUARDIAN DRUG CO INC
FOAMCOAT, ALUMINUM HYDROXIDE (OTC)
GUERBET
* GUERBET LLC
DOTAREM, GADOTERATE MEGLUMINE
HEXABRIX, IOXAGLATE MEGLUMINE
LIPIODOL, ETHIODIZED OIL
OXILAN-300, IOXILAN
OXILAN-350, IOXILAN
HANFORD GC
* GC HANFORD MANUFACTURING CO
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
AMPICILLIN SODIUM, AMPICILLIN SODIUM
PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM
** H **
HAEMONETICS
* HAEMONETICS CORP
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
HALOCARBON PRODS
* HALOCARBON PRODUCTS CORP
ISOFLURANE, ISOFLURANE
SEVOFLURANE, SEVOFLURANE
HALOZYME THERAP
* HALOZYME THERAPEUTICS INC
HYLENEX RECOMBINANT, HYALURONIDASE RECOMBINANT HUMAN
HAMELN RDS GMBH
* HAMELN RDS GMBH
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
HANMI PHARM CO LTD
* HANMI PHARMACEUTICAL CO LTD
ESOMEPRAZOLE STRONTIUM, ESOMEPRAZOLE STRONTIUM
HARRIS PHARM
* HARRIS PHARMACEUTICAL INC
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
HAUPT PHARMA
* HAUPT PHARMA INC
LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
NORETHINDRONE, NORETHINDRONE
HELSINN HLTHCARE
* HELSINN HEALTHCARE SA
AKYNZEO, NETUPITANT
ALOXI, PALONOSETRON HYDROCHLORIDE
HERCON PHARM
* HERCON PHARMACEUTICAL LLC
NITROGLYCERIN, NITROGLYCERIN
HERITAGE PHARMS INC
* HERITAGE PHARMACEUTICALS INC
ACETAZOLAMIDE, ACETAZOLAMIDE
ACHROMYCIN V, TETRACYCLINE HYDROCHLORIDE
CARISOPRODOL AND ASPIRIN, ASPIRIN
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 62
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** H **
* HERITAGE PHARMACEUTICALS INC
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
FELODIPINE, FELODIPINE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE
GLYBURIDE, GLYBURIDE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
INDOMETHACIN, INDOMETHACIN
LEFLUNOMIDE, LEFLUNOMIDE
MOEXIPRIL HYDROCHLORIDE AND HYDROCHOLROTHIAZIDE, HYDROCHLOROTHIAZIDE
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
NYSTATIN, NYSTATIN
PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE
SULINDAC, SULINDAC
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
HETERO LABS LTD III
* HETERO LABS LTD UNIT III
ABACAVIR SULFATE, ABACAVIR SULFATE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FINASTERIDE, FINASTERIDE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
INDOMETHACIN, INDOMETHACIN
LEVETIRACETAM, LEVETIRACETAM
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
LITHIUM CARBONATE, LITHIUM CARBONATE
METHOCARBAMOL, METHOCARBAMOL
NEVIRAPINE, NEVIRAPINE
SIMVASTATIN, SIMVASTATIN
STAVUDINE, STAVUDINE
TORSEMIDE, TORSEMIDE
ZIDOVUDINE, ZIDOVUDINE
HETERO LABS LTD V
* HETERO LABS LTD UNIT V
ACYCLOVIR, ACYCLOVIR
FAMCICLOVIR, FAMCICLOVIR
IRBESARTAN, IRBESARTAN
LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE
LAMIVUDINE, LAMIVUDINE
LEVOFLOXACIN, LEVOFLOXACIN
MONTELUKAST SODIUM, MONTELUKAST SODIUM
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
SILDENAFIL CITRATE, SILDENAFIL CITRATE
VALSARTAN, VALSARTAN
HEYL CHEMISCH
* HEYL CHEMISCH PHARMAZEUTISHE FABRIK
RADIOGARDASE (PRUSSIAN BLUE), FERRIC HEXACYANOFERRATE(II)
HI TECH PHARMA
* HI TECH PHARMACAL CO INC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
ACYCLOVIR, ACYCLOVIR
ALBUTEROL SULFATE, ALBUTEROL SULFATE
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
CALCIPOTRIENE, CALCIPOTRIENE
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE
CICLOPIROX, CICLOPIROX
CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE
CORMAX, CLOBETASOL PROPIONATE
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 63
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** H **
* HI TECH PHARMACAL CO INC
EMBELINE E, CLOBETASOL PROPIONATE
EMBELINE, CLOBETASOL PROPIONATE
ERYTHRO-STATIN, ERYTHROMYCIN
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
GABAPENTIN, GABAPENTIN
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
LACTULOSE, LACTULOSE
LEVOCARNITINE, LEVOCARNITINE
LEVOFLOXACIN, LEVOFLOXACIN
LIDOCAINE AND PRILOCAINE, LIDOCAINE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MINOXIDIL (FOR MEN), MINOXIDIL (OTC)
MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)
NYSTATIN, NYSTATIN
OFLOXACIN, OFLOXACIN
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
PROMETHAZINE HYDROCHLORIDE AND DEXTROMETHORPHAN HYDROBROMIDE, DEXTROMETHORPHAN
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
TIMOLOL MALEATE, TIMOLOL MALEATE
VOSOL HC, ACETIC ACID, GLACIAL
VOSOL, ACETIC ACID, GLACIAL
HI TECH PHARMA CO
* HI TECH PHARMACAL CO INC
FLUNISOLIDE, FLUNISOLIDE
PREDNISOLONE, PREDNISOLONE
HI-TECH PHARMA CO
* HI-TECH PHARMACAL CO INC
FAMOTIDINE, FAMOTIDINE
GATIFLOXACIN, GATIFLOXACIN
LORAZEPAM, LORAZEPAM
PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE
HI-TECH PHARMACAL
* HI-TECH PHARMACAL CO INC
BROMFENAC SODIUM, BROMFENAC SODIUM
LEVETIRACETAM, LEVETIRACETAM
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE
HIGH TECH PHARMA
* HIGH TECHNOLOGY PHARMACAL CO INC
VALPROIC ACID, VALPROIC ACID
HIKMA
* HIKMA FARMACEUTICA LDA
CEFOTAXIME, CEFOTAXIME SODIUM
* HIKMA PHARMACEUTICALS
AMOXICILLIN, AMOXICILLIN
CARVEDILOL, CARVEDILOL
CEFACLOR, CEFACLOR
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEPHALEXIN, CEPHALEXIN
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
GABAPENTIN, GABAPENTIN
GLYBURIDE (MICRONIZED), GLYBURIDE
NAPROXEN SODIUM, NAPROXEN SODIUM
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
HIKMA (MAPLE)
* HIKMA (MAPLE) LTD
SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE
HIKMA FARMACEUTICA
* HIKMA FARMACEUTICA (PORTUGAL) SA
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 64
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** H **
* HIKMA FARMACEUTICA (PORTUGAL) SA
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CEFOXITIN, CEFOXITIN SODIUM
CEFTRIAXONE, CEFTRIAXONE SODIUM
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPROFLOXACIN, CIPROFLOXACIN
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
ENALAPRILAT, ENALAPRILAT
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUMAZENIL, FLUMAZENIL
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
GLYCOPYRROLATE, GLYCOPYRROLATE
GRANISTERON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MILRINONE LACTATE IN PLASTIC CONTAINER, MILRINONE LACTATE
MILRINONE LACTATE, MILRINONE LACTATE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PROGESTERONE, PROGESTERONE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
TERBUTALINE SULFATE, TERBUTALINE SULFATE
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
VALPROATE SODIUM, VALPROATE SODIUM
* HIKMA FARMACEUTICA PORTUGAL LDA
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFUROXIME SODIUM, CEFUROXIME SODIUM
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
* HIKMA FARMACEUTICA PORTUGAL SA
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
OXYTOCIN, OXYTOCIN
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE
* HIKMA FARMACEUTICA SA
ZOLEDRONIC ACID, ZOLEDRONIC ACID
HIKMA INTL PHARMS
* HIKMA INTERNATIONAL PHARMACEUTICALS LLC
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN
BUTALBITAL, ASPIRIN AND CAFFEINE, ASPIRIN
CORTISONE ACETATE, CORTISONE ACETATE
DIGOXIN, DIGOXIN
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE
ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LITHIUM CARBONATE, LITHIUM CARBONATE
METHOCARBAMOL, METHOCARBAMOL
NAPROXEN, NAPROXEN
HIKMA MAPLE
* HIKMA MAPLE LTD
ACYCLOVIR IN SODIUM CHLORIDE 0.9% PRESERVATIVE FREE, ACYCLOVIR SODIUM
ADENOSINE, ADENOSINE
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
ATIVAN, LORAZEPAM
BUMETANIDE, BUMETANIDE
CEFOXITIN, CEFOXITIN SODIUM
CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 65
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** H **
* HIKMA MAPLE LTD
DIGOXIN, DIGOXIN
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
DIPYRIDAMOLE, DIPYRIDAMOLE
DOPRAM, DOXAPRAM HYDROCHLORIDE
DURAMORPH PF, MORPHINE SULFATE
FAMOTIDINE PRESERVATIVE FREE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE
FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE
FLUMAZENIL, FLUMAZENIL
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HEPARIN SODIUM, HEPARIN SODIUM
INFUMORPH, MORPHINE SULFATE
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MILRINONE LACTATE, MILRINONE LACTATE
MITOMYCIN, MITOMYCIN
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXYTOCIN, OXYTOCIN
PHENYTOIN SODIUM, PHENYTOIN SODIUM
PROCHLORPERAZINE EDISYLATE, PROCHLORPERAZINE EDISYLATE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
ROBAXIN, METHOCARBAMOL
ROBINUL, GLYCOPYRROLATE
SODIUM CHLORIDE 0.9% , SODIUM CHLORIDE
SUFENTANIL CITRATE, SUFENTANIL CITRATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
HIKMA PHARM CO LTD
* HIKMA PHARM CO LTD
ARGATROBAN, ARGATROBAN
HIKMA PHARMS
* HIKMA PHARMACEUTICALS
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN, AMOXICILLIN
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE
GABAPENTIN, GABAPENTIN
GEMFIBROZIL, GEMFIBROZIL
GLIMEPIRIDE, GLIMEPIRIDE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
LAMOTRIGINE, LAMOTRIGINE
MODAFINIL, MODAFINIL
PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TOPIRAMATE , TOPIRAMATE
* HIKMA PHARMACEUTICALS CO LTD
PARICALCITOL, PARICALCITOL
* HIKMA PHARMACEUTICALS LLC
PREDNISONE, PREDNISONE
SODIUM FERRIC GLUCONATE COMPLEX IN SUCROSE, SODIUM FERRIC GLUCONATE COMPLEX
HIKMA PHARMS LLC
* HIKMA PHARMACEUTICALS LLC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
CAPTOPRIL, CAPTOPRIL
CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
DOXERCALCIFEROL, DOXERCALCIFEROL
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 66
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** H **
* HIKMA PHARMACEUTICALS LLC
FOLIC ACID, FOLIC ACID
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
MITIGARE, COLCHICINE
PRIMIDONE, PRIMIDONE
ZALEPLON, ZALEPLON
HILL DERMAC
* HILL DERMACEUTICALS INC
DERMA-SMOOTHE/FS, FLUOCINOLONE ACETONIDE
DERMOTIC, FLUOCINOLONE ACETONIDE
HISAMITSU PHARM CO
* HISAMITSU PHARMACEUTICAL CO INC
SALONPAS, MENTHOL (OTC)
HISUN PHARM HANGZHOU
* HISUN PHARMACEUTICAL (HANGZHOU) CO LTD
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
HOFFMAN LA ROCHE
* HOFFMAN LA ROCHE INC
INVIRASE, SAQUINAVIR MESYLATE
HOFFMANN LA ROCHE
* HOFFMANN LA ROCHE INC
ANAPROX DS, NAPROXEN SODIUM
ANAPROX, NAPROXEN SODIUM
BONIVA, IBANDRONATE SODIUM
INVIRASE, SAQUINAVIR MESYLATE
ROCEPHIN, CEFTRIAXONE SODIUM
VALCYTE, VALGANCICLOVIR HYDROCHLORIDE
XELODA, CAPECITABINE
XENICAL, ORLISTAT
ZELBORAF, VEMURAFENIB
HOPE PHARMS
* HOPE PHARMACEUTICALS
NITHIODOTE, SODIUM NITRITE
SODIUM NITRITE, SODIUM NITRITE
SODIUM THIOSULFATE, SODIUM THIOSULFATE
HORIZON PHARMA
* HORIZON PHARMA INC
DUEXIS, FAMOTIDINE
RAYOS, PREDNISONE
VIMOVO, ESOMEPRAZOLE MAGNESIUM
* HORIZON PHARMA IRELAND LTD
PENNSAID, DICLOFENAC SODIUM
HOSPIRA
* HOSPIRA INC
A-HYDROCORT, HYDROCORTISONE SODIUM SUCCINATE
A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE
ACETIC ACID 0.25% IN PLASTIC CONTAINER, ACETIC ACID, GLACIAL
ACETYLCYSTEINE, ACETYLCYSTEINE
ALFENTANIL, ALFENTANIL HYDROCHLORIDE
AMIDATE, ETOMIDATE
AMINOCAPROIC ACID IN PLASTIC CONTAINER, AMINOCAPROIC ACID
AMINOPHYLLINE, AMINOPHYLLINE
AMINOSYN 10% (PH6), AMINO ACIDS
AMINOSYN 10%, AMINO ACIDS
AMINOSYN 3.5% M, AMINO ACIDS
AMINOSYN 3.5%, AMINO ACIDS
AMINOSYN 5%, AMINO ACIDS
AMINOSYN 7% (PH6), AMINO ACIDS
AMINOSYN 7% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN 7%, AMINO ACIDS
AMINOSYN 8.5% (PH6), AMINO ACIDS
AMINOSYN 8.5% W/ ELECTROLYTES, AMINO ACIDS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 67
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** H **
* HOSPIRA INC
AMINOSYN 8.5%, AMINO ACIDS
AMINOSYN II 10% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 10% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN II 10%, AMINO ACIDS
AMINOSYN II 15% IN PLASTIC CONTAINER, AMINO ACIDS
AMINOSYN II 7%, AMINO ACIDS
AMINOSYN II 8.5% W/ ELECTROLYTES, AMINO ACIDS
AMINOSYN II 8.5%, AMINO ACIDS
AMINOSYN-HBC 7%, AMINO ACIDS
AMINOSYN-HF 8%, AMINO ACIDS
AMINOSYN-PF 10%, AMINO ACIDS
AMINOSYN-PF 7%, AMINO ACIDS
AMINOSYN-RF 5.2%, AMINO ACIDS
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMMONIUM CHLORIDE IN PLASTIC CONTAINER, AMMONIUM CHLORIDE
AQUASOL A, VITAMIN A PALMITATE
ARTICAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, ARTICAINE HYDROCHLORIDE
ATROPINE SULFATE ANSYR PLASTIC SYRINGE, ATROPINE SULFATE
AZITHROMYCIN, AZITHROMYCIN
BACTERIOSTATIC SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
BACTERIOSTATIC WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
BLEOMYCIN SULFATE, BLEOMYCIN SULFATE
BUMETANIDE, BUMETANIDE
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE W/EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
BUTORPHANOL TARTRATE PRESERVATIVE FREE, BUTORPHANOL TARTRATE
CALCIUM CHLORIDE 10% IN PLASTIC CONTAINER, CALCIUM CHLORIDE
CARBOCAINE, MEPIVACAINE HYDROCHLORIDE
CARBOPLATIN, CARBOPLATIN
CHLOROPROCAINE HYDROCHLORIDE, CHLOROPROCAINE HYDROCHLORIDE
CHROMIC CHLORIDE IN PLASTIC CONTAINER, CHROMIC CHLORIDE
CIPROFLOXACIN IN DEXTROSE 5% IN PLASTIC CONTAINER, CIPROFLOXACIN
CIPROFLOXACIN, CIPROFLOXACIN
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CORLOPAM, FENOLDOPAM MESYLATE
CUPRIC CHLORIDE IN PLASTIC CONTAINER, CUPRIC CHLORIDE
CYTARABINE, CYTARABINE
DACARBAZINE, DACARBAZINE
DEFEROXAMINE MESYLATE, DEFEROXAMINE MESYLATE
DEMEROL, MEPERIDINE HYDROCHLORIDE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DEXTROSE 10% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 20% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 25%, DEXTROSE
DEXTROSE 30% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 40% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% AND RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 50% IN PLASTIC CONTAINER, DEXTROSE
DEXTROSE 70% IN PLASTIC CONTAINER, DEXTROSE
DIAZEPAM, DIAZEPAM
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
DOBUTAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOBUTAMINE HYDROCHLORIDE
DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE IN DEXTROSE 5% IN PLASTIC CONTAINER, DOPAMINE HYDROCHLORIDE
DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 68
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** H **
* HOSPIRA INC
DROPERIDOL, DROPERIDOL
ENALAPRILAT, ENALAPRILAT
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
ERYTHROCIN, ERYTHROMYCIN LACTOBIONATE
FENTANYL CITRATE PRESERVATIVE FREE, FENTANYL CITRATE
FENTANYL CITRATE, FENTANYL CITRATE
FLUCONAZOLE IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
FOSCARNET SODIUM, FOSCARNET SODIUM
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
FUROSEMIDE, FUROSEMIDE
GENTAMICIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, GENTAMICIN SULFATE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
GLYCINE 1.5% IN PLASTIC CONTAINER, GLYCINE
HEPARIN SODIUM 1,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN
HEPARIN SODIUM 10,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 12,500 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 12,500 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN
HEPARIN SODIUM 2,000 UNITS IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, HEPARIN
HEPARIN SODIUM 20,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN DEXTROSE 5% IN PLASTIC CONTAINER, HEPARIN SODIUM
HEPARIN SODIUM 25,000 UNITS IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, HEPARIN
HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM
HEPARIN SODIUM, HEPARIN SODIUM
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
IONOSOL B AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
IONOSOL MB AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
ISOFLURANE, ISOFLURANE
ISUPREL, ISOPROTERENOL HYDROCHLORIDE
KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
LACTATED RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
LEVOPHED, NOREPINEPHRINE BITARTRATE
LIDOCAINE HYDROCHLORIDE 0.4% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
LIDOCAINE HYDROCHLORIDE 0.8% IN DEXTROSE 5% IN PLASTIC CONTAINER, LIDOCAINE
LIDOCAINE HYDROCHLORIDE 5% AND DEXTROSE 7.5%, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE AND EPINEPHRINE, EPINEPHRINE
LIDOCAINE HYDROCHLORIDE IN PLASTIC CONTAINER, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE IN PLASTIC CONTAINER, LIDOCAINE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LORAZEPAM, LORAZEPAM
LTA II KIT, LIDOCAINE HYDROCHLORIDE
M.V.I. ADULT (PHARMACY BULK PACKAGE), ASCORBIC ACID
M.V.I. ADULT, ASCORBIC ACID
M.V.I. PEDIATRIC, ASCORBIC ACID
M.V.I.-12 (WITHOUT VITAMIN K), ASCORBIC ACID
MAGNESIUM SULFATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MAGNESIUM SULFATE
MAGNESIUM SULFATE IN PLASTIC CONTAINER, MAGNESIUM SULFATE
MAGNESIUM SULFATE, MAGNESIUM SULFATE
MANGANESE CHLORIDE IN PLASTIC CONTAINER, MANGANESE CHLORIDE
MANNITOL 10% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 15% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 20% IN PLASTIC CONTAINER, MANNITOL
MANNITOL 25%, MANNITOL
MANNITOL 5% IN PLASTIC CONTAINER, MANNITOL
MARCAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE W/ EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
MARCAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
MARCAINE, BUPIVACAINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE PRESERVATIVE FREE, MEPERIDINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 69
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** H **
* HOSPIRA INC
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
METHOTREXATE SODIUM, METHOTREXATE SODIUM
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONIDAZOLE IN PLASTIC CONTAINER, METRONIDAZOLE
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MILRINONE LACTATE IN DEXTROSE 5% IN PLASTIC CONTAINER, MILRINONE LACTATE
MORPHINE SULFATE, MORPHINE SULFATE
NALBUPHINE HYDROCHLORIDE, NALBUPHINE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
NITROGLYCERIN IN DEXTROSE 5%, NITROGLYCERIN
NORMOSOL-M AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
NORMOSOL-R AND DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
NORMOSOL-R IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PACLITAXEL, PACLITAXEL
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PANCURONIUM BROMIDE, PANCURONIUM BROMIDE
PHENYTOIN SODIUM, PHENYTOIN SODIUM
PHYSIOSOL IN PLASTIC CONTAINER, MAGNESIUM CHLORIDE
PLEGISOL IN PLASTIC CONTAINER, CALCIUM CHLORIDE
POTASSIUM ACETATE IN PLASTIC CONTAINER, POTASSIUM ACETATE
POTASSIUM CHLORIDE 0.149% IN SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 10MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 10MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 15MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 20MEQ IN DEXTROSE 5% IN SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 20MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 20MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 30MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 30MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND LACTATED RINGER'S IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 40MEQ IN DEXTROSE 5% IN PLASTIC CONTAINER, DEXTROSE
POTASSIUM CHLORIDE 40MEQ IN PLASTIC CONTAINER, POTASSIUM CHLORIDE
POTASSIUM CHLORIDE 40MEQ IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, POTASSIUM
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.225% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.3% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE 5MEQ IN DEXTROSE 5% AND SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER,
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PRECEDEX, DEXMEDETOMIDINE HYDROCHLORIDE
PROCAINAMIDE HYDROCHLORIDE, PROCAINAMIDE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 70
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** H **
* HOSPIRA INC
PROPOFOL, PROPOFOL
QUELICIN PRESERVATIVE FREE, SUCCINYLCHOLINE CHLORIDE
QUELICIN, SUCCINYLCHOLINE CHLORIDE
RINGER'S IN PLASTIC CONTAINER, CALCIUM CHLORIDE
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE
SODIUM ACETATE IN PLASTIC CONTAINER, SODIUM ACETATE ANHYDROUS
SODIUM BICARBONATE, SODIUM BICARBONATE
SODIUM CHLORIDE 0.45% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM CHLORIDE IN PLASTIC CONTAINER, SODIUM CHLORIDE
SODIUM LACTATE IN PLASTIC CONTAINER, SODIUM LACTATE
SODIUM PHOSPHATES IN PLASTIC CONTAINER, SODIUM PHOSPHATE, DIBASIC, HEPTAHYDRATE
SORBITOL-MANNITOL IN PLASTIC CONTAINER, MANNITOL
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
STERILE WATER IN PLASTIC CONTAINER, STERILE WATER FOR IRRIGATION
SUFENTANIL CITRATE, SUFENTANIL CITRATE
TALWIN, PENTAZOCINE LACTATE
TAZICEF, CEFTAZIDIME
THAM, TROMETHAMINE
TOBRAMYCIN SULFATE IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, TOBRAMYCIN SULFATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
TPN ELECTROLYTES IN PLASTIC CONTAINER, CALCIUM CHLORIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VECURONIUM BROMIDE, VECURONIUM BROMIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
VITAMIN K1, PHYTONADIONE
ZINC CHLORIDE IN PLASTIC CONTAINER, ZINC CHLORIDE
* HOSPIRA WORLDWIDE, INC
DOBUTAMINE HYDROCHLORIDE, DOBUTAMINE HYDROCHLORIDE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
NITROPRESS, SODIUM NITROPRUSSIDE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE
HOSPIRA INC
* HOSPIRA INC
A-METHAPRED, METHYLPREDNISOLONE SODIUM SUCCINATE
ADENOSINE, ADENOSINE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE
ATRACURIUM BESYLATE, ATRACURIUM BESYLATE
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFEPIME HYDROCHLORIDE, CEFEPIME HYDROCHLORIDE
CEFOTAXIME SODIUM, CEFOTAXIME SODIUM
CEFOXITIN, CEFOXITIN SODIUM
CEFTRIAXONE, CEFTRIAXONE SODIUM
CEFUROXIME SODIUM, CEFUROXIME SODIUM
DAPTOMYCIN, DAPTOMYCIN
DOCETAXEL, DOCETAXEL
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
HEPARIN SODIUM, HEPARIN SODIUM
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
IMIPENEM AND CILASTATIN, CILASTATIN SODIUM
LEVETIRACETAM, LEVETIRACETAM
MAXIPIME, CEFEPIME HYDROCHLORIDE
MEPIVACAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE
MEROPENEM, MEROPENEM
MILRINONE LACTATE, MILRINONE LACTATE
MORPHINE SULFATE, MORPHINE SULFATE
NIPENT, PENTOSTATIN
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 71
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** H **
* HOSPIRA INC
OXALIPLATIN, OXALIPLATIN
PARICALCITOL, PARICALCITOL
PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM
THEOPHYLLINE IN DEXTROSE 5% IN PLASTIC CONTAINER, THEOPHYLLINE
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
HOSPIRA WORLDWIDE
* HOSPIRA WORLDWIDE PTY
OXALIPLATIN, OXALIPLATIN
HOT SHOTS NM LLC
* HOT SHOTS NUCLEAR MEDICINE LLC
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
HOUSTON CYCLOTRON
* HOUSTON CYCLOTRON PARTNERS LP
AMMONIA N 13, AMMONIA N-13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
HQ SPCLT PHARMA
* HQ SPECIALTY PHARMA CORP
CISPLATIN, CISPLATIN
TAXOL, PACLITAXEL
HQ SPECIALITY PHARMA
* HQ SPECIALITY PHARMA LLC
LEVETIRACETAM IN SODIUM CHLORIDE, LEVETIRACETAM
HQ SPECLT PHARMA
* HQ SPECIALTY PHARMA
VUMON, TENIPOSIDE
HRA PHARMA
* HRA PHARMA LLC
METOPIRONE, METYRAPONE
HYPERION THERAP INC
* HYPERION THERAPEUTICS INC
RAVICTI, GLYCEROL PHENYLBUTYRATE
HYPERION THERAPS INC
* HYPERION THERAPEUTICS INC
BUPHENYL, SODIUM PHENYLBUTYRATE
ROCHE
* HOFFMANN LA ROCHE INC
BONIVA, IBANDRONATE SODIUM
COPEGUS, RIBAVIRIN
FUZEON, ENFUVIRTIDE
KLONOPIN, CLONAZEPAM
TAMIFLU, OSELTAMIVIR PHOSPHATE
VALIUM, DIAZEPAM
** I **
IDENTI PHARMS INC
* IDENTI PHARMACEUTICALS INC
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
IGI LABS INC
* IGI LABORATORIES INC
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
ECONAZOLE NITRATE, ECONAZOLE NITRATE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
IMPAX LABS
* IMPAX LABORATORIES INC
ACARBOSE, ACARBOSE
ALPRAZOLAM, ALPRAZOLAM
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
BACLOFEN, BACLOFEN
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 72
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** I **
* IMPAX LABORATORIES INC
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CARBIDOPA AND LEVODOPA, CARBIDOPA
CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
COLESTIPOL HYDROCHLORIDE, COLESTIPOL HYDROCHLORIDE
DANTROLENE SODIUM, DANTROLENE SODIUM
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE
DIGOXIN, DIGOXIN
DIPYRIDAMOLE, DIPYRIDAMOLE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
FENOFIBRATE (MICRONIZED), FENOFIBRATE
FENOFIBRATE, FENOFIBRATE
FLUDROCORTISONE ACETATE, FLUDROCORTISONE ACETATE
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC)
LORATADINE, LORATADINE (OTC)
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHYLTESTOSTERONE, METHYLTESTOSTERONE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
NADOLOL AND BENDROFLUMETHIAZIDE, BENDROFLUMETHIAZIDE
OMEPRAZOLE, OMEPRAZOLE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
PENTOXIFYLLINE, PENTOXIFYLLINE
PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE
PRIMIDONE, PRIMIDONE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PYRIDOSTIGMINE BROMIDE, PYRIDOSTIGMINE BROMIDE
RILUZOLE, RILUZOLE
RIMANTADINE HYDROCHLORIDE, RIMANTADINE HYDROCHLORIDE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TERBUTALINE SULFATE, TERBUTALINE SULFATE
TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE
IMPAX LABS INC
* IMPAX LABORATORIES INC
CABERGOLINE, CABERGOLINE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
LAMOTRIGINE, LAMOTRIGINE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
URSODIOL, URSODIOL
IMPAX PHARMS
* IMPAX PHARMACEUTICALS
FEXOFENADINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, FEXOFENADINE
FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE
GEMFIBROZIL, GEMFIBROZIL
MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
INCYTE CORP
* INCYTE CORP
JAKAFI, RUXOLITINIB PHOSPHATE
INDICUS PHARMA
* INDICUS PHARMA LLC
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
LETROZOLE, LETROZOLE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
INDOCO REMEDIES
* INDOCO REMEDIES LTD
BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE
GLIMEPIRIDE, GLIMEPIRIDE
INJECTALIA
* INJECTALIA SRL
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 73
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** I **
* INJECTALIA SRL
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
INNOCUTIS HOLDINGS
* INNOCUTIS HOLDINGS LLC
SITAVIG, ACYCLOVIR
INNOPHARMA LICENSING
* INNOPHARMA LICENSING LLC
ACETYLCYSTEINE, ACETYLCYSTEINE
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
INO
* INO THERAPEUTICS INC
INOMAX, NITRIC OXIDE
INST BIOCHEM
* INSTITUT BIOCHEMIQUE SA
FLECTOR, DICLOFENAC EPOLAMINE
INST BIOCHIMIQUE
* INSTITUTE BIOCHIMIQUE SA (IBSA)
TIROSINT, LEVOTHYROXINE SODIUM
INSTITUT BIOCHIMIQUE
* INSTITUT BIOCHIMIQUE SA IBSA
TIROSINT, LEVOTHYROXINE SODIUM
INSYS THERAP
* INSYS THERAPEUTICS INC
DRONABINOL, DRONABINOL
SUBSYS, FENTANYL
INTELLIPHARMACEUTICS
* INTELLIPHARMACEUTICS CORP
DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
INTERGEL PHARM
* INTERGEL PHARMACEUTICAL INC
NIFEDIPINE, NIFEDIPINE
INTERMUNE INC
* INTERMUNE INC
ESBRIET, PIRFENIDONE
INTL MEDICATED
* INTERNATIONAL MEDICATED SYSTEMS LTD
MILRINONE LACTATE, MILRINONE LACTATE
INTL MEDICATION
* INTERNATIONAL MEDICATION SYSTEM
LARYNG-O-JET KIT, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE PRESERVATIVE FREE, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
MANNITOL 25%, MANNITOL
NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
PHYTONADIONE, PHYTONADIONE
* INTERNATIONAL MEDICATION SYSTEMS LTD
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
INTL MEDICATION SYS
* INTERNATIONAL MEDICATION SYSTEMS LTD
LORAZEPAM, LORAZEPAM
INVAGEN PHARMS
* INVAGEN PHARMACEUTICALS INC
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
CALCIUM ACETATE, CALCIUM ACETATE
CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FOLIC ACID, FOLIC ACID
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GABAPENTIN, GABAPENTIN
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 74
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** I **
* INVAGEN PHARMACEUTICALS INC
GEMFIBROZIL, GEMFIBROZIL
GLIMEPIRIDE, GLIMEPIRIDE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
LEVETIRACETAM, LEVETIRACETAM
LISINOPRIL, LISINOPRIL
MEPROBAMATE, MEPROBAMATE
NABUMETONE, NABUMETONE
NAPROXEN, NAPROXEN
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE
RAMIPRIL, RAMIPRIL
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
TRANDOLAPRIL, TRANDOLAPRIL
WARFARIN SODIUM, WARFARIN SODIUM
ZOLMITRIPTAN, ZOLMITRIPTAN
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ZONISAMIDE, ZONISAMIDE
INVENTIA HLTHCARE
* INVENTIA HEALTHCARE PRIVATE LTD
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
IPCA LABS LTD
* IPCA LABORATORIES LTD
ALLOPURINOL, ALLOPURINOL
ATENOLOL, ATENOLOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
FUROSEMIDE, FUROSEMIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
WARFARIN SODIUM, WARFARIN SODIUM
IPR
* IPR PHARMACEUTICALS INC
ATENOLOL AND CHLORTHALIDONE, ATENOLOL
ATENOLOL, ATENOLOL
CRESTOR, ROSUVASTATIN CALCIUM
ZOMIG, ZOLMITRIPTAN
IPR PHARMS INC
* IPR PHARMACEUTICALS INC
CAPRELSA, VANDETANIB
IPSEN INC
* IPSEN BIOPHARMACEUTICALS INC
INCRELEX, MECASERMIN RECOMBINANT
IPSEN PHARMA
* IPSEN PHARMA BIOTECH SAS
SOMATULINE DEPOT, LANREOTIDE ACETATE
IROKO PHARMS
* IROKO PHARMACEUTICALS LLC
INDOCIN, INDOMETHACIN
IROKO PHARMS LLC
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 75
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** I **
* IROKO PHARMACEUTICALS LLC
TIVORBEX, INDOMETHACIN
ZORVOLEX, DICLOFENAC
ISO TEX
* ISO TEX DIAGNOSTICS INC
JEANATOPE, ALBUMIN IODINATED I-125 SERUM
MEGATOPE, ALBUMIN IODINATED I-131 SERUM
ISOTEX
* ISOTEX DIAGNOSTICS
GLOFIL-125, IOTHALAMATE SODIUM I-125
ISTITUTO BIO ITA SPA
* ISTITUTO BIOCHIMICO ITALIANO SPA
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
AMPICILLIN SODIUM, AMPICILLIN SODIUM
NAFCILLIN SODIUM, NAFCILLIN SODIUM
PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM
PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM
PIPERACILLIN, PIPERACILLIN SODIUM
IVAX INTL
* IVAX INTERNATIONAL GMBH
AMRIX, CYCLOBENZAPRINE HYDROCHLORIDE
SYNRIBO, OMACETAXINE MEPESUCCINATE
IVAX PHARMS
* IVAX PHARMACEUTICALS INC
VALSARTAN, VALSARTAN
IVAX SUB TEVA PHARMS
* IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
BACLOFEN, BACLOFEN
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BUMETANIDE, BUMETANIDE
CABERGOLINE, CABERGOLINE
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CIMETIDINE, CIMETIDINE (OTC)
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CLOZAPINE, CLOZAPINE
CYCLOSPORINE, CYCLOSPORINE
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
DIAZEPAM, DIAZEPAM
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
FAMOTIDINE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE (OTC)
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUTAMIDE, FLUTAMIDE
FUROSEMIDE, FUROSEMIDE
GABAPENTIN, GABAPENTIN
GLIPIZIDE, GLIPIZIDE
GLYBURIDE AND METFORMIN HYDROCHLORIDE, GLYBURIDE
GRISEOFULVIN, GRISEOFULVIN, MICROSIZE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
INDAPAMIDE, INDAPAMIDE
INDOMETHACIN, INDOMETHACIN
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LORAZEPAM, LORAZEPAM
METHYLDOPA, METHYLDOPA
MISOPROSTOL, MISOPROSTOL
NADOLOL, NADOLOL
NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)
NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE
OXAPROZIN, OXAPROZIN
PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 76
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** I **
* IVAX PHARMACEUTICALS INC SUB TEVA PHARMACEUTICALS USA
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
SIMVASTATIN, SIMVASTATIN
TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE
TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
** J **
JACOBUS
* JACOBUS PHARMACEUTICAL CO
DAPSONE, DAPSONE
PASER, AMINOSALICYLIC ACID
JANSSEN BIOTECH
* JANSSEN BIOTECH INC
ZYTIGA, ABIRATERONE ACETATE
JANSSEN PHARMS
* JANSSEN PHARMACEUTICALS INC
AXERT, ALMOTRIPTAN MALATE
CONCERTA, METHYLPHENIDATE HYDROCHLORIDE
DITROPAN XL, OXYBUTYNIN CHLORIDE
DURAGESIC-100, FENTANYL
DURAGESIC-12, FENTANYL
DURAGESIC-25, FENTANYL
DURAGESIC-50, FENTANYL
DURAGESIC-75, FENTANYL
ELMIRON, PENTOSAN POLYSULFATE SODIUM
HALDOL, HALOPERIDOL DECANOATE
HALDOL, HALOPERIDOL LACTATE
INVEGA SUSTENNA, PALIPERIDONE PALMITATE
INVEGA, PALIPERIDONE
INVOKAMET, CANAGLIFLOZIN
INVOKANA, CANAGLIFLOZIN
LEVAQUIN IN DEXTROSE 5% IN PLASTIC CONTAINER, LEVOFLOXACIN
LEVAQUIN, LEVOFLOXACIN
MICRONOR, NORETHINDRONE
MODICON 28, ETHINYL ESTRADIOL
NIZORAL, KETOCONAZOLE
NUCYNTA ER, TAPENTADOL HYDROCHLORIDE
NUCYNTA, TAPENTADOL HYDROCHLORIDE
ORTHO CYCLEN-28, ETHINYL ESTRADIOL
ORTHO EVRA, ETHINYL ESTRADIOL
ORTHO TRI-CYCLEN LO, ETHINYL ESTRADIOL
ORTHO TRI-CYCLEN, ETHINYL ESTRADIOL
ORTHO-CEPT, DESOGESTREL
ORTHO-NOVUM 1/35-28, ETHINYL ESTRADIOL
ORTHO-NOVUM 7/7/7-28, ETHINYL ESTRADIOL
PANCREAZE, PANCRELIPASE (AMYLASE
RAZADYNE ER, GALANTAMINE HYDROBROMIDE
RAZADYNE, GALANTAMINE HYDROBROMIDE
RISPERDAL CONSTA, RISPERIDONE
RISPERDAL, RISPERIDONE
SPORANOX, ITRACONAZOLE
TERAZOL 3, TERCONAZOLE
TERAZOL 7, TERCONAZOLE
TOPAMAX, TOPIRAMATE
TYLENOL W/ CODEINE NO. 3, ACETAMINOPHEN
TYLENOL W/ CODEINE NO. 4, ACETAMINOPHEN
ULTRACET, ACETAMINOPHEN
ULTRAM, TRAMADOL HYDROCHLORIDE
XARELTO, RIVAROXABAN
JANSSEN PRODS
* JANSSEN PRODUCTS LP
EDURANT, RILPIVIRINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 77
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** J **
* JANSSEN PRODUCTS LP
OLYSIO, SIMEPREVIR SODIUM
PREZISTA, DARUNAVIR ETHANOLATE
JANSSEN R AND D
* JANSSEN RESEARCH AND DEVELOPMENT LLC
INTELENCE, ETRAVIRINE
PARAFON FORTE DSC, CHLORZOXAZONE
JANSSEN RES AND DEV
* JANSSEN RESEARCH AND DEVELOPMENT LLC
DOXIL (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE
JANSSEN THERAP
* JANSSEN THERAPEUTICS DIV JANSSEN PRODUCTS LP
SIRTURO, BEDAQUILINE FUMARATE
JAVELIN PHARMS INC
* JAVELIN PHARMACEUTICALS INC A WHOLLY OWNED SUDSIDIARY OF HOSPIRA INC
DYLOJECT, DICLOFENAC SODIUM
JAZZ PHARMS
* JAZZ PHARMACEUTICALS INC
LUVOX CR, FLUVOXAMINE MALEATE
XYREM, SODIUM OXYBATE
JAZZ PHARMS III
* JAZZ PHARMACEUTICALS III INTERNATIONAL LTD
FAZACLO ODT, CLOZAPINE
* JAZZ PHARMACEUTICALS INTERNATIONAL III
VERSACLOZ, CLOZAPINE
JAZZ PHARMS INTL
* JAZZ PHARMACEUTICALS INTERNATIONAL LTD
PRIALT, ZICONOTIDE ACETATE
JIANGSU HANSOH PHARM
* JIANGSU HANSOH PHARMACEUTICAL CO LTD
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
JIANGSU HENGRUI MED
* JIANGSU HENGRUI MEDICINE CO LTD
CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LETROZOLE, LETROZOLE
OXALIPLATIN, OXALIPLATIN
JOHNS HOPKINS UNIV
* JOHNS HOPKINS UNIV
AMMONIA N 13, AMMONIA N-13
JOHNSON AND JOHNSON
* JOHNSON AND JOHNSON GROUP CONSUMER COMPANIES
MEN'S ROGAINE, MINOXIDIL (OTC)
ROGAINE (FOR MEN), MINOXIDIL (OTC)
ROGAINE (FOR WOMEN), MINOXIDIL (OTC)
ROGAINE EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)
VISINE-A, NAPHAZOLINE HYDROCHLORIDE (OTC)
WOMEN'S ROGAINE, MINOXIDIL (OTC)
* JOHNSON AND JOHNSON HEALTHCARE PRODUCTS
VISINE L.R., OXYMETAZOLINE HYDROCHLORIDE (OTC)
* JOHNSON AND JOHNSON HEALTHCARE PRODUCTS DIV MCNEIL-PPC INC
NIZORAL A-D, KETOCONAZOLE (OTC)
JUBILANT CADISTA
* JUBILANT CADISTA PHARMACEUTICALS INC
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
METHYLPREDNISOLONE, METHYLPREDNISOLONE
PREDNISONE, PREDNISONE
PROCOMP, PROCHLORPERAZINE MALEATE
TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE
JUBILANT DRAXIMAGE
* JUBILANT DRAXIMAGE INC
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 78
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** J **
* JUBILANT DRAXIMAGE INC
AN-DTPA, TECHNETIUM TC-99M PENTETATE KIT
DRAXIMAGE MDP-25, TECHNETIUM TC-99M MEDRONATE
HICON, SODIUM IODIDE I-131
PULMOLITE, TECHNETIUM TC-99M ALBUMIN AGGREGATED KIT
SODIUM IODIDE I-131, SODIUM IODIDE I-131
JUBILANT GENERICS
* JUBILANT GENERICS LTD
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
LAMOTRIGINE, LAMOTRIGINE
OLANZAPINE, OLANZAPINE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RISPERIDONE, RISPERIDONE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
SPIRONOLACTONE, SPIRONOLACTONE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VALSARTAN, VALSARTAN
ZOLMITRIPTAN, ZOLMITRIPTAN
STEVENS J
* JEROME STEVENS PHARMACEUTICALS INC
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN
DIGOXIN, DIGOXIN
METHOCARBAMOL AND ASPIRIN, ASPIRIN
UNITHROID, LEVOTHYROXINE SODIUM **
** K **
GRIFFEN
* KW GRIFFEN CO
BIOSCRUB, CHLORHEXIDINE GLUCONATE (OTC)
KALEO INC
* KALEO INC
EVZIO, NALOXONE HYDROCHLORIDE
KEN LIFESCIENCE
* KEN LIFESCIENCE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
KERYX BIOPHARMS
* KERYX BIOPHARMACEUTICALS INC
FERRIC CITRATE, FERRIC CITRATE
KING PHARMS
* KING PHARMACEUTICALS INC
ALTACE, RAMIPRIL
BICILLIN C-R 900/300, PENICILLIN G BENZATHINE
BICILLIN C-R, PENICILLIN G BENZATHINE
BICILLIN L-A, PENICILLIN G BENZATHINE
CORGARD, NADOLOL
CORZIDE, BENDROFLUMETHIAZIDE
PENICILLIN G PROCAINE, PENICILLIN G PROCAINE
SILVADENE, SILVER SULFADIAZINE
SKELAXIN, METAXALONE
SYNERCID, DALFOPRISTIN
TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE
* KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT INC SUB KING PHARMACEUTICALS INC
TAPAZOLE, METHIMAZOLE
TUSSIGON, HOMATROPINE METHYLBROMIDE
KING PHARMS LLC
* KING PHARMACEUTICALS LLC
AVINZA, MORPHINE SULFATE
KING PHARMS R AND D
* KING PHARMACEUTICALS RESEARCH AND DEVELOPMENT INC
CYTOMEL, LIOTHYRONINE SODIUM
LEVOXYL, LEVOTHYROXINE SODIUM **
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 79
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** K **
KNIGHT THERAPS
* KNIGHT THERAPEUTICS USA INC
IMPAVIDO, MILTEFOSINE
KOWA CO
* KOWA CO LTD
LIVALO, PITAVASTATIN CALCIUM
KREITCHMAN PET CTR
* KREITCHMAN PET CENTER
AMMONIA N 13, AMMONIA N-13
KREMERS URBAN DEV
* KREMERS URBAN DEVELOPMENT CO
RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM
KREMERS URBAN PHARMS
* KREMERS URBAN PHARMACEUTICALS INC
GLYCOLAX, POLYETHYLENE GLYCOL 3350
GLYCOLAX, POLYETHYLENE GLYCOL 3350 (OTC)
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
MONOKET, ISOSORBIDE MONONITRATE
OMEPRAZOLE, OMEPRAZOLE
KRKA TOVARNA ZDRAVIL
* KRKA TOVARNA ZDRAVIL DD NOVO MESTO
LANSOPRAZOLE , LANSOPRAZOLE
KUDCO IRELAND
* KUDCO IRELAND LTD
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
LETROZOLE, LETROZOLE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
KVK TECH
* KVK TECH INC
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
KALEXATE, SODIUM POLYSTYRENE SULFONATE
PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
** L **
L PERRIGO CO
* L PERRIGO CO
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
LAB HRA PHARMA
* LABORATOIRE HRA PHARMA
ELLA, ULIPRISTAL ACETATE
LANDELA PHARM
* LANDELA PHARMACEUTICAL
ALBUTEROL SULFATE, ALBUTEROL SULFATE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
LANNETT
* LANNETT CO INC
ACETAZOLAMIDE, ACETAZOLAMIDE
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE
LANIAZID, ISONIAZID
LANORINAL, ASPIRIN
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PRIMIDONE, PRIMIDONE
PROBALAN, PROBENECID
* LANNETT HOLDINGS INC
BACLOFEN, BACLOFEN
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 80
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** L **
* LANNETT HOLDINGS INC
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
DANAZOL, DANAZOL
DIPYRIDAMOLE, DIPYRIDAMOLE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE
RIFAMPIN, RIFAMPIN
TERBUTALINE SULFATE, TERBUTALINE SULFATE
URSODIOL, URSODIOL
LANNETT HOLDINGS INC
* LANNETT HOLDINGS INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
CODEINE SULFATE, CODEINE SULFATE
DIAZEPAM, DIAZEPAM
DIETHYLPROPION HYDROCHLORIDE, DIETHYLPROPION HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LETROZOLE, LETROZOLE
LOXAPINE SUCCINATE, LOXAPINE SUCCINATE
METHOCARBAMOL, METHOCARBAMOL
MORPHINE SULFATE, MORPHINE SULFATE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PHENTERMINE RESIN COMPLEX, PHENTERMINE RESIN COMPLEX
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LANTHEUS MEDCL
* LANTHEUS MEDICAL IMAGING INC
ABLAVAR, GADOFOSVESET TRISODIUM
CARDIOLITE, TECHNETIUM TC-99M SESTAMIBI KIT
DEFINITY, PERFLUTREN
GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67
NEUROLITE, TECHNETIUM TC-99M BICISATE KIT
TECHNELITE, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201
XENON XE 133, XENON XE-133
LANTHEUS MEDICAL
* LANTHEUS MEDICAL IMAGING INC
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
QUADRAMET, SAMARIUM SM-153 LEXIDRONAM PENTASODIUM
LARKEN LABS
* LARKEN LABORATORIES INC
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
LAVIPHARM LABS
* LAVIPHARM LABORATORIES INC
FENTANYL-100, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
LEHIGH VALLEY
* LEHIGH VALLEY TECHNOLOGIES INC
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
LEK PHARMS
* LEK PHARMACEUTICALS D D
BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE
LEK PHARMS DD
* LEK PHARMACEUTICALS DD
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 81
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** L **
LEO PHARMA AS
* LEO PHARMA AS
DOVONEX, CALCIPOTRIENE
PICATO, INGENOL MEBUTATE
TACLONEX, BETAMETHASONE DIPROPIONATE
LG LIFE
* LG LIFE SCIENCES LTD
VALTROPIN, SOMATROPIN RECOMBINANT
LG LIFE SCIENCES
* LG LIFE SCIENCES LTD
FACTIVE, GEMIFLOXACIN MESYLATE
LLOYD
* LLOYD INC
LEVOTHROID, LEVOTHYROXINE SODIUM **
LNK
* LNK INTERNATIONAL INC
DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC)
IBUPROFEN, IBUPROFEN (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
LOREAL USA
* LOREAL USA PRODUCTS INC
ANTHELIOS 20, AVOBENZONE (OTC)
ANTHELIOS 40, AVOBENZONE (OTC)
ANTHELIOS SX, AVOBENZONE (OTC)
CAPITAL SOLEIL 15, AVOBENZONE (OTC)
LOTUS PHARM CO LTD
* LOTUS PHARMACEUTICAL CO LTD
LEVETIRACETAM, LEVETIRACETAM
LUITPOLD
* LUITPOLD PHARMACEUTICALS INC
ACETYLCYSTEINE, ACETYLCYSTEINE
ADENOSINE, ADENOSINE
AMINOCAPROIC ACID, AMINOCAPROIC ACID
AMINOPHYLLINE, AMINOPHYLLINE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
BETAMETHASONE ACETATE AND BETAMETHASONE SODIUM PHOSPHATE, BETAMETHASONE ACETATE
BROMFENAC SODIUM, BROMFENAC SODIUM
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
CAFFEINE CITRATE, CAFFEINE CITRATE
CALCITRIOL, CALCITRIOL
CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
CYANOCOBALAMIN, CYANOCOBALAMIN
CYCLOSPORINE, CYCLOSPORINE
DACTINOMYCIN, DACTINOMYCIN
DEXAMETHASONE SODIUM PHOSPHATE, DEXAMETHASONE SODIUM PHOSPHATE
DEXFERRUM, IRON DEXTRAN
DOPAMINE HYDROCHLORIDE, DOPAMINE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
DROPERIDOL, DROPERIDOL
ESTRADIOL VALERATE, ESTRADIOL VALERATE
ETOMIDATE, ETOMIDATE
FOMEPIZOLE, FOMEPIZOLE
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
FUROSEMIDE, FUROSEMIDE
GANCICLOVIR, GANCICLOVIR SODIUM
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
IBUTILIDE FUMARATE, IBUTILIDE FUMARATE
INJECTAFER, FERRIC CARBOXYMALTOSE
LATANOPROST, LATANOPROST
LEVETIRACETAM, LEVETIRACETAM
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 82
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** L **
* LUITPOLD PHARMACEUTICALS INC
LEVOCARNITINE, LEVOCARNITINE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
MANNITOL 25%, MANNITOL
METHYLDOPATE HYDROCHLORIDE, METHYLDOPATE HYDROCHLORIDE
METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
NEOMYCIN AND POLYMYXIN B SULFATES AND GRAMICIDIN, GRAMICIDIN
NEOMYCIN AND POLYMYXIN B SULFATES AND HYDROCORTISONE, HYDROCORTISONE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
NITROGLYCERIN, NITROGLYCERIN
OLANZAPINE, OLANZAPINE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PHENYTOIN SODIUM, PHENYTOIN SODIUM
PROGESTERONE, PROGESTERONE
SPRIX, KETOROLAC TROMETHAMINE
TORSEMIDE, TORSEMIDE
TRANEXAMIC ACID, TRANEXAMIC ACID
TRIMETHOBENZAMIDE HYDROCHLORIDE PRESERVATIVE FREE, TRIMETHOBENZAMIDE HYDROCHLORIDE
TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE
VENOFER, IRON SUCROSE
ZIDOVUDINE, ZIDOVUDINE
LUKARE MEDICAL LLC
* LUKARE MEDICAL LLC
ELLIOTTS B SOLUTION, CALCIUM CHLORIDE
LUMARA HEALTH INC
* LUMARA HEALTH INC
MAKENA, HYDROXYPROGESTERONE CAPROATE
LUNDBECK LLC
* LUNDBECK LLC
ONFI, CLOBAZAM
SABRIL, VIGABATRIN
LUNDBECK NA LTD
* LUNDBECK NA LTD
NORTHERA, DROXIDOPA
LUPIN
* LUPIN LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
CARVEDILOL, CARVEDILOL
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFDINIR, CEFDINIR
CEFOTAXIME SODIUM, CEFOTAXIME SODIUM
CEFPROZIL, CEFPROZIL
CEFTRIAXONE, CEFTRIAXONE SODIUM
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CEPHALEXIN, CEPHALEXIN
DIVALPROEX SODIUM, DIVALPROEX SODIUM
ETHAMBUTOL HYDROCHLORIDE, ETHAMBUTOL HYDROCHLORIDE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LOVASTATIN, LOVASTATIN
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RAMIPRIL, RAMIPRIL
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
TOPIRAMATE, TOPIRAMATE
TRANDOLAPRIL, TRANDOLAPRIL
LUPIN ATLANTIS
* LUPIN ATLANTIS HOLDINGS SA
ANTARA (MICRONIZED), FENOFIBRATE
LUPIN LTD
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 83
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** L **
* LUPIN LIMITED
LEVETIRACETAM, LEVETIRACETAM
LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
* LUPIN LTD
ABACAVIR SULFATE, LAMIVUDINE AND ZIDOVUDINE, ABACAVIR SULFATE
CELECOXIB, CELECOXIB
CIPROFLOXACIN, CIPROFLOXACIN
DAYSEE, ETHINYL ESTRADIOL
DOXYCYCLINE, DOXYCYCLINE
DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
ENSKYCE, DESOGESTREL
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
ESZOPICLONE, ESZOPICLONE
FALLBACK SOLO, LEVONORGESTREL (OTC)
FAMOTIDINE, FAMOTIDINE
FENOFIBRATE, FENOFIBRATE
FENOFIBRIC ACID, CHOLINE FENOFIBRATE
GATIFLOXACIN, GATIFLOXACIN
IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE
IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
JENCYCLA, NORETHINDRONE
KURVELO, ETHINYL ESTRADIOL
LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE
LAMIVUDINE, LAMIVUDINE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
LORAZEPAM, LORAZEPAM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MEFENAMIC ACID, MEFENAMIC ACID
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE
NABUMETONE, NABUMETONE
NIACIN, NIACIN
NIKKI, DROSPIRENONE
NORETHINDRONE, NORETHINDRONE
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
PIRMELLA 1/35, ETHINYL ESTRADIOL
PIRMELLA 7/7/7, ETHINYL ESTRADIOL
PREGABALIN, PREGABALIN
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM
RANOLAZINE, RANOLAZINE
RIFABUTIN, RIFABUTIN
SUPRAX, CEFIXIME
TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE
TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
VALSARTAN, VALSARTAN
VYFEMLA, ETHINYL ESTRADIOL
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
LUPIN PHARMS
* LUPIN PHARMACEUTICALS INC
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
DESLORATADINE, DESLORATADINE
MELOXICAM, MELOXICAM
NORGESTIMATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 84
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** L **
* LUPIN PHARMACEUTICALS INC
RIFAMPIN, RIFAMPIN
SUPRAX, CEFIXIME
ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE
LYNE
* LYNE LABORATORIES INC
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE
CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
DEXAMETHASONE, DEXAMETHASONE
HYDROCORTISONE, HYDROCORTISONE
LEVOCARNITINE, LEVOCARNITINE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
PERRIGO
* L PERRIGO CO
ACETAMINOPHEN, ACETAMINOPHEN (OTC)
ACETAMINOPHEN, ASPIRIN AND CAFFEINE, ACETAMINOPHEN (OTC)
CHILDREN'S IBUPROFEN, IBUPROFEN (OTC)
CROMOLYN SODIUM, CROMOLYN SODIUM (OTC)
DOXYLAMINE SUCCINATE, DOXYLAMINE SUCCINATE (OTC)
FAMOTIDINE, FAMOTIDINE (OTC)
IBUPROFEN AND PSEUDOEPHEDRINE HYDROCHLORIDE, IBUPROFEN (OTC)
IBUPROFEN, IBUPROFEN (OTC)
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
LORATADINE, LORATADINE (OTC)
MICONAZOLE 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)
MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)
NAPROXEN SODIUM AND PSEUDOEPHEDRINE HYDROCHLORIDE, NAPROXEN SODIUM (OTC)
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
TAB-PROFEN, IBUPROFEN (OTC)
TIOCONAZOLE, TIOCONAZOLE (OTC)
** M **
MA GENERAL HOSP
* MASSACHUSETTS GENERAL HOSP
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
MACLEODS PHARMS LTD
* MACLEODS PHARMACEUTICALS LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FAMCICLOVIR, FAMCICLOVIR
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
LEVOFLOXACIN, LEVOFLOXACIN
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MONTELUKAST SODIUM, MONTELUKAST SODIUM
OLANZAPINE, OLANZAPINE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
MALLINCKRODT
* MALLINCKRODT CHEMICAL INC
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
METHADOSE, METHADONE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 85
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** M **
* MALLINCKRODT INC
ANEXSIA 5/325, ACETAMINOPHEN
ANEXSIA 7.5/325, ACETAMINOPHEN
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
FENTANYL CITRATE, FENTANYL CITRATE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
METHYLIN, METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
OPTIMARK IN PLASTIC CONTAINER, GADOVERSETAMIDE
OPTIMARK, GADOVERSETAMIDE
OXYCET, ACETAMINOPHEN
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
TECHNETIUM TC-99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
* MALLINCKRODT MEDICAL INC
CONRAY 30, IOTHALAMATE MEGLUMINE
CONRAY 43, IOTHALAMATE MEGLUMINE
CONRAY, IOTHALAMATE MEGLUMINE
CYSTO-CONRAY II, IOTHALAMATE MEGLUMINE
GALLIUM CITRATE GA 67, GALLIUM CITRATE GA-67
INDIUM IN 111 CHLORIDE, INDIUM IN-111 CHLORIDE
MD-76R, DIATRIZOATE MEGLUMINE
MD-GASTROVIEW, DIATRIZOATE MEGLUMINE
OCTREOSCAN, INDIUM IN-111 PENTETREOTIDE KIT
OPTIRAY 240, IOVERSOL
OPTIRAY 300, IOVERSOL
OPTIRAY 320, IOVERSOL
OPTIRAY 350, IOVERSOL
SODIUM IODIDE I 123, SODIUM IODIDE I-123
SODIUM IODIDE I 131, SODIUM IODIDE I-131
TECHNESCAN MAG3, TECHNETIUM TC-99M MERTIATIDE KIT
TECHNESCAN PYP KIT, TECHNETIUM TC-99M PYROPHOSPHATE KIT
TECHNESCAN, TECHNETIUM TC-99M OXIDRONATE KIT
THALLOUS CHLORIDE TL 201, THALLOUS CHLORIDE TL-201
ULTRA-TECHNEKOW FM, TECHNETIUM TC-99M SODIUM PERTECHNETATE GENERATOR
ULTRATAG, TECHNETIUM TC-99M RED BLOOD CELL KIT
MALLINCKRODT INC
* MALLINCKRODT INC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
EXALGO, HYDROMORPHONE HYDROCHLORIDE
FENTANYL-100, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
GABLOFEN, BACLOFEN
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
METHYLIN ER, METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
RESTORIL, TEMAZEPAM
ROXICODONE, OXYCODONE HYDROCHLORIDE
TOFRANIL, IMIPRAMINE HYDROCHLORIDE
TOFRANIL-PM, IMIPRAMINE PAMOATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 86
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** M **
* MALLINCKRODT INC
XARTEMIS XR, ACETAMINOPHEN
MALLINCKRODT LLC
* MALLINCKRODT LLC
ANAFRANIL, CLOMIPRAMINE HYDROCHLORIDE
PAMELOR, NORTRIPTYLINE HYDROCHLORIDE
MARATHON PHARMS
* MARATHON PHARMACEUTICALS LLC
PEPCID, FAMOTIDINE
SECONAL SODIUM, SECOBARBITAL SODIUM
MARATHON PHARMS LLC
* MARATHON PHARMACEUTICALS LLC
IPRIVASK, DESIRUDIN RECOMBINANT
MARKSANS PHARMA
* MARKSANS PHARMA LTD
GABAPENTIN, GABAPENTIN
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
NAPROXEN, NAPROXEN
MATAWAN PHARMS
* MATAWAN PHARMACEUTICALS LLC
TRETINOIN, TRETINOIN
MATRIX LABS LTD
* MATRIX LABORATORIES LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
NIFEDIPINE, NIFEDIPINE
STAVUDINE, STAVUDINE
MAYER LABS INC
* MAYER LABORATORIES INC
TODAY, NONOXYNOL-9 (OTC)
MAYNE PHARMA
* MAYNE PHARMA INTERNATIONAL PTY LTD
DORYX, DOXYCYCLINE HYCLATE
DOXTERIC, DOXYCYCLINE HYCLATE
ERYC, ERYTHROMYCIN
MCNEIL
* MCNEIL CONSUMER PRODUCTS CO DIV MCNEILAB INC
CHILDREN'S MOTRIN, IBUPROFEN (OTC)
IBUPROFEN, IBUPROFEN (OTC)
IMODIUM A-D EZ CHEWS, LOPERAMIDE HYDROCHLORIDE (OTC)
IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE (OTC)
MOTRIN IB, IBUPROFEN (OTC)
MOTRIN MIGRAINE PAIN, IBUPROFEN (OTC)
ZYRTEC-D 12 HOUR, CETIRIZINE HYDROCHLORIDE (OTC)
MCNEIL CONS
* MCNEIL CONSUMER HEALTHCARE
CHILDREN'S MOTRIN COLD, IBUPROFEN (OTC)
CHILDREN'S MOTRIN, IBUPROFEN (OTC)
IMODIUM A-D, LOPERAMIDE HYDROCHLORIDE (OTC)
IMODIUM MULTI-SYMPTOM RELIEF, LOPERAMIDE HYDROCHLORIDE (OTC)
IMODIUM, LOPERAMIDE HYDROCHLORIDE
JUNIOR STRENGTH MOTRIN, IBUPROFEN (OTC)
PEPCID AC , FAMOTIDINE (OTC)
PEPCID AC, FAMOTIDINE (OTC)
PEPCID COMPLETE, CALCIUM CARBONATE (OTC)
SINE-AID IB, IBUPROFEN (OTC)
SUDAFED 12 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)
SUDAFED 24 HOUR, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)
TYLENOL , ACETAMINOPHEN (OTC)
MCNEIL CONSUMER
* MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC
CHILDREN'S ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 87
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** M **
* MCNEIL CONSUMER HEALTHCARE DIV MCNEIL PPC INC
CHILDREN'S ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
ZYRTEC ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
ZYRTEC HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
ZYRTEC, CETIRIZINE HYDROCHLORIDE
MCPRF
* MAYO CLINIC PET RADIOCHEMISTRY FACILITY
AMMONIA N 13, AMMONIA N-13
CHOLINE C-11, CHOLINE C-11
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
MEDA PHARMS
* MEDA PHARMACEUTICALS
DYMISTA, AZELASTINE HYDROCHLORIDE
EDLUAR, ZOLPIDEM TARTRATE
* MEDA PHARMACEUTICALS INC
ANADROL-50, OXYMETHOLONE
ASTELIN, AZELASTINE HYDROCHLORIDE
ASTEPRO, AZELASTINE HYDROCHLORIDE
AVC, SULFANILAMIDE
BUTISOL SODIUM, BUTABARBITAL SODIUM
CESAMET, NABILONE
COLYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350
COLYTE, POLYETHYLENE GLYCOL 3350
CORTIFOAM, HYDROCORTISONE ACETATE
DEMADEX, TORSEMIDE
DEPEN, PENICILLAMINE
DIPENTUM, OLSALAZINE SODIUM
ELESTRIN, ESTRADIOL
EPIFOAM, HYDROCORTISONE ACETATE
FELBATOL, FELBAMATE
GASTROCROM, CROMOLYN SODIUM
LUFYLLIN, DYPHYLLINE
MUSE, ALPROSTADIL
OPTIVAR, AZELASTINE HYDROCHLORIDE
PROCTOFOAM HC, HYDROCORTISONE ACETATE
ROWASA, MESALAMINE
SFROWASA, MESALAMINE
TRILYTE, POLYETHYLENE GLYCOL 3350
* MEDA PHARMACEUTICALS MEDA PHARMACEUTICALS INC
SOMA COMPOUND W/ CODEINE, ASPIRIN
SOMA COMPOUND, ASPIRIN
SOMA, CARISOPRODOL
MEDA PHARMS INC
* MEDA PHARMACEUTICALS INC
AEROSPAN HFA, FLUNISOLIDE
MEDAC PHARMA INC
* MEDAC PHARMA INC
RASUVO, METHOTREXATE
MEDEFIL INC
* MEDEFIL INC
SODIUM CHLORIDE 0.9%, SODIUM CHLORIDE
MEDICIS
* MEDICIS PHARMACEUTICAL CORP
ALDARA, IMIQUIMOD
AMMONUL, SODIUM BENZOATE
CALCIUM DISODIUM VERSENATE, EDETATE CALCIUM DISODIUM
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
ESTRASORB, ESTRADIOL HEMIHYDRATE
LOPROX, CICLOPIROX
LUZU, LULICONAZOLE
MAXAIR, PIRBUTEROL ACETATE
METROGEL-VAGINAL, METRONIDAZOLE
MINITRAN, NITROGLYCERIN
NORFLEX, ORPHENADRINE CITRATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 88
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** M **
* MEDICIS PHARMACEUTICAL CORP
NORGESIC FORTE, ASPIRIN
NORGESIC, ASPIRIN
SOLODYN, MINOCYCLINE HYDROCHLORIDE
SYNACORT, HYDROCORTISONE
THEOLAIR, THEOPHYLLINE
VANOS, FLUOCINONIDE
ZIANA, CLINDAMYCIN PHOSPHATE
ZYCLARA, IMIQUIMOD
MEDICURE
* MEDICURE INTERNATIONAL INC
AGGRASTAT, TIROFIBAN HYDROCHLORIDE
MEDIGENE AG
* MEDIGENE AG
VEREGEN, SINECATECHINS
MEDIMETRIKS PHARMS
* MEDIMETRIKS PHARMACEUTICALS INC
LOPROX, CICLOPIROX
NEO-SYNALAR, FLUOCINOLONE ACETONIDE
SYNALAR, FLUOCINOLONE ACETONIDE
MEDTECH PRODUCTS
* MEDTECH PRODUCTS INC
MONISTAT 1 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MONISTAT 3 COMBINATION PACK (PREFILLED), MICONAZOLE NITRATE (OTC)
MONISTAT 3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MONISTAT 3, MICONAZOLE NITRATE
MONISTAT 3, MICONAZOLE NITRATE (OTC)
MONISTAT 7 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MONISTAT 7, MICONAZOLE NITRATE (OTC)
MONISTAT-3 COMBINATION PACK, MICONAZOLE NITRATE (OTC)
NIX, PERMETHRIN (OTC)
TAGAMET HB, CIMETIDINE (OTC)
MEDTRONIC NEURO
* MEDTRONIC NEUROMODULATION
LIORESAL, BACLOFEN
MERCK
* MERCK AND CO INC
CANCIDAS, CASPOFUNGIN ACETATE
EMEND, APREPITANT
FOSAMAX PLUS D, ALENDRONATE SODIUM
FOSAMAX, ALENDRONATE SODIUM
MAXALT, RIZATRIPTAN BENZOATE
MAXALT-MLT, RIZATRIPTAN BENZOATE
PRIMAXIN, CILASTATIN SODIUM
PROSCAR, FINASTERIDE
SINGULAIR, MONTELUKAST SODIUM
ZOLINZA, VORINOSTAT
* MERCK RESEARCH LABORATORIES DIV MERCK CO INC
CLINORIL, SULINDAC
PRINIVIL, LISINOPRIL
PRINZIDE, HYDROCHLOROTHIAZIDE
PROPECIA, FINASTERIDE
SINGULAIR, MONTELUKAST SODIUM
TRUSOPT, DORZOLAMIDE HYDROCHLORIDE
ZOCOR, SIMVASTATIN
MERCK AND CO INC
* MERCK AND CO INC
EMEND, FOSAPREPITANT DIMEGLUMINE
FOSAMAX, ALENDRONATE SODIUM
MERCK SANTE SAS
* MERCK SANTE SAS
CYANOKIT, HYDROXOCOBALAMIN
MERCK SHARP DOHME
* MERCK SHARP AND DOHME CORP
ASMANEX HFA, MOMETASONE FUROATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 89
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** M **
* MERCK SHARP AND DOHME CORP
ASMANEX TWISTHALER, MOMETASONE FUROATE
BELSOMRA, SUVOREXANT
CELESTONE SOLUSPAN, BETAMETHASONE ACETATE
CLARINEX D 24 HOUR, DESLORATADINE
CLARINEX, DESLORATADINE
CLARINEX-D 12 HOUR, DESLORATADINE
COZAAR, LOSARTAN POTASSIUM
CRIXIVAN, INDINAVIR SULFATE
DIPROLENE AF, BETAMETHASONE DIPROPIONATE
DIPROLENE, BETAMETHASONE DIPROPIONATE
DULERA, FORMOTEROL FUMARATE
ELOCON, MOMETASONE FUROATE
GUANIDINE HYDROCHLORIDE, GUANIDINE HYDROCHLORIDE
HYZAAR, HYDROCHLOROTHIAZIDE
INVANZ, ERTAPENEM SODIUM
ISENTRESS, RALTEGRAVIR POTASSIUM
JANUMET XR, METFORMIN HYDROCHLORIDE
JANUMET, METFORMIN HYDROCHLORIDE
JANUVIA, SITAGLIPTIN PHOSPHATE
LIPTRUZET, ATORVASTATIN CALCIUM
LOTRISONE, BETAMETHASONE DIPROPIONATE
NASONEX, MOMETASONE FUROATE MONOHYDRATE
NITRO-DUR, NITROGLYCERIN
NOXAFIL, POSACONAZOLE
REBETOL, RIBAVIRIN
SINEMET CR, CARBIDOPA
SINEMET, CARBIDOPA
STROMECTOL, IVERMECTIN
TEMODAR, TEMOZOLOMIDE
VICTRELIS, BOCEPREVIR
ZONTIVITY, VORAPAXAR SULFATE
MERIDIAN MEDCL
* MERIDIAN MEDICAL TECHNOLOGIES INC
DUODOTE, ATROPINE
* MERIDIAN MEDICAL TECHNOLOGIES INC SUB KING PHARMACEUTICALS INC
ALSUMA, SUMATRIPTAN SUCCINATE
MERIDIAN MEDCL TECHN
* MERIDIAN MEDICAL TECHNOLOGIES INC
ATROPEN, ATROPINE
MORPHINE SULFATE, MORPHINE SULFATE
PRALIDOXIME CHLORIDE, PRALIDOXIME CHLORIDE
MERRO PHARM
* MERRO PHARMACEUTICAL CO LTD
IBUPROFEN, IBUPROFEN (OTC)
MERZ PHARMS
* MERZ PHARMACEUTICALS LLC
CUVPOSA, GLYCOPYRROLATE
NAFTIN, NAFTIFINE HYDROCHLORIDE
ONMEL, ITRACONAZOLE
METHAPHARM
* METHAPHARM INC
LEVETIRACETAM, LEVETIRACETAM
PROVOCHOLINE, METHACHOLINE CHLORIDE
MICRO LABS LTD
* MICRO LABS LTD
MEFENAMIC ACID, MEFENAMIC ACID
NEVIRAPINE, NEVIRAPINE
SIMVASTATIN, SIMVASTATIN
MICRO LABS LTD INDIA
* MICRO LABS LTD INDIA
CROMOLYN SODIUM, CROMOLYN SODIUM
GLIMEPIRIDE, GLIMEPIRIDE
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 90
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** M **
* MICRO LABS LTD INDIA
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
MIKAH PHARMA
* MIKAH PHARMA LLC
DANTROLENE SODIUM, DANTROLENE SODIUM
ISRADIPINE, ISRADIPINE
LOXAPINE SUCCINATE, LOXAPINE SUCCINATE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
TRIMIPRAMINE MALEATE, TRIMIPRAMINE MALEATE
MIKART
* MIKART INC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
AMINOCAPROIC ACID, AMINOCAPROIC ACID
AMINOCAPROIC, AMINOCAPROIC ACID
BENZONATATE, BENZONATATE
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
BUTAPAP, ACETAMINOPHEN
CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE
CHLORZOXAZONE, CHLORZOXAZONE
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
ERGOTAMINE TARTRATE AND CAFFEINE, CAFFEINE
ETHOSUXIMIDE, ETHOSUXIMIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
METHAZOLAMIDE, METHAZOLAMIDE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE
PYRAZINAMIDE, PYRAZINAMIDE
TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE
MILLENNIUM PHARMS
* MILLENNIUM PHARMACEUTICALS INC
VELCADE, BORTEZOMIB
MIPS CRF
* MIPS CYCLOTRON AND RADIOCHEMISTRY FACILITY
AMMONIA N 13, AMMONIA N-13
MIRROR PHARMS
* MIRROR PHARMACEUTICALS LLC
CARISOPRODOL AND ASPIRIN, ASPIRIN
CARISOPRODOL, CARISOPRODOL
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PROBENECID AND COLCHICINE, COLCHICINE
MISSION PHARMA
* MISSION PHARMACAL CO
BINOSTO, ALENDRONATE SODIUM
LITHOSTAT, ACETOHYDROXAMIC ACID
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
TEXACORT, HYDROCORTISONE
THIOLA, TIOPRONIN
TINDAMAX, TINIDAZOLE
UROCIT-K, POTASSIUM CITRATE
MISSION PHARMACAL CO
* MISSION PHARMACAL CO
CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE
MIST PHARMS LLC
* MIST PHARMACEUTICALS LLC
NITROMIST, NITROGLYCERIN
MOBERG PHARMA NORTH
* MOBERG PHARMA NORTH AMERICA LLC
CHILDREN'S ELIXSURE, IBUPROFEN (OTC)
MOBIUS THERAP
* MOBIUS THERAPEUTICS LLC
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 91
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** M **
* MOBIUS THERAPEUTICS LLC
MITOSOL, MITOMYCIN
MOLNLYCKE HLTH
* MOLNLYCKE HEALTH CARE
HIBICLENS, CHLORHEXIDINE GLUCONATE (OTC)
HIBISTAT, CHLORHEXIDINE GLUCONATE (OTC)
MONARCH PHARMS
* MONARCH PHARMACEUTICALS INC
CORTISPORIN, BACITRACIN ZINC
CORTISPORIN, HYDROCORTISONE ACETATE
CORTISPORIN, HYDROCORTISONE
MENEST, ESTROGENS, ESTERIFIED
NEOSPORIN G.U. IRRIGANT, NEOMYCIN SULFATE
NEOSPORIN, GRAMICIDIN
PEDIOTIC, HYDROCORTISONE
SEPTRA DS, SULFAMETHOXAZOLE
SEPTRA, SULFAMETHOXAZOLE
VIROPTIC, TRIFLURIDINE
MORTON GROVE
* MORTON GROVE PHARMACEUTICALS INC
LACTULOSE, LACTULOSE
MORTON GROVE PHARMS
* MORTON GROVE PHARMACEUTICALS INC
GENERLAC, LACTULOSE
MSD CONSUMER
* MSD CONSUMER CARE INC
ZEGERID OTC, OMEPRAZOLE (OTC)
MSD INTL
* MSD INTERNATIONAL GMBH
VYTORIN, EZETIMIBE
MSD INTL GMBH
* MSD INTERNATIONAL GMBH
ZETIA, EZETIMIBE
MURTY PHARMS
* MURTY PHARMACEUTICALS INC
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
DIPYRIDAMOLE, DIPYRIDAMOLE
MUSTAFA NEVSAT
* MUSTAFA NEVSAT ILAC SANAYII AS
METHYLPREDNISOLONE SODIUM SUCCINATE, METHYLPREDNISOLONE SODIUM SUCCINATE
MUSTAFA NEVZAT
* MUSTAFA NEVZAT ILAC SANAYII AS
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
VECURONIUM BROMIDE, VECURONIUM BROMIDE
MUSTAFA NEVZAT ILAC
* MUSTAFA NEVZAT ILAC SANAYII AS (MN PHARMACEUTICALS)
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
MUTUAL PHARM
* MUTUAL PHARMACEUTICAL CO INC
ACETAZOLAMIDE, ACETAZOLAMIDE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALLOPURINOL, ALLOPURINOL
AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
ATENOLOL AND CHLORTHALIDONE, ATENOLOL
ATENOLOL, ATENOLOL
BACTRIM DS, SULFAMETHOXAZOLE
BACTRIM, SULFAMETHOXAZOLE
CARISOPRODOL, CARISOPRODOL
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 92
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** M **
* MUTUAL PHARMACEUTICAL CO INC
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
ERGOLOID MESYLATES, ERGOLOID MESYLATES
FELODIPINE, FELODIPINE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE
LOVASTATIN, LOVASTATIN
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONIDAZOLE, METRONIDAZOLE
MINOXIDIL, MINOXIDIL
NYSTATIN, NYSTATIN
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PINDOLOL, PINDOLOL
PIROXICAM, PIROXICAM
PREDNISONE, PREDNISONE
PRIMIDONE, PRIMIDONE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
QUINIDINE GLUCONATE, QUINIDINE GLUCONATE
QUINIDINE SULFATE, QUINIDINE SULFATE
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
SPIRONOLACTONE, SPIRONOLACTONE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
SULINDAC, SULINDAC
TEMAZEPAM, TEMAZEPAM
THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE
TOLMETIN SODIUM, TOLMETIN SODIUM
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
MUTUAL PHARM CO INC
* MUTUAL PHARMACEUTICAL CO INC
FIBRICOR, FENOFIBRIC ACID
IBANDRONATE SODIUM, IBANDRONATE SODIUM
LEVETIRACETAM, LEVETIRACETAM
QUALAQUIN, QUININE SULFATE
MUTUAL PHARMA
* MUTUAL PHARMACAL CO
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
TRIMETHOBENZAMIDE HYDROCHLORIDE, TRIMETHOBENZAMIDE HYDROCHLORIDE
MYLAN
* MYLAN LABORATORIES INC
ACYCLOVIR, ACYCLOVIR
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
CAPTOPRIL, CAPTOPRIL
ETODOLAC, ETODOLAC
OLANZAPINE, OLANZAPINE
TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE
* MYLAN PHARMACEUTICALS
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
* MYLAN PHARMACEUTICALS INC
ACARBOSE, ACARBOSE
ACEBUTOLOL HYDROCHLORIDE, ACEBUTOLOL HYDROCHLORIDE
ACYCLOVIR, ACYCLOVIR
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALENDRONATE SODIUM, ALENDRONATE SODIUM
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
ALLOPURINOL, ALLOPURINOL
ALPRAZOLAM, ALPRAZOLAM
AMILORIDE HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, AMILORIDE HYDROCHLORIDE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 93
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** M **
* MYLAN PHARMACEUTICALS INC
ANASTROZOLE, ANASTROZOLE
ATENOLOL AND CHLORTHALIDONE, ATENOLOL
ATENOLOL, ATENOLOL
AVITA, TRETINOIN
AZATHIOPRINE, AZATHIOPRINE
AZITHROMYCIN, AZITHROMYCIN
BACLOFEN, BACLOFEN
BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BICALUTAMIDE, BICALUTAMIDE
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE
BISOPROLOL FUMARATE, BISOPROLOL FUMARATE
BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE
BUDESONIDE, BUDESONIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL
CARBIDOPA AND LEVODOPA, CARBIDOPA
CARVEDILOL, CARVEDILOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
CHLOROTHIAZIDE, CHLOROTHIAZIDE
CHLORPROPAMIDE, CHLORPROPAMIDE
CHLORTHALIDONE, CHLORTHALIDONE
CILOSTAZOL, CILOSTAZOL
CIMETIDINE, CIMETIDINE
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLARITHROMYCIN, CLARITHROMYCIN
CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE
CLONAZEPAM, CLONAZEPAM
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM
CLORPRES, CHLORTHALIDONE
CLOZAPINE, CLOZAPINE
CYSTAGON, CYSTEAMINE BITARTRATE
DIAZEPAM, DIAZEPAM
DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
ENALAPRIL MALEATE, ENALAPRIL MALEATE
ESTRADIOL, ESTRADIOL
ESTROPIPATE, ESTROPIPATE
ETIDRONATE DISODIUM, ETIDRONATE DISODIUM
ETOPOSIDE, ETOPOSIDE
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
FAMCICLOVIR, FAMCICLOVIR
FAMOTIDINE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE (OTC)
FELODIPINE, FELODIPINE
FENOFIBRATE, FENOFIBRATE
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 94
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** M **
* MYLAN PHARMACEUTICALS INC
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FINASTERIDE, FINASTERIDE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE
FLURBIPROFEN, FLURBIPROFEN
FLUTAMIDE, FLUTAMIDE
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
FUROSEMIDE, FUROSEMIDE
GABAPENTIN, GABAPENTIN
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GLIMEPIRIDE, GLIMEPIRIDE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
GLIPIZIDE, GLIPIZIDE
GLYBURIDE (MICRONIZED), GLYBURIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE
HALOPERIDOL, HALOPERIDOL
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
INDAPAMIDE, INDAPAMIDE
INDOMETHACIN, INDOMETHACIN
KETOCONAZOLE, KETOCONAZOLE
KETOPROFEN, KETOPROFEN
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LAMOTRIGINE, LAMOTRIGINE
LATANOPROST, LATANOPROST
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
LEVOTHYROXINE SODIUM, LEVOTHYROXINE SODIUM **
LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE
LORATADINE, LORATADINE (OTC)
LORAZEPAM, LORAZEPAM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
LOVASTATIN, LOVASTATIN
LOXAPINE SUCCINATE, LOXAPINE SUCCINATE
MAPROTILINE HYDROCHLORIDE, MAPROTILINE HYDROCHLORIDE
MECLOFENAMATE SODIUM, MECLOFENAMATE SODIUM
MELOXICAM, MELOXICAM
MENTAX, BUTENAFINE HYDROCHLORIDE
MERCAPTOPURINE, MERCAPTOPURINE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHIMAZOLE, METHIMAZOLE
METHOTREXATE SODIUM, METHOTREXATE SODIUM
METHYLDOPA AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
METHYLDOPA, METHYLDOPA
METOLAZONE, METOLAZONE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MIRTAZAPINE, MIRTAZAPINE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NADOLOL AND BENDROFLUMETHIAZIDE, BENDROFLUMETHIAZIDE
NADOLOL, NADOLOL
NAPROXEN, NAPROXEN
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
NIFEDIPINE, NIFEDIPINE
NISOLDIPINE, NISOLDIPINE
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 95
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** M **
* MYLAN PHARMACEUTICALS INC
NITROFURANTOIN, NITROFURANTOIN, MACROCRYSTALLINE
NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE
OMEPRAZOLE, OMEPRAZOLE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON, ONDANSETRON
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350
PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE, POLYETHYLENE GLYCOL
PENTOXIFYLLINE, PENTOXIFYLLINE
PERPHENAZINE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
PHENYTEK, PHENYTOIN SODIUM
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
PIROXICAM, PIROXICAM
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE
PROBENECID, PROBENECID
PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROPOXYPHENE HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
RISPERIDONE, RISPERIDONE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
SPIRONOLACTONE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
SPIRONOLACTONE, SPIRONOLACTONE
STAVUDINE, STAVUDINE
SULINDAC, SULINDAC
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TACROLIMUS, TACROLIMUS
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TEMAZEPAM, TEMAZEPAM
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
THIORIDAZINE HYDROCHLORIDE, THIORIDAZINE HYDROCHLORIDE
THIOTHIXENE, THIOTHIXENE
TIMOLOL MALEATE, TIMOLOL MALEATE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TOLMETIN SODIUM, TOLMETIN SODIUM
TOPIRAMATE, TOPIRAMATE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRANDOLAPRIL, TRANDOLAPRIL
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE
URSODIOL, URSODIOL
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
WARFARIN SODIUM, WARFARIN SODIUM
ZALEPLON, ZALEPLON
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ZONISAMIDE, ZONISAMIDE
MYLAN INSTITUTIONAL
* MYLAN INSTITUTIONAL INC
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 96
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** M **
* MYLAN INSTITUTIONAL INC
SULFAMYLON, MAFENIDE ACETATE
* MYLAN INSTITUTIONAL LLC
ALOPRIM, ALLOPURINOL SODIUM
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
ARGATROBAN, ARGATROBAN
CARBOPLATIN, CARBOPLATIN
CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM
CIDOFOVIR, CIDOFOVIR
COSYNTROPIN, COSYNTROPIN
DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE
DEXRAZOXANE HYDROCHLORIDE, DEXRAZOXANE HYDROCHLORIDE
DIMETHYL SULFOXIDE, DIMETHYL SULFOXIDE
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
DURACLON, CLONIDINE HYDROCHLORIDE
ENLON, EDROPHONIUM CHLORIDE
ENLON-PLUS, ATROPINE SULFATE
ESMOLOL HYDROCHLORIDE, ESMOLOL HYDROCHLORIDE
FOMEPIZOLE, FOMEPIZOLE
IBUTILIDE FUMARATE, IBUTILIDE FUMARATE
ISOSULFAN BLUE, ISOSULFAN BLUE
KETAMINE HYDROCHLORIDE, KETAMINE HYDROCHLORIDE
MEFOXIN IN PLASTIC CONTAINER, CEFOXITIN SODIUM
MELPHALAN HYDROCHLORIDE, MELPHALAN HYDROCHLORIDE
MESNA, MESNA
METHOCARBAMOL, METHOCARBAMOL
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
NALOXONE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE
PENTOSTATIN, PENTOSTATIN
RIMSO-50, DIMETHYL SULFOXIDE
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
SOTRADECOL, SODIUM TETRADECYL SULFATE
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE
THIAMINE HYDROCHLORIDE, THIAMINE HYDROCHLORIDE
TRANEXAMIC ACID, TRANEXAMIC ACID
ULTIVA, REMIFENTANIL HYDROCHLORIDE
MYLAN IRELAND LTD
* MYLAN IRELAND LTD
ARIXTRA, FONDAPARINUX SODIUM
MYLAN LABS
* MYLAN LABORATORIES LTD
CANDESARTAN CILEXETIL AND HYDROCHLOROTHIAZIDE, CANDESARTAN CILEXETIL
NEVIRAPINE, NEVIRAPINE
MYLAN LABS LTD
* MYLAN LABORATORIES LTD
VALSARTAN, VALSARTAN
MYLAN PHARMS INC
* MYLAN PHARMACEUTICALS INC
ABACAVIR SULFATE, ABACAVIR SULFATE
ACAMPROSATE CALCIUM, ACAMPROSATE CALCIUM
ACYCLOVIR, ACYCLOVIR
ALPRAZOLAM, ALPRAZOLAM
AMLODIPINE BESYLATE AND ATORVASTATIN CALCIUM, AMLODIPINE BESYLATE
AMNESTEEM, ISOTRETINOIN
ANAGRELIDE HYDROCHLORIDE, ANAGRELIDE HYDROCHLORIDE
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
ATOVAQUONE AND PROGUANIL HYDROCHLORIDE, ATOVAQUONE
AVITA, TRETINOIN
BACLOFEN, BACLOFEN
CABERGOLINE, CABERGOLINE
CAPECITABINE, CAPECITABINE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 97
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** M **
* MYLAN PHARMACEUTICALS INC
CELECOXIB, CELECOXIB
CHLORDIAZEPOXIDE AND AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
CILOSTAZOL, CILOSTAZOL
CIPROFLOXACIN EXTENDED RELEASE, CIPROFLOXACIN
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE
CLONAZEPAM, CLONAZEPAM
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DESLORATADINE, DESLORATADINE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DIDANOSINE, DIDANOSINE
DIGOXIN, DIGOXIN
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
DOXYCYCLINE, DOXYCYCLINE
ENTACAPONE, ENTACAPONE
EPROSARTAN MESYLATE, EPROSARTAN MESYLATE
ERLOTINIB HYDROCHLORIDE, ERLOTINIB HYDROCHLORIDE
ESZOPICLONE, ESZOPICLONE
FENOFIBRATE (MICRONIZED), FENOFIBRATE
FENOFIBRATE, FENOFIBRATE
FENOFIBRIC ACID, CHOLINE FENOFIBRATE
FENOPROFEN CALCIUM, FENOPROFEN CALCIUM
FINASTERIDE, FINASTERIDE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLURAZEPAM HYDROCHLORIDE, FLURAZEPAM HYDROCHLORIDE
FROVATRIPTAN SUCCINATE, FROVATRIPTAN SUCCINATE
GABAPENTIN, GABAPENTIN
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IBANDRONATE SODIUM, IBANDRONATE SODIUM
IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE
INDAPAMIDE, INDAPAMIDE
INDOMETHACIN, INDOMETHACIN
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
ITRACONAZOLE, ITRACONAZOLE
LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE
LAMIVUDINE, LAMIVUDINE
LANSOPRAZOLE, LANSOPRAZOLE
LEVETIRACETAM, LEVETIRACETAM
LITHIUM CARBONATE, LITHIUM CARBONATE
MAXZIDE, HYDROCHLOROTHIAZIDE
MAXZIDE-25, HYDROCHLOROTHIAZIDE
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHYCLOTHIAZIDE, METHYCLOTHIAZIDE
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
MODAFINIL, MODAFINIL
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MORPHINE SULFATE, MORPHINE SULFATE
MYCOPHENOLIC ACID, MYCOPHENOLIC ACID
NABUMETONE, NABUMETONE
NAPROXEN, NAPROXEN
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
NEVIRAPINE, NEVIRAPINE
OLANZAPINE, OLANZAPINE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 98
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** M **
* MYLAN PHARMACEUTICALS INC
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PHENYTOIN, PHENYTOIN
PINDOLOL, PINDOLOL
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
QUININE SULFATE, QUININE SULFATE
RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM
RAMIPRIL, RAMIPRIL
REPAGLINIDE, REPAGLINIDE
RILUZOLE, RILUZOLE
RISEDRONATE SODIUM, RISEDRONATE SODIUM
RISPERIDONE, RISPERIDONE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
SIMVASTATIN, SIMVASTATIN
SUNITINIB MALATE, SUNITINIB MALATE
TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE
TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
TELMISARTAN, TELMISARTAN
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TOLAZAMIDE, TOLAZAMIDE
TOLBUTAMIDE, TOLBUTAMIDE
TOLTERODINE TARTRATE, TOLTERODINE TARTRATE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TRIAZOLAM, TRIAZOLAM
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
VORICONAZOLE, VORICONAZOLE
ZIDOVUDINE, ZIDOVUDINE
ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE
ZOLMITRIPTAN, ZOLMITRIPTAN
ZONISAMIDE, ZONISAMIDE
* MYLAN PHARMACEUTICALS INC.
FLUVASTATIN SODIUM, FLUVASTATIN SODIUM
NIZATIDINE, NIZATIDINE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
MYLAN SPECLT
* MYLAN SPECIALTY LP
ACCUNEB, ALBUTEROL SULFATE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
CROMOLYN SODIUM, CROMOLYN SODIUM
DUONEB, ALBUTEROL SULFATE
EPIPEN JR., EPINEPHRINE
EPIPEN, EPINEPHRINE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
PERFOROMIST, FORMOTEROL FUMARATE
MYLAN TECHNOLOGIES
* MYLAN TECHNOLOGIES
XULANE, ETHINYL ESTRADIOL
* MYLAN TECHNOLOGIES INC
CLONIDINE, CLONIDINE
ESTRADIOL, ESTRADIOL
FENTANYL-100, FENTANYL
FENTANYL-12, FENTANYL
FENTANYL-25, FENTANYL
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 99
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** M **
* MYLAN TECHNOLOGIES INC
FENTANYL-37, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-62, FENTANYL
FENTANYL-75, FENTANYL
FENTANYL-87, FENTANYL
NITROGLYCERIN, NITROGLYCERIN
** N **
NATCO PHARMA
* NATCO PHARMA LTD
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
NATCO PHARMA LTD
* NATCO PHARMA LIMITED
CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
* NATCO PHARMA LTD
ANASTROZOLE, ANASTROZOLE
CARISOPRODOL, CARISOPRODOL
CHLOROQUINE PHOSPHATE, CHLOROQUINE PHOSPHATE
LANSOPRAZOLE, LANSOPRAZOLE
LETROZOLE, LETROZOLE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE
NAVIDEA BIOPHARMS
* NAVIDEA BIOPHARMACEUTICALS INC
LYMPHOSEEK KIT, TECHNETIUM TC-99M TILMANOCEPT
NAVINTA LLC
* NAVINTA LLC
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
FAMOTIDINE, FAMOTIDINE
FOMEPIZOLE, FOMEPIZOLE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE
NCM USA BRONX LLC
* NCM USA BRONX LLC
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
NEOS THERAP INC
* NEOS THERAPEUTICS INC
HYDROCODONE POLISTIREX AND CHLORPHENIRAMNE POLISTIREX, CHLORPHENIRAMINE POLISTIREX
NEPHRON
* NEPHRON CORP
ALBUTEROL SULFATE, ALBUTEROL SULFATE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
* NEPHRON PHARMACEUTICALS CORP
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
NESHER PHARMS
* NESHER PHARMACEUTICALS USA LLC
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
MICRO-K 10, POTASSIUM CHLORIDE
MICRO-K, POTASSIUM CHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
NEW RIVER
* NEW RIVER PHARMACEUTICALS INC
PROFERDEX, IRON DEXTRAN
NEXGEN PHARMA
* NEXGEN PHARMA INC
BUTALBITAL AND ACETAMINOPHEN, ACETAMINOPHEN
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
CHENODIOL, CHENODIOL
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 100
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** N **
* NEXGEN PHARMA INC
GLYCOPYRROLATE, GLYCOPYRROLATE
MECAMYLAMINE HYDROCHLORIDE, MECAMYLAMINE HYDROCHLORIDE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)
NEXGEN PHARMA INC
* NEXGEN PHARMA INC
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN
BUTALBITAL, ASPIRIN, CAFFEINE, AND CODEINE PHOSPHATE, ASPIRIN
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
NEXTWAVE PHARMS
* NEXTWAVE PHARMACEUTICALS INC
QUILLIVANT XR, METHYLPHENIDATE HYDROCHLORIDE
NEXUS PHARMS
* NEXUS PHARMACEUTICALS INC
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
LEVOFLOXACIN, LEVOFLOXACIN
NIAGARA PHARMS
* NIAGARA PHARMACEUTICALS INC
PUR-WASH, PURIFIED WATER (OTC)
NORTEC DEV ASSOC
* NORTEC DEVELOPMENT ASSOC INC
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
NORTHSTAR HLTHCARE
* NORTHSTAR HEALTHCARE HOLDINGS LTD
ALLOPURINOL, ALLOPURINOL
ATENOLOL, ATENOLOL
BACLOFEN, BACLOFEN
GEMFIBROZIL, GEMFIBROZIL
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
NOSTRUM
* NOSTRUM PHARMACEUTICALS INC
CARBAMAZEPINE, CARBAMAZEPINE
THEOPHYLLINE, THEOPHYLLINE
NOSTRUM LABS
* NOSTRUM LABORATORIES INC
PIROXICAM, PIROXICAM
SUCRALFATE, SUCRALFATE
NOSTRUM PHARMS LLC
* NOSTRUM PHARMACEUTICALS LLC
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NOVA LABS LTD
* NOVA LABORATORIES LTD
PURIXAN, MERCAPTOPURINE
NOVADEL
* NOVADEL PHARMA INC
ZOLPIMIST, ZOLPIDEM TARTRATE
NOVARTIS
* NOVARTIS CONSUMER HEALTH INC
EXCEDRIN (MIGRAINE), ACETAMINOPHEN (OTC)
LAMISIL AT, TERBINAFINE (OTC)
LAMISIL AT, TERBINAFINE HYDROCHLORIDE (OTC)
LAMISIL, TERBINAFINE HYDROCHLORIDE (OTC)
PREVACID 24 HR, LANSOPRAZOLE (OTC)
THRIVE, NICOTINE POLACRILEX (OTC)
TRANSDERM SCOP, SCOPOLAMINE
VAGISTAT-1, TIOCONAZOLE (OTC)
VOLTAREN, DICLOFENAC SODIUM
* NOVARTIS PHARMACEUTICALS CORP
AFINITOR, EVEROLIMUS
AMTURNIDE, ALISKIREN HEMIFUMARATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 101
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** N **
* NOVARTIS PHARMACEUTICALS CORP
ARCAPTA NEOHALER, INDACATEROL MALEATE
CATAFLAM, DICLOFENAC POTASSIUM
CLOZARIL, CLOZAPINE
COARTEM, ARTEMETHER
DESFERAL, DEFEROXAMINE MESYLATE
DIOVAN HCT, HYDROCHLOROTHIAZIDE
DIOVAN, VALSARTAN
ESTRADERM, ESTRADIOL
EXELON, RIVASTIGMINE
EXELON, RIVASTIGMINE TARTRATE
EXFORGE HCT, AMLODIPINE BESYLATE
EXFORGE, AMLODIPINE BESYLATE
EXJADE, DEFERASIROX
FAMVIR, FAMCICLOVIR
FANAPT, ILOPERIDONE
FOCALIN XR, DEXMETHYLPHENIDATE HYDROCHLORIDE
FOCALIN, DEXMETHYLPHENIDATE HYDROCHLORIDE
FORADIL, FORMOTEROL FUMARATE
GILENYA, FINGOLIMOD
GLEEVEC, IMATINIB MESYLATE
HYDERGINE, ERGOLOID MESYLATES
LAMISIL, TERBINAFINE HYDROCHLORIDE
LAMPRENE, CLOFAZIMINE
LESCOL XL, FLUVASTATIN SODIUM
LESCOL, FLUVASTATIN SODIUM
LOPRESSOR, METOPROLOL TARTRATE
LOTREL, AMLODIPINE BESYLATE
MYFORTIC, MYCOPHENOLIC ACID
NEORAL, CYCLOSPORINE
OCUPRESS, CARTEOLOL HYDROCHLORIDE
RECLAST, ZOLEDRONIC ACID
REGITINE, PHENTOLAMINE MESYLATE
RITALIN LA, METHYLPHENIDATE HYDROCHLORIDE
RITALIN, METHYLPHENIDATE HYDROCHLORIDE
RITALIN-SR, METHYLPHENIDATE HYDROCHLORIDE
SANDIMMUNE, CYCLOSPORINE
SANDOSTATIN LAR, OCTREOTIDE ACETATE
SANDOSTATIN, OCTREOTIDE ACETATE
SIGNIFOR, PASIREOTIDE DIASPARTATE
STARLIX, NATEGLINIDE
TASIGNA, NILOTINIB HYDROCHLORIDE MONOHYDRATE
TAVIST-1, CLEMASTINE FUMARATE (OTC)
TEGRETOL, CARBAMAZEPINE
TEGRETOL-XR, CARBAMAZEPINE
TEKAMLO, ALISKIREN HEMIFUMARATE
TEKTURNA HCT, ALISKIREN HEMIFUMARATE
TEKTURNA, ALISKIREN HEMIFUMARATE
TOBI PODHALER, TOBRAMYCIN
TRILEPTAL, OXCARBAZEPINE
TYZEKA, TELBIVUDINE
VIVELLE, ESTRADIOL
VIVELLE-DOT, ESTRADIOL
VOLTAREN, DICLOFENAC SODIUM
VOLTAREN-XR, DICLOFENAC SODIUM
ZOMETA, ZOLEDRONIC ACID
ZORTRESS, EVEROLIMUS
NOVARTIS PHARM
* NOVARTIS PHARMACEUTICAL CORP
AFINITOR DISPERZ, EVEROLIMUS
NOVARTIS PHARMS
* NOVARTIS PHARMACEUTICALS CORP
FEMARA, LETROZOLE
TOBI, TOBRAMYCIN
NOVARTIS PHARMS CORP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 102
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** N **
* NOVARTIS PHARMACEUTICALS CORP
SIGNIFOR LAR, PASIREOTIDE PAMOATE
ZYKADIA, CERITINIB
NOVAST LABS
* NOVAST LABORATORIES CHINA LTD
NORETHINDRONE, NORETHINDRONE
NOVAST LABS LTD
* NOVAST LABORATORIES LTD
DASETTA 1/35, ETHINYL ESTRADIOL
DASETTA 7/7/7, ETHINYL ESTRADIOL
DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL
ELINEST, ETHINYL ESTRADIOL
FALMINA, ETHINYL ESTRADIOL
LARIN 1.5/30, ETHINYL ESTRADIOL
LARIN 1/20, ETHINYL ESTRADIOL
LARIN FE 1.5/30, ETHINYL ESTRADIOL
LARIN FE 1/20, ETHINYL ESTRADIOL
LEVONEST, ETHINYL ESTRADIOL
MONO-LINYAH, ETHINYL ESTRADIOL
NORETHINDRONE, NORETHINDRONE
PHILITH, ETHINYL ESTRADIOL
PIMTREA, DESOGESTREL
SETLAKIN, ETHINYL ESTRADIOL
TRI-LINYAH, ETHINYL ESTRADIOL
WERA, ETHINYL ESTRADIOL
YAELA, DROSPIRENONE
NOVEL LABS INC
* NOVEL LABORATORIES INC
FAMOTIDINE, FAMOTIDINE
HOMATROPINE METHYLBROMIDE AND HYDROCODONE BITARTRATE, HOMATROPINE METHYLBROMIDE
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL, LEVONORGESTREL (OTC)
METHYLERGONOVINE MALEATE, METHYLERGONOVINE MALEATE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
MISOPROSTOL, MISOPROSTOL
NITROFURANTOIN, NITROFURANTOIN
PEG 3350 AND ELECTROLYTES, POLYETHYLENE GLYCOL 3350
PEG-3350, SODIUM CHLORIDE, SODIUM BICARBONATE, POTASSIUM CHLORIDE AND BISACODYL,
PEG-3350;POTASSIUM CHLORIDE;SODIUM BICARBONATE;SODIUM CHLORIDE, POLYETHYLENE GLYCOL
PHENELZINE SULFATE, PHENELZINE SULFATE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)
TEMAZEPAM, TEMAZEPAM
TINIDAZOLE, TINIDAZOLE
TRIMETHOPRIM, TRIMETHOPRIM
NOVEN
* NOVEN PHARMACEUTICALS INC
MINIVELLE, ESTRADIOL
NOVEN PHARMS INC
* NOVEN PHARMACEUTICALS INC
COMBIPATCH, ESTRADIOL
DAYTRANA, METHYLPHENIDATE
NOVEN THERAP
* NOVEN THERAPEUTICS LLC
BRISDELLE, PAROXETINE MESYLATE
PEXEVA, PAROXETINE MESYLATE
NOVEX
* NOVEX PHARMA
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
NOVO NORDISK
* NOVO NORDISK PHARMACEUTICALS INC
GLUCAGEN, GLUCAGON HYDROCHLORIDE RECOMBINANT
NOVO NORDISK INC
* NOVO NORDISK INC
LEVEMIR FLEXPEN, INSULIN DETEMIR RECOMBINANT
LEVEMIR FLEXTOUCH, INSULIN DETEMIR RECOMBINANT
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 103
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** N **
* NOVO NORDISK INC
LEVEMIR, INSULIN DETEMIR RECOMBINANT
NORDITROPIN FLEXPRO, SOMATROPIN RECOMBINANT
NORDITROPIN NORDIFLEX, SOMATROPIN RECOMBINANT
NOVOLIN 70/30, INSULIN RECOMBINANT HUMAN (OTC)
NOVOLIN N, INSULIN SUSP ISOPHANE RECOMBINANT HUMAN (OTC)
NOVOLIN R, INSULIN RECOMBINANT HUMAN (OTC)
NOVOLOG FLEXPEN, INSULIN ASPART RECOMBINANT
NOVOLOG FLEXTOUCH, INSULIN ASPART RECOMBINANT
NOVOLOG MIX 70/30 FLEXPEN, INSULIN ASPART PROTAMINE RECOMBINANT
NOVOLOG MIX 70/30, INSULIN ASPART PROTAMINE RECOMBINANT
NOVOLOG PENFILL, INSULIN ASPART RECOMBINANT
NOVOLOG, INSULIN ASPART RECOMBINANT
PRANDIMET, METFORMIN HYDROCHLORIDE
PRANDIN, REPAGLINIDE
SAXENDA, LIRAGLUTIDE RECOMBINANT
VAGIFEM, ESTRADIOL
VICTOZA, LIRAGLUTIDE RECOMBINANT
NOVOCOL
* NOVOCOL PHARMACEUTICAL INC
ISOCAINE HYDROCHLORIDE, MEPIVACAINE HYDROCHLORIDE
NOVOCOL INC
* NOVOCOL INC
LIDOCAINE, LIDOCAINE
NPS PHARMS INC
* NPS PHARMACEUTICALS INC
GATTEX KIT, TEDUGLUTIDE RECOMBINANT
NU PHARM
* NU PHARM INC
DIVALPROEX SODIUM, DIVALPROEX SODIUM
NUVO PHARM INC
* NUVO PHARMACEUTICAL INC
SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
NUVO RES INC
* NUVO RESEARCH INC
PENNSAID, DICLOFENAC SODIUM
NYCOMED US
* NYCOMED US INC
TERCONAZOLE, TERCONAZOLE
** O **
OAK PHARMS
* OAK PHARMACEUTICALS INC
NEMBUTAL SODIUM, PENTOBARBITAL SODIUM
XYLOCAINE, LIDOCAINE HYDROCHLORIDE
OAK PHARMS AKORN
* OAK PHARMACEUTICALS INC SUB AKORN INC
COGENTIN, BENZTROPINE MESYLATE
DIURIL, CHLOROTHIAZIDE SODIUM
OAK PHARMS INC
* OAK PHARMACEUTICALS INC
ZIOPTAN, TAFLUPROST
* OAK PHARMACEUTICALS INC SUBSIDIARY OF AKORN INC
AZASITE, AZITHROMYCIN
BETIMOL, TIMOLOL
COSOPT PF, DORZOLAMIDE HYDROCHLORIDE
COSOPT, DORZOLAMIDE HYDROCHLORIDE
XOPENEX, LEVALBUTEROL HYDROCHLORIDE
ODYSSEY PHARMS
* ODYSSEY PHARMACEUTICALS INC
ANTABUSE, DISULFIRAM
NYSTATIN, NYSTATIN
SURMONTIL, TRIMIPRAMINE MALEATE
URECHOLINE, BETHANECHOL CHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 104
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** O **
* ODYSSEY PHARMACEUTICALS INC
VIVACTIL, PROTRIPTYLINE HYDROCHLORIDE
OHM
* OHM CORP
IBUPROFEN, IBUPROFEN (OTC)
OHM LABS
* OHM LABORATORIES INC
ACETAMINOPHEN, ACETAMINOPHEN (OTC)
IBUPROHM COLD AND SINUS, IBUPROFEN (OTC)
IBUPROHM, IBUPROFEN (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
OHM LABS INC
* OHM LABORATORIES INC
VALSARTAN, VALSARTAN
OLTA PHARMS
* OLTA PHARMACEUTICALS CORP
LINDANE, LINDANE
OMAN PHARM PRODUCTS
* OMAN PHARMACEUTICAL PRODUCTS CO LLC
NEOMYCIN SULFATE, NEOMYCIN SULFATE
OMEROS
* OMEROS CORP
OMIDRIA, KETOROLAC TROMETHAMINE
ONCO THERAPIES LTD
* ONCO THERAPIES LTD
CARBOPLATIN, CARBOPLATIN
CISPLATIN, CISPLATIN
CLADRIBINE, CLADRIBINE
CYTARABINE, CYTARABINE
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
FLUOROURACIL, FLUOROURACIL
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
IDARUBICIN HYDROCHLORIDE, IDARUBICIN HYDROCHLORIDE
IFOSFAMIDE, IFOSFAMIDE
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
OXALIPLATIN, OXALIPLATIN
PACLITAXEL, PACLITAXEL
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VINORELBINE, VINORELBINE
ONY
* ONY INC
INFASURF PRESERVATIVE FREE, CALFACTANT
ONYX PHARMS
* ONYX PHARMACEUTICALS INC
KYPROLIS, CARFILZOMIB
ORAPHARMA
* ORAPHARMA INC
ARESTIN, MINOCYCLINE HYDROCHLORIDE
ORCHID HLTHCARE
* ORCHID HEALTHCARE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFDINIR, CEFDINIR
CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL
CEFPROZIL, CEFPROZIL
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CEPHALEXIN, CEPHALEXIN
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
DESLORATADINE, DESLORATADINE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 105
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** O **
* ORCHID HEALTHCARE
ESZOPICLONE, ESZOPICLONE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
IBANDRONATE SODIUM, IBANDRONATE SODIUM
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
MODAFINIL, MODAFINIL
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
OLANZAPINE, OLANZAPINE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZALEPLON, ZALEPLON
OREXO AB
* OREXO AB
ZUBSOLV, BUPRENORPHINE HYDROCHLORIDE
ORGANON USA INC
* ORGANON USA INC
CYCLESSA, DESOGESTREL
DESOGEN, DESOGESTREL
FOLLISTIM AQ, FOLLITROPIN ALFA/BETA
GANIRELIX ACETATE, GANIRELIX ACETATE
IMPLANON, ETONOGESTREL
NEXPLANON, ETONOGESTREL
NUVARING, ETHINYL ESTRADIOL
PREGNYL, GONADOTROPIN, CHORIONIC
REMERON SOLTAB, MIRTAZAPINE
REMERON, MIRTAZAPINE
ORIENT PHARMA CO LTD
* ORIENT PHARMA CO LTD
CARISOPRODOL, CARISOPRODOL
ORION CORP ORION
* ORION CORP ORION PHARMA
SPIRONOLACTONE, SPIRONOLACTONE
ORION PHARMA
* ORION PHARMA
COMTAN, ENTACAPONE
STALEVO 100, CARBIDOPA
STALEVO 125, CARBIDOPA
STALEVO 150, CARBIDOPA
STALEVO 200, CARBIDOPA
STALEVO 50, CARBIDOPA
STALEVO 75, CARBIDOPA
ORIT LABS LLC
* ORIT LABORATORIES LLC
BENZONATATE, BENZONATATE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
ERGOCALCIFEROL, ERGOCALCIFEROL
LEVETIRACETAM, LEVETIRACETAM
ORPHAN EUROPE
* ORPHAN EUROPE
CARBAGLU, CARGLUMIC ACID
OSI PHARMS
* OSI PHARMACEUTICALS INC
TARCEVA, ERLOTINIB HYDROCHLORIDE
OSMOTICA PHARM
* OSMOTICA PHARMACEUTICAL CORP
NIFEDIPINE, NIFEDIPINE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
OSMOTICA PHARM CORP
* OSMOTICA PHARMACEUTICAL CORP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 106
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** O **
* OSMOTICA PHARMACEUTICAL CORP
KHEDEZLA, DESVENLAFAXINE
OTSUKA
* OTSUKA PHARMACEUTICAL CO LTD
ABILIFY, ARIPIPRAZOLE
PLETAL, CILOSTAZOL
* OTSUKA PHARMACEUTICAL DEVELOPMENT AND COMMERCIALIZATION INC
ABILIFY, ARIPIPRAZOLE
OTSUKA AMERICA PHARM
* OTSUKA AMERICA PHARMACEUTICAL INC
SAMSCA, TOLVAPTAN
OTSUKA PHARM
* OTSUKA PHARMACEUTICAL CO LTD
BUSULFEX, BUSULFAN
OTSUKA PHARM CO LTD
* OTSUKA PHARMACEUTICAL CO LTD
ABILIFY MAINTENA KIT, ARIPIPRAZOLE
OUTLOOK PHARMS
* OUTLOOK PHARMACEUTICALS INC
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
** P **
P AND L DEV LLC
* P AND L DEVELOPMENT LLC DBA PLD DEVELOPMENTS LLC
IBUPROFEN, IBUPROFEN (OTC)
PACIFIC PHARMA
* PACIFIC PHARMA
TIMOLOL MALEATE, TIMOLOL MALEATE
* PACIFIC PHARMA INC
TIMOLOL MALEATE, TIMOLOL MALEATE
PACIRA PHARMS INC
* PACIRA PHARMACEUTICALS INC
DEPOCYT, CYTARABINE
EXPAREL, BUPIVACAINE
PACK PHARMS LLC
* PACK PHARMACEUTICALS LLC
CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE
CROMOLYN SODIUM, CROMOLYN SODIUM
PADDOCK
* PADDOCK LABORATORIES INC
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
PADDOCK LABS
* PADDOCK LABORATORIES INC
CLINDAMYCIN PALMITATE HYDROCHLORIDE, CLINDAMYCIN PALMITATE HYDROCHLORIDE
PADDOCK LLC
* PADDOCK LABORATORIES LLC
BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN
CALCIUM ACETATE, CALCIUM ACETATE
CICLOPIROX, CICLOPIROX
CLINDA-DERM, CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOTRIMAZOLE, CLOTRIMAZOLE
COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM
COLOCORT, HYDROCORTISONE
COMPRO, PROCHLORPERAZINE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DIHYDROERGOTAMINE MESYLATE, DIHYDROERGOTAMINE MESYLATE
ERYTHRA-DERM, ERYTHROMYCIN
FLAVOXATE HYDROCHLORIDE, FLAVOXATE HYDROCHLORIDE
HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE, HYDROCODONE BITARTRATE
HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE ,
INDOMETHACIN, INDOMETHACIN
KIONEX, SODIUM POLYSTYRENE SULFONATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 107
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** P **
* PADDOCK LABORATORIES LLC
LAX-LYTE WITH FLAVOR PACKS, POLYETHYLENE GLYCOL 3350
LORAZEPAM, LORAZEPAM
MIDAMOR, AMILORIDE HYDROCHLORIDE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
NYSTOP, NYSTATIN
PODOFILOX, PODOFILOX
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
REPAGLINIDE, REPAGLINIDE
SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE
TROSPIUM CHLORIDE, TROSPIUM CHLORIDE
PALADIN LABS
* PALADIN LABS USA INC
ANTIZOL, FOMEPIZOLE
PANACEA BIOTEC LTD
* PANACEA BIOTEC LTD
TACROLIMUS, TACROLIMUS
PAR FORM
* PAR FORMULATIONS PRIVATE LTD
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
MAFENIDE ACETATE, MAFENIDE ACETATE
PAR PHARM
* PAR PHARMACEUTICAL
NABUMETONE, NABUMETONE
OMEPRAZOLE AND SODIUM BICARBONATE, OMEPRAZOLE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
* PAR PHARMACEUTICAL INC
ALPRAZOLAM, ALPRAZOLAM
AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
CABERGOLINE, CABERGOLINE
CALCITONIN-SALMON, CALCITONIN SALMON
CAPOTEN, CAPTOPRIL
CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE
CHOLESTYRAMINE, CHOLESTYRAMINE
CLOMIPHENE CITRATE, CLOMIPHENE CITRATE
CLONAZEPAM, CLONAZEPAM
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
DEXAMETHASONE, DEXAMETHASONE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE, ATROPINE SULFATE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
DOXYCYCLINE, DOXYCYCLINE
ESTAZOLAM, ESTAZOLAM
FENTANYL CITRATE, FENTANYL CITRATE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUTAMIDE, FLUTAMIDE
GLIPIZIDE, GLIPIZIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
HYDRA-ZIDE, HYDRALAZINE HYDROCHLORIDE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROXYUREA, HYDROXYUREA
IBUPROFEN, IBUPROFEN (OTC)
IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE
ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 108
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** P **
* PAR PHARMACEUTICAL INC
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
MEGACE ES, MEGESTROL ACETATE
MEGESTROL ACETATE, MEGESTROL ACETATE
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
METRONIDAZOLE, METRONIDAZOLE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MINOXIDIL, MINOXIDIL
NASCOBAL, CYANOCOBALAMIN
NATEGLINIDE, NATEGLINIDE
NIFEDIPINE, NIFEDIPINE
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
OLANZAPINE, OLANZAPINE
OXANDROLONE, OXANDROLONE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TORSEMIDE, TORSEMIDE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRANYLCYPROMINE SULFATE, TRANYLCYPROMINE SULFATE
TRAVOPROST, TRAVOPROST
URSODIOL, URSODIOL
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
PAR PHARM INC
* PAR PHARMACEUTICAL INC
AMLODIPINE BESYLATE AND VALSARTAN, AMLODIPINE BESYLATE
FENTANYL-100, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
PAR STERILE PRODUCTS
* PAR STERILE PRODUCTS LLC
ADRENALIN, EPINEPHRINE HYDROCHLORIDE
ARGATROBAN, ARGATROBAN
BREVITAL SODIUM, METHOHEXITAL SODIUM
COLY-MYCIN M, COLISTIMETHATE SODIUM
COLY-MYCIN S, COLISTIN SULFATE
DANTRIUM, DANTROLENE SODIUM
DELESTROGEN, ESTRADIOL VALERATE
DEXMEDETOMIDINE HYDROCHLORIDE, DEXMEDETOMIDINE HYDROCHLORIDE
ETOMIDATE, ETOMIDATE
FLUPHENAZINE DECANOATE, FLUPHENAZINE DECANOATE
KETALAR, KETAMINE HYDROCHLORIDE
PITOCIN, OXYTOCIN
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TIGAN, TRIMETHOBENZAMIDE HYDROCHLORIDE
TRIOSTAT, LIOTHYRONINE SODIUM
VASOSTRICT, VASOPRESSIN
PARAGON BIOTECK
* PARAGON BIOTECK INC
PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
PARAPRO LLC
* PARAPRO LLC
NATROBA, SPINOSAD
PARKE DAVIS
* PARKE DAVIS DIV WARNER LAMBERT CO
CELONTIN, METHSUXIMIDE
CEREBYX, FOSPHENYTOIN SODIUM
DILANTIN, PHENYTOIN SODIUM
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 109
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** P **
* PARKE DAVIS DIV WARNER LAMBERT CO
DILANTIN-125, PHENYTOIN
NARDIL, PHENELZINE SULFATE
NEURONTIN, GABAPENTIN
ZARONTIN, ETHOSUXIMIDE
* PARKE DAVIS PHARMACEUTICAL RESEARCH DIV WARNER LAMBERT CO
ZARONTIN, ETHOSUXIMIDE
PERNIX IRELAND LTD
* PERNIX IRELAND LTD
TREXIMET, NAPROXEN SODIUM
PERNIX THERAP
* PERNIX THERAPEUTICS LLC
CEDAX, CEFTIBUTEN DIHYDRATE
PERNIX THERAPS LLC
* PERNIX THERAPEUTICS LLC
SILENOR, DOXEPIN HYDROCHLORIDE
PERRIGO
* PERRIGO CO
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
CICLOPIROX, CICLOPIROX
CIMETIDINE, CIMETIDINE (OTC)
CLEMASTINE FUMARATE, CLEMASTINE FUMARATE (OTC)
CLINDETS, CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
ERYTHROMYCIN, ERYTHROMYCIN
FAMOTIDINE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE (OTC)
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
IBUPROFEN, IBUPROFEN (OTC)
JUNIOR STRENGTH IBUPROFEN, IBUPROFEN (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
MICONAZOLE NITRATE COMBINATION PACK, MICONAZOLE NITRATE (OTC)
MINOXIDIL (FOR MEN), MINOXIDIL (OTC)
MINOXIDIL (FOR WOMEN), MINOXIDIL (OTC)
MOMETASONE FUROATE, MOMETASONE FUROATE
NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)
PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)
STIE-CORT, HYDROCORTISONE
PERRIGO CO TENNESSEE
* PERRIGO CO TENNESSEE INC
BACITRACIN ZINC AND POLYMYXIN B SULFATE, BACITRACIN ZINC
BACITRACIN, BACITRACIN
BACITRACIN-NEOMYCIN-POLYMYXIN W/ HYDROCORTISONE ACETATE, BACITRACIN
ERYTHROMYCIN, ERYTHROMYCIN
GENTAMICIN SULFATE, GENTAMICIN SULFATE
GRISEOFULVIN, GRISEOFULVIN, MICROSIZE
NEOMYCIN AND POLYMYXIN B SULFATES AND BACITRACIN ZINC, BACITRACIN ZINC
NEOMYCIN AND POLYMYXIN B SULFATES AND DEXAMETHASONE, DEXAMETHASONE
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
PERRIGO ISRAEL
* PERRIGO ISRAEL PHARMACEUTICALS
FLUOCINONIDE, FLUOCINONIDE
* PERRIGO ISRAEL PHARMACEUTICALS LTD
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
BUTOCONAZOLE NITRATE, BUTOCONAZOLE NITRATE
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CLINDAMYCIN PHOSPHATE AND BENZOYL PEROXIDE, BENZOYL PEROXIDE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
IMIQUIMOD, IMIQUIMOD
KETOCONAZOLE, KETOCONAZOLE
MESALAMINE, MESALAMINE
MINOXIDIL, MINOXIDIL (OTC)
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 110
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** P **
* PERRIGO ISRAEL PHARMACEUTICALS LTD
NITROGLYCERIN, NITROGLYCERIN
TESTOSTERONE, TESTOSTERONE
PERRIGO NEW YORK
* PERRIGO NEW YORK INC
ACETAMINOPHEN, ACETAMINOPHEN (OTC)
AMMONIUM LACTATE, AMMONIUM LACTATE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CENTANY, MUPIROCIN
CICLOPIROX, CICLOPIROX
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
DESONIDE, DESONIDE
DESOXIMETASONE, DESOXIMETASONE
ECONAZOLE NITRATE, ECONAZOLE NITRATE
ERYTHROMYCIN, ERYTHROMYCIN
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
GENTAMICIN SULFATE, GENTAMICIN SULFATE
HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE
HYDROCORTISONE, HYDROCORTISONE
KETOCONAZOLE, KETOCONAZOLE
MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)
MOMETASONE FUROATE, MOMETASONE FUROATE
MUPIROCIN, MUPIROCIN
NYSTATIN, NYSTATIN
PERMETHRIN, PERMETHRIN
PERMETHRIN, PERMETHRIN (OTC)
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
SELENIUM SULFIDE, SELENIUM SULFIDE
TERCONAZOLE, TERCONAZOLE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
PERRIGO R AND D
* PERRIGO R AND D CO
CALCIUM CARBONATE, FAMOTIDINE AND MAGNESIUM HYDROXIDE, CALCIUM CARBONATE (OTC)
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
DESLORATADINE, DESLORATADINE
GUAIFENESIN, GUAIFENESIN (OTC)
IBUPROFEN AND DIPHENHYDRAMINE CITRATE, DIPHENHYDRAMINE CITRATE (OTC)
IBUPROFEN AND PHENYLEPHRINE HYDROCHLORIDE, IBUPROFEN (OTC)
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
LANSOPRAZOLE, LANSOPRAZOLE (OTC)
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL, LEVONORGESTREL (OTC)
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)
NAPROXEN, NAPROXEN
NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
POLYETHYLENE GLYCOL 3350, POLYETHYLENE GLYCOL 3350 (OTC)
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
PERRIGO UK FINCO
* PERRIGO UK FINCO LTD PARTNERSHIP
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
PETNET
* PETNET SOLUTIONS INC
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
PF PRISM CV
* PF PRISM CV
LYRICA, PREGABALIN
RAPAMUNE, SIROLIMUS
TORISEL, TEMSIROLIMUS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 111
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** P **
* PF PRISM CV
TYGACIL, TIGECYCLINE
VFEND, VORICONAZOLE
XALKORI, CRIZOTINIB
XELJANZ, TOFACITINIB CITRATE
ZMAX, AZITHROMYCIN
PFIZER
* PFIZER CENTRAL RESEARCH
DIFLUCAN, FLUCONAZOLE
ZITHROMAX, AZITHROMYCIN
* PFIZER CHEMICALS DIV PFIZER INC
DIFLUCAN, FLUCONAZOLE
ZITHROMAX, AZITHROMYCIN
* PFIZER INC
ACOVA, ARGATROBAN
ADVIL ALLERGY AND CONGESTION RELIEF, CHLORPHENIRAMINE MALEATE (OTC)
ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)
ADVIL COLD AND SINUS, IBUPROFEN (OTC)
ADVIL CONGESTION RELIEF, IBUPROFEN (OTC)
ADVIL LIQUI-GELS, IBUPROFEN (OTC)
ADVIL MIGRAINE LIQUI-GELS, IBUPROFEN (OTC)
ADVIL PM, DIPHENHYDRAMINE CITRATE (OTC)
ADVIL PM, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)
ADVIL, IBUPROFEN (OTC)
ALAVERT, LORATADINE (OTC)
AXID AR, NIZATIDINE (OTC)
CADUET, AMLODIPINE BESYLATE
CALAN SR, VERAPAMIL HYDROCHLORIDE
CARDURA XL, DOXAZOSIN MESYLATE
CHILDREN'S ADVIL ALLERGY SINUS, CHLORPHENIRAMINE MALEATE (OTC)
CHILDREN'S ADVIL COLD, IBUPROFEN (OTC)
CHILDREN'S ADVIL, IBUPROFEN (OTC)
CHILDREN'S ADVIL-FLAVORED, IBUPROFEN (OTC)
DIFLUCAN IN DEXTROSE 5% IN PLASTIC CONTAINER, FLUCONAZOLE
DIFLUCAN IN SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, FLUCONAZOLE
DIFLUCAN IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
ELELYSO, TALIGLUCERASE ALFA
FLAGYL I.V. RTU IN PLASTIC CONTAINER, METRONIDAZOLE
GEODON, ZIPRASIDONE HYDROCHLORIDE
GEODON, ZIPRASIDONE MESYLATE
GLUCOTROL XL, GLIPIZIDE
GLUCOTROL, GLIPIZIDE
HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM
HEPARIN SODIUM, HEPARIN SODIUM
INLYTA, AXITINIB
JUNIOR STRENGTH ADVIL, IBUPROFEN (OTC)
LIPITOR, ATORVASTATIN CALCIUM
LORATADINE, LORATADINE (OTC)
NAVANE, THIOTHIXENE
NORVASC, AMLODIPINE BESYLATE
PEDIATRIC ADVIL, IBUPROFEN (OTC)
PROCARDIA, NIFEDIPINE
REVATIO, SILDENAFIL CITRATE
SONATA, ZALEPLON
TESSALON, BENZONATATE
TOVIAZ, FESOTERODINE FUMARATE
UNASYN, AMPICILLIN SODIUM
ZITHROMAX, AZITHROMYCIN
* PFIZER LABORATORIES DIV PFIZER INC
CARDURA, DOXAZOSIN MESYLATE
DIABINESE, CHLORPROPAMIDE
FELDENE, PIROXICAM
MINIPRESS, PRAZOSIN HYDROCHLORIDE
PERMAPEN, PENICILLIN G BENZATHINE
PFIZERPEN, PENICILLIN G POTASSIUM
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 112
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** P **
* PFIZER LABORATORIES DIV PFIZER INC
PROCARDIA XL, NIFEDIPINE
TERRAMYCIN W/ POLYMYXIN B SULFATE, OXYTETRACYCLINE HYDROCHLORIDE
UNASYN, AMPICILLIN SODIUM
VIBRAMYCIN, DOXYCYCLINE
VIBRAMYCIN, DOXYCYCLINE CALCIUM
VIBRAMYCIN, DOXYCYCLINE HYCLATE
VISTARIL, HYDROXYZINE PAMOATE
* PFIZER PHARMACEUTICALS INC
ZOLOFT, SERTRALINE HYDROCHLORIDE
* PFIZER PHARMACEUTICALS PRODUCTION CORP LTD
TIKOSYN, DOFETILIDE
PFIZER CONS HLTHCARE
* PFIZER CONSUMER HEALTHCARE
ADVIL, IBUPROFEN SODIUM (OTC)
PFIZER INC
* PFIZER INC
CAMPTOSAR, IRINOTECAN HYDROCHLORIDE
CHANTIX, VARENICLINE TARTRATE
ELLENCE, EPIRUBICIN HYDROCHLORIDE
GEODON, ZIPRASIDONE HYDROCHLORIDE
NICOTROL, NICOTINE
PFIZER IRELAND
* PFIZER IRELAND PHARMACEUTICALS
RELPAX, ELETRIPTAN HYDROBROMIDE
VIAGRA, SILDENAFIL CITRATE
PFIZER LABS
* PFIZER LABS
DOCETAXEL, DOCETAXEL
PFIZER PHARMS
* PFIZER PHARMACEUTICALS LTD
ACCUPRIL, QUINAPRIL HYDROCHLORIDE
ACCURETIC, HYDROCHLOROTHIAZIDE
DILANTIN, PHENYTOIN
LOPID, GEMFIBROZIL
NEURONTIN, GABAPENTIN
NITROSTAT, NITROGLYCERIN
PHARM ASSOC
* PHARMACEUTICAL ASSOC INC
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
LORAZEPAM, LORAZEPAM
NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
* PHARMACEUTICAL ASSOC INC DIV BEACH PRODUCTS
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE
DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE
ETHOSUXIMIDE, ETHOSUXIMIDE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE
HALOPERIDOL, HALOPERIDOL LACTATE
LACTULOSE, LACTULOSE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
PREDNISOLONE, PREDNISOLONE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE
VALPROIC ACID, VALPROIC ACID
* PHARMACEUTICAL ASSOCIATES INC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
PHARMA-MED INC
* PHARMA-MED INC
POTASSIUM CHLORIDE, POTASSIUM CHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 113
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** P **
PHARMACEUTICS
* PHARMACEUTICS INTERNATIONAL INC
ZOLEDRONIC ACID, ZOLEDRONIC ACID
PHARMACHEMIE BV
* PHARMACHEMIE BV
CARBOPLATIN, CARBOPLATIN
CISPLATIN, CISPLATIN
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
METHOTREXATE PRESERVATIVE FREE, METHOTREXATE SODIUM
METHOTREXATE SODIUM PRESERVATIVE FREE, METHOTREXATE SODIUM
PHARMACIA AND UPJOHN
* PHARMACIA AND UPJOHN
XANAX XR, ALPRAZOLAM
* PHARMACIA AND UPJOHN CO
ANSAID, FLURBIPROFEN
AROMASIN, EXEMESTANE
AZULFIDINE EN-TABS, SULFASALAZINE
AZULFIDINE, SULFASALAZINE
BACITRACIN, BACITRACIN
CAVERJECT IMPULSE, ALPROSTADIL
CAVERJECT, ALPROSTADIL
CLEOCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLEOCIN PHOSPHATE IN DEXTROSE 5% IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE
CLEOCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLEOCIN T, CLINDAMYCIN PHOSPHATE
CLEOCIN, CLINDAMYCIN PALMITATE HYDROCHLORIDE
CLEOCIN, CLINDAMYCIN PHOSPHATE
COLESTID, COLESTIPOL HYDROCHLORIDE
CORTEF, HYDROCORTISONE
CORVERT, IBUTILIDE FUMARATE
CYKLOKAPRON, TRANEXAMIC ACID
DEPO-ESTRADIOL, ESTRADIOL CYPIONATE
DEPO-MEDROL, METHYLPREDNISOLONE ACETATE
DEPO-PROVERA, MEDROXYPROGESTERONE ACETATE
DEPO-TESTOSTERONE, TESTOSTERONE CYPIONATE
DETROL LA, TOLTERODINE TARTRATE
DETROL, TOLTERODINE TARTRATE
DIDREX, BENZPHETAMINE HYDROCHLORIDE
EMCYT, ESTRAMUSTINE PHOSPHATE SODIUM
ESTRING, ESTRADIOL
FLAVORED COLESTID, COLESTIPOL HYDROCHLORIDE
GENOTROPIN PRESERVATIVE FREE, SOMATROPIN RECOMBINANT
GENOTROPIN, SOMATROPIN RECOMBINANT
GLYNASE, GLYBURIDE
GLYSET, MIGLITOL
HALCION, TRIAZOLAM
HEMABATE, CARBOPROST TROMETHAMINE
IDAMYCIN PFS, IDARUBICIN HYDROCHLORIDE
LINCOCIN, LINCOMYCIN HYDROCHLORIDE
MEDROL, METHYLPREDNISOLONE
MYCOBUTIN, RIFABUTIN
NICOTROL, NICOTINE
OGEN .625, ESTROPIPATE
OGEN 1.25, ESTROPIPATE
OGEN 2.5, ESTROPIPATE
OGEN 5, ESTROPIPATE
PREPIDIL, DINOPROSTONE
PROSTIN E2, DINOPROSTONE
PROSTIN VR PEDIATRIC, ALPROSTADIL
PROVERA, MEDROXYPROGESTERONE ACETATE
R-GENE 10, ARGININE HYDROCHLORIDE
SOLU-CORTEF, HYDROCORTISONE SODIUM SUCCINATE
SOLU-MEDROL, METHYLPREDNISOLONE SODIUM SUCCINATE
SOMAVERT, PEGVISOMANT
XALATAN, LATANOPROST
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 114
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** P **
* PHARMACIA AND UPJOHN CO
XANAX, ALPRAZOLAM
ZINECARD, DEXRAZOXANE HYDROCHLORIDE
ZYVOX, LINEZOLID
* PHARMACIA AND UPJOHN SUB PFIZER INC
DEPO-SUBQ PROVERA 104, MEDROXYPROGESTERONE ACETATE
PHARMACYCLICS INC
* PHARMACYCLICS INC
IMBRUVICA, IBRUTINIB
PHARMAFORCE
* PHARMAFORCE INC
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
NANDROLONE DECANOATE, NANDROLONE DECANOATE
PHARMALUCENCE
* PHARMALUCENCE INC
AN-SULFUR COLLOID, TECHNETIUM TC-99M SULFUR COLLOID KIT
CIS-MDP, TECHNETIUM TC-99M MEDRONATE KIT
CIS-PYRO, TECHNETIUM TC-99M PYROPHOSPHATE KIT
HEPATOLITE, TECHNETIUM TC-99M DISOFENIN KIT
TECHNETIUM TC 99M SESTAMIBI, TECHNETIUM TC-99M SESTAMIBI KIT
TECHNETIUM TC-99M MEBROFENIN, TECHNETIUM TC-99M MEBROFENIN KIT
PHARMAX
* PHARMAX GROUP INC
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
PHARMS
* PHARMACEUTICALS INTERNATIONAL
ZOLEDRONIC ACID, ZOLEDRONIC ACID
PHOTOCURE ASA
* PHOTOCURE ASA
CYSVIEW KIT, HEXAMINOLEVULINATE HYDROCHLORIDE
PIERRE FABRE
* PIERRE FABRE MEDICAMENT
NAVELBINE, VINORELBINE TARTRATE
PIERRE FABRE DERMA
* PIERRE FABRE DERMATOLOGIE
HEMANGEOL, PROPRANOLOL HYDROCHLORIDE
PIERREL
* PIERREL S.P.A.
ORABLOC, ARTICAINE HYDROCHLORIDE
PIRAMAL CRITICAL
* PIRAMAL CRITICAL CARE INC
ENFLURANE, ENFLURANE
ISOFLURANE, ISOFLURANE
SOJOURN, SEVOFLURANE
PIRAMAL ENT
* PIRAMAL ENTERPRISES LTD
ISOFLURANE, ISOFLURANE
PIRAMAL IMAGING
* PIRAMAL IMAGING SA
NEURACEQ, FLORBETABEN F-18
PLIVA
* PLIVA INC
AZITHROMYCIN, AZITHROMYCIN
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
CIMETIDINE, CIMETIDINE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
METRONIDAZOLE, METRONIDAZOLE
NAPROXEN, NAPROXEN
PENTOXIFYLLINE, PENTOXIFYLLINE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 115
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** P **
* PLIVA INC
PROPRANOLOL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
THEOPHYLLINE, THEOPHYLLINE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
WARFARIN SODIUM, WARFARIN SODIUM
PLIVA HRVATSKA DOO
* PLIVA HRVATSKA DOO
ADAPALENE, ADAPALENE
CARVEDILOL, CARVEDILOL
CILOSTAZOL, CILOSTAZOL
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
PLIVA LACHEMA
* PLIVA LACHEMA AS
CARBOPLATIN, CARBOPLATIN
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PLIVA PHARM IND
* PLIVA PHARMACEUTICAL INDUSTRY INC
TORSEMIDE, TORSEMIDE
PLX PHARMA
* PLX PHARMA INC
ASPIRIN, ASPIRIN (OTC)
POHL BOSKAMP
* POHL BOSKAMP
NITROLINGUAL PUMPSPRAY, NITROGLYCERIN
POLYMEDICA
* POLYMEDICA INDUSTRIES INC
NEOPAP, ACETAMINOPHEN (OTC)
POWDER PHARMS
* POWDER PHARMACEUTICALS INC
ZINGO, LIDOCAINE HYDROCHLORIDE
PRAGMA PHARMS LLC
* PRAGMA PHARMACEUTICALS LLC
MOXATAG, AMOXICILLIN
PRECISION DERMAT
* PRECISION DERMATOLOGY INC
CLINDAGEL, CLINDAMYCIN PHOSPHATE
LOCOID LIPOCREAM, HYDROCORTISONE BUTYRATE
LOCOID, HYDROCORTISONE BUTYRATE
MINOCIN, MINOCYCLINE HYDROCHLORIDE
PODOFILOX, PODOFILOX
PRECISION DOSE
* PRECISION DOSE INC
RISPERIDONE, RISPERIDONE
PRINSTON INC
* PRINSTON PHARMACEUTICAL INC
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
LEVETIRACETAM, LEVETIRACETAM
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
METHOCARBAMOL, METHOCARBAMOL
NEVIRAPINE, NEVIRAPINE
PAROXETINE, PAROXETINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 116
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** P **
PROCTER AND GAMBLE
* PROCTER AND GAMBLE PHARMACEUTICALS INC SUB PROCTER AND GAMBLE CO
DIDRONEL, ETIDRONATE DISODIUM
PROF DSPLS
* PROFESSIONAL DISPOSABLES INC
PREVANTICS MAXI SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
PREVANTICS SWAB, CHLORHEXIDINE GLUCONATE (OTC)
PREVANTICS SWABSTICK, CHLORHEXIDINE GLUCONATE (OTC)
PROMETHEUS LABS
* PROMETHEUS LABORATORIES INC
IMURAN, AZATHIOPRINE
LOTRONEX, ALOSETRON HYDROCHLORIDE
MERCAPTOPURINE, MERCAPTOPURINE
RIDAURA, AURANOFIN
ZYLOPRIM, ALLOPURINOL
PROMIUS PHARMA
* PROMIUS PHARMA LLC
SECTRAL, ACEBUTOLOL HYDROCHLORIDE
TENEX, GUANFACINE HYDROCHLORIDE
PROMIUS PHARMA LLC
* PROMIUS PHARMA LLC
CLODERM, CLOCORTOLONE PIVALATE
PROSAM LABS
* PROSAM LABS LLC
BACLOFEN, BACLOFEN
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
CARISOPRODOL AND ASPIRIN, ASPIRIN
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
RIMACTANE, RIFAMPIN
RISPERIDONE, RISPERIDONE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
PROSTRAKAN INC
* PROSTRAKAN INC
FARESTON, TOREMIFENE CITRATE
SANCUSO, GRANISETRON
PROVENSIS
* PROVENSIS LTD
VARITHENA, POLIDOCANOL
PROVIDENT PHARM
* PROVIDENT PHARMACEUTICAL INC
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
PULMOFLOW INC
* PULMOFLOW INC
KITABIS PAK, TOBRAMYCIN
PULSION MEDCL
* PULSION MEDICAL SYSTEMS AG
INDOCYANINE GREEN, INDOCYANINE GREEN
PURACAP PHARM
* PURACAP PHARMACEUTICAL LLC
MELOXICAM, MELOXICAM
PURDUE GMP
* PURDUE GMP CENTER LLC DBA THE CHAO CENTER INDUSTRIAL PHARMACY
SEROMYCIN, CYCLOSERINE
PURDUE PHARM PRODS
* PURDUE PHARMACEUTICAL PRODUCTS LP
DILAUDID, HYDROMORPHONE HYDROCHLORIDE
DILAUDID-HP, HYDROMORPHONE HYDROCHLORIDE
PURDUE PHARMA
* PURDUE PHARMA PRODUCTS LP
INTERMEZZO, ZOLPIDEM TARTRATE
PURDUE PHARMA LP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 117
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** P **
* PURDUE PHARMA LP
BUTRANS, BUPRENORPHINE
HYSINGLA, HYDROCODONE BITARTRATE
MS CONTIN, MORPHINE SULFATE
OXYCONTIN, OXYCODONE HYDROCHLORIDE
PUREPAC PHARM
* PUREPAC PHARMACEUTICAL CO
DIPYRIDAMOLE, DIPYRIDAMOLE
PVT FORM
* PRIVATE FORMULATIONS INC
PROPOXYPHENE HYDROCHLORIDE, PROPOXYPHENE HYDROCHLORIDE
** Q **
QILU PHARM CO LTD
* QILU PHARMACEUTICAL CO LTD
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
QOL MEDCL
* QOL MEDICAL LLC
ETHAMOLIN, ETHANOLAMINE OLEATE
SUCRAID, SACROSIDASE
QUESTCOR PHARMS
* QUESTCOR PHARMACEUTICALS INC
H.P. ACTHAR GEL, CORTICOTROPIN
** R **
RANBAXY
* RANBAXY INC
ABSORICA, ISOTRETINOIN
GLYCOPYRROLATE, GLYCOPYRROLATE
* RANBAXY LABORATORIES INC
EURAX, CROTAMITON
EXELDERM, SULCONAZOLE NITRATE
FAMOTIDINE, FAMOTIDINE (OTC)
HALOG, HALCINONIDE
KENALOG, TRIAMCINOLONE ACETONIDE
LAC-HYDRIN, AMMONIUM LACTATE
RISPERIDONE, RISPERIDONE
ULTRAVATE, HALOBETASOL PROPIONATE
* RANBAXY LABORATORIES LTD
ACYCLOVIR, ACYCLOVIR
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN, AMOXICILLIN
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
CARVEDILOL, CARVEDILOL
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CEPHALEXIN, CEPHALEXIN
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CLARITHROMYCIN, CLARITHROMYCIN
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXYCYCLINE, DOXYCYCLINE
FENOFIBRATE, FENOFIBRATE
FLECAINIDE ACETATE, FLECAINIDE ACETATE
FLUCONAZOLE, FLUCONAZOLE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
GABAPENTIN, GABAPENTIN
LORATADINE AND PSEUDOEPHEDRINE SULFATE, LORATADINE (OTC)
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 118
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** R **
* RANBAXY LABORATORIES LTD
LORATADINE REDIDOSE, LORATADINE (OTC)
LORATADINE, LORATADINE (OTC)
LORAZEPAM, LORAZEPAM
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE
ONDANSETRON, ONDANSETRON
OXCARBAZEPINE, OXCARBAZEPINE
PSEUDOEPHEDRINE HYDROCHLORIDE, PSEUDOEPHEDRINE HYDROCHLORIDE (OTC)
QUINAPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
SOTRET, ISOTRETINOIN
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TOPIRAMATE, TOPIRAMATE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
* RANBAXY PHARMACEUTICALS INC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN, AMOXICILLIN
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LOPERAMIDE HYDROCHLORIDE AND SIMETHICONE, LOPERAMIDE HYDROCHLORIDE (OTC)
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
RIOMET, METFORMIN HYDROCHLORIDE
SOTRET, ISOTRETINOIN
RANBAXY LABS LTD
* RANBAXY LABORATORIES LIMITED
NAPROXEN SODIUM, NAPROXEN SODIUM (OTC)
* RANBAXY LABORATORIES LTD
ACETAMINOPHEN, ACETAMINOPHEN (OTC)
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
FELODIPINE, FELODIPINE
FENOFIBRATE, FENOFIBRATE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
RAPTOR INC
* RAPTOR PHARMACEUTICALS INC
PROCYSBI, CYSTEAMINE BITARTRATE
RARE DIS THERAP
* RARE DISEASE THERAPEUTICS INC
CYSTADANE, BETAINE HYDROCHLORIDE
RECIP
* RECIP AB
THYROSAFE, POTASSIUM IODIDE (OTC)
RECKITT BENCKISER
* RECKITT BENCKISER LLC
DELSYM, DEXTROMETHORPHAN POLISTIREX (OTC)
MUCINEX D, GUAIFENESIN (OTC)
MUCINEX DM, DEXTROMETHORPHAN HYDROBROMIDE (OTC)
MUCINEX, GUAIFENESIN (OTC)
* RECKITT BENCKISER PHARMACEUTICALS INC
BUPRENEX, BUPRENORPHINE HYDROCHLORIDE
SUBOXONE, BUPRENORPHINE HYDROCHLORIDE
RECORDATI RARE
* RECORDATI RARE DISEASES INC
CHEMET, SUCCIMER
COSMEGEN, DACTINOMYCIN
DESOXYN, METHAMPHETAMINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 119
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** R **
* RECORDATI RARE DISEASES INC
INDOCIN, INDOMETHACIN SODIUM
MUSTARGEN, MECHLORETHAMINE HYDROCHLORIDE
NEOPROFEN, IBUPROFEN LYSINE
PEGANONE, ETHOTOIN
TRANXENE, CLORAZEPATE DIPOTASSIUM
REMPEX PHARMS INC
* REMPEX PHARMACEUTICALS INC
MINOCIN, MINOCYCLINE HYDROCHLORIDE
RENAISSANCE PHARMA
* RENAISSANCE PHARMA US HOLDINGS INC
ELIMITE, PERMETHRIN
RHODES PHARMS
* RHODES PHARMACEUTICALS LP
MORPHINE SULFATE, MORPHINE SULFATE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
THEOPHYLLINE, THEOPHYLLINE
UNIPHYL, THEOPHYLLINE
RICONPHARMA LLC
* RICONPHARMA LLC
GRISEOFULVIN, ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE
RISING PHARMS INC
* RISING PHARMACEUTICALS INC
PARICALCITOL, PARICALCITOL
ROCHE PALO
* ROCHE PALO ALTO LLC
CELLCEPT, MYCOPHENOLATE MOFETIL
CELLCEPT, MYCOPHENOLATE MOFETIL HYDROCHLORIDE
CYTOVENE, GANCICLOVIR SODIUM
EC-NAPROSYN, NAPROXEN
NAPROSYN, NAPROXEN
ROCKWELL MEDCL
* ROCKWELL MEDICAL TECHNOLOGIES INC
CALCITRIOL, CALCITRIOL
ROMARK
* ROMARK LABORATORIES
ALINIA, NITAZOXANIDE
ROSEDALE THERAPEUTIC
* ROSEDALE THERAPEUTICS
ERGOMAR, ERGOTAMINE TARTRATE
ROUSES POINT PHARMS
* ROUSES POINT PHARMACEUTICALS LLC
LEVETIRACETAM, LEVETIRACETAM
ROXANE
* ROXANE LABORATORIES INC
ACARBOSE, ACARBOSE
ALENDRONATE SODIUM, ALENDRONATE SODIUM
ALPRAZOLAM, ALPRAZOLAM
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ANASTROZOLE, ANASTROZOLE
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
BALSALAZIDE DISODIUM, BALSALAZIDE DISODIUM
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
BUPRENORPHINE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
BUTORPHANOL TARTRATE, BUTORPHANOL TARTRATE
CALCITRIOL, CALCITRIOL
CALCIUM ACETATE, CALCIUM ACETATE
CEVIMELINE HYDROCHLORIDE, CEVIMELINE HYDROCHLORIDE
CILOSTAZOL, CILOSTAZOL
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLARITHROMYCIN, CLARITHROMYCIN
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
CLOTRIMAZOLE, CLOTRIMAZOLE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 120
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** R **
* ROXANE LABORATORIES INC
CODEINE SULFATE, CODEINE SULFATE
CYCLOPHOSPHAMIDE, CYCLOPHOSPHAMIDE
DEXAMETHASONE INTENSOL, DEXAMETHASONE
DEXAMETHASONE, DEXAMETHASONE
DIAZEPAM INTENSOL, DIAZEPAM
DIAZEPAM, DIAZEPAM
DIGOXIN, DIGOXIN
DIPHENOXYLATE HYDROCHLORIDE AND ATROPINE SULFATE,
ATROPINE SULFATE
DISULFIRAM, DISULFIRAM
DOLOPHINE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXERCALCIFEROL, DOXERCALCIFEROL
ESZOPICLONE, ESZOPICLONE
EXEMESTANE, EXEMESTANE
FAMCICLOVIR, FAMCICLOVIR
FLECAINIDE ACETATE, FLECAINIDE ACETATE
FLUCONAZOLE, FLUCONAZOLE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
FUROSEMIDE, FUROSEMIDE
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HYDROMORPHONE HYDROCHLORIDE, HYDROMORPHONE HYDROCHLORIDE
IMIPRAMINE PAMOATE, IMIPRAMINE PAMOATE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
LACTULOSE, LACTULOSE
LETROZOLE, LETROZOLE
LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM
LEVETIRACETAM, LEVETIRACETAM
LEVORPHANOL TARTRATE, LEVORPHANOL TARTRATE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LIDOCAINE VISCOUS, LIDOCAINE HYDROCHLORIDE
LITHIUM CARBONATE, LITHIUM CARBONATE
LITHIUM CITRATE, LITHIUM CITRATE
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
LORAZEPAM INTENSOL, LORAZEPAM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE
MEGESTROL ACETATE, MEGESTROL ACETATE
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
MERCAPTOPURINE, MERCAPTOPURINE
METHADONE HYDROCHLORIDE INTENSOL, METHADONE HYDROCHLORIDE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
METHOTREXATE SODIUM, METHOTREXATE SODIUM
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MORPHINE SULFATE, MORPHINE SULFATE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NAPROXEN, NAPROXEN
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXCARBAZEPINE, OXCARBAZEPINE
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
PERINDOPRIL ERBUMINE, PERINDOPRIL ERBUMINE
PHENOXYBENZAMINE HYDROCHLORIDE, PHENOXYBENZAMINE HYDROCHLORIDE
PILOCARPINE HYDROCHLORIDE, PILOCARPINE HYDROCHLORIDE
PREDNISONE INTENSOL, PREDNISONE
PREDNISONE, PREDNISONE
PROPANTHELINE BROMIDE, PROPANTHELINE BROMIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 121
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** R **
* ROXANE LABORATORIES INC
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RAMIPRIL, RAMIPRIL
RISPERIDONE, RISPERIDONE
RITONAVIR, RITONAVIR
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
ROXICET, ACETAMINOPHEN
SODIUM POLYSTYRENE SULFONATE, SODIUM POLYSTYRENE SULFONATE
TINIDAZOLE, TINIDAZOLE
TORSEMIDE, TORSEMIDE
TRIAZOLAM, TRIAZOLAM
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
ZALEPLON, ZALEPLON
ZIDOVUDINE, ZIDOVUDINE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
RUBICON RES PVT LTD
* RUBICON RESEARCH PVT LTD
METOPROLOL TARTRATE, METOPROLOL TARTRATE
** S **
SAGE PRODS
* SAGE PRODUCTS INC
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE (OTC)
SAGENT AGILA
* SAGENT AGILA LLC
ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM
BUPIVACAINE HYDROCHLORIDE PRESERVATIVE FREE, BUPIVACAINE HYDROCHLORIDE
BUPIVACAINE HYDROCHLORIDE, BUPIVACAINE HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
SAGENT PHARMS
* SAGENT PHARMACEUTICALS INC
ATRACURIUM BESYLATE PRESERVATIVE FREE, ATRACURIUM BESYLATE
ATRACURIUM BESYLATE, ATRACURIUM BESYLATE
CAFFEINE CITRATE, CAFFEINE CITRATE
CALCITRIOL, CALCITRIOL
CARBOPLATIN, CARBOPLATIN
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
FLUMAZENIL, FLUMAZENIL
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GLYDO, LIDOCAINE HYDROCHLORIDE
HALOPERIDOL, HALOPERIDOL LACTATE
HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM
HEPARIN SODIUM, HEPARIN SODIUM
IBANDRONATE SODIUM, IBANDRONATE SODIUM
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LEUCOVORIN CALCIUM PRESERVATIVE FREE, LEUCOVORIN CALCIUM
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
MESNA, MESNA
NAFCILLIN SODIUM, NAFCILLIN SODIUM
OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
OXACILLIN SODIUM, OXACILLIN SODIUM
OXYTOCIN, OXYTOCIN
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
SAGENT STRIDES
* SAGENT STRIDES LLC
ADENOSINE, ADENOSINE
AZITHROMYCIN, AZITHROMYCIN
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 122
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** S **
* SAGENT STRIDES LLC
BACITRACIN, BACITRACIN
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
LABETALOL HYDROCLORIDE, LABETALOL HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MIDAZOLAM HYDROCHLORIDE PRESERVATIVE FREE, MIDAZOLAM HYDROCHLORIDE
MIDOZALAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
POLYMYCIN B SULFATE, POLYMYXIN B SULFATE
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
ROPIVACAINE HYDROCHLORIDE, ROPIVACAINE HYDROCHLORIDE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
SALIX PHARMS
* SALIX PHARMACEUTICALS INC
ANUSOL HC, HYDROCORTISONE
APRISO, MESALAMINE
COLAZAL, BALSALAZIDE DISODIUM
DIURIL, CHLOROTHIAZIDE
FULYZAQ, CROFELEMER
GIAZO, BALSALAZIDE DISODIUM
METOZOLV ODT, METOCLOPRAMIDE HYDROCHLORIDE
MOVIPREP, ASCORBIC ACID
OSMOPREP, SODIUM PHOSPHATE, DIBASIC, ANHYDROUS
PEPCID, FAMOTIDINE
RELISTOR, METHYLNALTREXONE BROMIDE
XIFAXAN, RIFAXIMIN
SALIX PHARMS INC
* SALIX PHARMACEUTICALS INC
UCERIS, BUDESONIDE
SAMSON MEDCL
* SAMSON MEDICAL TECHNOLOGIES LLC
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFTRIAXONE, CEFTRIAXONE SODIUM
SANDOZ
* SANDOZ
DOCETAXEL, DOCETAXEL
* SANDOZ CANADA INC
ANECTINE, SUCCINYLCHOLINE CHLORIDE
ARISTOSPAN, TRIAMCINOLONE HEXACETONIDE
BRIMONIDINE TARTRATE, BRIMONIDINE TARTRATE
DIGOXIN, DIGOXIN
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
FENOLDOPAM MESYLATE, FENOLDOPAM MESYLATE
FLUMAZENIL, FLUMAZENIL
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
INFUVITE ADULT, ALPHA-TOCOPHEROL ACETATE
INFUVITE PEDIATRIC (PHARMACY BULK PACKAGE), ASCORBIC ACID
INFUVITE PEDIATRIC, ASCORBIC ACID
ISONIAZID, ISONIAZID
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE
METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
REGONOL, PYRIDOSTIGMINE BROMIDE
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
* SANDOZ INC
ALPRAZOLAM, ALPRAZOLAM
ALTAVERA, ETHINYL ESTRADIOL
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 123
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** S **
* SANDOZ INC
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN, AMOXICILLIN
AMPICILLIN AND SULBACTAM, AMPICILLIN SODIUM
AMPICILLIN SODIUM, AMPICILLIN SODIUM
AMPICILLIN TRIHYDRATE, AMPICILLIN/AMPICILLIN TRIHYDRATE
ANASTROZOLE, ANASTROZOLE
APREPITANT, APREPITANT
ARGATROBAN IN SODIUM CHLORIDE, ARGATROBAN
ATENOLOL, ATENOLOL
AZITHROMYCIN, AZITHROMYCIN
BENAZEPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, BENAZEPRIL HYDROCHLORIDE
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BICALUTAMIDE, BICALUTAMIDE
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE
BISOPROLOL FUMARATE, BISOPROLOL FUMARATE
BUDESONIDE, BUDESONIDE
BUMETANIDE, BUMETANIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CAFERGOT, CAFFEINE
CANDESARTAN CILEXETIL, CANDESARTAN CILEXETIL
CAPTOPRIL, CAPTOPRIL
CARISOPRODOL AND ASPIRIN, ASPIRIN
CARISOPRODOL, ASPIRIN AND CODEINE PHOSPHATE, ASPIRIN
CARVEDILOL, CARVEDILOL
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFDINIR, CEFDINIR
CEFPODOXIME PROXETIL, CEFPODOXIME PROXETIL
CEFPROZIL, CEFPROZIL
CEFTRIAXONE, CEFTRIAXONE SODIUM
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE
CHOLESTYRAMINE LIGHT, CHOLESTYRAMINE
CHOLESTYRAMINE, CHOLESTYRAMINE
CILOSTAZOL, CILOSTAZOL
CLARITHROMYCIN, CLARITHROMYCIN
CLEMASTINE FUMARATE, CLEMASTINE FUMARATE
CLEMASTINE FUMARATE, CLEMASTINE FUMARATE (OTC)
CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE
CLONAZEPAM, CLONAZEPAM
COSYNTROPIN, COSYNTROPIN
CYCLOSPORINE, CYCLOSPORINE
DECITABINE, DECITABINE
DESIPRAMINE HYDROCHLORIDE, DESIPRAMINE HYDROCHLORIDE
DESLORATADINE, DESLORATADINE
DEXTROAMP SACCHARATE, AMP ASPARTATE, DEXTROAMP SULFATE AND AMP SULFATE, AMPHETAMINE
DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM
DICLOFENAC SODIUM AND MISOPROSTOL, DICLOFENAC SODIUM
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DOXERCALCIFEROL, DOXERCALCIFEROL
ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM
EPLERENONE, EPLERENONE
ESTARYLLA, ETHINYL ESTRADIOL
ETODOLAC, ETODOLAC
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
FLUOROURACIL, FLUOROURACIL
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUPHENAZINE HYDROCHLORIDE, FLUPHENAZINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 124
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** S **
* SANDOZ INC
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
FOSINOPRIL SODIUM AND HYDROCHLOROTHIAZIDE, FOSINOPRIL SODIUM
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
FUROSEMIDE, FUROSEMIDE
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GLIPIZIDE, GLIPIZIDE
GRISEOFULVIN, GRISEOFULVIN, MICROSIZE
HALOPERIDOL, HALOPERIDOL
HEPARIN SODIUM, HEPARIN SODIUM
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE
IMIPRAMINE HYDROCHLORIDE, IMIPRAMINE HYDROCHLORIDE
INDOMETHACIN, INDOMETHACIN
INTROVALE, ETHINYL ESTRADIOL
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
ISONIAZID, ISONIAZID
ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE
ITRACONAZOLE, ITRACONAZOLE
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN, AMOXICILLIN
LANSOPRAZOLE, LANSOPRAZOLE
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE
LEVOFLOXACIN, LEVOFLOXACIN
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LISINOPRIL, LISINOPRIL
LONOX, ATROPINE SULFATE
LORATADINE, LORATADINE (OTC)
LORAZEPAM, LORAZEPAM
LORYNA, DROSPIRENONE
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
LOVASTATIN, LOVASTATIN
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
MEFLOQUINE HYDROCHLORIDE, MEFLOQUINE HYDROCHLORIDE
MEROPENEM, MEROPENEM
METAXALONE, METAXALONE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
METHAZOLAMIDE, METHAZOLAMIDE
METHIMAZOLE, METHIMAZOLE
METHOCARBAMOL, METHOCARBAMOL
METHYLPREDNISOLONE, METHYLPREDNISOLONE
METOLAZONE, METOLAZONE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MIDODRINE HYDROCHLORIDE, MIDODRINE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NABUMETONE, NABUMETONE
NADOLOL, NADOLOL
NAFCILLIN SODIUM, NAFCILLIN SODIUM
NAPROXEN, NAPROXEN
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
NEVIRAPINE, NEVIRAPINE
NITROFURANTOIN (MONOHYDRATE/MACROCRYSTALS), NITROFURANTOIN
NIZATIDINE, NIZATIDINE
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
OMEPRAZOLE, OMEPRAZOLE
OMNITROPE, SOMATROPIN RECOMBINANT
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON, ONDANSETRON
ORPHENADRINE CITRATE, ASPIRIN, AND CAFFEINE, ASPIRIN
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 125
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** S **
* SANDOZ INC
OXACILLIN SODIUM, OXACILLIN SODIUM
OXALIPLATIN, OXALIPLATIN
OXAPROZIN, OXAPROZIN
OXAZEPAM, OXAZEPAM
PENICILLIN G POTASSIUM, PENICILLIN G POTASSIUM
PENICILLIN G SODIUM, PENICILLIN G SODIUM
PENICILLIN V POTASSIUM, PENICILLIN V POTASSIUM
PERPHENAZINE, PERPHENAZINE
PHENDIMETRAZINE TARTRATE, PHENDIMETRAZINE TARTRATE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE AND GLIMEPIRIDE, GLIMEPIRIDE
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
PIPERACILLIN AND TAZOBACTAM, PIPERACILLIN SODIUM
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
QUINIDINE SULFATE, QUINIDINE SULFATE
RAMIPRIL, RAMIPRIL
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
REPAGLINIDE, REPAGLINIDE
RESERPINE, RESERPINE
RIBAVIRIN, RIBAVIRIN
RIFAMPIN, RIFAMPIN
RISPERIDONE, RISPERIDONE
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
SPIRONOLACTONE, SPIRONOLACTONE
SULFADIAZINE, SULFADIAZINE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
SYEDA, DROSPIRENONE
TACROLIMUS, TACROLIMUS
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TELMISARTAN, TELMISARTAN
TEMAZEPAM, TEMAZEPAM
TERAZOSIN HYDROCHLORIDE, TERAZOSIN HYDROCHLORIDE
THIOTHIXENE, THIOTHIXENE
TRI-ESTARYLLA, ETHINYL ESTRADIOL
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
TRIFLUOPERAZINE HYDROCHLORIDE, TRIFLUOPERAZINE HYDROCHLORIDE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
SANDOZ CANADA INC
* SANDOZ CANADA INC
PARICALCITOL, PARICALCITOL
SANDOZ INC
* SANDOZ INC
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
ATORVASTATIN CALCIUM, ATORVASTATIN CALCIUM
CEFTRIAXONE, CEFTRIAXONE SODIUM
CISATRACURIUM BESYLATE PRESERVATIVE FREE, CISATRACURIUM BESYLATE
CISATRACURIUM BESYLATE, CISATRACURIUM BESYLATE
CLINDAMYCIN PHOSPHATE IN 5% DEXTROSE IN PLASTIC CONTAINER, CLINDAMYCIN PHOSPHATE
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
ENOXAPARIN SODIUM, ENOXAPARIN SODIUM
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
OLANZAPINE, OLANZAPINE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 126
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** S **
* SANDOZ INC
VORICONAZOLE, VORICONAZOLE
ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE
SANOCHEMIA CORP USA
* SANOCHEMIA CORP USA
SCANLUX-300, IOPAMIDOL
SCANLUX-370, IOPAMIDOL
SANOFI AVENTIS
* SANOFI AVENTIS
AFREZZA, INSULIN RECOMBINANT HUMAN
SANOFI AVENTIS US
* SANOFI AVENTIS US INC
JEVTANA KIT, CABAZITAXEL
* SANOFI AVENTIS US LLC
ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
ALLEGRA, FEXOFENADINE HYDROCHLORIDE
ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE (OTC)
ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION, FEXOFENADINE HYDROCHLORIDE (OTC)
AMARYL, GLIMEPIRIDE
AMBIEN CR, ZOLPIDEM TARTRATE
AMBIEN, ZOLPIDEM TARTRATE
ANZEMET, DOLASETRON MESYLATE
APIDRA SOLOSTAR, INSULIN GLULISINE RECOMBINANT
APIDRA, INSULIN GLULISINE RECOMBINANT
ARALEN, CHLOROQUINE PHOSPHATE
ARAVA, LEFLUNOMIDE
AUBAGIO, TERIFLUNOMIDE
AUVI-Q, EPINEPHRINE
AVALIDE, HYDROCHLOROTHIAZIDE
AVAPRO, IRBESARTAN
CANTIL, MEPENZOLATE BROMIDE
CHILDREN'S ALLEGRA ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S ALLEGRA HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
CLAFORAN IN DEXTROSE 5% IN PLASTIC CONTAINER, CEFOTAXIME SODIUM
CLAFORAN, CEFOTAXIME SODIUM
CLOMID, CLOMIPHENE CITRATE
DDAVP, DESMOPRESSIN ACETATE
DEMEROL, MEPERIDINE HYDROCHLORIDE
DIABETA, GLYBURIDE
DRISDOL, ERGOCALCIFEROL
ELOXATIN, OXALIPLATIN
FERRLECIT, SODIUM FERRIC GLUCONATE COMPLEX
GAVISCON, ALUMINUM HYDROXIDE (OTC)
HIPREX, METHENAMINE HIPPURATE
KETEK, TELITHROMYCIN
LANTUS SOLOSTAR, INSULIN GLARGINE RECOMBINANT
LANTUS, INSULIN GLARGINE RECOMBINANT
LASIX, FUROSEMIDE
LOVENOX (PRESERVATIVE FREE), ENOXAPARIN SODIUM
LOVENOX, ENOXAPARIN SODIUM
MULTAQ, DRONEDARONE HYDROCHLORIDE
NASACORT ALLERGY 24 HOUR, TRIAMCINOLONE ACETONIDE (OTC)
NICODERM CQ, NICOTINE (OTC)
NORPRAMIN, DESIPRAMINE HYDROCHLORIDE
PHISOHEX, HEXACHLOROPHENE
PLAQUENIL, HYDROXYCHLOROQUINE SULFATE
PLAVIX, CLOPIDOGREL BISULFATE
PRIFTIN, RIFAPENTINE
PRIMAQUINE, PRIMAQUINE PHOSPHATE
RIFADIN, RIFAMPIN
RIFAMATE, ISONIAZID
RIFATER, ISONIAZID
TAXOTERE, DOCETAXEL
SANOFI PASTEUR INC
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 127
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** S **
* SANOFI PASTEUR INC
SKLICE, IVERMECTIN
SANTARUS INC
* SANTARUS INC
FENOGLIDE, FENOFIBRATE
GLUMETZA, METFORMIN HYDROCHLORIDE
UCERIS, BUDESONIDE
ZEGERID, OMEPRAZOLE
SANTEN
* SANTEN INC
QUIXIN, LEVOFLOXACIN
SANTOS BIOTECH
* SANTOS BIOTECH INDUSTRIES INC
ANASTROZOLE, ANASTROZOLE
SB PHARMCO
* SB PHARMCO PUERTO RICO INC
AVANDAMET, METFORMIN HYDROCHLORIDE
AVANDARYL, GLIMEPIRIDE
AVANDIA, ROSIGLITAZONE MALEATE
COREG CR, CARVEDILOL PHOSPHATE
SCHERING
* SCHERING CORP
INTEGRILIN, EPTIFIBATIDE
NOXAFIL, POSACONAZOLE
REBETOL, RIBAVIRIN
SCHERING PLOUGH
* SCHERING PLOUGH HEALTHCARE PRODUCTS INC
AFRINOL, PSEUDOEPHEDRINE SULFATE (OTC)
CHILDREN'S CLARITIN, LORATADINE (OTC)
CHLOR-TRIMETON, CHLORPHENIRAMINE MALEATE (OTC)
CHLOR-TRIMETON, CHLORPHENIRAMINE MALEATE (OTC)
CLARITIN REDITABS, LORATADINE (OTC)
CLARITIN, LORATADINE (OTC)
CLARITIN-D 24 HOUR, LORATADINE (OTC)
CLARITIN-D, LORATADINE (OTC)
GYNE-LOTRIMIN 3, CLOTRIMAZOLE (OTC)
GYNE-LOTRIMIN COMBINATION PACK, CLOTRIMAZOLE (OTC)
GYNE-LOTRIMIN, CLOTRIMAZOLE (OTC)
LOTRIMIN ULTRA, BUTENAFINE HYDROCHLORIDE (OTC)
MIRALAX, POLYETHYLENE GLYCOL 3350 (OTC)
OCUCLEAR, OXYMETAZOLINE HYDROCHLORIDE (OTC)
SHADE UVAGUARD, AVOBENZONE (OTC)
SCIECURE PHARMA INC
* SCIECURE PHARMA INC
DORAL, QUAZEPAM
SCIEGEN PHARMS INC
* SCIEGEN PHARMACEUTICALS INC
CARISOPRODOL, CARISOPRODOL
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NEVIRAPINE, NEVIRAPINE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
SCIOS LLC
* SCIOS LLC
NATRECOR, NESIRITIDE RECOMBINANT
SEBELA IRELAND LTD
* SEBELA IRELAND LTD
MIACALCIN, CALCITONIN SALMON
MICORT-HC, HYDROCORTISONE ACETATE
PRAMOSONE, HYDROCORTISONE ACETATE
SECAN PHARMS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 128
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** S **
* SECAN PHARMACEUTICALS INC
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
SEPTODONT
* SEPTODONT INC
BUPIVACAINE HYDROCHLORIDE AND EPINEPHRINE, BUPIVACAINE HYDROCHLORIDE
OCTOCAINE, EPINEPHRINE
SEPTODONT HOLDING
* SEPTODONT HOLDING SAS
ORAVERSE, PHENTOLAMINE MESYLATE
SEPTODONT INC
* SEPTODONT INC
PRILOCAINE HYDROCHLORIDE AND EPINEPHRINE BITARTRATE, EPINEPHRINE BITARTRATE
PRILOCAINE HYDROCHLORIDE, PRILOCAINE HYDROCHLORIDE
SETON PHARM
* SETON PHARMACEUTICAL LLC
PEDIAPRED, PREDNISOLONE SODIUM PHOSPHATE
SHASUN CHEMS
* SHASUN CHEMICALS AND DRUGS LTD
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
SHASUN USA
* SHASUN USA INC
IBUPROFEN, IBUPROFEN
SHENZHEN TECHDOW
* SHENZHEN TECHDOW PHARMACEUTICAL CO LTD
HEPARIN SODIUM PRESERVATIVE FREE, HEPARIN SODIUM
HEPARIN SODIUM, HEPARIN SODIUM
SHERTECH LABS LLC
* SHERTECH LABORATORIES LLC
AMMONIA N 13, AMMONIA N-13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
SHIONOGI INC
* SHIONOGI INC
DORIBAX, DORIPENEM
FURADANTIN, NITROFURANTOIN
KEFLEX, CEPHALEXIN
OSPHENA, OSPEMIFENE
PONSTEL, MEFENAMIC ACID
ROBINUL FORTE, GLYCOPYRROLATE
ROBINUL, GLYCOPYRROLATE
SULAR, NISOLDIPINE
ULESFIA, BENZYL ALCOHOL
SHIRE
* SHIRE DEVELOPMENT INC
ADDERALL XR 10, AMPHETAMINE ASPARTATE
ADDERALL XR 15, AMPHETAMINE ASPARTATE
ADDERALL XR 20, AMPHETAMINE ASPARTATE
ADDERALL XR 25, AMPHETAMINE ASPARTATE
ADDERALL XR 30, AMPHETAMINE ASPARTATE
ADDERALL XR 5, AMPHETAMINE ASPARTATE
CARBATROL, CARBAMAZEPINE
INTUNIV, GUANFACINE HYDROCHLORIDE
LIALDA, MESALAMINE
PENTASA, MESALAMINE
SHIRE DEV LLC
* SHIRE DEVELOPMENT LLC
FOSRENOL, LANTHANUM CARBONATE
SHIRE DEVELOPMENT
* SHIRE DEVELOPMENT INC
VYVANSE, LISDEXAMFETAMINE DIMESYLATE
SHIRE HUMAN GENETIC
* SHIRE HUMAN GENETIC THERAPIES INC
VPRIV, VELAGLUCERASE ALFA
SHIRE LLC
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 129
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** S **
* SHIRE DEVELOPMENT LLC
AGRYLIN, ANAGRELIDE HYDROCHLORIDE
FOSRENOL, LANTHANUM CARBONATE
SALURON, HYDROFLUMETHIAZIDE
SHIRE ORPHAN THERAP
* SHIRE ORPHAN THERAPIES INC
FIRAZYR, ICATIBANT ACETATE
SIGMA TAU
* SIGMA TAU PHARMACEUTICALS INC
ABELCET, AMPHOTERICIN B
ADAGEN, PEGADEMASE BOVINE
CARNITOR SF, LEVOCARNITINE
CARNITOR, LEVOCARNITINE
CYSTARAN, CYSTEAMINE HYDROCHLORIDE
MATULANE, PROCARBAZINE HYDROCHLORIDE
SIGMAPHARM LABS LLC
* SIGMAPHARM LABORATORIES LLC
ADEFOVIR DIPIVOXIL, ADEFOVIR DIPIVOXIL
AMILORIDE HYDROCHLORIDE, AMILORIDE HYDROCHLORIDE
DISULFIRAM, DISULFIRAM
ERGOCALCIFEROL, ERGOCALCIFEROL
FLUCYTOSINE, FLUCYTOSINE
GRISEOFULVIN, GRISEOFULVIN, MICROSIZE
GRISEOFULVIN,ULTRAMICROSIZE, GRISEOFULVIN, ULTRAMICROSIZE
LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM
PROTRIPTYLINE HYDROCHLORIDE, PROTRIPTYLINE HYDROCHLORIDE
SODIUM PHENYLBUTYRATE, SODIUM PHENYLBUTYRATE
SILARX
* SILARX PHARMACEUTICALS INC
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
HALOPERIDOL, HALOPERIDOL LACTATE
LEVETIRACETAM, LEVETIRACETAM
LORATADINE, LORATADINE (OTC)
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
THEOPHYLLINE, THEOPHYLLINE
SILARX PHARMS INC
* SILARX PHARMACEUTICALS INC
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
LAMIVUDINE, LAMIVUDINE
RISPERIDONE, RISPERIDONE
SILVERGATE PHARMS
* SILVERGATE PHARMACEUTICALS INC
EPANED KIT, ENALAPRIL MALEATE
SKINMEDICA
* SKINMEDICA INC
VANIQA, EFLORNITHINE HYDROCHLORIDE
SKYEPHARMA AG
* SKYEPHARMA AG
TRIGLIDE, FENOFIBRATE
SMITHKLINE BEECHAM
* SMITHKLINE BEECHAM
LOVAZA, OMEGA-3-ACID ETHYL ESTERS
* SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE
ARRANON, NELARABINE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 130
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** S **
* SMITHKLINE BEECHAM CORP DBA GLAXOSMITHKLINE
COREG, CARVEDILOL
TYKERB, LAPATINIB DITOSYLATE
SOAPCO
* SOAPCO INC
BRIAN CARE, CHLORHEXIDINE GLUCONATE (OTC)
SOFGEN PHARMS
* SOFGEN PHARMACEUTICALS LLC
PROGESTERONE, PROGESTERONE
SOMERSET
* SOMERSET PHARMACEUTICALS INC
ELDEPRYL, SELEGILINE HYDROCHLORIDE
EMSAM, SELEGILINE
SOVEREIGN PHARMS
* SOVEREIGN PHARMACEUTICALS LLC
OBREDON, GUAIFENESIN
SPEAR PHARMS
* SPEAR PHARMACEUTICALS INC
FLUOROURACIL, FLUOROURACIL
SPEAR PHARMS INC
* SPEAR PHARMACEUTICALS INC
TRETINOIN, TRETINOIN
SPECTRUM PHARMS
* SPECTRUM PHARMACEUTICALS INC
BELEODAQ, BELINOSTAT
FUSILEV, LEVOLEUCOVORIN CALCIUM
STAND HOMEOPATH
* STANDARD HOMEOPATHIC CO
IVY BLOCK, BENTOQUATAM (OTC)
STASON
* STASON INDUSTRIAL CORP
ACYCLOVIR, ACYCLOVIR
CAPTOPRIL, CAPTOPRIL
SELEGILINE HYDROCHLORIDE, SELEGILINE HYDROCHLORIDE
STASON PHARMS
* STASON PHARMACEUTICALS INC
CYPROHEPTADINE HYDROCHLORIDE, CYPROHEPTADINE HYDROCHLORIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
STERI PHARMA
* STERI PHARMA LLC
CEFAZOLIN SODIUM, CEFAZOLIN SODIUM
CEFTRIAXONE, CEFTRIAXONE SODIUM
CEFUROXIME SODIUM, CEFUROXIME SODIUM
STI PHARMA LLC
* STI PHARMA LLC
BETAMETHASONE VALERATE, BETAMETHASONE VALERATE
DEXAMETHASONE, DEXAMETHASONE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
MYAMBUTOL, ETHAMBUTOL HYDROCHLORIDE
SULFATRIM PEDIATRIC, SULFAMETHOXAZOLE
TRIACIN-C, CODEINE PHOSPHATE
STIEFEL
* STIEFEL LABORATORIES INC
DUAC, BENZOYL PEROXIDE
STIEFEL GSK
* STIEFEL A GSK CO
VELTIN, CLINDAMYCIN PHOSPHATE
STIEFEL LABS INC
* STIEFEL LABORATORIES INC
FABIOR, TAZAROTENE
SORIATANE, ACITRETIN
SORILUX, CALCIPOTRIENE
STRIDES ARCOLAB LTD
* STRIDES ARCOLAB LTD
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 131
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** S **
* STRIDES ARCOLAB LTD
AMPICILLIN SODIUM, AMPICILLIN SODIUM
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
CALCITRIOL, CALCITRIOL
STRIDES PHARMA
* STRIDES PHARMA GLOBAL PTE LTD
ACARBOSE, ACARBOSE
ERGOCALCIFEROL, ERGOCALCIFEROL
HYDRALAZINE HYDROCHLORIDE, HYDRALAZINE HYDROCHLORIDE
IBUPROFEN AND DIPHENHYDRAMINE HYDROCHLORIDE, DIPHENHYDRAMINE HYDROCHLORIDE (OTC)
IMIQUIMOD, IMIQUIMOD
MELOXICAM, MELOXICAM
METHOXSALEN, METHOXSALEN
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NEVIRAPINE, NEVIRAPINE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
TACROLIMUS, TACROLIMUS
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
SUCAMPO PHARMA LLC
* SUCAMPO PHARMA AMERICAS LLC
AMITIZA, LUBIPROSTONE
SUCAMPO PHARMS
* SUCAMPO PHARMACEUTICALS INC
RESCULA, UNOPROSTONE ISOPROPYL
SUMMERS
* SUMMERS LABORATORIES INC
CROTAN, CROTAMITON
SUN PHARM INDS
* SUN PHARMACEUTICAL INDUSTRIES LTD
CARBIDOPA AND LEVODOPA, CARBIDOPA
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
DESLORATADINE, DESLORATADINE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
EPINASTINE HYDROCHLORIDE, EPINASTINE HYDROCHLORIDE
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
METOPROLOL TARTRATE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE
OLANZAPINE, OLANZAPINE
ONDANSETRON, ONDANSETRON
OXCARBAZEPINE, OXCARBAZEPINE
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TIAGABINE HYDROCHLORIDE, TIAGABINE HYDROCHLORIDE
TORSEMIDE, TORSEMIDE
SUN PHARM INDS (IN)
* SUN PHARMACEUTICAL INDUSTRIES LTD
CEPHALEXIN, CEPHALEXIN
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
ZONISAMIDE, ZONISAMIDE
SUN PHARM INDS INC
* SUN PHARMACEUTICAL INDUSTRIES INC
ALLOPURINOL, ALLOPURINOL
AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ATENOLOL, ATENOLOL
BACLOFEN, BACLOFEN
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 132
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** S **
* SUN PHARMACEUTICAL INDUSTRIES INC
BENZONATATE, BENZONATATE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
CARVEDILOL, CARVEDILOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLONAZEPAM, CLONAZEPAM
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
CLOZAPINE, CLOZAPINE
ELIXOPHYLLIN, THEOPHYLLINE
ERGOCALCIFEROL, ERGOCALCIFEROL
FLURBIPROFEN, FLURBIPROFEN
FUROSEMIDE, FUROSEMIDE
GEMFIBROZIL, GEMFIBROZIL
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
GLIPIZIDE, GLIPIZIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
INDOMETHACIN, INDOMETHACIN
ISOSORBIDE DINITRATE, ISOSORBIDE DINITRATE
LITHIUM CARBONATE, LITHIUM CARBONATE
MELOXICAM, MELOXICAM
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METHIMAZOLE, METHIMAZOLE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
MORPHINE SULFATE, MORPHINE SULFATE
NIMODIPINE, NIMODIPINE
NITROFURANTOIN, NITROFURANTOIN
OXAPROZIN, OXAPROZIN
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PAROMOMYCIN SULFATE, PAROMOMYCIN SULFATE
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
REPAGLINIDE, REPAGLINIDE
RISPERIDONE, RISPERIDONE
THEOCHRON, THEOPHYLLINE
TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
VALPROIC ACID, VALPROIC ACID
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
SUN PHARM INDS LTD
* SUN PHARMACEUTICAL INDUSTRIES LTD
AZITHROMYCIN, AZITHROMYCIN
CARISOPRODOL, CARISOPRODOL
CETIRIZINE HYDROCHLORIDE AND PSEUDOEPHEDRINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
GABAPENTIN, GABAPENTIN
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 133
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** S **
* SUN PHARMACEUTICAL INDUSTRIES LTD
IBANDRONATE SODIUM, IBANDRONATE SODIUM
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
OPCICON ONE-STEP, LEVONORGESTREL (OTC)
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RILUZOLE, RILUZOLE
RISPERIDONE, RISPERIDONE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VALPROIC ACID, VALPROIC ACID
* SUN PHARMACEUTICAL INDUSTRIES LTD.
ANASTROZOLE, ANASTROZOLE
SUN PHARMA GLOBAL
* SUN PHARMA GLOBAL FZE
ALENDRONATE SODIUM, ALENDRONATE SODIUM
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CAFFEINE CITRATE, CAFFEINE CITRATE
CARBIDOPA AND LEVODOPA, CARBIDOPA
CARBIDOPA, LEVODOPA AND ENTACAPONE, CARBIDOPA
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CHLOROTHIAZIDE SODIUM, CHLOROTHIAZIDE SODIUM
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DECITABINE, DECITABINE
DESMOPRESSIN ACETATE (NEEDS NO REFRIGERATION), DESMOPRESSIN ACETATE
DESVENLAFAXINE, DESVENLAFAXINE FUMARATE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DOCEFREZ, DOCETAXEL
DOXORUBICIN HYDROCHLORIDE (LIPOSOMAL), DOXORUBICIN HYDROCHLORIDE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
ENTACAPONE, ENTACAPONE
ESOMEPRAZOLE SODIUM, ESOMEPRAZOLE SODIUM
ESZOPICLONE, ESZOPICLONE
FINASTERIDE, FINASTERIDE
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
LANSOPRAZOLE, LANSOPRAZOLE
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE
LEVETIRACETAM, LEVETIRACETAM
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
NALTREXONE HYDROCHLORIDE, NALTREXONE HYDROCHLORIDE
NIACIN, NIACIN
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
OXALIPLATIN, OXALIPLATIN
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RISEDRONATE SODIUM, RISEDRONATE SODIUM
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TEMOZOLOMIDE, TEMOZOLOMIDE
TOPIRAMATE, TOPIRAMATE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
VECURONIUM BROMIDE, VECURONIUM BROMIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZOLEDRONIC ACID, ZOLEDRONIC ACID
ZOLMITRIPTAN, ZOLMITRIPTAN
* SUN PHARMA GLOBAL INC
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
ALPRAZOLAM, ALPRAZOLAM
AMIFOSTINE, AMIFOSTINE
AZELASTINE HYDROCHLORIDE, AZELASTINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 134
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** S **
* SUN PHARMA GLOBAL INC
BICALUTAMIDE, BICALUTAMIDE
CARBOPLATIN, CARBOPLATIN
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
SUNEVA MEDCL
* SUNEVA MEDICAL INC
TRETINOIN, TRETINOIN
SUNOVION
* SUNOVION PHARMACEUTICALS INC
BROVANA, ARFORMOTEROL TARTRATE
XOPENEX HFA, LEVALBUTEROL TARTRATE
SUNOVION PHARMS INC
* SUNOVION PHARMACEUTICALS INC
APTIOM, ESLICARBAZEPINE ACETATE
LATUDA, LURASIDONE HYDROCHLORIDE
LUNESTA, ESZOPICLONE
SUNSHINE LAKE
* SUNSHINE LAKE PHARMA CO LTD
ZIDOVUDINE, ZIDOVUDINE
SUNSTAR AMERICAS
* SUNSTAR AMERICAS INC
PAROEX, CHLORHEXIDINE GLUCONATE
SUPERNUS PHARMS
* SUPERNUS PHARMACEUTICALS INC
OXTELLAR XR, OXCARBAZEPINE
TROKENDI XR, TOPIRAMATE
SUVEN LIFE
* SUVEN LIFE SCIENCES LTD
MALATHION, MALATHION
SVADS HOLDINGS SA
* SVADS HOLDINGS SA
IBUPROFEN, IBUPROFEN (OTC)
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
SVC PHARMA
* SVC PHARMA LP
DRONABINOL, DRONABINOL
SWEDISH ORPHAN
* SWEDISH ORPHAN BIOVITRUM AB PUBL
ORFADIN, NITISINONE
SYMPLMED PHARMS LLC
* SYMPLMED PHARMACEUTICALS LLC
ACEON, PERINDOPRIL ERBUMINE
SYNTHON PHARMS
* SYNTHON PHARMACEUTICALS INC
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
** T **
MEDICINES CO
* THE MEDICINES CO
ANGIOMAX, BIVALIRUDIN
CLEVIPREX, CLEVIDIPINE
ORBACTIV, ORITAVANCIN DIPHOSPHATE
RITEDOSE CORP
* THE RITEDOSE CORP
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
TAKEDA GMBH
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 135
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** T **
* TAKEDA GMBH
ALVESCO, CICLESONIDE
OMNARIS, CICLESONIDE
ZETONNA, CICLESONIDE
TAKEDA PHARMS USA
* TAKEDA PHARMACEUTICALS USA INC
ACTOPLUS MET XR, METFORMIN HYDROCHLORIDE
ACTOPLUS MET, METFORMIN HYDROCHLORIDE
ACTOS, PIOGLITAZONE HYDROCHLORIDE
BRINTELLIX, VORTIOXETINE HYDROBROMIDE
COLCRYS, COLCHICINE
CONTRAVE, BUPROPION HYDROCHLORIDE
DEXILANT, DEXLANSOPRAZOLE
DUETACT, GLIMEPIRIDE
KAZANO, ALOGLIPTIN BENZOATE
NESINA, ALOGLIPTIN BENZOATE
OSENI, ALOGLIPTIN BENZOATE
PREVACID, LANSOPRAZOLE
PREVPAC, AMOXICILLIN
ROZEREM, RAMELTEON
ULORIC, FEBUXOSTAT
TALON THERAP
* TALON THERAPEUTICS INC
MARQIBO KIT, VINCRISTINE SULFATE
TAMARANG
* TAMARANG SA
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
TARO
* TARO PHARMACEUTICAL INDUSTRIES LTD
ACETAZOLAMIDE, ACETAZOLAMIDE
CARBAMAZEPINE, CARBAMAZEPINE
CARVEDILOL, CARVEDILOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE
DESONIDE, DESONIDE
ENALAPRIL MALEATE, ENALAPRIL MALEATE
ETODOLAC, ETODOLAC
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
FLUCONAZOLE, FLUCONAZOLE
FLUOROURACIL, FLUOROURACIL
GABAPENTIN, GABAPENTIN
HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE
IMIQUIMOD, IMIQUIMOD
KETOCONAZOLE, KETOCONAZOLE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LORATADINE, LORATADINE (OTC)
MELOXICAM, MELOXICAM
METRONIDAZOLE, METRONIDAZOLE
NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
OXCARBAZEPINE, OXCARBAZEPINE
PHENYTOIN, PHENYTOIN
* TARO PHARMACEUTICALS INC
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOTRIMAZOLE, CLOTRIMAZOLE
CLOTRIMAZOLE, CLOTRIMAZOLE (OTC)
DIFLORASONE DIACETATE, DIFLORASONE DIACETATE
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
FLUOCINONIDE, FLUOCINONIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 136
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** T **
* TARO PHARMACEUTICALS INC
HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE
MICONAZOLE NITRATE, MICONAZOLE NITRATE (OTC)
NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE
TOPICORT, DESOXIMETASONE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
WARFARIN SODIUM, WARFARIN SODIUM
* TARO PHARMACEUTICALS USA INC
ACETIC ACID, ACETIC ACID, GLACIAL
ALCLOMETASONE DIPROPIONATE, ALCLOMETASONE DIPROPIONATE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMMONIUM LACTATE, AMMONIUM LACTATE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CICLOPIROX, CICLOPIROX
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CLOBETASOL PROPIONATE (EMOLLIENT), CLOBETASOL PROPIONATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLORAZEPATE DIPOTASSIUM, CLORAZEPATE DIPOTASSIUM
CLOTRIMAZOLE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CLOTRIMAZOLE, CLOTRIMAZOLE
DERMABET, BETAMETHASONE VALERATE
DESONIDE, DESONIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DIFLORASONE DIACETATE, DIFLORASONE DIACETATE
ECONAZOLE NITRATE, ECONAZOLE NITRATE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FLO-PRED, PREDNISOLONE ACETATE
FLUOCINOLONE ACETONIDE, FLUOCINOLONE ACETONIDE
FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE
FLUOCINONIDE, FLUOCINONIDE
FLUOROURACIL, FLUOROURACIL
GENTAMICIN SULFATE, GENTAMICIN SULFATE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HALOBETASOL PROPIONATE, HALOBETASOL PROPIONATE
HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL
HYDROCORTISONE, HYDROCORTISONE
KETOZOLE, KETOCONAZOLE
LIDOCAINE, LIDOCAINE
LORATADINE, LORATADINE (OTC)
MICONAZOLE 3, MICONAZOLE NITRATE (OTC)
MOMETASONE FUROATE, MOMETASONE FUROATE
MUPIROCIN, MUPIROCIN
NYSTATIN AND TRIAMCINOLONE ACETONIDE, NYSTATIN
NYSTATIN, NYSTATIN
PHENYTOIN, PHENYTOIN
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
SULFACETAMIDE SODIUM, SULFACETAMIDE SODIUM
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE (OTC)
TERCONAZOLE, TERCONAZOLE
TERIL, CARBAMAZEPINE
TOPICORT, DESOXIMETASONE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
TRIVAGIZOLE 3, CLOTRIMAZOLE (OTC)
U-CORT, HYDROCORTISONE ACETATE
* TARO PHARMACEUTICALS, INC.
HYDROCORTISONE VALERATE, HYDROCORTISONE VALERATE
TOPICORT, DESOXIMETASONE
TARO PHARM INDS
* TARO PHARMACEUTICAL INDUSTRIES LTD
AMCINONIDE, AMCINONIDE
CARBAMAZEPINE, CARBAMAZEPINE
CICLOPIROX, CICLOPIROX
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 137
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** T **
* TARO PHARMACEUTICAL INDUSTRIES LTD
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
ETODOLAC, ETODOLAC
HYDROCORTISONE BUTYRATE, HYDROCORTISONE BUTYRATE
LAMOTRIGINE, LAMOTRIGINE
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
TARO PHARMS IRELAND
* TARO PHARMACEUTICALS IRELAND LTD
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
SODIUM CHLORIDE 0.9% IN PLASTIC CONTAINER, SODIUM CHLORIDE
STERILE WATER FOR INJECTION IN PLASTIC CONTAINER, STERILE WATER FOR INJECTION
TARO PHARMS NORTH
* TARO PHARMACEUTICALS NORTH AMERICA INC
ACETAMINOPHEN, ACETAMINOPHEN (OTC)
INFANTS' FEVERALL, ACETAMINOPHEN (OTC)
OVIDE, MALATHION
TOPICORT, DESOXIMETASONE
TEDOR PHARM
* TEDOR PHARMA INC
BENZPHETAMINE HYDROCHLORIDE, BENZPHETAMINE HYDROCHLORIDE
TEDOR PHARMA INC
* TEDOR PHARMA INC
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
TEIKOKU PHARMA USA
* TEIKOKU PHARMA USA INC
LIDODERM, LIDOCAINE
TEVA
* TEVA NEUROSCIENCE INC
AZILECT, RASAGILINE MESYLATE
* TEVA PHARMACEUTICALS USA INC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
ACYCLOVIR, ACYCLOVIR
ADIPEX-P, PHENTERMINE HYDROCHLORIDE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN PEDIATRIC, AMOXICILLIN
AMOXICILLIN, AMOXICILLIN
AMPHETAMINE ASP AMPHETAMINE SULF DEXTROAMPHET SACCHARATE & DEXTR SULF, AMPHETAMINE
ATENOLOL, ATENOLOL
AZITHROMYCIN, AZITHROMYCIN
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BETA-VAL, BETAMETHASONE VALERATE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
BICALUTAMIDE, BICALUTAMIDE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
CALCITRIOL, CALCITRIOL
CAPTOPRIL AND HYDROCHLOROTHIAZIDE, CAPTOPRIL
CAPTOPRIL, CAPTOPRIL
CARBIDOPA AND LEVODOPA, CARBIDOPA
CARVEDILOL, CARVEDILOL
CEFACLOR, CEFACLOR
CEFPROZIL, CEFPROZIL
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CELECOXIB, CELECOXIB
CEPHALEXIN, CEPHALEXIN
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE
CILOSTAZOL, CILOSTAZOL
CIMETIDINE, CIMETIDINE
CLARITHROMYCIN, CLARITHROMYCIN
CLEMASTINE FUMARATE, CLEMASTINE FUMARATE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLOMIPRAMINE HYDROCHLORIDE, CLOMIPRAMINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 138
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** T **
* TEVA PHARMACEUTICALS USA INC
CLONAZEPAM, CLONAZEPAM
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
CLOTRIMAZOLE, CLOTRIMAZOLE
DICLOFENAC POTASSIUM, DICLOFENAC POTASSIUM
DICLOXACILLIN SODIUM, DICLOXACILLIN SODIUM
DIFLUNISAL, DIFLUNISAL
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DOXAZOSIN MESYLATE, DOXAZOSIN MESYLATE
ENALAPRIL MALEATE AND HYDROCHLOROTHIAZIDE, ENALAPRIL MALEATE
ENALAPRIL MALEATE, ENALAPRIL MALEATE
ENOXAPARIN SODIUM (PRESERVATIVE FREE), ENOXAPARIN SODIUM
EPITOL, CARBAMAZEPINE
ESTAZOLAM, ESTAZOLAM
ESZOPICLONE, ESZOPICLONE
ETODOLAC, ETODOLAC
FAMOTIDINE, FAMOTIDINE
FAMOTIDINE, FAMOTIDINE (OTC)
FENOFIBRATE (MICRONIZED), FENOFIBRATE
FENOFIBRATE, FENOFIBRATE
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE, FEXOFENADINE HYDROCHLORIDE
FINASTERIDE, FINASTERIDE
FLUCONAZOLE, FLUCONAZOLE
FLUOCINONIDE EMULSIFIED BASE, FLUOCINONIDE
FLUOCINONIDE, FLUOCINONIDE
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLURBIPROFEN, FLURBIPROFEN
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
FOSINOPRIL SODIUM, FOSINOPRIL SODIUM
GALZIN, ZINC ACETATE
GEMFIBROZIL, GEMFIBROZIL
GLIMEPIRIDE, GLIMEPIRIDE
GLYBURIDE (MICRONIZED), GLYBURIDE
GLYBURIDE, GLYBURIDE
HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
KETOCONAZOLE, KETOCONAZOLE
KETOPROFEN, KETOPROFEN
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LAMOTRIGINE, LAMOTRIGINE
LEVOFLOXACIN, LEVOFLOXACIN
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE
LORATADINE, LORATADINE (OTC)
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
LOVASTATIN, LOVASTATIN
MESALAMINE, MESALAMINE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
MEXILETINE HYDROCHLORIDE, MEXILETINE HYDROCHLORIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MIRTAZAPINE, MIRTAZAPINE
MOEXIPRIL HYDROCHLORIDE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
MOEXIPRIL HYDROCHLORIDE, MOEXIPRIL HYDROCHLORIDE
MUPIROCIN, MUPIROCIN
NABUMETONE, NABUMETONE
NAPROXEN SODIUM, NAPROXEN SODIUM
NAPROXEN, NAPROXEN
NEFAZODONE HYDROCHLORIDE, NEFAZODONE HYDROCHLORIDE
NEOMYCIN SULFATE, NEOMYCIN SULFATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 139
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** T **
* TEVA PHARMACEUTICALS USA INC
NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE
NYSTATIN, NYSTATIN
OFLOXACIN, OFLOXACIN
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON, ONDANSETRON
ORAP, PIMOZIDE
OXAPROZIN, OXAPROZIN
OXYMORPHONE HYDROCHLORIDE, OXYMORPHONE HYDROCHLORIDE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PENICILLIN-VK, PENICILLIN V POTASSIUM
PIROXICAM, PIROXICAM
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PRELONE, PREDNISOLONE
QUINAPRIL HYDROCHLORIDE, QUINAPRIL HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RIBAVIRIN, RIBAVIRIN
RISPERIDONE, RISPERIDONE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
ROSIGLITAZONE MALEATE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
ROSIGLITAZONE MALEATE, ROSIGLITAZONE MALEATE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
SUCRALFATE, SUCRALFATE
SULFAMETHOXAZOLE AND TRIMETHOPRIM DOUBLE STRENGTH, SULFAMETHOXAZOLE
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TICLOPIDINE HYDROCHLORIDE, TICLOPIDINE HYDROCHLORIDE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TOLMETIN SODIUM, TOLMETIN SODIUM
TOPIRAMATE, TOPIRAMATE
TORSEMIDE, TORSEMIDE
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
TRIMETHOPRIM, TRIMETHOPRIM
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
TEVA BRANDED PHARM
* TEVA BRANDED PHARMACEUTICAL PRODUCTS R AND D INC
CENESTIN, ESTROGENS, CONJUGATED SYNTHETIC A
LOSEASONIQUE, ETHINYL ESTRADIOL
NORDETTE-28, ETHINYL ESTRADIOL
PLAN B ONE-STEP, LEVONORGESTREL (OTC)
PLAN B, LEVONORGESTREL
PLAN B, LEVONORGESTREL (OTC)
PROAIR HFA, ALBUTEROL SULFATE
PROGLYCEM, DIAZOXIDE
QNASL, BECLOMETHASONE DIPROPIONATE
QUARTETTE, ETHINYL ESTRADIOL
QVAR 40, BECLOMETHASONE DIPROPIONATE
QVAR 80, BECLOMETHASONE DIPROPIONATE
SEASONALE, ETHINYL ESTRADIOL
SEASONIQUE, ETHINYL ESTRADIOL
ZECUITY, SUMATRIPTAN SUCCINATE
TEVA PARENTERAL
* TEVA PARENTERAL MEDICINES INC
LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE
TEVA PHARMS
* TEVA PHARMACEUTICALS USA
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALENDRONATE SODIUM, ALENDRONATE SODIUM
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 140
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** T **
* TEVA PHARMACEUTICALS USA
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
AMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDE, AMLODIPINE
ANASTROZOLE, ANASTROZOLE
AZITHROMYCIN, AZITHROMYCIN
BISOPROLOL FUMARATE, BISOPROLOL FUMARATE
BUDESONIDE, BUDESONIDE
CARBAMAZEPINE, CARBAMAZEPINE
CEFADROXIL, CEFADROXIL/CEFADROXIL HEMIHYDRATE
CEFDINIR, CEFDINIR
CEFPROZIL, CEFPROZIL
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
CROMOLYN SODIUM, CROMOLYN SODIUM
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
ETHOSUXIMIDE, ETHOSUXIMIDE
FAMCICLOVIR, FAMCICLOVIR
FLUVASTATIN SODIUM, FLUVASTATIN SODIUM
GABAPENTIN, GABAPENTIN
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GEMCITABINE HYDROCHLORIDE, GEMCITABINE HYDROCHLORIDE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HALOPERIDOL, HALOPERIDOL LACTATE
HYDROCORTISONE, HYDROCORTISONE
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
IRBESARTAN, IRBESARTAN
LAMIVUDINE AND ZIDOVUDINE, LAMIVUDINE
LANSOPRAZOLE, LANSOPRAZOLE
LEFLUNOMIDE, LEFLUNOMIDE
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
LEVOCETIRIZINE DIHYDROCHLORIDE, LEVOCETIRIZINE DIHYDROCHLORIDE
LINEZOLID, LINEZOLID
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
MEGESTROL ACETATE, MEGESTROL ACETATE
MELOXICAM, MELOXICAM
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
NARATRIPTAN, NARATRIPTAN HYDROCHLORIDE
OLANZAPINE AND FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
OLANZAPINE, OLANZAPINE
OXALIPLATIN, OXALIPLATIN
PACLITAXEL, PACLITAXEL
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PRAZOSIN HYDROCHLORIDE, PRAZOSIN HYDROCHLORIDE
PREGABALIN, PREGABALIN
PROCHLORPERAZINE MALEATE, PROCHLORPERAZINE MALEATE
PROGESTERONE, PROGESTERONE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
QUINIDINE SULFATE, QUINIDINE SULFATE
QUININE SULFATE, QUININE SULFATE
RAMIPRIL, RAMIPRIL
RISEDRONATE SODIUM, RISEDRONATE SODIUM
RIZATRIPTAN BENZOATE, RIZATRIPTAN BENZOATE
ROCURONIUM BROMIDE, ROCURONIUM BROMIDE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 141
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** T **
* TEVA PHARMACEUTICALS USA
SULFAMETHOXAZOLE AND TRIMETHOPRIM SINGLE STRENGTH, SULFAMETHOXAZOLE
TAMOXIFEN CITRATE, TAMOXIFEN CITRATE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TESTOSTERONE, TESTOSTERONE
THEOPHYLLINE, THEOPHYLLINE
TRANDOLAPRIL, TRANDOLAPRIL
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
URSODIOL, URSODIOL
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VANDAZOLE, METRONIDAZOLE
VARDENAFIL HYDROCHLORIDE, VARDENAFIL HYDROCHLORIDE
VORICONAZOLE, VORICONAZOLE
ZALEPLON, ZALEPLON
TEVA PHARMS USA
* TEVA PHARMACEUTICALS USA
ACITRETIN, ACITRETIN
ADENOSINE, ADENOSINE
ALPROSTADIL, ALPROSTADIL
AMIKACIN SULFATE, AMIKACIN SULFATE
ARGATROBAN IN 0.9% SODIUM CHLORIDE, ARGATROBAN
ATAZANAVIR SULFATE, ATAZANAVIR SULFATE
BLEOMYCIN SULFATE, BLEOMYCIN SULFATE
BUPRENORPHINE HYDROCHLORIDE AND NALOXONE HYDROCHLORIDE, BUPRENORPHINE HYDROCHLORIDE
CARBOPLATIN, CARBOPLATIN
CLARAVIS, ISOTRETINOIN
COPAXONE, GLATIRAMER ACETATE
CYTOSAR-U, CYTARABINE
DACARBAZINE, DACARBAZINE
DAUNORUBICIN HYDROCHLORIDE, DAUNORUBICIN HYDROCHLORIDE
DESMOPRESSIN ACETATE, DESMOPRESSIN ACETATE
DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
DOXORUBICIN HYDROCHLORIDE, DOXORUBICIN HYDROCHLORIDE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
ENALAPRILAT, ENALAPRILAT
ENTECAVIR, ENTECAVIR
EPIRUBICIN HYDROCHLORIDE, EPIRUBICIN HYDROCHLORIDE
EPOPROSTENOL SODIUM, EPOPROSTENOL SODIUM
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
ETOPOSIDE, ETOPOSIDE
FLUCONAZOLE IN SODIUM CHLORIDE 0.9%, FLUCONAZOLE
FLUDARABINE PHOSPHATE, FLUDARABINE PHOSPHATE
FLUOROURACIL, FLUOROURACIL
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
HALOPERIDOL DECANOATE, HALOPERIDOL DECANOATE
HALOPERIDOL, HALOPERIDOL LACTATE
IDARUBICIN HYDROCHLORIDE PFS, IDARUBICIN HYDROCHLORIDE
IFOSFAMIDE, IFOSFAMIDE
IFOSFAMIDE/MESNA KIT, IFOSFAMIDE
IRINOTECAN HYDROCHLORIDE, IRINOTECAN HYDROCHLORIDE
LANSOPRAZOLE, AMOXICILLIN AND CLARITHROMYCIN, AMOXICILLIN
LEUCOVORIN CALCIUM, LEUCOVORIN CALCIUM
LEUPROLIDE ACETATE, LEUPROLIDE ACETATE
LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE
LEVOCARNITINE, LEVOCARNITINE
MEDROXYPROGESTERONE ACETATE, MEDROXYPROGESTERONE ACETATE
MESNA, MESNA
METHYLPREDNISOLONE ACETATE, METHYLPREDNISOLONE ACETATE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
MITOXANTRONE HYDROCHLORIDE, MITOXANTRONE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE
MYCOPHENOLIC ACID, MYCOPHENOLIC ACID
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 142
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** T **
* TEVA PHARMACEUTICALS USA
NOREPINEPHRINE BITARTRATE, NOREPINEPHRINE BITARTRATE
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE
OMEGA-3-ACID ETHYL ESTERS, OMEGA-3-ACID ETHYL ESTERS
PAMIDRONATE DISODIUM, PAMIDRONATE DISODIUM
PANCURONIUM BROMIDE, PANCURONIUM BROMIDE
PARICALCITOL, PARICALCITOL
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
PROPOFOL, PROPOFOL
RALOXIFENE HYDROCHLORIDE, RALOXIFENE HYDROCHLORIDE
RAMELTEON, RAMELTEON
RISEDRONATE SODIUM, RISEDRONATE SODIUM
SOLIFENACIN SUCCINATE, SOLIFENACIN SUCCINATE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
TOBRAMYCIN, TOBRAMYCIN
TOPOTECAN HYDROCHLORIDE, TOPOTECAN HYDROCHLORIDE
VECURONIUM BROMIDE, VECURONIUM BROMIDE
VINCRISTINE SULFATE PFS, VINCRISTINE SULFATE
VINORELBINE TARTRATE, VINORELBINE TARTRATE
ZANOSAR, STREPTOZOCIN
ZOLMITRIPTAN, ZOLMITRIPTAN
* TEVA PHARMACEUTICALS USA INC
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
CAPECITABINE, CAPECITABINE
ESTRADIOL AND NORETHINDRONE ACETATE, ESTRADIOL
IMIQUIMOD, IMIQUIMOD
METRONIDAZOLE, METRONIDAZOLE
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM
SELFEMRA, FLUOXETINE HYDROCHLORIDE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TEVA PHARMS USA INC
* TEVA PHARMACEUTICALS USA INC
ADASUVE, LOXAPINE
TEVA WOMENS
* TEVA WOMENS HEALTH INC
ENJUVIA, ESTROGENS, CONJUGATED SYNTHETIC B
PARAGARD T 380A, COPPER
REVIA, NALTREXONE HYDROCHLORIDE
ZEBETA, BISOPROLOL FUMARATE
ZIAC, BISOPROLOL FUMARATE
THE FEINSTEIN INST
* THE FEINSTEIN INSTITUTE FOR MEDICAL RESEARCH
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
THE PHARMA NETWORK
* THE PHARMA NETWORK LLC
BENZONATATE, BENZONATATE
THE PHARMANETWORK
* THE PHARMANETWORK LLC
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
THEPHARMANETWORK LLC
* THEPHARMANETWORK LLC
BENZONATATE, BENZONATATE
ISONIAZID, ISONIAZID
NIMODIPINE, NIMODIPINE
THERMAZENE, SILVER SULFADIAZINE
THERAKOS
* THERAKOS INC
UVADEX, METHOXSALEN
THERATECHNOLOGIES
* THERATECHNOLOGIES INC
EGRIFTA, TESAMORELIN ACETATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 143
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** T **
THERAVANCE BIOPHARMA
* THERAVANCE BIOPHARMA ANTIBIOTICS INC
VIBATIV, TELAVANCIN HYDROCHLORIDE
THREE RIVERS PHARMS
* THREE RIVERS PHARMACEUTICALS LLC
RIBASPHERE, RIBAVIRIN
RIBAVIRIN, RIBAVIRIN
TOLMAR
* TOLMAR INC
ADAPALENE, ADAPALENE
ATRIDOX, DOXYCYCLINE HYCLATE
BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE, BETAMETHASONE DIPROPIONATE
CALCIPOTRIENE, CALCIPOTRIENE
CICLOPIROX, CICLOPIROX
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
DICLOFENAC SODIUM , DICLOFENAC SODIUM
ERYTHROMYCIN AND BENZOYL PEROXIDE, BENZOYL PEROXIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
IMIQUIMOD, IMIQUIMOD
KETOCONAZOLE, KETOCONAZOLE
LEVETIRACETAM, LEVETIRACETAM
LIDOCAINE AND PRILOCAINE, LIDOCAINE
METRONIDAZOLE, METRONIDAZOLE
MOMETASONE FUROATE, MOMETASONE FUROATE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
TOLMAR THERAP
* TOLMAR THERAPEUTICS INC
ELIGARD, LEUPROLIDE ACETATE
TORPHARM
* TORPHARM INC
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
TORRENT PHARM
* TORRENT PHARMA INC
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
TORRENT PHARMS
* TORRENT PHARMACEUTICALS LIMITED
LEVOFLOXACIN, LEVOFLOXACIN
* TORRENT PHARMACEUTICALS LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
CARBAMAZEPINE, CARBAMAZEPINE
CITALOPRAM HYDROBROMIDE, CITALOPRAM HYDROBROMIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
RISPERIDONE, RISPERIDONE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
* TORRENT PHARMACEUTICALS LTD.
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
TORRENT PHARMS LLC
* TORRENT PHARMACEUTICALS LLC
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
OLANZAPINE, OLANZAPINE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
TORRENT PHARMS LTD
* TORRENT PHARMACEUTICALS LTD
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 144
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** T **
* TORRENT PHARMACEUTICALS LTD
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
FELODIPINE, FELODIPINE
FLUVOXAMINE MALEATE, FLUVOXAMINE MALEATE
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MOXIFLOXACIN HYDROCHLORIDE, MOXIFLOXACIN HYDROCHLORIDE
OLANZAPINE, OLANZAPINE
PIOGLITAZONE HYDROCHLORIDE AND METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
QUETIAPINE FUMARATE, QUETIAPINE FUMARATE
RABEPRAZOLE SODIUM, RABEPRAZOLE SODIUM
SILDENAFIL CITRATE, SILDENAFIL CITRATE
TELMISARTAN AND AMLODIPINE, AMLODIPINE BESYLATE
TELMISARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
TELMISARTAN, TELMISARTAN
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
VALSARTAN, VALSARTAN
TRIS PHARMA INC
* TRIS PHARMA INC
CHILDREN'S CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CHILDREN'S CETIRIZINE HYDROCHLORIDE HIVES RELIEF, CETIRIZINE HYDROCHLORIDE (OTC)
DEXTROAMPHETAMINE SULFATE, DEXTROAMPHETAMINE SULFATE
DEXTROMETHORPHAN POLISTIREX, DEXTROMETHORPHAN POLISTIREX (OTC)
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROCODONE BITARTRATE AND PSEUDOEPHEDRINE HYDROCHLORIDE, HYDROCODONE BITARTRATE
HYDROCODONE BITARTRATE, CHLORPHENIRAMINE MALEATE AND PSEUDOEPHEDRINE HYDROCHLORIDE,
HYDROCODONE POLISTIREX AND CHLORPHENIRAMINE POLISTIREX, CHLORPHENIRAMINE POLISTIREX
IBUPROFEN, IBUPROFEN (OTC)
KARBINAL ER, CARBINOXAMINE MALEATE
LEVETIRACETAM, LEVETIRACETAM
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
THEOPHYLLINE, THEOPHYLLINE
TRUSTEES UNIV PA
* TRUSTEES OF THE UNIV OF PENNSYLVANIA
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
TRYGG
* TRYGG PHARMA INC
OMTRYG, OMEGA-3-ACID ETHYL ESTERS
TWI PHARMS INC
* TWI PHARMACEUTICALS INC
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
MEGESTROL ACETATE, MEGESTROL ACETATE
NIFEDIPINE, NIFEDIPINE
** U **
UCB INC
* UCB INC
KEPPRA XR, LEVETIRACETAM
KEPPRA, LEVETIRACETAM
METADATE CD, METHYLPHENIDATE HYDROCHLORIDE
METADATE ER, METHYLPHENIDATE HYDROCHLORIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
NEUPRO, ROTIGOTINE
TUSSIONEX PENNKINETIC, CHLORPHENIRAMINE POLISTIREX
UNIRETIC, HYDROCHLOROTHIAZIDE
UNIVASC, MOEXIPRIL HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 145
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** U **
* UCB INC
VIMPAT, LACOSAMIDE
XYZAL, LEVOCETIRIZINE DIHYDROCHLORIDE
ZAROXOLYN, METOLAZONE
UCLA BIOMEDICAL
* UCLA BIOMEDICAL CYCLOTRON
AMMONIA N 13, AMMONIA N-13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
UCSF RODIOPHARM
* UCSF RADIOPHARMACEUTICAL FACILITY
AMMONIA N 13, AMMONIA N-13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
UIHC PET IMAGING
* UNIV IOWA HOSPS AND CLINICS PET IMAGING CENTER
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
UNICHEM
* UNICHEM LABORATORIES LTD
BISOPROLOL FUMARATE AND HYDROCHLOROTHIAZIDE, BISOPROLOL FUMARATE
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
MELOXICAM, MELOXICAM
ZALEPLON, ZALEPLON
UNICHEM LABS LTD
* UNICHEM LABORATORIES LIMITED
DIVALPROEX SODIUM, DIVALPROEX SODIUM
* UNICHEM LABORATORIES LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
LAMOTRIGINE, LAMOTRIGINE
METRONIDAZOLE, METRONIDAZOLE
TIZANIDINE HYDROCHLORIDE, TIZANIDINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
UNICHEM PHARMS (USA)
* UNICHEM PHARMACEUTICALS (USA) INC
BISOPROLOL FUMARATE, BISOPROLOL FUMARATE
UNIMARK REMEDIES LTD
* UNIMARK REMEDIES LTD
MONTELUKAST SODIUM, MONTELUKAST SODIUM
UNIQUE PHARM LABS
* UNIQUE PHARMACEUTICAL LABORATORIES
ATENOLOL, ATENOLOL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE HIVES, CETIRIZINE HYDROCHLORIDE (OTC)
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
FLUCONAZOLE, FLUCONAZOLE
TINIDAZOLE, TINIDAZOLE
UNITED BIOMEDCL
* UNITED BIOMEDICAL INC
TERBUTALINE SULFATE, TERBUTALINE SULFATE
UNITED GUARDIAN
* UNITED GUARDIAN INC
RENACIDIN, CITRIC ACID
UNITED THERAP
* UNITED THERAPEUTICS CORP
ORENITRAM, TREPROSTINIL DIOLAMINE
REMODULIN, TREPROSTINIL
TYVASO, TREPROSTINIL
UNIV TX MD ANDERSON
* UNIV TEXAS MD ANDERSON CANCER CENTER
AMMONIA N 13, AMMONIA N-13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 146
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** U **
* UNIV TEXAS MD ANDERSON CANCER CENTER
SODIUM FLUORIDE F-18, SODIUM FLUORIDE F-18
UPSHER SMITH
* UPSHER SMITH LABORATORIES INC
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
FORTICAL, CALCITONIN SALMON RECOMBINANT
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
MORPHINE SULFATE, MORPHINE SULFATE
NIACOR, NIACIN
NYSTATIN, NYSTATIN
ORVATEN, MIDODRINE HYDROCHLORIDE
OXANDROLONE, OXANDROLONE
PACERONE, AMIODARONE HYDROCHLORIDE
PENTOXIL, PENTOXIFYLLINE
PREVALITE, CHOLESTYRAMINE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
QUDEXY XR, TOPIRAMATE
SORINE, SOTALOL HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
VOGELXO, TESTOSTERONE
ZALEPLON, ZALEPLON
UPSHER SMITH LABS
* UPSHER SMITH LABORATORIES INC
KLOR-CON M10, POTASSIUM CHLORIDE
KLOR-CON M15, POTASSIUM CHLORIDE
KLOR-CON M20, POTASSIUM CHLORIDE
UPSHER-SMITH LABS
* UPSHER-SMITH LABORATORIES INC
KLOR-CON, POTASSIUM CHLORIDE
US PHARMS HOLDINGS I
* US PHARMACEUTICALS HOLDINGS I LLC
LOPRESSOR HCT, HYDROCHLOROTHIAZIDE
LOPRESSOR, METOPROLOL TARTRATE
LOTENSIN HCT, BENAZEPRIL HYDROCHLORIDE
LOTENSIN, BENAZEPRIL HYDROCHLORIDE
PARLODEL, BROMOCRIPTINE MESYLATE
US WORLDMEDS
* US WORLDMEDS LLC
APOKYN, APOMORPHINE HYDROCHLORIDE
REVONTO, DANTROLENE SODIUM
USL PHARMA
* USL PHARMA INC
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
BACLOFEN, BACLOFEN
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
CHLORDIAZEPOXIDE HYDROCHLORIDE, CHLORDIAZEPOXIDE HYDROCHLORIDE
CHLORPROMAZINE HYDROCHLORIDE, CHLORPROMAZINE HYDROCHLORIDE
ESTRADIOL, ESTRADIOL
FLUOXYMESTERONE, FLUOXYMESTERONE
JANTOVEN, WARFARIN SODIUM
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
USV NORTH AMERICA
* USV NORTH AMERICA INC
ZOLEDRONIC ACID, ZOLEDRONIC ACID
** V **
VALEANT
* VALEANT PHARMACEUTICALS INTERNATIONAL
ANCOBON, FLUCYTOSINE
BONTRIL PDM, PHENDIMETRAZINE TARTRATE
BONTRIL, PHENDIMETRAZINE TARTRATE
D.H.E. 45, DIHYDROERGOTAMINE MESYLATE
MIGRANAL, DIHYDROERGOTAMINE MESYLATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 147
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** V **
* VALEANT PHARMACEUTICALS INTERNATIONAL
MOTOFEN, ATROPINE SULFATE
MYSOLINE, PRIMIDONE
VALEANT BERMUDA
* VALEANT INTERNATIONAL BERMUDA
APLENZIN, BUPROPION HYDROBROMIDE
BENZACLIN, BENZOYL PEROXIDE
CARAC, FLUOROURACIL
DERMATOP E EMOLLIENT, PREDNICARBATE
DERMATOP, PREDNICARBATE
ELIDEL, PIMECROLIMUS
ISORDIL, ISOSORBIDE DINITRATE
KLARON, SULFACETAMIDE SODIUM
NORITATE, METRONIDAZOLE
PENLAC, CICLOPIROX
PENTOXIFYLLINE, PENTOXIFYLLINE
RETIN-A, TRETINOIN
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
XENAZINE, TETRABENAZINE
XERESE, ACYCLOVIR
ZOVIRAX, ACYCLOVIR
VALEANT INTL
* VALEANT INTERNATIONAL BARBADOS SRL
ATIVAN, LORAZEPAM
CARDIZEM CD, DILTIAZEM HYDROCHLORIDE
CARDIZEM LA, DILTIAZEM HYDROCHLORIDE
CARDIZEM, DILTIAZEM HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DILTIAZEM HYDROCHLORIDE, DILTIAZEM HYDROCHLORIDE
FENOFIBRATE, FENOFIBRATE
NIFEDIPINE, NIFEDIPINE
RENOVA, TRETINOIN
RETIN-A MICRO, TRETINOIN
RETIN-A, TRETINOIN
RETIN-A-MICRO, TRETINOIN
TIAZAC, DILTIAZEM HYDROCHLORIDE
ULTRAM ER, TRAMADOL HYDROCHLORIDE
VASERETIC, ENALAPRIL MALEATE
VASOTEC, ENALAPRIL MALEATE
WELLBUTRIN XL, BUPROPION HYDROCHLORIDE
* VALEANT INTERNATIONAL SRL
BENZAMYCIN, BENZOYL PEROXIDE
VALEANT LUXEMBOURG
* VALEANT PHARMACEUTICALS LUXEMBOURG SARL
BENZAMYCIN PAK, BENZOYL PEROXIDE
ERTACZO, SERTACONAZOLE NITRATE
GRIFULVIN V, GRISEOFULVIN, MICROSIZE
TARGRETIN, BEXAROTENE
VALEANT PHARM INTL
* VALEANT PHARMACEUTICALS INTERNATIONAL
8-MOP, METHOXSALEN
ANDROID 10, METHYLTESTOSTERONE
ANDROID 25, METHYLTESTOSTERONE
EFUDEX, FLUOROURACIL
LIBRIUM, CHLORDIAZEPOXIDE HYDROCHLORIDE
MESTINON, PYRIDOSTIGMINE BROMIDE
OXSORALEN, METHOXSALEN
TESTRED, METHYLTESTOSTERONE
VIRAZOLE, RIBAVIRIN
ZELAPAR, SELEGILINE HYDROCHLORIDE
VALEANT PHARM NORTH
* VALEANT PHARMACEUTICAL NORTH AMERICA LLC
MESTINON, PYRIDOSTIGMINE BROMIDE
MINITRAN, NITROGLYCERIN
VALEANT PHARMS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 148
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** V **
* VALEANT PHARMACEUTICALS NORTH AMERICA
MEPHYTON, PHYTONADIONE
TENSILON PRESERVATIVE FREE, EDROPHONIUM CHLORIDE
TENSILON, EDROPHONIUM CHLORIDE
VALEANT PHARMS INC
* VALEANT PHARMACEUTICALS INTERNATIONAL INC
GRIS-PEG, GRISEOFULVIN, ULTRAMICROSIZE
VISUDYNE, VERTEPORFIN
VALEANT PHARMS LLC
* VALEANT PHARMACEUTICALS NORTH AMERICA LLC
CAPITAL AND CODEINE, ACETAMINOPHEN
MACUGEN, PEGAPTANIB SODIUM
MESTINON, PYRIDOSTIGMINE BROMIDE
TASMAR, TOLCAPONE
TIMOPTIC-XE, TIMOLOL MALEATE
VALEANT PHARMS NORTH
* VALEANT PHARMACEUTICALS NORTH AMERICA LLC
DIASTAT ACUDIAL, DIAZEPAM
DIASTAT, DIAZEPAM
VALIDUS PHARMS
* VALIDUS PHARMACEUTICALS LLC
ROCALTROL, CALCITRIOL
VALIDUS PHARMS INC
* VALIDUS PHARMACEUTICALS INC
EQUETRO, CARBAMAZEPINE
MARPLAN, ISOCARBOXAZID
VANDA PHARMS INC
* VANDA PHARMACEUTICALS INC
HETLIOZ, TASIMELTEON
VANSEN PHARMA
* VANSEN PHARMA
SPECTRACEF, CEFDITOREN PIVOXIL
VELDANA MEDICAL SA
* VELDANA MEDICAL SA
ECOZA, ECONAZOLE NITRATE
VEROSCIENCE
* VEROSCIENCE LLC
CYCLOSET, BROMOCRIPTINE MESYLATE
VERSAPHARM
* VERSAPHARM INC
CICLOPIROX, CICLOPIROX
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
DEMECLOCYCLINE HYDROCHLORIDE, DEMECLOCYCLINE HYDROCHLORIDE
DESOXIMETASONE, DESOXIMETASONE
ERYTHROMYCIN, ERYTHROMYCIN
ETHOSUXIMIDE, ETHOSUXIMIDE
RIFAMPIN, RIFAMPIN
VERSAPHARM INC
* VERSAPHARM INC
DESOXIMETASONE, DESOXIMETASONE
RIFAMPIN, RIFAMPIN
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
* VERSAPHARM INCORPORATED
TRANEXAMIC ACID, TRANEXAMIC ACID
VERTEX PHARMS
* VERTEX PHARMACEUTICALS INC
INCIVEK, TELAPREVIR
KALYDECO, IVACAFTOR
VERTICAL PHARMS LLC
* VERTICAL PHARMACEUTICALS LLC
DIVIGEL, ESTRADIOL
VICURON
* VICURON PHARMACEUTICALS INC
ERAXIS, ANIDULAFUNGIN
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 149
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** V **
VIFOR FRESENIUS
* VIFOR FRESENIUS MEDICAL CARE RENAL PHARMA FRANCE
VELPHORO, SUCROFERRIC OXYHYDROXIDE
VIIV HLTHCARE
* VIIV HEALTHCARE CO
COMBIVIR, LAMIVUDINE
EPIVIR, LAMIVUDINE
EPZICOM, ABACAVIR SULFATE
LEXIVA, FOSAMPRENAVIR CALCIUM
RESCRIPTOR, DELAVIRDINE MESYLATE
RETROVIR, ZIDOVUDINE
SELZENTRY, MARAVIROC
TIVICAY, DOLUTEGRAVIR SODIUM
TRIUMEQ, ABACAVIR SULFATE
TRIZIVIR, ABACAVIR SULFATE
ZIAGEN, ABACAVIR SULFATE
VINTAGE
* VINTAGE PHARMACEUTICALS LLC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
ACETIC ACID, ACETIC ACID, GLACIAL
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALPRAZOLAM, ALPRAZOLAM
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
BENZTROPINE MESYLATE, BENZTROPINE MESYLATE
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
FOLIC ACID, FOLIC ACID
GLIMEPIRIDE, GLIMEPIRIDE
GLYCOPYRROLATE, GLYCOPYRROLATE
HYDROCORTISONE AND ACETIC ACID, ACETIC ACID, GLACIAL
HYDROCORTISONE, HYDROCORTISONE
LIDOCAINE HYDROCHLORIDE VISCOUS, LIDOCAINE HYDROCHLORIDE
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LISINOPRIL, LISINOPRIL
NYSTATIN, NYSTATIN
PHENYLEPHRINE HYDROCHLORIDE AND PROMETHAZINE HYDROCHLORIDE, PHENYLEPHRINE
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PREDNISOLONE, PREDNISOLONE
PROMETH HYDROCHLORIDE,PHENYLEPHRINE HYDROCHLORIDE W/CODEINE PHOSPHATE, CODEINE
PROMETHAZINE DM, DEXTROMETHORPHAN HYDROBROMIDE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE WITH CODEINE, CODEINE PHOSPHATE
RISPERIDONE, RISPERIDONE
SPIRONOLACTONE, SPIRONOLACTONE
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
TRAZODONE HYDROCHLORIDE, TRAZODONE HYDROCHLORIDE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
VALPROIC ACID, VALPROIC ACID
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
VINTAGE PHARMS
* VINTAGE PHARMACEUTICALS
ALPRAZOLAM, ALPRAZOLAM
BROMPHENIRAMINE MALEATE, PSEUDOEPHEDRINE HYDROCHLORIDE AND DEXTROMETHORPHAN
CARBINOXAMINE MALEATE, CARBINOXAMINE MALEATE
DISULFIRAM, DISULFIRAM
GILDAGIA, ETHINYL ESTRADIOL
GILDESS 24 FE, ETHINYL ESTRADIOL
GLYCOPYRROLATE, GLYCOPYRROLATE
GRISEOFULVIN, GRISEOFULVIN, MICROSIZE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
LEVETIRACETAM, LEVETIRACETAM
METHIMAZOLE, METHIMAZOLE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 150
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** V **
* VINTAGE PHARMACEUTICALS
METHSCOPOLAMINE BROMIDE, METHSCOPOLAMINE BROMIDE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
OXYCODONE HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
* VINTAGE PHARMACEUTICALS INC
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
ALLOPURINOL, ALLOPURINOL
AMITRIPTYLINE HYDROCHLORIDE, AMITRIPTYLINE HYDROCHLORIDE
BACLOFEN, BACLOFEN
BUTALBITAL, ACETAMINOPHEN AND CAFFEINE, ACETAMINOPHEN
BUTALBITAL, ACETAMINOPHEN, CAFFEINE AND CODEINE PHOSPHATE, ACETAMINOPHEN
CARISOPRODOL, CARISOPRODOL
CLONAZEPAM, CLONAZEPAM
CYCLOBENZAPRINE HYDROCHLORIDE, CYCLOBENZAPRINE HYDROCHLORIDE
DEXAMETHASONE, DEXAMETHASONE
DIAZEPAM, DIAZEPAM
DOXYCYCLINE HYCLATE, DOXYCYCLINE HYCLATE
FUROSEMIDE, FUROSEMIDE
HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
HYDROCODONE BITARTRATE AND IBUPROFEN, HYDROCODONE BITARTRATE
HYDROCORTISONE, HYDROCORTISONE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
IBUPROFEN, IBUPROFEN
IBUPROFEN, IBUPROFEN (OTC)
ISOSORBIDE MONONITRATE, ISOSORBIDE MONONITRATE
LACTULOSE, LACTULOSE
LEVETIRACETAM, LEVETIRACETAM
LORAZEPAM, LORAZEPAM
MECLIZINE HYDROCHLORIDE, MECLIZINE HYDROCHLORIDE
MEPERIDINE HYDROCHLORIDE, MEPERIDINE HYDROCHLORIDE
METHOCARBAMOL, METHOCARBAMOL
METHYLPREDNISOLONE, METHYLPREDNISOLONE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
NYSTATIN, NYSTATIN
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PERPHENAZINE, PERPHENAZINE
PHENTERMINE HYDROCHLORIDE, PHENTERMINE HYDROCHLORIDE
PREDNISONE, PREDNISONE
PRIMIDONE, PRIMIDONE
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
SOTALOL HYDROCHLORIDE, SOTALOL HYDROCHLORIDE
SULFASALAZINE, SULFASALAZINE
TORSEMIDE, TORSEMIDE
TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE
VINTAGE PHARMS LLC
* VINTAGE PHARMACEUTICALS LLC
CYCLAFEM 1/35, ETHINYL ESTRADIOL
CYCLAFEM 7/7/7, ETHINYL ESTRADIOL
EMOQUETTE, DESOGESTREL
FELODIPINE, FELODIPINE
GILDESS 1.5/30, ETHINYL ESTRADIOL
GILDESS 1/20, ETHINYL ESTRADIOL
GILDESS FE 1.5/30, ETHINYL ESTRADIOL
GILDESS FE 1/20, ETHINYL ESTRADIOL
LETROZOLE, LETROZOLE
LEVETIRACETAM, LEVETIRACETAM
MEFENAMIC ACID, MEFENAMIC ACID
MONTELUKAST SODIUM, MONTELUKAST SODIUM
MORPHINE SULFATE, MORPHINE SULFATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 151
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** V **
* VINTAGE PHARMACEUTICALS LLC
MYCOPHENOLATE MOFETIL, MYCOPHENOLATE MOFETIL
MYZILRA, ETHINYL ESTRADIOL
ORSYTHIA, ETHINYL ESTRADIOL
PERCOCET, ACETAMINOPHEN
PREVIFEM, ETHINYL ESTRADIOL
TRI-PREVIFEM, ETHINYL ESTRADIOL
VIRTUS PHARM
* VIRTUS PHARMACEUTICAL INC
ACARBOSE, ACARBOSE
VISTA PHARMS
* VISTA PHARMACEUTICALS INC
SULFAMETHOXAZOLE AND TRIMETHOPRIM, SULFAMETHOXAZOLE
VISTAPHARM
* VISTAPHARM INC
ALBUTEROL SULFATE, ALBUTEROL SULFATE
HYDROCODONE BITARTRATE AND ACETAMINOPHEN, ACETAMINOPHEN
LACTULOSE, LACTULOSE
METHADONE HYDROCHLORIDE, METHADONE HYDROCHLORIDE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
MORPHINE SULFATE, MORPHINE SULFATE
NYSTATIN, NYSTATIN
OXYCODONE HYDROCHLORIDE, OXYCODONE HYDROCHLORIDE
PHENYTOIN, PHENYTOIN
VIVIMED LABS
* VIVIMED LABS ALATHUR PRIVATE LTD
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
VIVUS
* VIVUS INC
QSYMIA, PHENTERMINE HYDROCHLORIDE
STENDRA, AVANAFIL
** W **
WA UNIV SCH MED
* WASHINGTON UNIV SCHOOL MEDICINE
AMMONIA N 13, AMMONIA N-13
WARNER CHILCOTT
* WARNER CHILCOTT CO LLC
LO MINASTRIN FE, ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE, ETHINYL ESTRADIOL
* WARNER CHILCOTT INC
LOESTRIN 24 FE, ETHINYL ESTRADIOL
LOESTRIN FE 1/20, ETHINYL ESTRADIOL
WARNER CHILCOTT LLC
* WARNER CHILCOTT CO LLC
ACTONEL, RISEDRONATE SODIUM
ASACOL HD, MESALAMINE
ASACOL, MESALAMINE
ATELVIA, RISEDRONATE SODIUM
CHOLEDYL SA, OXTRIPHYLLINE
DELZICOL, MESALAMINE
ENABLEX, DARIFENACIN HYDROBROMIDE
ESTROSTEP FE, ETHINYL ESTRADIOL
FEMCON FE, ETHINYL ESTRADIOL
FEMHRT, ETHINYL ESTRADIOL
FEMTRACE, ESTRADIOL ACETATE
LO LOESTRIN FE, ETHINYL ESTRADIOL
LOESTRIN 21 1.5/30, ETHINYL ESTRADIOL
LOESTRIN 21 1/20, ETHINYL ESTRADIOL
LOESTRIN FE 1.5/30, ETHINYL ESTRADIOL
MINASTRIN 24 FE, ETHINYL ESTRADIOL
OVCON-35, ETHINYL ESTRADIOL
SARAFEM, FLUOXETINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 152
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** W **
WARNER CHILCOTT US
* WARNER CHILCOTT US LLC
ESTRACE, ESTRADIOL
WARNER IRELAND
* WARNER CHILCOTT IRELAND LTD
FEMRING, ESTRADIOL ACETATE
WATSON LABS
* WATSON LABORATORIES
FOLIC ACID, FOLIC ACID
LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
MICROGESTIN 1.5/30, ETHINYL ESTRADIOL
MICROGESTIN 1/20, ETHINYL ESTRADIOL
MICROGESTIN FE 1.5/30, ETHINYL ESTRADIOL
MICROGESTIN FE 1/20, ETHINYL ESTRADIOL
NORCO, ACETAMINOPHEN
NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
PROPAFENONE HYDROCHLORIDE, PROPAFENONE HYDROCHLORIDE
* WATSON LABORATORIES INC
ACARBOSE, ACARBOSE
AFEDITAB CR, NIFEDIPINE
ALBUTEROL SULFATE AND IPRATROPIUM BROMIDE, ALBUTEROL SULFATE
ALBUTEROL SULFATE, ALBUTEROL SULFATE
ALENDRONATE SODIUM, ALENDRONATE SODIUM
ALLOPURINOL, ALLOPURINOL
ALORA, ESTRADIOL
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AMOXAPINE, AMOXAPINE
ATENOLOL AND CHLORTHALIDONE, ATENOLOL
BACLOFEN, BACLOFEN
BREVICON 28-DAY, ETHINYL ESTRADIOL
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
CAPTOPRIL, CAPTOPRIL
CARISOPRODOL, CARISOPRODOL
CHLORZOXAZONE, CHLORZOXAZONE
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
CLONAZEPAM, CLONAZEPAM
COL-PROBENECID, COLCHICINE
CRINONE, PROGESTERONE
CYCLOSPORINE, CYCLOSPORINE
DESOGESTREL AND ETHINYL ESTRADIOL, DESOGESTREL
DIAZEPAM, DIAZEPAM
DICYCLOMINE HYDROCHLORIDE, DICYCLOMINE HYDROCHLORIDE
DILACOR XR, DILTIAZEM HYDROCHLORIDE
DISOPYRAMIDE PHOSPHATE, DISOPYRAMIDE PHOSPHATE
DROSPIRENONE AND ETHINYL ESTRADIOL, DROSPIRENONE
ESTAZOLAM, ESTAZOLAM
ESTRADIOL, ESTRADIOL
ESTROPIPATE, ESTROPIPATE
FENTANYL-100, FENTANYL
FENTANYL-25, FENTANYL
FENTANYL-50, FENTANYL
FENTANYL-75, FENTANYL
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GELNIQUE, OXYBUTYNIN CHLORIDE
GLIPIZIDE, GLIPIZIDE
GUANFACINE HYDROCHLORIDE, GUANFACINE HYDROCHLORIDE
HYDROXOCOBALAMIN, HYDROXOCOBALAMIN
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
HYDROXYZINE PAMOATE, HYDROXYZINE PAMOATE
IPRATROPIUM BROMIDE, IPRATROPIUM BROMIDE
ISRADIPINE, ISRADIPINE
LABETALOL HYDROCHLORIDE, LABETALOL HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 153
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** W **
* WATSON LABORATORIES INC
LAMOTRIGINE, LAMOTRIGINE
LEVONORGESTREL AND ETHINYL ESTRADIOL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
LEVONORGESTREL AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL, LEVONORGESTREL (OTC)
LEVORA 0.15/30-28, ETHINYL ESTRADIOL
LISINOPRIL, LISINOPRIL
LORAZEPAM, LORAZEPAM
LOXAPINE SUCCINATE, LOXAPINE SUCCINATE
MEPROBAMATE, MEPROBAMATE
METHOCARBAMOL, METHOCARBAMOL
METHYLDOPA, METHYLDOPA
METHYLPREDNISOLONE, METHYLPREDNISOLONE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
METOPROLOL TARTRATE, METOPROLOL TARTRATE
METRONIDAZOLE, METRONIDAZOLE
MICROZIDE, HYDROCHLOROTHIAZIDE
MINOCYCLINE HYDROCHLORIDE, MINOCYCLINE HYDROCHLORIDE
MINOXIDIL, MINOXIDIL
MIRTAZAPINE, MIRTAZAPINE
NABUMETONE, NABUMETONE
NALOXONE HYDROCHLORIDE AND PENTAZOCINE HYDROCHLORIDE, NALOXONE HYDROCHLORIDE
NATEGLINIDE, NATEGLINIDE
NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE
NICOTINE POLACRILEX, NICOTINE POLACRILEX (OTC)
NIZATIDINE, NIZATIDINE
NORETHINDRONE AND ETHINYL ESTRADIOL (10/11), ETHINYL ESTRADIOL
NORETHINDRONE AND ETHINYL ESTRADIOL, ETHINYL ESTRADIOL
NORINYL 1+35 21-DAY, ETHINYL ESTRADIOL
NORINYL 1+35 28-DAY, ETHINYL ESTRADIOL
NORINYL 1+50 28-DAY, MESTRANOL
NORTRIPTYLINE HYDROCHLORIDE, NORTRIPTYLINE HYDROCHLORIDE
OGESTREL 0.5/50-28, ETHINYL ESTRADIOL
ORPHENADRINE CITRATE, ORPHENADRINE CITRATE
OXYCODONE AND ACETAMINOPHEN, ACETAMINOPHEN
OXYCODONE AND ASPIRIN, ASPIRIN
OXYCODONE HYDROCHLORIDE AND IBUPROFEN, IBUPROFEN
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PREDNISOLONE, PREDNISOLONE
PREDNISONE, PREDNISONE
PRIMIDONE, PRIMIDONE
PROBENECID, PROBENECID
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
QUASENSE, ETHINYL ESTRADIOL
QUINIDINE SULFATE, QUINIDINE SULFATE
RAMIPRIL, RAMIPRIL
RAPAFLO, SILODOSIN
RIVASTIGMINE TARTRATE, RIVASTIGMINE TARTRATE
SIMVASTATIN, SIMVASTATIN
SULFASALAZINE, SULFASALAZINE
SULINDAC, SULINDAC
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TELMISARTAN, TELMISARTAN
TESTOSTERONE CYPIONATE, TESTOSTERONE CYPIONATE
TESTOSTERONE ENANTHATE, TESTOSTERONE ENANTHATE
TETRACYCLINE HYDROCHLORIDE, TETRACYCLINE HYDROCHLORIDE
TOPIRAMATE, TOPIRAMATE
TRANDOLAPRIL, TRANDOLAPRIL
TRELSTAR, TRIPTORELIN PAMOATE
TRI-NORINYL 28-DAY, ETHINYL ESTRADIOL
TRIAMTERENE AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
TRIHEXYPHENIDYL HYDROCHLORIDE, TRIHEXYPHENIDYL HYDROCHLORIDE
TRIMETHOPRIM, TRIMETHOPRIM
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 154
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** W **
* WATSON LABORATORIES INC
TRIVORA-28, ETHINYL ESTRADIOL
VANCOMYCIN HYDROCHLORIDE, VANCOMYCIN HYDROCHLORIDE
VERAPAMIL HYDROCHLORIDE, VERAPAMIL HYDROCHLORIDE
ZOVIA 1/35E-28, ETHINYL ESTRADIOL
ZOVIA 1/50E-28, ETHINYL ESTRADIOL
* WATSON LABS INC
LISINOPRIL AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
WATSON LABS (UTAH)
* WATSON LABORATORIES INC
INFED, IRON DEXTRAN
NOR-QD, NORETHINDRONE
OXYTROL, OXYBUTYNIN
PROGESTERONE, PROGESTERONE
WATSON LABS FLORIDA
* WATSON LABORATORIES INC FLORIDA
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
WATSON LABS INC
* WATSON LABORATORIES INC
ALBUTEROL SULFATE, ALBUTEROL SULFATE
AMLODIPINE BESYLATE AND BENAZEPRIL HYDROCHLORIDE, AMLODIPINE BESYLATE
AMMONIUM LACTATE, AMMONIUM LACTATE
BUDESONIDE, BUDESONIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CIPROFLOXACIN HYDROCHLORIDE, CIPROFLOXACIN HYDROCHLORIDE
CLONIDINE, CLONIDINE
CORDRAN, FLURANDRENOLIDE
CYCLOSPORINE, CYCLOSPORINE
DEXMETHYLPHENIDATE HYDROCHLORIDE, DEXMETHYLPHENIDATE HYDROCHLORIDE
DICLOFENAC SODIUM, DICLOFENAC SODIUM
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
EMLA, LIDOCAINE
FIORICET W/ CODEINE, ACETAMINOPHEN
FIORINAL W/CODEINE, ASPIRIN
FIORINAL, ASPIRIN
GELNIQUE 3%, OXYBUTYNIN
IBANDRONATE SODIUM, IBANDRONATE SODIUM
INDOMETHACIN, INDOMETHACIN
IRBESARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
IRBESARTAN, IRBESARTAN
KADIAN, MORPHINE SULFATE
LEVALBUTEROL HYDROCHLORIDE, LEVALBUTEROL HYDROCHLORIDE
LEVOFLOXACIN, LEVOFLOXACIN
LEVONORGESTREL, LEVONORGESTREL
LEVONORGESTREL, LEVONORGESTREL (OTC)
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LIDOCAINE, LIDOCAINE
METHYLPHENIDATE HYDROCHLORIDE, METHYLPHENIDATE HYDROCHLORIDE
METRONIDAZOLE, METRONIDAZOLE
PREGABALIN, PREGABALIN
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SILDENAFIL CITRATE, SILDENAFIL CITRATE
TRETINOIN, TRETINOIN
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VALSARTAN AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
VALSARTAN, VALSARTAN
WATSON PHARMS
* WATSON PHARMACEUTICALS
TENUATE DOSPAN, DIETHYLPROPION HYDROCHLORIDE
TENUATE, DIETHYLPROPION HYDROCHLORIDE
* WATSON PHARMACEUTICALS INC
ACTIGALL, URSODIOL
CONDYLOX, PODOFILOX
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 155
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** W **
WEST WARD PHARM CORP
* WEST WARD PHARMACEUTICAL CORP
PHENYLEPHRINE HYDROCHLORIDE, PHENYLEPHRINE HYDROCHLORIDE
WEST-WARD PHARM CORP
* WEST-WARD PHARMACEUTICAL CORP
CEFOTETAN, CEFOTETAN DISODIUM
WI MEDCL CYCLOTRON
* WISCONSIN MEDICAL CYCLOTRON LLC
AMMONIA N 13, AMMONIA N-13
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
WILSHIRE PHARMS INC
* WILSHIRE PHARMACEUTICALS INC
LAMOTRIGINE, LAMOTRIGINE
WOCKHARDT
* WOCKHARDT AMERICAS INC
CAPTOPRIL, CAPTOPRIL
FAMOTIDINE, FAMOTIDINE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
* WOCKHARDT EU OPERATIONS (SWISS) AG
ACETAMINOPHEN AND CODEINE PHOSPHATE, ACETAMINOPHEN
ACETIC ACID, ACETIC ACID, GLACIAL
AMANTADINE HYDROCHLORIDE, AMANTADINE HYDROCHLORIDE
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
AMOXICILLIN, AMOXICILLIN
BROMFED-DM, BROMPHENIRAMINE MALEATE
CARBAMAZEPINE, CARBAMAZEPINE
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE
CIMETIDINE HYDROCHLORIDE, CIMETIDINE HYDROCHLORIDE
CLEMASTINE FUMARATE, CLEMASTINE FUMARATE
CLINDAMYCIN PHOSPHATE, CLINDAMYCIN PHOSPHATE
CLOBETASOL PROPIONATE, CLOBETASOL PROPIONATE
CROMOLYN SODIUM, CROMOLYN SODIUM
CYCLOSPORINE, CYCLOSPORINE
DEXCHLORPHENIRAMINE MALEATE, DEXCHLORPHENIRAMINE MALEATE
DOXEPIN HYDROCHLORIDE, DOXEPIN HYDROCHLORIDE
ERYTHROMYCIN, ERYTHROMYCIN
FLUOXETINE HYDROCHLORIDE, FLUOXETINE HYDROCHLORIDE
FLUTICASONE PROPIONATE, FLUTICASONE PROPIONATE
FUROSEMIDE, FUROSEMIDE
HYDROCODONE BITARTRATE AND HOMATROPINE METHYLBROMIDE, HOMATROPINE METHYLBROMIDE
HYDROXYZINE HYDROCHLORIDE, HYDROXYZINE HYDROCHLORIDE
LEVETIRACETAM, LEVETIRACETAM
LIDOCAINE HYDROCHLORIDE, LIDOCAINE HYDROCHLORIDE
LINDANE, LINDANE
LITHIUM CITRATE, LITHIUM CITRATE
LOPERAMIDE HYDROCHLORIDE, LOPERAMIDE HYDROCHLORIDE (OTC)
LORATADINE, LORATADINE (OTC)
MEGESTROL ACETATE, MEGESTROL ACETATE
METAPROTERENOL SULFATE, METAPROTERENOL SULFATE
METOCLOPRAMIDE HYDROCHLORIDE, METOCLOPRAMIDE HYDROCHLORIDE
MINOXIDIL (FOR MEN), MINOXIDIL (OTC)
MINOXIDIL EXTRA STRENGTH (FOR MEN), MINOXIDIL (OTC)
NYSTATIN, NYSTATIN
OXYBUTYNIN CHLORIDE, OXYBUTYNIN CHLORIDE
PHENYTOIN, PHENYTOIN
PREDNISOLONE SODIUM PHOSPHATE, PREDNISOLONE SODIUM PHOSPHATE
PREDNISOLONE, PREDNISOLONE
PROMETHAZINE HYDROCHLORIDE AND CODEINE PHOSPHATE, CODEINE PHOSPHATE
PROMETHAZINE PLAIN, PROMETHAZINE HYDROCHLORIDE
PROMETHAZINE W/ DEXTROMETHORPHAN, DEXTROMETHORPHAN HYDROBROMIDE
SELENIUM SULFIDE, SELENIUM SULFIDE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
VALPROIC ACID, VALPROIC ACID
* WOCKHARDT LTD
ADENOSINE, ADENOSINE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 156
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** W **
* WOCKHARDT LTD
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
AZITHROMYCIN, AZITHROMYCIN
BETAXOLOL HYDROCHLORIDE, BETAXOLOL HYDROCHLORIDE
BETHANECHOL CHLORIDE, BETHANECHOL CHLORIDE
CEFOTAXIME SODIUM, CEFOTAXIME SODIUM
CEFOTAXIME, CEFOTAXIME SODIUM
CEFPROZIL, CEFPROZIL
CEFTAZIDIME, CEFTAZIDIME
CEFTRIAXONE, CEFTRIAXONE SODIUM
CEFUROXIME AXETIL, CEFUROXIME AXETIL
CETIRIZINE HYDROCHLORIDE ALLERGY, CETIRIZINE HYDROCHLORIDE (OTC)
CETIRIZINE HYDROCHLORIDE, CETIRIZINE HYDROCHLORIDE
CLARITHROMYCIN, CLARITHROMYCIN
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
FAMOTIDINE, FAMOTIDINE (OTC)
FOSPHENYTOIN SODIUM, FOSPHENYTOIN SODIUM
FUROSEMIDE, FUROSEMIDE
KETOROLAC TROMETHAMINE, KETOROLAC TROMETHAMINE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
LISINOPRIL, LISINOPRIL
METOPROLOL SUCCINATE, METOPROLOL SUCCINATE
MIDAZOLAM HYDROCHLORIDE, MIDAZOLAM HYDROCHLORIDE
NIACIN, NIACIN
NICARDIPINE HYDROCHLORIDE, NICARDIPINE HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE PRESERVATIVE FREE, ONDANSETRON HYDROCHLORIDE
ONDANSETRON HYDROCHLORIDE, ONDANSETRON HYDROCHLORIDE
PANTOPRAZOLE SODIUM, PANTOPRAZOLE SODIUM
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE (OTC)
RISPERIDONE, RISPERIDONE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SUMATRIPTAN SUCCINATE, SUMATRIPTAN SUCCINATE
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TERBINAFINE HYDROCHLORIDE, TERBINAFINE HYDROCHLORIDE
TIMOLOL MALEATE, TIMOLOL MALEATE
VALACYCLOVIR HYDROCHLORIDE, VALACYCLOVIR HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZOLPIDEM TARTRATE, ZOLPIDEM TARTRATE
ZONISAMIDE, ZONISAMIDE
WOCKHARDT EU OPERATN
* WOCKHARDT EU OPERATIONS SWISS AG
AMOXICILLIN AND CLAVULANATE POTASSIUM, AMOXICILLIN
DEXAMETHASONE, DEXAMETHASONE
TRIAMCINOLONE ACETONIDE, TRIAMCINOLONE ACETONIDE
WOCKHARDT LTD
* WOCKHARDT LTD
ALFUZOSIN HYDROCHLORIDE, ALFUZOSIN HYDROCHLORIDE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
CARBIDOPA, LEVODOPA AND ENTACAPONE, CARBIDOPA
CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
ENTACAPONE, ENTACAPONE
FEXOFENADINE HYDROCHLORIDE ALLERGY, FEXOFENADINE HYDROCHLORIDE (OTC)
FEXOFENADINE HYDROCHLORIDE HIVES, FEXOFENADINE HYDROCHLORIDE (OTC)
LAMOTRIGINE, LAMOTRIGINE
LANSOPRAZOLE, LANSOPRAZOLE (OTC)
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
ZIPRASIDONE HYDROCHLORIDE, ZIPRASIDONE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 157
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** W **
WOCKHARDT USA
* WOCKHARDT USA INC
EXTENDED PHENYTOIN SODIUM, PHENYTOIN SODIUM
GRANISETRON HYDROCHLORIDE, GRANISETRON HYDROCHLORIDE
OCTREOTIDE ACETATE (PRESERVATIVE FREE), OCTREOTIDE ACETATE
OCTREOTIDE ACETATE, OCTREOTIDE ACETATE
* WOCKHARDT USA LLC
ENALAPRIL MALEATE, ENALAPRIL MALEATE
LANSOPRAZOLE, LANSOPRAZOLE
TOPIRAMATE, TOPIRAMATE
WRASER PHARMS
* WRASER PHARMACEUTICALS LLC
CETRAXAL, CIPROFLOXACIN HYDROCHLORIDE
WRASER PHARMS LLC
* WRASER PHARMACEUTICALS LLC
TREZIX, ACETAMINOPHEN
WUSM CYCLOTRON
* WASHINGTON UNIV SCH MEDICINE CYCLOTRON FACILITY
FLUDEOXYGLUCOSE F18, FLUDEOXYGLUCOSE F-18
WYETH PHARMS
* WYETH PHARMACEUTICALS INC SUB PFIZER INC
LO/OVRAL-28, ETHINYL ESTRADIOL
WYETH PHARMS INC
* WYETH PHARMACEUTICALS INC
BOSULIF, BOSUTINIB MONOHYDRATE
CORDARONE, AMIODARONE HYDROCHLORIDE
EFFEXOR XR, VENLAFAXINE HYDROCHLORIDE
INDERIDE-40/25, HYDROCHLOROTHIAZIDE
PHOSPHOLINE IODIDE, ECHOTHIOPHATE IODIDE
PREMARIN, ESTROGENS, CONJUGATED
PREMPHASE 14/14, ESTROGENS, CONJUGATED
PREMPRO, ESTROGENS, CONJUGATED
PRISTIQ, DESVENLAFAXINE SUCCINATE
PROTONIX IV, PANTOPRAZOLE SODIUM
PROTONIX, PANTOPRAZOLE SODIUM
TRECATOR, ETHIONAMIDE
ZOSYN IN PLASTIC CONTAINER, PIPERACILLIN SODIUM
ZOSYN, PIPERACILLIN SODIUM
WYETH PHARMS PFIZER
* WYETH PHARMACEUTICALS INC WHOLLY OWNED SUB PFIZER INC
DUAVEE, BAZEDOXIFENE ACETATE
** X **
X GEN PHARMS
* X GEN PHARMACEUTICALS INC
ACETAZOLAMIDE SODIUM, ACETAZOLAMIDE SODIUM
AMPHOTERICIN B, AMPHOTERICIN B
BACIIM, BACITRACIN
COLISTIMETHATE SODIUM, COLISTIMETHATE SODIUM
HYDRO-RX, HYDROCORTISONE
HYDROCORTISONE ACETATE, HYDROCORTISONE ACETATE
LEVETIRACETAM, LEVETIRACETAM
LIOTHYRONINE SODIUM, LIOTHYRONINE SODIUM
NEO-FRADIN, NEOMYCIN SULFATE
NEOMYCIN AND POLYMYXIN B SULFATE, NEOMYCIN SULFATE
NEOMYCIN SULFATE, NEOMYCIN SULFATE
NYSTATIN, NYSTATIN
POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
STREPTOMYCIN SULFATE, STREPTOMYCIN SULFATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
X-GEN PHARMS
* X-GEN PHARMACEUTICALS INC
PHENYTOIN SODIUM, PHENYTOIN SODIUM
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 158
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** X **
X-GEN PHARMS INC
* X-GEN PHARMACEUTICALS INC
TRANEXAMIC ACID, TRANEXAMIC ACID
XELLIA PHARMS APS
* XELLIA PHARMACEUTICALS APS
BACITRACIN, BACITRACIN
POLYMYXIN B SULFATE, POLYMYXIN B SULFATE
TOBRAMYCIN SULFATE, TOBRAMYCIN SULFATE
XENOPORT INC
* XENOPORT INC
HORIZANT, GABAPENTIN ENACARBIL
XSPIRE
* XSPIRE LLC
NALFON, FENOPROFEN CALCIUM
XTTRIUM
* XTTRIUM LABORATORIES INC
CHLORHEXIDINE GLUCONATE, CHLORHEXIDINE GLUCONATE
EXIDINE, CHLORHEXIDINE GLUCONATE (OTC)
** Y **
YUNG SHIN PHARM
* YUNG SHIN PHARMACEUTICAL INDUSTRIAL CO LTD
CEFACLOR, CEFACLOR
CEPHALEXIN, CEPHALEXIN
** Z **
ZACH SYSTEMS
* ZACH SYSTEMS SPA
DORZOLAMIDE HYDROCHLORIDE AND TIMOLOL MALEATE, DORZOLAMIDE HYDROCHLORIDE
DORZOLAMIDE HYDROCHLORIDE, DORZOLAMIDE HYDROCHLORIDE
ZAMBON SPA
* ZAMBON SPA ITALY
MONUROL, FOSFOMYCIN TROMETHAMINE
ZOGENIX INC
* ZOGENIX INC
ZOHYDRO ER, HYDROCODONE BITARTRATE
ZYDUS HLTHCARE
* ZYDUS HEALTHCARE USA LLC
LANSOPRAZOLE, LANSOPRAZOLE
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
ZYDUS PHARMS USA
* ZYDUS PHARMACEUTICALS USA INC
AMLODIPINE BESYLATE, AMLODIPINE BESYLATE
ATENOLOL, ATENOLOL
AZATHIOPRINE, AZATHIOPRINE
BENAZEPRIL HYDROCHLORIDE, BENAZEPRIL HYDROCHLORIDE
BENZONATATE, BENZONATATE
CLINDAMYCIN HYDROCHLORIDE, CLINDAMYCIN HYDROCHLORIDE
HALOPERIDOL, HALOPERIDOL
LAMOTRIGINE, LAMOTRIGINE
MELOXICAM, MELOXICAM
METFORMIN HYDROCHLORIDE, METFORMIN HYDROCHLORIDE
NAPROXEN, NAPROXEN
PAROXETINE HYDROCHLORIDE, PAROXETINE HYDROCHLORIDE
PRAVASTATIN SODIUM, PRAVASTATIN SODIUM
PROMETHAZINE HYDROCHLORIDE, PROMETHAZINE HYDROCHLORIDE
RAMIPRIL, RAMIPRIL
RIBAVIRIN, RIBAVIRIN
RISPERIDONE, RISPERIDONE
SERTRALINE HYDROCHLORIDE, SERTRALINE HYDROCHLORIDE
SIMVASTATIN, SIMVASTATIN
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
WARFARIN SODIUM, WARFARIN SODIUM
ZONISAMIDE, ZONISAMIDE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST B - 159
APPENDIX B - PRODUCT NAME SORTED BY APPLICANT
** Z **
ZYDUS PHARMS USA INC
* ZYDUS PHARMACEUTICALS USA INC
ACETAZOLAMIDE, ACETAZOLAMIDE
ACYCLOVIR, ACYCLOVIR
ALPRAZOLAM, ALPRAZOLAM
AMIODARONE HYDROCHLORIDE, AMIODARONE HYDROCHLORIDE
ANASTROZOLE, ANASTROZOLE
BICALUTAMIDE, BICALUTAMIDE
BROMOCRIPTINE MESYLATE, BROMOCRIPTINE MESYLATE
BUPROPION HYDROCHLORIDE, BUPROPION HYDROCHLORIDE
BUSPIRONE HYDROCHLORIDE, BUSPIRONE HYDROCHLORIDE
CARVEDILOL, CARVEDILOL
CLONIDINE HYDROCHLORIDE, CLONIDINE HYDROCHLORIDE
CLOPIDOGREL BISULFATE, CLOPIDOGREL BISULFATE
DIPYRIDAMOLE, DIPYRIDAMOLE
DIVALPROEX SODIUM, DIVALPROEX SODIUM
DONEPEZIL HYDROCHLORIDE, DONEPEZIL HYDROCHLORIDE
DULOXETINE HYDROCHLORIDE, DULOXETINE HYDROCHLORIDE
ESCITALOPRAM OXALATE, ESCITALOPRAM OXALATE
ETHOSUXIMIDE, ETHOSUXIMIDE
ETODOLAC, ETODOLAC
ETOMIDATE, ETOMIDATE
FINASTERIDE, FINASTERIDE
GABAPENTIN, GABAPENTIN
GALANTAMINE HYDROBROMIDE, GALANTAMINE HYDROBROMIDE
GLIPIZIDE AND METFORMIN HYDROCHLORIDE, GLIPIZIDE
HYDROXYCHLOROQUINE SULFATE, HYDROXYCHLOROQUINE SULFATE
INDOMETHACIN, INDOMETHACIN
IRBESARTAN, IRBESARTAN
LAMOTRIGINE, LAMOTRIGINE
LEVETIRACETAM, LEVETIRACETAM
LEVOFLOXACIN, LEVOFLOXACIN
LOSARTAN POTASSIUM AND HYDROCHLOROTHIAZIDE, HYDROCHLOROTHIAZIDE
LOSARTAN POTASSIUM, LOSARTAN POTASSIUM
OMEPRAZOLE, OMEPRAZOLE
PIOGLITAZONE HYDROCHLORIDE, PIOGLITAZONE HYDROCHLORIDE
POTASSIUM CITRATE, POTASSIUM CITRATE
PRAMIPEXOLE DIHYDROCHLORIDE, PRAMIPEXOLE DIHYDROCHLORIDE
PROPRANOLOL HYDROCHLORIDE, PROPRANOLOL HYDROCHLORIDE
RAMIPRIL, RAMIPRIL
RANITIDINE HYDROCHLORIDE, RANITIDINE HYDROCHLORIDE
RISPERIDONE, RISPERIDONE
ROPINIROLE HYDROCHLORIDE, ROPINIROLE HYDROCHLORIDE
SIROLIMUS, SIROLIMUS
TAMSULOSIN HYDROCHLORIDE, TAMSULOSIN HYDROCHLORIDE
TELMISARTAN, TELMISARTAN
TOPIRAMATE, TOPIRAMATE
TRAMADOL HYDROCHLORIDE AND ACETAMINOPHEN, ACETAMINOPHEN
TRAMADOL HYDROCHLORIDE, TRAMADOL HYDROCHLORIDE
VENLAFAXINE HYDROCHLORIDE, VENLAFAXINE HYDROCHLORIDE
ZOLMITRIPTAN, ZOLMITRIPTAN
35TH EDITION - 2015 - APPROVED DRUG PRODUCTS LIST C-1
APPENDIX C
UNIFORM TERMS
DOSAGE FORMS
AEROSOL OIL
AEROSOL, FOAM OIL/DROPS
AEROSOL, METERED OINTMENT
CAPSULE OINTMENT, AUGMENTED
CAPSULE, DELAYED REL PELLETS PASTE
CAPSULE, DELAYED RELEASE PATCH
CAPSULE, EXTENDED RELEASE PELLET
CLOTH POWDER
CONCENTRATE POWDER, EXTENDED RELEASE
CREAM POWDER, METERED
CREAM, AUGMENTED RING
ELIXIR SHAMPOO
EMULSION SOLUTION
ENEMA SOLUTION FOR SLUSH
FILM SOLUTION, GEL FORMING/DROPS
FILM, EXTENDED RELEASE SOLUTION, METERED
FOR SOLUTION SOLUTION/DROPS
FOR SUSPENSION SPONGE
FOR SUSPENSION, DELAYED RELEASE SPRAY
FOR SUSPENSION, EXTENDED RELEASE SPRAY, METERED
GAS SUPPOSITORY
GEL SUSPENSION
GEL, AUGMENTED SUSPENSION, EXTENDED RELEASE
GEL, METERED SUSPENSION/DROPS
GRANULE SWAB
GRANULE, DELAYED RELEASE SYRUP
GUM, CHEWING SYSTEM
IMPLANT SYSTEM, EXTENDED RELEASE
INHALANT TABLET
INJECTABLE TABLET, CHEWABLE
INJECTABLE, LIPID COMPLEX TABLET, COATED PARTICLES
INJECTABLE, LIPOSOMAL TABLET, DELAYED RELEASE
INSERT TABLET, DELAYED RELEASE, ORALLY
INSERT, EXTENDED RELEASE DISINTEGRATING
INTRAUTERINE DEVICE TABLET, EFFERVESCENT
JELLY TABLET, EXTENDED RELEASE
LIQUID TABLET, FOR SUSPENSION
LOTION TABLET, ORALLY DISINTEGRATING
LOTION, AUGMENTED TAPE
LOTION/SHAMPOO TROCHE/LOZENGE
Note: Terms comprise currently marketed products
35TH EDITION - 2015 - APPROVED DRUG PRODUCTS LIST C-2
APPENDIX C
UNIFORM TERMS
ROUTES OF ADMINISTRATION
BUCCAL IRRIGATION
DENTAL IV (INFUSION)
ENDOCERVICAL N/A
FOR RX COMPOUNDING NASAL
IMPLANTATION OPHTHALMIC
INHALATION ORAL
INJECTION ORAL-21
INTRA-ANAL ORAL-28
INTRACRANIAL OTIC
INTRADERMAL PERFUSION, CARDIAC
INTRAMUSCULAR PERIODONTAL
INTRAOCULAR RECTAL
INTRAPERITONEAL SPINAL
INTRAPLEURAL SUBCUTANEOUS
INTRATHECAL SUBLINGUAL
INTRATRACHEAL TOPICAL
INTRAUTERINE TRANSDERMAL
INTRAVENOUS TRANSMUCOSAL
INTRAVESICAL URETHRAL
INTRAVITREAL VAGINAL
IONTOPHORESIS
Note: Terms comprise currently marketed products
35TH EDITION - 2015 - APPROVED DRUG PRODUCTS LIST C-3
APPENDIX
UNIFORM TERMS
ABBREVIATIONS
AMP AMPULE
AMPICIL AMPICILLIN
APPROX APPROXIMATELY
BOT BOTTLE
CI CURIE
CSR CAROTID SINUS REFLEX
CU CLINICAL UNITS
DIPROP DIPROPIONATE
ELECT ELECTROLYTE
EQ EQUIVALENT TO
ER EXTENDED RELEASE
GM GRAM
HBR HYDROBROMIDE
HCL HYDROCHLORIDE
HR HOUR
IM INTRAMUSCULAR
INH INHALATION
IU INTERNATIONAL UNITS
IV INTRAVENOUS
KIU KALLIKREIN INHIBITOR UNITS
MCG MICROGRAM
MCI MILLICURIE
MEQ MILLIEQUIVALENT
MG MILLIGRAM
ML MILLILITER
N/A NOT APPLICABLE
PPM PARTS PER MILLION
REL RELEASE
SC SUBCUTANEOUS
SQ CM SQUARE CENTIMETER
U UNITS
UCI MICROCURIE
UMOLAR MICROMOLAR
USP UNITED STATES PHARMACOPEIA
PATENT AND EXCLUSIVITY INFORMATION ADDENDUM
This Addendum identifies drugs that qualify under the Drug Price
Competition and Patent Term Restoration Act (1984 Amendments) for periods of
exclusivity, during which abbreviated new drug applications (ANDAs) and
applications described in Section 505(b)(2) of the Federal Food, Drug, and
Cosmetic Act (the Act) for those drug products may, in some instances, not be
submitted or made effective as described below, and provides patent
information concerning the listed drug products. Those drugs that have
qualified for Orphan Drug Exclusivity pursuant to Section 527 of the Act,
those drugs that have qualified for Pediatric Exclusivity pursuant to Section
505A of the Act, and those drugs that have qualified for Generating
Antibiotics Incentives Now (GAIN) exclusivity pursuant to Section 505E of the
Act are also included in this Addendum. This section is arranged in
alphabetical order by active ingredient name followed by the trade name.
Active ingredient headings for multiple ingredient (combination) drug
products are arranged alphabetically. For an explanation of the codes used
in the Addendum, see the Patent and Exclusivity Terms Section. Exclusivity
prevents the submission or effective approval of ANDAs or applications
described in Section 505(b)(2) of the Act. It does not prevent the
submission or approval of a second 505(b)(1) application except in the case
of Orphan Drug exclusivity. Applications qualifying for periods of
exclusivity are:
(1) A new drug application approved after September 24, 1984, for a drug
product (including an ester or salt of the active ingredient) of which
has never been approved in any other new drug application under Section
505 (b) of the Act. No subsequent ANDA or application described in
Section 505(b)(2) of the Act for the same drug may be submitted for a
period of five years from the date of approval of the original
application, except that such an application may be submitted after four
years if it contains a certification that a patent claiming the drug is
invalid or will not be infringed by the product for which approval is
sought.
(2) A new drug application approved after September 24, 1984, for a drug
product containing an active ingredient (including any ester or salt of
that active ingredient) that has been approved in an earlier new drug
application and that includes reports of new clinical investigations
(other than bioavailability studies). Such investigations must have
been conducted or sponsored by the applicant and must have been
essential to approval of the application. If these requirements are
met, the approval of a subsequent ANDA or an application described in
Section 505(b)(2) of the Act may not be made effective for the same drug
or use, if for a new indication, before the expiration of three years
from the date of approval of the original application. If an applicant
has exclusivity for a new application or 505(b)(2) application for the
drug product with indications or use, this does not preclude the
approval of an ANDA or 505(b)(2) application not covered by the
exclusivity.
(3) A supplement to a new drug application for a drug containing a
previously approved active ingredient including (any ester or salt of
the active ingredient) approved after September 24, 1984, that contains
reports of new clinical investigations (other than bioavailability
studies) essential to the approval of the supplement and conducted or
AD 1
sponsored by the applicant. The approval of a subsequent ANDA or
505(b)(2) application for a change approved in the supplement may not be
made effective for three years from the date of approval of the original
supplement.
The Act requires that patent information be filed with all newly
submitted Section 505(b) drug applications. No NDA may be approved after
September 24, 1984, without the submission of patent information to the
Agency. Effective August 18, 2003, this information must be filed using FDA
Form 3524a “Patent Information Submitted with the Filing of an NDA, Amendment
or Supplement”.
Effective August 18, 2003, upon approval of an application, patent
information for purposes of listing in the Orange Book must be submitted to
the agency within 30 days of approval on FDA Form 3542 “Patent Information
Submitted Upon and After Approval of an NDA or Supplement”. Patent
information on unapproved applications or on patents beyond the scope of the
Act (i.e., process or manufacturing patents) will not be published. FDA form
3542 will be the only form used for the purposes of this publication.
The patents that FDA regards as covered by the statutory provisions for
submission of patent information are: patents that claim the active
ingredient(s); drug product patents which include formulation/composition
patents; use patents for a particular approved indication or method of using
the product; and certain other patents as detailed on FDA Form 3542. This
information, as provided by the sponsor on FDA form 3542, will be published
as described above.
A requirement for submission of patent information to FDA for certain
old antibiotics became effective October 7, 2008 under section 4(b)(1) of the
Q1 Act. A guidance for industry on this subject is available at
http://www.fda.gov/downloads/AboutFDA/ReportsManualsForms/Forms/UCM048345.pdf
Upon approval, patent numbers and expiration dates, in addition to
certain other information on appropriate patents claiming drug products that
are the subject of approved applications, will be published daily in the
Electronic Orange Book Query. The Addendum lists patent and exclusivity
information up to January of the Edition year. The monthly Cumulative
Supplements to the annual edition list patent and exclusivity information
changes since the Annual Edition Addendum. Since all parts of this
publication are subject to changes, additions, or deletions, the Electronic
Orange Book, updated daily, should be consulted for the most recent patent
and exclusivity information.
AD 2
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 1 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ABACAVIR SULFATE - ZIAGEN
N 020977 001 6294540 May 14, 2018 DS DP U-65
ABACAVIR SULFATE - ZIAGEN
N 020978 001 6294540 May 14, 2018 DS DP U-65
6641843 Feb 04, 2019 DP
ABACAVIR SULFATE; DOLUTEGRAVIR SODIUM; LAMIVUDINE - TRIUMEQ
N 205551 001 5905082 May 18, 2016 DS DP NCE Aug 12, 2018
5905082*PED Nov 18, 2016
6294540 May 14, 2018 DS DP U-1572
6294540*PED Nov 14, 2018
6417191 Mar 28, 2016 DP U-1572
8129385 Oct 05, 2027 DS DP
ABACAVIR SULFATE; LAMIVUDINE - EPZICOM
N 021652 001 5905082 May 18, 2016 DS DP
6294540 May 14, 2018 DS DP U-257
6417191 Mar 28, 2016 DP U-257
ABACAVIR SULFATE; LAMIVUDINE; ZIDOVUDINE - TRIZIVIR
N 021205 001 5905082 May 18, 2016 DS DP U-248
6294540 May 14, 2018 DS DP U-65
6417191 Mar 28, 2016 DP U-248
ABARELIX - PLENAXIS
N 021320 001 5843901 Dec 01, 2015 DS DP
5968895 Dec 11, 2016 DP
6180608 Dec 11, 2016 DP U-549
6423686 Jun 07, 2015 DS
6455499 Jun 07, 2015 U-549
6699833 Dec 11, 2016 DP
ABIRATERONE ACETATE - ZYTIGA
N 202379 001 5604213 Dec 13, 2016 DS DP U-1126 I-663 Dec 10, 2015
5604213 Dec 13, 2016 DS DP U-1314 NCE Apr 28, 2016
8822438 Aug 24, 2027 U-1579
8822438 Aug 24, 2027 U-1580
ACETAMINOPHEN - OFIRMEV
N 022450 001 6028222 Aug 05, 2017 DP
6992218 Jun 06, 2021 DP
ACETAMINOPHEN; ASPIRIN; CAFFEINE - EXCEDRIN (MIGRAINE)
N 020802 001 5972916 Jul 14, 2017 U-296
ACETAMINOPHEN; OXYCODONE HYDROCHLORIDE - XARTEMIS XR
N 204031 001 6488962 Jun 20, 2020 DP NP Mar 11, 2017
7976870 Jun 01, 2027 U-1498
8372432 Mar 11, 2029 DP U-1499
8377453 Nov 19, 2029 DP U-1499
8394408 Mar 11, 2029 DP
8597681 Dec 21, 2030 DP
8658631 May 16, 2032 DP
8668929 Mar 11, 2029 U-1499
8741885 May 16, 2032 DP U-1499
ACETYLCYSTEINE - ACETADOTE
N 021539 001 8148356 May 21, 2026 DP
8399445 Aug 24, 2025 U-1373
8653061 Aug 24, 2025 U-1373
8722738 Apr 06, 2032 U-1373
ACLIDINIUM BROMIDE - TUDORZA PRESSAIR
N 202450 001 5840279 Jun 21, 2016 DP NCE Jul 23, 2017
6071498 Jun 21, 2016 DP
6681768 Aug 07, 2022 DP
6750226 Sep 05, 2020 DS DP U-1264
7078412 Jul 16, 2020 DS DP U-1263
8051851 Apr 22, 2027 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 2 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ACYCLOVIR - SITAVIG
N 203791 001 8592434 Jun 16, 2030 DP U-1460 NP Apr 12, 2016
8747896 Jun 03, 2027 DP U-1460
8791127 Mar 23, 2027 DP U-1460
ACYCLOVIR; HYDROCORTISONE - XERESE
N 022436 001 6514980 Jan 24, 2019 DP U-1006 NPP Jan 22, 2017
6514980 Jan 24, 2019 DP U-1484
7223387 May 13, 2023 DP U-1006
7223387 May 13, 2023 DP U-1484
RE39264 Aug 02, 2016 DP U-1006
RE39264 Aug 02, 2016 DP U-1484
ADAPALENE - ADAPALENE
A 200298 001 PC Oct 25, 2014
ADAPALENE - DIFFERIN
N 021753 001 7579377 Feb 23, 2025 U-818
7737181 Aug 29, 2024 DP
7834060 Mar 12, 2023 U-1078
7838558 Mar 12, 2023 DP
7868044 Mar 12, 2023 U-1078
8703820 Mar 12, 2023 U-1078
ADAPALENE - DIFFERIN
N 022502 001 7998467 May 31, 2028 DP U-1078
8435502 Sep 15, 2026 DP U-1078
8709392 Sep 15, 2026 DP U-1078
ADAPALENE; BENZOYL PEROXIDE - EPIDUO
N 022320 001 7820186 Nov 23, 2025 DP NPP Feb 01, 2016
7964202 Sep 01, 2024 DP U-1078
8071644 Jul 18, 2027 DP U-1078
8080537 Jul 18, 2027 U-1078
8105618 Dec 23, 2022 U-1078
8129362 Jul 18, 2027 U-1078
8241649 Dec 23, 2022 DP
8445543 Jul 12, 2027 U-1078
8809305 Dec 23, 2022 U-1078
ADEFOVIR DIPIVOXIL - HEPSERA
N 021449 001 5663159 Sep 02, 2014 DS DP
6451340 Jul 23, 2018 DS DP U-470
ADENOSINE - ADENOSCAN
N 020059 001 5731296 Mar 24, 2015 U-221
ADENOSINE - ADENOSCAN
N 020059 002 5731296 Mar 24, 2015 U-221
AFATINIB DIMALEATE - GILOTRIF
N 201292 001 6251912 Jul 29, 2018 DS DP U-1067 NCE Jul 12, 2018
8426586 Oct 10, 2029 DS DP ODE Jul 12, 2020
8545884 Dec 19, 2029 DP
RE43431 Jan 22, 2022 DS DP
AFATINIB DIMALEATE - GILOTRIF
N 201292 002 6251912 Jul 29, 2018 DS DP U-1067 NCE Jul 12, 2018
8426586 Oct 10, 2029 DS DP ODE Jul 12, 2020
8545884 Dec 19, 2029 DP
RE43431 Jan 22, 2022 DS DP
AFATINIB DIMALEATE - GILOTRIF
N 201292 003 6251912 Jul 29, 2018 DS DP U-1067 NCE Jul 12, 2018
8426586 Oct 10, 2029 DS DP ODE Jul 12, 2020
8545884 Dec 19, 2029 DP
RE43431 Jan 22, 2022 DS DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 3 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ALATROFLOXACIN MESYLATE - TROVAN PRESERVATIVE FREE
N 020760 001 5763454 Jun 15, 2015 U-282
6080756 Jul 05, 2016
6194429 Jul 23, 2018
ALATROFLOXACIN MESYLATE - TROVAN PRESERVATIVE FREE
N 020760 002 5763454 Jun 15, 2015 U-282
6080756 Jul 05, 2016
6194429 Jul 23, 2018
ALBUMIN HUMAN - OPTISON
N 020899 001 6723303 Apr 20, 2021 DP M-120 Aug 17, 2015
ALBUTEROL SULFATE - PROVENTIL-HFA
N 020503 001 5775321 Jul 07, 2015 DP
6006745 Dec 28, 2016 DP
ALBUTEROL SULFATE - ACCUNEB
N 020949 001 6702997 Dec 28, 2021 U-558
ALBUTEROL SULFATE - ACCUNEB
N 020949 002 6702997 Dec 28, 2021 U-558
ALBUTEROL SULFATE - VENTOLIN HFA
N 020983 001 6161724 Jan 16, 2018 DP
6170717 Dec 23, 2017 DP
6315173 Dec 23, 2017 DP
6431168 Jun 08, 2018 DP
6435372 Jan 16, 2018 DP
6510969 Dec 23, 2017 DP
6558651 Dec 19, 2016 DP U-716
6596260 Aug 10, 2014 DP
6743413 Jun 01, 2021 U-716
6938796 Jan 16, 2018 DP
6966467 Dec 23, 2017 DP
6997349 Jan 16, 2018 DP
7107986 Jun 08, 2018 DP
7143908 Jan 16, 2018 DP
7350676 Aug 24, 2018 DP
7500444 Feb 26, 2026 DP
7500444*PED Aug 26, 2026
7832351 Jun 19, 2023 DP
ALBUTEROL SULFATE - PROAIR HFA
N 021457 001 6446627 Dec 18, 2017 DP
7105152 Sep 12, 2023 DP
7566445 Jun 04, 2017 DP
8132712 Sep 07, 2028 DP
8834849 Jun 04, 2017 DP
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - COMBIVENT
N 020291 001 5603918 Jun 09, 2015
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - DUONEB
N 020950 001 6632842 Dec 28, 2021 U-532
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 4 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ALBUTEROL SULFATE; IPRATROPIUM BROMIDE - COMBIVENT RESPIMAT
N 021747 001 5662271 Sep 02, 2014 DP NP Oct 07, 2014
5964416 Oct 04, 2016 DP
6149054 Dec 19, 2016 DP
6176442 Oct 04, 2016 DP
6453795 Dec 05, 2016 DP
6726124 Oct 04, 2016 DP
6846413 Aug 28, 2018 DP
6977042 Aug 28, 2018 DP
6988496 Feb 23, 2020 DP
7104470 Oct 04, 2016 DP
7246615 May 31, 2016 DP
7284474 Aug 26, 2024 DP
7396341 Oct 10, 2026 DP
7802568 Feb 26, 2019 DP
7837235 Mar 13, 2028 DP
7896264 May 26, 2025 DP
7988001 Aug 04, 2021 DP
ALCAFTADINE - LASTACAFT
N 022134 001 5468743 Apr 20, 2016 DS DP NCE Jul 28, 2015
8664215 Oct 05, 2029 U-1493
ALCOHOL; CHLORHEXIDINE GLUCONATE - AVAGARD
N 021074 001 5897031 Jun 21, 2016
6090395 Jun 22, 2015 DP
6534069 Jun 22, 2015 DP
6623744 Jun 23, 2015 U-1008
7081246 Aug 03, 2016 DP
7566460 Jun 22, 2015 DP U-1008
ALENDRONATE SODIUM - FOSAMAX
N 021575 001 5994329 Jul 17, 2018 Y
6015801 Jul 17, 2018 Y
6225294 Jul 17, 2018 Y
ALENDRONATE SODIUM - BINOSTO
N 202344 001 7488496 Aug 11, 2023 DS DP
7964212 Mar 06, 2023 DS DP
ALENDRONATE SODIUM; CHOLECALCIFEROL - FOSAMAX PLUS D
N 021762 001 5994329 Jul 17, 2018 U-647 Y
ALFUZOSIN HYDROCHLORIDE - UROXATRAL
N 021287 001 6149940 Aug 22, 2017
ALISKIREN HEMIFUMARATE - TEKTURNA
N 021985 001 5559111 Jul 21, 2018 DS DP U-3
8617595 Feb 19, 2026 DP
ALISKIREN HEMIFUMARATE - TEKTURNA
N 021985 002 5559111 Jul 21, 2018 DS DP U-3
8617595 Feb 19, 2026 DP
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO
N 022545 001 5559111 Jul 21, 2018 DS DP U-3
8613949 Dec 21, 2029 DP
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO
N 022545 002 5559111 Jul 21, 2018 DS DP U-3
8613949 Dec 21, 2029 DP
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO
N 022545 003 5559111 Jul 21, 2018 DS DP U-3
8613949 Dec 21, 2029 DP
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE - TEKAMLO
N 022545 004 5559111 Jul 21, 2018 DS DP U-3
8613949 Dec 21, 2029 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 5 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE
N 200045 001 5559111 Jul 21, 2018 DS DP U-3
8183295 May 16, 2023 DP
8618174 Nov 15, 2021 DP
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE
N 200045 002 5559111 Jul 21, 2018 DS DP U-3
8183295 May 16, 2023 DP
8618174 Nov 15, 2021 DP
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE
N 200045 003 5559111 Jul 21, 2018 DS DP U-3
8183295 May 16, 2023 DP
8618174 Nov 15, 2021 DP
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE
N 200045 004 5559111 Jul 21, 2018 DS DP U-3
8183295 May 16, 2023 DP
8618174 Nov 15, 2021 DP
ALISKIREN HEMIFUMARATE; AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE - AMTURNIDE
N 200045 005 5559111 Jul 21, 2018 DS DP U-3
8183295 May 16, 2023 DP
8618174 Nov 15, 2021 DP
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT
N 022107 001 5559111 Jul 21, 2018 DS DP U-3
8618172 Jul 13, 2028 DP
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT
N 022107 002 5559111 Jul 21, 2018 DS DP U-3
8618172 Jul 13, 2028 DP
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT
N 022107 003 5559111 Jul 21, 2018 DS DP U-3
8618172 Jul 13, 2028 DP
ALISKIREN HEMIFUMARATE; HYDROCHLOROTHIAZIDE - TEKTURNA HCT
N 022107 004 5559111 Jul 21, 2018 DS DP U-3
8618172 Jul 13, 2028 DP
ALISKIREN HEMIFUMARATE; VALSARTAN - VALTURNA
N 022217 001 5559111 Jul 21, 2018 DS DP U-3
8168616 Jul 03, 2026 DP
ALISKIREN HEMIFUMARATE; VALSARTAN - VALTURNA
N 022217 002 5559111 Jul 21, 2018 DS DP U-3
8168616 Jul 03, 2026 DP
ALITRETINOIN - PANRETIN
N 020886 001 5932622 Aug 03, 2016 U-562
ALMOTRIPTAN MALATE - AXERT
N 021001 001 5565447 May 07, 2015 DS DP U-969
ALMOTRIPTAN MALATE - AXERT
N 021001 002 5565447 May 07, 2015 DS DP U-969
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 6 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
PATENT PATENT EXCLUSIVITY
NO PATENT NO
EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ALOGLIPTIN BENZOATE - NESINA
N 022271 001 6150383
Jun 19, 2016 U-1330 NCE Jan 25, 2018
6211205
Jun 19, 2016 U-1331
6303640
Aug 09, 2016 U-1332
6303661
Apr 24, 2017 U-1333
6329404
Jun 19, 2016 DP U-1334
6890898
Feb 02, 2019 U-1335
7078381
Feb 02, 2019 U-1335
7459428
Feb 02, 2019 U-1336
7807689
Jun 27, 2028 DS DP U-1337
8173663
Mar 15, 2025 U-1338
8288539
Mar 15, 2025 DS
8697125
Jan 22, 2029 DP
ALOGLIPTIN BENZOATE - NESINA
N 022271 002 6150383
Jun 19, 2016 U-1330 NCE Jan 25, 2018
6211205
Jun 19, 2016 U-1331
6303640
Aug 09, 2016 U-1332
6303661
Apr 24, 2017 U-1333
6329404
Jun 19, 2016 DP U-1334
6890898
Feb 02, 2019 U-1335
7078381
Feb 02, 2019 U-1335
7459428
Feb 02, 2019 U-1336
7807689
Jun 27, 2028 DS DP U-1337
8173663
Mar 15, 2025 U-1338
8288539
Mar 15, 2025 DS
8697125
Jan 22, 2029 DP
ALOGLIPTIN BENZOATE - NESINA
N 022271 003 6150383
Jun 19, 2016 U-1330 NCE Jan 25, 2018
6211205
Jun 19, 2016 U-1331
6303640
Aug 09, 2016 U-1332
6303661
Apr 24, 2017 U-1333
6329404
Jun 19, 2016 DP U-1334
6890898
Feb 02, 2019 U-1335
7078381
Feb 02, 2019 U-1335
7459428
Feb 02, 2019 U-1336
7807689
Jun 27, 2028 DS DP U-1337
8173663
Mar 15, 2025 U-1338
8288539
Mar 15, 2025 DS
8697125
Jan 22, 2029 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 7 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE - KAZANO
N 203414 001 5965584 Jun 19, 2016 U-1339 NC Jan 25, 2016
6150383 Jun 19, 2016 U-1330 NCE Jan 25, 2018
6150384 Jun 19, 2016 U-1340
6166042 Jun 19, 2016 U-1341
6166043 Jun 19, 2016 U-1342
6172090 Jun 19, 2016 U-1343
6211205 Jun 19, 2016 U-1331
6303640 Aug 09, 2016 U-1332
6303661 Apr 24, 2017 U-1333
6329404 Jun 19, 2016 U-1334
6890898 Feb 02, 2019 U-1335
7078381 Feb 02, 2019 U-1335
7459428 Feb 02, 2019 U-1336
7807689 Jun 27, 2028 DS DP U-1337
8173663 Mar 15, 2025 U-1338
8288539 Mar 15, 2025 DS
8900638 May 24, 2029 DP
ALOGLIPTIN BENZOATE; METFORMIN HYDROCHLORIDE - KAZANO
N 203414 002 5965584 Jun 19, 2016 U-1339 NC Jan 25, 2016
6150383 Jun 19, 2016 U-1330 NCE Jan 25, 2018
6150384 Jun 19, 2016 U-1340
6166042 Jun 19, 2016 U-1341
6166043 Jun 19, 2016 U-1342
6172090 Jun 19, 2016 U-1343
6211205 Jun 19, 2016 U-1331
6303640 Aug 09, 2016 U-1332
6303661 Apr 24, 2017 U-1333
6329404 Jun 19, 2016 U-1334
6890898 Feb 02, 2019 U-1335
7078381 Feb 02, 2019 U-1335
7459428 Feb 02, 2019 U-1336
7807689 Jun 27, 2028 DS DP U-1337
8173663 Mar 15, 2025 U-1338
8288539 Mar 15, 2025 DS
8900638 May 24, 2029 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 8 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI
N 022426 001 5965584 Jun 19, 2016 DP U-1339 NC Jan 25, 2016
6150383 Jun 19, 2016 U-1330 NCE Jan 25, 2018
6150384 Jun 19, 2016 U-1340
6166042 Jun 19, 2016 U-1341
6166043 Jun 19, 2016 U-1342
6172090 Jun 19, 2016 U-1343
6211205 Jun 19, 2016 U-1331
6271243 Jun 19, 2016 U-1344
6303640 Aug 09, 2016 U-1332
6303661 Apr 24, 2017 U-1333
6329404 Jun 19, 2016 DP U-1334
6890898 Feb 02, 2019 U-1335
7078381 Feb 02, 2019 U-1335
7459428 Feb 02, 2019 U-1336
7807689 Jun 27, 2028 DS DP U-1337
8173663 Mar 15, 2025 U-1338
8288539 Mar 15, 2025 DS
8637079 Jan 23, 2029 DP
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI
N 022426 002 5965584 Jun 19, 2016 DP U-1339 NC Jan 25, 2016
6150383 Jun 19, 2016 U-1330 NCE Jan 25, 2018
6150384 Jun 19, 2016 U-1340
6166042 Jun 19, 2016 U-1341
6166043 Jun 19, 2016 U-1342
6172090 Jun 19, 2016 U-1343
6211205 Jun 19, 2016 U-1331
6271243 Jun 19, 2016 U-1344
6303640 Aug 09, 2016 U-1332
6303661 Apr 24, 2017 U-1333
6329404 Jun 19, 2016 DP U-1334
6890898 Feb 02, 2019 U-1335
7078381 Feb 02, 2019 U-1335
7459428 Feb 02, 2019 U-1336
7807689 Jun 27, 2028 DS DP U-1337
8173663 Mar 15, 2025 U-1338
8288539 Mar 15, 2025 DS
8637079 Jan 23, 2029 DP
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI
N 022426 003 5965584 Jun 19, 2016 DP U-1339 NC Jan 25, 2016
6150383 Jun 19, 2016 U-1330 NCE Jan 25, 2018
6150384 Jun 19, 2016 U-1340
6166042 Jun 19, 2016 U-1341
6166043 Jun 19, 2016 U-1342
6172090 Jun 19, 2016 U-1343
6211205 Jun 19, 2016 U-1331
6271243 Jun 19, 2016 U-1344
6303640 Aug 09, 2016 U-1332
6303661 Apr 24, 2017 U-1333
6329404 Jun 19, 2016 DP U-1334
6890898 Feb 02, 2019 U-1335
7078381 Feb 02, 2019 U-1335
7459428 Feb 02, 2019 U-1336
7807689 Jun 27, 2028 DS DP U-1337
8173663 Mar 15, 2025 U-1338
8288539 Mar 15, 2025 DS
8637079 Jan 23, 2029 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 9 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI
N 022426 004 5965584 Jun 19, 2016 DP U-1339 NC Jan 25, 2016
6150383 Jun 19, 2016 U-1330 NCE Jan 25, 2018
6150384 Jun 19, 2016 U-1340
6166042 Jun 19, 2016 U-1341
6166043 Jun 19, 2016 U-1342
6172090 Jun 19, 2016 U-1343
6211205 Jun 19, 2016 U-1331
6271243 Jun 19, 2016 U-1344
6303640 Aug 09, 2016 U-1332
6303661 Apr 24, 2017 U-1333
6329404 Jun 19, 2016 DP U-1334
6890898 Feb 02, 2019 U-1335
7078381 Feb 02, 2019 U-1335
7459428 Feb 02, 2019 U-1336
7807689 Jun 27, 2028 DS DP U-1337
8173663 Mar 15, 2025 U-1338
8288539 Mar 15, 2025 DS
8637079 Jan 23, 2029 DP
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI
N 022426 005 5965584 Jun 19, 2016 DP U-1339 NC Jan 25, 2016
6150383 Jun 19, 2016 U-1330 NCE Jan 25, 2018
6150384 Jun 19, 2016 U-1340
6166042 Jun 19, 2016 U-1341
6166043 Jun 19, 2016 U-1342
6172090 Jun 19, 2016 U-1343
6211205 Jun 19, 2016 U-1331
6271243 Jun 19, 2016 U-1344
6303640 Aug 09, 2016 U-1332
6303661 Apr 24, 2017 U-1333
6329404 Jun 19, 2016 DP U-1334
6890898 Feb 02, 2019 U-1335
7078381 Feb 02, 2019 U-1335
7459428 Feb 02, 2019 U-1336
7807689 Jun 27, 2028 DS DP U-1337
8173663 Mar 15, 2025 U-1338
8288539 Mar 15, 2025 DS
8637079 Jan 23, 2029 DP
ALOGLIPTIN BENZOATE; PIOGLITAZONE HYDROCHLORIDE - OSENI
N 022426 006 5965584 Jun 19, 2016 DP U-1339 NC Jan 25, 2016
6150383 Jun 19, 2016 U-1330 NCE Jan 25, 2018
6150384 Jun 19, 2016 U-1340
6166042 Jun 19, 2016 U-1341
6166043 Jun 19, 2016 U-1342
6172090 Jun 19, 2016 U-1343
6211205 Jun 19, 2016 U-1331
6271243 Jun 19, 2016 U-1344
6303640 Aug 09, 2016 U-1332
6303661 Apr 24, 2017 U-1333
6329404 Jun 19, 2016 DP U-1334
6890898 Feb 02, 2019 U-1335
7078381 Feb 02, 2019 U-1335
7459428 Feb 02, 2019 U-1336
7807689 Jun 27, 2028 DS DP U-1337
8173663 Mar 15, 2025 U-1338
8288539 Mar 15, 2025 DS
8637079 Jan 23, 2029 DP
ALOSETRON HYDROCHLORIDE - LOTRONEX
N 021107 001 6284770 Oct 05, 2018 U-405
ALOSETRON HYDROCHLORIDE - LOTRONEX
N 021107 002 6284770 Oct 05, 2018 U-405
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 10 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ALPRAZOLAM - NIRAVAM
N 021726 001 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
ALPRAZOLAM - NIRAVAM
N 021726 002 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
ALPRAZOLAM - NIRAVAM
N 021726 003 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
ALPRAZOLAM - NIRAVAM
N 021726 004 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
ALPROSTADIL - CAVERJECT
N 020379 001 5741523 Apr 21, 2015
ALPROSTADIL - CAVERJECT
N 020379 002 5741523 Apr 21, 2015
ALPROSTADIL - CAVERJECT
N 020379 003 5741523 Apr 21, 2015
ALPROSTADIL - CAVERJECT
N 020379 004 5741523 Apr 21, 2015
ALPROSTADIL - MUSE
N 020700 001 5886039 Mar 23, 2016 DP U-155
ALPROSTADIL - MUSE
N 020700 002 5886039 Mar 23, 2016 DP U-155
ALPROSTADIL - MUSE
N 020700 003 5886039 Mar 23, 2016 DP U-155
ALPROSTADIL - MUSE
N 020700 004 5886039 Mar 23, 2016 DP U-155
ALPROSTADIL - CAVERJECT IMPULSE
N 021212 001 5716338 Feb 10, 2015 DP
ALPROSTADIL - CAVERJECT IMPULSE
N 021212 002 5716338 Feb 10, 2015 DP
ALVIMOPAN - ENTEREG
N 021775 001 5250542 Mar 29, 2016 DS DP U-878 M-128 Oct 18, 2016
6469030 Nov 29, 2020 U-879
8112290 Jul 31, 2030 U-1443
8645160 Jun 18, 2029 U-1485
AMBRISENTAN - LETAIRIS
N 022081 001 5703017 Dec 30, 2014 DS
5840722 Nov 24, 2015 U-821
5840722 Nov 24, 2015 U-1297
7109205 Oct 07, 2015 DS DP
7601730 Oct 07, 2015 U-1080
8349843 Oct 07, 2015 DS DP
RE42462 Jul 29, 2018 DS
AMBRISENTAN - LETAIRIS
N 022081 002 5703017 Dec 30, 2014 DS
5840722 Nov 24, 2015 U-821
5840722 Nov 24, 2015 U-1297
7109205 Oct 07, 2015 DS DP
7601730 Oct 07, 2015 U-1080
8349843 Oct 07, 2015 DS DP
RE42462 Jul 29, 2018 DS
AMIFOSTINE - ETHYOL
N 020221 001 5994409 Dec 08, 2017 U-305
AMIFOSTINE - ETHYOL
N 020221 002 5994409 Dec 08, 2017 U-305
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 11 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
AMINOLEVULINIC ACID HYDROCHLORIDE - LEVULAN
N 020965 001 5954703 Oct 31, 2017 U-289
6709446 May 01, 2018 U-289
7723910 Jun 17, 2019 U-289
8216289 May 01, 2018 U-289
8758418 May 01, 2018 U-289
AMIODARONE HYDROCHLORIDE - NEXTERONE
N 022325 001 6869939 May 04, 2022 DP
7635773 Mar 13, 2029 DP
AMIODARONE HYDROCHLORIDE - NEXTERONE
N 022325 002 6869939 May 04, 2022 DP
7635773 Mar 13, 2029 DP
AMIODARONE HYDROCHLORIDE - NEXTERONE
N 022325 003 6869939 May 04, 2022 DP
7635773 Mar 13, 2029 DP
AMLODIPINE BESYLATE - AMLODIPINE BESYLATE
N 022026 001 6828339 Nov 20, 2022 DS
AMLODIPINE BESYLATE - AMLODIPINE BESYLATE
N 022026 002 6828339 Nov 20, 2022 DS
AMLODIPINE BESYLATE - AMLODIPINE BESYLATE
N 022026 003 6828339 Nov 20, 2022 DS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 12 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 001 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 002 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 003 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 004 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 005 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 006 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 007 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 008 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 009 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 010 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; ATORVASTATIN CALCIUM - CADUET
N 021540 011 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
6455574 Aug 11, 2018 U-552
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N 020364 002 6162802 Dec 19, 2017 U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N 020364 003 6162802 Dec 19, 2017 U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N 020364 004 6162802 Dec 19, 2017 U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N 020364 005 6162802 Dec 19, 2017 U-367
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N 020364 006 6162802 Dec 19, 2017 DS DP U-185
AMLODIPINE BESYLATE; BENAZEPRIL HYDROCHLORIDE - LOTREL
N 020364 007 6162802 Dec 19, 2017 DS DP U-185
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 13 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR
N 200175 001 5616599 Apr 25, 2016 DS DP U-3
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR
N 200175 002 5616599 Apr 25, 2016 DS DP U-3
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR
N 200175 003 5616599 Apr 25, 2016 DS DP U-3
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR
N 200175 004 5616599 Apr 25, 2016 DS DP U-3
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - TRIBENZOR
N 200175 005 5616599 Apr 25, 2016 DS DP U-3
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
N 022314 001 6294197 Jun 18, 2017 DP U-3
8101599 May 16, 2023 DP
8475839 May 16, 2023 DP
8475839*PED Nov 16, 2023
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
N 022314 002 6294197 Jun 18, 2017 DP U-3
8101599 May 16, 2023 DP
8475839 May 16, 2023 DP
8475839*PED Nov 16, 2023
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
N 022314 003 6294197 Jun 18, 2017 DP U-3
8101599 May 16, 2023 DP
8475839 May 16, 2023 DP
8475839*PED Nov 16, 2023
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
N 022314 004 6294197 Jun 18, 2017 DP U-3
8101599 May 16, 2023 DP
8475839 May 16, 2023 DP
8475839*PED Nov 16, 2023
AMLODIPINE BESYLATE; HYDROCHLOROTHIAZIDE; VALSARTAN - EXFORGE HCT
N 022314 005 6294197 Jun 18, 2017 DP U-3
8101599 May 16, 2023 DP
8475839 May 16, 2023 DP
8475839*PED Nov 16, 2023
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR
N 022100 001 5616599 Apr 25, 2016 DS DP U-3
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR
N 022100 002 5616599 Apr 25, 2016 DS DP U-3
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR
N 022100 003 5616599 Apr 25, 2016 DS DP U-3
AMLODIPINE BESYLATE; OLMESARTAN MEDOXOMIL - AZOR
N 022100 004 5616599 Apr 25, 2016 DS DP U-3
AMLODIPINE BESYLATE; VALSARTAN - AMLODIPINE BESYLATE AND VALSARTAN
A 090011 001 PC Mar 29, 2015
AMLODIPINE BESYLATE; VALSARTAN - AMLODIPINE BESYLATE AND VALSARTAN
A 090011 002 PC Mar 29, 2015
AMLODIPINE BESYLATE; VALSARTAN - AMLODIPINE BESYLATE AND VALSARTAN
A 090011 004 PC Mar 29, 2015
AMLODIPINE BESYLATE; VALSARTAN - AMLODIPINE BESYLATE AND VALSARTAN
A 090144 001 PC Mar 29, 2015
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 14 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
AMLODIPINE BESYLATE; VALSARTAN - EXFORGE
N 021990 002 6294197 Jun 18, 2017 DP U-3
6395728 Jul 08, 2019 DP
AMLODIPINE BESYLATE; VALSARTAN - EXFORGE
N 021990 003 6294197 Jun 18, 2017 DP U-3
6395728 Jul 08, 2019 DP
AMLODIPINE BESYLATE; VALSARTAN - EXFORGE
N 021990 004 6294197 Jun 18, 2017 DP U-3
6395728 Jul 08, 2019 DP
AMLODIPINE BESYLATE; VALSARTAN - EXFORGE
N 021990 005 6294197 Jun 18, 2017 DP U-3
6395728 Jul 08, 2019 DP
AMLODIPINE; HYDROCHLOROTHIAZIDE; VALSARTAN - AMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDE
A 200435 001 PC May 30, 2015
PC May 30, 2015
AMLODIPINE; HYDROCHLOROTHIAZIDE; VALSARTAN - AMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDE
A 200435 002 PC May 30, 2015
PC May 30, 2015
AMLODIPINE; HYDROCHLOROTHIAZIDE; VALSARTAN - AMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDE
A 200435 003 PC May 30, 2015
PC May 30, 2015
AMLODIPINE; HYDROCHLOROTHIAZIDE; VALSARTAN - AMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDE
A 200435 004 PC May 30, 2015
PC May 30, 2015
AMLODIPINE; HYDROCHLOROTHIAZIDE; VALSARTAN - AMLODIPINE,VALSARTAN AND HYDROCHLOROTHIAZIDE
A 200435 005 PC May 30, 2015
PC May 30, 2015
AMOXICILLIN - MOXATAG
N 050813 001 6544555 Oct 13, 2020 DS DP U-897
6669948 Oct 13, 2020 DS DP U-897
6723341 Oct 13, 2020 DS DP U-897
8299052 May 07, 2027 U-1304
8357394 Dec 08, 2026 DP
AMOXICILLIN; CLAVULANATE POTASSIUM - AUGMENTIN XR
N 050785 001 6746692 Apr 04, 2020 DP
6783773 Apr 04, 2020 DP
6878386 Apr 04, 2020 U-926
7217430 Apr 04, 2020 DP U-926
7250176 Apr 04, 2020 U-926
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 10
N 011522 007 6384020 Jul 06, 2020
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 20
N 011522 008 6384020 Jul 06, 2020
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 5
N 011522 009 6384020 Jul 06, 2020
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 30
N 011522 010 6384020 Jul 06, 2020
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 7.5
N 011522 011 6384020 Jul 06, 2020
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 12.5
N 011522 012 6384020 Jul 06, 2020
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL 15
N 011522 013 6384020 Jul 06, 2020
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 15 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL XR 10
N 021303 001 6322819 Oct 21, 2018
6605300 Oct 21, 2018
RE41148 Oct 21, 2018 DP
RE42096 Oct 21, 2018 DP
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL XR 20
N 021303 002 6322819 Oct 21, 2018
6605300 Oct 21, 2018
RE41148 Oct 21, 2018 DP
RE42096 Oct 21, 2018 DP
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL XR 30
N 021303 003 6322819 Oct 21, 2018
6605300 Oct 21, 2018
RE41148 Oct 21, 2018 DP
RE42096 Oct 21, 2018 DP
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL XR 25
N 021303 004 6322819 Oct 21, 2018
6605300 Oct 21, 2018
RE41148 Oct 21, 2018 DP
RE42096 Oct 21, 2018 DP
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL XR 5
N 021303 005 6322819 Oct 21, 2018
6605300 Oct 21, 2018
RE41148 Oct 21, 2018 DP
RE42096 Oct 21, 2018 DP
AMPHETAMINE ASPARTATE; AMPHETAMINE SULFATE; DEXTROAMPHETAMINE SACCHARATE; DEXTROAMPHETAMINE SULFATE -
ADDERALL XR 15
N 021303 006 6322819 Oct 21, 2018
6605300 Oct 21, 2018
RE41148 Oct 21, 2018 DP
RE42096 Oct 21, 2018 DP
AMPHOTERICIN B - ABELCET
N 050724 001 6406713 Jun 18, 2019 DS
AMPHOTERICIN B - AMBISOME
N 050740 001 5874104 Feb 23, 2016 DP U-922
5965156 Oct 12, 2016 DP U-922
AMPRENAVIR - AGENERASE
N 021007 001 5646180 Jul 08, 2014 U-257
5723490 Mar 03, 2015 U-257
6730679 Nov 11, 2017 DP
AMPRENAVIR - AGENERASE
N 021007 002 5646180 Jul 08, 2014 U-257
5723490 Mar 03, 2015 U-257
6730679 Nov 11, 2017 DP
AMPRENAVIR - AGENERASE
N 021039 001 5646180 Jul 08, 2014 U-257
5723490 Mar 03, 2015 U-257
ANIDULAFUNGIN - ERAXIS
N 021632 001 5965525 Feb 17, 2020 DS DP U-540
6960564 Apr 12, 2021 DP U-540
7709444 Apr 12, 2021 DP U-540
ANIDULAFUNGIN - ERAXIS
N 021632 002 5965525 Feb 17, 2020 DS DP U-540
6960564 Apr 12, 2021 DP U-540
7709444 Apr 12, 2021 DP U-540
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 16 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
PATENT
PATENT
EXCLUSIVITY
NO PATENT NO
EXPIRATION
PATENT DELIST
EXCLUSIVITY EXPIRATION
DATE
CODES REQUESTED
CODE(S) DATE
APIXABAN - ELIQUIS
N 202155 001 6413980
Dec 22, 2019
DS DP U-1200
I-661 Aug 21, 2017
6413980
Dec 22, 2019
DS DP U-1301
I-681 Mar 03, 2017
6413980
Dec 22, 2019
DS DP U-1302
I-690 Aug 21, 2017
6413980
Dec 22, 2019
DS DP U-1501
I-691 Aug 21, 2017
6967208
Feb 03, 2023
DS DP U-1167
NCE Dec 28, 2017
6967208
Feb 03, 2023
DS DP U-1200
6967208
Feb 03, 2023
DS DP U-1301
6967208
Feb 03, 2023
DS DP U-1302
6967208
Feb 03, 2023
DS DP U-1323
6967208
Feb 03, 2023
DS DP U-1501
6967208
Feb 03, 2023
DS DP U-1502
APIXABAN - ELIQUIS
N 202155 002 6413980
Dec 22, 2019
DS DP U-1200
I-661 Aug 21, 2017
6967208
Feb 03, 2023
DS DP U-1200
I-690 Aug 21, 2017
6967208
Feb 03, 2023
DS DP U-1323
I-691 Aug 21, 2017
NCE Dec 28, 2017
APREMILAST - OTEZLA
N 205437 001 6020358
Oct 30, 2018
DS DP U-1504
I-694 Sep 23, 2017
6962940
Mar 19, 2023
U-1504
NCE Mar 21, 2019
7208516
Mar 19, 2023
U-1505
7427638
Nov 17, 2024
DS DP
7659302
Mar 19, 2023
U-1505
7659302
Mar 19, 2023
U-1595
7893101
Dec 09, 2023
DS DP
8455536
Mar 19, 2023
U-1505
8455536
Mar 19, 2023
U-1595
8802717
Mar 19, 2023
U-1561
APREMILAST - OTEZLA
N 205437 002 6020358
Oct 30, 2018
DS DP U-1504
I-694 Sep 23, 2017
6962940
Mar 19, 2023
U-1504
NCE Mar 21, 2019
7208516
Mar 19, 2023
U-1505
7427638
Nov 17, 2024
DS DP
7659302
Mar 19, 2023
U-1505
7659302
Mar 19, 2023
U-1595
7893101
Dec 09, 2023
DS DP
8455536
Mar 19, 2023
U-1505
8455536
Mar 19, 2023
U-1595
8802717
Mar 19, 2023
U-1561
APREMILAST - OTEZLA
N 205437 003 6020358
Oct 30, 2018
DS DP U-1504
I-694 Sep 23, 2017
6962940
Mar 19, 2023
U-1504
NCE Mar 21, 2019
7208516
Mar 19, 2023
U-1505
7427638
Nov 17, 2024
DS DP
7659302
Mar 19, 2023
U-1505
7659302
Mar 19, 2023
U-1595
7893101
Dec 09, 2023
DS DP
8455536
Mar 19, 2023
U-1505
8455536
Mar 19, 2023
U-1595
8802717
Mar 19, 2023
U-1561
APREPITANT - EMEND
N 021549 001 5719147
Apr 17, 2015
DS DP U-853
6096742
Jul 01, 2018
DS DP U-745
8258132
Sep 26, 2027
DP U-901
8258132
Sep 26, 2027
DP U-1282
APREPITANT - EMEND
N 021549 002 5719147
Apr 17, 2015
DS DP U-853
6096742
Jul 01, 2018
DS DP U-745
8258132
Sep 26, 2027
DP U-901
8258132
Sep 26, 2027
DP U-1282
APREPITANT - EMEND
N 021549 003 5719147
Apr 17, 2015
DS DP U-853
6096742
Jul 01, 2018
DS DP U-745
8258132
Sep 26, 2027
DP U-901
8258132
Sep 26, 2027
DP U-1282
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 17 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ARFORMOTEROL TARTRATE - BROVANA
N 021912 001 6040344 Nov 12, 2016 DS
6472563 Nov 09, 2021 DS
6667344 Jun 22, 2021 DP
6720453 Nov 09, 2021 DS
6814953 Jun 22, 2021 U-793
7145036 Nov 09, 2021 DS
7348362 Jun 22, 2021 DP U-793
7462645 Jun 22, 2021 U-793
7465756 Jun 22, 2021 DP
7473710 Jun 22, 2021 U-793
7541385 Jun 22, 2021 U-793
8110706 Nov 09, 2021 DP
ARGATROBAN - ARGATROBAN IN SODIUM CHLORIDE
N 022434 001 7589106 Sep 26, 2027 DP U-1163
7687516 Sep 26, 2027 DP U-1164
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 18 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
PATENT
PATENT
EXCLUSIVITY
NO PATENT NO
EXPIRATION
PATENT DELIST
EXCLUSIVITY EXPIRATION
DATE
CODES REQUESTED
CODE(S) DATE
ARIPIPRAZOLE - ABILIFY
N 021436 001 5006528
Oct 20, 2014
DS DP U-761
I-700 Dec 12, 2017
7053092
Jan 28, 2022
U-839
M-137 Jun 09, 2017
8017615
Jun 16, 2024
DP
8017615*PED
Dec 16, 2024
8580796
Sep 25, 2022
DS
8580796*PED
Mar 25, 2023
8642600
Jan 28, 2022
U-1492
8642600*PED
Jul 28, 2022
8642760
Sep 25, 2022
DS
8642760*PED
Mar 25, 2023
8759350
Mar 02, 2027
U-1529
ARIPIPRAZOLE - ABILIFY
N 021436 002 5006528
Oct 20, 2014
DS DP U-761
I-700 Dec 12, 2017
7053092
Jan 28, 2022
U-839
M-137 Jun 09, 2017
8017615
Jun 16, 2024
DP
8017615*PED
Dec 16, 2024
8580796
Sep 25, 2022
DS
8580796*PED
Mar 25, 2023
8642600
Jan 28, 2022
U-1492
8642600*PED
Jul 28, 2022
8642760
Sep 25, 2022
DS
8642760*PED
Mar 25, 2023
8759350
Mar 02, 2027
U-1529
ARIPIPRAZOLE - ABILIFY
N 021436 003 5006528
Oct 20, 2014
DS DP U-761
I-700 Dec 12, 2017
7053092
Jan 28, 2022
U-839
M-137 Jun 09, 2017
8017615
Jun 16, 2024
DP
8017615*PED
Dec 16, 2024
8580796
Sep 25, 2022
DS
8580796*PED
Mar 25, 2023
8642600
Jan 28, 2022
U-1492
8642600*PED
Jul 28, 2022
8642760
Sep 25, 2022
DS
8642760*PED
Mar 25, 2023
8759350
Mar 02, 2027
U-1529
ARIPIPRAZOLE - ABILIFY
N 021436 004 5006528
Oct 20, 2014
DS DP U-761
I-700 Dec 12, 2017
7053092
Jan 28, 2022
U-839
M-137 Jun 09, 2017
8017615
Jun 16, 2024
DP
8017615*PED
Dec 16, 2024
8580796
Sep 25, 2022
DS
8580796*PED
Mar 25, 2023
8642600
Jan 28, 2022
U-1492
8642600*PED
Jul 28, 2022
8642760
Sep 25, 2022
DS
8642760*PED
Mar 25, 2023
8759350
Mar 02, 2027
U-1529
ARIPIPRAZOLE - ABILIFY
N 021436 005 5006528
Oct 20, 2014
DS DP U-761
I-700 Dec 12, 2017
7053092
Jan 28, 2022
U-839
M-137 Jun 09, 2017
8017615
Jun 16, 2024
DP
8017615*PED
Dec 16, 2024
8580796
Sep 25, 2022
DS
8580796*PED
Mar 25, 2023
8642600
Jan 28, 2022
U-1492
8642600*PED
Jul 28, 2022
8642760
Sep 25, 2022
DS
8642760*PED
Mar 25, 2023
8759350
Mar 02, 2027
U-1529
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 19 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ARIPIPRAZOLE - ABILIFY
N 021436 006 5006528 Oct 20, 2014 DS DP U-761 I-700 Dec 12, 2017
7053092 Jan 28, 2022 U-839 M-137 Jun 09, 2017
8017615 Jun 16, 2024 DP
8017615*PED Dec 16, 2024
8580796 Sep 25, 2022 DS
8580796*PED Mar 25, 2023
8642600 Jan 28, 2022 U-1492
8642600*PED Jul 28, 2022
8642760 Sep 25, 2022 DS
8642760*PED Mar 25, 2023
8759350 Mar 02, 2027 U-1529
ARIPIPRAZOLE - ABILIFY
N 021713 001 5006528 Oct 20, 2014 DS DP U-761 M-137 Jun 09, 2017
6977257 Apr 24, 2022 DS DP
7053092 Jan 28, 2022 U-839
8642600 Jan 28, 2022 U-1492
8642600*PED Jul 28, 2022
8759350 Mar 02, 2027 U-1529
ARIPIPRAZOLE - ABILIFY
N 021729 002 5006528 Oct 20, 2014 DS DP U-761 I-700 Dec 12, 2017
7053092 Jan 28, 2022 U-839 M-137 Jun 09, 2017
8017615 Jun 16, 2024 DP
8017615*PED Dec 16, 2024
8518421 Jan 24, 2021 DP
8518421*PED Jul 24, 2021
8580796 Sep 25, 2022 DS
8580796*PED Mar 25, 2023
8642600 Jan 28, 2022 U-1492
8642600*PED Jul 28, 2022
8642760 Sep 25, 2022 DS
8642760*PED Mar 25, 2023
8759350 Mar 02, 2027 U-1529
ARIPIPRAZOLE - ABILIFY
N 021729 003 5006528 Oct 20, 2014 DS DP U-761 I-700 Dec 12, 2017
7053092 Jan 28, 2022 U-839 M-137 Jun 09, 2017
8017615 Jun 16, 2024 DP
8017615*PED Dec 16, 2024
8518421 Jan 24, 2021 DP
8518421*PED Jul 24, 2021
8580796 Sep 25, 2022 DS
8580796*PED Mar 25, 2023
8642600 Jan 28, 2022 U-1492
8642600*PED Jul 28, 2022
8642760 Sep 25, 2022 DS
8642760*PED Mar 25, 2023
8759350 Mar 02, 2027 U-1529
ARIPIPRAZOLE - ABILIFY
N 021729 004 5006528 Oct 20, 2014 DS DP U-761 I-700 Dec 12, 2017
7053092 Jan 28, 2022 U-839 M-137 Jun 09, 2017
8017615 Jun 16, 2024 DP
8017615*PED Dec 16, 2024
8518421 Jan 24, 2021 DP
8518421*PED Jul 24, 2021
8580796 Sep 25, 2022 DS
8580796*PED Mar 25, 2023
8642600 Jan 28, 2022 U-1492
8642600*PED Jul 28, 2022
8642760 Sep 25, 2022 DS
8642760*PED Mar 25, 2023
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 20 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT
PATENT
EXCLUSIVITY
NO PATENT NO EXPIRATION
PATENT DELIST
EXCLUSIVITY EXPIRATION
DATE
CODES REQUESTED
CODE(S) DATE
ARIPIPRAZOLE - ABILIFY
N 021729 005 5006528 Oct 20, 2014
DS DP U-761
I-700 Dec 12, 2017
7053092 Jan 28, 2022
U-839
M-137 Jun 09, 2017
8017615 Jun 16, 2024
DP
8017615*PED Dec 16, 2024
8518421 Jan 24, 2021
DP
8518421*PED Jul 24, 2021
8580796 Sep 25, 2022
DS
8580796*PED Mar 25, 2023
8642600 Jan 28, 2022
U-1492
8642600*PED Jul 28, 2022
8642760 Sep 25, 2022
DS
8642760*PED Mar 25, 2023
ARIPIPRAZOLE - ABILIFY
N 021866 001 5006528 Oct 20, 2014
DS DP U-763
I-700 Dec 12, 2017
7115587 Jul 21, 2024
DS DP U-764
M-137 Jun 09, 2017
7550445 Jul 21, 2024
DP
ARIPIPRAZOLE - ABILIFY MAINTENA KIT
N 202971 001 5006528 Apr 20, 2015
DS DP U-543
M-150 Dec 05, 2017
7807680 Oct 19, 2024
DP
NDF Feb 28, 2016
8030313 Oct 19, 2024
U-543
8338427 Mar 15, 2025
DP U-543
8338428 Aug 06, 2023
DP U-543
8399469 Dec 29, 2023
DS
8722679 Oct 19, 2024
DP
8759351 Aug 06, 2023
DP U-1530
ARIPIPRAZOLE - ABILIFY MAINTENA KIT
N 202971 002 5006528 Apr 20, 2015
DS DP U-543
M-150 Dec 05, 2017
7807680 Oct 19, 2024
DP
NDF Feb 28, 2016
8030313 Oct 19, 2024
U-543
8338427 Mar 15, 2025
DP U-543
8338428 Aug 06, 2023
DP U-543
8399469 Dec 29, 2023
DS
8722679 Oct 19, 2024
DP
8759351 Aug 06, 2023
DP U-1530
ARIPIPRAZOLE - ABILIFY MAINTENA KIT
N 202971 003 5006528 Apr 20, 2015
DS DP U-1530
M-150 Dec 05, 2017
7807680 Oct 19, 2024
DP
NDF Feb 28, 2016
8030313 Oct 19, 2024
U-543
8338427 Mar 15, 2025
DP U-1530
8338428 Aug 06, 2023
DP U-1530
8399469 Dec 29, 2023
DS
8722679 Oct 19, 2024
DP
8759351 Aug 06, 2023
DP U-1530
ARIPIPRAZOLE - ABILIFY MAINTENA KIT
N 202971 004 5006528 Apr 20, 2015
DS DP U-1530
M-150 Dec 05, 2017
7807680 Oct 19, 2024
DP
NDF Feb 28, 2016
8030313 Oct 19, 2024
U-543
8338427 Mar 15, 2025
DP U-1530
8338428 Aug 06, 2023
DP U-1530
8399469 Dec 29, 2023
DS
8722679 Oct 19, 2024
DP
8759351 Aug 06, 2023
DP U-1530
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 21 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ARMODAFINIL - NUVIGIL
N 021875 001 7132570 Dec 18, 2023 DS DP
7297346 Nov 29, 2023 DP
RE37516 Oct 06, 2014 DP U-820
ARMODAFINIL - NUVIGIL
N 021875 002 7132570 Dec 18, 2023 DS DP
7297346 Nov 29, 2023 DP
RE37516 Oct 06, 2014 DP U-820
ARMODAFINIL - NUVIGIL
N 021875 003 7132570 Dec 18, 2023 DS DP
7297346 Nov 29, 2023 DP
RE37516 Oct 06, 2014 DP U-820
ARMODAFINIL - NUVIGIL
N 021875 004 7132570 Dec 18, 2023 DS DP
7297346 Nov 29, 2023 DP
RE37516 Oct 06, 2014 DP U-820
ARMODAFINIL - NUVIGIL
N 021875 005 7132570 Dec 18, 2023 DS DP
7297346 Nov 29, 2023 DP
RE37516 Oct 06, 2014 DP U-820
ARSENIC TRIOXIDE - TRISENOX
N 021248 001 6723351 Nov 10, 2018 U-573
6855339 Nov 10, 2018 U-617
6861076 Nov 10, 2018 U-617
6884439 Nov 10, 2018 U-651
6982096 Nov 10, 2018 U-651
8273379 Nov 10, 2018 U-1291
ARTEMETHER; LUMEFANTRINE - COARTEM
N 022268 001 5677331 Oct 14, 2014 DP U-977 ODE Apr 07, 2016
ASCORBIC ACID; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM ASCORBATE; SODIUM CHLORIDE; SODIUM
SULFATE - MOVIPREP
N 021881 001 7169381 Sep 01, 2024 DS DP
7658914 Sep 01, 2024 DS DP
ASENAPINE MALEATE - SAPHRIS
N 022117 001 5763476 Jun 09, 2020 DP U-326 NCE Aug 13, 2014
7741358 Apr 06, 2026 DS DP U-1064
8022228 Apr 06, 2026 DS DP
ASENAPINE MALEATE - SAPHRIS
N 022117 002 5763476 Jun 09, 2020 DP U-326 NCE Aug 13, 2014
7741358 Apr 06, 2026 DS DP U-1064
8022228 Apr 06, 2026 DS DP
ASPIRIN - ASPIRIN
N 203697 001 8865187 Mar 23, 2022 DP
ASPIRIN; DIPYRIDAMOLE - AGGRENOX
N 020884 001 6015577 Jan 18, 2017 U-302
ATAZANAVIR SULFATE - REYATAZ
N 021567 001 5849911 Jun 20, 2017 DS DP U-167
6087383 Dec 21, 2018 DS DP
ATAZANAVIR SULFATE - REYATAZ
N 021567 002 5849911 Jun 20, 2017 DS DP U-167
6087383 Dec 21, 2018 DS DP
ATAZANAVIR SULFATE - REYATAZ
N 021567 003 5849911 Jun 20, 2017 DS DP U-167
6087383 Dec 21, 2018 DS DP
ATAZANAVIR SULFATE - REYATAZ
N 021567 004 5849911 Jun 20, 2017 DS DP U-167
6087383 Dec 21, 2018 DS DP
ATAZANAVIR SULFATE - REYATAZ
N 206352 001 5849911 Jun 20, 2017 DS DP U-167 NP Jun 02, 2017
6087383 Dec 21, 2018 DS DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 22 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N 021411 001 5658590 Nov 26, 2016 U-494
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N 021411 002 5658590 Nov 26, 2016 U-494
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N 021411 003 5658590 Nov 26, 2016 U-494
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N 021411 004 5658590 Nov 26, 2016 U-494
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N 021411 005 5658590 Nov 26, 2016 U-494
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N 021411 006 5658590 Nov 26, 2016 U-494
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N 021411 007 5658590 Nov 26, 2016 U-494
ATOMOXETINE HYDROCHLORIDE - STRATTERA
N 021411 008 5658590 Nov 26, 2016 U-494
ATORVASTATIN CALCIUM - LIPITOR
N 020702 001 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
ATORVASTATIN CALCIUM - LIPITOR
N 020702 002 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
ATORVASTATIN CALCIUM - LIPITOR
N 020702 003 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
ATORVASTATIN CALCIUM - LIPITOR
N 020702 004 5686104 Nov 11, 2014 DP U-213
5969156 Jul 08, 2016 DS
ATORVASTATIN CALCIUM; EZETIMIBE - LIPTRUZET
N 200153 001 5686104 Nov 11, 2014 DP U-1400 NC May 03, 2016
5686104*PED May 11, 2015
5969156 Jul 08, 2016 DS
5969156*PED Jan 08, 2017
RE42461 Oct 25, 2016 DS DP U-1400
RE42461*PED Apr 25, 2017
ATORVASTATIN CALCIUM; EZETIMIBE - LIPTRUZET
N 200153 002 5686104 Nov 11, 2014 DP U-1400 NC May 03, 2016
5686104*PED May 11, 2015
5969156 Jul 08, 2016 DS
5969156*PED Jan 08, 2017
RE42461 Oct 25, 2016 DS DP U-1400
RE42461*PED Apr 25, 2017
ATORVASTATIN CALCIUM; EZETIMIBE - LIPTRUZET
N 200153 003 5686104 Nov 11, 2014 DP U-1400 NC May 03, 2016
5686104*PED May 11, 2015
5969156 Jul 08, 2016 DS
5969156*PED Jan 08, 2017
RE42461 Oct 25, 2016 DS DP U-1400
RE42461*PED Apr 25, 2017
ATORVASTATIN CALCIUM; EZETIMIBE - LIPTRUZET
N 200153 004 5686104 Nov 11, 2014 DP U-1400 NC May 03, 2016
5686104*PED May 11, 2015
5969156 Jul 08, 2016 DS
5969156*PED Jan 08, 2017
RE42461 Oct 25, 2016 DS DP U-1400
RE42461*PED Apr 25, 2017
ATOVAQUONE - MEPRON
N 020500 001 6649659 Jul 10, 2016 DS DP U-69
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 23 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
AVANAFIL - STENDRA
N 202276 001 6656935 Sep 13, 2020 DS DP U-155 D-140 Sep 17, 2017
7501409 May 05, 2023 DP NCE Apr 27, 2017
AVANAFIL - STENDRA
N 202276 002 6656935 Sep 13, 2020 DS DP U-155 D-140 Sep 17, 2017
7501409 May 05, 2023 DP NCE Apr 27, 2017
AVANAFIL - STENDRA
N 202276 003 6656935 Sep 13, 2020 DS DP U-155 D-140 Sep 17, 2017
7501409 May 05, 2023 DP NCE Apr 27, 2017
AXITINIB - INLYTA
N 202324 001 6534524 Jun 30, 2020 DS DP NCE Jan 27, 2017
7141581 Jun 30, 2020 U-1220
8791140 Aug 05, 2030 DS
AXITINIB - INLYTA
N 202324 002 6534524 Jun 30, 2020 DS DP NCE Jan 27, 2017
7141581 Jun 30, 2020 U-1220
8791140 Aug 05, 2030 DS
AZELAIC ACID - FINACEA
N 021470 001 6534070 Nov 18, 2018
AZELASTINE HYDROCHLORIDE - ASTEPRO
N 022203 001 8071073 Jun 04, 2028 DP M-129 Aug 30, 2016
8518919 Nov 22, 2025 U-1430 NPP Aug 30, 2016
AZELASTINE HYDROCHLORIDE - ASTEPRO
N 022371 001 8071073 Jun 04, 2028 DP
8518919 Nov 22, 2025 U-1430
AZELASTINE HYDROCHLORIDE; FLUTICASONE PROPIONATE - DYMISTA
N 202236 001 8163723 Aug 29, 2023 U-77 NC May 01, 2015
8163723 Aug 29, 2023 U-81
8163723 Aug 29, 2023 U-644
8163723 Aug 29, 2023 U-707
8168620 Feb 24, 2026 DP
AZILSARTAN KAMEDOXOMIL - EDARBI
N 200796 001 7157584 May 22, 2025 DS NCE Feb 25, 2016
7572920 Jan 07, 2025 DP U-3
AZILSARTAN KAMEDOXOMIL - EDARBI
N 200796 002 7157584 May 22, 2025 DS NCE Feb 25, 2016
7572920 Jan 07, 2025 DP U-3
AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE - EDARBYCLOR
N 202331 001 7157584 May 22, 2025 DS NC Dec 20, 2014
7572920 Jan 07, 2025 DP U-3 NCE Feb 25, 2016
AZILSARTAN KAMEDOXOMIL; CHLORTHALIDONE - EDARBYCLOR
N 202331 002 7157584 May 22, 2025 DS NC Dec 20, 2014
7572920 Jan 07, 2025 DP U-3 NCE Feb 25, 2016
AZITHROMYCIN - ZITHROMAX
N 050693 001 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZITHROMAX
N 050710 001 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZITHROMAX
N 050710 002 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZITHROMAX
N 050711 001 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZITHROMAX
N 050730 001 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZITHROMAX
N 050733 001 6268489 Jul 31, 2018 DS
AZITHROMYCIN - ZITHROMAX
N 050784 001 6268489 Jul 31, 2018 DS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 24 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
AZITHROMYCIN - ZMAX
N 050797 001 6068859 May 30, 2017 DP
6268489 Jul 31, 2018 DS
6984403 Feb 14, 2024 DP U-282
7887844 Feb 14, 2024 DP
AZITHROMYCIN - AZASITE
N 050810 001 6159458 Nov 04, 2017 DP U-709
6239113 Mar 31, 2019 U-709
6569443 Mar 31, 2019 DP U-709
6861411 Nov 25, 2018 U-709
7056893 Mar 31, 2019 DP U-709
AZTREONAM - CAYSTON
N 050814 001 7208141 Dec 20, 2021 DP U-1031 ODE Feb 22, 2017
7214364 Dec 20, 2021 DP
7427633 Dec 20, 2021 DP U-1031
8399496 Dec 20, 2021 DP U-1377
BACLOFEN - KEMSTRO
N 021589 001 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
BACLOFEN - KEMSTRO
N 021589 002 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
BALSALAZIDE DISODIUM - COLAZAL
N 020610 001 7452872 Aug 24, 2026 U-141
7625884 Aug 24, 2026 U-141
BALSALAZIDE DISODIUM - GIAZO
N 022205 001 6197341 Mar 13, 2018 DP U-1229 NDF Feb 03, 2015
7452872 Aug 24, 2026 U-1229
7625884 Aug 24, 2026 U-1229
8497256 Jun 23, 2031 U-1229
BAZEDOXIFENE ACETATE; ESTROGENS, CONJUGATED - DUAVEE
N 022247 001 5998402 Apr 04, 2017 DS DP U-594 NP Oct 03, 2016
6479535 May 06, 2019 DP U-594
6479535 May 06, 2019 DP U-904
7138392 Apr 04, 2017 DS DP U-594
7683051 Mar 10, 2027 DS DP U-594
7683051 Mar 10, 2027 DS DP U-904
8815934 May 06, 2019 DP
BECLOMETHASONE DIPROPIONATE - QVAR 80
N 020911 001 5683677 Nov 04, 2014 DP
5776432 Jul 07, 2015 DP U-645
6446627 Dec 18, 2017 DP
BECLOMETHASONE DIPROPIONATE - QVAR 40
N 020911 002 5683677 Nov 04, 2014 DP
5776432 Jul 07, 2015 DP U-645
6446627 Dec 18, 2017 DP
BECLOMETHASONE DIPROPIONATE - QNASL
N 202813 001 5683677 Nov 04, 2014 DP NP Mar 23, 2015
5776432 Jul 07, 2015 DP
7780038 Jan 24, 2027 DP
BECLOMETHASONE DIPROPIONATE - QNASL
N 202813 002 5776432 Jul 07, 2015 DP NP Mar 23, 2015
7780038 Jan 24, 2027 DP NS Dec 17, 2017
BEDAQUILINE FUMARATE - SIRTURO
N 204384 001 7498343 Oct 02, 2024 DS DP U-1321 NCE Dec 28, 2017
8546428 Mar 19, 2029 DS DP U-1321 ODE Dec 28, 2019
BELINOSTAT - BELEODAQ
N 206256 001 6888027 Sep 27, 2021 DS DP U-1544 NCE Jul 03, 2019
8835501 Oct 27, 2027 DP ODE Jul 03, 2021
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 25 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT
PATENT
EXCLUSIVITY
NO PATENT NO EXPIRATION
PATENT DELIST
EXCLUSIVITY EXPIRATION
DATE
CODES REQUESTED
CODE(S) DATE
BENDAMUSTINE HYDROCHLORIDE - TREANDA
N 022249 001 8436190 Oct 26, 2030
DP
ODE Mar 20, 2015
8436190*PED Apr 26, 2031
ODE Oct 31, 2015
8445524 Mar 26, 2029
DS DP U-1402
PED Sep 20, 2015
8445524*PED Sep 26, 2029
PED May 01, 2016
8609863 Jan 12, 2026
DP
8609863*PED Jul 12, 2026
8669279 Mar 26, 2029
DP U-1402
8669279*PED Sep 26, 2029
8791270 Jan 12, 2026
DP U-1542
8791270*PED Jul 12, 2026
8883836 Mar 26, 2029
DP U-1402
8883836*PED Sep 26, 2029
8895756 Jan 12, 2026
DP
8895756*PED Jul 12, 2026
BENDAMUSTINE HYDROCHLORIDE - TREANDA
N 022249 002 8436190 Oct 26, 2030
DP
ODE Mar 20, 2015
8436190*PED Apr 26, 2031
ODE Oct 31, 2015
8445524 Mar 26, 2029
DS DP U-1402
PED Sep 20, 2015
8445524*PED Sep 26, 2029
PED May 01, 2016
8609863 Jan 12, 2026
DP
8609863*PED Jul 12, 2026
8669279 Mar 26, 2029
DP U-1402
8669279*PED Sep 26, 2029
8791270 Jan 12, 2026
DP U-1542
8791270*PED Jul 12, 2026
8883836 Mar 26, 2029
DP U-1402
8883836*PED Sep 26, 2029
8895756 Jan 12, 2026
DP
8895756*PED Jul 12, 2026
BENDAMUSTINE HYDROCHLORIDE - TREANDA
N 022249 003 8344006 Sep 23, 2029
DP U-1402
ODE Mar 20, 2015
8344006*PED Mar 23, 2030
ODE Oct 31, 2015
8445524 Mar 26, 2029
DS
PED Sep 20, 2015
8445524*PED Sep 26, 2029
PED May 01, 2016
8791270 Jan 12, 2026
DP U-1542
8791270*PED Jul 12, 2026
BENDAMUSTINE HYDROCHLORIDE - TREANDA
N 022249 004 8344006 Sep 23, 2029
DP U-1402
ODE Mar 20, 2015
8344006*PED Mar 23, 2030
ODE Oct 31, 2015
8445524 Mar 26, 2029
DS
PED Sep 20, 2015
8445524*PED Sep 26, 2029
PED May 01, 2016
8791270 Jan 12, 2026
DP U-1542
8791270*PED Jul 12, 2026
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - ACANYA
N 050819 001 5733886 Mar 31, 2015
DP U-124
5733886 Mar 31, 2015
DP
8288434 Aug 05, 2029
DP U-124
8663699 Jun 03, 2029
U-124
BENZOYL PEROXIDE; CLINDAMYCIN PHOSPHATE - ONEXTON
N 050819 002 5733886 Mar 31, 2015
DP
8288434 Aug 05, 2029
DP U-124
8288434 Aug 05, 2029
DP U-134
8288434 Aug 05, 2029
DP U-818
8288434 Aug 05, 2029
DP U-916
8288434 Aug 05, 2029
DP U-921
8288434 Aug 05, 2029
DP U-1033
BENZYL ALCOHOL - ULESFIA
N 022129 001 5858383 Aug 11, 2017
U-970
6139859 Aug 11, 2017
U-970
6793931 Jul 11, 2022
DP U-970
7294342 May 19, 2024
U-970
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 26 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
BEPOTASTINE BESILATE - BEPREVE
N 022288 001 6780877 Sep 19, 2019 DS DP NCE Sep 08, 2014
8784789 Sep 05, 2024 DP
8877168 Jul 30, 2023 DP
BESIFLOXACIN HYDROCHLORIDE - BESIVANCE
N 022308 001 5447926 Apr 13, 2016 DS DP U-80
6685958 Jun 29, 2021 DP U-80
6699492 Mar 31, 2019 DP U-80
8415342 Nov 07, 2030 U-80
8481526 Jan 09, 2031 DS
8604020 Mar 12, 2030 DP
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE - CALCIPOTRIENE AND BETAMETHASONE DIPROPIONATE
A 201615 001 PC Sep 27, 2014
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE - TACLONEX
N 021852 001 5763426 Jun 09, 2015 DS DP NPP Dec 23, 2017
6753013 Jan 27, 2020 DP U-88
6753013 Jan 27, 2020 DP U-193
RE39706 Jun 09, 2015 DS DP
BETAMETHASONE DIPROPIONATE; CALCIPOTRIENE HYDRATE - TACLONEX
N 022185 001 6753013 Jan 27, 2020 DP U-88 I-659 Oct 17, 2015
6753013 Jan 27, 2020 DP U-193 NPP Aug 29, 2017
6787529 Jan 27, 2020 DP U-88
6787529 Jan 27, 2020 DP U-193
RE39706 Jun 09, 2015 DS DP
BETAMETHASONE VALERATE - LUXIQ
N 020934 001 6126920 Mar 01, 2016 U-484
7078058 May 24, 2017 DP
BEXAROTENE - TARGRETIN
N 021055 001 5780676 Jul 14, 2015 U-509
5962731 Oct 05, 2016 U-475
BEXAROTENE - TARGRETIN
N 021056 001 5780676 Jul 14, 2015 U-510
5962731 Oct 05, 2016
BIMATOPROST - LUMIGAN
N 021275 001 5688819 Aug 19, 2014 U-446
BIMATOPROST - LUMIGAN
N 022184 001 5688819 Aug 19, 2014 U-1081
7851504 Jun 13, 2027 DS DP
8278353 Mar 16, 2025 DP
8299118 Mar 16, 2025 U-1295
8309605 Mar 16, 2025 U-1293
8309605 Mar 16, 2025 U-1294
8338479 Mar 16, 2025 DP U-1295
8524777 Mar 16, 2025 U-1235
8586630 Mar 16, 2025 U-1458
8772338 Mar 16, 2025 DP U-1528
BIMATOPROST - LATISSE
N 022369 001 7351404 May 25, 2024 U-939 M-140 Sep 04, 2017
7388029 Jan 21, 2022 U-938
8038988 Aug 25, 2023 DS DP U-1208
8101161 May 25, 2024 U-1217
8101161 May 25, 2024 U-1218
8263054 Jan 15, 2023 U-1277
8541466 Jan 21, 2022 U-1217
8632760 Jan 15, 2023 U-1487
8758733 Jan 15, 2023 U-1487
8906962 Jan 31, 2021 U-1217
8926953 Jan 15, 2023 U-1217
BISACODYL; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - HALFLYTELY
N 021551 003 7291324 Oct 22, 2022 U-837
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 27 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
BISMUTH SUBCITRATE POTASSIUM; METRONIDAZOLE; TETRACYCLINE - PYLERA
N 050786 001 6350468 Dec 14, 2018 U-932
6350468 Dec 14, 2018 U-956
BIVALIRUDIN - ANGIOMAX
N 020873 001 5196404 Dec 15, 2014 DS DP U-1040
5196404 Dec 15, 2014 DS DP U-1232
7582727 Jul 27, 2028 DP
7598343 Jul 27, 2028 DP
BOCEPREVIR - VICTRELIS
N 202258 001 7772178 Nov 11, 2027 DP U-1128 M-126 Feb 27, 2016
8119602 Mar 17, 2027 U-1233 NCE May 13, 2016
RE43298 Feb 22, 2022 DS DP U-1128 NPP Feb 13, 2016
BORTEZOMIB - VELCADE
N 021602 001 5780454 May 03, 2017 DS DP D-141 Oct 08, 2017
6083903 Oct 28, 2014 DP U-515 D-142 Oct 08, 2017
6297217 Oct 28, 2014 U-515 I-695 Oct 08, 2017
6297217 Oct 28, 2014 U-884 M-139 Aug 08, 2017
6297217 Oct 28, 2014 U-885 NR Jan 23, 2015
6617317 Oct 28, 2014 DS DP ODE Jun 20, 2015
6713446 Jan 25, 2022 DS DP ODE Oct 08, 2021
6747150 Oct 28, 2014 DP
6958319 Jan 25, 2022 DS DP
7119080 Oct 28, 2014 DP
BOSENTAN - TRACLEER
N 021290 001 5292740 Nov 20, 2015
BOSENTAN - TRACLEER
N 021290 002 5292740 Nov 20, 2015
BOSUTINIB MONOHYDRATE - BOSULIF
N 203341 001 6002008 Mar 27, 2018 DS DP U-1284 NCE Sep 04, 2017
7417148 Jan 23, 2026 U-1283 ODE Sep 04, 2019
7767678 Nov 23, 2026 DS DP
7919625 Dec 11, 2025 DP
RE42376 Sep 24, 2019 DS
BOSUTINIB MONOHYDRATE - BOSULIF
N 203341 002 6002008 Mar 27, 2018 DS DP U-1284 NCE Sep 04, 2017
7417148 Jan 23, 2026 U-1283 ODE Sep 04, 2019
7767678 Nov 23, 2026 DS DP
7919625 Dec 11, 2025 DP
RE42376 Sep 24, 2019 DS
BRIMONIDINE TARTRATE - ALPHAGAN P
N 021262 001 6562873 Jul 10, 2021
6627210 Jul 18, 2021 DP
6641834 Jul 28, 2021 DP
6673337 Jul 26, 2021 DP
BRIMONIDINE TARTRATE - QOLIANA
N 021764 001 7265117 Aug 19, 2025 DP
BRIMONIDINE TARTRATE - ALPHAGAN P
N 021770 001 6562873 Jul 10, 2021 DP
6627210 Jul 18, 2021 DP
6641834 Jul 28, 2021 DP
6673337 Jul 26, 2021 DP
8858961 Sep 02, 2023 DP
8858961*PED Mar 02, 2024
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 28 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
BRIMONIDINE TARTRATE - MIRVASO
N 204708 001 7439241 Aug 25, 2025 U-1428 NDF Aug 23, 2016
8053427 Jun 13, 2031 DP U-1428
8163725 Jun 13, 2031 DP
8231885 May 24, 2025 DP
8410102 May 24, 2025 U-1428
8426410 May 24, 2025 U-1428
8513247 Mar 25, 2031 DP U-1428
8513249 Mar 25, 2031 DP U-1428
8859551 May 25, 2024 U-1428
BRIMONIDINE TARTRATE; BRINZOLAMIDE - SIMBRINZA
N 204251 001 6316441 Dec 07, 2019 U-778 NC Apr 19, 2016
BRIMONIDINE TARTRATE; TIMOLOL MALEATE - COMBIGAN
N 021398 001 7030149 Apr 19, 2022 U-849
7320976 Apr 19, 2022 U-849
7323463 Jan 19, 2023 DP Y
7642258 Apr 19, 2022 DS DP U-1024
8133890 Apr 19, 2022 U-1235
8354409 Apr 19, 2022 DP U-1371
8748425 Apr 19, 2022 DP U-1524
BROMFENAC SODIUM - PROLENSA
N 203168 001 8129431 Sep 11, 2025 DS DP NP Apr 05, 2016
8669290 Jan 16, 2024 DP
8754131 Jan 16, 2024 DP
8871813 Jan 16, 2024 DP
8927606 Jan 16, 2024 U-100
8927606 Jan 16, 2024 U-810
8927606 Jan 16, 2024 U-1095
BROMOCRIPTINE MESYLATE - CYCLOSET
N 020866 001 5679685 Oct 21, 2014 DP
5716957 Feb 10, 2015 U-976
7888310 Jul 25, 2023 U-1433
8137992 Jul 25, 2023 U-1433
8137993 Jul 25, 2023 U-1433
8137994 Jul 25, 2023 U-1433
8431155 Apr 30, 2032 DP U-976
8613947 Apr 30, 2032 DP U-976
BUDESONIDE - RHINOCORT
N 020746 001 6291445 Apr 29, 2017 Y
6686346 Apr 29, 2017 DP U-557 Y
6986904 Apr 29, 2017 DP U-699 Y
BUDESONIDE - RHINOCORT
N 020746 002 6291445 Apr 29, 2017
6686346 Apr 29, 2017 DP U-557
6986904 Apr 29, 2017 DP U-699
BUDESONIDE - PULMICORT RESPULES
N 020929 001 6598603 Dec 23, 2018 U-529
6899099 Dec 23, 2018 U-529
7524834 Nov 11, 2018 DP U-966
BUDESONIDE - PULMICORT RESPULES
N 020929 002 6598603 Dec 23, 2018 U-529
6899099 Dec 23, 2018 U-529
7524834 Nov 11, 2018 DP U-966
BUDESONIDE - PULMICORT RESPULES
N 020929 003 6598603 Dec 23, 2018 U-529
6899099 Dec 23, 2018 U-529
7524834 Nov 11, 2018 DP U-966
BUDESONIDE - ENTOCORT EC
N 021324 001 5643602 Jul 01, 2014 U-655
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 29 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
BUDESONIDE - PULMICORT FLEXHALER
N 021949 001 6027714 Jan 09, 2018 DP U-787
6142145 May 08, 2018 DP
6287540 Jan 09, 2018 DP
7143764 Mar 13, 2018 DP
BUDESONIDE - PULMICORT FLEXHALER
N 021949 002 6027714 Jan 09, 2018 DP U-787
6142145 May 08, 2018 DP
6287540 Jan 09, 2018 DP
7143764 Mar 13, 2018 DP
BUDESONIDE - UCERIS
N 203634 001 7410651 Jun 09, 2020 DP U-1325 NDF Jan 14, 2016
7431943 Jun 09, 2020 DP
8293273 Jun 09, 2020 DP
8784888 Jun 09, 2020 DP
8895064 Sep 07, 2031 DP
RE43799 Jun 09, 2020 DP U-1325
BUDESONIDE - UCERIS
N 205613 001 NP Oct 07, 2017
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - SYMBICORT
N 021929 001 5674860 Oct 07, 2014 DP U-1075
6123924 Sep 26, 2017 DP
7367333 Nov 11, 2018 DP
7587988 Apr 10, 2026 DP
7759328 Jan 29, 2023 DP U-1073
7967011 Aug 11, 2021 DP
8143239 Jan 29, 2023 DP U-1073
8387615 Nov 10, 2024 DP
8528545 Oct 16, 2028 DP
8575137 Jan 29, 2023 DP U-1073
8616196 Apr 07, 2029 DP
8875699 Nov 10, 2024 DP
BUDESONIDE; FORMOTEROL FUMARATE DIHYDRATE - SYMBICORT
N 021929 002 5674860 Oct 07, 2014 DP U-1075
6123924 Sep 26, 2017 DP
7367333 Nov 11, 2018 DP
7587988 Apr 10, 2026 DP
7759328 Jan 29, 2023 DP U-1073
7897646 Sep 09, 2018 U-1118
7967011 Aug 11, 2021 DP
8143239 Jan 29, 2023 DP U-1073
8387615 Nov 10, 2024 DP
8461211 Sep 09, 2018 U-1118
8528545 Oct 16, 2028 DP
8575137 Jan 29, 2023 DP U-1073
8616196 Apr 07, 2029 DP
8875699 Nov 10, 2024 DP
BUPIVACAINE - EXPAREL
N 022496 001 8182835 Sep 18, 2018 DP U-1246 NP Oct 28, 2014
8834921 Sep 18, 2018 DP U-1587
BUPIVACAINE - EXPAREL
N 022496 002 8182835 Sep 18, 2018 DP U-1246 NP Oct 28, 2014
8834921 Sep 18, 2018 DP U-1587
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 30 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
BUPRENORPHINE - BUTRANS
N 021306 001 6264980 Dec 18, 2015 DP
6344211 Dec 18, 2015 U-1072
6344211 Dec 18, 2015 U-1556
RE41408 Sep 29, 2017 U-1072
RE41408 Sep 29, 2017 U-1556
RE41489 Sep 29, 2017 U-1072
RE41489 Sep 29, 2017 U-1556
RE41571 Sep 29, 2017 U-1072
RE41571 Sep 29, 2017 U-1556
BUPRENORPHINE - BUTRANS
N 021306 002 6264980 Dec 18, 2015 DP
6344211 Dec 18, 2015 U-1072
6344211 Dec 18, 2015 U-1556
RE41408 Sep 29, 2017 U-1072
RE41408 Sep 29, 2017 U-1556
RE41489 Sep 29, 2017 U-1072
RE41489 Sep 29, 2017 U-1556
RE41571 Sep 29, 2017 U-1072
RE41571 Sep 29, 2017 U-1556
BUPRENORPHINE - BUTRANS
N 021306 003 6264980 Dec 18, 2015 DP
6344211 Dec 18, 2015 U-1072
6344211 Dec 18, 2015 U-1556
RE41408 Sep 29, 2017 U-1072
RE41408 Sep 29, 2017 U-1556
RE41489 Sep 29, 2017 U-1072
RE41489 Sep 29, 2017 U-1556
RE41571 Sep 29, 2017 U-1072
RE41571 Sep 29, 2017 U-1556
BUPRENORPHINE - BUTRANS
N 021306 004 6264980 Dec 18, 2015 DP
6344211 Dec 18, 2015 U-1072
6344211 Dec 18, 2015 U-1556
RE41408 Sep 29, 2017 U-1072
RE41408 Sep 29, 2017 U-1556
RE41489 Sep 29, 2017 U-1072
RE41489 Sep 29, 2017 U-1556
RE41571 Sep 29, 2017 U-1072
RE41571 Sep 29, 2017 U-1556
BUPRENORPHINE - BUTRANS
N 021306 005 6264980 Dec 18, 2015 DP
6344211 Dec 18, 2015 U-1072
6344211 Dec 18, 2015 U-1556
RE41408 Sep 29, 2017 U-1072
RE41408 Sep 29, 2017 U-1556
RE41489 Sep 29, 2017 U-1072
RE41489 Sep 29, 2017 U-1556
RE41571 Sep 29, 2017 U-1072
RE41571 Sep 29, 2017 U-1556
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 31 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE
N 022410 001 8017150 Feb 13, 2023 DP
8475832 Mar 26, 2030 DP U-1411
8603514 Apr 03, 2024 DP U-1464
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE
N 022410 002 8017150 Feb 13, 2023 DP
8475832 Mar 26, 2030 DP U-1411
8603514 Apr 03, 2024 DP
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE
N 022410 003 8017150 Feb 13, 2023 DP
8475832 Mar 26, 2030 DP U-1411
8603514 Apr 03, 2024 DP
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - SUBOXONE
N 022410 004 8017150 Feb 13, 2023 DP
8475832 Mar 26, 2030 DP U-1411
8603514 Apr 03, 2024 DP
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - ZUBSOLV
N 204242 001 8454996 Sep 24, 2019 U-1421
8470361 Oct 14, 2029 DP U-1425
8658198 Dec 03, 2027 DP U-1494
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - ZUBSOLV
N 204242 002 8454996 Sep 24, 2019 U-1421
8470361 Oct 14, 2029 DP U-1425
8658198 Dec 03, 2027 DP U-1494
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - ZUBSOLV
N 204242 003 8454996 Sep 24, 2019 U-1421
8470361 Oct 14, 2029 DP U-1425
8658198 Dec 03, 2027 DP U-1494
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - ZUBSOLV
N 204242 004 8454996 Sep 24, 2019 U-1421
8470361 Oct 14, 2029 DP U-1425
8658198 Dec 03, 2027 DP U-1494
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - BUNAVAIL
N 205637 001 6159498 Oct 18, 2016 DP NP Jun 06, 2017
7579019 Jan 22, 2020 U-1521
8147866 Jul 23, 2027 DP U-1521
8703177 Aug 20, 2032 DP
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - BUNAVAIL
N 205637 002 6159498 Oct 18, 2016 DP NP Jun 06, 2017
7579019 Jan 22, 2020 U-1521
8147866 Jul 23, 2027 DP U-1521
8703177 Aug 20, 2032 DP
BUPRENORPHINE HYDROCHLORIDE; NALOXONE HYDROCHLORIDE - BUNAVAIL
N 205637 003 6159498 Oct 18, 2016 DP NP Jun 06, 2017
7579019 Jan 22, 2020 U-1521
8147866 Jul 23, 2027 DP U-1521
8703177 Aug 20, 2032 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 32 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
BUPROPION HYDROBROMIDE - APLENZIN
N 022108 001 7241805 Jun 27, 2026 DP
7569610 Jun 27, 2026 U-997
7572935 Jun 27, 2026 DP
7585897 Jun 27, 2026 DP
7645802 Jun 27, 2026 DP
7649019 Jun 27, 2026 DP
7662407 Jun 27, 2026 DP
7671094 Jun 27, 2026 DP
BUPROPION HYDROBROMIDE - APLENZIN
N 022108 002 7241805 Jun 27, 2026 DP
7569610 Jun 27, 2026 U-997
7572935 Jun 27, 2026 DP
7585897 Jun 27, 2026 DP
7645802 Jun 27, 2026 DP
7649019 Jun 27, 2026 DP
7662407 Jun 27, 2026 DP
7671094 Jun 27, 2026 DP
BUPROPION HYDROBROMIDE - APLENZIN
N 022108 003 7241805 Jun 27, 2026 DP
7569610 Jun 27, 2026 U-997
7572935 Jun 27, 2026 DP
7585897 Jun 27, 2026 DP
7645802 Jun 27, 2026 DP
7649019 Jun 27, 2026 DP
7662407 Jun 27, 2026 DP
7671094 Jun 27, 2026 DP
BUPROPION HYDROCHLORIDE - WELLBUTRIN XL
N 021515 001 6096341 Oct 30, 2018
BUPROPION HYDROCHLORIDE - WELLBUTRIN XL
N 021515 002 6096341 Oct 30, 2018
BUPROPION HYDROCHLORIDE - FORFIVO XL
N 022497 001 7674479 Jun 25, 2027 DP
BUPROPION HYDROCHLORIDE; NALTREXONE HYDROCHLORIDE - CONTRAVE
N 200063 001 7375111 Mar 26, 2025 DP NC Sep 10, 2017
7462626 Jul 20, 2024 U-1583
8088786 Feb 03, 2029 DP
8318788 Nov 08, 2027 U-1584
8722085 Nov 08, 2027 U-1585
8815889 Jul 20, 2024 U-1586
BUTOCONAZOLE NITRATE - GYNAZOLE-1
N 019881 001 5993856 Nov 17, 2017 DP U-457
CABAZITAXEL - JEVTANA KIT
N 201023 001 5847170 Mar 26, 2021 DS DP NCE Jun 17, 2015
6331635 Mar 26, 2016 DS DP
6372780 Mar 26, 2016 U-1067
6387946 Mar 26, 2016 U-1067
7241907 Dec 10, 2025 DS
8927592 Oct 27, 2030 U-1630
CABOZANTINIB S-MALATE - COMETRIQ
N 203756 001 7579473 Sep 24, 2024 DS DP NCE Nov 29, 2017
8877776 Oct 08, 2030 DS DP U-1617 ODE Nov 29, 2019
CABOZANTINIB S-MALATE - COMETRIQ
N 203756 002 7579473 Sep 24, 2024 DS DP NCE Nov 29, 2017
8877776 Oct 08, 2030 DS DP U-1617 ODE Nov 29, 2019
CALCIPOTRIENE - DOVONEX
N 020554 001 5763426 Jun 09, 2015 DS DP
RE39706 Jun 09, 2015 DS DP
CALCIPOTRIENE - DOVONEX
N 020611 001 5763426 Jun 09, 2015 DS DP
RE39706 Jun 09, 2015 DS DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 33 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
CALCIPOTRIENE - SORILUX
N 022563 001 8263580 Sep 27, 2028 DP U-1280 I-657 Sep 27, 2015
8269128 May 26, 2026 DP U-1280
CALCITONIN SALMON - MIACALCIN
N 020313 002 5733569 Mar 31, 2015 U-227
5759565 Mar 31, 2015
CALCITONIN SALMON RECOMBINANT - FORTICAL
N 021406 001 6440392 Feb 02, 2021 DP U-227
RE40812 Feb 02, 2021 DP
RE43580 Feb 02, 2021 DP U-227
CALCITRIOL - CALCIJEX
N 018874 001 6051567 Aug 02, 2019
6265392 Aug 02, 2019
6274169 Aug 02, 2019
CALCITRIOL - CALCIJEX
N 018874 002 6051567 Aug 02, 2019
6265392 Aug 02, 2019
6274169 Aug 02, 2019
CALCIUM ACETATE - PHOSLO
N 021160 002 6576665 Apr 03, 2021
CALCIUM ACETATE - PHOSLO GELCAPS
N 021160 003 6576665 Apr 03, 2021
CALCIUM ACETATE - PHOSLYRA
N 022581 001 8591938 Feb 23, 2030 DP U-1469
8592480 Jul 20, 2027 U-1469
CALCIUM CARBONATE; FAMOTIDINE; MAGNESIUM HYDROXIDE - PEPCID COMPLETE
N 020958 001 5989588 Sep 30, 2015 U-349
6814978 Aug 26, 2021 DP
CALCIUM CARBONATE; RISEDRONATE SODIUM - ACTONEL WITH CALCIUM (COPACKAGED)
N 021823 001 5994329 Jul 17, 2018 U-353
6015801 Jul 17, 2018 U-353
6165513 Jun 10, 2018 DP
6432932 Jul 17, 2018 U-595
6465443 Aug 14, 2018 DP
CALCIUM CHLORIDE; DEXTROSE; MAGNESIUM CHLORIDE; OXIGLUTATIONE; POTASSIUM CHLORIDE; SODIUM BICARBONATE;
SODIUM CHLORIDE; SODIUM PHOSPHATE - NAVSTEL
N 022193 001 7084130 Nov 29, 2021 DP U-891
CANAGLIFLOZIN - INVOKANA
N 204042 001 7943582 Feb 26, 2029 DS DP U-493 NCE Mar 29, 2018
7943788 Jul 14, 2027 DS DP
8222219 Jul 30, 2024 U-493
8513202 Dec 03, 2027 DS DP U-493
CANAGLIFLOZIN - INVOKANA
N 204042 002 7943582 Feb 26, 2029 DS DP U-493 NCE Mar 29, 2018
7943788 Jul 14, 2027 DS DP
8222219 Jul 30, 2024 U-493
8513202 Dec 03, 2027 DS DP U-493
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 34 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE - INVOKAMET
N 204353 001 7943582 Feb 26, 2029 DS DP U-493 NC Aug 08, 2017
7943788 Jul 14, 2027 DS DP NCE Mar 29, 2018
8222219 Jul 30, 2024 U-493
8513202 Dec 03, 2027 DS DP U-493
8785403 Jul 30, 2024 DP
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE - INVOKAMET
N 204353 002 7943582 Feb 26, 2029 DS DP U-493 NC Aug 08, 2017
7943788 Jul 14, 2027 DS DP NCE Mar 29, 2018
8222219 Jul 30, 2024 U-493
8513202 Dec 03, 2027 DS DP U-493
8785403 Jul 30, 2024 DP
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE - INVOKAMET
N 204353 003 7943582 Feb 26, 2029 DS DP U-493 NC Aug 08, 2017
7943788 Jul 14, 2027 DS DP NCE Mar 29, 2018
8222219 Jul 30, 2024 U-493
8513202 Dec 03, 2027 DS DP U-493
8785403 Jul 30, 2024 DP
CANAGLIFLOZIN; METFORMIN HYDROCHLORIDE - INVOKAMET
N 204353 004 7943582 Feb 26, 2029 DS DP U-493 NC Aug 08, 2017
7943788 Jul 14, 2027 DS DP NCE Mar 29, 2018
8222219 Jul 30, 2024 U-493
8513202 Dec 03, 2027 DS DP U-493
8785403 Jul 30, 2024 DP
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - ATACAND HCT
N 021093 001 5721263 Feb 24, 2015 DP U-3
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - ATACAND HCT
N 021093 002 5721263 Feb 24, 2015 DP U-3
CANDESARTAN CILEXETIL; HYDROCHLOROTHIAZIDE - ATACAND HCT
N 021093 003 5721263 Feb 24, 2015 DP U-3
CAPECITABINE - XELODA
N 020896 001 M-131 Dec 10, 2016
PED Jun 10, 2017
CAPECITABINE - XELODA
N 020896 002 M-131 Dec 10, 2016
PED Jun 10, 2017
CAPSAICIN - QUTENZA
N 022395 001 6239180 Nov 06, 2016 DP NCE Nov 16, 2014
ODE Nov 16, 2016
CARBAMAZEPINE - CARBATROL
N 020712 001 5912013 Jun 15, 2016 U-277
CARBAMAZEPINE - CARBATROL
N 020712 002 5912013 Jun 15, 2016 U-277
CARBAMAZEPINE - CARBATROL
N 020712 003 5912013 Jun 15, 2016 U-277
CARBAMAZEPINE - EQUETRO
N 021710 001 5912013 Jun 15, 2016 DP
6977253 May 19, 2024 U-693
CARBAMAZEPINE - EQUETRO
N 021710 002 5912013 Jun 15, 2016 DP
6977253 May 19, 2024 U-693
CARBAMAZEPINE - EQUETRO
N 021710 003 5912013 Jun 15, 2016 DP
6977253 May 19, 2024 U-693
CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 50
N 021485 001 6500867 Jun 29, 2020 DP U-219
6797732 Jun 29, 2020 DP
CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 100
N 021485 002 6500867 Jun 29, 2020 DP U-219
6797732 Jun 29, 2020 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 35 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 150
N 021485 003 6500867 Jun 29, 2020 DP U-219
6797732 Jun 29, 2020 DP
CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 200
N 021485 004 6500867 Jun 29, 2020 DP U-219
6797732 Jun 29, 2020 DP
CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 75
N 021485 005 6500867 Jun 29, 2020 DP U-219
6797732 Jun 29, 2020 DP
CARBIDOPA; ENTACAPONE; LEVODOPA - STALEVO 125
N 021485 006 6500867 Jun 29, 2020 DP U-219
6797732 Jun 29, 2020 DP
CARBINOXAMINE MALEATE - KARBINAL ER
N 022556 001 8062667 Mar 29, 2029 DP
CARFILZOMIB - KYPROLIS
N 202714 001 7232818 Apr 14, 2025 DS DP NCE Jul 20, 2017
7417042 Jun 07, 2026 DS DP ODE Jul 20, 2019
7491704 Apr 14, 2025 U-1260
7737112 Dec 07, 2027 DP
8129346 Dec 25, 2026 U-1260
8207125 Apr 14, 2025 DS DP
8207126 Apr 14, 2025 DP
8207127 Apr 14, 2025 U-1260
8207297 Apr 14, 2025 DS DP
CARGLUMIC ACID - CARBAGLU
N 022562 001 NCE Mar 18, 2015
ODE Mar 18, 2017
CARVEDILOL - COREG
N 020297 001 RE40000 Jun 07, 2015 U-233
CARVEDILOL - COREG
N 020297 002 RE40000 Jun 07, 2015 U-233
CARVEDILOL - COREG
N 020297 003 RE40000 Jun 07, 2015 U-233
CARVEDILOL - COREG
N 020297 004 RE40000 Jun 07, 2015 U-233
CARVEDILOL PHOSPHATE - COREG CR
N 022012 001 6022562 Oct 17, 2015 DP Y
7268156 Jun 27, 2023 DS DP U-3
7268156 Jun 27, 2023 DS DP U-313
8101209 Sep 11, 2025 DP
RE40000 Jun 07, 2015 U-777
CARVEDILOL PHOSPHATE - COREG CR
N 022012 002 6022562 Oct 17, 2015 DP Y
7268156 Jun 27, 2023 DS DP U-3
7268156 Jun 27, 2023 DS DP U-313
8101209 Sep 11, 2025 DP
RE40000 Jun 07, 2015 U-777
CARVEDILOL PHOSPHATE - COREG CR
N 022012 003 6022562 Oct 17, 2015 DP Y
7268156 Jun 27, 2023 DS DP U-3
7268156 Jun 27, 2023 DS DP U-313
8101209 Sep 11, 2025 DP
RE40000 Jun 07, 2015 U-777
CARVEDILOL PHOSPHATE - COREG CR
N 022012 004 6022562 Oct 17, 2015 DP Y
7268156 Jun 27, 2023 DS DP U-3
7268156 Jun 27, 2023 DS DP U-313
8101209 Sep 11, 2025 DP
RE40000 Jun 07, 2015 U-777
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 36 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
CASPOFUNGIN ACETATE - CANCIDAS
N 021227 001 5514650 Jan 26, 2015 DP U-607
5952300 Mar 28, 2017 DP
6136783 Mar 28, 2017 U-607
CASPOFUNGIN ACETATE - CANCIDAS
N 021227 002 5514650 Jan 26, 2015 DP U-607
5952300 Mar 28, 2017 DP
6136783 Mar 28, 2017 U-607
CEFDITOREN PIVOXIL - SPECTRACEF
N 021222 001 5958915 Oct 14, 2016
CEFDITOREN PIVOXIL - SPECTRACEF
N 021222 002 5958915 Oct 14, 2016 DP
CEFTAROLINE FOSAMIL - TEFLARO
N 200327 001 6417175 Dec 17, 2018 DS DP U-282 NCE Oct 29, 2015
6906055 Dec 15, 2021 DS DP
7419973 Dec 15, 2021 DP
8247400 Feb 10, 2031 DP U-282
CEFTAROLINE FOSAMIL - TEFLARO
N 200327 002 6417175 Dec 17, 2018 DS DP U-282 NCE Oct 29, 2015
6906055 Dec 15, 2021 DS DP
7419973 Dec 15, 2021 DP
8247400 Feb 10, 2031 DP U-282
CEFTOLOZANE SULFATE; TAZOBACTAM SODIUM - ZERBAXA
N 206829 001 7129232 Oct 21, 2024 DS DP U-36 NCE Dec 19, 2019
8476425 Sep 27, 2032 DS GAIN Dec 19, 2024
8685957 Sep 27, 2032 DS U-36
8906898 May 28, 2034 DS DP
CELECOXIB - CELEBREX
N 020998 001 5760068 Jun 02, 2015 U-672
RE44048 Jun 02, 2015 U-247
RE44048 Jun 02, 2015 U-1348
RE44048 Jun 02, 2015 U-1349
RE44048 Jun 02, 2015 U-1350
RE44048 Jun 02, 2015 U-1351
RE44048 Jun 02, 2015 U-1352
RE44048*PED Dec 02, 2015
CELECOXIB - CELEBREX
N 020998 002 5760068 Jun 02, 2015 U-672
RE44048 Jun 02, 2015 U-247
RE44048 Jun 02, 2015 U-1348
RE44048 Jun 02, 2015 U-1349
RE44048 Jun 02, 2015 U-1350
RE44048 Jun 02, 2015 U-1351
RE44048 Jun 02, 2015 U-1352
RE44048*PED Dec 02, 2015
CELECOXIB - CELEBREX
N 020998 003 5760068 Jun 02, 2015 U-672
RE44048 Jun 02, 2015 U-247
RE44048 Jun 02, 2015 U-1348
RE44048 Jun 02, 2015 U-1349
RE44048 Jun 02, 2015 U-1350
RE44048 Jun 02, 2015 U-1351
RE44048 Jun 02, 2015 U-1352
RE44048*PED Dec 02, 2015
CELECOXIB - CELEBREX
N 020998 004 5760068 Jun 02, 2015 U-672
RE44048 Jun 02, 2015 U-247
RE44048 Jun 02, 2015 U-1348
RE44048 Jun 02, 2015 U-1349
RE44048 Jun 02, 2015 U-1350
RE44048 Jun 02, 2015 U-1351
RE44048 Jun 02, 2015 U-1352
RE44048*PED Dec 02, 2015
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 37 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
CERITINIB - ZYKADIA
N 205755 001 7153964 Feb 26, 2021 DS DP NCE Apr 29, 2019
7893074 Apr 25, 2026 DS DP ODE Apr 29, 2021
7964592 Jan 13, 2027 DS DP
8039474 Jun 29, 2030 DS DP
8039479 Jun 29, 2030 DS DP
8377921 Nov 20, 2027 U-1179
8703787 Feb 02, 2032 U-1179
CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC ALLERGY
N 021621 003 6455533 Jul 02, 2018 DP U-295
CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC ALLERGY
N 021621 004 6455533 Jul 02, 2018 DP U-295
CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC HIVES RELIEF
N 021621 005 6455533 Jul 02, 2018 DP U-295
CETIRIZINE HYDROCHLORIDE - CHILDREN'S ZYRTEC HIVES RELIEF
N 021621 006 6455533 Jul 02, 2018 DP U-295
CETIRIZINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - ZYRTEC-D 12 HOUR
N 021150 002 6469009 Jul 13, 2019 DP U-295
6489329 Apr 08, 2016 DP
7014867 Jun 10, 2022 DP
7226614 Jun 10, 2022 U-295
CETRORELIX - CETROTIDE
N 021197 001 6319192 Apr 23, 2019 U-426
CETRORELIX - CETROTIDE
N 021197 002 6319192 Apr 23, 2019 U-426
CHLORHEXIDINE GLUCONATE - CHLORHEXIDINE GLUCONATE
N 021669 001 7066916 Feb 17, 2024 U-737
7427574 Apr 25, 2026 DP
7595021 May 12, 2023 DP U-1022
7717889 Feb 27, 2025 DP U-1022
7935093 Oct 02, 2027 DP U-1022
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP
N 020832 001 5690958 Sep 30, 2016 DP
6536975 Nov 10, 2020 DP
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT
N 020832 002 5690958 Sep 30, 2016 DP
6729786 Mar 14, 2023 DP
6991394 Jan 31, 2024 DP
7182536 Dec 30, 2023 DP
7241065 Mar 14, 2023 DP
7422388 Apr 25, 2027 DP U-1397
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP FREPP
N 020832 003 5538353 Aug 25, 2015 DP
5690958 Sep 30, 2016 DP
5772346 Apr 22, 2017 DP
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP
N 020832 004 5690958 Sep 30, 2016 DP
6536975 Nov 10, 2020 DP
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT
N 020832 005 5690958 Sep 30, 2016 DP
6536975 Nov 10, 2020 DP
6729786 Mar 14, 2023 DP
7241065 Mar 14, 2023 DP
7422388 Apr 25, 2027 DP U-1397
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP
N 020832 006 5690958 Sep 30, 2016 DP
6991394 Jan 31, 2024 DP
7182536 Dec 30, 2023 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 38 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP WITH TINT
N 020832 007 5690958 Sep 30, 2016 DP
6536975 Nov 10, 2020 DP
6729786 Mar 14, 2023 DP
7241065 Mar 14, 2023 DP
7422388 Apr 25, 2027 DP U-1397
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - PREVANTICS MAXI SWABSTICK
N 021524 003 D468424 Jan 07, 2017
CHLORHEXIDINE GLUCONATE; ISOPROPYL ALCOHOL - CHLORAPREP ONE-STEP SEPP
N 021555 001 5690958 Sep 30, 2016 DP
CHLORPHENIRAMINE MALEATE; IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE - ADVIL ALLERGY SINUS
N 021441 001 7863287 Feb 28, 2027 DP
CHOLINE C-11 - CHOLINE C-11
N 203155 001 NCE Sep 12, 2017
W Sep 12, 2017
CHOLINE FENOFIBRATE - TRILIPIX
N 022224 001 7259186 Jan 07, 2025 DS
CHOLINE FENOFIBRATE - TRILIPIX
N 022224 002 7259186 Jan 07, 2025 DS
CHORIOGONADOTROPIN ALFA - OVIDREL
N 021149 001 5767251 Jun 16, 2015
CHORIOGONADOTROPIN ALFA - OVIDREL
N 021149 002 5767251 Jun 16, 2015 DS
6706681 Mar 16, 2021 DP
CICLESONIDE - ALVESCO
N 021658 002 5482934 Oct 24, 2017 DS DP U-1002 M-125 Dec 17, 2015
5683677 Nov 04, 2014 DP
5775321 Jul 07, 2015 DP
6006745 Dec 28, 2016 DP
6120752 May 13, 2018 DP
6264923 May 13, 2018 DP
8371292 Aug 25, 2027 U-1355
CICLESONIDE - ALVESCO
N 021658 003 5482934 Oct 24, 2017 DS DP U-1002 M-125 Dec 17, 2015
5683677 Nov 04, 2014 DP
5775321 Jul 07, 2015 DP
6006745 Dec 28, 2016 DP
6120752 May 13, 2018 DP
6264923 May 13, 2018 DP
8371292 Aug 25, 2027 U-1355
CICLESONIDE - OMNARIS
N 022004 001 5482934 Oct 24, 2017 DS DP U-557
6767901 Oct 21, 2020 DP
6939559 Apr 21, 2019 DP
7235247 Apr 21, 2019 DP
8371292 Aug 25, 2027 U-1356
8383611 Oct 20, 2020 DP
CICLESONIDE - ZETONNA
N 202129 001 5482934 Oct 24, 2017 DS DP U-1002 NP Jan 20, 2015
5683677 Nov 04, 2014 DP
5775321 Jul 07, 2015 DP
6006745 Dec 28, 2016 DP
6120752 May 13, 2018 DP
6264923 May 13, 2018 DP
8371292 Aug 25, 2027 U-1357
CICLOPIROX - LOPROX
N 020519 001 7018656 Sep 05, 2018 DP
7026337 Nov 21, 2016 U-714
CICLOPIROX - LOPROX
N 021159 001 7981909 Sep 16, 2017 U-1162
8227490 Sep 16, 2017 U-1256
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 39 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
CINACALCET HYDROCHLORIDE - SENSIPAR
N 021688 001 6011068 Mar 08, 2018 DS DP ODE Feb 25, 2018
6031003 Dec 14, 2016 U-559 ODE Nov 21, 2021
6211244 Oct 23, 2015 DS DP U-560
6313146 Dec 14, 2016 DS DP
7829595 Sep 22, 2026 DP U-1098
CINACALCET HYDROCHLORIDE - SENSIPAR
N 021688 002 6011068 Mar 08, 2018 DS DP ODE Feb 25, 2018
6031003 Dec 14, 2016 ODE Nov 21, 2021
6211244 Oct 23, 2015 DS DP U-560
6313146 Dec 14, 2016 DS DP
7829595 Sep 22, 2026 DP U-1098
CINACALCET HYDROCHLORIDE - SENSIPAR
N 021688 003 6011068 Mar 08, 2018 DS DP ODE Feb 25, 2018
6031003 Dec 14, 2016 U-559 ODE Nov 21, 2021
6211244 Oct 23, 2015 DS DP U-560
6313146 Dec 14, 2016 DS DP
7829595 Sep 22, 2026 DP U-1098
CIPROFLOXACIN - CIPRO
N 020780 001 5695784 Dec 09, 2014
CIPROFLOXACIN - CIPRO
N 020780 002 5695784 Dec 09, 2014
CIPROFLOXACIN HYDROCHLORIDE - PROQUIN XR
N 021744 001 5972389 Sep 19, 2016 DP U-663
6340475 Sep 19, 2016 DP U-663
6488962 Jun 20, 2020 DP
6635280 Sep 19, 2016 DP U-663
CIPROFLOXACIN HYDROCHLORIDE; HYDROCORTISONE - CIPRO HC
N 020805 001 5843930 Jun 06, 2015 U-646
5965549 Jun 06, 2015 DP
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE - CIPRO XR
N 021473 001 7709022 Jun 23, 2021 DP
8187632 Jun 23, 2021 DP
8187632*PED Dec 23, 2021
CIPROFLOXACIN; CIPROFLOXACIN HYDROCHLORIDE - CIPRO XR
N 021473 002 7709022 Jun 23, 2021 DP
8187632 Jun 23, 2021 DP
8187632*PED Dec 23, 2021
CIPROFLOXACIN; DEXAMETHASONE - CIPRODEX
N 021537 001 6284804 Aug 10, 2020
6359016 Aug 10, 2020
8846650 Jun 04, 2025 DP U-1578
CISAPRIDE MONOHYDRATE - PROPULSID QUICKSOLV
N 020767 001 5648093 Jul 15, 2014
CITRIC ACID; MAGNESIUM OXIDE; SODIUM PICOSULFATE - PREPOPIK
N 202535 001 8450338 Oct 10, 2028 DP NP Jul 16, 2015
8481083 Oct 10, 2028 DP
CLARITHROMYCIN - BIAXIN XL
N 050775 001 6010718 Apr 11, 2017 DP U-924
6551616 Jun 15, 2017 U-924
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 40 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
CLEVIDIPINE - CLEVIPREX
N 022156 001 5739152 Apr 14, 2015 DP U-893
5856346 Jan 05, 2021 DS DP U-893
8658676 Oct 10, 2031 DP
CLEVIDIPINE - CLEVIPREX
N 022156 002 5739152 Apr 14, 2015 DP U-893
5856346 Jan 05, 2021 DS DP U-893
8658676 Oct 10, 2031 DP
CLEVIDIPINE - CLEVIPREX
N 022156 003 5739152 Apr 14, 2015 DP U-893
5856346 Jan 05, 2021 DS DP U-893
8658676 Oct 10, 2031 DP
CLINDAMYCIN PHOSPHATE - CLEOCIN
N 050767 001 6495157 Jul 20, 2020 DP
CLINDAMYCIN PHOSPHATE - CLINDAGEL
N 050782 001 6387383 Aug 03, 2020 DP U-818
CLINDAMYCIN PHOSPHATE - CLINDESSE
N 050793 001 5993856 Nov 17, 2017 DP U-137
6899890 Apr 27, 2023 DP U-137
CLINDAMYCIN PHOSPHATE - EVOCLIN
N 050801 001 7141237 Jan 23, 2024 DS DP
7374747 Aug 09, 2026 DS DP U-921
CLINDAMYCIN PHOSPHATE; TRETINOIN - ZIANA
N 050802 001 6387383 Aug 03, 2020 DP U-916
RE41134 Feb 24, 2015 DP U-1033
CLINDAMYCIN PHOSPHATE; TRETINOIN - VELTIN
N 050803 001 5690923 Nov 25, 2014 DP
CLOBAZAM - ONFI
N 202067 001 NCE Oct 21, 2016
ODE Oct 21, 2018
CLOBAZAM - ONFI
N 202067 002 NCE Oct 21, 2016
ODE Oct 21, 2018
CLOBAZAM - ONFI
N 202067 003 NCE Oct 21, 2016
ODE Oct 21, 2018
CLOBAZAM - ONFI
N 203993 001 NCE Oct 21, 2016
ODE Oct 21, 2018
CLOBETASOL PROPIONATE - OLUX
N 021142 001 6126920 Mar 01, 2016 U-484
CLOBETASOL PROPIONATE - CLOBEX
N 021535 001 6106848 Sep 22, 2017
CLOBETASOL PROPIONATE - CLOBEX
N 021644 001 7316810 Jun 17, 2019 DP
7700081 Jan 03, 2022 U-1044
8066975 Jun 17, 2019 DP
8066976 Jun 17, 2019 DP
CLOBETASOL PROPIONATE - CLOBEX
N 021835 001 5972920 Feb 12, 2018 DP
5990100 Mar 24, 2018 DP U-742
CLOBETASOL PROPIONATE - OLUX E
N 022013 001 6730288 Sep 08, 2019 DP
7029659 Sep 08, 2019 DP
8460641 Nov 05, 2028 DP U-1410
CLOFARABINE - CLOLAR
N 021673 001 5661136 Jan 14, 2018 U-626
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 41 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT
EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY
EXPIRATION
DATE CODES REQUESTED CODE(S)
DATE
CLONIDINE HYDROCHLORIDE - KAPVAY
N 022331 003 M-149
Nov 20, 2017
CLONIDINE HYDROCHLORIDE - KAPVAY
N 022331 004 M-149
Nov 20, 2017
CLOPIDOGREL BISULFATE - PLAVIX
N 020839 001 6429210 Jun 10, 2019 DS DP PED
Nov 06, 2014
6504030 Jun 10, 2019 DS
CLOPIDOGREL BISULFATE - PLAVIX
N 020839 002 6429210 Jun 10, 2019 DS DP PED
Nov 06, 2014
6504030 Jun 10, 2019 DS
CLOZAPINE - FAZACLO ODT
N 021590 001 6024981 Apr 09, 2018 DP
6106861 Dec 05, 2017 DP
6221392 Apr 09, 2018 DP
CLOZAPINE - FAZACLO ODT
N 021590 002 6024981 Apr 09, 2018 DP
6106861 Dec 05, 2017 DP
6221392 Apr 09, 2018 DP
CLOZAPINE - FAZACLO ODT
N 021590 003 6024981 Apr 09, 2018 DP
6106861 Dec 05, 2017 DP
6221392 Apr 09, 2018 DP
CLOZAPINE - FAZACLO ODT
N 021590 004 6024981 Apr 09, 2018 DP
6106861 Dec 05, 2017 DP
6221392 Apr 09, 2018 DP
CLOZAPINE - FAZACLO ODT
N 021590 005 6024981 Apr 09, 2018 DP
6106861 Dec 05, 2017 DP
6221392 Apr 09, 2018 DP
CLOZAPINE - FAZACLO ODT
N 021590 006 6024981 Apr 09, 2018 DP
6106861 Dec 05, 2017 DP
6221392 Apr 09, 2018 DP
COBICISTAT - TYBOST
N 203094 001 8148374 Sep 03, 2029 DS DP U-1279 NP
Sep 24, 2017
COBICISTAT; ELVITEGRAVIR; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - STRIBILD
N 203100 001 5814639 Sep 29, 2015 DS DP NP
Aug 27, 2015
5914331 Jul 02, 2017 DS
5922695 Jul 25, 2017 DS U-257
5935946 Jul 25, 2017 DS DP U-257
5977089 Jul 25, 2017 DS DP U-257
6043230 Jul 25, 2017 U-257
6642245 Nov 04, 2020 U-257
6703396 Mar 09, 2021 DS DP
7176220 Nov 20, 2023 DS DP U-257
7635704 Oct 26, 2026 DS DP U-257
8148374 Sep 03, 2029 DS DP U-1279
8592397 Jan 13, 2024 DP U-257
8633219 Oct 11, 2031 DP U-257
8716264 Jan 13, 2024 DP U-257
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 42 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
COLCHICINE - COLCRYS
N 022352 001 7601758 Feb 10, 2029 U-1007 ODE Jul 29, 2016
7619004 Dec 03, 2028 U-1020
7820681 Feb 17, 2029 U-1020
7906519 Feb 17, 2029 U-1116
7915269 Feb 17, 2029 U-1007
7935731 Dec 03, 2028 U-1116
7964647 Oct 06, 2028 U-1007
7964648 Oct 06, 2028 U-1161
7981938 Oct 06, 2028 U-1166
8093296 Oct 06, 2028 U-1007
8093297 Oct 06, 2028 U-1161
8093298 Oct 06, 2028 U-1116
8097655 Oct 06, 2028 U-1020
8415395 Oct 06, 2028 U-1007
8415396 Oct 06, 2028 U-1007
8440721 Feb 17, 2029 U-1007
8440722 Feb 17, 2029 U-1020
COLESEVELAM HYDROCHLORIDE - WELCHOL
N 021141 001 5693675 Dec 02, 2014
COLESEVELAM HYDROCHLORIDE - WELCHOL
N 021176 001 5693675 Dec 02, 2014 DS
7229613 Apr 17, 2022 U-851
COLESEVELAM HYDROCHLORIDE - WELCHOL
N 022362 001 5693675 Dec 02, 2014 DS
7229613 Apr 17, 2022 U-493
COLESEVELAM HYDROCHLORIDE - WELCHOL
N 022362 002 5693675 Dec 02, 2014 DS
7229613 Apr 17, 2022 U-493
CONIVAPTAN HYDROCHLORIDE - VAPRISOL
N 021697 001 5723606 Dec 15, 2019 DS DP U-698
5723606 Dec 15, 2019 DS DP U-868
CONIVAPTAN HYDROCHLORIDE - VAPRISOL IN 5% DEXTROSE IN PLASTIC CONTAINER
N 021697 002 5723606 Dec 15, 2019 DS DP U-698
5723606 Dec 15, 2019 DS DP U-868
CORTICOTROPIN - H.P. ACTHAR GEL
N 008372 008 ODE Oct 15, 2017
CRIZOTINIB - XALKORI
N 202570 001 7230098 Mar 01, 2025 DS NCE Aug 26, 2016
7825137 May 12, 2027 U-1179 ODE Aug 26, 2018
7858643 Oct 08, 2029 DS DP
8217057 Nov 06, 2029 DS DP
8785632 Mar 01, 2025 DS
CRIZOTINIB - XALKORI
N 202570 002 7230098 Mar 01, 2025 DS NCE Aug 26, 2016
7825137 May 12, 2027 U-1179 ODE Aug 26, 2018
7858643 Oct 08, 2029 DS DP
8217057 Nov 06, 2029 DS DP
8785632 Mar 01, 2025 DS
CROFELEMER - FULYZAQ
N 202292 001 7323195 Jun 07, 2018 DP NCE Dec 31, 2017
7341744 Jun 16, 2018 U-1319
8574634 Jan 11, 2018 U-1319
CYANOCOBALAMIN - NASCOBAL
N 021642 001 7229636 Jun 11, 2024 DP U-817
7404489 Mar 12, 2024 DP
7879349 Jun 01, 2024 DP U-1152
8003353 Jun 11, 2024 U-817
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 43 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
CYCLOBENZAPRINE HYDROCHLORIDE - AMRIX
N 021777 001 7387793 Feb 26, 2025 DP
7544372 Nov 14, 2023 U-979
7790199 Nov 14, 2023 DP
7820203 Nov 14, 2023 DP
7829121 Nov 14, 2023 U-1088
CYCLOBENZAPRINE HYDROCHLORIDE - AMRIX
N 021777 002 7387793 Feb 26, 2025 DP
7544372 Nov 14, 2023 U-979
7790199 Nov 14, 2023 DP
7820203 Nov 14, 2023 DP
7829121 Nov 14, 2023 U-1088
CYCLOSPORINE - NEORAL
N 050715 001 5985321 Sep 26, 2014 DP
CYCLOSPORINE - NEORAL
N 050715 002 5985321 Sep 26, 2014 DP
CYCLOSPORINE - NEORAL
N 050715 003 5985321 Sep 26, 2014 DP
CYCLOSPORINE - NEORAL
N 050716 001 5985321 Sep 26, 2014 DP
CYCLOSPORINE - RESTASIS
N 050790 001 8629111 Aug 27, 2024 DP
8633162 Aug 27, 2024 U-1479
8642556 Aug 27, 2024 DP
8648048 Aug 27, 2024 U-1483
8685930 Aug 27, 2024 DP
CYSTEAMINE BITARTRATE - PROCYSBI
N 203389 001 8026284 Sep 22, 2027 U-1399 NDF Apr 30, 2016
8129433 Jan 26, 2027 DP ODE Apr 30, 2020
CYSTEAMINE BITARTRATE - PROCYSBI
N 203389 002 8026284 Sep 22, 2027 U-1399 NDF Apr 30, 2016
8129433 Jan 26, 2027 DP ODE Apr 30, 2020
CYSTEAMINE HYDROCHLORIDE - CYSTARAN
N 200740 001 NP Oct 02, 2015
ODE Oct 02, 2019
CYTARABINE - DEPOCYT
N 021041 001 5723147 Mar 03, 2015 DP U-806
DABIGATRAN ETEXILATE MESYLATE - PRADAXA
N 022512 001 6087380 Feb 18, 2018 DS DP U-1089 I-682 Apr 04, 2017
7866474 Aug 31, 2027 DP I-683 Apr 04, 2017
7932273 Sep 07, 2025 DS DP NCE Oct 19, 2015
DABIGATRAN ETEXILATE MESYLATE - PRADAXA
N 022512 002 6087380 Feb 18, 2018 DS DP U-1089 I-682 Apr 04, 2017
7866474 Aug 31, 2027 DP I-683 Apr 04, 2017
7932273 Sep 07, 2025 DS DP NCE Oct 19, 2015
DABRAFENIB MESYLATE - TAFINLAR
N 202806 001 7994185 Jan 20, 2030 DS DP U-1406 I-678 Jan 08, 2017
8415345 Jan 20, 2030 DS DP U-1406 NCE May 29, 2018
ODE May 29, 2020
ODE Jan 09, 2021
DABRAFENIB MESYLATE - TAFINLAR
N 202806 002 7994185 Jan 20, 2030 DS DP U-1406 I-678 Jan 08, 2017
8415345 Jan 20, 2030 DS DP U-1406 NCE May 29, 2018
ODE May 29, 2020
ODE Jan 09, 2021
DALBAVANCIN HYDROCHLORIDE - DALVANCE
N 021883 001 6900175 Dec 25, 2023 U-1517 NCE May 23, 2019
7115564 Nov 14, 2023 DP GAIN May 23, 2024
7119061 Nov 14, 2023 DP
8143212 Nov 14, 2023 U-1517
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 44 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DALFAMPRIDINE - AMPYRA
N 022250 001 5540938 Jul 30, 2018 U-1030 NCE Jan 22, 2015
8007826 May 26, 2027 U-1030 ODE Jan 22, 2017
8354437 Dec 22, 2026 U-1030
8440703 Apr 08, 2025 U-1030
8663685 Jan 18, 2025 U-1030
DANTROLENE SODIUM - RYANODEX
N 205579 001 7758890 Jul 01, 2025 DP
8110225 Dec 24, 2022 DP
8604072 Dec 24, 2022 DP
8685460 Feb 15, 2023 U-1546
DAPAGLIFLOZIN - FARXIGA
N 202293 001 6414126 Oct 04, 2020 DS DP U-493 NCE Jan 08, 2019
6515117 Oct 04, 2020 DS DP U-493
6936590 Oct 04, 2020 U-493
7851502 Aug 19, 2028 DP
7919598 Dec 16, 2029 DS
8221786 Mar 21, 2028 DP
8361972 Mar 21, 2028 U-493
8501698 Jun 20, 2027 DP U-493
8685934 May 26, 2030 U-1522
8716251 Mar 21, 2028 DP
DAPAGLIFLOZIN - FARXIGA
N 202293 002 6414126 Oct 04, 2020 DS DP U-493 NCE Jan 08, 2019
6515117 Oct 04, 2020 DS DP U-493
6936590 Oct 04, 2020 U-493
7851502 Aug 19, 2028 DP
7919598 Dec 16, 2029 DS
8221786 Mar 21, 2028 DP
8361972 Mar 21, 2028 U-493
8501698 Jun 20, 2027 DP U-493
8685934 May 26, 2030 U-1522
8716251 Mar 21, 2028 DP
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - XIGDUO XR
N 205649 001 6414126 Oct 04, 2020 DS DP U-493 NCE Jan 08, 2019
6515117 Oct 04, 2020 DS DP U-493
6936590 Oct 04, 2020 U-493
7919598 Dec 16, 2029 DS
8501698 Jun 20, 2027 DP U-493
8685934 May 26, 2030 U-1522
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - XIGDUO XR
N 205649 002 6414126 Oct 04, 2020 DS DP U-493 NCE Jan 08, 2019
6515117 Oct 04, 2020 DS DP U-493
6936590 Oct 04, 2020 U-493
7919598 Dec 16, 2029 DS
8501698 Jun 20, 2027 DP U-493
8685934 May 26, 2030 U-1522
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - XIGDUO XR
N 205649 003 6414126 Oct 04, 2020 DS DP U-493 NCE Jan 08, 2019
6515117 Oct 04, 2020 DS DP U-493
6936590 Oct 04, 2020 U-493
7919598 Dec 16, 2029 DS
8501698 Jun 20, 2027 DP U-493
8685934 May 26, 2030 U-1522
DAPAGLIFLOZIN; METFORMIN HYDROCHLORIDE - XIGDUO XR
N 205649 004 6414126 Oct 04, 2020 DS DP U-493 NCE Jan 08, 2019
6515117 Oct 04, 2020 DS DP U-493
6936590 Oct 04, 2020 U-493
7919598 Dec 16, 2029 DS
8501698 Jun 20, 2027 DP U-493
8685934 May 26, 2030 U-1522
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 45 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT
PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION
PATENT DELIST EXCLUSIVITY EXPIRATION
DATE
CODES REQUESTED CODE(S) DATE
DAPSONE - ACZONE
N 021794 001 5863560 Sep 11, 2016
DP
6060085 Sep 11, 2016
U-124
6620435 Sep 11, 2016
DP
DAPTOMYCIN - CUBICIN
N 021572 001 6468967 Sep 24, 2019
U-282
6852689 Sep 24, 2019
U-282
8058238 Nov 28, 2020
DS DP
DAPTOMYCIN - CUBICIN
N 021572 002 6468967 Sep 24, 2019
U-282
6852689 Sep 24, 2019
U-282
8003673 Sep 04, 2028
U-1180
8058238 Nov 28, 2020
DS DP
8129342 Nov 28, 2020
DS DP
RE39071 Jun 15, 2016
DS DP U-728
DARIFENACIN HYDROBROMIDE - ENABLEX
N 021513 001 5096890 Mar 13, 2015
DS DP U-631
6106864 Aug 21, 2016
DP U-630
DARIFENACIN HYDROBROMIDE - ENABLEX
N 021513 002 5096890 Mar 13, 2015
DS DP U-631
6106864 Aug 21, 2016
DP U-630
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 46 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DARUNAVIR ETHANOLATE - PREZISTA
N 021976 001 5843946 Dec 01, 2015 DP U-744 D-135 Feb 01, 2016
5843946 Dec 01, 2015 DP U-903 NPP Dec 16, 2014
5843946 Dec 01, 2015 DP U-935 PED Jun 16, 2015
5843946 Dec 01, 2015 DP U-1209 PED Aug 01, 2016
5843946 Dec 01, 2015 DP U-1305
6037157 Jun 26, 2016 U-935
6037157 Jun 26, 2016 U-1209
6037157 Jun 26, 2016 U-1305
6248775 Aug 13, 2014 DS
6703403 Jun 26, 2016 U-935
6703403 Jun 26, 2016 U-1209
6703403 Jun 26, 2016 U-1305
7470506 Jun 23, 2019 U-935
7470506 Jun 23, 2019 U-1209
7470506 Jun 23, 2019 U-1305
7700645 Dec 26, 2026 DS DP
8518987 Feb 16, 2024 DS DP
8518987*PED Aug 16, 2024
8597876 Jun 23, 2019 U-1305
8597876*PED Dec 23, 2019
RE42889 Oct 19, 2016 DP
RE43596 May 09, 2017 DS DP
RE43802 Oct 19, 2016 U-1305
DARUNAVIR ETHANOLATE - PREZISTA
N 021976 002 5843946 Dec 01, 2015 DP U-744 D-135 Feb 01, 2016
5843946 Dec 01, 2015 DP U-903 NPP Dec 16, 2014
5843946 Dec 01, 2015 DP U-935 PED Jun 16, 2015
5843946 Dec 01, 2015 DP U-1209 PED Aug 01, 2016
5843946 Dec 01, 2015 DP U-1305
6037157 Jun 26, 2016 U-935
6037157 Jun 26, 2016 U-1209
6037157 Jun 26, 2016 U-1305
6248775 Aug 13, 2014 DS
6703403 Jun 26, 2016 U-935
6703403 Jun 26, 2016 U-1209
6703403 Jun 26, 2016 U-1305
7470506 Jun 23, 2019 U-935
7470506 Jun 23, 2019 U-1209
7470506 Jun 23, 2019 U-1305
7700645 Dec 26, 2026 DS DP
8518987 Feb 16, 2024 DS DP
8518987*PED Aug 16, 2024
8597876 Jun 23, 2019 U-1305
8597876*PED Dec 23, 2019
RE42889 Oct 19, 2016 DP
RE43596 May 09, 2017 DS DP
RE43802 Oct 19, 2016 U-1305
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 47 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DARUNAVIR ETHANOLATE - PREZISTA
N 021976 003 5843946 Dec 01, 2015 DP U-744 D-135 Feb 01, 2016
5843946 Dec 01, 2015 DP U-903 NPP Dec 16, 2014
5843946 Dec 01, 2015 DP U-935 PED Jun 16, 2015
5843946 Dec 01, 2015 DP U-1209 PED Aug 01, 2016
5843946 Dec 01, 2015 DP U-1305
6037157 Jun 26, 2016 U-935
6037157 Jun 26, 2016 U-1209
6037157 Jun 26, 2016 U-1305
6248775 Aug 13, 2014 DS
6703403 Jun 26, 2016 U-935
6703403 Jun 26, 2016 U-1209
6703403 Jun 26, 2016 U-1305
7470506 Jun 23, 2019 U-935
7470506 Jun 23, 2019 U-1209
7470506 Jun 23, 2019 U-1305
7700645 Dec 26, 2026 DS DP
8518987 Feb 16, 2024 DS DP
8518987*PED Aug 16, 2024
8597876 Jun 23, 2019 U-1305
8597876*PED Dec 23, 2019
RE42889 Oct 19, 2016 DP
RE43596 May 09, 2017 DS DP
RE43802 Oct 19, 2016 U-1305
DARUNAVIR ETHANOLATE - PREZISTA
N 021976 004 5843946 Dec 01, 2015 DP U-744 D-135 Feb 01, 2016
5843946 Dec 01, 2015 DP U-903 NPP Dec 16, 2014
5843946 Dec 01, 2015 DP U-935 PED Jun 16, 2015
5843946 Dec 01, 2015 DP U-1209 PED Aug 01, 2016
5843946 Dec 01, 2015 DP U-1305
6037157 Jun 26, 2016 U-935
6037157 Jun 26, 2016 U-1209
6037157 Jun 26, 2016 U-1305
6248775 Aug 13, 2014 DS
6703403 Jun 26, 2016 U-935
6703403 Jun 26, 2016 U-1209
6703403 Jun 26, 2016 U-1305
7470506 Jun 23, 2019 U-935
7470506 Jun 23, 2019 U-1209
7470506 Jun 23, 2019 U-1305
7700645 Dec 26, 2026 DS DP
8518987 Feb 16, 2024 DS DP
8518987*PED Aug 16, 2024
8597876 Jun 23, 2019 U-1305
8597876*PED Dec 23, 2019
RE42889 Oct 19, 2016 DP
RE43596 May 09, 2017 DS DP
RE43802 Oct 19, 2016 U-1305
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 48 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DARUNAVIR ETHANOLATE - PREZISTA
N 021976 005 5843946 Dec 01, 2015 DP U-744 D-135 Feb 01, 2016
5843946 Dec 01, 2015 DP U-903 NPP Dec 16, 2014
5843946 Dec 01, 2015 DP U-935 PED Jun 16, 2015
5843946 Dec 01, 2015 DP U-1209 PED Aug 01, 2016
5843946 Dec 01, 2015 DP U-1305
6037157 Jun 26, 2016 U-935
6037157 Jun 26, 2016 U-1209
6037157 Jun 26, 2016 U-1305
6248775 Aug 13, 2014 DS
6703403 Jun 26, 2016 U-935
6703403 Jun 26, 2016 U-1209
6703403 Jun 26, 2016 U-1305
7470506 Jun 23, 2019 U-935
7470506 Jun 23, 2019 U-1209
7470506 Jun 23, 2019 U-1305
7700645 Dec 26, 2026 DS DP
8518987 Feb 16, 2024 DS DP
8518987*PED Aug 16, 2024
8597876 Jun 23, 2019 U-1305
8597876*PED Dec 23, 2019
RE42889 Oct 19, 2016 DP
RE43596 May 09, 2017 DS DP
RE43802 Oct 19, 2016 U-1305
DARUNAVIR ETHANOLATE - PREZISTA
N 021976 006 5843946 Dec 01, 2015 DP U-744 D-135 Feb 01, 2016
5843946 Dec 01, 2015 DP U-903 NPP Dec 16, 2014
5843946 Dec 01, 2015 DP U-935 PED Jun 16, 2015
5843946 Dec 01, 2015 DP U-1209 PED Aug 01, 2016
5843946 Dec 01, 2015 DP U-1305
6037157 Jun 26, 2016 U-935
6037157 Jun 26, 2016 U-1209
6037157 Jun 26, 2016 U-1305
6248775 Aug 13, 2014 DS
6703403 Jun 26, 2016 U-935
6703403 Jun 26, 2016 U-1209
6703403 Jun 26, 2016 U-1305
7470506 Jun 23, 2019 U-935
7470506 Jun 23, 2019 U-1209
7470506 Jun 23, 2019 U-1305
7700645 Dec 26, 2026 DS DP
8518987 Feb 16, 2024 DS DP
8518987*PED Aug 16, 2024
8597876 Jun 23, 2019 U-1305
8597876*PED Dec 23, 2019
RE42889 Oct 19, 2016 DP
RE43596 May 09, 2017 DS DP
RE43802 Oct 19, 2016 U-1305
DARUNAVIR ETHANOLATE - PREZISTA
N 202895 001 5843946 Dec 01, 2015 DP U-1209 D-135 Feb 01, 2016
5843946 Dec 01, 2015 DP U-1305 NDF Dec 16, 2014
6037157 Jun 26, 2016 U-1209 PED Jun 16, 2015
6037157 Jun 26, 2016 U-1305 PED Aug 01, 2016
6248775 Aug 13, 2014 DS
6703403 Jun 26, 2016 U-1209
6703403 Jun 26, 2016 U-1305
7470506 Jun 23, 2019 U-1209
7470506 Jun 23, 2019 U-1305
7700645 Dec 26, 2026 DS DP
8518987 Feb 16, 2024 DS DP
8518987*PED Aug 16, 2024
8597876 Jun 23, 2019 U-1305
8597876*PED Dec 23, 2019
RE42889 Oct 19, 2016 DP
RE43596 May 09, 2017 DS DP
RE43802 Oct 19, 2016 U-1305
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 49 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT
EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY
EXPIRATION
DATE CODES REQUESTED CODE(S)
DATE
DASABUVIR SODIUM ; OMBITASVIR; PARITAPREVIR; RITONAVIR - VIEKIRA PAK (COPACKAGED)
N 206619 001 NCE
Dec 19, 2019
DASATINIB - SPRYCEL
N 021986 001 6596746 Jun 28, 2020 DS DP U-748
6596746 Jun 28, 2020 DS DP U-780
7125875 Apr 13, 2020 U-779
7125875 Apr 13, 2020 U-780
7153856 Apr 28, 2020 U-780
7491725 Mar 28, 2026 DS DP
8680103 Feb 04, 2025 DP
DASATINIB - SPRYCEL
N 021986 002 6596746 Jun 28, 2020 DS DP U-748
6596746 Jun 28, 2020 DS DP U-780
7125875 Apr 13, 2020 U-779
7125875 Apr 13, 2020 U-780
7153856 Apr 28, 2020 U-780
7491725 Mar 28, 2026 DS DP
8680103 Feb 04, 2025 DP
DASATINIB - SPRYCEL
N 021986 003 6596746 Jun 28, 2020 DS DP U-748
6596746 Jun 28, 2020 DS DP U-780
7125875 Apr 13, 2020 U-779
7125875 Apr 13, 2020 U-780
7153856 Apr 28, 2020 U-780
7491725 Mar 28, 2026 DS DP
8680103 Feb 04, 2025 DP
DASATINIB - SPRYCEL
N 021986 004 6596746 Jun 28, 2020 DS DP U-748
6596746 Jun 28, 2020 DS DP U-780
7125875 Apr 13, 2020 U-779
7125875 Apr 13, 2020 U-780
7153856 Apr 28, 2020 U-780
7491725 Mar 28, 2026 DS DP
8680103 Feb 04, 2025 DP
DASATINIB - SPRYCEL
N 021986 005 6596746 Jun 28, 2020 DS DP U-748
6596746 Jun 28, 2020 DS DP U-780
7125875 Apr 13, 2020 U-779
7125875 Apr 13, 2020 U-780
7153856 Apr 28, 2020 U-780
7491725 Mar 28, 2026 DS DP
8680103 Feb 04, 2025 DP
DASATINIB - SPRYCEL
N 021986 006 6596746 Jun 28, 2020 DS DP U-748
6596746 Jun 28, 2020 DS DP U-780
7125875 Apr 13, 2020 U-779
7125875 Apr 13, 2020 U-780
7153856 Apr 28, 2020 U-780
7491725 Mar 28, 2026 DS DP
8680103 Feb 04, 2025 DP
DEFERASIROX - EXJADE
N 021882 001 6465504 Apr 05, 2019 DS DP I-665
Jan 23, 2016
6596750 Jun 24, 2017 DS U-735
DEFERASIROX - EXJADE
N 021882 002 6465504 Apr 05, 2019 DS DP I-665
Jan 23, 2016
6596750 Jun 24, 2017 DS U-735
DEFERASIROX - EXJADE
N 021882 003 6465504 Apr 05, 2019 DS DP I-665
Jan 23, 2016
6596750 Jun 24, 2017 DS U-735
DEFERIPRONE - FERRIPROX
N 021825 001 NCE
Oct 14, 2016
ODE
Oct 14, 2018
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 50 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DEGARELIX ACETATE - FIRMAGON
N 022201 001 5925730 May 18, 2021 DS DP U-943
DEGARELIX ACETATE - FIRMAGON
N 022201 002 5925730 May 18, 2021 DS DP U-943
DELAVIRDINE MESYLATE - RESCRIPTOR
N 020705 002 6177101 Jun 07, 2019
DESIRUDIN RECOMBINANT - IPRIVASK
N 021271 001 5733874 Mar 31, 2015
DESLORATADINE - CLARINEX
N 021165 001 6100274 Jul 07, 2019
7211582 Dec 30, 2014 U-809
7214683 Dec 30, 2014 DP
7214684 Dec 30, 2014 U-138
7405223 Jul 07, 2019 U-886
DESLORATADINE - CLARINEX
N 021300 001 6514520 Jun 01, 2018 DP
7211582 Dec 30, 2014 U-809
7214683 Dec 30, 2014 DP
7214684 Dec 30, 2014 U-138
DESLORATADINE - CLARINEX
N 021312 001 5607697 Jun 07, 2015 DP
6100274 Jul 07, 2019 DP
7211582 Dec 30, 2014 U-809
7214683 Dec 30, 2014 DP
7214684 Dec 30, 2014 U-138
7618649 Dec 19, 2020 DP U-1017
DESLORATADINE - CLARINEX
N 021312 002 5607697 Jun 07, 2015 DP
6100274 Jul 07, 2019 DP
7211582 Dec 30, 2014 U-809
7214683 Dec 30, 2014 DP
7214684 Dec 30, 2014 U-138
7618649 Dec 19, 2020 DP U-1017
DESLORATADINE; PSEUDOEPHEDRINE SULFATE - CLARINEX-D 12 HOUR
N 021313 001 6100274 Jul 07, 2019 DP
6709676 Feb 18, 2021 DP U-707
7214683 Dec 30, 2014 DP
7214684 Dec 30, 2014 U-138
7618649 Dec 19, 2020 DP U-1017
8187630 Dec 19, 2020 DP U-1017
DESLORATADINE; PSEUDOEPHEDRINE SULFATE - CLARINEX D 24 HOUR
N 021605 001 6100274 Jul 07, 2019 DP
6979463 Mar 28, 2022 DP
7214683 Dec 30, 2014 DP
7214684 Dec 30, 2014 U-138
7618649 Dec 19, 2020 DP U-1017
7820199 Mar 28, 2022 DP
DESMOPRESSIN ACETATE - DDAVP
N 019955 001 7022340 Apr 30, 2023 DP Y
DESMOPRESSIN ACETATE - DDAVP
N 019955 002 7022340 Apr 30, 2023 DP Y
DESONIDE - DESONATE
N 021844 001 6387383 Aug 03, 2020 DS DP U-783
DESONIDE - VERDESO
N 021978 001 6730288 Sep 08, 2019 DP
7029659 Sep 08, 2019 DP
8460641 Nov 05, 2028 DP U-1412
DESOXIMETASONE - TOPICORT
N 204141 001 5990100 Mar 24, 2018 DP U-1408 NDF Apr 11, 2016
8277780 Sep 01, 2028 DP U-1408
8715624 May 26, 2026 DP U-1408
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 51 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DESVENLAFAXINE SUCCINATE - PRISTIQ
N 021992 001 6673838 Mar 01, 2022 DS U-860 I-675 Feb 14, 2016
6673838 Mar 01, 2022 DS U-1364
8269040 Jul 05, 2027 DS
DESVENLAFAXINE SUCCINATE - PRISTIQ
N 021992 002 6673838 Mar 01, 2022 DS U-860 I-675 Feb 14, 2016
6673838 Mar 01, 2022 DS U-1364
8269040 Jul 05, 2027 DS
DEXAMETHASONE - OZURDEX
N 022315 001 6726918 Oct 20, 2020 DP U-1204 I-686 Jun 29, 2017
6726918 Oct 20, 2020 DP U-1205 ODE Sep 24, 2017
6899717 Nov 01, 2023 U-1206
7033605 Oct 20, 2020 DP
7767223 Nov 28, 2021 DP
8034366 Jan 09, 2023 DP U-1204
8034366 Jan 09, 2023 DP U-1205
8034370 Jan 09, 2023 DP
8043628 Oct 20, 2020 DP U-1205
8063031 Oct 20, 2020 DP
8088407 Oct 20, 2020 DP U-1205
8506987 Jan 09, 2023 U-1204
8506987 Jan 09, 2023 U-1205
DEXAMETHASONE; TOBRAMYCIN - TOBRADEX ST
N 050818 001 7795316 Aug 03, 2028 DP U-1082
8101582 Dec 19, 2027 DP U-1082
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 52 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DEXLANSOPRAZOLE - DEXILANT
N 022287 001 6462058 Jun 15, 2020 DS DP U-949
6462058 Jun 15, 2020 DS DP U-950
6462058 Jun 15, 2020 DS DP U-951
6664276 Jan 30, 2023 DS DP U-949
6664276 Jan 30, 2023 DS DP U-950
6664276 Jan 30, 2023 DS DP U-951
6664276 Jan 30, 2023 DS DP U-1507
6664276*PED Jul 30, 2023
6939971 Jun 15, 2020 U-949
6939971 Jun 15, 2020 U-950
6939971 Jun 15, 2020 U-951
7285668 Jun 15, 2020 DS
7790755 Aug 02, 2026 DP
8105626 Sep 27, 2026 DP
8173158 Mar 17, 2030 U-949
8173158 Mar 17, 2030 U-950
8173158 Mar 17, 2030 U-951
8461187 Jan 17, 2026 DP
8461187*PED Jul 17, 2026
8722084 Oct 15, 2023 DP
8784885 Oct 15, 2023 DP U-1552
8784885 Oct 15, 2023 DP U-1553
8784885 Oct 15, 2023 DP U-1554
8871273 Jan 11, 2028 DP
DEXLANSOPRAZOLE - DEXILANT
N 022287 002 6462058 Jun 15, 2020 DS DP U-949
6462058 Jun 15, 2020 DS DP U-950
6462058 Jun 15, 2020 DS DP U-951
6664276 Jan 30, 2023 DS DP U-949
6664276 Jan 30, 2023 DS DP U-950
6664276 Jan 30, 2023 DS DP U-951
6664276 Jan 30, 2023 DS DP U-1507
6664276*PED Jul 30, 2023
6939971 Jun 15, 2020 U-949
6939971 Jun 15, 2020 U-950
6939971 Jun 15, 2020 U-951
7285668 Jun 15, 2020 DS
7790755 Aug 02, 2026 DP
8105626 Sep 27, 2026 DP
8173158 Mar 17, 2030 U-949
8173158 Mar 17, 2030 U-950
8173158 Mar 17, 2030 U-951
8461187 Jan 17, 2026 DP
8461187*PED Jul 17, 2026
8722084 Oct 15, 2023 DP
8722084*PED Apr 15, 2024
8871273 Jan 11, 2028 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 53 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX
N 021038 001 6716867 Mar 31, 2019 U-1472 M-61 Jun 17, 2016
6716867*PED Oct 01, 2019 PED Dec 17, 2016
DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX
N 021038 002 6716867 Mar 31, 2019 U-1472 M-61 Jun 17, 2016
6716867*PED Oct 01, 2019 PED Dec 17, 2016
8242158 Jan 04, 2032 DP
8242158*PED Jul 04, 2032
8338470 Jan 04, 2032 DP
8338470*PED Jul 04, 2032
8455527 Jan 04, 2032 U-421
8455527*PED Jul 04, 2032
8648106 Jan 04, 2032 DP
8648106*PED Jul 04, 2032
DEXMEDETOMIDINE HYDROCHLORIDE - PRECEDEX
N 021038 003 6716867 Mar 31, 2019 U-1472 M-61 Jun 17, 2016
6716867*PED Oct 01, 2019 PED Dec 17, 2016
8242158 Jan 04, 2032 DP
8242158*PED Jul 04, 2032
8338470 Jan 04, 2032 DP
8338470*PED Jul 04, 2032
8455527 Jan 04, 2032 U-421
8455527*PED Jul 04, 2032
8648106 Jan 04, 2032 DP
8648106*PED Jul 04, 2032
DEXMETHYLPHENIDATE HYDROCHLORIDE - DEXMETHYLPHENIDATE HYDROCHLORIDE
A 078908 001 PC May 09, 2015
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN
N 021278 001 5908850 Dec 04, 2015 U-422
6355656 Dec 04, 2015
6528530 Dec 04, 2015 DS DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN
N 021278 002 5908850 Dec 04, 2015 U-422
6355656 Dec 04, 2015
6528530 Dec 04, 2015 DS DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN
N 021278 003 5908850 Dec 04, 2015 U-422
6355656 Dec 04, 2015
6528530 Dec 04, 2015 DS DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 54 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N 021802 001 5837284 Dec 04, 2015 DP
5908850 Dec 04, 2015 U-678
6228398 Nov 01, 2019 DP U-676
6355656 Dec 04, 2015 DP
6528530 Dec 04, 2015 DP
6635284 Dec 04, 2015 DP U-677
6730325 Nov 01, 2019 DP U-676
7431944 Dec 04, 2015 DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N 021802 002 5837284 Dec 04, 2015 DP
5908850 Dec 04, 2015 U-678
6228398 Nov 01, 2019 DP U-676
6355656 Dec 04, 2015 DP
6528530 Dec 04, 2015 DP
6635284 Dec 04, 2015 DP U-677
6730325 Nov 01, 2019 DP U-676
7431944 Dec 04, 2015 DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N 021802 003 5837284 Dec 04, 2015 DP
5908850 Dec 04, 2015 U-678
6228398 Nov 01, 2019 DP U-676
6355656 Dec 04, 2015 DP
6528530 Dec 04, 2015 DP
6635284 Dec 04, 2015 DP U-677
6730325 Nov 01, 2019 DP U-676
7431944 Dec 04, 2015 DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N 021802 004 5837284 Dec 04, 2015 DP
5908850 Dec 04, 2015 U-678
6228398 Nov 01, 2019 DP U-676
6355656 Dec 04, 2015 DP
6528530 Dec 04, 2015 DP
6635284 Dec 04, 2015 DP U-677
6730325 Nov 01, 2019 DP U-676
7431944 Dec 04, 2015 DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N 021802 005 5837284 Dec 04, 2015 DP
5908850 Dec 04, 2015 DP U-678
6228398 Nov 01, 2019 DP U-676
6355656 Dec 04, 2015 DP
6528530 Dec 04, 2015 DP
6635284 Dec 04, 2015 DP U-677
6730325 Nov 01, 2019 DP U-676
7431944 Dec 04, 2015 DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N 021802 006 5837284 Dec 04, 2015 DP U-677
5908850 Dec 04, 2015 DP U-678
6228398 Nov 01, 2019 DP U-676
6355656 Dec 04, 2015 DP
6528530 Dec 04, 2015 DP
6635284 Dec 04, 2015 DP U-677
6730325 Nov 01, 2019 DP U-676
7431944 Dec 04, 2015 DP
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N 021802 007 5837284 Dec 04, 2015 DP
5908850 Dec 04, 2015 DP U-678
6228398 Nov 01, 2019 DP U-676
6355656 Dec 04, 2015 DP
6528530 Dec 04, 2015 DP
6635284 Dec 04, 2015 DP U-677
6730325 Nov 01, 2019 DP U-676
7431944 Dec 04, 2015 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 55 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DEXMETHYLPHENIDATE HYDROCHLORIDE - FOCALIN XR
N 021802 008 5837284 Dec 04, 2015 DP
5908850 Dec 04, 2015 DP U-678
6228398 Nov 01, 2019 DP U-676
6355656 Dec 04, 2015 DP
6528530 Dec 04, 2015 DP
6635284 Dec 04, 2015 DP U-677
6730325 Nov 01, 2019 DP U-676
7431944 Dec 04, 2015 DP
DEXRAZOXANE HYDROCHLORIDE - TOTECT
N 022025 001 6727253 Mar 13, 2020 U-829 ODE Sep 06, 2014
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN - MUCINEX DM
N 021620 001 6372252 Apr 28, 2020 DP
6955821 Apr 28, 2020 DP U-685
7838032 Apr 28, 2020 DP
DEXTROMETHORPHAN HYDROBROMIDE; GUAIFENESIN - MUCINEX DM
N 021620 002 6372252 Apr 28, 2020 DP
6955821 Apr 28, 2020 DP U-685
7838032 Apr 28, 2020 DP
DEXTROMETHORPHAN HYDROBROMIDE; QUINIDINE SULFATE - NUEDEXTA
N 021879 001 7659282 Aug 13, 2026 U-1093
8227484 Jul 17, 2023 U-1093
RE38115 Jan 26, 2016 DP Y
DEXTROMETHORPHAN POLISTIREX - DELSYM
N 018658 001 5980882 Apr 16, 2017 DP
DICLOFENAC - ZORVOLEX
N 204592 001 8679544 Apr 23, 2030 DP I-692 Aug 22, 2017
NP Oct 18, 2016
DICLOFENAC - ZORVOLEX
N 204592 002 8679544 Apr 23, 2030 DP I-692 Aug 22, 2017
NP Oct 18, 2016
DICLOFENAC EPOLAMINE - FLECTOR
N 021234 001 5607690 Apr 13, 2019 DP
DICLOFENAC POTASSIUM - CAMBIA
N 022165 001 6974595 May 15, 2017 U-436
7482377 May 15, 2017 DS DP U-436
7759394 Jun 16, 2026 DS DP U-436
8097651 Jun 16, 2026 DS DP U-436
DICLOFENAC POTASSIUM - ZIPSOR
N 022202 001 6287594 Jan 15, 2019 DP
6365180 Jul 15, 2019 DP U-980
7662858 Feb 24, 2029 U-1035
7884095 Feb 24, 2029 U-1111
7939518 Feb 24, 2029 U-980
8110606 Feb 24, 2029 U-980
8623920 Feb 24, 2029 U-1482
DICLOFENAC SODIUM - DICLOFENAC SODIUM
A 202027 001 PC Nov 23, 2014
DICLOFENAC SODIUM - DICLOFENAC SODIUM
N 020809 001 5603929 Nov 16, 2014 U-239
5653972 Nov 16, 2014 U-239
DICLOFENAC SODIUM - PENNSAID
N 020947 001 8217078 Jul 10, 2029 U-1248
8546450 Aug 09, 2030 U-1435
8546450 Aug 09, 2030 U-1436
8618164 Jul 10, 2029 U-1477
8741956 Jul 10, 2029 U-1435
DICLOFENAC SODIUM - SOLARAZE
N 021005 001 5792753 Aug 11, 2015
5914322 Aug 11, 2015
5985850 Aug 11, 2015 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 56 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DICLOFENAC SODIUM - DYLOJECT
N 022396 001 NP Dec 23, 2017
DICLOFENAC SODIUM - PENNSAID
N 204623 001 8217078 Jul 10, 2029 U-1477 NP Jan 16, 2017
8252838 Apr 21, 2028 DP U-1489
8546450 Aug 09, 2030 U-1435
8546450 Aug 09, 2030 U-1436
8563613 Oct 17, 2027 DP U-1488
8618164 Jul 10, 2029 U-1477
8741956 Jul 10, 2029 U-1435
8871809 Oct 17, 2027 U-1614
DIENOGEST; DIENOGEST; DIENOGEST; ESTRADIOL VALERATE; ESTRADIOL VALERATE; ESTRADIOL VALERATE; ESTRADIOL
VALERATE; ESTRADIOL VALERATE - NATAZIA
N 022252 001 6133251 Oct 25, 2016 DP U-1 Y I-648 Mar 14, 2015
6133251 Oct 25, 2016 DP U-112 Y
6133251 Oct 25, 2016 DP U-828 Y
6884793 Oct 25, 2016 DP Y
8071577 May 13, 2026 DP U-1
8153616 Jan 30, 2028 U-1240
DIFLUPREDNATE - DUREZOL
N 022212 001 6114319 May 18, 2019 DP I-653 Jun 13, 2015
6114319*PED Nov 18, 2019 M-127 Mar 22, 2016
ODE Jun 13, 2019
PED Dec 13, 2015
PED Sep 22, 2016
PED Dec 13, 2019
DILTIAZEM HYDROCHLORIDE - CARDIZEM LA
N 021392 001 6923984 Feb 25, 2021 DP
7108866 Dec 17, 2019 DP U-107
DILTIAZEM HYDROCHLORIDE - CARDIZEM LA
N 021392 002 6923984 Feb 25, 2021 DP
7108866 Dec 17, 2019 DP U-107
DILTIAZEM HYDROCHLORIDE - CARDIZEM LA
N 021392 003 6923984 Feb 25, 2021 DP
7108866 Dec 17, 2019 DP U-107
DILTIAZEM HYDROCHLORIDE - CARDIZEM LA
N 021392 004 6923984 Feb 25, 2021 DP
7108866 Dec 17, 2019 DP U-107
DILTIAZEM HYDROCHLORIDE - CARDIZEM LA
N 021392 005 6923984 Feb 25, 2021 DP
7108866 Dec 17, 2019 DP U-107
DILTIAZEM HYDROCHLORIDE - CARDIZEM LA
N 021392 006 6923984 Feb 25, 2021 DP
7108866 Dec 17, 2019 DP U-107
DIMETHYL FUMARATE - TECFIDERA
N 204063 001 6509376 Oct 29, 2019 DP NCE Mar 27, 2018
7320999 May 18, 2020 U-1384
7619001 Apr 01, 2018 U-1384
7803840 Apr 01, 2018 U-1385
8399514 Feb 07, 2028 U-1384
8524773 Apr 01, 2018 U-1384
8759393 Oct 29, 2019 DP
DIMETHYL FUMARATE - TECFIDERA
N 204063 002 6509376 Oct 29, 2019 DP NCE Mar 27, 2018
7320999 May 18, 2020 U-1384
7619001 Apr 01, 2018 U-1384
7803840 Apr 01, 2018 U-1385
8399514 Feb 07, 2028 U-1384
8524773 Apr 01, 2018 U-1384
8759393 Oct 29, 2019 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 57 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DIMYRISTOYL LECITHIN; PERFLEXANE - IMAGENT
N 021191 001 5695741 Dec 09, 2014 U-458
5720938 Feb 24, 2015
5798091 Aug 25, 2015 U-458
DIPHENHYDRAMINE CITRATE; IBUPROFEN - ADVIL PM
N 021394 001 8263647 May 30, 2022 DP
DIPHENHYDRAMINE HYDROCHLORIDE; IBUPROFEN - ADVIL PM
N 021393 001 8883849 Jan 17, 2022 U-1618
DIPHENHYDRAMINE HYDROCHLORIDE; NAPROXEN SODIUM - ALEVE PM
N 205352 001 NC Jan 17, 2017
DIVALPROEX SODIUM - DEPAKOTE ER
N 021168 001 6419953 Dec 18, 2018
6511678 Dec 18, 2018
6528090 Dec 18, 2018 DP
6528091 Dec 18, 2018 U-106
6713086 Dec 18, 2018 DP U-579
6720004 Dec 18, 2018 DP
DIVALPROEX SODIUM - DEPAKOTE ER
N 021168 002 6511678 Dec 18, 2018
6528090 Dec 18, 2018 DP
6713086 Dec 18, 2018 DP U-579
6720004 Dec 18, 2018 DP
DOFETILIDE - TIKOSYN
N 020931 001 6124363 Oct 09, 2018
DOFETILIDE - TIKOSYN
N 020931 002 6124363 Oct 09, 2018
DOFETILIDE - TIKOSYN
N 020931 003 6124363 Oct 09, 2018
DOLUTEGRAVIR SODIUM - TIVICAY
N 204790 001 8129385 Oct 05, 2027 DS DP NCE Aug 12, 2018
DONEPEZIL HYDROCHLORIDE - ARICEPT ODT
N 021720 001 7727548 Jun 23, 2022 DP U-1062
7727552 Mar 26, 2018 DP
DONEPEZIL HYDROCHLORIDE - ARICEPT ODT
N 021720 002 7727548 Jun 23, 2022 DP U-1062
7727552 Mar 26, 2018 DP
DONEPEZIL HYDROCHLORIDE - ARICEPT
N 022568 001 8481565 Oct 04, 2026 DP
DORIPENEM - DORIBAX
N 022106 001 5317016 Jun 05, 2015 DS DP U-282
8247402 Mar 30, 2021 DS DP
DORIPENEM - DORIBAX
N 022106 002 5317016 Jun 05, 2015 DS DP U-282
8247402 Mar 30, 2021 DS DP
DORZOLAMIDE HYDROCHLORIDE; TIMOLOL MALEATE - COSOPT PF
N 202667 001 NP Feb 01, 2015
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 58 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DOXEPIN HYDROCHLORIDE - SILENOR
N 022036 001 5585115 Jan 09, 2015 DP
5725884 Jan 09, 2015 DP
5866166 Jan 09, 2015 DP
5948438 Jan 09, 2015 DP
6103219 Jan 09, 2015 DP
6211229 Feb 17, 2020 U-620
6217909 Jan 09, 2015 DP
7915307 Aug 24, 2027 U-620
8513299 Apr 14, 2030 U-620
DOXEPIN HYDROCHLORIDE - SILENOR
N 022036 002 5585115 Jan 09, 2015 DP
5725884 Jan 09, 2015 DP
5866166 Jan 09, 2015 DP
5948438 Jan 09, 2015 DP
6103219 Jan 09, 2015 DP
6211229 Feb 17, 2020 U-620
6217909 Jan 09, 2015 DP
7915307 Aug 24, 2027 U-620
8513299 Apr 14, 2030 U-620
DOXERCALCIFEROL - HECTOROL
N 020862 001 6903083 Jul 18, 2021 DS DP Y
DOXERCALCIFEROL - HECTOROL
N 020862 002 6903083 Jul 18, 2021 DS DP Y
DOXYCYCLINE - ORACEA
N 050805 001 5789395 Aug 30, 2016 U-925 Y
5919775 Aug 30, 2016 U-925 Y
7211267 Apr 05, 2022 U-925
7232572 Apr 05, 2022 U-925
7749532 Dec 19, 2027 DP U-1063
8206740 Dec 24, 2025 DP U-925
8394405 Apr 07, 2024 DP U-925
8394406 Apr 07, 2024 DP U-925
8470364 Apr 07, 2024 DP U-925
8603506 Apr 05, 2022 U-1063
8709478 Apr 07, 2024 U-1063
DOXYCYCLINE HYCLATE - DORYX
N 050795 001 6958161 Dec 15, 2022 DP U-918
8715724 Feb 03, 2028 DP
DOXYCYCLINE HYCLATE - DORYX
N 050795 002 6958161 Dec 15, 2022 DP U-918
8715724 Feb 03, 2028 DP
DOXYCYCLINE HYCLATE - DORYX
N 050795 003 6958161 Dec 15, 2022 DP U-918
8715724 Feb 03, 2028 DP
DOXYCYCLINE HYCLATE - DORYX
N 050795 004 6958161 Dec 15, 2022 DP U-918
8715724 Feb 03, 2028 DP
DOXYCYCLINE HYCLATE - DORYX
N 050795 005 6958161 Dec 15, 2022 DP U-918 D-136 Apr 11, 2016
8715724 Feb 03, 2028 DP NS Apr 11, 2016
DOXYLAMINE SUCCINATE; PYRIDOXINE HYDROCHLORIDE - DICLEGIS
N 021876 001 6340695 Jun 21, 2021 DP U-1382 NP Apr 08, 2016
7560122 Jan 25, 2019 DP
DRONEDARONE HYDROCHLORIDE - MULTAQ
N 022425 001 5223510 Jul 26, 2016 DS DP U-992 NCE Jul 01, 2014
5223510 Jul 26, 2016 DS DP U-1261
7323493 Jun 19, 2018 DP
8318800 Jun 19, 2018 DP
8410167 Apr 16, 2029 U-1387
8410167 Apr 16, 2029 U-1388
8602215 Jun 30, 2031 U-1473
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 59 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
DROSPIRENONE; ESTRADIOL - ANGELIQ
N 021355 001 8906890 Oct 22, 2031 DP NS Mar 01, 2015
DROSPIRENONE; ESTRADIOL - ANGELIQ
N 021355 002 6933395 Aug 11, 2017 DS
DROSPIRENONE; ETHINYL ESTRADIOL - YASMIN
N 021098 001 6787531 Aug 31, 2020 DP
6933395 Aug 11, 2017 DS
DROSPIRENONE; ETHINYL ESTRADIOL - YAZ
N 021676 001 5798338 Jul 10, 2015 DP
6787531 Aug 31, 2020 DP
6933395 Aug 11, 2017 DP
6958326 Dec 20, 2021 DP
6987101 Dec 22, 2017 U-758
7163931 Dec 20, 2021 U-1
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM - BEYAZ
N 022532 001 5798338 Jul 10, 2015 DP
6441168 Apr 17, 2020 DS
6958326 Dec 20, 2021 DP
7163931 Mar 03, 2022 U-1
8617597 Feb 08, 2030 DP
DROSPIRENONE; ETHINYL ESTRADIOL; LEVOMEFOLATE CALCIUM - SAFYRAL
N 022574 001 5798338 Jul 10, 2015 DP
6441168 Apr 17, 2020 DS
6958326 Dec 20, 2021 DP
7163931 Mar 03, 2022 U-1
8617597 Feb 08, 2030 DP
DROXIDOPA - NORTHERA
N 203202 001 NCE Feb 18, 2019
ODE Feb 18, 2021
DROXIDOPA - NORTHERA
N 203202 002 NCE Feb 18, 2019
ODE Feb 18, 2021
DROXIDOPA - NORTHERA
N 203202 003 NCE Feb 18, 2019
ODE Feb 18, 2021
DULOXETINE HYDROCHLORIDE - CYMBALTA
N 021427 001 5508276 Jul 18, 2014 DP M-61 Oct 18, 2015
6596756 Sep 10, 2019 U-882 NPP Oct 16, 2017
NPP Oct 16, 2017
PED Apr 18, 2016
DULOXETINE HYDROCHLORIDE - CYMBALTA
N 021427 002 5508276 Jul 18, 2014 DP M-61 Oct 18, 2015
6596756 Sep 10, 2019 U-882 NPP Oct 16, 2017
NPP Oct 16, 2017
PED Apr 18, 2016
DULOXETINE HYDROCHLORIDE - CYMBALTA
N 021427 004 5508276 Jul 18, 2014 DP M-61 Oct 18, 2015
6596756 Sep 10, 2019 U-882 NPP Oct 16, 2017
NPP Oct 16, 2017
PED Apr 18, 2016
DUTASTERIDE - AVODART
N 021319 001 5565467 Nov 20, 2015 DS DP
DUTASTERIDE; TAMSULOSIN HYDROCHLORIDE - JALYN
N 022460 001 5565467 Nov 20, 2015 DS DP
ECONAZOLE NITRATE - ECOZA
N 205175 001 5993830 Jan 16, 2018 DP U-1449 NDF Oct 24, 2016
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 60 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
PATENT PATENT EXCLUSIVITY
NO PATENT NO
EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
EFAVIRENZ - SUSTIVA
N 020972 001 5663169
Sep 02, 2014 U-257 NPP May 02, 2016
5663169*PED
Mar 02, 2015 PED Nov 02, 2016
6238695
Apr 06, 2019 DP
6238695*PED
Oct 06, 2019
6555133
Apr 06, 2019 U-248
6555133*PED
Oct 06, 2019
6639071
Feb 14, 2018 DS
6639071*PED
Aug 14, 2018
6939964
Jan 20, 2018 DS
6939964*PED
Jul 20, 2018
EFAVIRENZ - SUSTIVA
N 020972 002 5663169
Sep 02, 2014 U-257
5663169*PED
Mar 02, 2015
6238695
Apr 06, 2019 DP
6238695*PED
Oct 06, 2019
6555133
Apr 06, 2019 U-248
6555133*PED
Oct 06, 2019
6639071
Feb 14, 2018 DS
6639071*PED
Aug 14, 2018
6939964
Jan 20, 2018 DS
6939964*PED
Jul 20, 2018
EFAVIRENZ - SUSTIVA
N 020972 003 5663169
Sep 02, 2014 U-257 NPP May 02, 2016
5663169*PED
Mar 02, 2015 PED Nov 02, 2016
6238695
Apr 06, 2019 DP
6238695*PED
Oct 06, 2019
6555133
Apr 06, 2019 U-248
6555133*PED
Oct 06, 2019
6639071
Feb 14, 2018 DS
6639071*PED
Aug 14, 2018
6939964
Jan 20, 2018 DS
6939964*PED
Jul 20, 2018
EFAVIRENZ - SUSTIVA
N 021360 001 5663169
Sep 02, 2014
5663169*PED
Mar 02, 2015
6639071
Feb 14, 2018 DS
6639071*PED
Aug 14, 2018
6939964
Jan 20, 2018 DS
6939964*PED
Jul 20, 2018
EFAVIRENZ - SUSTIVA
N 021360 002 5663169
Sep 02, 2014 U-248 NPP May 02, 2016
5663169*PED
Mar 02, 2015 PED Nov 02, 2016
6639071
Feb 14, 2018 DS
6639071*PED
Aug 14, 2018
6939964
Jan 20, 2018 DS
6939964*PED
Jul 20, 2018
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 61 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
EFAVIRENZ; EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - ATRIPLA
N 021937 001 5663169 Sep 02, 2014 U-750
5663169 Sep 02, 2014 U-1170
5663169*PED Mar 02, 2015
5814639 Sep 29, 2015 DS DP
5914331 Jul 02, 2017 DS
5922695 Jul 25, 2017 DS U-750
5922695 Jul 25, 2017 DS U-1170
5935946 Jul 25, 2017 DS DP U-750
5935946 Jul 25, 2017 DS DP U-1170
5977089 Jul 25, 2017 DS DP U-750
5977089 Jul 25, 2017 DS DP U-1170
6043230 Jul 25, 2017 U-750
6043230 Jul 25, 2017 U-1170
6639071 Feb 14, 2018 DS
6639071*PED Aug 14, 2018
6642245 Nov 04, 2020 U-750
6642245 Nov 04, 2020 U-1170
6703396 Mar 09, 2021 DS DP
6939964 Jan 20, 2018 DS
6939964*PED Jul 20, 2018
8592397 Jan 13, 2024 DP U-750
8592397 Jan 13, 2024 DP U-1170
8598185 May 01, 2028 DP
8716264 Jan 13, 2024 DP U-257
EFINACONAZOLE - JUBLIA
N 203567 001 7214506 Oct 05, 2021 U-281 NCE Jun 06, 2019
8039494 Jul 08, 2030 U-281
8486978 Oct 24, 2030 DP
EFLORNITHINE HYDROCHLORIDE - VANIQA
N 021145 001 5648394 Jul 15, 2014 U-334
ELETRIPTAN HYDROBROMIDE - RELPAX
N 021016 001 5545644 Dec 26, 2016 DS DP U-876
6110940 Aug 29, 2017
ELETRIPTAN HYDROBROMIDE - RELPAX
N 021016 002 5545644 Dec 26, 2016 DS DP U-876
6110940 Aug 29, 2017
ELIGLUSTAT TARTRATE - CERDELGA
N 205494 001 6916802 Apr 29, 2022 U-1571 NCE Aug 19, 2019
7196205 Apr 29, 2022 DS ODE Aug 19, 2021
7615573 Apr 29, 2022 U-1571
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 62 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
PATENT
PATENT EXCLUSIVITY
NO PATENT NO
EXPIRATION
PATENT DELIST EXCLUSIVITY EXPIRATION
DATE
CODES REQUESTED CODE(S) DATE
ELTROMBOPAG OLAMINE - PROMACTA
N 022291 001 6280959
Oct 30, 2018
DS DP U-930 I-664 Nov 16, 2015
6280959
Oct 30, 2018
DS DP U-1306 ODE Nov 20, 2015
6280959
Oct 30, 2018
DS DP U-1575 ODE Aug 26, 2021
7160870
Nov 20, 2022
DS DP U-930
7160870
Nov 20, 2022
DS DP U-1306
7160870
Nov 20, 2022
DS DP U-1575
7332481
May 24, 2021
U-930
7332481
May 24, 2021
U-1306
7332481
May 24, 2021
U-1575
7452874
May 24, 2021
DS DP
7473686
May 24, 2021
DS DP U-930
7473686
May 24, 2021
DS DP U-1306
7473686
May 24, 2021
DS DP U-1575
7547719
Jul 13, 2025
DS DP U-930
7547719
Jul 13, 2025
DS DP U-1306
7547719
Jul 13, 2025
DS DP U-1575
7790704
May 24, 2021
U-930
7790704
May 24, 2021
U-1306
7790704
May 24, 2021
U-1575
7795293
May 21, 2023
U-930
7795293
May 21, 2023
U-1306
7795293
May 21, 2023
U-1575
8052993
Aug 01, 2027
DP U-930
8052993
Aug 01, 2027
DP U-1306
8052993
Aug 01, 2027
DP U-1575
8828430
Aug 01, 2027
DP U-1306
8828430
Aug 01, 2027
DP U-1619
ELTROMBOPAG OLAMINE - PROMACTA
N 022291 002 6280959
Oct 30, 2018
DS DP U-930 I-664 Nov 16, 2015
6280959
Oct 30, 2018
DS DP U-1306 ODE Nov 20, 2015
6280959
Oct 30, 2018
DS DP U-1575 ODE Aug 26, 2021
7160870
Nov 20, 2022
DS DP U-930
7160870
Nov 20, 2022
DS DP U-1306
7160870
Nov 20, 2022
DS DP U-1575
7332481
May 24, 2021
U-930
7332481
May 24, 2021
U-1306
7332481
May 24, 2021
U-1575
7452874
May 24, 2021
DS DP
7473686
May 24, 2021
DS DP U-930
7473686
May 24, 2021
DS DP U-1306
7473686
May 24, 2021
DS DP U-1575
7547719
Jul 13, 2025
DS DP U-930
7547719
Jul 13, 2025
DS DP U-1306
7547719
Jul 13, 2025
DS DP U-1575
7790704
May 24, 2021
U-930
7790704
May 24, 2021
U-1306
7790704
May 24, 2021
U-1575
7795293
May 21, 2023
U-930
7795293
May 21, 2023
U-1306
7795293
May 21, 2023
U-1575
8052994
Aug 01, 2027
DP U-930
8052994
Aug 01, 2027
DP U-1306
8052994
Aug 01, 2027
DP U-1575
8828430
Aug 01, 2027
DP U-1306
8828430
Aug 01, 2027
DP U-1619
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 63 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
PATENT
PATENT EXCLUSIVITY
NO PATENT NO
EXPIRATION
PATENT DELIST EXCLUSIVITY EXPIRATION
DATE
CODES REQUESTED CODE(S) DATE
ELTROMBOPAG OLAMINE - PROMACTA
N 022291 003 6280959
Oct 30, 2018
DS DP U-930 I-664 Nov 16, 2015
6280959
Oct 30, 2018
DS DP U-1306 ODE Nov 20, 2015
6280959
Oct 30, 2018
DS DP U-1575 ODE Aug 26, 2021
7160870
Nov 20, 2022
DS DP U-930
7160870
Nov 20, 2022
DS DP U-1306
7160870
Nov 20, 2022
DS DP U-1575
7332481
May 24, 2021
U-930
7332481
May 24, 2021
U-1306
7332481
May 24, 2021
U-1575
7452874
May 24, 2021
DS DP
7473686
May 24, 2021
DS DP U-930
7473686
May 24, 2021
DS DP U-1306
7473686
May 24, 2021
DS DP U-1575
7547719
Jul 13, 2025
DS DP U-930
7547719
Jul 13, 2025
DS DP U-1306
7547719
Jul 13, 2025
DS DP U-1575
7790704
May 24, 2021
U-930
7790704
May 24, 2021
U-1306
7790704
May 24, 2021
U-1575
7795293
May 21, 2023
U-930
7795293
May 21, 2023
U-1306
7795293
May 21, 2023
U-1575
8062665
Aug 01, 2027
DP U-930
8062665
Aug 01, 2027
DP U-1306
8062665
Aug 01, 2027
DP U-1575
8828430
Aug 01, 2027
DP U-1306
8828430
Aug 01, 2027
DP U-1619
ELTROMBOPAG OLAMINE - PROMACTA
N 022291 004 6280959
Oct 30, 2018
DS DP U-930 I-664 Nov 16, 2015
6280959
Oct 30, 2018
DS DP U-1306 ODE Nov 20, 2015
6280959
Oct 30, 2018
DS DP U-1575 ODE Aug 26, 2021
7160870
Nov 20, 2022
DS DP U-930
7160870
Nov 20, 2022
DS DP U-1306
7160870
Nov 20, 2022
DS DP U-1575
7332481
May 24, 2021
U-930
7332481
May 24, 2021
U-1306
7332481
May 24, 2021
U-1575
7452874
May 24, 2021
DS DP
7473686
May 24, 2021
DS DP U-930
7473686
May 24, 2021
DS DP U-1306
7473686
May 24, 2021
DS DP U-1575
7547719
Jul 13, 2025
DS DP U-930
7547719
Jul 13, 2025
DS DP U-1306
7547719
Jul 13, 2025
DS DP U-1575
7790704
May 24, 2021
U-930
7790704
May 24, 2021
U-1306
7790704
May 24, 2021
U-1575
7795293
May 21, 2023
U-930
7795293
May 21, 2023
U-1306
7795293
May 21, 2023
U-1575
8071129
Aug 01, 2027
DP U-930
8071129
Aug 01, 2027
DP U-1306
8071129
Aug 01, 2027
DP U-1575
8828430
Aug 01, 2027
DP U-1306
8828430
Aug 01, 2027
DP U-1619
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 64 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT
EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY
EXPIRATION
DATE CODES REQUESTED CODE(S)
DATE
ELTROMBOPAG OLAMINE - PROMACTA
N 022291 005 6280959 Oct 30, 2018 DS DP U-930 I-664
Nov 16, 2015
6280959 Oct 30, 2018 DS DP U-1306 ODE
Nov 20, 2015
6280959 Oct 30, 2018 DS DP U-1575 ODE
Aug 26, 2021
7160870 Nov 20, 2022 DS DP U-930
7160870 Nov 20, 2022 DS DP U-1306
7160870 Nov 20, 2022 DS DP U-1575
7332481 May 24, 2021 U-930
7332481 May 24, 2021 U-1306
7332481 May 24, 2021 U-1575
7452874 May 24, 2021 DS DP
7473686 May 24, 2021 DS DP U-930
7473686 May 24, 2021 DS DP U-1306
7473686 May 24, 2021 DS DP U-1575
7547719 Jul 13, 2025 DS DP U-930
7547719 Jul 13, 2025 DS DP U-1306
7547719 Jul 13, 2025 DS DP U-1575
7790704 May 24, 2021 U-930
7790704 May 24, 2021 U-1306
7790704 May 24, 2021 U-1575
7795293 May 21, 2023 U-930
7795293 May 21, 2023 U-1306
7795293 May 21, 2023 U-1575
8052995 Aug 01, 2027 DP U-1306
8052995 Aug 01, 2027 DP U-1575
ELVITEGRAVIR - VITEKTA
N 203093 001 7176220 Nov 20, 2023 DS DP U-257 NP
Sep 24, 2017
7635704 Oct 26, 2026 DS DP U-257
ELVITEGRAVIR - VITEKTA
N 203093 002 7176220 Nov 20, 2023 DS DP U-257 NP
Sep 24, 2017
7635704 Oct 26, 2026 DS DP U-257
EMPAGLIFLOZIN - JARDIANCE
N 204629 001 7579449 Nov 05, 2025 DS NCE
Aug 01, 2019
7713938 Apr 15, 2027 DS DP
EMPAGLIFLOZIN - JARDIANCE
N 204629 002 7579449 Nov 05, 2025 DS NCE
Aug 01, 2019
7713938 Apr 15, 2027 DS DP
EMTRICITABINE - EMTRIVA
N 021500 001 5814639 Sep 29, 2015 DS DP
5914331 Jul 02, 2017 DS
6642245 Nov 04, 2020 U-257
6642245 Nov 04, 2020 U-541
6703396 Mar 09, 2021 DS DP
EMTRICITABINE - EMTRIVA
N 021896 001 5814639 Sep 29, 2015 DS DP
5914331 Jul 02, 2017 DS
6642245 Nov 04, 2020 U-257
6703396 Mar 09, 2021 DS DP
EMTRICITABINE; RILPIVIRINE HYDROCHLORIDE; TENOFOVIR DISOPROXIL FUMARATE - COMPLERA
N 202123 001 5814639 Sep 29, 2015 DS DP NCE
May 20, 2016
5914331 Jul 02, 2017 DS NPP
Dec 13, 2016
5922695 Jul 25, 2017 DS U-257
5935946 Jul 25, 2017 DS DP U-257
5977089 Jul 25, 2017 DS DP U-257
6043230 Jul 25, 2017 U-257
6642245 Nov 04, 2020 U-257
6703396 Mar 09, 2021 DS DP
6838464 Feb 26, 2021 DS DP
7067522 Dec 20, 2019 DS DP
7125879 Apr 14, 2023 DS DP U-257
8080551 Apr 11, 2023 DS DP
8101629 Aug 09, 2022 DP
8592397 Jan 13, 2024 DP U-257
8716264 Jan 13, 2024 DP U-257
8841310 Dec 09, 2025 DP U-257
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 65 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
EMTRICITABINE; TENOFOVIR DISOPROXIL FUMARATE - TRUVADA
N 021752 001 5814639 Sep 29, 2015 DS DP
5914331 Jul 02, 2017 DS DP U-248
5922695 Jul 25, 2017 DS U-248
5922695 Jul 25, 2017 DS U-541
5922695 Jul 25, 2017 DS U-1170
5922695 Jul 25, 2017 DS U-1259
5935946 Jul 25, 2017 DS DP U-248
5935946 Jul 25, 2017 DS DP U-541
5935946 Jul 25, 2017 DS DP U-1170
5935946 Jul 25, 2017 DS DP U-1259
5977089 Jul 25, 2017 DS DP U-248
5977089 Jul 25, 2017 DS DP U-541
5977089 Jul 25, 2017 DS DP U-1170
5977089 Jul 25, 2017 DS DP U-1259
6043230 Jul 25, 2017 DP U-248
6043230 Jul 25, 2017 DP U-541
6043230 Jul 25, 2017 DP U-1170
6043230 Jul 25, 2017 DP U-1259
6642245 Nov 04, 2020 U-248
6642245 Nov 04, 2020 U-541
6642245 Nov 04, 2020 U-1170
6703396 Mar 09, 2021 DS DP
8592397 Jan 13, 2024 DP U-248
8592397 Jan 13, 2024 DP U-541
8592397 Jan 13, 2024 DP U-1170
8716264 Jan 13, 2024 DP U-257
ENALAPRIL MALEATE - EPANED KIT
N 204308 001 8568747 Nov 06, 2032 DP
8778366 Nov 06, 2032 U-3
8778366 Nov 06, 2032 U-185
ENFUVIRTIDE - FUZEON
N 021481 001 6133418 Nov 17, 2014 DS DP
6475491 Jun 07, 2015 U-248
ENTACAPONE - COMTAN
N 020796 001 6599530 Sep 14, 2018 DP U-219
ENTECAVIR - ENTECAVIR
A 202122 001 PC Feb 21, 2015
ENTECAVIR - ENTECAVIR
A 202122 002 PC Feb 21, 2015
ENTECAVIR - BARACLUDE
N 021797 001 5206244 Feb 21, 2015 DS NPP Oct 12, 2015
5206244*PED Aug 21, 2015 NPP Mar 20, 2017
PED Apr 12, 2016
PED Sep 20, 2017
ENTECAVIR - BARACLUDE
N 021797 002 5206244 Feb 21, 2015 DS NPP Oct 12, 2015
5206244*PED Aug 21, 2015 NPP Mar 20, 2017
PED Apr 12, 2016
PED Sep 20, 2017
ENTECAVIR - BARACLUDE
N 021798 001 5206244 Feb 21, 2015 DS NPP Oct 12, 2015
5206244*PED Aug 21, 2015 NPP Mar 20, 2017
PED Apr 12, 2016
PED Sep 20, 2017
ENZALUTAMIDE - XTANDI
N 203415 001 7709517 Aug 13, 2027 DS DP I-693 Sep 10, 2017
8183274 May 15, 2026 U-1281 NCE Aug 31, 2017
8183274 May 15, 2026 U-1588
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 66 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
EPINEPHRINE - EPIPEN
N 019430 001 7449012 Sep 11, 2025 DP
7794432 Sep 11, 2025 DP
8048035 Sep 11, 2025 DP
8870827 Sep 11, 2025 DP
EPINEPHRINE - EPIPEN JR.
N 019430 002 7449012 Sep 11, 2025 DP
7794432 Sep 11, 2025 DP
8048035 Sep 11, 2025 DP
8870827 Sep 11, 2025 DP
EPINEPHRINE - TWINJECT 0.3
N 020800 001 7297136 Jan 18, 2025 DP
7621891 Feb 04, 2025 DP
EPINEPHRINE - TWINJECT 0.15
N 020800 002 7297136 Jan 18, 2025 DP
7621891 Feb 04, 2025 DP
EPINEPHRINE - AUVI-Q
N 201739 001 7731686 Jun 01, 2026 DP
7731690 Jan 15, 2025 DP
7749194 Oct 30, 2028 DP
7918823 Nov 23, 2024 DP
7947017 Mar 12, 2028 DP
8016788 Mar 21, 2025 DP
8021344 Nov 02, 2029 DP
8206360 Feb 27, 2027 DP
8226610 Apr 10, 2029 DP
8231573 Nov 25, 2028 DP
8313466 Nov 23, 2024 DP
8361029 Nov 23, 2024 DP
8425462 Nov 23, 2024 DP
EPINEPHRINE - AUVI-Q
N 201739 002 7731686 Jun 01, 2026 DP
7731690 Jan 15, 2025 DP
7749194 Oct 30, 2028 DP
7918823 Nov 23, 2024 DP
7947017 Mar 12, 2028 DP
8016788 Mar 21, 2025 DP
8021344 Nov 02, 2029 DP
8206360 Feb 27, 2027 DP
8226610 Apr 10, 2029 DP
8231573 Nov 25, 2028 DP
8313466 Nov 23, 2024 DP
8361029 Nov 23, 2024 DP
8425462 Nov 23, 2024 DP
EPINEPHRINE; LIDOCAINE HYDROCHLORIDE - LIDOSITE TOPICAL SYSTEM KIT
N 021504 001 6629968 Jun 30, 2020 DS DP
6635045 Jun 29, 2021 DS DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 67 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
EPLERENONE - INSPRA
N 021437 001 6410054 Dec 08, 2019 U-3
6410054 Dec 08, 2019 U-537
6410524 Nov 05, 2019 U-467
6495165 Dec 08, 2019 U-3
6495165 Dec 08, 2019 U-537
6534093 Dec 08, 2019 U-3
6534093 Dec 08, 2019 U-537
6558707 Dec 08, 2019 DP U-537
6747020 Nov 05, 2019 U-587
7157101 Dec 08, 2019 DP U-664
EPLERENONE - INSPRA
N 021437 002 6410054 Dec 08, 2019 U-3
6410054 Dec 08, 2019 U-537
6410524 Nov 05, 2019 U-467
6495165 Dec 08, 2019 U-3
6495165 Dec 08, 2019 U-537
6534093 Dec 08, 2019 U-3
6534093 Dec 08, 2019 U-537
6558707 Dec 08, 2019 DP U-537
6747020 Nov 05, 2019 U-587
7157101 Dec 08, 2019 DP U-664
EPLERENONE - INSPRA
N 021437 003 6410054 Dec 08, 2019 U-3
6410054 Dec 08, 2019 U-537
6410524 Nov 05, 2019 U-467
6495165 Dec 08, 2019 U-3
6495165 Dec 08, 2019 U-537
6534093 Dec 08, 2019 U-3
6534093 Dec 08, 2019 U-537
6558707 Dec 08, 2019 DP U-537
6747020 Nov 05, 2019 U-587
7157101 Dec 08, 2019 DP U-664
EPOPROSTENOL SODIUM - VELETRI
N 022260 001 8318802 Mar 15, 2027 DP
8598227 Feb 02, 2027
EPOPROSTENOL SODIUM - VELETRI
N 022260 002 8318802 Mar 15, 2027 DP
8598227 Feb 02, 2027
EPROSARTAN MESYLATE - TEVETEN
N 020738 004 5656650 Aug 12, 2014 U-3
EPROSARTAN MESYLATE - TEVETEN
N 020738 005 5656650 Aug 12, 2014 U-3
EPROSARTAN MESYLATE - TEVETEN
N 020738 006 5656650 Aug 12, 2014 U-3
EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE - TEVETEN HCT
N 021268 001 5656650 Aug 12, 2014 U-3
EPROSARTAN MESYLATE; HYDROCHLOROTHIAZIDE - TEVETEN HCT
N 021268 002 5656650 Aug 12, 2014 U-3
EPTIFIBATIDE - INTEGRILIN
N 020718 001 5686570 Nov 11, 2014
5747447 May 05, 2015
5756451 Nov 11, 2014
5807825 Sep 15, 2015 U-244
5968902 Jun 02, 2015 U-453
EPTIFIBATIDE - INTEGRILIN
N 020718 002 5686570 Nov 11, 2014
5747447 May 05, 2015
5756451 Nov 11, 2014
5807825 Sep 15, 2015 U-244
5968902 Jun 02, 2015 U-453
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 68 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ERIBULIN MESYLATE - HALAVEN
N 201532 001 6214865 Jun 16, 2019 DS NCE Nov 15, 2015
6469182 Jun 16, 2019 U-1096
7470720 Jun 16, 2019 DP
8097648 Jan 22, 2021 U-1096
ERLOTINIB HYDROCHLORIDE - TARCEVA
N 021743 001 5747498 Nov 08, 2018 DS DP U-659 I-671 May 14, 2016
6900221 Nov 09, 2020 DS DP U-659
6900221 Nov 09, 2020 DS DP U-875
6900221 Nov 09, 2020 DS DP U-1046
6900221 Nov 09, 2020 DS DP U-1403
7087613 Nov 09, 2020 U-659
7087613 Nov 09, 2020 U-1045
7087613 Nov 09, 2020 U-1403
RE41065 Nov 08, 2018 DS DP
ERLOTINIB HYDROCHLORIDE - TARCEVA
N 021743 002 5747498 Nov 08, 2018 DS DP U-659 I-671 May 14, 2016
6900221 Nov 09, 2020 DS DP U-659
6900221 Nov 09, 2020 DS DP U-875
6900221 Nov 09, 2020 DS DP U-1046
6900221 Nov 09, 2020 DS DP U-1403
7087613 Nov 09, 2020 U-659
7087613 Nov 09, 2020 U-1045
7087613 Nov 09, 2020 U-1403
RE41065 Nov 08, 2018 DS DP
ERLOTINIB HYDROCHLORIDE - TARCEVA
N 021743 003 5747498 Nov 08, 2018 DS DP U-659 I-671 May 14, 2016
6900221 Nov 09, 2020 DS DP U-659
6900221 Nov 09, 2020 DS DP U-875
6900221 Nov 09, 2020 DS DP U-1046
6900221 Nov 09, 2020 DS DP U-1403
7087613 Nov 09, 2020 U-659
7087613 Nov 09, 2020 U-1045
7087613 Nov 09, 2020 U-1403
RE41065 Nov 08, 2018 DS DP
ERTAPENEM SODIUM - INVANZ
N 021337 001 5478820 Nov 21, 2015 DS DP U-160
5952323 May 15, 2017 DP
ESCITALOPRAM OXALATE - LEXAPRO
N 021323 001 6916941 Aug 12, 2022 DS DP
7420069 Aug 12, 2022 DP
ESCITALOPRAM OXALATE - LEXAPRO
N 021323 002 6916941 Aug 12, 2022 DS DP
7420069 Aug 12, 2022 DP
ESCITALOPRAM OXALATE - LEXAPRO
N 021323 003 6916941 Aug 12, 2022 DS DP
7420069 Aug 12, 2022 DP
ESLICARBAZEPINE ACETATE - APTIOM
N 022416 001 5753646 Jun 27, 2016 DS DP U-1451 NCE Nov 08, 2018
8372431 Apr 17, 2030 DP
ESLICARBAZEPINE ACETATE - APTIOM
N 022416 002 5753646 Jun 27, 2016 DS DP U-1451 NCE Nov 08, 2018
8372431 Apr 17, 2030 DP
ESLICARBAZEPINE ACETATE - APTIOM
N 022416 003 5753646 Jun 27, 2016 DS DP U-1451 NCE Nov 08, 2018
8372431 Apr 17, 2030 DP
ESLICARBAZEPINE ACETATE - APTIOM
N 022416 004 5753646 Jun 27, 2016 DS DP U-1451 NCE Nov 08, 2018
8372431 Apr 17, 2030 DP
ESMOLOL HYDROCHLORIDE - BREVIBLOC IN PLASTIC CONTAINER
N 019386 004 6310094 Jan 12, 2021
6528540 Jan 12, 2021
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 69 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ESMOLOL HYDROCHLORIDE - BREVIBLOC DOUBLE STRENGTH IN PLASTIC CONTAINER
N 019386 005 6310094 Jan 12, 2021
6528540 Jan 12, 2021
ESMOLOL HYDROCHLORIDE - BREVIBLOC
N 019386 006 6310094 Jan 12, 2021
6528540 Jan 12, 2021
ESMOLOL HYDROCHLORIDE - BREVIBLOC
N 019386 007 6310094 Jan 12, 2021
6528540 Jan 12, 2021
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 70 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ESOMEPRAZOLE MAGNESIUM - NEXIUM
N 021153 001 5690960 Nov 25, 2014 DP U-373
5690960 Nov 25, 2014 DP U-729
5690960 Nov 25, 2014 DP U-770
5714504 Feb 03, 2015 DP U-373
5714504 Feb 03, 2015 DP U-729
5714504 Feb 03, 2015 DP U-770
5900424 May 04, 2016 DS U-373
5900424 May 04, 2016 DS U-729
5900424 May 04, 2016 DS U-770
6147103 Oct 09, 2018
6166213 Oct 09, 2018
6191148 Oct 09, 2018
6369085 May 25, 2018 DS DP U-729
6369085 May 25, 2018 DS DP U-770
6428810 Nov 03, 2019 DP U-469
6428810 Nov 03, 2019 DP U-729
6428810 Nov 03, 2019 DP U-770
7411070 May 25, 2018 DS
8466175 May 25, 2018 U-1417
8466175*PED Nov 25, 2018
ESOMEPRAZOLE MAGNESIUM - NEXIUM
N 021153 002 5690960 Nov 25, 2014 DP U-373
5690960 Nov 25, 2014 DP U-729
5690960 Nov 25, 2014 DP U-770
5714504 Feb 03, 2015 DP U-373
5714504 Feb 03, 2015 DP U-729
5714504 Feb 03, 2015 DP U-770
5900424 May 04, 2016 DS U-373
5900424 May 04, 2016 DS U-729
5900424 May 04, 2016 DS U-770
6147103 Oct 09, 2018
6166213 Oct 09, 2018
6191148 Oct 09, 2018
6369085 May 25, 2018 DS DP U-729
6369085 May 25, 2018 DS DP U-770
6428810 Nov 03, 2019 DP U-469
6428810 Nov 03, 2019 DP U-729
6428810 Nov 03, 2019 DP U-770
7411070 May 25, 2018 DS
8466175 May 25, 2018 U-1417
8466175*PED Nov 25, 2018
ESOMEPRAZOLE MAGNESIUM - NEXIUM
N 021957 001 5690960 Nov 25, 2014 DP U-729
5690960 Nov 25, 2014 DP U-773
5690960 Nov 25, 2014 DP U-1207
5714504 Feb 03, 2015 DP U-729
5714504 Feb 03, 2015 DP U-773
5714504 Feb 03, 2015 DP U-1207
5900424 May 04, 2016 DS U-729
5900424 May 04, 2016 DS U-773
5900424 May 04, 2016 DS U-1207
6369085 May 25, 2018 DS DP U-729
6369085 May 25, 2018 DS DP U-773
6369085 May 25, 2018 DS DP U-1207
6428810 Nov 03, 2019 DP U-729
6428810 Nov 03, 2019 DP U-773
6428810 Nov 03, 2019 DP U-1207
7411070 May 25, 2018 DS
8466175 May 25, 2018 U-1417
8466175*PED Nov 25, 2018
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 71 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ESOMEPRAZOLE MAGNESIUM - NEXIUM
N 021957 002 5690960 Nov 25, 2014 DP U-729
5690960 Nov 25, 2014 DP U-773
5690960 Nov 25, 2014 DP U-1207
5714504 Feb 03, 2015 DP U-729
5714504 Feb 03, 2015 DP U-773
5714504 Feb 03, 2015 DP U-1207
5900424 May 04, 2016 DS U-729
5900424 May 04, 2016 DS U-773
5900424 May 04, 2016 DS U-1207
6369085 May 25, 2018 DS DP U-729
6369085 May 25, 2018 DS DP U-773
6369085 May 25, 2018 DS DP U-1207
6428810 Nov 03, 2019 DP U-729
6428810 Nov 03, 2019 DP U-773
6428810 Nov 03, 2019 DP U-1207
7411070 May 25, 2018 DS
8466175 May 25, 2018 U-1417
8466175*PED Nov 25, 2018
ESOMEPRAZOLE MAGNESIUM - NEXIUM
N 021957 003 5690960 Nov 25, 2014 DP U-1207
5714504 Feb 03, 2015 DP U-1207
5900424 May 04, 2016 DS U-1207
6369085 May 25, 2018 DS DP U-1207
6428810 Nov 03, 2019 DP U-1207
7411070 May 25, 2018 DS
ESOMEPRAZOLE MAGNESIUM - NEXIUM
N 021957 004 5690960 Nov 25, 2014 DP U-1207
5714504 Feb 03, 2015 DP U-1207
5900424 May 04, 2016 DS U-1207
6369085 May 25, 2018 DS DP U-1207
6428810 Nov 03, 2019 DP U-1207
7411070 May 25, 2018 DS
ESOMEPRAZOLE MAGNESIUM - NEXIUM
N 022101 001 5690960 Nov 25, 2014 DP U-858
5714504 Feb 03, 2015 DP U-858
5900424 May 04, 2016 DS U-858
6369085 May 25, 2018 DS DP U-858
6428810 Nov 03, 2019 DP U-858
7411070 May 25, 2018 DS
ESOMEPRAZOLE MAGNESIUM - NEXIUM 24HR
N 204655 001 5690960 Nov 25, 2014 DP U-1509 RTO Mar 28, 2017
5714504 Feb 03, 2015 DP U-1509
5900424 May 04, 2016 DS U-1509
6369085 May 25, 2018 DS DP U-1509
6428810 Nov 03, 2019 DP U-1509
7411070 May 25, 2018 DS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 72 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ESOMEPRAZOLE MAGNESIUM; NAPROXEN - VIMOVO
N 022511 001 5714504 Feb 03, 2015 DP U-1053
5900424 May 04, 2016 DS U-1053
6369085 May 25, 2018 DS DP U-1053
6926907 Feb 28, 2023 DP U-1052
7411070 May 25, 2018 DS U-1053
7745466 Oct 13, 2018 DP U-1053
8557285 May 31, 2022 DP
8852636 May 31, 2022 DP U-1052
8858996 May 31, 2022 DP U-1052
ESOMEPRAZOLE MAGNESIUM; NAPROXEN - VIMOVO
N 022511 002 5714504 Feb 03, 2015 DP U-1053
5900424 May 04, 2016 DS U-1053
6369085 May 25, 2018 DS DP U-1053
6926907 Feb 28, 2023 DP U-1052
7411070 May 25, 2018 DS U-1053
7745466 Oct 13, 2018 DP U-1053
8557285 May 31, 2022 DP
8852636 May 31, 2022 DP U-1052
8858996 May 31, 2022 DP U-1052
ESOMEPRAZOLE SODIUM - NEXIUM IV
N 021689 001 5877192*PED Nov 27, 2014 D-138 Mar 04, 2017
6143771 May 27, 2015 DP U-643 I-679 Mar 04, 2017
6143771 May 27, 2015 DP U-1495
ESOMEPRAZOLE SODIUM - NEXIUM IV
N 021689 002 5877192*PED Nov 27, 2014 D-138 Mar 04, 2017
6143771 May 27, 2015 DP U-643 I-679 Mar 04, 2017
6143771 May 27, 2015 DP U-1495
ESTRADIOL - VIVELLE-DOT
N 020538 005 5656286 Aug 12, 2014
ESTRADIOL - VIVELLE-DOT
N 020538 006 5656286 Aug 12, 2014
ESTRADIOL - VIVELLE-DOT
N 020538 007 5656286 Aug 12, 2014
ESTRADIOL - VIVELLE-DOT
N 020538 008 5656286 Aug 12, 2014
ESTRADIOL - VIVELLE-DOT
N 020538 009 5656286 Aug 12, 2014 DP
ESTRADIOL - VAGIFEM
N 020908 002 5860946 Jul 01, 2017 DP
7018992 Sep 17, 2022 U-1023
ESTRADIOL - MENOSTAR
N 021674 001 5891868 Nov 21, 2017 DP U-594
6692763 Nov 21, 2017 DP U-594
ESTRADIOL - ELESTRIN
N 021813 001 7198801 Jun 25, 2022 DP
7470433 Aug 03, 2021 DP
ESTRADIOL - EVAMIST
N 022014 001 6299900 Feb 19, 2017 DP U-888
6299900 Feb 19, 2017 DP U-889
6818226 Feb 19, 2017 DP U-888
6818226 Feb 19, 2017 DP U-889
6923983 Feb 19, 2017 DP U-888
6923983 Feb 19, 2017 DP U-889
6978945 Jul 31, 2022 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 73 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ESTRADIOL - MINIVELLE
N 203752 001 5656286 Aug 12, 2014 DS DP
6841716 Apr 27, 2020 DP
8231906 Jul 04, 2030 DS DP
ESTRADIOL - MINIVELLE
N 203752 002 5656286 Aug 12, 2014 DS DP
6841716 Apr 27, 2020 DP
8231906 Jul 04, 2030 DS DP
ESTRADIOL - MINIVELLE
N 203752 003 5656286 Aug 12, 2014 DS DP
6841716 Apr 27, 2020 DP
8231906 Jul 04, 2030 DS DP
ESTRADIOL - MINIVELLE
N 203752 004 5656286 Aug 12, 2014 DS DP
6841716 Apr 27, 2020 DP
8231906 Jul 04, 2030 DS DP
ESTRADIOL ACETATE - FEMRING
N 021367 001 5855906 Dec 19, 2015 U-508
ESTRADIOL ACETATE - FEMRING
N 021367 002 5855906 Dec 19, 2015 U-508
ESTRADIOL ACETATE - FEMTRACE
N 021633 001 6962908 Dec 21, 2021 DP
7572779 Oct 02, 2025 U-904
7799771 Dec 21, 2021 DP
ESTRADIOL ACETATE - FEMTRACE
N 021633 002 6962908 Dec 21, 2021 DP
7572779 Oct 02, 2025 U-904
7799771 Dec 21, 2021 DP
ESTRADIOL ACETATE - FEMTRACE
N 021633 003 6962908 Dec 21, 2021 DP
7572779 Oct 02, 2025 U-904
7799771 Dec 21, 2021 DP
ESTRADIOL HEMIHYDRATE - ESTRASORB
N 021371 001 5629021 Jan 31, 2015 DP
ESTRADIOL; ESTRADIOL; NORGESTIMATE - PREFEST
N 021040 001 6747019 Mar 20, 2020 U-311
7320970 Mar 30, 2020 DP U-844
ESTRADIOL; LEVONORGESTREL - CLIMARA PRO
N 021258 001 5676968 Oct 14, 2014 DP
ESTRADIOL; NORETHINDRONE ACETATE - COMBIPATCH
N 020870 001 5656286 Aug 12, 2014
ESTRADIOL; NORETHINDRONE ACETATE - COMBIPATCH
N 020870 002 5656286 Aug 12, 2014
ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN
N 020992 001 5908638 Jul 26, 2015 DP
ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN
N 020992 002 5908638 Jul 26, 2015
ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN
N 020992 003 5908638 Jul 26, 2015
ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN
N 020992 004 5908638 Jul 26, 2015
ESTROGENS, CONJUGATED SYNTHETIC A - CENESTIN
N 020992 005 5908638 Jul 26, 2015
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 74 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA
N 021443 001 6660726 Mar 08, 2021 DS DP U-904
6660726 Mar 08, 2021 DS DP U-905
6855703 Feb 12, 2021 DS DP U-904
6855703 Feb 12, 2021 DS DP U-905
ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA
N 021443 002 6660726 Mar 08, 2021 DS DP U-904
6660726 Mar 08, 2021 DS DP U-905
6855703 Feb 12, 2021 DS DP U-904
6855703 Feb 12, 2021 DS DP U-905
ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA
N 021443 003 6660726 Mar 08, 2021 DS DP U-904
6660726 Mar 08, 2021 DS DP U-905
6855703 Feb 12, 2021 DS DP U-904
6855703 Feb 12, 2021 DS DP U-905
ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA
N 021443 004 6660726 Mar 08, 2021 DS DP U-904
6660726 Mar 08, 2021 DS DP U-905
6855703 Feb 12, 2021 DS DP U-904
6855703 Feb 12, 2021 DS DP U-905
ESTROGENS, CONJUGATED SYNTHETIC B - ENJUVIA
N 021443 005 6660726 Mar 08, 2021 DS DP U-904
6660726 Mar 08, 2021 DS DP U-905
6855703 Feb 12, 2021 DS DP U-904
6855703 Feb 12, 2021 DS DP U-905
ESTROGENS, CONJUGATED; ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPHASE 14/14
N 020527 002 5547948 Jan 17, 2015
ESTROGENS, CONJUGATED; ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE; MEDROXYPROGESTERONE ACETATE -
PREMPRO
N 020527 001 5547948 Jan 17, 2015
ESTROGENS, CONJUGATED; ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE; MEDROXYPROGESTERONE ACETATE -
PREMPRO
N 020527 003 5547948 Jan 17, 2015
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPRO
N 020527 004 5547948 Jan 17, 2015
ESTROGENS, CONJUGATED; MEDROXYPROGESTERONE ACETATE - PREMPRO
N 020527 005 5547948 Jan 17, 2015
ESZOPICLONE - LUNESTA
N 021476 001 M-61 Oct 10, 2015
PED Apr 10, 2016
ESZOPICLONE - LUNESTA
N 021476 002 M-61 Oct 10, 2015
PED Apr 10, 2016
ESZOPICLONE - LUNESTA
N 021476 003 M-61 Oct 10, 2015
PED Apr 10, 2016
ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; NORGESTIMATE; NORGESTIMATE; NORGESTIMATE - ORTHO
TRI-CYCLEN LO
N 021241 001 6214815 Jun 09, 2019 U-112
ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; LEVONORGESTREL - SEASONIQUE
N 021840 001 7320969 Jan 30, 2024 U-828
7615545 Jun 15, 2023 U-1
7855190 Dec 05, 2028 U-1
7858605 Jun 23, 2023 DP
ETHINYL ESTRADIOL; ETHINYL ESTRADIOL; LEVONORGESTREL - LOSEASONIQUE
N 022262 001 7615545 Jun 15, 2023 U-1
7855190 Dec 05, 2028 U-1
7858605 Jun 23, 2023 DP
ETHINYL ESTRADIOL; ETONOGESTREL - NUVARING
N 021187 001 5989581 Apr 08, 2018
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 75 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ETHINYL ESTRADIOL; LEVONORGESTREL - PREVEN EMERGENCY CONTRACEPTIVE KIT
N 020946 001 6156742 Dec 05, 2020 U-374
ETHINYL ESTRADIOL; LEVONORGESTREL - SEASONALE
N 021544 001 5898032 Jun 23, 2017 U-1
RE39861 Jun 23, 2017 U-828
ETHINYL ESTRADIOL; LEVONORGESTREL - LYBREL
N 021864 001 6500814 Sep 03, 2018 U-1
ETHINYL ESTRADIOL; LEVONORGESTREL - QUARTETTE
N 204061 001 8415332 Mar 11, 2029 DP NP Mar 28, 2016
8450299 Oct 07, 2025 U-1
ETHINYL ESTRADIOL; NORELGESTROMIN - ORTHO EVRA
N 021180 001 5876746 Nov 20, 2015 DP U-514
5972377 Jun 07, 2015 U-514
ETHINYL ESTRADIOL; NORETHINDRONE - FEMCON FE
N 021490 001 6667050 Apr 06, 2019 DP U-1
ETHINYL ESTRADIOL; NORETHINDRONE - NORETHINDRONE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
N 022573 001 5552394 Jul 22, 2014 U-828
6667050 Apr 06, 2019 DP U-828
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - LOESTRIN 24 FE
N 021871 001 5552394 Jul 22, 2014 U-1
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - LO LOESTRIN FE
N 022501 001 5552394 Jul 22, 2014 U-1090
7704984 Feb 02, 2029 U-1090
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - MINASTRIN 24 FE
N 203667 001 5552394 Jul 22, 2014 U-1 NDF May 08, 2016
6667050 Apr 06, 2019 DP U-1
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - NORETHINDRONE ACETATE AND ETHINYL ESTRADIOL AND FERROUS FUMARATE
N 204426 001 5552394 Jul 22, 2014 U-1
6652880 Mar 29, 2020 DP
ETHINYL ESTRADIOL; NORETHINDRONE ACETATE - LO MINASTRIN FE
N 204654 001 5552394 Jul 22, 2014 U-1
6667050 Apr 06, 2019 DP U-1
7704984 Feb 02, 2029 U-1
ETHIODIZED OIL - LIPIODOL
N 009190 001 ODE Apr 04, 2021
ETONOGESTREL - NEXPLANON
N 021529 002 8722037 Sep 28, 2027 DP
8888745 Aug 28, 2026 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 76 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
PATENT
PATENT
EXCLUSIVITY
NO PATENT NO
EXPIRATION
PATENT DELIST
EXCLUSIVITY EXPIRATION
DATE
CODES REQUESTED
CODE(S) DATE
ETRAVIRINE - INTELENCE
N 022187 001 6878717
Nov 05, 2019
U-256
NPP Mar 26, 2015
6878717
Nov 05, 2019
U-1016
6878717
Nov 05, 2019
U-1237
7037917
Dec 13, 2020
DS DP U-256
7037917
Dec 13, 2020
DS DP U-1016
7037917
Dec 13, 2020
DS DP U-1237
7887845
Mar 25, 2019
DP
8003789
Nov 01, 2019
DS DP
ETRAVIRINE - INTELENCE
N 022187 002 6878717
Nov 05, 2019
U-256
NPP Mar 26, 2015
6878717
Nov 05, 2019
U-1016
6878717
Nov 05, 2019
U-1237
7037917
Dec 13, 2020
DS DP U-256
7037917
Dec 13, 2020
DS DP U-1016
7037917
Dec 13, 2020
DS DP U-1237
7887845
Mar 25, 2019
DP
8003789
Nov 01, 2019
DS DP
ETRAVIRINE - INTELENCE
N 022187 003 6878717
Nov 05, 2019
U-256
NPP Mar 26, 2015
6878717
Nov 05, 2019
U-1016
6878717
Nov 05, 2019
U-1237
7037917
Dec 13, 2020
DS DP U-1237
7887845
Mar 25, 2019
DP
8003789
Nov 01, 2019
DS DP
EVEROLIMUS - ZORTRESS
N 021560 001 5665772
Sep 09, 2019
DS DP U-1049
I-668 Feb 15, 2016
5665772
Sep 09, 2019
DS DP U-1365
PED Sep 30, 2014
5665772*PED
Mar 09, 2020
6004973
Jul 12, 2016
DP U-1049
6004973
Jul 12, 2016
DP U-1365
6004973*PED
Jan 12, 2017
6239124
Aug 11, 2017
U-1049
6455518
Jul 29, 2017
U-1049
6455518
Jul 29, 2017
U-1365
6455518*PED
Jan 29, 2018
EVEROLIMUS - ZORTRESS
N 021560 002 5665772
Sep 09, 2019
DS DP U-1049
I-668 Feb 15, 2016
5665772
Sep 09, 2019
DS DP U-1365
PED Sep 30, 2014
5665772*PED
Mar 09, 2020
6004973
Jul 12, 2016
DP U-1049
6004973
Jul 12, 2016
DP U-1365
6004973*PED
Jan 12, 2017
6239124
Aug 11, 2017
U-1049
6455518
Jul 29, 2017
U-1049
6455518
Jul 29, 2017
U-1365
6455518*PED
Jan 29, 2018
EVEROLIMUS - ZORTRESS
N 021560 003 5665772
Sep 09, 2019
DS DP U-1049
I-668 Feb 15, 2016
5665772
Sep 09, 2019
DS DP U-1365
PED Sep 30, 2014
5665772*PED
Mar 09, 2020
6004973
Jul 12, 2016
DP U-1049
6004973
Jul 12, 2016
DP U-1365
6004973*PED
Jan 12, 2017
6239124
Aug 11, 2017
U-1049
6455518
Jul 29, 2017
U-1049
6455518
Jul 29, 2017
U-1365
6455518*PED
Jan 29, 2018
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 77 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
PATENT
PATENT EXCLUSIVITY
NO PATENT NO
EXPIRATION
PATENT DELIST EXCLUSIVITY EXPIRATION
DATE
CODES REQUESTED CODE(S) DATE
EVEROLIMUS - AFINITOR
N 022334 001 5665772
Sep 09, 2019
DS DP I-650 Apr 26, 2015
6004973
Jul 12, 2016
DP I-655 Jul 20, 2015
7297703
Dec 06, 2019
DP ODE Oct 29, 2017
7741338
Dec 06, 2019
DP ODE May 05, 2018
8410131
May 22, 2025
DS DP U-1368 ODE Apr 26, 2019
8410131*PED
Nov 22, 2025
PED Sep 30, 2014
8436010
Feb 22, 2022
DS DP U-1396 PED Nov 05, 2014
8436010*PED
Aug 22, 2022
PED Oct 26, 2015
8778962
Feb 18, 2022
U-1541 PED Apr 29, 2018
8778962*PED
Aug 18, 2022
PED Nov 05, 2018
PED Oct 26, 2019
EVEROLIMUS - AFINITOR
N 022334 002 5665772
Sep 09, 2019
DS DP I-650 Apr 26, 2015
6004973
Jul 12, 2016
DP I-655 Jul 20, 2015
7297703
Dec 06, 2019
DP ODE Oct 29, 2017
7741338
Dec 06, 2019
DP ODE May 05, 2018
8410131
May 22, 2025
DS DP U-1368 ODE Apr 26, 2019
8410131*PED
Nov 22, 2025
PED Sep 30, 2014
8436010
Feb 22, 2022
DS DP U-1396 PED Nov 05, 2014
8436010*PED
Aug 22, 2022
PED Oct 26, 2015
8778962
Feb 18, 2022
U-1541 PED Apr 29, 2018
8778962*PED
Aug 18, 2022
PED Nov 05, 2018
PED Oct 26, 2019
EVEROLIMUS - AFINITOR
N 022334 003 5665772
Sep 09, 2019
DS DP I-650 Apr 26, 2015
6004973
Jul 12, 2016
DP I-655 Jul 20, 2015
7297703
Dec 06, 2019
DP ODE Oct 29, 2017
7741338
Dec 06, 2019
DP ODE May 05, 2018
8410131
May 22, 2025
DS DP U-1368 ODE Apr 26, 2019
8410131*PED
Nov 22, 2025
PED Sep 30, 2014
8436010
Feb 22, 2022
DS DP U-1396 PED Nov 05, 2014
8436010*PED
Aug 22, 2022
PED Oct 26, 2015
8778962
Feb 18, 2022
U-1541 PED Apr 29, 2018
8778962*PED
Aug 18, 2022
PED Nov 05, 2018
PED Oct 26, 2019
EVEROLIMUS - AFINITOR
N 022334 004 5665772
Sep 09, 2019
DS DP I-650 Apr 26, 2015
6004973
Jul 12, 2016
DP I-655 Jul 20, 2015
7297703
Dec 06, 2019
DP ODE Oct 29, 2017
7741338
Dec 06, 2019
DP ODE May 05, 2018
8410131
May 22, 2025
DS DP U-1368 ODE Apr 26, 2019
8410131*PED
Nov 22, 2025
PED Sep 30, 2014
8436010
Feb 22, 2022
DS DP U-1396 PED Nov 05, 2014
8436010*PED
Aug 22, 2022
PED Oct 26, 2015
8778962
Feb 18, 2022
U-1541 PED Apr 29, 2018
8778962*PED
Aug 18, 2022
PED Nov 05, 2018
PED Oct 26, 2019
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 78 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
EVEROLIMUS - AFINITOR DISPERZ
N 203985 001 5665772 Sep 09, 2019 DS DP ODE Oct 29, 2017
6004973 Jul 12, 2016 DP PED Sep 30, 2014
7297703 Dec 06, 2019 DP PED Apr 29, 2018
8617598 Sep 27, 2022 DP
8617598*PED Mar 27, 2023
8778962 Feb 18, 2022 U-1541
8778962*PED Aug 18, 2022
EVEROLIMUS - AFINITOR DISPERZ
N 203985 002 5665772 Sep 09, 2019 DS DP ODE Oct 29, 2017
6004973 Jul 12, 2016 DP PED Sep 30, 2014
7297703 Dec 06, 2019 DP PED Apr 29, 2018
8617598 Sep 27, 2022 DP
8617598*PED Mar 27, 2023
8778962 Feb 18, 2022 U-1541
8778962*PED Aug 18, 2022
EVEROLIMUS - AFINITOR DISPERZ
N 203985 003 5665772 Sep 09, 2019 DS DP ODE Oct 29, 2017
6004973 Jul 12, 2016 DP PED Sep 30, 2014
7297703 Dec 06, 2019 DP PED Apr 29, 2018
8617598 Sep 27, 2022 DP
8617598*PED Mar 27, 2023
8778962 Feb 18, 2022 U-1541
8778962*PED Aug 18, 2022
EXENATIDE SYNTHETIC - BYETTA
N 021773 001 5424286 Dec 01, 2016 U-653 M-111 Oct 19, 2014
5424286 Dec 01, 2016 U-1108 M-113 Oct 19, 2014
6858576 Jan 06, 2017 U-656 M-148 Nov 24, 2017
6858576 Jan 06, 2017 U-1108
6872700 Jan 14, 2020 U-654
6902744 Jan 14, 2020 DP
6956026 Jan 07, 2018 U-687
6956026 Jan 07, 2018 U-1074
6956026 Jan 07, 2018 U-1623
7297761 Oct 15, 2017 DP
7521423 Oct 15, 2017 DP
7741269 Jan 07, 2018 U-653
7741269 Jan 07, 2018 U-1074
7741269 Jan 07, 2018 U-1108
EXENATIDE SYNTHETIC - BYETTA
N 021773 002 5424286 Dec 01, 2016 U-653 M-111 Oct 19, 2014
5424286 Dec 01, 2016 U-1108 M-113 Oct 19, 2014
6858576 Jan 06, 2017 U-656 M-148 Nov 24, 2017
6858576 Jan 06, 2017 U-1108
6872700 Jan 14, 2020 U-654
6902744 Jan 14, 2020 DP
6956026 Jan 07, 2018 U-687
6956026 Jan 07, 2018 U-1074
6956026 Jan 07, 2018 U-1623
7297761 Oct 15, 2017 DP
7521423 Oct 15, 2017 DP
7741269 Jan 07, 2018 U-653
7741269 Jan 07, 2018 U-1074
7741269 Jan 07, 2018 U-1108
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 79 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
EXENATIDE SYNTHETIC - BYDUREON
N 022200 001 5424286 Dec 01, 2016 U-1108 NP Jan 27, 2015
6479065 Aug 10, 2020 DP
6495164 May 25, 2020 DP
6667061 May 25, 2020 DP
6824822 Oct 09, 2022 DP
6858576 Jan 06, 2017 U-656
6872700 Jan 14, 2020 U-654
6956026 Jan 07, 2018 U-687
7223440 Aug 31, 2021 DP
7456254 Jun 30, 2025 DP U-1223
7563871 Apr 15, 2024 DP
7612176 Apr 13, 2025 DP U-1223
7741269 Jan 07, 2018 U-1224
8216180 Jan 12, 2028 DP
8329648 Aug 18, 2026 U-1313
8431685 Apr 13, 2025 DP U-412
8439864 Mar 25, 2028 DP
8461105 Apr 13, 2025 DP U-412
8906851 Aug 18, 2026 U-1313
EZETIMIBE - ZETIA
N 021445 001 7030106 Jan 25, 2022 DP M-109 Jan 24, 2015
7612058 Oct 30, 2025 U-1027
7612058 Oct 30, 2025 U-1173
7612058*PED Apr 30, 2026
RE37721 Oct 25, 2016 DS DP U-473
RE42461 Oct 25, 2016 DS DP U-473
RE42461 Oct 25, 2016 DS DP U-1173
EZETIMIBE; SIMVASTATIN - VYTORIN
N 021687 001 RE37721 Oct 25, 2016 DS DP U-473 M-109 Jan 24, 2015
RE42461 Oct 25, 2016 DS DP U-473
EZETIMIBE; SIMVASTATIN - VYTORIN
N 021687 002 RE37721 Oct 25, 2016 DS DP U-473 M-109 Jan 24, 2015
RE42461 Oct 25, 2016 DS DP U-473
EZETIMIBE; SIMVASTATIN - VYTORIN
N 021687 003 RE37721 Oct 25, 2016 DS DP U-473 M-109 Jan 24, 2015
RE42461 Oct 25, 2016 DS DP U-473
EZETIMIBE; SIMVASTATIN - VYTORIN
N 021687 004 RE37721 Oct 25, 2016 DS DP U-473 M-109 Jan 24, 2015
RE42461 Oct 25, 2016 DS DP U-473
EZOGABINE - POTIGA
N 022345 001 NCE Jun 10, 2016
EZOGABINE - POTIGA
N 022345 002 NCE Jun 10, 2016
EZOGABINE - POTIGA
N 022345 003 NCE Jun 10, 2016
EZOGABINE - POTIGA
N 022345 004 NCE Jun 10, 2016
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 80 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FAMCICLOVIR - FAMVIR
N 020363 001 5840763 Sep 01, 2015 U-96 M-112 Feb 09, 2015
5866581 Oct 04, 2014 U-96
5916893 Sep 01, 2015 U-96
6124304 Oct 04, 2014 U-96
FAMCICLOVIR - FAMVIR
N 020363 002 5840763 Sep 01, 2015 U-96 M-112 Feb 09, 2015
5866581 Oct 04, 2014 U-96
5916893 Sep 01, 2015 U-96
6124304 Oct 04, 2014 U-96
FAMCICLOVIR - FAMVIR
N 020363 003 5840763 Sep 01, 2015 U-96 M-112 Feb 09, 2015
5866581 Oct 04, 2014 U-96
5916893 Sep 01, 2015 U-96
6124304 Oct 04, 2014 U-96
FAMOTIDINE - PEPCID AC
N 020325 001 5854267 Dec 29, 2015 U-267
FAMOTIDINE - PEPCID AC
N 020801 001 5667794 May 02, 2015 Y
5854267 Dec 29, 2015 U-267
FAMOTIDINE - PEPCID AC
N 020801 002 6814978 Aug 26, 2021 DP
FAMOTIDINE - PEPCID AC
N 020902 001 5854267 Dec 29, 2015 U-368
FAMOTIDINE - FLUXID
N 021712 001 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
FAMOTIDINE - FLUXID
N 021712 002 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
FAMOTIDINE; IBUPROFEN - DUEXIS
N 022519 001 8067033 Jul 18, 2026 DP
8067451 Jul 18, 2026 DP U-1196
8309127 Jul 18, 2026 DP
8318202 Jul 18, 2026 DP
8449910 Jul 18, 2026 DP
8501228 Jul 18, 2026 U-1196
FEBUXOSTAT - ULORIC
N 021856 001 5614520 Mar 25, 2019 DS DP U-954
6225474 Jun 18, 2019 DS
7361676 Mar 08, 2024 DP
8372872 Sep 08, 2031 U-1346
FEBUXOSTAT - ULORIC
N 021856 002 5614520 Mar 25, 2019 DS DP U-954
6225474 Jun 18, 2019 DS
7361676 Mar 08, 2024 DP
8372872 Sep 08, 2031 U-1346
FENOFIBRATE - TRICOR
N 021203 001 6074670 Jan 09, 2018
6277405 Jan 09, 2018
6589552 Jan 09, 2018
6652881 Jan 09, 2018 DP
7037529 Jan 09, 2018 DP
7041319 Jan 09, 2018 DP
FENOFIBRATE - TRICOR
N 021203 003 6074670 Jan 09, 2018
6277405 Jan 09, 2018
6589552 Jan 09, 2018
6652881 Jan 09, 2018 DP
7037529 Jan 09, 2018 DP
7041319 Jan 09, 2018 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 81 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FENOFIBRATE - TRIGLIDE
N 021350 001 6696084 Sep 11, 2021 DS DP U-680
FENOFIBRATE - TRIGLIDE
N 021350 002 6696084 Sep 11, 2021 DS DP U-680
FENOFIBRATE - LIPOFEN
N 021612 001 5545628 Jan 10, 2015 DP U-701
FENOFIBRATE - LIPOFEN
N 021612 002 5545628 Jan 10, 2015 DP U-701
FENOFIBRATE - LIPOFEN
N 021612 003 5545628 Jan 10, 2015 DP U-701
FENOFIBRATE - TRICOR
N 021656 001 6277405 Jan 09, 2018 DS
6375986 Sep 21, 2020 DP U-615
6652881 Jan 09, 2018 DS
7037529 Jan 09, 2018 DP
7041319 Jan 09, 2018 DP
7276249 Feb 21, 2023 DP
7320802 Feb 21, 2023 U-847
FENOFIBRATE - TRICOR
N 021656 002 6277405 Jan 09, 2018 DS
6375986 Sep 21, 2020 DP U-615
6652881 Jan 09, 2018 DS
7037529 Jan 09, 2018 DP
7041319 Jan 09, 2018 DP
7276249 Feb 21, 2023 DP
7320802 Feb 21, 2023 U-847
FENOFIBRATE - ANTARA (MICRONIZED)
N 021695 001 7101574 Aug 20, 2020 DS DP
7863331 Aug 08, 2020 U-1106
7863331 Aug 08, 2020 U-1107
FENOFIBRATE - ANTARA (MICRONIZED)
N 021695 003 7101574 Aug 20, 2020 DS DP
7863331 Aug 08, 2020 U-1106
7863331 Aug 08, 2020 U-1107
FENOFIBRATE - ANTARA (MICRONIZED)
N 021695 004 8026281 Apr 22, 2025 U-1447
8026281 Apr 22, 2025 U-1448
FENOFIBRATE - ANTARA (MICRONIZED)
N 021695 005 8026281 Apr 22, 2025 U-1447
8026281 Apr 22, 2025 U-1448
FENOFIBRATE - FENOGLIDE
N 022118 001 7658944 Dec 09, 2024 DP
8124125 Oct 01, 2024 DP U-1234
8481078 Oct 01, 2024 DP U-1416
FENOFIBRATE - FENOGLIDE
N 022118 002 7658944 Dec 09, 2024 DP
8124125 Oct 01, 2024 DP U-1234
8481078 Oct 01, 2024 DP U-1416
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 82 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FENOFIBRIC ACID - FIBRICOR
N 022418 001 7569612 Aug 20, 2027 U-1000
7741373 Aug 20, 2027 U-1059
7741374 Aug 20, 2027 U-1060
7741374 Aug 20, 2027 U-1061
7915247 Aug 20, 2027 U-1000
7915247 Aug 20, 2027 U-1059
7915247 Aug 20, 2027 U-1061
FENOFIBRIC ACID - FIBRICOR
N 022418 002 7569612 Aug 20, 2027 U-1000
7741373 Aug 20, 2027 U-1059
7741374 Aug 20, 2027 U-1060
7741374 Aug 20, 2027 U-1061
7915247 Aug 20, 2027 U-1000
7915247 Aug 20, 2027 U-1059
7915247 Aug 20, 2027 U-1061
FENTANYL - SUBSYS
N 202788 001 8486972 Apr 27, 2030 DP NP Jan 04, 2015
8486973 Apr 27, 2030 U-55
8835459 Jan 25, 2027 DP
8835460 Jan 25, 2027 DP U-55
FENTANYL - SUBSYS
N 202788 002 8486972 Apr 27, 2030 DP NP Jan 04, 2015
8486973 Apr 27, 2030 U-55
8835460 Jan 25, 2027 DP U-55
FENTANYL - SUBSYS
N 202788 003 8486972 Apr 27, 2030 DP NP Jan 04, 2015
8486973 Apr 27, 2030 U-55
8835459 Jan 25, 2027 DP
8835460 Jan 25, 2027 DP U-55
FENTANYL - SUBSYS
N 202788 004 8486972 Apr 27, 2030 DP NP Jan 04, 2015
8486973 Apr 27, 2030 U-55
8835459 Jan 25, 2027 DP
8835460 Jan 25, 2027 DP U-55
FENTANYL - SUBSYS
N 202788 005 8486972 Apr 27, 2030 DP NP Jan 04, 2015
8486973 Apr 27, 2030 U-55
8835460 Jan 25, 2027 DP U-55
FENTANYL - SUBSYS
N 202788 006 8486972 Apr 27, 2030 DP NP Jan 04, 2015
8486973 Apr 27, 2030 U-55
8835459 Jan 25, 2027 DP
8835460 Jan 25, 2027 DP U-55
FENTANYL - SUBSYS
N 202788 007 8486972 Apr 27, 2030 DP NP Jan 04, 2015
8486973 Apr 27, 2030 U-55
8835459 Jan 25, 2027 DP
8835460 Jan 25, 2027 DP U-55
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 83 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FENTANYL CITRATE - FENTORA
N 021947 001 6200604 Mar 26, 2019 U-767
6974590 Mar 26, 2019 U-767
7862832 Jun 15, 2028 DP
7862833 Jun 15, 2028 DP
8092832 Dec 30, 2024 DP
8728441 Mar 26, 2019 U-1514
8753611 Mar 26, 2019 U-1514
8765100 Mar 26, 2019 DP
FENTANYL CITRATE - FENTORA
N 021947 002 6200604 Mar 26, 2019 U-767
6974590 Mar 26, 2019 U-767
7862832 Jun 15, 2028 DP
7862833 Jun 15, 2028 DP
8092832 Dec 30, 2024 DP
8119158 Dec 30, 2024 DP
8728441 Mar 26, 2019 U-1514
8753611 Mar 26, 2019 U-1514
8765100 Mar 26, 2019 DP
FENTANYL CITRATE - FENTORA
N 021947 003 6200604 Mar 26, 2019 U-767
6974590 Mar 26, 2019 U-767
7862832 Jun 15, 2028 DP
7862833 Jun 15, 2028 DP
8092832 Dec 30, 2024 DP
8119158 Dec 30, 2024 DP
8728441 Mar 26, 2019 U-1514
8753611 Mar 26, 2019 U-1514
8765100 Mar 26, 2019 DP
FENTANYL CITRATE - FENTORA
N 021947 004 6200604 Mar 26, 2019 U-767
6974590 Mar 26, 2019 U-767
7862832 Jun 15, 2028 DP
7862833 Jun 15, 2028 DP
8092832 Dec 30, 2024 DP
8119158 Dec 30, 2024 DP
8728441 Mar 26, 2019 U-1514
8753611 Mar 26, 2019 U-1514
8765100 Mar 26, 2019 DP
FENTANYL CITRATE - FENTORA
N 021947 005 6200604 Mar 26, 2019 U-767
6974590 Mar 26, 2019 U-767
7862832 Jun 15, 2028 DP
7862833 Jun 15, 2028 DP
8092832 Dec 30, 2024 DP
8119158 Dec 30, 2024 DP
8728441 Mar 26, 2019 U-1514
8753611 Mar 26, 2019 U-1514
8765100 Mar 26, 2019 DP
FENTANYL CITRATE - FENTORA
N 021947 006 6200604 Mar 26, 2019 U-767
6974590 Mar 26, 2019 U-767
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 84 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FENTANYL CITRATE - ONSOLIS
N 022266 001 6159498 Oct 18, 2016 DP
7579019 Jan 22, 2020 U-767
FENTANYL CITRATE - ONSOLIS
N 022266 002 6159498 Oct 18, 2016 DP
7579019 Jan 22, 2020 U-767
FENTANYL CITRATE - ONSOLIS
N 022266 003 6159498 Oct 18, 2016 DP
7579019 Jan 22, 2020 U-767
FENTANYL CITRATE - ONSOLIS
N 022266 004 6159498 Oct 18, 2016 DP
7579019 Jan 22, 2020 U-767
FENTANYL CITRATE - ONSOLIS
N 022266 005 6159498 Oct 18, 2016 DP
7579019 Jan 22, 2020 U-767
FENTANYL CITRATE - ABSTRAL
N 022510 001 6759059 Sep 24, 2019 DP U-767
6761910 Sep 24, 2019 DP U-767
7910132 Sep 24, 2019 DP U-767
FENTANYL CITRATE - ABSTRAL
N 022510 002 6759059 Sep 24, 2019 DP U-767
6761910 Sep 24, 2019 DP U-767
7910132 Sep 24, 2019 DP U-767
FENTANYL CITRATE - ABSTRAL
N 022510 003 6759059 Sep 24, 2019 DP U-767
6761910 Sep 24, 2019 DP U-767
7910132 Sep 24, 2019 DP U-767
FENTANYL CITRATE - ABSTRAL
N 022510 004 6759059 Sep 24, 2019 DP U-767
6761910 Sep 24, 2019 DP U-767
7910132 Sep 24, 2019 DP U-767
FENTANYL CITRATE - ABSTRAL
N 022510 005 6759059 Sep 24, 2019 DP U-767
6761910 Sep 24, 2019 DP U-767
7910132 Sep 24, 2019 DP U-767
FENTANYL CITRATE - ABSTRAL
N 022510 006 6759059 Sep 24, 2019 DP U-767
6761910 Sep 24, 2019 DP U-767
7910132 Sep 24, 2019 DP U-767
FENTANYL CITRATE - LAZANDA
N 022569 001 6432440 Apr 20, 2018 DP U-1169
8216604 Oct 03, 2024 U-767
8889176 Jan 16, 2024 U-767
FENTANYL CITRATE - LAZANDA
N 022569 002 6432440 Apr 20, 2018 DP U-1169
8216604 Oct 03, 2024 U-767
8889176 Jan 16, 2024 U-767
FENTANYL HYDROCHLORIDE - IONSYS
N 021338 001 5697896 Dec 16, 2014 DP
5843014 Dec 01, 2015 DP
6169920 Jan 02, 2018 DP
6171294 Jun 05, 2015 U-736
6181963 Nov 02, 2019 DP
6195582 Jan 28, 2019 DP U-736
6216033 Jun 05, 2015 DP
6425892 Jun 05, 2015 U-736
6842640 Jun 02, 2015 DP
6881208 Apr 19, 2022 U-736
6975902 Apr 01, 2024 DP
7018370 Jun 05, 2015 U-736
7027859 Sep 26, 2014 DP
7302293 Jun 05, 2015 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 85 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FERRIC CARBOXYMALTOSE - INJECTAFER
N 203565 001 7612109 Feb 05, 2024 DS DP NP Jul 25, 2016
7754702 Feb 13, 2027 DP U-1432
8895612 Jan 08, 2027 DP U-1620
FERRIC CITRATE - FERRIC CITRATE
N 205874 001 5753706 Feb 03, 2017 DP U-1577
7767851 Feb 18, 2024 DS DP
8093423 Apr 21, 2026 U-1577
8299298 Feb 18, 2024 DP
8338642 Feb 18, 2024 DS DP U-1577
8609896 Feb 18, 2024 DP
8754257 Feb 18, 2024 DP
8754258 Feb 18, 2024 DP
8846976 Feb 18, 2024 U-1577
FERUMOXYTOL - FERAHEME
N 022180 001 6599498 Jun 30, 2023 DS DP
7553479 Mar 08, 2020 DS DP
7871597 Mar 08, 2020 DS DP
8501158 Mar 08, 2020 U-1422
8591864 Mar 08, 2020 DP
8926947 Mar 08, 2020 DS DP
FESOTERODINE FUMARATE - TOVIAZ
N 022030 001 6858650 Jul 03, 2022 DS U-913
7384980 May 11, 2019 DS DP U-913
7807715 Jun 07, 2027 DP U-913
7855230 May 11, 2019 U-913
7985772 May 11, 2019 DS DP U-913
8088398 Jun 07, 2027 DP U-913
8338478 May 11, 2019 DS DP U-913
8501723 Jun 07, 2027 DP
FESOTERODINE FUMARATE - TOVIAZ
N 022030 002 6858650 Jul 03, 2022 DS U-913
7384980 May 11, 2019 DS DP U-913
7807715 Jun 07, 2027 DP U-913
7855230 May 11, 2019 U-913
7985772 May 11, 2019 DS DP U-913
8088398 Jun 07, 2027 DP U-913
8338478 May 11, 2019 DS DP U-913
8501723 Jun 07, 2027 DP
FEXOFENADINE HYDROCHLORIDE - CHILDREN'S FEXOFENADINE HYDROCHLORIDE ALLERGY
A 203330 001 PC Jun 20, 2015
FEXOFENADINE HYDROCHLORIDE - CHILDREN'S FEXOFENADINE HYDROCHLORIDE HIVES
A 203330 002 PC Jun 20, 2015
FEXOFENADINE HYDROCHLORIDE - ALLEGRA
N 020625 001 5738872 Feb 28, 2015
5855912 Feb 28, 2015
5932247 Feb 28, 2015
6037353 Mar 14, 2017 U-138
6113942 Feb 28, 2015
FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA ALLERGY
N 020872 005 5855912 Feb 28, 2015 DP
5932247 Feb 28, 2015 DP
6037353 Mar 14, 2017 U-1160
6113942 Feb 28, 2015 DP
FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA HIVES
N 020872 006 5855912 Feb 28, 2015 DP
5932247 Feb 28, 2015 DP
6037353 Mar 14, 2017 U-1160
6113942 Feb 28, 2015 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 86 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FEXOFENADINE HYDROCHLORIDE - ALLEGRA ALLERGY
N 020872 007 5855912 Feb 28, 2015 DP
5932247 Feb 28, 2015 DP
6037353 Mar 14, 2017 U-1160
6113942 Feb 28, 2015 DP
FEXOFENADINE HYDROCHLORIDE - ALLEGRA HIVES
N 020872 008 5855912 Feb 28, 2015 DP
5932247 Feb 28, 2015 DP
6037353 Mar 14, 2017 U-1160
6113942 Feb 28, 2015 DP
FEXOFENADINE HYDROCHLORIDE - ALLEGRA HIVES
N 020872 009 5855912 Feb 28, 2015 DP
5932247 Feb 28, 2015 DP
6037353 Mar 14, 2017 U-1160
6113942 Feb 28, 2015 DP
FEXOFENADINE HYDROCHLORIDE - ALLEGRA ALLERGY
N 020872 010 5855912 Feb 28, 2015 DP
5932247 Feb 28, 2015 DP
6037353 Mar 14, 2017 U-1160
6113942 Feb 28, 2015 DP
FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA ALLERGY
N 021909 002 5738872 Feb 28, 2015 DP
6037353 Mar 14, 2017 U-1158
6037353 Mar 14, 2017 U-1466
6723348 Nov 26, 2021 DP U-1466
FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA HIVES
N 021909 003 5738872 Feb 28, 2015 DP
6037353 Mar 14, 2017
6723348 Nov 26, 2021 DP
FEXOFENADINE HYDROCHLORIDE - ALLEGRA
N 021963 001 6037353 Mar 14, 2017 U-772
FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA ALLERGY
N 201373 001 6037353 Mar 14, 2017 U-1157
FEXOFENADINE HYDROCHLORIDE - CHILDREN'S ALLEGRA HIVES
N 201373 002 6037353 Mar 14, 2017 U-1157
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - ALLEGRA-D 12 HOUR ALLERGY AND CONGESTION
N 020786 002 5855912 Feb 28, 2015 DP
6037353 Mar 14, 2017 U-1159
6039974 Jul 31, 2018 DP
6113942 Feb 28, 2015 DP
FEXOFENADINE HYDROCHLORIDE; PSEUDOEPHEDRINE HYDROCHLORIDE - ALLEGRA-D 24 HOUR ALLERGY AND CONGESTION
N 021704 002 6037353 Mar 14, 2017 U-1159
6613357 Dec 25, 2020 DP U-1159
RE39069 May 29, 2018 DP
FIDAXOMICIN - DIFICID
N 201699 001 7378508 Jul 31, 2027 DS DP NCE May 27, 2016
7863249 Jul 31, 2027 DS DP
7906489 Mar 04, 2027 U-319
8586551 Apr 12, 2024 DS DP
8859510 Jul 31, 2027 U-319
FINAFLOXACIN - XTORO
N 206307 001 NCE Dec 17, 2019
PED Jun 17, 2020
FINASTERIDE - PROSCAR
N 020180 001 5942519 Oct 23, 2018 U-280
FINGOLIMOD - GILENYA
N 022527 001 5604229 Feb 18, 2019 DS U-1086 M-106 Jul 20, 2014
6004565 Sep 23, 2017 U-1086 NCE Sep 21, 2015
8324283 Mar 29, 2026
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 87 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FLORBETABEN F-18 - NEURACEQ
N 204677 001 7807135 Mar 18, 2029 DS DP U-1497 NCE Mar 21, 2019
FLORBETAPIR F-18 - AMYVID
N 202008 001 7687052 Apr 30, 2027 DS DP NCE Apr 06, 2017
8506929 Apr 30, 2027 DS DP U-1423
FLORBETAPIR F-18 - AMYVID
N 202008 002 7687052 Apr 30, 2027 DS DP NCE Apr 06, 2017
8506929 Apr 30, 2027 DS DP U-1423
FLORBETAPIR F-18 - AMYVID
N 202008 003 7687052 Apr 30, 2027 DS DP NCE Apr 06, 2017
8506929 Apr 30, 2027 DS DP U-1423
FLUDARABINE PHOSPHATE - OFORTA
N 022273 001 7148207 Dec 20, 2022 DP U-944 ODE Dec 18, 2015
7547776 Dec 10, 2018 DS
FLUNISOLIDE - AEROSPAN HFA
N 021247 001 5776433 Jul 07, 2015 DP M-128 Aug 28, 2016
FLUOCINOLONE ACETONIDE - RETISERT
N 021737 001 6217895 Mar 22, 2019 DP U-708
6548078 Mar 22, 2019 DP U-708
FLUOCINOLONE ACETONIDE - ILUVIEN
N 201923 001 6217895 Mar 22, 2019 DP U-1597 NP Sep 26, 2017
6375972 Apr 26, 2020 DP U-1597
6548078 Mar 22, 2019 DP U-1597
8252307 Jun 27, 2019 DP
8871241 Aug 12, 2027 DP
FLUOCINOLONE ACETONIDE; HYDROQUINONE; TRETINOIN - TRI-LUMA
N 021112 001 7915243 Mar 22, 2026 DP
7939516 May 04, 2025 DP
8247395 Oct 22, 2022 DP
8653053 Oct 25, 2022 DP
FLUOCINONIDE - FLUOCINONIDE
A 090256 001 PC Jul 13, 2014
FLUOCINONIDE - VANOS
N 021758 001 6765001 Dec 21, 2021 DP
7220424 Jan 07, 2023 U-861
7794738 Sep 11, 2022 U-1084
8232264 Mar 09, 2023 DP
FLUOROURACIL - CARAC
N 020985 001 6670335 Jun 02, 2021 DP U-68
FLUOXETINE HYDROCHLORIDE - PROZAC
N 018936 001 6960577 Nov 01, 2017 U-963 NPP Jul 26, 2016
FLUOXETINE HYDROCHLORIDE - PROZAC
N 018936 003 6960577 Nov 01, 2017 U-963 NPP Jul 26, 2016
FLUOXETINE HYDROCHLORIDE - PROZAC
N 018936 004 NPP Jul 26, 2016
FLUOXETINE HYDROCHLORIDE - PROZAC
N 018936 006 6960577 Nov 01, 2017 U-963 NPP Jul 26, 2016
FLUOXETINE HYDROCHLORIDE - PROZAC WEEKLY
N 021235 001 5910319 May 29, 2017 U-396
5985322 May 29, 2017 U-397
RE39030 May 29, 2017 DP U-396
RE39030 May 29, 2017 DP U-397
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 88 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N 021520 001 6960577 Nov 01, 2017 U-962 M-142 Oct 10, 2017
NPP Jul 26, 2016
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N 021520 002 5945416 Mar 24, 2017 DS DP Y M-142 Oct 10, 2017
6960577 Nov 01, 2017 U-962 NPP Jul 26, 2016
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N 021520 003 5945416 Mar 24, 2017 DS DP Y M-142 Oct 10, 2017
6960577 Nov 01, 2017 U-962 NPP Jul 26, 2016
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N 021520 004 5945416 Mar 24, 2017 DS DP Y M-142 Oct 10, 2017
6960577 Nov 01, 2017 U-962 NPP Jul 26, 2016
FLUOXETINE HYDROCHLORIDE; OLANZAPINE - SYMBYAX
N 021520 005 5945416 Mar 24, 2017 DS DP Y M-142 Oct 10, 2017
6960577 Nov 01, 2017 U-962 NPP Jul 26, 2016
FLUTEMETAMOL F-18 - VIZAMYL
N 203137 001 7270800 Jan 24, 2023 DS DP U-336 NCE Oct 25, 2018
7351401 Jan 24, 2023 DS DP U-336
8236282 May 21, 2024 DS DP
8691185 Jan 24, 2023 U-336
FLUTEMETAMOL F-18 - VIZAMYL
N 203137 002 7270800 Jan 24, 2023 DS DP U-336 NCE Oct 25, 2018
7351401 Jan 24, 2023 DS DP U-336
8236282 May 21, 2024 DS DP
8691185 Jan 24, 2023 U-336
FLUTICASONE FUROATE - VERAMYST
N 022051 001 6858596 Aug 03, 2021 DP U-808
7101866 Aug 03, 2021 DS DP U-808
7541350 Aug 03, 2021 DP U-988
8062264 Apr 05, 2026 DP
8147461 Oct 15, 2028 DP
8347879 Jul 15, 2028 DP
8752543 Apr 05, 2026 DP
FLUTICASONE FUROATE - ARNUITY ELLIPTA
N 205625 001 5873360 Feb 23, 2016 DP NP Aug 20, 2017
7101866 Aug 03, 2021 DS DP U-1559
7629335 Aug 03, 2021 DP
8113199 Oct 23, 2027 DP
8161968 Feb 05, 2028 DP
8201556 Feb 05, 2029 DP
8534281 Aug 10, 2029 DP
8746242 Oct 11, 2030 DP
FLUTICASONE FUROATE - ARNUITY ELLIPTA
N 205625 002 5873360 Feb 23, 2016 DP NP Aug 20, 2017
7101866 Aug 03, 2021 DS DP U-1559
7629335 Aug 03, 2021 DP
8113199 Oct 23, 2027 DP
8161968 Feb 05, 2028 DP
8201556 Feb 05, 2029 DP
8534281 Aug 10, 2029 DP
8746242 Oct 11, 2030 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 89 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FLUTICASONE FUROATE; VILANTEROL TRIFENATATE - BREO ELLIPTA
N 204275 001 5873360 Feb 23, 2016 DP NP May 10, 2016
6537983 Aug 03, 2021 DP U-1401
6759398 Aug 03, 2021 DP U-1401
6878698 Aug 03, 2021 U-1401
7101866 Aug 03, 2021 DS DP U-1401
7439393 Sep 11, 2022 DS DP U-1401
7629335 Aug 03, 2021 DP
7776895 Sep 11, 2022 DP
8113199 Oct 23, 2027 DP
8161968 Feb 05, 2028 DP
8511304 Nov 11, 2025 DP U-1424
8534281 Aug 10, 2029 DP
8746242 Oct 11, 2030 DP
RE44874 Mar 23, 2023 DS DP U-1548
FLUTICASONE PROPIONATE - FLOVENT DISKUS 50
N 020833 001 5873360 Feb 23, 2016 DP
FLUTICASONE PROPIONATE - FLOVENT DISKUS 100
N 020833 002 5873360 Feb 23, 2016 DP
FLUTICASONE PROPIONATE - FLOVENT DISKUS 250
N 020833 003 5873360 Feb 23, 2016 DP
FLUTICASONE PROPIONATE - CUTIVATE
N 021152 001 7300669 Oct 20, 2019 DP U-835
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 90 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FLUTICASONE PROPIONATE - FLOVENT HFA
N 021433 001 5658549 Aug 19, 2014 DP U-710
5674472 Oct 07, 2014 DP
6161724 Jan 16, 2018 DP
6170717 Dec 23, 2017 DP
6315173 Dec 23, 2017 DP
6431168 Jun 08, 2018 DP
6435372 Jan 16, 2018 DP
6510969 Dec 23, 2017 DP
6596260 Aug 10, 2014 DP
6743413 Jun 01, 2021 U-581
6938796 Jan 16, 2018 DP
6966467 Dec 23, 2017 DP
6997349 Jan 16, 2018 DP
7107986 Jun 08, 2018 DP
7107986*PED Dec 08, 2018
7143908 Jan 16, 2018 DP
7350676 Aug 24, 2018 DP
7500444 Feb 26, 2026 DP
7500444*PED Aug 26, 2026
7832351 Jun 19, 2023 DP
FLUTICASONE PROPIONATE - FLOVENT HFA
N 021433 002 5658549 Aug 19, 2014 DP U-710
5674472 Oct 07, 2014 DP
6161724 Jan 16, 2018 DP
6170717 Dec 23, 2017 DP
6315173 Dec 23, 2017 DP
6431168 Jun 08, 2018 DP
6435372 Jan 16, 2018 DP
6510969 Dec 23, 2017 DP
6596260 Aug 10, 2014 DP
6743413 Jun 01, 2021 U-581
6938796 Jan 16, 2018 DP
6966467 Dec 23, 2017 DP
6997349 Jan 16, 2018 DP
7107986 Jun 08, 2018 DP
7107986*PED Dec 08, 2018
7143908 Jan 16, 2018 DP
7350676 Aug 24, 2018 DP
7500444 Feb 26, 2026 DP
7500444*PED Aug 26, 2026
7832351 Jun 19, 2023 DP
FLUTICASONE PROPIONATE - FLOVENT HFA
N 021433 003 5658549 Aug 19, 2014 DP U-710
5674472 Oct 07, 2014 DP
6161724 Jan 16, 2018 DP
6170717 Dec 23, 2017 DP
6315173 Dec 23, 2017 DP
6431168 Jun 08, 2018 DP
6435372 Jan 16, 2018 DP
6510969 Dec 23, 2017 DP
6596260 Aug 10, 2014 DP
6743413 Jun 01, 2021 U-581
6938796 Jan 16, 2018 DP
6966467 Dec 23, 2017 DP
6997349 Jan 16, 2018 DP
7107986 Jun 08, 2018 DP
7107986*PED Dec 08, 2018
7143908 Jan 16, 2018 DP
7350676 Aug 24, 2018 DP
7500444 Feb 26, 2026 DP
7500444*PED Aug 26, 2026
7832351 Jun 19, 2023 DP
FLUTICASONE PROPIONATE - FLONASE ALLERGY RELIEF
N 205434 001 M-147 Jul 23, 2017
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR DISKUS 100/50
N 021077 001 5873360 Feb 23, 2016 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 91 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR DISKUS 250/50
N 021077 002 5873360 Feb 23, 2016 DP
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR DISKUS 500/50
N 021077 003 5873360 Feb 23, 2016 DP
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA
N 021254 001 5658549 Aug 19, 2014 DP U-738
5674472 Oct 07, 2014 DP
6161724 Jan 16, 2018 DP
6170717 Dec 23, 2017 DP
6315173 Dec 23, 2017 DP
6431168 Jun 08, 2018 DP
6435372 Jan 16, 2018 DP
6510969 Dec 23, 2017
6596260 Aug 10, 2014 DP
6743413 Jun 01, 2021 U-1591
6743413*PED Dec 01, 2021
6938796 Jan 16, 2018 DP
6966467 Dec 23, 2017 DP
6997349 Jan 16, 2018 DP
7107986 Jun 08, 2018 DP
7143908 Jan 16, 2018 DP
7350676 Aug 24, 2018 DP
7500444 Feb 26, 2026 DP
7500444*PED Aug 26, 2026
7832351 Jun 19, 2023 DP
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA
N 021254 002 5658549 Aug 19, 2014 DP U-738
5674472 Oct 07, 2014 DP
6161724 Jan 16, 2018 DP
6170717 Dec 23, 2017 DP
6315173 Dec 23, 2017 DP
6431168 Jun 08, 2018 DP
6435372 Jan 16, 2018 DP
6510969 Dec 23, 2017 DP
6596260 Aug 10, 2014 DP
6743413 Jun 01, 2021 U-1591
6743413*PED Dec 01, 2021
6938796 Jan 16, 2018 DP
6966467 Dec 23, 2017 DP
6997349 Jan 16, 2018 DP
7107986 Jun 08, 2018 DP
7143908 Jan 16, 2018 DP
7350676 Aug 24, 2018 DP
7500444 Feb 26, 2026 DP
7500444*PED Aug 26, 2026
7832351 Jun 19, 2023 DP
FLUTICASONE PROPIONATE; SALMETEROL XINAFOATE - ADVAIR HFA
N 021254 003 5658549 Aug 19, 2014 DP U-738
5674472 Oct 07, 2014 DP
6161724 Jan 16, 2018 DP
6170717 Dec 23, 2017 DP
6315173 Dec 23, 2017 DP
6431168 Jun 08, 2018 DP
6435372 Jan 16, 2018 DP
6510969 Dec 23, 2017 DP
6596260 Aug 10, 2014 DP
6743413 Jun 01, 2021 U-1591
6743413*PED Dec 01, 2021
6938796 Jan 16, 2018 DP
6966467 Dec 23, 2017 DP
6997349 Jan 16, 2018 DP
7107986 Jun 08, 2018 DP
7143908 Jan 16, 2018 DP
7350676 Aug 24, 2018 DP
7500444 Feb 26, 2026 DP
7500444*PED Aug 26, 2026
7832351 Jun 19, 2023 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 92 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FLUVASTATIN SODIUM - LESCOL XL
N 021192 001 6242003 Apr 13, 2020
FLUVOXAMINE MALEATE - LUVOX CR
N 022033 001 7465462 May 10, 2020 DP U-929
FLUVOXAMINE MALEATE - LUVOX CR
N 022033 002 7465462 May 10, 2020 DP U-929
FOLLITROPIN ALFA/BETA - GONAL-F
N 020378 001 5767251 Jun 16, 2015 DS
FOLLITROPIN ALFA/BETA - GONAL-F
N 020378 002 5767251 Jun 16, 2015 DS
FOLLITROPIN ALFA/BETA - GONAL-F
N 020378 003 5767251 Jun 16, 2015 DS
FOLLITROPIN ALFA/BETA - GONAL-F
N 020378 004 5767067 Jun 16, 2015 DS
5767251 Jun 16, 2015 DS
7563763 Aug 23, 2019 DP
FOLLITROPIN ALFA/BETA - GONAL-F
N 020378 005 5767067 Jun 16, 2015 DS
5767251 Jun 16, 2015 DS
7563763 Aug 23, 2019 DP
FOLLITROPIN ALFA/BETA - FOLLISTIM
N 020582 001 5767251 Jun 16, 2015
FOLLITROPIN ALFA/BETA - FOLLISTIM
N 020582 002 5767251 Jun 16, 2015
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 93 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FOLLITROPIN ALFA/BETA - FOLLISTIM AQ
N 021211 001 5767251 Jun 16, 2015 DS D-133 Aug 22, 2014
5929028 Jan 14, 2018 DP U-567
5929028 Jan 14, 2018 DP U-1366
7446090 Aug 23, 2019 DP
7563763 Aug 23, 2019 U-993
7563763 Aug 23, 2019 U-1183
7563763 Aug 23, 2019 U-1367
FOLLITROPIN ALFA/BETA - FOLLISTIM AQ
N 021211 002 5767251 Jun 16, 2015 DS D-133 Aug 22, 2014
5929028 Jan 14, 2018 DP U-567
5929028 Jan 14, 2018 DP U-1366
7446090 Aug 23, 2019 DP
7563763 Aug 23, 2019 U-993
7563763 Aug 23, 2019 U-1183
7563763 Aug 23, 2019 U-1367
FOLLITROPIN ALFA/BETA - FOLLISTIM AQ
N 021211 003 5767251 Jun 16, 2015 DS D-133 Aug 22, 2014
5929028 Jan 14, 2018 DP U-567
5929028 Jan 14, 2018 DP U-1366
7446090 Aug 23, 2019 DP
7563763 Aug 23, 2019 U-993
7563763 Aug 23, 2019 U-1183
7563763 Aug 23, 2019 U-1367
FOLLITROPIN ALFA/BETA - FOLLISTIM AQ
N 021211 004 5767251 Jun 16, 2015 DS D-133 Aug 22, 2014
5929028 Jan 14, 2018 DP U-567
5929028 Jan 14, 2018 DP U-1366
7446090 Aug 23, 2019 DP
7563763 Aug 23, 2019 U-993
7563763 Aug 23, 2019 U-1183
7563763 Aug 23, 2019 U-1367
FOLLITROPIN ALFA/BETA - FOLLISTIM AQ
N 021273 001 5767251 Jun 16, 2015 DS
5929028 Jan 14, 2018 DP U-1366
FOLLITROPIN ALFA/BETA - FOLLISTIM AQ
N 021273 002 5767251 Jun 16, 2015 DS
5929028 Jan 14, 2018 DP U-1366
FOLLITROPIN ALFA/BETA - GONAL-F RFF REDI-JECT
N 021684 001 5767067 Jun 16, 2015 DS
5767251 Jun 16, 2015 DS
7446090 Aug 23, 2019 DP
7741268 Apr 02, 2024 DP
FOLLITROPIN ALFA/BETA - GONAL-F RFF REDI-JECT
N 021684 002 5767067 Jun 16, 2015 DS
5767251 Jun 16, 2015 DS
7446090 Aug 23, 2019 DP
7741268 Apr 02, 2024 DP
FOLLITROPIN ALFA/BETA - GONAL-F RFF REDI-JECT
N 021684 003 5767067 Jun 16, 2015 DS
5767251 Jun 16, 2015 DS
7446090 Aug 23, 2019 DP
7741268 Apr 02, 2024 DP
FOLLITROPIN ALFA/BETA - GONAL-F
N 021765 001 5767251 Jun 16, 2015 DS
FOLLITROPIN ALFA/BETA - GONAL-F RFF
N 021765 002 5767067 Jun 16, 2015 DS
5767251 Jun 16, 2015 DS
FOLLITROPIN ALFA/BETA - GONAL-F
N 021765 003 5767251 Jun 16, 2015 DS
FOMEPIZOLE - ANTIZOL
N 020696 001 7553863 Jun 30, 2027 DS DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 94 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
FORMOTEROL FUMARATE - FORADIL
N 020831 001 6488027 Mar 08, 2019
6887459 Nov 28, 2020 U-762
FORMOTEROL FUMARATE - PERFOROMIST
N 022007 001 6667344 Jun 22, 2021 DP
6814953 Jun 22, 2021 DP U-813
7348362 Jun 22, 2021 DP
7462645 Jun 22, 2021 DP U-813
8623922 Jun 22, 2021 DP
FORMOTEROL FUMARATE; MOMETASONE FUROATE - DULERA
N 022518 001 6068832 Aug 27, 2017 DP U-1068
7067502 May 21, 2020 DP U-1068
7566705 May 21, 2020 DP U-1068
FORMOTEROL FUMARATE; MOMETASONE FUROATE - DULERA
N 022518 002 6068832 Aug 27, 2017 DP U-1068
7067502 May 21, 2020 DP U-1068
7566705 May 21, 2020 DP U-1068
FOSAMPRENAVIR CALCIUM - LEXIVA
N 021548 001 6436989 Dec 24, 2017 DS DP U-257 NPP Apr 27, 2015
6514953 Jul 15, 2019 DS DP U-257 PED Oct 27, 2015
FOSAMPRENAVIR CALCIUM - LEXIVA
N 022116 001 6436989 Dec 24, 2017 DS DP U-257 NPP Apr 27, 2015
PED Oct 27, 2015
FOSAPREPITANT DIMEGLUMINE - EMEND
N 022023 001 5691336 Mar 04, 2019 DS DP
5716942 Feb 10, 2015 U-850
FOSAPREPITANT DIMEGLUMINE - EMEND
N 022023 002 5691336 Mar 04, 2019 DS DP
5716942 Feb 10, 2015 U-850
FOSPROPOFOL DISODIUM - LUSEDRA
N 022244 001 6204257 Jul 01, 2022 DS DP U-945
6872838 Aug 07, 2018 DS
FROVATRIPTAN SUCCINATE - FROVA
N 021006 001 5464864 Nov 07, 2015 U-436
5827871 Oct 27, 2015 U-436
FULVESTRANT - FASLODEX
N 021344 001 6774122 Jan 09, 2021 U-596 M-123 Nov 09, 2015
7456160 Jan 09, 2021 U-596 PED Nov 17, 2014
8329680 Jan 09, 2021 U-596
8466139 Jan 09, 2021 U-596
8466139*PED Jul 09, 2021
GABAPENTIN - NEURONTIN
N 020235 001 6054482 Apr 25, 2017
GABAPENTIN - NEURONTIN
N 020235 002 6054482 Apr 25, 2017
GABAPENTIN - NEURONTIN
N 020235 003 6054482 Apr 25, 2017
GABAPENTIN - NEURONTIN
N 020882 001 6054482 Apr 25, 2017
GABAPENTIN - NEURONTIN
N 020882 002 6054482 Apr 25, 2017
GABAPENTIN - NEURONTIN
N 021129 001 6054482 Apr 25, 2017
7256216 May 28, 2022 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 95 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
GABAPENTIN - GRALISE
N 022544 001 6340475 Sep 19, 2016 DP ODE Jan 28, 2018
6488962 Jun 20, 2020 DP
6635280 Sep 19, 2016 DP
6723340 Oct 25, 2021 DP
7438927 Feb 26, 2024 U-1114
7731989 Oct 25, 2022 DP
8192756 Oct 25, 2022 DP U-1114
8252332 Oct 25, 2022 DP U-1114
8333992 Oct 25, 2022 DP U-1114
GABAPENTIN - GRALISE
N 022544 002 6340475 Sep 19, 2016 DP ODE Jan 28, 2018
6488962 Jun 20, 2020 DP
6635280 Sep 19, 2016 DP
6723340 Oct 25, 2021 DP
7438927 Feb 26, 2024 U-1114
7731989 Oct 25, 2022 DP
8192756 Oct 25, 2022 DP U-1114
8252332 Oct 25, 2022 DP U-1114
8333992 Oct 25, 2022 DP U-1114
GABAPENTIN ENACARBIL - HORIZANT
N 022399 001 6818787 Nov 06, 2022 DS DP I-652 Jun 06, 2015
8026279 Nov 10, 2026 DS DP NCE Apr 06, 2016
8048917 Nov 06, 2022 DS DP U-1247 ODE Jun 06, 2019
8114909 Apr 11, 2026 U-1231
8686034 Jan 24, 2025 U-1231
8686034 Jan 24, 2025 U-1247
8795725 Jun 10, 2029 DP U-1231
8795725 Jun 10, 2029 DP U-1247
GABAPENTIN ENACARBIL - HORIZANT
N 022399 002 6818787 Nov 06, 2022 DS DP I-652 Jun 06, 2015
8026279 Nov 10, 2026 DS DP NCE Apr 06, 2016
8048917 Nov 06, 2022 DS DP U-1247 ODE Jun 06, 2019
8114909 Apr 11, 2026 U-1231
8686034 Jan 24, 2025 U-1231
8686034 Jan 24, 2025 U-1247
8795725 Jun 10, 2029 DP U-1231
8795725 Jun 10, 2029 DP U-1247
GADOBENATE DIMEGLUMINE - MULTIHANCE
N 021357 001 I-654 Jul 06, 2015
GADOBENATE DIMEGLUMINE - MULTIHANCE
N 021357 002 I-654 Jul 06, 2015
GADOBENATE DIMEGLUMINE - MULTIHANCE
N 021357 003 I-654 Jul 06, 2015
GADOBENATE DIMEGLUMINE - MULTIHANCE
N 021357 004 I-654 Jul 06, 2015
GADOBENATE DIMEGLUMINE - MULTIHANCE MULTIPACK
N 021358 001 I-654 Jul 06, 2015
GADOBENATE DIMEGLUMINE - MULTIHANCE MULTIPACK
N 021358 002 I-654 Jul 06, 2015
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 96 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
GADOBUTROL - GADAVIST
N 201277 001 5980864 Nov 09, 2016 DS DP U-1119 I-688 Jun 11, 2017
NCE Mar 14, 2016
GADOBUTROL - GADAVIST
N 201277 002 5980864 Nov 09, 2016 DS DP U-1119 I-688 Jun 11, 2017
NCE Mar 14, 2016
GADOBUTROL - GADAVIST
N 201277 003 5980864 Nov 09, 2016 DS DP U-1119 I-688 Jun 11, 2017
NCE Mar 14, 2016
GADOBUTROL - GADAVIST
N 201277 004 5980864 Nov 09, 2016 DS DP U-1119 I-688 Jun 11, 2017
NCE Mar 14, 2016
GADOBUTROL - GADAVIST
N 201277 005 5980864 Nov 09, 2016 DS DP U-1119 I-688 Jun 11, 2017
NCE Mar 14, 2016
GADOBUTROL - GADAVIST
N 201277 006 I-688 Jun 11, 2017
NCE Mar 14, 2016
GADOFOSVESET TRISODIUM - ABLAVAR
N 021711 001 6676929 May 04, 2020 DP
7011815 Feb 01, 2015 U-1112
7060250 May 26, 2015 DS
7229606 May 26, 2015 U-1112
8017105 May 26, 2015 DS
8394356 Feb 01, 2015 U-1112
GADOFOSVESET TRISODIUM - ABLAVAR
N 021711 002 6676929 May 04, 2020 DP
7011815 Feb 01, 2015 U-1112
7060250 May 26, 2015 DS
7229606 May 26, 2015 U-1112
8017105 May 26, 2015 DS
8394356 Feb 01, 2015 U-1112
GADOTERATE MEGLUMINE - DOTAREM
N 204781 001 NCE Mar 20, 2018
GADOTERATE MEGLUMINE - DOTAREM
N 204781 002 NCE Mar 20, 2018
GADOTERATE MEGLUMINE - DOTAREM
N 204781 003 NCE Mar 20, 2018
GADOTERATE MEGLUMINE - DOTAREM
N 204781 004 NCE Mar 20, 2018
GADOTERIDOL - PROHANCE
N 020131 001 5846519 Dec 08, 2015
GADOTERIDOL - PROHANCE MULTIPACK
N 021489 001 5846519 Dec 08, 2015
GADOXETATE DISODIUM - EOVIST
N 022090 001 5798092 Aug 25, 2015 DS DP
6039931 Nov 13, 2021 U-1239
GALANTAMINE HYDROBROMIDE - RAZADYNE
N 021169 001 6099863 Jun 06, 2017
6358527 Jun 06, 2017 DP U-322
GALANTAMINE HYDROBROMIDE - RAZADYNE
N 021169 002 6099863 Jun 06, 2017
6358527 Jun 06, 2017 DP U-322
GALANTAMINE HYDROBROMIDE - RAZADYNE
N 021169 003 6099863 Jun 06, 2017
6358527 Jun 06, 2017 DP U-322
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 97 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
GALANTAMINE HYDROBROMIDE - RAZADYNE ER
N 021615 001 7160559 Dec 20, 2019 DP
GALANTAMINE HYDROBROMIDE - RAZADYNE ER
N 021615 002 7160559 Dec 20, 2019 DP
GALANTAMINE HYDROBROMIDE - RAZADYNE ER
N 021615 003 7160559 Dec 20, 2019 DP
GANCICLOVIR - ZIRGAN
N 022211 001 ODE Sep 15, 2016
GANIRELIX ACETATE - GANIRELIX ACETATE
N 021057 001 5767082 Jun 16, 2015
6653286 Jun 16, 2018 U-1354
GATIFLOXACIN - ZYMAR
N 021493 001 5880283 Dec 05, 2015
6333045 Aug 20, 2019 DP
GATIFLOXACIN - ZYMAXID
N 022548 001 5880283 Dec 05, 2015 DS
6333045 Aug 20, 2019 DS DP
GEFITINIB - IRESSA
N 021399 001 5770599 May 05, 2017 DS DP U-881
GEMIFLOXACIN MESYLATE - FACTIVE
N 021158 001 5633262 Jun 15, 2015
5776944 Apr 04, 2017 DS DP
5962468 Jun 15, 2015 U-282
6262071 Sep 21, 2019 U-513
6331550 Sep 21, 2019 U-511
6340689 Sep 14, 2019 U-512
6455540 Sep 21, 2019 U-511
6723734 Mar 20, 2018 DS DP
6803376 Sep 21, 2019 DS DP U-608
6803376 Sep 21, 2019 DS DP U-609
GEMTUZUMAB OZOGAMICIN - MYLOTARG
N 021174 001 5693762 Dec 02, 2014
5739116 Apr 14, 2015
5767285 Jun 16, 2015
5773001 Jun 30, 2015 U-320
GLATIRAMER ACETATE - COPAXONE
N 020622 003 8232250 Aug 19, 2030 U-441 NP Jan 28, 2017
8399413 Aug 19, 2030 U-441
GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE - DUETACT
N 021925 001 6150383 Jun 19, 2016 U-753
6211205 Jun 19, 2016 U-753
6303640 Aug 09, 2016 U-753
6329404 Jun 19, 2016 DP U-753
7538125 Jun 19, 2016 DP
7700128 Jan 30, 2027 DP
8071130 Jun 08, 2028 DP
GLIMEPIRIDE; PIOGLITAZONE HYDROCHLORIDE - DUETACT
N 021925 002 6150383 Jun 19, 2016 U-753
6211205 Jun 19, 2016 U-753
6303640 Aug 09, 2016 U-753
6329404 Jun 19, 2016 DP U-753
7538125 Jun 19, 2016 DP
7700128 Jan 30, 2027 DP
8071130 Jun 08, 2028 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 98 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N 021700 001 5741803 Apr 21, 2015 DS DP U-690
5741803 Apr 21, 2015 DS DP U-781
7358366 Apr 19, 2020 DS
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N 021700 002 5741803 Apr 21, 2015 DS DP U-690
5741803 Apr 21, 2015 DS DP U-781
7358366 Apr 19, 2020 DS
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N 021700 003 5741803 Apr 21, 2015 DS DP U-690
5741803 Apr 21, 2015 DS DP U-781
7358366 Apr 19, 2020 DS
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N 021700 004 7358366 Apr 19, 2020 DS
GLIMEPIRIDE; ROSIGLITAZONE MALEATE - AVANDARYL
N 021700 005 7358366 Apr 19, 2020 DS
GLIPIZIDE - GLUCOTROL XL
N 020329 001 RE44459 Mar 26, 2019 U-1431
GLIPIZIDE - GLUCOTROL XL
N 020329 002 RE44459 Mar 26, 2019 U-1431
GLIPIZIDE - GLUCOTROL XL
N 020329 003 RE44459 Mar 26, 2019 U-1431
GLYBURIDE; METFORMIN HYDROCHLORIDE - GLUCOVANCE
N 021178 001 6303146 Jul 14, 2019 U-412
GLYBURIDE; METFORMIN HYDROCHLORIDE - GLUCOVANCE
N 021178 002 6303146 Jul 14, 2019 U-412
GLYBURIDE; METFORMIN HYDROCHLORIDE - GLUCOVANCE
N 021178 003 6303146 Jul 14, 2019 U-412
GLYCEROL PHENYLBUTYRATE - RAVICTI
N 203284 001 5968979 Feb 07, 2015 DS DP U-1378 NE Feb 01, 2016
8404215 Mar 09, 2032 U-1383 ODE Feb 01, 2020
8642012 Sep 22, 2030 U-1383
GLYCOPYRROLATE - ROBINUL
N 012827 001 7091236 Apr 24, 2024 U-877 Y
GLYCOPYRROLATE - ROBINUL FORTE
N 012827 002 7091236 Apr 24, 2024 U-877 Y
GLYCOPYRROLATE - CUVPOSA
N 022571 001 7638552 Aug 20, 2023 U-1076 ODE Jul 28, 2017
7816396 Aug 20, 2023 U-1076
GOSERELIN ACETATE - ZOLADEX
N 019726 001 7118552 Apr 13, 2022 DP
7220247 Apr 09, 2022 DP
7500964 Feb 26, 2021 DP
GOSERELIN ACETATE - ZOLADEX
N 020578 001 7118552 Apr 13, 2022 DP
7220247 Apr 09, 2022 DP
7500964 Feb 26, 2021 DP
GRANISETRON - SANCUSO
N 022198 001 7608282 Oct 22, 2024 DP U-1011
GRANISETRON HYDROCHLORIDE - KYTRIL
N 020239 001 5952340 Sep 14, 2016 U-519
GRANISETRON HYDROCHLORIDE - KYTRIL
N 020239 002 5952340 Sep 14, 2016 U-519
GRANISETRON HYDROCHLORIDE - KYTRIL
N 020239 004 5952340 Sep 14, 2016 U-519
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 99 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT
PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT
DELIST EXCLUSIVITY EXPIRATION
DATE CODES
REQUESTED CODE(S) DATE
GUAIFENESIN - MUCINEX
N 021282 001 6372252 Apr 28, 2020 U-489
6955821 Apr 28, 2020 DP U-489
7838032 Apr 28, 2020 DP
GUAIFENESIN - MUCINEX
N 021282 002 6372252 Apr 28, 2020 U-489
6955821 Apr 28, 2020 DP U-489
7838032 Apr 28, 2020 DP
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE - MUCINEX D
N 021585 001 6372252 Apr 28, 2020 DP
6955821 Apr 28, 2020 DP U-686
7838032 Apr 28, 2020 DP
GUAIFENESIN; PSEUDOEPHEDRINE HYDROCHLORIDE - MUCINEX D
N 021585 002 6372252 Apr 28, 2020 DP
6955821 Apr 28, 2020 DP U-686
7838032 Apr 28, 2020 DP
GUANFACINE HYDROCHLORIDE - INTUNIV
N 022037 001 5854290 Sep 21, 2015 U-494
Y D-145 Nov 19, 2017
5854290*PED Mar 21, 2016
PED May 19, 2018
6287599 Dec 20, 2020 DP
6287599*PED Jun 20, 2021
6811794 Jul 04, 2022 DP U-494
6811794*PED Jan 04, 2023
GUANFACINE HYDROCHLORIDE - INTUNIV
N 022037 002 5854290 Sep 21, 2015 U-494
Y D-145 Nov 19, 2017
5854290*PED Mar 21, 2016
PED May 19, 2018
6287599 Dec 20, 2020 DP
6287599*PED Jun 20, 2021
6811794 Jul 04, 2022 DP U-494
6811794*PED Jan 04, 2023
GUANFACINE HYDROCHLORIDE - INTUNIV
N 022037 003 5854290 Sep 21, 2015 U-494
Y D-145 Nov 19, 2017
5854290*PED Mar 21, 2016
PED May 19, 2018
6287599 Dec 20, 2020 DP
6287599*PED Jun 20, 2021
6811794 Jul 04, 2022 DP U-494
6811794*PED Jan 04, 2023
GUANFACINE HYDROCHLORIDE - INTUNIV
N 022037 004 5854290 Sep 21, 2015 U-494
Y D-145 Nov 19, 2017
5854290*PED Mar 21, 2016
PED May 19, 2018
6287599 Dec 20, 2020 DP
6287599*PED Jun 20, 2021
6811794 Jul 04, 2022 DP U-494
6811794*PED Jan 04, 2023
HEXAMINOLEVULINATE HYDROCHLORIDE - CYSVIEW KIT
N 022555 001 6034267 Mar 08, 2016 U-1087
7247655 Mar 08, 2016 DP U-1087
7348361 Nov 06, 2020 DP U-1087
7530461 Jan 11, 2017 DP U-1087
HISTRELIN ACETATE - SUPPRELIN LA
N 022058 001 8062652 Jun 16, 2026 U-1197
HYALURONIDASE RECOMBINANT HUMAN - HYLENEX RECOMBINANT
N 021859 001 7767429 Sep 23, 2027 DS DP
HYDRALAZINE HYDROCHLORIDE; ISOSORBIDE DINITRATE - BIDIL
N 020727 001 6465463 Sep 08, 2020 U-71
6784177 Sep 08, 2020 U-71
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 100 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE
N 020758 001 5994348 Jun 07, 2015
HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE
N 020758 002 5994348 Jun 07, 2015
HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE
N 020758 003 5994348 Jun 07, 2015
HYDROCHLOROTHIAZIDE; IRBESARTAN - AVALIDE
N 020758 004 5994348 Jun 07, 2015 DP
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - BENICAR HCT
N 021532 002 5616599 Apr 25, 2016 DS DP U-500
6878703 Nov 19, 2021 U-3 Y
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - BENICAR HCT
N 021532 003 5616599 Apr 25, 2016 DS DP U-500
6878703 Nov 19, 2021 U-3 Y
HYDROCHLOROTHIAZIDE; OLMESARTAN MEDOXOMIL - BENICAR HCT
N 021532 005 5616599 Apr 25, 2016 DS DP U-500
6878703 Nov 19, 2021 U-3 Y
HYDROCHLOROTHIAZIDE; TELMISARTAN - MICARDIS HCT
N 021162 001 6358986 Jan 10, 2020
HYDROCHLOROTHIAZIDE; TELMISARTAN - MICARDIS HCT
N 021162 002 6358986 Jan 10, 2020
HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT
N 020818 001 6294197 Jun 18, 2017 U-3
HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT
N 020818 002 6294197 Jun 18, 2017 U-3
HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT
N 020818 003 6294197 Jun 18, 2017 U-3
HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT
N 020818 004 6294197 Jun 18, 2017 U-3
HYDROCHLOROTHIAZIDE; VALSARTAN - DIOVAN HCT
N 020818 005 6294197 Jun 18, 2017 U-3
HYDROCODONE BITARTRATE - ZOHYDRO ER
N 202880 001 6228398 Nov 01, 2019 DP NP Oct 25, 2016
6902742 Nov 01, 2019 DP
HYDROCODONE BITARTRATE - ZOHYDRO ER
N 202880 002 6228398 Nov 01, 2019 DP NP Oct 25, 2016
6902742 Nov 01, 2019 DP
HYDROCODONE BITARTRATE - ZOHYDRO ER
N 202880 003 6228398 Nov 01, 2019 DP NP Oct 25, 2016
6902742 Nov 01, 2019 DP
HYDROCODONE BITARTRATE - ZOHYDRO ER
N 202880 004 6228398 Nov 01, 2019 DP NP Oct 25, 2016
6902742 Nov 01, 2019 DP
HYDROCODONE BITARTRATE - ZOHYDRO ER
N 202880 005 6228398 Nov 01, 2019 DP NP Oct 25, 2016
6902742 Nov 01, 2019 DP
HYDROCODONE BITARTRATE - ZOHYDRO ER
N 202880 006 6228398 Nov 01, 2019 DP NP Oct 25, 2016
6902742 Nov 01, 2019 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 101 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
HYDROCODONE BITARTRATE - HYSINGLA
N 206627 001 8808740 Dec 21, 2031 DP U-1556
HYDROCODONE BITARTRATE - HYSINGLA
N 206627 002 8808740 Dec 21, 2031 DP U-1556
HYDROCODONE BITARTRATE - HYSINGLA
N 206627 003 8808740 Dec 21, 2031 DP U-1556
HYDROCODONE BITARTRATE - HYSINGLA
N 206627 004 8808740 Dec 21, 2031 DP U-1556
HYDROCODONE BITARTRATE - HYSINGLA
N 206627 005 8808740 Dec 21, 2031 DP U-1556
HYDROCODONE BITARTRATE - HYSINGLA
N 206627 006 8808740 Dec 21, 2031 DP U-1556
HYDROCODONE BITARTRATE - HYSINGLA
N 206627 007 8808740 Dec 21, 2031 DP U-1556
HYDROCODONE BITARTRATE; IBUPROFEN - VICOPROFEN
N 020716 001 6348216 Jun 10, 2017
6599531 Jun 10, 2017
HYDROCORTISONE BUTYRATE - LOCOID
N 022076 001 7378405 Dec 19, 2026 DP
7981877 Jan 23, 2025 DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID-HP
N 019034 001 6589960 Nov 09, 2020 DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID-HP
N 019034 002 6589960 Nov 09, 2020 DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID
N 019034 003 6589960 Nov 09, 2020 DS DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID
N 019034 004 6589960 Nov 09, 2020 DS DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID
N 019034 005 6589960 Nov 09, 2020 DS DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID
N 019891 001 6589960 Nov 09, 2020 DS DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID
N 019892 001 6589960 Nov 09, 2020 DS DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID
N 019892 002 6589960 Nov 09, 2020 DS DP
HYDROMORPHONE HYDROCHLORIDE - DILAUDID
N 019892 003 6589960 Nov 09, 2020 DS DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 102 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
HYDROMORPHONE HYDROCHLORIDE - PALLADONE
N 021044 001 5958452 Nov 04, 2014 DP
5965161 Nov 04, 2014 DP U-616
6335033 Nov 04, 2014 DP U-616
6589960 Nov 09, 2020 DP
6706281 Nov 04, 2014 DP U-616
6743442 Nov 04, 2014 DP
HYDROMORPHONE HYDROCHLORIDE - PALLADONE
N 021044 002 5958452 Nov 04, 2014 DP
5965161 Nov 04, 2014 DP U-616
6335033 Nov 04, 2014 DP U-616
6589960 Nov 09, 2020 DP
6706281 Nov 04, 2014 DP U-616
6743442 Nov 04, 2014 DP
HYDROMORPHONE HYDROCHLORIDE - PALLADONE
N 021044 003 5958452 Nov 04, 2014 DP
5965161 Nov 04, 2014 DP U-616
6335033 Nov 04, 2014 DP U-616
6589960 Nov 09, 2020 DP
6706281 Nov 04, 2014 DP U-616
6743442 Nov 04, 2014 DP
HYDROMORPHONE HYDROCHLORIDE - PALLADONE
N 021044 004 5958452 Nov 04, 2014 DP
5965161 Nov 04, 2014 DP U-616
6335033 Nov 04, 2014 DP U-616
6589960 Nov 09, 2020 DP
6706281 Nov 04, 2014 DP U-616
6743442 Nov 04, 2014 DP
HYDROMORPHONE HYDROCHLORIDE - EXALGO
N 021217 001 5702725 Jul 07, 2014 DP U-1043
5914131 Jul 07, 2014 DP U-1043
HYDROMORPHONE HYDROCHLORIDE - EXALGO
N 021217 002 5702725 Jul 07, 2014 DP U-1043
5914131 Jul 07, 2014 DP U-1043
HYDROMORPHONE HYDROCHLORIDE - EXALGO
N 021217 003 5702725 Jul 07, 2014 DP U-1043
5914131 Jul 07, 2014 DP U-1043
HYDROMORPHONE HYDROCHLORIDE - EXALGO
N 021217 004 5702725 Jul 07, 2014 DP U-1043
5914131 Jul 07, 2014 DP U-1043
HYDROXOCOBALAMIN - CYANOKIT
N 022041 001 5834448 Nov 14, 2016 DP
HYDROXOCOBALAMIN - CYANOKIT
N 022041 002 5834448 Nov 14, 2016 DP U-789
HYDROXYPROGESTERONE CAPROATE - MAKENA
N 021945 001 ODE Feb 03, 2018
IBANDRONATE SODIUM - BONIVA
N 021455 001 6143326 Apr 21, 2017 U-642
6294196 Oct 07, 2019 DP
IBANDRONATE SODIUM - BONIVA
N 021455 002 6294196 Oct 07, 2019 DP
7192938 May 06, 2023 U-798
7410957 May 06, 2023 U-887
7718634 May 06, 2023 U-642
IBANDRONATE SODIUM - BONIVA
N 021858 001 5662918 Sep 02, 2014 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 103 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
IBRUTINIB - IMBRUVICA
N 205552 001 7514444 Dec 28, 2026 DS DP I-680 Feb 12, 2017
8008309 Dec 28, 2026 DS DP I-689 Jul 28, 2017
8476284 Dec 28, 2026 U-1456 NCE Nov 13, 2018
8476284 Dec 28, 2026 U-1491 ODE Nov 13, 2020
8497277 Dec 28, 2026 U-1456 ODE Feb 12, 2021
8497277 Dec 28, 2026 U-1491 ODE Jul 28, 2021
8697711 Dec 28, 2026 DS DP
8703780 Dec 28, 2026 U-1491
8735403 Dec 28, 2026 DS DP
8754090 Jun 03, 2031 U-1456
8754091 Dec 28, 2026 DP
IBUPROFEN - MIDOL LIQUID GELS
N 021472 001 6251426 Jun 25, 2018
IBUPROFEN - CALDOLOR
N 022348 001 6727286 Nov 27, 2021 DP U-981
IBUPROFEN - CALDOLOR
N 022348 002 6727286 Nov 27, 2021 DP U-981
8735452 Sep 30, 2029 U-981
8871810 Aug 27, 2030 U-1599
IBUPROFEN LYSINE - NEOPROFEN
N 021903 001 6342530 Nov 14, 2020 DP U-794
6342530 Nov 14, 2020 DP U-1127
6344479 Mar 20, 2021 DS DP U-794 Y
8415337 Mar 02, 2032 DS DP
IBUPROFEN; PSEUDOEPHEDRINE HYDROCHLORIDE - CHILDREN'S MOTRIN COLD
N 021128 001 6211246 Jun 10, 2019
ICATIBANT ACETATE - FIRAZYR
N 022150 001 5648333 Jul 15, 2015 DS DP U-1187 NCE Aug 25, 2016
ODE Aug 25, 2018
ICODEXTRIN - EXTRANEAL
N 021321 001 6077836 Jun 20, 2017 U-495
6248726 Jun 19, 2018 U-495
ICOSAPENT ETHYL - VASCEPA
N 202057 001 8188146 Jan 27, 2020 DS DP NP Jul 26, 2015
8293727 Feb 09, 2030 U-1287
8293728 Feb 09, 2030 U-1287
8298554 Apr 29, 2030 DP
8314086 Feb 09, 2030 U-1287
8318715 Feb 09, 2030 U-1287
8357677 Feb 09, 2030 U-1287
8367652 Feb 09, 2030 U-1287
8377920 Feb 09, 2030 U-1287
8399446 Feb 09, 2030 U-1287
8415335 Feb 09, 2030 U-1287
8426399 Feb 09, 2030 U-1287
8431560 Feb 09, 2030 U-1287
8440650 Feb 09, 2030 U-1287
8445003 Apr 29, 2030 U-1287
8445013 Apr 29, 2030 U-1287
8501225 Apr 29, 2030 U-1287
8518929 Apr 29, 2030 U-1287
8524698 Apr 29, 2030 U-1287
8546372 Apr 29, 2030 U-1287
8551521 Apr 29, 2030 U-1287
8563608 Apr 29, 2030 U-1287
8617593 Apr 29, 2030 U-1478
8617594 Apr 29, 2030 U-1287
8623406 Apr 29, 2030 U-1478
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 104 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
IDELALISIB - ZYDELIG
N 205858 001 6800620 Apr 24, 2021 DS U-1560 NCE Jul 23, 2019
6949535 Apr 24, 2021 DS U-1560
8138195 Apr 24, 2021 DS DP
8492389 Apr 24, 2021 DS DP
8637533 Apr 24, 2021 DS DP
8865730 Mar 05, 2033 DS DP U-1615
RE44599 Jul 21, 2025 U-1558
RE44638 Aug 05, 2025 DS DP
IDELALISIB - ZYDELIG
N 205858 002 6800620 Apr 24, 2021 DS U-1560 NCE Jul 23, 2019
6949535 Apr 24, 2021 DS U-1560
8138195 Apr 24, 2021 DS DP
8492389 Apr 24, 2021 DS DP
8637533 Apr 24, 2021 DS DP
8865730 Mar 05, 2033 DS DP U-1615
RE44599 Jul 21, 2025 U-1558
RE44638 Aug 05, 2025 DS DP
ILOPERIDONE - FANAPT
N 022192 001 8586610 Nov 02, 2027 U-1625
RE39198 Nov 15, 2016 DS DP U-971
ILOPERIDONE - FANAPT
N 022192 002 8586610 Nov 02, 2027 U-1625
RE39198 Nov 15, 2016 DS DP U-971
ILOPERIDONE - FANAPT
N 022192 003 8586610 Nov 02, 2027 U-1625
RE39198 Nov 15, 2016 DS DP U-971
ILOPERIDONE - FANAPT
N 022192 004 8586610 Nov 02, 2027 U-1625
RE39198 Nov 15, 2016 DS DP U-971
ILOPERIDONE - FANAPT
N 022192 005 8586610 Nov 02, 2027 U-1625
RE39198 Nov 15, 2016 DS DP U-971
ILOPERIDONE - FANAPT
N 022192 006 8586610 Nov 02, 2027 U-1625
RE39198 Nov 15, 2016 DS DP U-971
ILOPERIDONE - FANAPT
N 022192 007 8586610 Nov 02, 2027 U-1625
RE39198 Nov 15, 2016 DS DP U-971
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 105 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
IMATINIB MESYLATE - GLEEVEC
N 021335 001 5521184 Jan 04, 2015 DS DP
6894051 May 23, 2019 DS DP U-649
6958335 Dec 19, 2021 U-791
RE43932 Jan 16, 2019 DS DP
RE43932*PED Jul 16, 2019
IMATINIB MESYLATE - GLEEVEC
N 021335 002 5521184 Jan 04, 2015 DS DP U-649
6894051 May 23, 2019 DS DP U-649
6958335 Dec 19, 2021 U-791
RE43932 Jan 16, 2019 DS DP
RE43932*PED Jul 16, 2019
IMATINIB MESYLATE - GLEEVEC
N 021588 001 5521184 Jan 04, 2015 DS DP I-666 Jan 25, 2016
6894051 May 23, 2019 DS DP U-649 ODE Dec 19, 2015
6958335 Dec 19, 2021 U-791 ODE Jan 25, 2020
7544799 Jan 16, 2019 DS DP Y
7544799*PED Jul 16, 2019
RE43932 Jan 16, 2019 DS DP
RE43932*PED Jul 16, 2019
IMATINIB MESYLATE - GLEEVEC
N 021588 002 5521184 Jan 04, 2015 I-666 Jan 25, 2016
6894051 May 23, 2019 DS DP U-649 ODE Dec 19, 2015
6958335 Dec 19, 2021 U-791 ODE Jan 25, 2020
7544799 Jan 16, 2019 DS DP Y
7544799*PED Jul 16, 2019
RE43932 Jan 16, 2019 DS DP
RE43932*PED Jul 16, 2019
IMIQUIMOD - ALDARA
N 020723 001 7696159 Apr 01, 2024 DS U-1047
7696159 Apr 01, 2024 DS U-1048
IMIQUIMOD - ZYCLARA
N 022483 001 8236816 Dec 11, 2029 U-68
8299109 Dec 11, 2029 U-68
8598196 Aug 18, 2029 U-172
8598196 Aug 18, 2029 U-1455
IMIQUIMOD - ZYCLARA
N 022483 002 8222270 Dec 11, 2029 U-68 NS Jul 15, 2014
INDACATEROL MALEATE - ARCAPTA NEOHALER
N 022383 001 6878721 Oct 10, 2020 DS DP U-1168 NCE Jul 01, 2016
8067437 Jun 02, 2020 U-1168
8479730 Oct 11, 2028 DP
INDINAVIR SULFATE - CRIXIVAN
N 020685 001 6645961 Mar 04, 2018 DP
6689761 Feb 10, 2021 U-554
INDINAVIR SULFATE - CRIXIVAN
N 020685 003 6645961 Mar 04, 2018 DP
6689761 Feb 10, 2021 U-554
INDINAVIR SULFATE - CRIXIVAN
N 020685 005 6645961 Mar 04, 2018 DP
6689761 Feb 10, 2021 U-554
INDINAVIR SULFATE - CRIXIVAN
N 020685 006 6645961 Mar 04, 2018 DP
6689761 Feb 10, 2021 U-554
INDIUM IN-111 PENTETREOTIDE KIT - OCTREOSCAN
N 020314 001 5753627 May 19, 2015 U-1125
5776894 Jul 07, 2015 DS DP
6123916 Sep 26, 2017 U-1125
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 106 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT
EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY
EXPIRATION
DATE CODES REQUESTED CODE(S)
DATE
INDOMETHACIN - TIVORBEX
N 204768 001 8734847 Apr 23, 2030 DP NP
Feb 24, 2017
INDOMETHACIN - TIVORBEX
N 204768 002 8734847 Apr 23, 2030 DP NP
Feb 24, 2017
INGENOL MEBUTATE - PICATO
N 202833 001 6432452 Aug 19, 2018 DS U-68 NCE
Jan 23, 2017
6844013 Dec 13, 2018 DS DP U-1221
7410656 Aug 19, 2018 DS U-1222
8278292 Feb 20, 2027 DS DP
8372827 Dec 18, 2026 DS DP
8372828 Dec 18, 2026 DS DP
8377919 Dec 18, 2026 DS DP
8536163 Dec 18, 2026 U-1440
8716271 Dec 18, 2026 U-1440
8735375 Dec 18, 2026 U-1440
INGENOL MEBUTATE - PICATO
N 202833 002 6432452 Aug 19, 2018 DS U-68 NCE
Jan 23, 2017
6844013 Dec 13, 2018 DS DP U-1221
7410656 Aug 19, 2018 DS U-1222
8278292 Feb 20, 2027 DS DP
8372827 Dec 18, 2026 DS DP
8372828 Dec 18, 2026 DS DP
8377919 Dec 18, 2026 DS DP
8536163 Dec 18, 2026 U-1440
8716271 Dec 18, 2026 U-1440
8735375 Dec 18, 2026 U-1440
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30
N 021172 001 5866538 Jun 20, 2017 DP
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30 PENFILL
N 021172 002 5866538 Jun 19, 2017 DP
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30 PENFILL
N 021172 003 5866538 Jun 19, 2017 DP
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 70/30 FLEXPEN
N 021172 004 5866538 Jun 20, 2017 DP
6004297 Jan 28, 2019 DP
RE41956 Jan 21, 2021 DP
RE43834 Jan 28, 2019 DP
INSULIN ASPART PROTAMINE RECOMBINANT; INSULIN ASPART RECOMBINANT - NOVOLOG MIX 50/50
N 021810 001 5866538 Jun 20, 2017 DP
INSULIN ASPART RECOMBINANT - NOVOLOG
N 020986 001 5866538 Jun 20, 2017 DP
INSULIN ASPART RECOMBINANT - NOVOLOG PENFILL
N 020986 002 5693027 Dec 02, 2014 DP
5866538 Jun 20, 2017 DP
INSULIN ASPART RECOMBINANT - NOVOLOG FLEXPEN
N 020986 003 5866538 Jun 20, 2017 DP
6004297 Jan 28, 2019 DP
RE41956 Jan 21, 2021 DP
RE43834 Jan 28, 2019 DP
INSULIN ASPART RECOMBINANT - NOVOLOG INNOLET
N 020986 004 5866538 Jun 20, 2017 DP
RE41956 Jan 21, 2021 DP
INSULIN ASPART RECOMBINANT - NOVOLOG FLEXTOUCH
N 020986 005 5618913*PED Dec 07, 2014
5866538 Jun 20, 2017 DP
5866538*PED Dec 20, 2017
6899699 Jan 02, 2022 DP
7686786 Aug 03, 2026 DP
8672898 Jan 02, 2022 DP
8684969 Oct 20, 2025 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 107 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
INSULIN DETEMIR RECOMBINANT - LEVEMIR
N 021536 001 5750497 Jun 16, 2019 DS DP U-668 M-115 Apr 06, 2015
5866538 Jun 20, 2017 DS DP M-117 May 18, 2015
INSULIN DETEMIR RECOMBINANT - LEVEMIR FLEXPEN
N 021536 002 5750497 Jun 16, 2019 DS DP U-668
5866538 Jun 20, 2017 DS DP
6004297 Jan 28, 2019 DP
RE41956 Jan 21, 2021 DP
RE43834 Jan 28, 2019 DP
INSULIN DETEMIR RECOMBINANT - LEVEMIR INNOLET
N 021536 003 5750497 Jun 16, 2019 DS DP U-668
5866538 Jun 20, 2017 DS DP
INSULIN DETEMIR RECOMBINANT - LEVEMIR PENFILL
N 021536 004 5750497 Jun 16, 2019 DS DP U-668
5866538 Jun 20, 2017 DS DP
INSULIN DETEMIR RECOMBINANT - LEVEMIR FLEXTOUCH
N 021536 005 5750497 Jun 16, 2019 DS DP U-668
5866538 Jun 20, 2017 DP
6899699 Jan 02, 2022 DP
7686786 Aug 03, 2026 DP
8672898 Jan 02, 2022 DP
8684969 Oct 20, 2025 DP
INSULIN GLARGINE RECOMBINANT - LANTUS
N 021081 001 5656722 Aug 12, 2014 DS DP U-948
7476652 Jul 23, 2023 DP
7713930 Jun 13, 2023 DP
7918833 Sep 23, 2027 DP
INSULIN GLARGINE RECOMBINANT - LANTUS SOLOSTAR
N 021081 002 8512297 Sep 15, 2024 DP
8556864 Mar 03, 2024 DP
8603044 Mar 02, 2024 DP
8679069 Apr 12, 2025 DP
INSULIN GLULISINE RECOMBINANT - APIDRA
N 021629 001 6221633 Jun 18, 2018 DS DP U-471
6960561 Jan 25, 2023 DP U-471
7452860 Mar 22, 2022 DP
7696162 Mar 22, 2022 DP U-471
INSULIN GLULISINE RECOMBINANT - APIDRA
N 021629 002 6221633 Jun 18, 2018 DS DP U-471
6960561 Jan 25, 2023 DP U-471
7452860 Mar 22, 2022 DP
7696162 Mar 22, 2022 DP U-471
INSULIN GLULISINE RECOMBINANT - APIDRA SOLOSTAR
N 021629 003 6221633 Jun 18, 2018 DS DP U-471
6960561 Jan 25, 2023 DP U-471
7452860 Mar 22, 2022 DP
7696162 Mar 22, 2022 DP U-471
7918833 Sep 23, 2027 DP
8512297 Sep 15, 2024 DP
8556864 Mar 03, 2024 DP
8603044 Mar 02, 2024 DP
8679069 Apr 12, 2025 DP
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT - HUMALOG MIX 75/25 KWIKPEN
N 021017 002 7291132 Aug 09, 2024 DP
INSULIN LISPRO PROTAMINE RECOMBINANT; INSULIN LISPRO RECOMBINANT - HUMALOG MIX 50/50 KWIKPEN
N 021018 002 7291132 Aug 09, 2024 DP
INSULIN LISPRO RECOMBINANT - HUMALOG
N 020563 001 NR Oct 12, 2015
INSULIN LISPRO RECOMBINANT - HUMALOG PEN
N 020563 002 NR Oct 12, 2015
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 108 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
INSULIN LISPRO RECOMBINANT - HUMALOG KWIKPEN
N 020563 003 7291132 Aug 09, 2024 DP
INSULIN RECOMBINANT HUMAN - EXUBERA
N 021868 001 5740794 Apr 21, 2015 DP
6257233 May 14, 2019 U-704
6543448 Sep 21, 2014 DP
6546929 May 14, 2019 U-704
6582728 Jun 24, 2020 DP
6685967 Sep 11, 2018 DP
INSULIN RECOMBINANT HUMAN - EXUBERA
N 021868 002 5740794 Apr 21, 2015 DP
6257233 May 14, 2019 U-704
6543448 Sep 21, 2014 DP
6546929 May 14, 2019 U-704
6582728 Jun 24, 2020 DP
6685967 Sep 11, 2018 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 109 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
INSULIN RECOMBINANT HUMAN - AFREZZA
N 022472 001 6071497 May 15, 2015 DP U-1533 NP Jun 27, 2017
6428771 May 15, 2015 DP U-1533
6444226 Jun 29, 2020 DP U-1534
6652885 Jun 29, 2020 U-1535
6663898 Sep 30, 2014 DP
6906030 Sep 30, 2014 DP
7276534 Sep 30, 2014 DP U-1536
7305986 Jan 16, 2023 DP
7464706 Mar 02, 2023 DP
7648960 Jun 29, 2020 U-1535
7943178 Jun 29, 2020 DP U-1535
7943572 Aug 10, 2026 U-1539
8119593 Aug 11, 2029 U-1537
8133514 Sep 30, 2014 DP
8146588 Apr 24, 2023 DP
8156936 Jan 16, 2023 DP
8215300 Nov 24, 2022 DP
8227409 Mar 08, 2031 DP U-1538
8258095 Aug 11, 2029 U-1537
8389470 Jun 29, 2020 DP
8394414 May 15, 2015 DP U-1533
8424518 Oct 17, 2031 DP
8485180 Mar 25, 2030 DP
8499757 Feb 19, 2032 DP
8551528 Jun 11, 2030 DP
8623817 Sep 18, 2029 U-1537
8636001 Jul 12, 2032 DP
8729019 Jun 06, 2028 DP
8734845 Jun 11, 2030 DP
8778403 Jun 11, 2030 DP U-1538
8889099 Jun 29, 2020 DP U-1621
INSULIN RECOMBINANT HUMAN - AFREZZA
N 022472 002 6071497 May 15, 2015 DP U-1533 NP Jun 27, 2017
6428771 May 15, 2015 DP U-1533
6444226 Jun 29, 2020 DP U-1534
6652885 Jun 29, 2020 U-1535
6663898 Sep 30, 2014 DP
6906030 Sep 30, 2014 DP
7276534 Sep 30, 2014 DP U-1536
7305986 Jan 16, 2023 DP
7464706 Mar 02, 2023 DP
7648960 Jun 29, 2020 U-1535
7943178 Jun 29, 2020 DP U-1535
8119593 Aug 11, 2029 U-1537
8133514 Sep 30, 2014 DP
8146588 Apr 24, 2023 DP
8156936 Jan 16, 2023 DP
8215300 Nov 24, 2022 DP
8227409 Mar 08, 2031 DP U-1538
8258095 Aug 11, 2029 U-1537
8389470 Jun 29, 2020 DP
8394414 May 15, 2015 DP U-1533
8485180 Mar 25, 2030 DP
8499757 Feb 19, 2032 DP
8551528 Jun 11, 2030 DP
8636001 Jul 12, 2032 DP
8729019 Jun 06, 2028 DP
8734845 Jun 11, 2030 DP
8778403 Jun 11, 2030 DP U-1538
8889099 Jun 29, 2020 DP U-1621
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN - HUMULIN 70/30
N 019717 001 7291132 Aug 09, 2024 DP
INSULIN RECOMBINANT HUMAN; INSULIN SUSP ISOPHANE RECOMBINANT HUMAN - HUMULIN 70/30 PEN
N 019717 002 7291132 Aug 09, 2024 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 110 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT
PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION
PATENT DELIST EXCLUSIVITY
EXPIRATION
DATE
CODES REQUESTED CODE(S)
DATE
INSULIN SUSP ISOPHANE RECOMBINANT HUMAN - HUMULIN N
N 018781 001 7291132 Aug 09, 2024
DP
IOBENGUANE SULFATE I-123 - ADREVIEW
N 022290 001
I-669
Mar 20, 2016
ODE
Sep 19, 2015
IOFLUPANE I-123 - DATSCAN
N 022454 001 5310912 Feb 25, 2015 DS
NCE
Jan 14, 2016
IPRATROPIUM BROMIDE - ATROVENT HFA
N 021527 001 5676930 Oct 14, 2014
DP
5683677 Nov 04, 2014
DP
6739333 May 26, 2020
DP
6983743 May 26, 2020
DP
IRBESARTAN - AVAPRO
N 020757 001 6342247 Jun 07, 2015
IRBESARTAN - AVAPRO
N 020757 002 6342247 Jun 07, 2015
IRBESARTAN - AVAPRO
N 020757 003 6342247 Jun 07, 2015
IRINOTECAN HYDROCHLORIDE - CAMPTOSAR
N 020571 001 6403569 Apr 28, 2020
U-449
6794370 May 01, 2020
U-606
IRINOTECAN HYDROCHLORIDE - CAMPTOSAR
N 020571 002 6403569
Apr 28, 2020
U-449
6794370
May 01, 2020
U-606
IRON DEXTRAN - DEXFERRUM
N 040024 001 5624668
Sep 29, 2015
IRON SUCROSE - VENOFER
N 021135 001
NPP
Sep 21, 2015
IRON SUCROSE - VENOFER
N 021135 002
NPP
Sep 21, 2015
IRON SUCROSE - VENOFER
N 021135 005
NPP
Sep 21, 2015
ISOTRETINOIN - ABSORICA
N 021951 001 7435427
Sep 21, 2021
DP
NP
May 25, 2015
8367102
Sep 21, 2021
U-1347
ISOTRETINOIN - ABSORICA
N 021951 002 7435427
Sep 21, 2021
DP
NP
May 25, 2015
8367102
Sep 21, 2021
U-1347
ISOTRETINOIN - ABSORICA
N 021951 003 7435427
Sep 21, 2021
DP
NP
May 25, 2015
8367102
Sep 21, 2021
U-1347
ISOTRETINOIN - ABSORICA
N 021951 004 7435427
Sep 21, 2021
DP
NP
May 25, 2015
8367102
Sep 21, 2021
U-1347
ITRACONAZOLE - SPORANOX
N 020657 001 5707975
Jan 13, 2015
6407079
Jun 18, 2019
ITRACONAZOLE - SPORANOX
N 020966 001 6407079
Jun 18, 2019
ITRACONAZOLE - ONMEL
N 022484 001 6509038
May 12, 2017
DP U-1054
7081255
May 12, 2017
DP U-1054
8486456
Oct 03, 2028
DP U-1054
8591948
May 12, 2017
DP U-1054
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 111 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT
PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT
DELIST EXCLUSIVITY EXPIRATION
DATE CODES
REQUESTED CODE(S) DATE
IVACAFTOR - KALYDECO
N 203188 001 7495103 May 20, 2027 DS DP
NCE Jan 31, 2017
8324242 Apr 18, 2027 U-1311
ODE Jan 31, 2019
8410274 Dec 28, 2026 DP
8754224 Dec 28, 2026 DS DP
IVERMECTIN - SKLICE
N 202736 001 6103248 May 22, 2018 DP
NP Feb 07, 2015
8791153 Oct 12, 2027 DP
IVERMECTIN - SOOLANTRA
N 206255 001
NP Dec 19, 2017
IXABEPILONE - IXEMPRA KIT
N 022065 001 6670384 Jan 23, 2022 DP U-959
M-61 Oct 18, 2014
6670384 Jan 23, 2022 DP U-960
PED Apr 18, 2015
7022330 Jan 23, 2022 DP U-958
7125899 May 26, 2018 DS DP U-957
7312237 Aug 21, 2024 U-965
RE41393 Feb 08, 2022 U-961
RE41911 Sep 28, 2020 DS DP U-961
IXABEPILONE - IXEMPRA KIT
N 022065 002 6670384 Jan 23, 2022 DP U-959
M-61 Oct 18, 2014
6670384 Jan 23, 2022 DP U-960
PED Apr 18, 2015
7022330 Jan 23, 2022 DP U-958
7125899 May 26, 2018 DS DP U-957
7312237 Aug 21, 2024 U-965
RE41393 Feb 08, 2022 U-961
RE41911 Sep 28, 2020 DS DP U-961
KETOCONAZOLE - EXTINA
N 021738 001 7553835 Oct 19, 2018 DP U-245
8026238 Oct 19, 2018 DP U-1213
KETOCONAZOLE - XOLEGEL
N 021946 001 7179475 Dec 04, 2018 DP U-792
8232276 Nov 24, 2020 DP
8735393 Dec 04, 2018 DP
KETOROLAC TROMETHAMINE - ACULAR LS
N 021528 001 8008338 May 24, 2027 DS DP U-1181
8207215 May 28, 2024 U-1251
8377982 May 28, 2024 U-1363
8377982*PED Nov 28, 2024
8541463 May 28, 2024 U-1441
8541463*PED Nov 28, 2024
8648107 May 28, 2024 DP
8906950 May 28, 2024 U-1626
KETOROLAC TROMETHAMINE - SPRIX
N 022382 001 6333044 Dec 25, 2018 DP U-1057
KETOROLAC TROMETHAMINE - ACUVAIL
N 022427 001 7842714 Aug 15, 2029 DS DP
8512717 Mar 07, 2028 DP
KETOROLAC TROMETHAMINE; PHENYLEPHRINE HYDROCHLORIDE - OMIDRIA
N 205388 001 8173707 Jul 30, 2023 U-1518
NP May 30, 2017
8586633 Jul 30, 2023 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 112 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LACOSAMIDE - VIMPAT
N 022253 001 5654301 Aug 05, 2014 DS DP U-914 D-143 Aug 29, 2017
RE38551 Mar 17, 2022 DS DP U-1566 D-144 Aug 29, 2017
RE38551 Mar 17, 2022 DS DP U-1567 I-696 Aug 29, 2017
LACOSAMIDE - VIMPAT
N 022253 002 5654301 Aug 05, 2014 DS DP U-914 D-143 Aug 29, 2017
RE38551 Mar 17, 2022 DS DP U-1566 D-144 Aug 29, 2017
RE38551 Mar 17, 2022 DS DP U-1567 I-696 Aug 29, 2017
LACOSAMIDE - VIMPAT
N 022253 003 5654301 Aug 05, 2014 DS DP U-914 D-143 Aug 29, 2017
RE38551 Mar 17, 2022 DS DP U-1566 D-144 Aug 29, 2017
RE38551 Mar 17, 2022 DS DP U-1567 I-696 Aug 29, 2017
LACOSAMIDE - VIMPAT
N 022253 004 5654301 Aug 05, 2014 DS DP U-914 D-143 Aug 29, 2017
RE38551 Mar 17, 2022 DS DP U-1566 D-144 Aug 29, 2017
RE38551 Mar 17, 2022 DS DP U-1567 I-696 Aug 29, 2017
LACOSAMIDE - VIMPAT
N 022254 001 5654301 Aug 05, 2014 DS DP U-911 D-143 Aug 29, 2017
RE38551 Mar 17, 2022 DS DP U-1565 D-144 Aug 29, 2017
RE38551 Mar 17, 2022 DS DP U-1568 I-696 Aug 29, 2017
LACOSAMIDE - VIMPAT
N 022255 001 5654301 Aug 05, 2014 DS DP U-914 D-143 Aug 29, 2017
RE38551 Mar 17, 2022 DS DP U-1566 D-144 Aug 29, 2017
RE38551 Mar 17, 2022 DS DP U-1567 I-696 Aug 29, 2017
LAMIVUDINE - EPIVIR
N 020564 001 5905082 May 18, 2016 DS DP U-248
LAMIVUDINE - EPIVIR
N 020564 003 5905082 May 18, 2016
LAMIVUDINE - EPIVIR
N 020596 001 6004968 Mar 20, 2018
LAMIVUDINE - EPIVIR-HBV
N 021003 001 5905082 May 18, 2016
LAMIVUDINE - EPIVIR-HBV
N 021004 001 6004968 Mar 20, 2018
LAMIVUDINE; ZIDOVUDINE - COMBIVIR
N 020857 001 5905082 May 18, 2016 DS DP U-248
LAMOTRIGINE - LAMICTAL XR
N 022115 001 8637512 Jun 14, 2028 DP
LAMOTRIGINE - LAMICTAL XR
N 022115 002 8637512 Jun 14, 2028 DP
LAMOTRIGINE - LAMICTAL XR
N 022115 003 8637512 Jun 14, 2028 DP
LAMOTRIGINE - LAMICTAL XR
N 022115 004 8637512 Jun 14, 2028 DP
LAMOTRIGINE - LAMICTAL XR
N 022115 005 8637512 Jun 14, 2028 DP
LAMOTRIGINE - LAMICTAL XR
N 022115 006 8637512 Jun 14, 2028 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 113 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LAMOTRIGINE - LAMICTAL ODT
N 022251 001 7919115 Jan 04, 2029 DS DP
8840925 Jul 02, 2028 DP U-1596
LAMOTRIGINE - LAMICTAL ODT
N 022251 002 7919115 Jan 04, 2029 DS DP
8840925 Jul 02, 2028 DP U-1596
LAMOTRIGINE - LAMICTAL ODT
N 022251 003 7919115 Jan 04, 2029 DS DP
8840925 Jul 02, 2028 DP U-1596
LAMOTRIGINE - LAMICTAL ODT
N 022251 004 7919115 Jan 04, 2029 DS DP
8840925 Jul 02, 2028 DP U-1596
LANREOTIDE ACETATE - SOMATULINE DEPOT
N 022074 001 5595760 Mar 08, 2020 DP U-831 I-701 Dec 19, 2017
ODE Aug 30, 2014
ODE Dec 16, 2021
LANREOTIDE ACETATE - SOMATULINE DEPOT
N 022074 002 5595760 Mar 08, 2020 DP U-831 I-701 Dec 19, 2017
ODE Aug 30, 2014
ODE Dec 16, 2021
LANREOTIDE ACETATE - SOMATULINE DEPOT
N 022074 003 5595760 Mar 08, 2020 DP U-831 I-701 Dec 19, 2017
ODE Aug 30, 2014
ODE Dec 16, 2021
LANSOPRAZOLE - PREVACID
N 021428 001 6328994 May 17, 2019
7399485 May 26, 2018 DP
7431942 May 17, 2019 DP
7875292 May 17, 2019 DP
LANSOPRAZOLE - PREVACID
N 021428 002 6328994 May 17, 2019
7399485 May 26, 2018 DP
7431942 May 17, 2019 DP
7875292 May 17, 2019 DP
LANSOPRAZOLE - PREVACID IV
N 021566 001 7396841 Aug 17, 2021 DP U-947
LANTHANUM CARBONATE - FOSRENOL
N 021468 001 5968976 Oct 26, 2018 DP U-613
7381428 Aug 26, 2024 U-890
7465465 Aug 26, 2024 DP
LANTHANUM CARBONATE - FOSRENOL
N 021468 002 5968976 Oct 26, 2018 DP U-613
7381428 Aug 26, 2024 U-890
7465465 Aug 26, 2024 DP
LANTHANUM CARBONATE - FOSRENOL
N 021468 003 5968976 Oct 26, 2018 DP U-613
7381428 Aug 26, 2024 U-890
7465465 Aug 26, 2024 DP
LANTHANUM CARBONATE - FOSRENOL
N 021468 004 5968976 Oct 26, 2018 DP U-613
7381428 Aug 26, 2024 U-890
7465465 Aug 26, 2024 DP
LANTHANUM CARBONATE - FOSRENOL
N 204734 001 5968976 Oct 26, 2018 DP U-1592
7465465 Aug 26, 2024 DP
LANTHANUM CARBONATE - FOSRENOL
N 204734 002 5968976 Oct 26, 2018 DP U-1592
7465465 Aug 26, 2024 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 114 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
PATENT
PATENT EXCLUSIVITY
NO PATENT NO
EXPIRATION
PATENT DELIST EXCLUSIVITY EXPIRATION
DATE
CODES REQUESTED CODE(S) DATE
LAPATINIB DITOSYLATE - TYKERB
N 022059 001 6391874
Jul 11, 2017
DS DP U-800
6391874
Jul 11, 2017
DS DP U-1429
6713485
Sep 29, 2020
DS DP U-800
6713485
Sep 29, 2020
DS DP U-1429
6727256
Jan 08, 2019
DS DP U-800
6727256
Jan 08, 2019
DS DP U-1429
6828320
Jul 11, 2017
U-800
6828320
Jul 11, 2017
U-1429
7157466
Nov 19, 2021
DS DP
8513262
Jan 08, 2019
DS DP
8821927
Jun 12, 2029
DS DP
LEDIPASVIR; SOFOSBUVIR - HARVONI
N 205834 001 7964580
Mar 26, 2029
DS DP U-1470 NCE Oct 10, 2019
8088368
May 12, 2030
DS DP
8273341
May 12, 2030
U-1470
8334270
Mar 21, 2028
DS DP U-1470
8580765
Mar 21, 2028
DS DP U-1470
8618076
Dec 11, 2030
DS DP U-1470
8633309
Mar 26, 2029
DS DP U-1470
8735372
Mar 21, 2028
U-1470
8822430
May 12, 2030
DS DP U-1470
8841278
May 12, 2030
DP U-1470
8889159
Mar 26, 2029
DP U-1470
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 115 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LENALIDOMIDE - REVLIMID
N 021880 001 5635517 Oct 04, 2019 DS U-1211 I-672 Jun 05, 2016
6045501 Aug 28, 2018 U-1210 ODE Jun 05, 2020
6281230 Jul 24, 2016 U-1212
6281230 Jul 24, 2016 U-1414
6315720 Oct 23, 2020 U-1210
6555554 Jul 24, 2016 DP U-1211
6561976 Aug 28, 2018 U-1210
6561977 Oct 23, 2020 U-1210
6755784 Oct 23, 2020 U-1210
6908432 Aug 28, 2018 U-1210
7119106 Jul 24, 2016 DP
7189740 Apr 11, 2023 U-1215
7465800 Apr 27, 2027 DS DP
7468363 Oct 07, 2023 U-1414
7855217 Nov 24, 2024 DS DP
7968569 Oct 07, 2023 U-1216
8204763 Aug 28, 2018 U-1249
8288415 Jul 24, 2016 DS DP
8315886 Oct 23, 2020 U-1249
8404717 Apr 11, 2023 U-1215
8530498 May 15, 2023 U-1216
8589188 Aug 28, 2018 U-1210
8626531 Oct 23, 2020 U-1210
8648095 May 15, 2023 U-1216
8741929 Mar 08, 2028 U-1414
LENALIDOMIDE - REVLIMID
N 021880 002 5635517 Oct 04, 2019 DS U-1211 I-672 Jun 05, 2016
6045501 Aug 28, 2018 U-1210 ODE Jun 05, 2020
6281230 Jul 24, 2016 U-1212
6281230 Jul 24, 2016 U-1414
6315720 Oct 23, 2020 U-1210
6555554 Jul 24, 2016 DP U-1211
6561976 Aug 28, 2018 U-1210
6561977 Oct 23, 2020 U-1210
6755784 Oct 23, 2020 U-1210
6908432 Aug 28, 2018 U-1210
7119106 Jul 24, 2016 DP
7189740 Apr 11, 2023 U-1215
7465800 Apr 27, 2027 DS DP
7468363 Oct 07, 2023 U-1414
7855217 Nov 24, 2024 DS DP
7968569 Oct 07, 2023 U-1216
8204763 Aug 28, 2018 U-1249
8288415 Jul 24, 2016 DS DP
8315886 Oct 23, 2020 U-1249
8404717 Apr 11, 2023 U-1215
8530498 May 15, 2023 U-1216
8589188 Aug 28, 2018 U-1210
8626531 Oct 23, 2020 U-1210
8648095 May 15, 2023 U-1216
8741929 Mar 08, 2028 U-1414
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 116 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LENALIDOMIDE - REVLIMID
N 021880 003 5635517 Oct 04, 2019 DS U-1211 I-672 Jun 05, 2016
6045501 Aug 28, 2018 U-1210 ODE Jun 05, 2020
6281230 Jul 24, 2016 U-1212
6281230 Jul 24, 2016 U-1414
6315720 Oct 23, 2020 U-1210
6555554 Jul 24, 2016 DP U-1211
6561976 Aug 28, 2018 U-1210
6561977 Oct 23, 2020 U-1210
6755784 Oct 23, 2020 U-1210
6908432 Aug 28, 2018 U-1210
7119106 Jul 24, 2016 DP
7189740 Apr 11, 2023 U-1215
7465800 Apr 27, 2027 DS DP
7468363 Oct 07, 2023 U-1414
7855217 Nov 24, 2024 DS DP
7968569 Oct 07, 2023 U-1216
8204763 Aug 28, 2018 U-1249
8288415 Jul 24, 2016 DS DP
8315886 Oct 23, 2020 U-1249
8404717 Apr 11, 2023 U-1215
8530498 May 15, 2023 U-1216
8589188 Aug 28, 2018 U-1210
8626531 Oct 23, 2020 U-1210
8648095 May 15, 2023 U-1216
8741929 Mar 08, 2028 U-1414
LENALIDOMIDE - REVLIMID
N 021880 004 5635517 Oct 04, 2019 DS U-1211 I-672 Jun 05, 2016
6045501 Aug 28, 2018 U-1210 ODE Jun 05, 2020
6281230 Jul 24, 2016 U-1212
6281230 Jul 24, 2016 U-1414
6315720 Oct 23, 2020 U-1210
6555554 Jul 24, 2016 DP U-1211
6561976 Aug 28, 2018 U-1210
6561977 Oct 23, 2020 U-1210
6755784 Oct 23, 2020 U-1210
6908432 Aug 28, 2018 U-1210
7119106 Jul 24, 2016 DP
7189740 Apr 11, 2023 U-1215
7465800 Apr 27, 2027 DS DP
7468363 Oct 07, 2023 U-1414
7855217 Nov 24, 2024 DS DP
7968569 Oct 07, 2023 U-1216
8204763 Aug 28, 2018 U-1249
8288415 Jul 24, 2016 DS DP
8315886 Oct 23, 2020 U-1249
8404717 Apr 11, 2023 U-1215
8530498 May 15, 2023 U-1216
8589188 Aug 28, 2018 U-1210
8626531 Oct 23, 2020 U-1210
8648095 May 15, 2023 U-1216
8741929 Mar 08, 2028 U-1414
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 117 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LENALIDOMIDE - REVLIMID
N 021880 005 5635517 Oct 04, 2019 DS U-1211 I-672 Jun 05, 2016
6045501 Aug 28, 2018 U-1210 ODE Jun 05, 2020
6281230 Jul 24, 2016 U-1212
6281230 Jul 24, 2016 U-1414
6315720 Oct 23, 2020 U-1210
6555554 Jul 24, 2016 DP U-1211
6561976 Aug 28, 2018 U-1210
6561977 Oct 23, 2020 U-1210
6755784 Oct 23, 2020 U-1210
6908432 Aug 28, 2018 U-1210
7119106 Jul 24, 2016 DP
7189740 Apr 11, 2023 U-1215
7465800 Apr 27, 2027 DS DP
7468363 Oct 07, 2023 U-1414
7855217 Nov 24, 2024 DS DP
7968569 Oct 07, 2023 U-1216
8204763 Aug 28, 2018 U-1249
8288415 Jul 24, 2016 DS DP
8315886 Oct 23, 2020 U-1249
8404717 Apr 11, 2023 U-1215
8530498 May 15, 2023 U-1216
8589188 Aug 28, 2018 U-1210
8626531 Oct 23, 2020 U-1210
8648095 May 15, 2023 U-1216
8741929 Mar 08, 2028 U-1414
LENALIDOMIDE - REVLIMID
N 021880 006 5635517 Oct 04, 2019 DS DP U-1211 I-672 Jun 05, 2016
6045501 Aug 28, 2018 U-1210 NS Jun 05, 2016
6281230 Jul 24, 2016 U-1212 ODE Jun 05, 2020
6281230 Jul 24, 2016 U-1414
6315720 Oct 23, 2020 U-1210
6555554 Jul 24, 2016 DP U-1211
6561976 Aug 28, 2018 U-1210
6561977 Oct 23, 2020 U-1210
6755784 Oct 23, 2020 U-1210
6908432 Aug 28, 2018 U-1210
7119106 Jul 24, 2016 DP
7189740 Apr 11, 2023 U-1215
7465800 Apr 27, 2027 DS DP
7468363 Oct 07, 2023 U-1414
7855217 Nov 24, 2024 DS DP
7968569 Oct 07, 2023 U-1216
8204763 Aug 28, 2018 U-1249
8288415 Jul 24, 2016 DS DP
8315886 Oct 23, 2020 U-1249
8404717 Apr 11, 2023 U-1215
8530498 May 15, 2023 U-1216
8589188 Aug 28, 2018 U-1210
8626531 Oct 23, 2020 U-1210
8648095 May 15, 2023 U-1216
8741929 Mar 08, 2028 U-1414
LEUPROLIDE ACETATE - LUPRON DEPOT
N 019732 001 6036976 Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT-PED
N 020263 002 6036976 Dec 13, 2016 M-107 Oct 08, 2014
LEUPROLIDE ACETATE - LUPRON DEPOT-PED
N 020263 005 6036976 Dec 13, 2016 M-107 Oct 08, 2014
LEUPROLIDE ACETATE - LUPRON DEPOT-PED
N 020263 006 6036976 Dec 13, 2016 M-107 Oct 08, 2014
LEUPROLIDE ACETATE - LUPRON DEPOT-PED
N 020263 007 6036976 Dec 13, 2016 DP NP Aug 15, 2014
LEUPROLIDE ACETATE - LUPRON DEPOT-PED
N 020263 008 6036976 Dec 13, 2016 DP NP Aug 15, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 118 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LEUPROLIDE ACETATE - LUPRON DEPOT
N 020517 001 6036976 Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT
N 020517 002 6036976 Dec 13, 2016
LEUPROLIDE ACETATE - LUPRON DEPOT
N 020517 003 6036976 Dec 13, 2016 DP
7429559 Dec 13, 2016 DP
LEUPROLIDE ACETATE - LUPRON DEPOT
N 020708 001 6036976 Dec 13, 2016
LEUPROLIDE ACETATE - VIADUR
N 021088 001 5728396 Jan 30, 2017 U-316
5932547 Jun 13, 2017
5985305 Jan 30, 2017
6113938 Jul 24, 2018
6124261 Jun 13, 2017
6132420 Jan 30, 2017
6156331 Jan 30, 2017
6235712 Jun 13, 2017
6375978 Dec 17, 2018
6395292 Jan 30, 2017
LEUPROLIDE ACETATE - ELIGARD
N 021343 001 6565874 Oct 28, 2018 DP U-801
6626870 Mar 27, 2020 DP
6773714 Oct 28, 2018 DP U-801
LEUPROLIDE ACETATE - ELIGARD
N 021379 001 6565874 Oct 28, 2018 DP U-801
6626870 Mar 27, 2020 DP
6773714 Oct 28, 2018 DP U-801
LEUPROLIDE ACETATE - ELIGARD
N 021488 001 6565874 Oct 28, 2018 DP U-801
6626870 Mar 27, 2020 DP
6773714 Oct 28, 2018 DP U-801
LEUPROLIDE ACETATE - ELIGARD
N 021731 001 6565874 Oct 28, 2018 DP U-621
6626870 Mar 27, 2020 DP
6773714 Oct 28, 2018 U-621
LEUPROLIDE ACETATE; NORETHINDRONE ACETATE - LUPANETA PACK
N 203696 001 6036976 Dec 13, 2016 DP
LEUPROLIDE ACETATE; NORETHINDRONE ACETATE - LUPANETA PACK
N 203696 002 6036976 Dec 13, 2016 DP
LEVALBUTEROL HYDROCHLORIDE - XOPENEX
N 020837 001 6451289 Mar 21, 2021
LEVALBUTEROL HYDROCHLORIDE - XOPENEX
N 020837 002 6451289 Mar 21, 2021
LEVALBUTEROL HYDROCHLORIDE - XOPENEX
N 020837 003 6451289 Mar 21, 2021
LEVALBUTEROL HYDROCHLORIDE - XOPENEX
N 020837 004 6451289 Mar 21, 2021 DP
LEVALBUTEROL TARTRATE - XOPENEX HFA
N 021730 001 5836299 Nov 17, 2015 DP
7256310 Oct 08, 2024 DS DP U-636
8765153 Dec 08, 2023 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 119 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LEVETIRACETAM - KEPPRA
N 021035 001 8802142 Jun 07, 2031 DP NPP Dec 16, 2014
8802142*PED Dec 07, 2031 PED Jun 16, 2015
LEVETIRACETAM - KEPPRA
N 021035 002 8802142 Jun 07, 2031 DP NPP Dec 16, 2014
8802142*PED Dec 07, 2031 PED Jun 16, 2015
LEVETIRACETAM - KEPPRA
N 021035 003 8802142 Jun 07, 2031 DP NPP Dec 16, 2014
8802142*PED Dec 07, 2031 PED Jun 16, 2015
LEVETIRACETAM - KEPPRA
N 021035 004 8802142 Jun 07, 2031 DP NPP Dec 16, 2014
8802142*PED Dec 07, 2031 PED Jun 16, 2015
LEVETIRACETAM - KEPPRA
N 021505 001 NPP Dec 16, 2014
PED Jun 16, 2015
LEVETIRACETAM - KEPPRA XR
N 022285 001 7858122 Sep 17, 2028 DP
LEVETIRACETAM - KEPPRA XR
N 022285 002 7858122 Sep 17, 2028 DP
LEVOBUPIVACAINE HYDROCHLORIDE - CHIROCAINE
N 020997 001 5708011 Oct 13, 2014 U-276
LEVOBUPIVACAINE HYDROCHLORIDE - CHIROCAINE
N 020997 002 5708011 Oct 13, 2014 U-276
LEVOBUPIVACAINE HYDROCHLORIDE - CHIROCAINE
N 020997 003 5708011 Oct 13, 2014 U-276
LEVOCARNITINE - CARNITOR
N 020182 001 6335369 Jan 18, 2021 U-433
6429230 Jan 18, 2021 U-433
6696493 Jan 18, 2021 U-433
LEVOFLOXACIN - LEVAQUIN
N 021721 001 6806256 Feb 26, 2022 DP
LEVOLEUCOVORIN CALCIUM - FUSILEV
N 020140 001 6500829 Mar 07, 2022 DS DP ODE Mar 07, 2015
ODE Apr 29, 2018
LEVOLEUCOVORIN CALCIUM - FUSILEV
N 020140 002 6500829 Mar 07, 2022 DS DP ODE Mar 07, 2015
ODE Apr 29, 2018
LEVOLEUCOVORIN CALCIUM - FUSILEV
N 020140 003 6500829 Mar 07, 2022 DS DP ODE Mar 07, 2015
ODE Apr 29, 2018
LEVOMILNACIPRAN HYDROCHLORIDE - FETZIMA
N 204168 001 8481598 Mar 02, 2031 U-839 NCE* Jul 25, 2018
8865937 May 23, 2032 DS DP
RE43879 Jun 03, 2023 U-839
LEVOMILNACIPRAN HYDROCHLORIDE - FETZIMA
N 204168 002 8481598 Mar 02, 2031 U-839 NCE* Jul 25, 2018
8865937 May 23, 2032 DS DP
RE43879 Jun 03, 2023 U-839
LEVOMILNACIPRAN HYDROCHLORIDE - FETZIMA
N 204168 003 8481598 Mar 02, 2031 U-839 NCE* Jul 25, 2018
8865937 May 23, 2032 DS DP
RE43879 Jun 03, 2023 U-839
LEVOMILNACIPRAN HYDROCHLORIDE - FETZIMA
N 204168 004 8481598 Mar 02, 2031 U-839 NCE* Jul 25, 2018
8865937 May 23, 2032 DS DP
RE43879 Jun 03, 2023 U-839
LEVONORGESTREL - MIRENA
N 021225 001 5785053 Dec 05, 2015 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 120 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LEVONORGESTREL - PLAN B ONE-STEP
N 021998 001 RTO* Apr 30, 2016
RTO** Apr 30, 2016
LEVONORGESTREL - SKYLA
N 203159 001 5785053 Dec 05, 2015 DP NP Jan 09, 2016
7252839 Nov 13, 2023 DP
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 001 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Oct 02, 2023 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 002 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Oct 02, 2023 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 003 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Oct 02, 2023 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 004 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Oct 02, 2023 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 005 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Oct 02, 2023 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 006 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Oct 02, 2023 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 007 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Oct 02, 2023 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 008 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Oct 02, 2023 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 009 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Oct 02, 2023 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 010 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Oct 02, 2023 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 011 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Oct 02, 2023 U-759
LEVOTHYROXINE SODIUM - LEVOXYL
N 021301 012 6555581 Feb 15, 2022
7067148 Feb 15, 2022 DP
7101569 Oct 02, 2023 U-759
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 121 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 001 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 002 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 003 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 004 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 005 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 006 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 007 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 008 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 009 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 010 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - LEVO-T
N 021342 011 6399101 Mar 30, 2020
LEVOTHYROXINE SODIUM - TIROSINT
N 021924 002 7723390 Mar 14, 2024 DP
LEVOTHYROXINE SODIUM - TIROSINT
N 021924 003 7723390 Mar 14, 2024 DP
LEVOTHYROXINE SODIUM - TIROSINT
N 021924 004 7723390 Mar 14, 2024 DP
LEVOTHYROXINE SODIUM - TIROSINT
N 021924 005 7723390 Mar 14, 2024 DP
LEVOTHYROXINE SODIUM - TIROSINT
N 021924 006 7723390 Mar 14, 2024 DP
LEVOTHYROXINE SODIUM - TIROSINT
N 021924 007 7723390 Mar 14, 2024 DP
LEVOTHYROXINE SODIUM - TIROSINT
N 021924 008 7723390 Mar 14, 2024 DP
LEVOTHYROXINE SODIUM - TIROSINT
N 021924 009 7723390 Mar 14, 2024 DP
LEVOTHYROXINE SODIUM - TIROSINT
N 021924 010 7723390 Mar 14, 2024 DP
LEVOTHYROXINE SODIUM - TIROSINT
N 022121 001 7723390 Mar 14, 2024 DP
LIDOCAINE - LIDODERM
N 020612 001 5827529 Oct 27, 2015 U-486
LIDOCAINE HYDROCHLORIDE - ZINGO
N 022114 001 5899880 May 04, 2016 DP
6004286 Mar 17, 2017 DP
6881200 Jun 11, 2016 DP
8540665 Oct 22, 2029 U-1438
LIDOCAINE HYDROCHLORIDE - AKTEN
N 022221 001 8759401 Jul 24, 2026 DP U-1523
LIDOCAINE; PRILOCAINE - ORAQIX
N 021451 001 6031007 Apr 01, 2017 DP U-553
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 122 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LIDOCAINE; TETRACAINE - SYNERA
N 021623 001 5658583 Jul 28, 2015 DP
5919479 Jul 28, 2015 DP
6306431 Jul 28, 2015 DP
6465006 Jul 28, 2015 DP
6465709 Jul 07, 2020 DP
6546281 Jul 28, 2015 DP
6780426 Jul 28, 2015 DP
LIDOCAINE; TETRACAINE - PLIAGLIS
N 021717 001 5919479 Jul 28, 2015 DP
6528086 Sep 28, 2019 DP
LINACLOTIDE - LINZESS
N 202811 001 7304036 Jan 28, 2024 DS DP U-1278 NCE Aug 30, 2017
7371727 Jan 28, 2024 DS
7704947 Jan 28, 2024 DS DP
7745409 Jan 28, 2024 DS DP
8080526 Jan 28, 2024 DS DP
8110553 Jan 28, 2024 U-1278
8748573 Jun 20, 2031 U-1515
8748573 Jun 20, 2031 U-1516
8802628 Jul 24, 2031 DP
LINACLOTIDE - LINZESS
N 202811 002 7304036 Jan 28, 2024 DS DP U-1278 NCE Aug 30, 2017
7371727 Jan 28, 2024 DS
7704947 Jan 28, 2024 DS DP
7745409 Jan 28, 2024 DS DP
8080526 Jan 28, 2024 DS DP
8110553 Jan 28, 2024 U-1278
8748573 Jun 20, 2031 U-1515
8748573 Jun 20, 2031 U-1516
8802628 Jul 24, 2031 DP
LINAGLIPTIN - TRADJENTA
N 201280 001 6303661 Apr 24, 2017 U-774 M-118 Aug 13, 2015
6303661 Apr 24, 2017 U-1270 M-121 Aug 13, 2015
6890898 Feb 02, 2019 U-493 NCE May 02, 2016
6890898 Feb 02, 2019 U-1270
7078381 Feb 02, 2019 U-493
7078381 Feb 02, 2019 U-1270
7407955 Aug 12, 2023 DS DP
7459428 Feb 02, 2019 U-493
7459428 Feb 02, 2019 U-1270
8119648 Aug 12, 2023 U-774
8119648 Aug 12, 2023 U-1270
8178541 Aug 12, 2023 U-775
8178541 Aug 12, 2023 U-1244
8178541 Aug 12, 2023 U-1245
8178541 Aug 12, 2023 U-1270
8673927 Aug 23, 2027 U-1503
8846695 Jun 04, 2030 U-1503
8883805 Nov 26, 2025 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 123 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO
N 201281 001 6303661 Apr 24, 2017 U-802 M-146 Jul 30, 2017
6890898 Feb 02, 2019 U-1039 NC Jan 30, 2015
7078381 Feb 02, 2019 U-1039 NCE May 02, 2016
7407955 Aug 12, 2023 DS DP
7459428 Feb 02, 2019 U-1039
8119648 Aug 12, 2023 U-802
8178541 Aug 12, 2023 DP U-775
8673927 Aug 23, 2027 U-1503
8846695 Jun 04, 2030 U-1503
8883805 Nov 26, 2025 DP
LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO
N 201281 002 6303661 Apr 24, 2017 U-802 M-146 Jul 30, 2017
6890898 Feb 02, 2019 U-1039 NC Jan 30, 2015
7078381 Feb 02, 2019 U-1039 NCE May 02, 2016
7407955 Aug 12, 2023 DS DP
7459428 Feb 02, 2019 U-1039
8119648 Aug 12, 2023 U-802
8178541 Aug 12, 2023 DP U-775
8673927 Aug 23, 2027 U-1503
8846695 Jun 04, 2030 U-1503
8883805 Nov 26, 2025 DP
LINAGLIPTIN; METFORMIN HYDROCHLORIDE - JENTADUETO
N 201281 003 6303661 Apr 24, 2017 U-802 M-146 Jul 30, 2017
6890898 Feb 02, 2019 U-1039 NC Jan 30, 2015
7078381 Feb 02, 2019 U-1039 NCE May 02, 2016
7407955 Aug 12, 2023 DS DP
7459428 Feb 02, 2019 U-1039
8119648 Aug 12, 2023 U-802
8178541 Aug 12, 2023 DP U-775
8673927 Aug 23, 2027 U-1503
8846695 Jun 04, 2030 U-1503
8883805 Nov 26, 2025 DP
LINEZOLID - ZYVOX
N 021130 001 5688792 Nov 18, 2014 DS U-319
6514529 Mar 15, 2021 DP
6559305 Jan 29, 2021 DS
LINEZOLID - ZYVOX
N 021130 002 5688792 Nov 18, 2014 DS U-319
6514529 Mar 15, 2021 DP
6559305 Jan 29, 2021 DS
LINEZOLID - ZYVOX
N 021131 001 5688792 Nov 18, 2014 U-319
6559305 Jan 29, 2021 DS
LINEZOLID - ZYVOX
N 021132 001 5688792 Nov 18, 2014 DS U-319
6559305 Jan 29, 2021 DS
LIRAGLUTIDE RECOMBINANT - VICTOZA
N 022341 001 6004297 Jan 28, 2019 DP M-115 Apr 06, 2015
6268343 Aug 22, 2022 DS DP U-968 NCE Jan 25, 2015
6458924 Aug 22, 2017 DS DP U-968
7235627 Aug 22, 2017 DS DP
8114833 Aug 13, 2025 DP
RE41956 Jan 21, 2021 DP
RE43834 Jan 28, 2019 DP
LIRAGLUTIDE RECOMBINANT - SAXENDA
N 206321 001 NCE Jan 25, 2015
NP Jan 25, 2017
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 124 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LISDEXAMFETAMINE DIMESYLATE - VYVANSE
N 021977 001 7105486 Jun 29, 2023 U-727 I-645 Jan 31, 2015
7223735 Jun 29, 2023 DP
7655630 Feb 24, 2023 DS
7659253 Feb 24, 2023 DS DP U-727
7659254 Feb 24, 2023 U-1034
7662787 Feb 24, 2023 DS
7662788 Feb 24, 2023 U-727
7671030 Feb 24, 2023 DP U-727
7671031 Feb 28, 2023 U-727
7674774 Mar 18, 2023 DP U-842
7678770 Mar 25, 2023 U-842
7678771 Mar 25, 2023 DP U-842
7687466 Feb 24, 2023 DP
7687467 Apr 08, 2023 DP U-842
7700561 Jun 29, 2023 DP
7713936 Feb 24, 2023 U-727
7718619 Feb 24, 2023 DP U-842
7723305 Feb 24, 2023 DP U-842
LISDEXAMFETAMINE DIMESYLATE - VYVANSE
N 021977 002 7105486 Jun 29, 2023 U-727 I-645 Jan 31, 2015
7223735 Jun 29, 2023 DP
7655630 Feb 24, 2023 DS
7659253 Feb 24, 2023 DS DP U-727
7659254 Feb 24, 2023 U-1034
7662787 Feb 24, 2023 DS
7662788 Feb 24, 2023 U-727
7671030 Feb 24, 2023 DP U-727
7671031 Feb 28, 2023 U-727
7674774 Mar 18, 2023 DP U-842
7678770 Mar 25, 2023 U-842
7678771 Mar 25, 2023 DP U-842
7687466 Feb 24, 2023 DP
7687467 Apr 08, 2023 DP U-842
7700561 Jun 29, 2023 DP
7713936 Feb 24, 2023 U-727
7718619 Feb 24, 2023 DP U-842
7723305 Feb 24, 2023 DP U-842
LISDEXAMFETAMINE DIMESYLATE - VYVANSE
N 021977 003 7105486 Jun 29, 2023 U-727 I-645 Jan 31, 2015
7223735 Jun 29, 2023 DP
7655630 Feb 24, 2023 DS
7659253 Feb 24, 2023 DS DP U-727
7659254 Feb 24, 2023 U-1034
7662787 Feb 24, 2023 DS
7662788 Feb 24, 2023 U-727
7671030 Feb 24, 2023 DP U-727
7671031 Feb 28, 2023 U-727
7674774 Mar 18, 2023 DP U-842
7678770 Mar 25, 2023 U-842
7678771 Mar 25, 2023 DP U-842
7687466 Feb 24, 2023 DP
7687467 Apr 08, 2023 DP U-842
7700561 Jun 29, 2023 DP
7713936 Feb 24, 2023 U-727
7718619 Feb 24, 2023 DP U-842
7723305 Feb 24, 2023 DP U-842
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 125 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LISDEXAMFETAMINE DIMESYLATE - VYVANSE
N 021977 004 7105486 Jun 29, 2023 U-842 I-645 Jan 31, 2015
7223735 Jun 29, 2023 DP
7655630 Feb 24, 2023 DS
7659253 Feb 24, 2023 DS DP U-727
7659254 Feb 24, 2023 U-1034
7662787 Feb 24, 2023 DS
7662788 Feb 24, 2023 U-727
7671030 Feb 24, 2023 DP U-727
7671031 Feb 28, 2023 U-727
7674774 Mar 18, 2023 DP U-842
7678770 Mar 25, 2023 U-842
7678771 Mar 25, 2023 DP U-842
7687466 Feb 24, 2023 DP
7687467 Apr 08, 2023 DP U-842
7700561 Jun 29, 2023 DP
7713936 Feb 24, 2023 U-727
7718619 Feb 24, 2023 DP U-842
7723305 Feb 24, 2023 DP U-842
LISDEXAMFETAMINE DIMESYLATE - VYVANSE
N 021977 005 7105486 Jun 29, 2023 U-842 I-645 Jan 31, 2015
7223735 Jun 29, 2023 DP
7655630 Feb 24, 2023 DS
7659253 Feb 24, 2023 DS DP U-727
7659254 Feb 24, 2023 U-1034
7662787 Feb 24, 2023 DS
7662788 Feb 24, 2023 U-727
7671030 Feb 24, 2023 DP U-727
7671031 Feb 28, 2023 U-727
7674774 Mar 18, 2023 DP U-842
7678770 Mar 25, 2023 U-842
7678771 Mar 25, 2023 DP U-842
7687466 Feb 24, 2023 DP
7687467 Apr 08, 2023 DP U-842
7700561 Jun 29, 2023 DP
7713936 Feb 24, 2023 U-727
7718619 Feb 24, 2023 DP U-842
7723305 Feb 24, 2023 DP U-842
LISDEXAMFETAMINE DIMESYLATE - VYVANSE
N 021977 006 7105486 Jun 29, 2023 U-842 I-645 Jan 31, 2015
7223735 Jun 29, 2023 DP
7655630 Feb 24, 2023 DS
7659253 Feb 24, 2023 DS DP U-727
7659254 Feb 24, 2023 U-1034
7662787 Feb 24, 2023 DS
7662788 Feb 24, 2023 U-727
7671030 Feb 24, 2023 DP U-727
7671031 Feb 28, 2023 U-727
7674774 Mar 18, 2023 DP U-842
7678770 Mar 25, 2023 U-842
7678771 Mar 25, 2023 DP U-842
7687466 Feb 24, 2023 DP
7687467 Apr 08, 2023 DP U-842
7700561 Jun 29, 2023 DP
7713936 Feb 24, 2023 U-727
7718619 Feb 24, 2023 DP U-842
7723305 Feb 24, 2023 DP U-842
LISDEXAMFETAMINE DIMESYLATE - VYVANSE
N 021977 007 I-645 Jan 31, 2015
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 126 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT
EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST
EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED
CODE(S) DATE
LOMITAPIDE MESYLATE - JUXTAPID
N 203858 001 5712279 Feb 21, 2015 DS U-1317
NCE Dec 21, 2017
5739135 Apr 14, 2015 DS U-1317
ODE Dec 21, 2019
6492365 Dec 10, 2019 U-1318
7932268 Aug 19, 2027 U-1316
8618135 Mar 07, 2025 U-1316
LOMITAPIDE MESYLATE - JUXTAPID
N 203858 002 5712279 Feb 21, 2015 DS U-1317
NCE Dec 21, 2017
5739135 Apr 14, 2015 DS U-1317
ODE Dec 21, 2019
6492365 Dec 10, 2019 U-1318
7932268 Aug 19, 2027 U-1316
8618135 Mar 07, 2025 U-1316
LOMITAPIDE MESYLATE - JUXTAPID
N 203858 003 5712279 Feb 21, 2015 DS U-1317
NCE Dec 21, 2017
5739135 Apr 14, 2015 DS U-1317
ODE Dec 21, 2019
6492365 Dec 10, 2019 U-1318
7932268 Aug 19, 2027 U-1316
8618135 Mar 07, 2025 U-1316
LOPERAMIDE HYDROCHLORIDE - IMODIUM A-D EZ CHEWS
N 020448 001 6814978 Aug 26, 2021 DP
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE - IMODIUM MULTI-SYMPTOM RELIEF
N 020606 001 5679376 Oct 21, 2014 Y
LOPERAMIDE HYDROCHLORIDE; SIMETHICONE - IMODIUM MULTI-SYMPTOM RELIEF
N 021140 001 6103260 Jul 17, 2017 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 127 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LOPINAVIR; RITONAVIR - KALETRA
N 021226 001 5648497 Jul 15, 2014
5914332 Dec 13, 2015 U-351
6037157 Jun 26, 2016 U-346
6232333 Nov 07, 2017
6284767 Feb 15, 2016 DP U-401
6284767 Feb 15, 2016 DP U-688
6458818 Nov 07, 2017
6521651 Nov 07, 2017 DP
6703403 Jun 26, 2016 U-257
7141593 May 22, 2020 DP
7432294 May 22, 2020 DP
LOPINAVIR; RITONAVIR - KALETRA
N 021251 001 5648497 Jul 15, 2014 DS
5914332 Dec 13, 2015 DS DP U-351
5914332 Dec 13, 2015 DS DP U-895
6037157 Jun 26, 2016 U-346
6037157 Jun 26, 2016 U-895
6284767 Feb 15, 2016 DP U-401
6284767 Feb 15, 2016 DP U-895
6703403 Jun 26, 2016 U-257
6703403 Jun 26, 2016 U-895
6911214 Nov 28, 2021 DP U-895
8501219 Nov 28, 2021 DP
LOPINAVIR; RITONAVIR - KALETRA
N 021906 001 5648497 Jul 15, 2014 DS DP
5914332 Dec 13, 2015 DS DP U-688
6037157 Jun 26, 2016 U-688
6284767 Feb 15, 2016 DP U-688
6703403 Jun 26, 2016 U-688
7148359 Jul 19, 2019 DP
7364752 Nov 10, 2020 DP U-688
8025899 Dec 14, 2027 DP
8025899*PED Jun 14, 2028
8268349 Aug 25, 2024 DP
8309613 Dec 24, 2024 U-688
8377952 Oct 22, 2027 U-1372
8377952*PED Apr 22, 2028
8399015 Aug 25, 2024 DP
8399015*PED Feb 25, 2025
8470347 Sep 17, 2026 DP
8470347*PED Mar 17, 2027
8691878 Aug 25, 2024 U-1513
8691878*PED Feb 25, 2025
LOPINAVIR; RITONAVIR - KALETRA
N 021906 002 5648497 Jul 15, 2014 DS DP
5914332 Dec 13, 2015 DS DP U-688
6037157 Jun 26, 2016 U-688
6284767 Feb 15, 2016 DP U-688
6703403 Jun 26, 2016 U-688
7148359 Jul 19, 2019 DP
7364752 Nov 10, 2020 DP U-688
8025899 Dec 14, 2027 DP
8025899*PED Jun 14, 2028
8268349 Aug 25, 2024 DP
8309613 Dec 24, 2024 U-688
8377952 Oct 22, 2027 U-1372
8377952*PED Apr 22, 2028
8399015 Aug 25, 2024 DP
8399015*PED Feb 25, 2025
8470347 Sep 17, 2026 DP
8470347*PED Mar 17, 2027
8691878 Aug 25, 2024 U-1513
8691878*PED Feb 25, 2025
LORATADINE - CLARITIN
N 020641 002 6132758 Jun 01, 2018
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 128 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LORCASERIN HYDROCHLORIDE - BELVIQ
N 022529 001 6953787 Apr 10, 2023 DS DP U-1252 NCE Jun 27, 2017
6953787 Apr 10, 2023 DS DP U-1253
6953787 Apr 10, 2023 DS DP U-1254
6953787 Apr 10, 2023 DS DP U-1255
7514422 Apr 10, 2023 U-1252
7514422 Apr 10, 2023 U-1253
7514422 Apr 10, 2023 U-1254
7514422 Apr 10, 2023 U-1255
7977329 Apr 10, 2023 DS DP U-1252
7977329 Apr 10, 2023 DS DP U-1253
7977329 Apr 10, 2023 DS DP U-1254
7977329 Apr 10, 2023 DS DP U-1255
8168624 Apr 18, 2029 DS DP
8207158 Apr 10, 2023 U-1252
8207158 Apr 10, 2023 U-1253
8207158 Apr 10, 2023 U-1254
8207158 Apr 10, 2023 U-1255
8273734 Apr 10, 2023 U-1254
8273734 Apr 10, 2023 U-1255
8367657 Apr 10, 2023 DS DP U-1252
8367657 Apr 10, 2023 DS DP U-1253
8367657 Apr 10, 2023 DS DP U-1254
8367657 Apr 10, 2023 DS DP U-1255
8546379 Apr 10, 2023 DS DP U-1252
8546379 Apr 10, 2023 DS DP U-1253
8546379 Apr 10, 2023 DS DP U-1254
8546379 Apr 10, 2023 DS DP U-1255
8575149 Apr 10, 2023 U-1452
8697686 Dec 20, 2025 DS DP
LOTEPREDNOL ETABONATE - LOTEMAX
N 200738 001 PED Oct 15, 2014
LOTEPREDNOL ETABONATE - LOTEMAX
N 202872 001 5800807 Jan 29, 2017 DP NDF Sep 28, 2015
LOVASTATIN - ALTOPREV
N 021316 001 5916595 Dec 12, 2017
6080778 Mar 23, 2018 U-456
6485748 Dec 12, 2017 DP
LOVASTATIN - ALTOPREV
N 021316 002 5916595 Dec 12, 2017
6080778 Mar 23, 2018 U-456
6485748 Dec 12, 2017 DP
LOVASTATIN - ALTOPREV
N 021316 003 5916595 Dec 12, 2017
6080778 Mar 23, 2018 U-456
6485748 Dec 12, 2017 DP
LOVASTATIN - ALTOPREV
N 021316 004 5916595 Dec 12, 2017
6080778 Mar 23, 2018 U-456
6485748 Dec 12, 2017 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 129 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LOVASTATIN; NIACIN - ADVICOR
N 021249 001 6080428 May 27, 2017 U-447
6080428 May 27, 2017 U-1132
6080428 May 27, 2017 U-1133
6080428 May 27, 2017 U-1134
6469035 Mar 15, 2018 U-768
6469035 Mar 15, 2018 U-1129
6469035 Mar 15, 2018 U-1130
6469035 Mar 15, 2018 U-1131
LOVASTATIN; NIACIN - ADVICOR
N 021249 002 6080428 May 27, 2017 U-447
6080428 May 27, 2017 U-1132
6080428 May 27, 2017 U-1133
6080428 May 27, 2017 U-1134
6469035 Mar 15, 2018 U-768
6469035 Mar 15, 2018 U-1129
6469035 Mar 15, 2018 U-1130
6469035 Mar 15, 2018 U-1131
LOVASTATIN; NIACIN - ADVICOR
N 021249 003 6080428 May 27, 2017 U-447
6080428 May 27, 2017 U-1132
6080428 May 27, 2017 U-1133
6080428 May 27, 2017 U-1134
6469035 Mar 15, 2018 U-768
6469035 Mar 15, 2018 U-1129
6469035 Mar 15, 2018 U-1130
6469035 Mar 15, 2018 U-1131
LOVASTATIN; NIACIN - ADVICOR
N 021249 004 6080428 May 27, 2017 U-447
6080428 May 27, 2017 U-1132
6080428 May 27, 2017 U-1133
6080428 May 27, 2017 U-1134
6469035 Mar 15, 2018 U-768
6469035 Mar 15, 2018 U-1129
6469035 Mar 15, 2018 U-1130
6469035 Mar 15, 2018 U-1131
LOXAPINE - ADASUVE
N 022549 001 6716416 May 20, 2022 DP NDF Dec 21, 2015
7052679 Oct 26, 2021 DP
7078020 Oct 26, 2021 DP U-1375
7090830 Oct 26, 2021 DP
7458374 Aug 18, 2024 DP
7537009 Oct 28, 2024 DP
7585493 Oct 26, 2021 DP
7601337 Oct 26, 2021 DP
8074644 Jul 25, 2022 DP
8173107 Oct 26, 2021 DP
8235037 Oct 26, 2021 DP
8387612 Oct 23, 2026 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 130 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
LUBIPROSTONE - AMITIZA
N 021908 001 5284858 Jul 14, 2014 DS I-670 Apr 19, 2016
6414016 Sep 05, 2020 U-717
6414016 Sep 05, 2020 U-1392
6583174 Oct 16, 2020 DP
6982283 Dec 04, 2022 U-1391
7064148 Aug 30, 2022 U-739
7064148 Aug 30, 2022 U-1404
7417067 Oct 16, 2020 DP
8026393 Oct 25, 2027 DP
8071613 Sep 05, 2020 U-1203
8071613 Sep 05, 2020 U-1393
8088934 May 18, 2021 DS
8097649 Oct 16, 2020 DP
8097653 Nov 14, 2022 U-1214
8097653 Nov 14, 2022 U-1394
8114890 Sep 05, 2020 DP
8338639 Jan 23, 2027 DP
8389542 Nov 14, 2022 DP U-1345
8389542 Nov 14, 2022 DP U-1395
8748481 Sep 01, 2025 U-1520
8779187 Jul 23, 2027 DP
LUBIPROSTONE - AMITIZA
N 021908 002 5284858 Jul 14, 2014 DS
6414016 Sep 05, 2020 U-874
6583174 Oct 16, 2020 DP
7064148 Aug 30, 2022 U-739
7064148 Aug 30, 2022 U-873
7417067 Oct 16, 2020 DP
7795312 Sep 17, 2024 U-1085
8026393 Oct 25, 2027 DP
8071613 Sep 05, 2020 U-1202
8088934 May 18, 2021 DS
8097649 Oct 16, 2020 DP
8114890 Sep 05, 2020 DP
8338639 Jan 23, 2027 DP
8748481 Sep 01, 2025 U-1519
8779187 Jan 23, 2027 DP
LUCINACTANT - SURFAXIN
N 021746 001 5407914 Nov 17, 2014 DS DP U-1242
LULICONAZOLE - LUZU
N 204153 001 5900488 Jul 05, 2016 DS DP U-540 NCE Nov 14, 2018
LURASIDONE HYDROCHLORIDE - LATUDA
N 200603 001 5532372 Jul 02, 2018 DS D-134 Apr 26, 2015
8729085 May 26, 2026 DP I-674 Jun 28, 2016
8883794 May 26, 2026 DP NCE Oct 28, 2015
LURASIDONE HYDROCHLORIDE - LATUDA
N 200603 002 5532372 Jul 02, 2018 DS D-134 Apr 26, 2015
8729085 May 26, 2026 DP I-674 Jun 28, 2016
8883794 May 26, 2026 DP NCE Oct 28, 2015
LURASIDONE HYDROCHLORIDE - LATUDA
N 200603 003 5532372 Jul 02, 2018 DS D-134 Apr 26, 2015
8729085 May 26, 2026 DP I-674 Jun 28, 2016
8883794 May 26, 2026 DP NCE Oct 28, 2015
LURASIDONE HYDROCHLORIDE - LATUDA
N 200603 004 5532372 Jul 02, 2018 DS D-134 Apr 26, 2015
8729085 May 26, 2026 DP I-674 Jun 28, 2016
8883794 May 26, 2026 DP NCE Oct 28, 2015
LURASIDONE HYDROCHLORIDE - LATUDA
N 200603 005 5532372 Jul 02, 2018 DS D-134 Apr 26, 2015
8729085 May 26, 2026 DP I-674 Jun 28, 2016
8883794 May 26, 2026 DP NCE Oct 28, 2015
LUTROPIN ALFA - LUVERIS
N 021322 001 5767251 Jun 16, 2015 DS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 131 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
MACITENTAN - OPSUMIT
N 204410 001 7094781 Oct 12, 2022 DS DP NCE Oct 18, 2018
8268847 Apr 18, 2029 U-1446 ODE Oct 18, 2020
8367685 Oct 04, 2028 DP U-1445
MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - NORMOCARB HF 25
N 021910 001 5945449 Oct 31, 2017 DP U-785
7300674 Mar 04, 2023 DP U-785
MAGNESIUM CHLORIDE; SODIUM BICARBONATE; SODIUM CHLORIDE - NORMOCARB HF 35
N 021910 002 5945449 Oct 31, 2017 DP U-785
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID
N 021850 001 6489346 Jul 16, 2016 DS DP U-588
6645988 Jul 16, 2016 DS DP U-588
6699885 Jul 16, 2016 U-588
7399772 Jul 16, 2016 U-588
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID
N 021850 002 6489346 Jul 16, 2016 DS DP U-623
6645988 Jul 16, 2016 DS DP U-623
6699885 Jul 16, 2016 U-623
7399772 Jul 16, 2016 U-623
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE - MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM
BICARBONATE
N 022456 001 6489346 Jul 16, 2016 DP U-588
6489346 Jul 16, 2016 DP U-1021
6645988 Jul 16, 2016 DP
6699885 Jul 16, 2016 DP U-588
6699885 Jul 16, 2016 DP U-1021
7399772 Jul 16, 2016 DP U-588
7399772 Jul 16, 2016 DP U-1021
MAGNESIUM HYDROXIDE; OMEPRAZOLE; SODIUM BICARBONATE - MAGNESIUM HYDROXIDE AND OMEPRAZOLE AND SODIUM
BICARBONATE
N 022456 002 6489346 Jul 16, 2016 DP U-588
6489346 Jul 16, 2016 DP U-1021
6645988 Jul 16, 2016 DP
6699885 Jul 16, 2016 DP U-588
6699885 Jul 16, 2016 DP U-1021
7399772 Jul 16, 2016 DP U-588
7399772 Jul 16, 2016 DP U-1021
MAGNESIUM SULFATE ANHYDROUS; POTASSIUM SULFATE; SODIUM SULFATE - SUPREP BOWEL PREP KIT
N 022372 001 6946149 Mar 07, 2023 DP U-837
MAGNESIUM SULFATE; POLYETHYLENE GLYCOL 3350; POTASSIUM CHLORIDE; POTASSIUM SULFATE; SODIUM BICARBONATE;
SODIUM CHLORIDE; SODIUM SULFATE - SUCLEAR
N 203595 001 NC Jan 18, 2016
MALATHION - OVIDE
N 018613 001 7560445 Feb 01, 2027 DS DP U-986
7977324 Aug 14, 2026 DP
MANNITOL - ARIDOL KIT
N 022368 001 5817028 Feb 23, 2015 U-1091
MARAVIROC - SELZENTRY
N 022128 001 6586430 Dec 01, 2019 DS DP U-824
6667314 Aug 06, 2021 DS DP U-824
7368460 Nov 25, 2022 U-824
7576097 May 25, 2021 DS
MARAVIROC - SELZENTRY
N 022128 002 6586430 Dec 01, 2019 DS DP U-824
6667314 Aug 06, 2021 DS DP U-824
7368460 Nov 25, 2022 U-824
7576097 May 25, 2021 DS
MECASERMIN RECOMBINANT - INCRELEX
N 021839 001 5681814 Sep 18, 2017 DP
5824642 Jul 08, 2014 U-681
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 132 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
MECASERMIN RINFABATE RECOMBINANT - IPLEX
N 021884 001 5681818 Oct 28, 2014 U-697
MECHLORETHAMINE HYDROCHLORIDE - VALCHLOR
N 202317 001 7838564 Mar 07, 2026 DP NDF Aug 23, 2016
7872050 Jul 08, 2029 U-1427 ODE Aug 23, 2020
8450375 Mar 07, 2026 DP
8501818 Mar 07, 2026 DP
8501819 Mar 07, 2026 U-1427
MEDROXYPROGESTERONE ACETATE - DEPO-SUBQ PROVERA 104
N 021583 001 6495534 May 15, 2020 DP
MEGESTROL ACETATE - MEGACE ES
N 021778 001 6592903 Sep 21, 2020 DP
7101576 Apr 22, 2024 U-755
MELOXICAM - MOBIC
N 021530 001 6184220 Mar 25, 2019 DP
MEMANTINE HYDROCHLORIDE - NAMENDA
N 021487 001 5061703 Apr 11, 2015 U-539
5061703*PED Oct 11, 2015
MEMANTINE HYDROCHLORIDE - NAMENDA
N 021487 002 5061703 Apr 11, 2015 U-539
5061703*PED Oct 11, 2015
MEMANTINE HYDROCHLORIDE - NAMENDA
N 021627 001 5061703 Apr 11, 2015 U-539
5061703*PED Oct 11, 2015
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 133 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
MEMANTINE HYDROCHLORIDE - NAMENDA XR
N 022525 001 5061703 Apr 11, 2015 U-539 M-138 Jul 03, 2017
5061703*PED Oct 11, 2015 PED Jan 03, 2018
8039009 Mar 24, 2029 U-539
8039009*PED Sep 24, 2029
8168209 Nov 22, 2025 DP
8168209*PED May 22, 2026
8173708 Nov 22, 2025 U-539
8173708*PED May 22, 2026
8283379 Nov 22, 2025 U-539
8283379*PED May 22, 2026
8329752 Nov 22, 2025 DP
8329752*PED May 22, 2026
8362085 Nov 22, 2025 U-539
8362085*PED May 22, 2026
MEMANTINE HYDROCHLORIDE - NAMENDA XR
N 022525 002 5061703 Apr 11, 2015 U-539 M-138 Jul 03, 2017
5061703*PED Oct 11, 2015 PED Jan 03, 2018
8039009 Mar 24, 2029 U-539
8039009*PED Sep 24, 2029
8168209 Nov 22, 2025 DP
8168209*PED May 22, 2026
8173708 Nov 22, 2025 U-539
8173708*PED May 22, 2026
8283379 Nov 22, 2025 U-539
8283379*PED May 22, 2026
8329752 Nov 22, 2025 DP
8329752*PED May 22, 2026
8362085 Nov 22, 2025 U-539
8362085*PED May 22, 2026
MEMANTINE HYDROCHLORIDE - NAMENDA XR
N 022525 003 5061703 Apr 11, 2015 U-539 M-138 Jul 03, 2017
5061703*PED Oct 11, 2015 PED Jan 03, 2018
8039009 Mar 24, 2029 U-539
8039009*PED Sep 24, 2029
8168209 Nov 22, 2025 DP
8168209*PED May 22, 2026
8173708 Nov 22, 2025 U-539
8173708*PED May 22, 2026
8283379 Nov 22, 2025 U-539
8283379*PED May 22, 2026
8329752 Nov 22, 2025 DP
8329752*PED May 22, 2026
8362085 Nov 22, 2025 U-539
8362085*PED May 22, 2026
MEMANTINE HYDROCHLORIDE - NAMENDA XR
N 022525 004 5061703 Apr 11, 2015 U-539 M-138 Jul 03, 2017
5061703*PED Oct 11, 2015 PED Jan 03, 2018
8039009 Mar 24, 2029 U-539
8039009*PED Sep 24, 2029
8168209 Nov 22, 2025 DP
8168209*PED May 22, 2026
8173708 Nov 22, 2025 U-539
8173708*PED May 22, 2026
8283379 Nov 22, 2025 U-539
8283379*PED May 22, 2026
8329752 Nov 22, 2025 DP
8329752*PED May 22, 2026
8362085 Nov 22, 2025 U-539
8362085*PED May 22, 2026
8598233 Nov 22, 2025 DP
8598233*PED May 22, 2026
MENOTROPINS (FSH;LH); MENOTROPINS (FSH;LH) - MENOPUR
N 021663 001 D-139 Feb 19, 2017
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 134 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
MENTHOL; METHYL SALICYLATE - SALONPAS
N 022029 001 8809615 Jan 03, 2030 DP
MENTHOL; METHYL SALICYLATE - SALONPAS
N 022029 002 8809615 Jan 03, 2030 DP
MEQUINOL; TRETINOIN - SOLAGE
N 020922 001 6353029 Aug 24, 2020
MERCAPTOPURINE - PURIXAN
N 205919 001 ODE Apr 28, 2021
MESALAMINE - SFROWASA
N 019618 002 7645801 Jul 24, 2027 DS DP
MESALAMINE - CANASA
N 021252 002 8217083 Jun 06, 2028 DP
8436051 Jun 06, 2028 DP
MESALAMINE - ASACOL HD
N 021830 001 6893662 Nov 15, 2021 DP U-141
8580302 Nov 15, 2021 DP
MESALAMINE - LIALDA
N 022000 001 6773720 Jun 08, 2020 DP I-640 Jul 14, 2014
MESALAMINE - APRISO
N 022301 001 6551620 Apr 20, 2018 DS DP U-907
8337886 Apr 20, 2018 DP U-1310
8496965 Apr 20, 2018 DP
8865688 May 01, 2030 U-1310
8911778 Apr 20, 2018 DP U-1310
MESALAMINE - DELZICOL
N 204412 001 6649180 Apr 13, 2020 DP
METAXALONE - SKELAXIN
N 013217 003 7122566 Feb 06, 2026 U-915
7714006 Dec 03, 2021 U-1050
METFORMIN HYDROCHLORIDE - GLUCOPHAGE XR
N 021202 001 6475521 Mar 19, 2018
6660300 Mar 19, 2018 U-542
METFORMIN HYDROCHLORIDE - GLUCOPHAGE XR
N 021202 004 6475521 Mar 19, 2018
6660300 Mar 19, 2018 U-542
METFORMIN HYDROCHLORIDE - FORTAMET
N 021574 001 6099859 Mar 20, 2018 DP
6495162 Mar 20, 2018 DP
6790459 Mar 17, 2021 U-604
6866866 Mar 17, 2021 DP
7919116 Mar 20, 2018 DP
8475841 Mar 20, 2018 U-604
METFORMIN HYDROCHLORIDE - FORTAMET
N 021574 002 6099859 Mar 20, 2018 DP
6495162 Mar 20, 2018 DP
6790459 Mar 17, 2021 U-604
6866866 Mar 17, 2021 DP
7919116 Mar 20, 2018 DP
8475841 Mar 20, 2018 U-604
METFORMIN HYDROCHLORIDE - RIOMET
N 021591 001 6890957 Sep 14, 2023 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 135 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
METFORMIN HYDROCHLORIDE - GLUMETZA
N 021748 001 6340475 Sep 19, 2016 DS DP U-669
6488962 Jun 20, 2020 DS DP
6635280 Sep 19, 2016 DS DP
6723340 Oct 25, 2021 DS DP
METFORMIN HYDROCHLORIDE - GLUMETZA
N 021748 002 6488962 Jun 20, 2020 DS DP
7780987 Mar 23, 2025 DS DP
8323692 Mar 23, 2025 DP
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET
N 021842 001 5965584 Jun 19, 2016 DP U-1055 M-116 May 17, 2015
6166042 Jun 19, 2016 U-679
6166043 Jun 19, 2016 U-679
6172090 Jun 19, 2016 U-679
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET
N 021842 002 5965584 Jun 19, 2016 DP U-1055 M-116 May 17, 2015
6166042 Jun 19, 2016 U-679
6166043 Jun 19, 2016 U-679
6172090 Jun 19, 2016 U-679
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET XR
N 022024 001 5965584 Jun 19, 2016 DP U-973
6099859 Mar 20, 2018 DP
6166042 Jun 19, 2016 U-973
6166043 Jun 19, 2016 U-973
6172090 Jun 19, 2016 U-973
6495162 Mar 20, 2018 DP
6790459 Mar 17, 2021 U-974
6866866 Mar 17, 2021 DP
7785627 Jul 31, 2026 DP
7919116 Mar 20, 2018 U-973
7919116 Mar 20, 2018 U-1120
7959946 Jul 31, 2026 DP
8470368 Sep 19, 2023 DP
8475841 Mar 20, 2018 U-973
8668931 Sep 19, 2023 DP
METFORMIN HYDROCHLORIDE; PIOGLITAZONE HYDROCHLORIDE - ACTOPLUS MET XR
N 022024 002 5965584 Jun 19, 2016 DP U-973
6099859 Mar 20, 2018 DP
6166042 Jun 19, 2016 U-973
6166043 Jun 19, 2016 U-973
6172090 Jun 19, 2016 U-973
6495162 Mar 20, 2018 DP
6790459 Mar 17, 2021 U-974
6866866 Mar 17, 2021 DP
7785627 Jul 31, 2026 DP
7919116 Mar 20, 2018 U-973
7919116 Mar 20, 2018 U-1120
7959946 Jul 31, 2026 DP
8470368 Sep 19, 2023 DP
8475841 Mar 20, 2018 U-973
8668931 Sep 19, 2023 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 136 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
N 021410 001 5741803 Apr 21, 2015 DS DP U-493 Y
5741803 Apr 21, 2015 DS DP U-734 Y
5965584 Jun 19, 2016 U-493 Y
6166042 Jun 19, 2016 U-493 Y
6288095 Feb 11, 2017 U-493 Y
7358366 Apr 19, 2020 DS
8236345 Oct 07, 2022 DP
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
N 021410 002 5741803 Apr 21, 2015 DS DP U-493 Y
5741803 Apr 21, 2015 DS DP U-734 Y
5965584 Jun 19, 2016 U-493 Y
6166042 Jun 19, 2016 U-493 Y
6288095 Feb 11, 2017 U-493 Y
7358366 Apr 19, 2020 DS
8236345 Oct 07, 2022 DP
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
N 021410 003 5741803 Apr 21, 2015 DS DP U-493 Y
5741803 Apr 21, 2015 DS DP U-734 Y
5965584 Jun 19, 2016 U-493 Y
6166042 Jun 19, 2016 U-493 Y
6288095 Feb 11, 2017 U-493 Y
7358366 Apr 19, 2020 DS
8236345 Oct 07, 2022 DP
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
N 021410 004 5741803 Apr 21, 2015 DS DP U-493 Y
5741803 Apr 21, 2015 DS DP U-734 Y
7358366 Apr 19, 2020 DS
8236345 Oct 07, 2022 DP
METFORMIN HYDROCHLORIDE; ROSIGLITAZONE MALEATE - AVANDAMET
N 021410 005 5741803 Apr 21, 2015 DS DP U-493 Y
5741803 Apr 21, 2015 DS DP U-734 Y
7358366 Apr 19, 2020 DS
8236345 Oct 07, 2022 DP
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - KOMBIGLYZE XR
N 200678 001 8628799 Jul 13, 2025 DP M-134 May 24, 2016
RE44186 Jul 31, 2023 DS DP U-1097 NCE Jul 31, 2014
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - KOMBIGLYZE XR
N 200678 002 RE44186 Jul 31, 2023 DS DP U-1097 M-134 May 24, 2016
NCE Jul 31, 2014
METFORMIN HYDROCHLORIDE; SAXAGLIPTIN HYDROCHLORIDE - KOMBIGLYZE XR
N 200678 003 RE44186 Jul 31, 2023 DS DP U-1097 M-134 May 24, 2016
NCE Jul 31, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 137 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET
N 022044 001 6303661 Apr 24, 2017 U-802
6699871 Jul 26, 2022 DS DP U-802
6890898 Feb 02, 2019 U-803
6890898 Feb 02, 2019 U-1036
6890898 Feb 02, 2019 U-1038
7078381 Feb 02, 2019 U-803
7078381 Feb 02, 2019 U-1036
7078381 Feb 02, 2019 U-1038
7125873 Jul 26, 2022 DP U-803
7125873 Jul 26, 2022 DP U-1036
7125873 Jul 26, 2022 DP U-1038
7326708 Apr 11, 2026 DS DP U-802
7459428 Feb 02, 2019 U-1036
8414921 Jul 21, 2028 DP U-1036
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET
N 022044 002 6303661 Apr 24, 2017 U-802
6699871 Jul 26, 2022 DS DP U-802
6890898 Feb 02, 2019 U-803
6890898 Feb 02, 2019 U-1036
6890898 Feb 02, 2019 U-1038
7078381 Feb 02, 2019 U-803
7078381 Feb 02, 2019 U-1036
7078381 Feb 02, 2019 U-1038
7125873 Jul 26, 2022 DP U-803
7125873 Jul 26, 2022 DP U-1036
7125873 Jul 26, 2022 DP U-1038
7326708 Apr 11, 2026 DS DP U-802
7459428 Feb 02, 2019 U-1036
8414921 Jul 21, 2028 DP U-1036
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET XR
N 202270 001 6303661 Apr 24, 2017 U-1227
6340475 Sep 19, 2016 DP
6635280 Sep 19, 2016 DP
6699871 Jul 26, 2022 DS DP U-1227
6890898 Feb 02, 2019 U-1228
7078381 Feb 02, 2019 U-1227
7125873 Jul 26, 2022 DP U-1227
7326708 Apr 11, 2026 DS DP U-1227
7459428 Feb 02, 2019 U-1227
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET XR
N 202270 002 6303661 Apr 24, 2017 U-1227
6340475 Sep 19, 2016 DP
6635280 Sep 19, 2016 DP
6699871 Jul 26, 2022 DS DP U-1227
6890898 Feb 02, 2019 U-1228
7078381 Feb 02, 2019 U-1227
7125873 Jul 26, 2022 DP U-1227
7326708 Apr 11, 2026 DS DP U-1227
7459428 Feb 02, 2019 U-1227
METFORMIN HYDROCHLORIDE; SITAGLIPTIN PHOSPHATE - JANUMET XR
N 202270 003 6303661 Apr 24, 2017 U-1227
6340475 Sep 19, 2016 DP
6635280 Sep 19, 2016 DP
6699871 Jul 26, 2022 DS DP U-1227
6890898 Feb 02, 2019 U-1228
7078381 Feb 02, 2019 U-1227
7125873 Jul 26, 2022 DP U-1227
7326708 Apr 11, 2026 DS DP U-1227
7459428 Feb 02, 2019 U-1227
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 138 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
METHOTREXATE - OTREXUP
N 204824 001 6746429 Apr 12, 2020 DP
7744582 Aug 10, 2019 DP U-1442
7776015 Aug 10, 2019 DP
8021335 Oct 04, 2026 DP
8480631 Mar 19, 2030 DP U-1442
8562564 Jan 24, 2026 DP
8579865 Mar 19, 2030 DP U-1442
RE44846 Aug 10, 2019 DP
RE44847 Aug 10, 2019 DP U-1442
METHOTREXATE - OTREXUP
N 204824 002 6746429 Apr 12, 2020 DP
7744582 Aug 10, 2019 DP U-1442
7776015 Aug 10, 2019 DP
8021335 Oct 04, 2026 DP
8480631 Mar 19, 2030 DP U-1442
8562564 Jan 24, 2026 DP
8579865 Mar 19, 2030 DP U-1442
RE44846 Aug 10, 2019 DP
RE44847 Aug 10, 2019 DP U-1442
METHOTREXATE - OTREXUP
N 204824 003 6746429 Apr 12, 2020 DP
7744582 Aug 10, 2019 DP U-1442
7776015 Aug 10, 2019 DP
8021335 Oct 04, 2026 DP
8480631 Mar 19, 2030 DP U-1442
8562564 Jan 24, 2026 DP
8579865 Mar 19, 2030 DP U-1442
RE44846 Aug 10, 2019 DP
RE44847 Aug 10, 2019 DP U-1442
METHOTREXATE - OTREXUP
N 204824 004 6746429 Apr 12, 2020 DP
7744582 Aug 10, 2019 DP U-1442
7776015 Aug 10, 2019 DP
8021335 Oct 04, 2026 DP
8480631 Mar 19, 2030 DP U-1442
8562564 Jan 24, 2026 DP
8579865 Mar 19, 2030 DP U-1442
RE44846 Aug 10, 2019 DP
RE44847 Aug 10, 2019 DP U-1442
METHOTREXATE - OTREXUP
N 204824 005 6746429 Apr 12, 2020 DP
8021335 Oct 04, 2026 DP
8480631 Mar 19, 2030 DP U-1442
8562564 Jan 24, 2026 DP
8579865 Mar 19, 2030 DP U-1442
RE44846 Aug 10, 2019 DP
RE44847 Aug 10, 2019 DP U-1442
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 139 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
METHOTREXATE - RASUVO
N 205776 001 8664231 Jun 01, 2029 U-1442
METHOTREXATE - RASUVO
N 205776 002 8664231 Jun 01, 2029 U-1442
METHOTREXATE - RASUVO
N 205776 003 8664231 Jun 01, 2029 U-1442
METHOTREXATE - RASUVO
N 205776 004 8664231 Jun 01, 2029 U-1442
METHOTREXATE - RASUVO
N 205776 005 8664231 Jun 01, 2029 U-1442
METHOTREXATE - RASUVO
N 205776 006 8664231 Jun 01, 2029 U-1442
METHOTREXATE - RASUVO
N 205776 007 8664231 Jun 01, 2029 U-1442
METHOTREXATE - RASUVO
N 205776 008 8664231 Jun 01, 2029 U-1442
METHOTREXATE - RASUVO
N 205776 009 8664231 Jun 01, 2029 U-1442
METHOTREXATE - RASUVO
N 205776 010 8664231 Jun 01, 2029 U-1442
METHYL AMINOLEVULINATE HYDROCHLORIDE - METVIXIA
N 021415 001 6034267 Mar 08, 2016 U-804
METHYLNALTREXONE BROMIDE - RELISTOR
N 021964 001 6559158 Nov 03, 2017 U-1185
8247425 Dec 31, 2030 U-1185
8420663 Sep 30, 2029 U-1185
8552025 Apr 08, 2024 DP
8822490 Sep 30, 2029 DP U-1185
METHYLNALTREXONE BROMIDE - RELISTOR
N 021964 002 6559158 Nov 03, 2017 U-1185
8247425 Dec 31, 2030 U-1185
8420663 Sep 30, 2029 U-1185
8552025 Apr 08, 2024 DP
8822490 Sep 30, 2029 DP U-1185
METHYLNALTREXONE BROMIDE - RELISTOR
N 021964 003 8247425 Dec 31, 2030 U-1185
8420663 Sep 30, 2029 U-1185
8552025 Apr 08, 2024 DP
8822490 Sep 30, 2029 DP U-1185
METHYLPHENIDATE - DAYTRANA
N 021514 001 6210705 Sep 30, 2018 DP U-727
6348211 Sep 30, 2018 DP U-727
8632802 Oct 07, 2025 DP
METHYLPHENIDATE - DAYTRANA
N 021514 002 6210705 Sep 30, 2018 DP U-727
6348211 Sep 30, 2018 DP U-727
8632802 Oct 07, 2025 DP
METHYLPHENIDATE - DAYTRANA
N 021514 003 6210705 Sep 30, 2018 DP U-727
6348211 Sep 30, 2018 DP U-727
8632802 Oct 07, 2025 DP
METHYLPHENIDATE - DAYTRANA
N 021514 004 6210705 Sep 30, 2018 DP U-727
6348211 Sep 30, 2018 DP U-727
8632802 Oct 07, 2025 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 140 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
METHYLPHENIDATE HYDROCHLORIDE - CONCERTA
N 021121 001 6919373 Jul 31, 2017 U-666
6930129 Jul 31, 2017 U-666
8163798 Jul 31, 2017 DP
8629179 Jul 31, 2017 DP
8629179*PED Jan 31, 2018
METHYLPHENIDATE HYDROCHLORIDE - CONCERTA
N 021121 002 6919373 Jul 31, 2017 U-666
6930129 Jul 31, 2017 U-666
8163798 Jul 31, 2017 DP
8629179 Jul 31, 2017 DP
8629179*PED Jan 31, 2018
METHYLPHENIDATE HYDROCHLORIDE - CONCERTA
N 021121 003 6919373 Jul 31, 2017 U-666
6930129 Jul 31, 2017 U-666
8163798 Jul 31, 2017 DP
8629179 Jul 31, 2017 DP
8629179*PED Jan 31, 2018
METHYLPHENIDATE HYDROCHLORIDE - CONCERTA
N 021121 004 6919373 Jul 31, 2017 U-666
6930129 Jul 31, 2017 U-666
8163798 Jul 31, 2017 DP
8629179 Jul 31, 2017 DP
8629179*PED Jan 31, 2018
METHYLPHENIDATE HYDROCHLORIDE - METADATE CD
N 021259 001 6344215 Oct 27, 2020 DP
METHYLPHENIDATE HYDROCHLORIDE - METADATE CD
N 021259 002 6344215 Oct 27, 2020 DP
METHYLPHENIDATE HYDROCHLORIDE - METADATE CD
N 021259 003 6344215 Oct 27, 2020 DP
METHYLPHENIDATE HYDROCHLORIDE - METADATE CD
N 021259 004 6344215 Oct 27, 2020 DP
METHYLPHENIDATE HYDROCHLORIDE - RITALIN LA
N 021284 001 5837284 Dec 04, 2015 DP
6228398 Nov 01, 2019 DP U-472
6635284 Dec 04, 2015 DP U-591
7431944 Dec 04, 2015 DP
METHYLPHENIDATE HYDROCHLORIDE - RITALIN LA
N 021284 002 5837284 Dec 04, 2015 DP
6228398 Nov 01, 2019 DP U-472
6635284 Dec 04, 2015 DP U-591
7431944 Dec 04, 2015 DP
METHYLPHENIDATE HYDROCHLORIDE - RITALIN LA
N 021284 003 5837284 Dec 04, 2015 DP
6228398 Nov 01, 2019 DP U-472
6635284 Dec 04, 2015 DP U-591
7431944 Dec 04, 2015 DP
METHYLPHENIDATE HYDROCHLORIDE - RITALIN LA
N 021284 004 5837284 Dec 04, 2015 DP
6228398 Nov 01, 2019 DP U-472
6635284 Dec 04, 2015 DP U-591
7431944 Dec 04, 2015 DP
METHYLPHENIDATE HYDROCHLORIDE - METHYLIN
N 021419 001 7691880 Oct 07, 2024 DP
METHYLPHENIDATE HYDROCHLORIDE - METHYLIN
N 021419 002 7691880 Oct 07, 2024 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 141 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
METHYLPHENIDATE HYDROCHLORIDE - QUILLIVANT XR
N 202100 001 8062667 Mar 29, 2029 DP NDF Sep 27, 2015
8287903 Feb 15, 2031 DP
8465765 Feb 15, 2031 DP U-1415
8563033 Feb 15, 2031 DP U-1415
8778390 Feb 15, 2031 DP U-1543
METOCLOPRAMIDE HYDROCHLORIDE - REGLAN ODT
N 021793 001 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
METOCLOPRAMIDE HYDROCHLORIDE - REGLAN ODT
N 021793 002 6024981 Apr 09, 2018 DP
6221392 Apr 09, 2018 DP
METOCLOPRAMIDE HYDROCHLORIDE - METOZOLV ODT
N 022246 001 6413549 Jul 11, 2017 DP
METOCLOPRAMIDE HYDROCHLORIDE - METOZOLV ODT
N 022246 002 6413549 Jul 11, 2017 DP
METRONIDAZOLE - METROGEL
N 021789 001 6881726 Feb 21, 2022 DP U-743
7348317 Feb 21, 2022 DP U-743
METRONIDAZOLE - VANDAZOLE
N 021806 001 7456207 Sep 22, 2024 DP
METRONIDAZOLE - METRONIDAZOLE
N 205223 001 NP Mar 24, 2017
MICAFUNGIN SODIUM - MYCAMINE
N 021506 002 6107458 Mar 16, 2019 DS DP U-650
6107458 Mar 16, 2019 DS DP U-845
6265536 Sep 29, 2015 DS DP U-650
6265536 Sep 29, 2015 DS DP U-845
6774104 Jan 08, 2021 DP U-650
6774104 Jan 08, 2021 DP U-845
MICAFUNGIN SODIUM - MYCAMINE
N 021506 003 6107458 Mar 16, 2019 DS DP U-650
6107458 Mar 16, 2019 DS DP U-845
6265536 Sep 29, 2015 DS DP U-650
6265536 Sep 29, 2015 DS DP U-845
6774104 Jan 08, 2021 DP U-650
6774104 Jan 08, 2021 DP U-845
MICONAZOLE - ORAVIG
N 022404 001 6916485 Sep 11, 2022 DP U-1051
7651698 Sep 11, 2022 U-1051
8518442 Sep 11, 2022 DP
MICONAZOLE NITRATE; MICONAZOLE NITRATE - MONISTAT 1 COMBINATION PACK
N 021308 001 6153635 Nov 28, 2020 Y
MICONAZOLE NITRATE; PETROLATUM, WHITE; ZINC OXIDE - VUSION
N 021026 001 8147852 Mar 30, 2028 U-1426
MIFEPRISTONE - KORLYM
N 202107 001 NP Feb 17, 2015
ODE Feb 17, 2019
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 142 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
MILNACIPRAN HYDROCHLORIDE - SAVELLA
N 022256 001 6602911 Jan 14, 2023 U-882
6992110 Nov 05, 2021 U-882
7888342 Nov 05, 2021 U-882
7994220 Sep 19, 2029 U-819
MILNACIPRAN HYDROCHLORIDE - SAVELLA
N 022256 002 6602911 Jan 14, 2023 U-882
6992110 Nov 05, 2021 U-882
7888342 Nov 05, 2021 U-882
7994220 Sep 19, 2029 U-819
MILNACIPRAN HYDROCHLORIDE - SAVELLA
N 022256 003 6602911 Jan 14, 2023 U-882
6992110 Nov 05, 2021 U-882
7888342 Nov 05, 2021 U-882
7994220 Sep 19, 2029 U-819
MILNACIPRAN HYDROCHLORIDE - SAVELLA
N 022256 004 6602911 Jan 14, 2023 U-882
6992110 Nov 05, 2021 U-882
7888342 Nov 05, 2021 U-882
7994220 Sep 19, 2029 U-819
MILTEFOSINE - IMPAVIDO
N 204684 001 NCE Mar 19, 2019
ODE Mar 19, 2021
MINOCYCLINE HYDROCHLORIDE - ARESTIN
N 050781 001 6682348 Mar 29, 2022 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 143 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N 050808 001 5908838 Feb 19, 2018 U-917
7790705 Jun 24, 2025 U-1078
7919483 Mar 07, 2027 U-1078
8252776 Jun 24, 2025 U-124
8268804 Jun 24, 2025 U-1078
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N 050808 002 5908838 Feb 19, 2018 U-917
7541347 Apr 02, 2027 U-917
7544373 Apr 02, 2027 DP
7790705 Jun 24, 2025 U-1078
7919483 Mar 07, 2027 U-1078
8252776 Jun 24, 2025 U-124
8268804 Jun 24, 2025 U-1078
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N 050808 003 5908838 Feb 19, 2018 U-917
7790705 Jun 24, 2025 U-1078
7919483 Mar 07, 2027 U-1078
8252776 Jun 24, 2025 U-124
8268804 Jun 24, 2025 U-1078
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N 050808 004 5908838 Feb 19, 2018 U-917
7790705 Jun 24, 2025 U-1078
7919483 Mar 07, 2027 U-1078
8252776 Jun 24, 2025 U-124
8268804 Jun 24, 2025 U-1078
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N 050808 005 5908838 Feb 19, 2018 U-917
7790705 Jun 24, 2025 U-1078
7919483 Mar 07, 2027 U-1078
8252776 Jun 24, 2025 U-124
8268804 Jun 24, 2025 U-1078
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N 050808 006 5908838 Feb 19, 2018 U-917
7790705 Jun 24, 2025 U-1078
7919483 Mar 07, 2027 U-1078
8252776 Jun 24, 2025 U-124
8268804 Jun 24, 2025 U-1078
8722650 Jun 24, 2025 U-1078
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N 050808 007 5908838 Feb 19, 2018 U-917
7790705 Jun 24, 2025 U-1078
7919483 Mar 07, 2027 U-1078
8252776 Jun 24, 2025 U-124
8268804 Jun 24, 2025 U-1078
8722650 Jun 24, 2025 U-1078
MINOCYCLINE HYDROCHLORIDE - SOLODYN
N 050808 008 5908838 Feb 19, 2018 U-917
7790705 Jun 24, 2025 U-1078
7919483 Mar 07, 2027 U-1078
8252776 Jun 24, 2025 U-124
8268804 Jun 24, 2025 U-1078
8722650 Jun 24, 2025 U-1078
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 144 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
MINOCYCLINE HYDROCHLORIDE - XIMINO
N 201922 001 5908838 Feb 19, 2018 U-1376
7541347 Apr 02, 2027 U-917
7544373 Apr 02, 2027 DP
7790705 Jun 24, 2025 U-124
7919483 Mar 07, 2027 U-124
8252776 Jun 24, 2025 U-124
8268804 Jun 24, 2025 U-124
MINOCYCLINE HYDROCHLORIDE - XIMINO
N 201922 003 5908838 Feb 19, 2018 U-1376
7541347 Apr 02, 2027 U-917
7544373 Apr 02, 2027 DP
7790705 Jun 24, 2025 U-124
7919483 Mar 07, 2027 U-124
8252776 Jun 24, 2025 U-124
8268804 Jun 24, 2025 U-124
MINOCYCLINE HYDROCHLORIDE - XIMINO
N 201922 005 5908838 Feb 19, 2018 U-1376
7541347 Apr 02, 2027 U-917
7544373 Apr 02, 2027 DP
7790705 Jun 24, 2025 U-124
7919483 Mar 07, 2027 U-124
8252776 Jun 24, 2025 U-124
8268804 Jun 24, 2025 U-124
MINOXIDIL - MEN'S ROGAINE
N 021812 001 6946120 Apr 20, 2019 DP U-702
MINOXIDIL - WOMEN'S ROGAINE
N 021812 002 NP Feb 28, 2017
MIPOMERSEN SODIUM - KYNAMRO
N 203568 001 6166197 Dec 26, 2017 DS NCE Jan 29, 2018
6222025 Mar 06, 2015 DS ODE Jan 29, 2020
6451991 Feb 11, 2017 DS
7015315 Mar 21, 2023 DS
7101993 Sep 05, 2023 DS
7407943 Aug 01, 2021 U-1353
7511131 Dec 13, 2025 DS
MIRABEGRON - MYRBETRIQ
N 202611 001 6346532 Oct 15, 2018 DS DP NCE Jun 28, 2017
6562375 Aug 01, 2020 DP
7342117 Nov 04, 2023 DS
7750029 Dec 18, 2023 U-913
7982049 Nov 04, 2023 DP
8835474 Nov 04, 2023 U-1527
RE44872 Dec 18, 2023 U-1527
MIRABEGRON - MYRBETRIQ
N 202611 002 6346532 Oct 15, 2018 DS DP NCE Jun 28, 2017
6562375 Aug 01, 2020 DP
7342117 Nov 04, 2023 DS
7750029 Dec 18, 2023 U-913
7982049 Nov 04, 2023 DP
8835474 Nov 04, 2023 U-1527
RE44872 Dec 18, 2023 U-1527
MITOMYCIN - MITOSOL
N 022572 001 7806265 Feb 01, 2029 DP ODE Feb 07, 2019
8186511 Jul 19, 2026 DP
MODAFINIL - PROVIGIL
N 020717 001 7297346 Nov 29, 2023 DP
RE37516 Oct 06, 2014 U-255
MODAFINIL - PROVIGIL
N 020717 002 7297346 Nov 29, 2023 DP
RE37516 Oct 06, 2014 U-255
MOMETASONE FUROATE - ELOCON
N 019625 002 NP Apr 19, 2016
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 145 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
MOMETASONE FUROATE - ASMANEX TWISTHALER
N 021067 001 5687710 Nov 18, 2014 DP
5829434 Nov 03, 2015 DP
6240918 Feb 20, 2017 DP
6503537 Mar 17, 2018 DP
8173172 Mar 17, 2018 DP
MOMETASONE FUROATE - ASMANEX TWISTHALER
N 021067 002 5687710 Nov 18, 2014 DP
5829434 Nov 03, 2015 DP
6240918 Feb 20, 2017 DP
6503537 Mar 17, 2018 DP
8173172 Mar 17, 2018 DP
MOMETASONE FUROATE - ASMANEX HFA
N 205641 001 5889015*PED Jul 27, 2014
6057307*PED Jul 27, 2014
6068832 Aug 27, 2017 DP U-645
6365581*PED Jul 27, 2014
MOMETASONE FUROATE - ASMANEX HFA
N 205641 002 5889015*PED Jul 27, 2014
6057307*PED Jul 27, 2014
6068832 Aug 27, 2017 DP U-645
6365581*PED Jul 27, 2014
MOMETASONE FUROATE MONOHYDRATE - NASONEX
N 020762 001 6127353 Oct 03, 2017 DS DP
MONTELUKAST SODIUM - SINGULAIR
N 020829 002 NPP Mar 26, 2015
MONTELUKAST SODIUM - SINGULAIR
N 020830 001 NPP Mar 26, 2015
MONTELUKAST SODIUM - SINGULAIR
N 020830 002 NPP Mar 26, 2015
MONTELUKAST SODIUM - SINGULAIR
N 021409 001 8007830 Oct 24, 2022 DP NPP Mar 26, 2015
MORPHINE SULFATE - AVINZA
N 021260 001 6066339 Nov 25, 2017 DP
MORPHINE SULFATE - AVINZA
N 021260 002 6066339 Nov 25, 2017 DP
MORPHINE SULFATE - AVINZA
N 021260 003 6066339 Nov 25, 2017 DP
MORPHINE SULFATE - AVINZA
N 021260 004 6066339 Nov 25, 2017 DP
MORPHINE SULFATE - AVINZA
N 021260 005 6066339 Nov 25, 2017 DP
MORPHINE SULFATE - AVINZA
N 021260 006 6066339 Nov 25, 2017 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 146 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
MORPHINE SULFATE - DEPODUR
N 021671 001 5723147 Mar 03, 2015 DP U-584
5807572 Sep 15, 2015 DP
5891467 Jan 31, 2017 DP
5931809 Jul 14, 2015 U-584
5962016 Jan 31, 2017 DP U-584
5997899 Sep 01, 2016 DP
6171613 Oct 01, 2016 DP
6193998 Sep 01, 2016 DP
6241999 Sep 01, 2016 DP
MORPHINE SULFATE - DEPODUR
N 021671 002 5723147 Mar 03, 2015 DP U-584
5807572 Sep 15, 2015 DP
5891467 Jan 31, 2017 DP
5931809 Jul 14, 2015 U-584
5962016 Jan 31, 2017 DP U-584
5997899 Sep 01, 2016 DP
6171613 Oct 01, 2016 DP
6193998 Sep 01, 2016 DP
6241999 Sep 01, 2016 DP
MORPHINE SULFATE - DEPODUR
N 021671 003 5723147 Mar 03, 2015 DP U-584
5807572 Sep 15, 2015 DP
5891467 Jan 31, 2017 DP
5931809 Jul 14, 2015 U-584
5962016 Jan 31, 2017 DP U-584
5997899 Sep 01, 2016 DP
6171613 Oct 01, 2016 DP
6193998 Sep 01, 2016 DP
6241999 Sep 01, 2016 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 147 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA
N 022321 001 7682633 Jun 19, 2027 U-1510
7682634 Jun 19, 2027 DP
7815934 Dec 12, 2027 DP
8158156 Jun 19, 2027 U-1510
8685443 Jul 03, 2025 U-1508
8685444 Jul 03, 2025 DP
8846104 Jun 19, 2027 DP
8877247 Jun 19, 2027 DP
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA
N 022321 002 7682633 Jun 19, 2027 U-1510
7682634 Jun 19, 2027 DP
7815934 Dec 12, 2027 DP
8158156 Jun 19, 2027 U-1510
8685443 Jul 03, 2025 U-1508
8685444 Jul 03, 2025 DP
8846104 Jun 19, 2027 DP
8877247 Jun 19, 2027 DP
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA
N 022321 003 7682633 Jun 19, 2027 U-1510
7682634 Jun 19, 2027 DP
7815934 Dec 12, 2027 DP
8158156 Jun 19, 2027 U-1510
8685443 Jul 03, 2025 U-1508
8685444 Jul 03, 2025 DP
8846104 Jun 19, 2027 DP
8877247 Jun 19, 2027 DP
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA
N 022321 004 7682633 Jun 19, 2027 U-1510
7682634 Jun 19, 2027 DP
7815934 Dec 12, 2027 DP
8158156 Jun 19, 2027 U-1510
8685443 Jul 03, 2025 U-1508
8685444 Jul 03, 2025 DP
8846104 Jun 19, 2027 DP
8877247 Jun 19, 2027 DP
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA
N 022321 005 7682633 Jun 19, 2027 U-1510
7682634 Jun 19, 2027 DP
7815934 Dec 12, 2027 DP
8158156 Jun 19, 2027 U-1510
8685443 Jul 03, 2025 U-1508
8685444 Jul 03, 2025 DP
8846104 Jun 19, 2027 DP
8877247 Jun 19, 2027 DP
MORPHINE SULFATE; NALTREXONE HYDROCHLORIDE - EMBEDA
N 022321 006 7682633 Jun 19, 2027 U-1510
7682634 Jun 19, 2027 DP
7815934 Dec 12, 2027 DP
8158156 Jun 19, 2027 U-1510
8685443 Jul 03, 2025 U-1508
8685444 Jul 03, 2025 DP
8846104 Jun 19, 2027 DP
8877247 Jun 19, 2027 DP
MOXIFLOXACIN HYDROCHLORIDE - AVELOX
N 021085 001 5849752 Dec 05, 2016 U-298
6610327 Oct 29, 2019 DP U-298
MOXIFLOXACIN HYDROCHLORIDE - AVELOX IN SODIUM CHLORIDE 0.8% IN PLASTIC CONTAINER
N 021277 001 5849752 Dec 05, 2016 U-298
6548079 Jul 25, 2020 DP U-298
MOXIFLOXACIN HYDROCHLORIDE - VIGAMOX
N 021598 001 6716830 Sep 29, 2019 DP
7671070 Sep 29, 2019 U-709
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 148 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
MOXIFLOXACIN HYDROCHLORIDE - MOXEZA
N 022428 001 6716830 Sep 29, 2019 DP
7671070 Sep 29, 2019 DP U-709
8450311 May 29, 2029 DP
MUPIROCIN - CENTANY
N 050788 001 6013657 Jul 08, 2018 DP
MUPIROCIN CALCIUM - BACTROBAN
N 050746 001 6025389 Oct 20, 2014 DP U-1122
MYCOPHENOLATE MOFETIL - CELLCEPT
N 050759 001 5688529 Nov 18, 2014 DP
MYCOPHENOLIC ACID - MYCOPHENOLIC ACID
A 091248 001 PC Jul 07, 2014
MYCOPHENOLIC ACID - MYFORTIC
N 050791 001 6025391 Apr 10, 2017 DP U-908
6172107 Apr 10, 2017 DP U-908
6306900 Feb 27, 2018 DP
MYCOPHENOLIC ACID - MYFORTIC
N 050791 002 6025391 Apr 10, 2017 DP U-908
6172107 Apr 10, 2017 DP U-908
6306900 Feb 27, 2018 DP
NAFTIFINE HYDROCHLORIDE - NAFTIN
N 019599 002 NS Jan 13, 2015
NAFTIFINE HYDROCHLORIDE - NAFTIN
N 204286 001 8778365 Jan 31, 2033 DP NP Jun 27, 2016
NALOXEGOL OXALATE - MOVANTIK
N 204760 001 7662365 Oct 18, 2022 DS DP NCE Sep 16, 2019
7786133 Dec 19, 2027 DP
8067431 Dec 16, 2024 U-1185
8617530 Oct 18, 2022 U-1185
NALOXEGOL OXALATE - MOVANTIK
N 204760 002 7662365 Oct 18, 2022 DS DP NCE Sep 16, 2019
7786133 Dec 19, 2027 DP
8067431 Dec 16, 2024 U-1185
8617530 Oct 18, 2022 U-1185
NALOXONE HYDROCHLORIDE - EVZIO
N 205787 001 7731686 Jun 10, 2026 DP
7731690 Jan 15, 2025 DP
7749194 Oct 30, 2028 DP
7918823 Nov 23, 2024 DP
7947017 Mar 12, 2028 DP
8016788 Mar 21, 2025 DP
8021344 Nov 02, 2029 DP
8206360 Feb 27, 2027 DP
8226610 Apr 10, 2029 DP
8231573 Nov 25, 2028 DP
8313466 Nov 23, 2024 DP
8361029 Nov 23, 2024 DP
8425462 Nov 23, 2024 DP
8608698 Nov 23, 2024 DP
8627816 Feb 04, 2032 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 149 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE - TARGINIQ
N 205777 001 6277384 Dec 22, 2018 DP
6696066 Dec 22, 2018 DP
7674799 Mar 30, 2025 DP
7674800 Mar 30, 2025 DS
7683072 Mar 30, 2025 DS
8673355 Dec 22, 2018 DP
8822487 Dec 22, 2018 DP
8846090 Apr 04, 2023 DP
8846091 Apr 04, 2023 DP
NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE - TARGINIQ
N 205777 002 6277384 Dec 22, 2018 DP
6696066 Dec 22, 2018 DP
7674799 Mar 30, 2025 DP
7674800 Mar 30, 2025 DS
7683072 Mar 30, 2025 DS
8673355 Dec 22, 2018 DP
8822487 Dec 22, 2018 DP
8846090 Apr 04, 2023 DP
8846091 Apr 04, 2023 DP
NALOXONE HYDROCHLORIDE; OXYCODONE HYDROCHLORIDE - TARGINIQ
N 205777 003 6277384 Dec 22, 2018 DP
6696066 Dec 22, 2018 DP
7674799 Mar 30, 2025 DP
7674800 Mar 30, 2025 DS
7683072 Mar 30, 2025 DS
8673355 Dec 22, 2018 DP
8822487 Dec 22, 2018 DP
8846090 Apr 04, 2023 DP
8846091 Apr 04, 2023 DP
NALTREXONE - VIVITROL
N 021897 001 5792477 May 02, 2017 DP
5916598 May 02, 2017 DP
6194006 Dec 30, 2018 DP
6264987 May 19, 2020 DP
6331317 Nov 12, 2019 DP
6379703 Dec 30, 2018 DP
6379704 May 19, 2020 DP
6395304 Nov 12, 2019 DP
6403114 May 02, 2017 DP
6495164 May 25, 2020 DP
6495166 Nov 12, 2019 DP
6534092 May 19, 2020 DP
6537586 Nov 12, 2019 DP
6596316 Dec 30, 2018 DP
6667061 May 25, 2020 DP
6713090 Nov 12, 2019 DP
6939033 Nov 12, 2019 DP
7799345 May 25, 2020 DP
7919499 Oct 15, 2029 U-1123
7919499 Oct 15, 2029 U-1124
NAPROXEN SODIUM; SUMATRIPTAN SUCCINATE - TREXIMET
N 021926 001 6060499 Aug 14, 2017 DP U-867
6586458 Aug 14, 2017 DP U-867
7332183 Oct 02, 2025 DP U-867
8022095 Aug 14, 2017 DP U-867
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 150 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
NATEGLINIDE - STARLIX
N 021204 001 6559188 Sep 15, 2020 DP U-827
6641841 Nov 14, 2017 DP U-214
6844008 Nov 14, 2017 DP U-214
6878749 Sep 15, 2020 DP
NATEGLINIDE - STARLIX
N 021204 002 6559188 Sep 15, 2020 DP U-827
6641841 Nov 14, 2017 DP U-214
6844008 Nov 14, 2017 DP U-214
6878749 Sep 15, 2020 DP
NEBIVOLOL HYDROCHLORIDE - BYSTOLIC
N 021742 002 5759580 Jun 02, 2015 DP
6545040 Dec 17, 2021 DP U-3
NEBIVOLOL HYDROCHLORIDE - BYSTOLIC
N 021742 003 5759580 Jun 02, 2015 DP
6545040 Dec 17, 2021 DP U-3
NEBIVOLOL HYDROCHLORIDE - BYSTOLIC
N 021742 004 5759580 Jun 02, 2015 DP
6545040 Dec 17, 2021 DP U-3
NEBIVOLOL HYDROCHLORIDE - BYSTOLIC
N 021742 005 5759580 Jun 02, 2015 DP
6545040 Dec 17, 2021 DP U-3
NELARABINE - ARRANON
N 021877 001 5424295 Jun 13, 2017 DS DP
NEPAFENAC - NEVANAC
N 021862 001 7834059 Jan 31, 2027 U-1095
8071648 Dec 02, 2025 DP
8324281 Dec 02, 2025 DP
NEPAFENAC - ILEVRO
N 203491 001 6403609 Jul 17, 2018 DP NP Oct 16, 2015
7947295 Jun 08, 2024 DP
NETUPITANT; PALONOSETRON HYDROCHLORIDE - AKYNZEO
N 205718 001 5202333 Apr 13, 2015 DS DP U-528 NCE Oct 10, 2019
6297375 Feb 22, 2020 DS
8623826 Nov 18, 2030 U-528
NEVIRAPINE - NEVIRAPINE
A 203411 001 PC Oct 12, 2014
NEVIRAPINE - NEVIRAPINE
A 205258 001 PC Oct 12, 2014
NEVIRAPINE - VIRAMUNE XR
N 201152 001 8460704 Mar 12, 2029 U-1409 NPP Nov 08, 2015
NEVIRAPINE - VIRAMUNE XR
N 201152 002 NPP Nov 08, 2015
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 151 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
NIACIN - NIASPAN
N 020381 001 6080428 May 27, 2017 U-331
NIACIN - NIASPAN
N 020381 002 6080428 May 27, 2017 U-331
6080428 May 27, 2017 U-1138
6080428 May 27, 2017 U-1139
6080428 May 27, 2017 U-1140
6080428 May 27, 2017 U-1141
6469035 Mar 15, 2018 U-768
6469035 Mar 15, 2018 U-1142
6469035 Mar 15, 2018 U-1143
6469035 Mar 15, 2018 U-1144
6469035 Mar 15, 2018 U-1145
NIACIN - NIASPAN
N 020381 003 6080428 May 27, 2017 U-331
6080428 May 27, 2017 U-1138
6080428 May 27, 2017 U-1139
6080428 May 27, 2017 U-1140
6080428 May 27, 2017 U-1141
6469035 Mar 15, 2018 U-768
6469035 Mar 15, 2018 U-1142
6469035 Mar 15, 2018 U-1143
6469035 Mar 15, 2018 U-1144
6469035 Mar 15, 2018 U-1145
NIACIN - NIASPAN
N 020381 004 6080428 May 27, 2017 U-331
6080428 May 27, 2017 U-1138
6080428 May 27, 2017 U-1139
6080428 May 27, 2017 U-1140
6080428 May 27, 2017 U-1141
6469035 Mar 15, 2018 U-768
6469035 Mar 15, 2018 U-1142
6469035 Mar 15, 2018 U-1143
6469035 Mar 15, 2018 U-1144
6469035 Mar 15, 2018 U-1145
NIACIN - NIASPAN TITRATION STARTER PACK
N 020381 005 6080428 May 27, 2017 U-331
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 152 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
NIACIN; SIMVASTATIN - SIMCOR
N 022078 001 6080428 May 27, 2017 U-862
6080428 May 27, 2017 U-1132
6080428 May 27, 2017 U-1134
6469035 Mar 15, 2018 U-863
6469035 Mar 15, 2018 U-1129
6469035 Mar 15, 2018 U-1149
NIACIN; SIMVASTATIN - SIMCOR
N 022078 002 6080428 May 27, 2017 U-862
6080428 May 27, 2017 U-1132
6080428 May 27, 2017 U-1134
6469035 Mar 15, 2018 U-863
6469035 Mar 15, 2018 U-1129
6469035 Mar 15, 2018 U-1149
NIACIN; SIMVASTATIN - SIMCOR
N 022078 003 6080428 May 27, 2017 U-862
6080428 May 27, 2017 U-1132
6080428 May 27, 2017 U-1134
6469035 Mar 15, 2018 U-863
6469035 Mar 15, 2018 U-1129
6469035 Mar 15, 2018 U-1149
NIACIN; SIMVASTATIN - SIMCOR
N 022078 004 6080428 May 27, 2017 U-862
6080428 May 27, 2017 U-1132
6080428 May 27, 2017 U-1134
6469035 Mar 15, 2018 U-863
6469035 Mar 15, 2018 U-1129
6469035 Mar 15, 2018 U-1149
NIACIN; SIMVASTATIN - SIMCOR
N 022078 005 6080428 May 27, 2017 U-862
6080428 May 27, 2017 U-1132
6080428 May 27, 2017 U-1134
6469035 Mar 15, 2018 U-863
6469035 Mar 15, 2018 U-1129
6469035 Mar 15, 2018 U-1149
NICARDIPINE HYDROCHLORIDE - CARDENE IN 4.8% DEXTROSE IN PLASTIC CONTAINER
N 019734 002 7612102 Dec 26, 2027 DP
7659291 Apr 18, 2027 U-1029
8455524 Apr 18, 2027 U-1029
NICARDIPINE HYDROCHLORIDE - CARDENE IN 0.86% SODIUM CHLORIDE IN PLASTIC CONTAINER
N 019734 003 7612102 Dec 26, 2027 DP
7659291 Apr 18, 2027 U-1029
8455524 Apr 18, 2027 U-1029
NICARDIPINE HYDROCHLORIDE - CARDENE IN 0.83% SODIUM CHLORIDE IN PLASTIC CONTAINER
N 019734 004 7612102 Dec 26, 2027 DP
7659291 Apr 18, 2027 U-1029
8455524 Apr 18, 2027 U-1029
NICARDIPINE HYDROCHLORIDE - CARDENE IN 5.0% DEXTROSE IN PLASTIC CONTAINER
N 019734 005 7612102 Dec 26, 2027 DP
7659291 Apr 18, 2027 U-1029
8455524 Apr 18, 2027 U-1029
NICOTINE - NICODERM CQ
N 020165 004 8075911 May 22, 2021 DP
8663680 Feb 13, 2020 DP
NICOTINE - NICODERM CQ
N 020165 005 8075911 May 22, 2021 DP
8663680 Feb 13, 2020 DP
NICOTINE - NICODERM CQ
N 020165 006 8075911 May 22, 2021 DP
8663680 Feb 13, 2020 DP
NICOTINE - NICOTROL
N 020385 001 5656255 Aug 12, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 153 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
NICOTINE POLACRILEX - NICORETTE
N 018612 002 8323683 Apr 30, 2028
NICOTINE POLACRILEX - NICORETTE
N 020066 002 8323683 Apr 30, 2028 DP
NICOTINE POLACRILEX - NICORETTE
N 022360 001 8501164 Jun 14, 2029 DP
NICOTINE POLACRILEX - NICORETTE
N 022360 002 8501164 Jun 14, 2029 DP
NILOTINIB HYDROCHLORIDE MONOHYDRATE - TASIGNA
N 022068 001 7169791 Jul 04, 2023 DS DP U-836 ODE Oct 29, 2014
8163904 Aug 23, 2028 DS DP
8293756 Sep 25, 2027 DP
8389537 Jul 18, 2026 DS DP U-1374
8415363 Jul 18, 2026 DS DP U-1407
8501760 Jul 18, 2026 DS DP
NILOTINIB HYDROCHLORIDE MONOHYDRATE - TASIGNA
N 022068 002 7169791 Jul 04, 2023 DS DP U-836 ODE Oct 29, 2014
8163904 Aug 23, 2028 DS DP
8293756 Sep 25, 2027 DP
8389537 Jul 18, 2026 DS DP U-1374
8415363 Jul 18, 2026 DS DP U-1407
8501760 Jul 18, 2026 DS DP
NIMODIPINE - NYMALIZE
N 203340 001 ODE May 10, 2020
NINTEDANIB - OFEV
N 205832 001 6762180 Dec 10, 2020 DS DP NCE Oct 15, 2019
7119093 Feb 21, 2024 DS DP ODE Oct 15, 2021
NINTEDANIB - OFEV
N 205832 002 6762180 Dec 10, 2020 DS DP NCE Oct 15, 2019
7119093 Feb 21, 2024 DS DP ODE Oct 15, 2021
NISOLDIPINE - SULAR
N 020356 005 5626874 Nov 30, 2014 DP
NISOLDIPINE - SULAR
N 020356 006 5626874 Nov 30, 2014 DP
NISOLDIPINE - SULAR
N 020356 007 5626874 Nov 30, 2014 DP
NISOLDIPINE - SULAR
N 020356 008 5626874 Nov 30, 2014 DP
NITAZOXANIDE - ALINIA
N 021497 001 5968961 May 07, 2017 DP
6020353 Sep 18, 2014 DS DP
NITAZOXANIDE - ALINIA
N 021498 001 5578621 Sep 08, 2014 U-525
5965590 Jul 03, 2017 U-523
5968961 May 07, 2017
6020353 Sep 08, 2014
6117894 May 07, 2017
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 154 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
NITRIC OXIDE - INOMAX
N 020845 002 5732693 Dec 13, 2016 DP U-1230
5752504 Dec 13, 2016 DP U-1230
6125846 May 16, 2017 DP U-1457
8282966 Jun 30, 2029 U-1286
8291904 Jan 06, 2031 DP U-1226
8293284 Jun 30, 2029 U-1286
8431163 Jun 30, 2029 U-1286
8431163*PED Dec 30, 2029
8573209 Jan 06, 2031 DP
8573209*PED Jul 06, 2031
8573210 Jan 06, 2031 DP U-1453
8573210*PED Jul 06, 2031
8776794 Jan 06, 2031 DP U-1226
8776794*PED Jul 06, 2031
8776795 Jan 06, 2031 DP U-1226
8776795*PED Jul 06, 2031
8795741 Jun 30, 2029 U-1286
8795741*PED Dec 30, 2029
8846112 Jun 30, 2029 U-1286
8846112*PED Dec 30, 2029
NITRIC OXIDE - INOMAX
N 020845 003 5732693 Dec 13, 2016 DP U-1230
5752504 Dec 13, 2016 DP U-1230
6125846 May 16, 2017 DP U-1457
8282966 Jun 30, 2029 U-1286
8291904 Jan 06, 2031 DP U-1226
8293284 Jun 30, 2029 U-1286
8431163 Jun 30, 2029 U-1286
8431163*PED Dec 30, 2029
8573209 Jan 06, 2031 DP
8573209*PED Jul 06, 2031
8573210 Jan 06, 2031 DP U-1453
8573210*PED Jul 06, 2031
8776794 Jan 06, 2031 DP U-1226
8776794*PED Jul 06, 2031
8776795 Jan 06, 2031 DP U-1226
8776795*PED Jul 06, 2031
8795741 Jun 30, 2029 U-1286
8795741*PED Dec 30, 2029
8846112 Jun 30, 2029 U-1286
8846112*PED Dec 30, 2029
NITROGLYCERIN - NITROLINGUAL PUMPSPRAY
N 018705 002 7872049 Mar 14, 2028 DP U-39
NITROGLYCERIN - NITROSTAT
N 021134 001 6500456 Sep 16, 2018
NITROGLYCERIN - NITROSTAT
N 021134 002 6500456 Sep 16, 2018
NITROGLYCERIN - NITROSTAT
N 021134 003 6500456 Sep 16, 2018
NITROGLYCERIN - NITROMIST
N 021780 001 5869082 Apr 16, 2016 DP
NIZATIDINE - AXID
N 021494 001 6930119 Jul 17, 2022 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 155 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
OCTREOTIDE ACETATE - SANDOSTATIN
N 019667 001 5753618 May 19, 2015
OCTREOTIDE ACETATE - SANDOSTATIN
N 019667 002 5753618 May 19, 2015
OCTREOTIDE ACETATE - SANDOSTATIN
N 019667 003 5753618 May 19, 2015
OCTREOTIDE ACETATE - SANDOSTATIN
N 019667 004 5753618 May 19, 2015
OCTREOTIDE ACETATE - SANDOSTATIN
N 019667 005 5753618 May 19, 2015
OCTREOTIDE ACETATE - SANDOSTATIN LAR
N 021008 001 5688530 Nov 18, 2014 U-268
5922338 Jul 13, 2016 DP
5922682 Jul 13, 2016 DP
OCTREOTIDE ACETATE - SANDOSTATIN LAR
N 021008 002 5688530 Nov 18, 2014 U-268
5922338 Jul 13, 2016 DP
5922682 Jul 13, 2016 DP
OCTREOTIDE ACETATE - SANDOSTATIN LAR
N 021008 003 5688530 Nov 18, 2014 U-268
5922338 Jul 13, 2016 DP
5922682 Jul 13, 2016 DP
OLANZAPINE - ZYPREXA
N 020592 001 6960577 Nov 01, 2017 U-963 NPP Jul 26, 2016
OLANZAPINE - ZYPREXA
N 020592 002 6960577 Nov 01, 2017 U-963 NPP Jul 26, 2016
OLANZAPINE - ZYPREXA
N 020592 003 6960577 Nov 01, 2017 U-963 NPP Jul 26, 2016
OLANZAPINE - ZYPREXA
N 020592 004 6960577 Nov 01, 2017 U-963 NPP Jul 26, 2016
OLANZAPINE - ZYPREXA
N 020592 005 6960577 Nov 01, 2017 U-963 NPP Jul 26, 2016
OLANZAPINE - ZYPREXA
N 020592 006 6960577 Nov 01, 2017 U-963 NPP Jul 26, 2016
OLANZAPINE - ZYPREXA ZYDIS
N 021086 001 6960577 Nov 01, 2017 U-964 NPP Jul 26, 2016
OLANZAPINE - ZYPREXA ZYDIS
N 021086 002 6960577 Nov 01, 2017 U-964 NPP Jul 26, 2016
OLANZAPINE - ZYPREXA ZYDIS
N 021086 003 6960577 Nov 01, 2017 U-964 NPP Jul 26, 2016
OLANZAPINE - ZYPREXA ZYDIS
N 021086 004 6960577 Nov 01, 2017 U-964 NPP Jul 26, 2016
OLANZAPINE PAMOATE - ZYPREXA RELPREVV
N 022173 001 6169084 Sep 30, 2018 DS DP U-1026
OLANZAPINE PAMOATE - ZYPREXA RELPREVV
N 022173 002 6169084 Sep 30, 2018 DS DP U-1026
OLANZAPINE PAMOATE - ZYPREXA RELPREVV
N 022173 003 6169084 Sep 30, 2018 DS DP U-1026
OLAPARIB - OLAPARIB
N 206162 001 NCE Dec 19, 2019
OLIVE OIL; SOYBEAN OIL - CLINOLIPID 20%
N 204508 001 5840757 Nov 24, 2015 DP NP Oct 03, 2016
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 156 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
OLMESARTAN MEDOXOMIL - BENICAR
N 021286 001 5616599 Apr 25, 2016 DS DP U-500
6878703 Nov 19, 2021 U-3 Y
OLMESARTAN MEDOXOMIL - BENICAR
N 021286 003 5616599 Apr 25, 2016 DS DP U-500
6878703 Nov 19, 2021 U-3 Y
OLMESARTAN MEDOXOMIL - BENICAR
N 021286 004 5616599 Apr 25, 2016 DS DP U-500
6878703 Nov 19, 2021 U-3 Y
OLODATEROL HYDROCHLORIDE - STRIVERDI RESPIMAT
N 203108 001 5964416 Oct 04, 2016 DP NCE Jul 31, 2019
6149054 Dec 19, 2016 DP
6176442 Oct 04, 2016 DP
6453795 Dec 05, 2016 DP
6726124 Oct 04, 2016 DP
6846413 Aug 28, 2018 DP
6977042 Aug 28, 2018 DP
6988496 Feb 23, 2020 DP U-1547
7056916 Dec 07, 2023 DS DP
7104470 Oct 04, 2016 DP
7220742 May 12, 2025 DS DP U-1547
7246615 May 31, 2016 DP
7284474 Aug 26, 2024 DP
7396341 Oct 10, 2026 DP U-1547
7491719 Nov 10, 2023 DS DP
7727984 Nov 10, 2023 DS
7786111 Nov 10, 2023 DP
7802568 Feb 26, 2019 DP
7837235 Mar 13, 2028 DP
7896264 May 26, 2025 DP
7988001 Aug 04, 2021 DP
8034809 May 12, 2025 U-1547
8044046 Nov 10, 2023 U-1547
OLOPATADINE HYDROCHLORIDE - PATANOL
N 020688 001 5641805 Jun 06, 2015 U-184
OLOPATADINE HYDROCHLORIDE - PATADAY
N 021545 001 5641805 Jun 06, 2015 U-765 Y
5641805*PED Dec 06, 2015
6995186 Nov 12, 2023 DP U-765
7402609 Jun 19, 2022 DP
OLOPATADINE HYDROCHLORIDE - PATANASE
N 021861 001 7977376 Feb 02, 2023 DP
8399508 Sep 17, 2022 U-726
8399508*PED Mar 17, 2023
OMACETAXINE MEPESUCCINATE - SYNRIBO
N 203585 001 6987103 Jun 28, 2023 U-1300 NCE Oct 26, 2017
RE45128 Mar 16, 2019 DS DP U-1576 ODE Oct 26, 2019
OMEGA-3-ACID ETHYL ESTERS - LOVAZA
N 021654 001 5656667 Apr 10, 2017 DS DP U-822
OMEGA-3-CARBOXYLIC ACIDS - EPANOVA
N 205060 001 5792795 May 13, 2016 DP
5948818 May 13, 2016 DP
7960370 Feb 07, 2025 DP
8383678 Feb 07, 2025 DP U-1511
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 157 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT
PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT
DELIST EXCLUSIVITY EXPIRATION
DATE CODES
REQUESTED CODE(S) DATE
OMEPRAZOLE - PRILOSEC
N 019810 001 6147103 Oct 09, 2018
6150380 Nov 10, 2018
6166213 Oct 09, 2018
6191148 Oct 09, 2018
OMEPRAZOLE - PRILOSEC
N 019810 002 6147103 Oct 09, 2018
6150380 Nov 10, 2018
6166213 Oct 09, 2018
6191148 Oct 09, 2018
OMEPRAZOLE - PRILOSEC
N 019810 003 6147103 Oct 09, 2018
6150380 Nov 10, 2018
6166213 Oct 09, 2018
6191148 Oct 09, 2018
OMEPRAZOLE MAGNESIUM - PRILOSEC OTC
N 021229 001 5690960 Nov 25, 2014
5753265 Jun 07, 2015
5817338 Oct 06, 2015
5900424 May 04, 2016
6403616 Nov 15, 2019
6428810 Nov 03, 2019
OMEPRAZOLE MAGNESIUM - PRILOSEC
N 022056 001 5690960 Nov 25, 2014 DP U-864
5900424 May 04, 2016 DS U-864
6428810 Nov 03, 2019 DP U-864
OMEPRAZOLE MAGNESIUM - PRILOSEC
N 022056 002 5690960 Nov 25, 2014 DP U-864
5900424 May 04, 2016 DS U-864
6428810 Nov 03, 2019 DP U-864
OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID
N 021636 001 5840737 Jul 16, 2016 U-588
6489346 Jul 16, 2016 DS DP U-588
Y
6645988 Jul 16, 2016 DS DP
Y
6699885 Jul 16, 2016 U-588
Y
6780882 Jul 16, 2016 DS DP
7399772 Jul 16, 2016 U-588
RE45198 Jul 16, 2016 U-588
OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID
N 021636 002 5840737 Jul 16, 2016 U-623
5840737 Jul 16, 2016 U-624
6489346 Jul 16, 2016 DS DP U-623
Y
6489346 Jul 16, 2016 DS DP U-624
Y
6645988 Jul 16, 2016 DS DP
Y
6699885 Jul 16, 2016 U-623
Y
6699885 Jul 16, 2016 U-624
Y
6780882 Jul 16, 2016 DS DP
7399772 Jul 16, 2016 U-623
7399772 Jul 16, 2016 U-624
RE45198 Jul 16, 2016 U-588
OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID
N 021849 001 7399772 Jul 16, 2016 U-588
OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID
N 021849 002 7399772 Jul 16, 2016 U-623
OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID OTC
N 022281 001 6489346 Jul 15, 2016 DP U-1025
Y
6645988 Jul 15, 2016 DP
Y
6699885 Jul 15, 2016 DP
Y
7399772 Jul 15, 2016 U-1025
OMEPRAZOLE; SODIUM BICARBONATE - ZEGERID OTC
N 022283 001 5840737 Jul 16, 2016 U-1025
6780882 Jul 16, 2016 DP
7399772 Jul 16, 2016 U-1025
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 158 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ONDANSETRON - ZOFRAN ODT
N 020781 001 5955488 Nov 14, 2015
6063802 Nov 14, 2015
ONDANSETRON - ZOFRAN ODT
N 020781 002 5955488 Nov 14, 2015
6063802 Nov 14, 2015
ONDANSETRON - ZUPLENZ
N 022524 001 8580830 Nov 23, 2029 DP
ONDANSETRON - ZUPLENZ
N 022524 002 8580830 Nov 23, 2029 DP
ONDANSETRON HYDROCHLORIDE - ZOFRAN
N 020605 001 5854270 Nov 20, 2015 DP U-44
ORITAVANCIN DIPHOSPHATE - ORBACTIV
N 206334 001 5840684 Nov 24, 2015 DS DP U-1569 NCE Aug 06, 2019
5998581 Nov 12, 2017 DS GAIN Aug 06, 2024
8420592 Aug 29, 2029 U-1570
ORLISTAT - XENICAL
N 020766 001 6004996 Jan 06, 2018
ORLISTAT - ALLI
N 021887 001 6004996 Jan 06, 2018 DP
OSELTAMIVIR PHOSPHATE - TAMIFLU
N 021087 001 5763483 Dec 27, 2016 DS U-1113 NPP Dec 21, 2015
5866601 Feb 02, 2016 DS DP
5952375 Feb 27, 2015 DS DP
OSELTAMIVIR PHOSPHATE - TAMIFLU
N 021087 002 5763483 Dec 27, 2016 DS U-1113 NPP Dec 21, 2015
5866601 Feb 02, 2016 DS DP
5952375 Feb 27, 2015 DS DP
OSELTAMIVIR PHOSPHATE - TAMIFLU
N 021087 003 5763483 Dec 27, 2016 DS U-1113 NPP Dec 21, 2015
5866601 Feb 02, 2016 DS DP
5952375 Feb 27, 2015 DS DP
OSELTAMIVIR PHOSPHATE - TAMIFLU
N 021246 001 5763483 Dec 27, 2016 DS U-376 NPP Dec 21, 2015
5763483 Dec 27, 2016 DS U-1113
5866601 Feb 02, 2016 DS DP
5952375 Feb 27, 2015 DS DP
OSELTAMIVIR PHOSPHATE - TAMIFLU
N 021246 002 5763483 Dec 27, 2016 DS DP U-1113 NPP Dec 21, 2015
5866601 Feb 02, 2016 DS DP
5952375 Feb 27, 2015 DS DP
OSPEMIFENE - OSPHENA
N 203505 001 6245819 Jul 21, 2020 U-1369 NCE Feb 26, 2018
8236861 Aug 11, 2026 U-1369
8236861 Aug 11, 2026 U-1370
8470890 Feb 13, 2024 U-1369
8470890 Feb 13, 2024 U-1370
8642079 Mar 01, 2028 DP
8772353 Feb 13, 2024 U-1369
8772353 Feb 13, 2024 U-1370
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 159 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
OXALIPLATIN - ELOXATIN
N 021492 001 5420319 Aug 09, 2016 DS
OXALIPLATIN - ELOXATIN
N 021492 002 5420319 Aug 09, 2016 DS
OXALIPLATIN - ELOXATIN
N 021759 001 5420319 Aug 09, 2016 DS
5716988 Aug 07, 2015 DP
OXALIPLATIN - ELOXATIN
N 021759 002 5420319 Aug 09, 2016 DS
5716988 Aug 07, 2015 DP
OXALIPLATIN - ELOXATIN
N 021759 003 5420319 Aug 09, 2016 DS
5716988 Aug 07, 2015 DP
OXANDROLONE - OXANDRIN
N 013718 001 5872147 Dec 05, 2017 U-585
6090799 Jul 18, 2017 U-585
6576659 Dec 05, 2017 U-585
6828313 Dec 05, 2017 U-585
OXANDROLONE - OXANDRIN
N 013718 002 5872147 Dec 05, 2017 U-585
6090799 Jul 18, 2017 U-585
6576659 Dec 05, 2017 U-585
6828313 Dec 05, 2017 U-585
OXCARBAZEPINE - TRILEPTAL
N 021014 001 7037525 Feb 12, 2018 U-724
OXCARBAZEPINE - TRILEPTAL
N 021014 002 7037525 Feb 12, 2018 U-724
OXCARBAZEPINE - TRILEPTAL
N 021014 003 7037525 Feb 12, 2018 U-724
OXCARBAZEPINE - TRILEPTAL
N 021285 001 7037525 Feb 12, 2018 U-724
8119148 Dec 19, 2020 DP U-724
OXCARBAZEPINE - OXTELLAR XR
N 202810 001 7722898 Apr 13, 2027 DP NDF Oct 19, 2015
7910131 Apr 13, 2027 U-1298
8617600 Apr 13, 2027 DP
8821930 Apr 13, 2027 DP
OXCARBAZEPINE - OXTELLAR XR
N 202810 002 7722898 Apr 13, 2027 DP NDF Oct 19, 2015
7910131 Apr 13, 2027 U-1298
8617600 Apr 13, 2027 DP
8821930 Apr 13, 2027 DP
OXCARBAZEPINE - OXTELLAR XR
N 202810 003 7722898 Apr 13, 2027 DP NDF Oct 19, 2015
7910131 Apr 13, 2027 U-1298
8617600 Apr 13, 2027 DP
8821930 Apr 13, 2027 DP
OXYBUTYNIN - OXYTROL
N 021351 002 5601839 Apr 26, 2015
5834010 Apr 26, 2015
6743441 Apr 26, 2020 DP U-318
7081249 Apr 26, 2020 DP U-318
7081250 Apr 26, 2020 DP U-318
7081251 Apr 26, 2020 DP U-318
7081252 Apr 26, 2020 DP U-318
7179483 Apr 26, 2020 DS DP U-318
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 160 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
OXYBUTYNIN - OXYTROL FOR WOMEN
N 202211 001 5601839 Apr 26, 2015 DP U-1329 NP Jan 25, 2016
5834010 Apr 26, 2015 DP U-1329
6743441 Apr 26, 2020 DP U-1329
7081249 Apr 26, 2020 DP U-1329
7081250 Apr 26, 2020 DP U-1329
7081251 Apr 26, 2020 DP U-1329
7081252 Apr 26, 2020 DP U-1329
7179483 Apr 26, 2020 U-1329
OXYBUTYNIN - GELNIQUE 3%
N 202513 001 7029694 Apr 26, 2020 DP U-318 NP Dec 07, 2014
7179483 Apr 26, 2020 U-318
7198801 Jun 25, 2022 DP
8241662 Apr 26, 2020 U-318
OXYBUTYNIN CHLORIDE - DITROPAN XL
N 020897 001 5674895 May 22, 2015
5840754 May 22, 2015
5912268 May 22, 2015
6262115 May 22, 2015 U-393
OXYBUTYNIN CHLORIDE - DITROPAN XL
N 020897 002 5674895 May 22, 2015
5840754 May 22, 2015
5912268 May 22, 2015
6262115 May 22, 2015 U-393
OXYBUTYNIN CHLORIDE - DITROPAN XL
N 020897 003 5674895 May 22, 2015
5840754 May 22, 2015
5912268 May 22, 2015
6262115 May 22, 2015 U-393
OXYBUTYNIN CHLORIDE - GELNIQUE
N 022204 001 7029694 Apr 26, 2020 DP U-318
7179483 Apr 26, 2020 U-318
8241662 Apr 26, 2020 U-318
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 161 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N 022272 001 6488963 Jun 24, 2017 DP
7674799 Mar 30, 2025 DP
7674800 Mar 30, 2025 DS
7683072 Mar 30, 2025 DS
7776314 Apr 19, 2025 DP Y
8114383 Oct 10, 2024 DP
8309060 Nov 20, 2023 DP U-1556
8337888 Aug 06, 2022 DP
8808741 Aug 24, 2027 U-1556
8894987 Mar 29, 2030 DP
8894988 Aug 24, 2027 DP
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N 022272 002 6488963 Jun 24, 2017 DP
7674799 Mar 30, 2025 DP
7674800 Mar 30, 2025 DS
7683072 Mar 30, 2025 DS
7776314 Apr 19, 2025 DP Y
8114383 Oct 10, 2024 DP
8309060 Nov 20, 2023 DP U-1556
8337888 Aug 06, 2022 DP
8808741 Aug 24, 2027 U-1556
8894987 Mar 29, 2030 DP
8894988 Aug 24, 2027 DP
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N 022272 003 6488963 Jun 24, 2017 DP
7674799 Mar 30, 2025 DP
7674800 Mar 30, 2025 DS
7683072 Mar 30, 2025 DS
7776314 Apr 19, 2025 DP Y
8114383 Oct 10, 2024 DP
8309060 Nov 20, 2023 DP U-1556
8337888 Aug 06, 2022 DP
8808741 Aug 24, 2027 U-1556
8894987 Mar 29, 2030 DP
8894988 Aug 24, 2027 DP
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N 022272 004 6488963 Jun 24, 2017 DP
7674799 Mar 30, 2025 DP
7674800 Mar 30, 2025 DS
7683072 Mar 30, 2025 DS
7776314 Apr 19, 2025 DP Y
8114383 Oct 10, 2024 DP
8309060 Nov 20, 2023 DP U-1556
8337888 Aug 06, 2022 DP
8808741 Aug 24, 2027 U-1556
8894987 Mar 29, 2030 DP
8894988 Aug 24, 2027 DP
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N 022272 005 6488963 Jun 24, 2017 DP
7674799 Mar 30, 2025 DP
7674800 Mar 30, 2025 DS
7683072 Mar 30, 2025 DS
7776314 Apr 19, 2025 DP Y
8114383 Oct 10, 2024 DP
8309060 Nov 20, 2023 DP U-1556
8337888 Aug 06, 2022 DP
8808741 Aug 24, 2027 U-1556
8894988 Aug 24, 2027 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 162 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N 022272 006 6488963 Jun 24, 2017 DP
7674799 Mar 30, 2025 DP
7674800 Mar 30, 2025 DS
7683072 Mar 30, 2025 DS
7776314 Apr 19, 2025 DP Y
8114383 Oct 10, 2024 DP
8309060 Nov 20, 2023 DP U-1556
8337888 Aug 06, 2022 DP
8808741 Aug 24, 2027 U-1556
8894988 Aug 24, 2027 DP
OXYCODONE HYDROCHLORIDE - OXYCONTIN
N 022272 007 6488963 Jun 24, 2017 DP
7674799 Mar 30, 2025 DP
7674800 Mar 30, 2025 DS
7683072 Mar 30, 2025 DS
7776314 Apr 19, 2025 DP Y
8114383 Oct 10, 2024 DP
8309060 Nov 20, 2023 DP U-1556
8337888 Aug 06, 2022 DP
8808741 Aug 24, 2027 U-1556
8894988 Aug 24, 2027 DP
OXYCODONE HYDROCHLORIDE - OXECTA
N 202080 001 7201920 Mar 16, 2025 DP
7510726 Nov 26, 2023 DP
7981439 Nov 26, 2023 DP
8409616 Nov 26, 2023 DP
8637540 Nov 26, 2023 DP
OXYCODONE HYDROCHLORIDE - OXECTA
N 202080 002 7201920 Mar 16, 2025 DP
7510726 Nov 26, 2023 DP
7981439 Nov 26, 2023 DP
8409616 Nov 26, 2023 DP
8637540 Nov 26, 2023 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 163 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 021610 001 7276250 Feb 04, 2023 DP U-826
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 021610 002 7276250 Feb 04, 2023 DP U-826
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 021610 003 7276250 Feb 04, 2023 DP U-826
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 021610 004 7276250 Feb 04, 2023 DP U-826
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 021610 005 7276250 Feb 04, 2023 DP U-826
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 021610 006 7276250 Feb 04, 2023 DP U-826
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 021610 007 7276250 Feb 04, 2023 DP U-826
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 201655 001 7851482 Jul 10, 2029 DS
8075872 Nov 20, 2023 DP
8114383 Aug 08, 2024 DP
8192722 Sep 15, 2025 DP
8309060 Nov 20, 2023 DP
8309122 Feb 04, 2023 DP
8329216 Feb 04, 2023 DP
8808737 Jun 21, 2027 U-1598
8871779 Nov 22, 2029 DS
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 201655 002 7851482 Jul 10, 2029 DS
8075872 Nov 20, 2023 DP
8114383 Aug 08, 2024 DP
8192722 Sep 15, 2025 DP
8309060 Nov 20, 2023 DP
8309122 Feb 04, 2023 DP
8329216 Feb 04, 2023 DP
8808737 Jun 21, 2027 U-1598
8871779 Nov 22, 2029 DS
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 201655 003 7851482 Jul 10, 2029 DS
8075872 Nov 20, 2023 DP
8114383 Aug 08, 2024 DP
8192722 Sep 15, 2025 DP
8309060 Nov 20, 2023 DP
8309122 Feb 04, 2023 DP
8329216 Feb 04, 2023 DP
8808737 Jun 21, 2027 U-1598
8871779 Nov 22, 2029 DS
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 201655 004 7851482 Jul 10, 2029 DS
8075872 Nov 20, 2023 DP
8114383 Aug 08, 2024 DP
8192722 Sep 15, 2025 DP
8309060 Nov 20, 2023 DP
8309122 Feb 04, 2023 DP
8329216 Feb 04, 2023 DP
8808737 Jun 21, 2027 U-1598
8871779 Nov 22, 2029 DS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 164 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 201655 005 7851482 Jul 10, 2029 DS
8075872 Nov 20, 2023 DP
8114383 Aug 08, 2024 DP
8192722 Sep 15, 2025 DP
8309060 Nov 20, 2023 DP
8309122 Feb 04, 2023 DP
8329216 Feb 04, 2023 DP
8808737 Jun 21, 2027 U-1598
8871779 Nov 22, 2029 DS
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 201655 006 7851482 Jul 10, 2029 DS
8075872 Nov 20, 2023 DP
8114383 Aug 08, 2024 DP
8192722 Sep 15, 2025 DP
8309060 Nov 20, 2023 DP
8309122 Feb 04, 2023 DP
8329216 Feb 04, 2023 DP
8808737 Jun 21, 2027 U-1598
8871779 Nov 22, 2029 DS
OXYMORPHONE HYDROCHLORIDE - OPANA ER
N 201655 007 7851482 Jul 10, 2029 DS
8075872 Nov 20, 2023 DP
8114383 Aug 08, 2024 DP
8192722 Sep 15, 2025 DP
8309060 Nov 20, 2023 DP
8309122 Feb 04, 2023 DP
8329216 Feb 04, 2023 DP
8808737 Jun 21, 2027 U-1598
8871779 Nov 22, 2029 DS
PACLITAXEL - ABRAXANE
N 021660 001 7758891 Feb 21, 2026 U-1434 I-658 Oct 11, 2015
7820788 Mar 03, 2024 DP U-1092 I-676 Sep 06, 2016
7820788 Mar 03, 2024 DP U-1290 ODE Sep 06, 2020
7820788 Mar 03, 2024 DP U-1434
7923536 Dec 09, 2023 U-1117
7923536 Dec 09, 2023 U-1290
7923536 Dec 09, 2023 U-1434
8034375 Aug 13, 2026 U-1290
8138229 Dec 09, 2023 DP U-1092
8138229 Dec 09, 2023 DP U-1290
8138229 Dec 09, 2023 DP U-1434
8268348 Feb 21, 2026 U-1290
8314156 Dec 09, 2023 U-1290
8314156 Dec 09, 2023 U-1434
8853260 Aug 14, 2020 DP
RE41884 Aug 14, 2016 U-1117
RE41884 Aug 14, 2016 U-1290
RE41884 Aug 14, 2016 U-1434
PALIPERIDONE - INVEGA
N 021999 001 PED Oct 06, 2014
PALIPERIDONE - INVEGA
N 021999 002 PED Oct 06, 2014
PALIPERIDONE - INVEGA
N 021999 003 PED Oct 06, 2014
PALIPERIDONE - INVEGA
N 021999 004 PED Oct 06, 2014
PALIPERIDONE - INVEGA
N 021999 006 PED Oct 06, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 165 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PALIPERIDONE PALMITATE - INVEGA SUSTENNA
N 022264 001 6077843 May 12, 2017 DP U-543 I-698 Nov 12, 2017
6555544 Nov 10, 2018 DP U-543 M-119 Aug 29, 2015
PALIPERIDONE PALMITATE - INVEGA SUSTENNA
N 022264 002 6077843 May 12, 2017 DP U-543 I-698 Nov 12, 2017
6555544 Nov 10, 2018 DP U-543 M-119 Aug 29, 2015
PALIPERIDONE PALMITATE - INVEGA SUSTENNA
N 022264 003 6077843 May 12, 2017 DP U-543 I-698 Nov 12, 2017
6555544 Nov 10, 2018 DP U-543 M-119 Aug 29, 2015
PALIPERIDONE PALMITATE - INVEGA SUSTENNA
N 022264 004 6077843 May 12, 2017 DP U-543 I-698 Nov 12, 2017
6555544 Nov 10, 2018 DP U-543 M-119 Aug 29, 2015
PALIPERIDONE PALMITATE - INVEGA SUSTENNA
N 022264 005 6077843 May 12, 2017 DP U-543 I-698 Nov 12, 2017
6555544 Nov 10, 2018 DP U-543 M-119 Aug 29, 2015
PALONOSETRON HYDROCHLORIDE - ALOXI
N 021372 001 5202333 Apr 13, 2015 DS DP U-528 I-684 May 27, 2017
5202333*PED Oct 13, 2015 M-136 May 27, 2017
7947724 Jan 30, 2024 DP PED Nov 27, 2017
7947724*PED Jul 30, 2024 PED Nov 27, 2017
7947725 Jan 30, 2024 DP
7947725*PED Jul 30, 2024
7960424 Jan 30, 2024 DP
7960424*PED Jul 30, 2024
8518981 Jan 30, 2024 DP
8518981*PED Jul 30, 2024
8598218 Jan 30, 2024 DP
8598218*PED Jul 30, 2024
8598219 Jan 30, 2024 DP
8598219*PED Jul 30, 2024
8729094 Jan 30, 2024 DP U-528
8729094*PED Jul 30, 2024
PALONOSETRON HYDROCHLORIDE - ALOXI
N 021372 002 5202333 Apr 13, 2015 DS DP U-901 I-684 May 27, 2017
5202333*PED Oct 13, 2015 M-136 May 27, 2017
7947724 Jan 30, 2024 DP PED Nov 27, 2017
7947724*PED Jul 30, 2024 PED Nov 27, 2017
7947725 Jan 30, 2024 DP
7947725*PED Jul 30, 2024
7960424 Jan 30, 2024 DP
7960424*PED Jul 30, 2024
8518981 Jan 30, 2024 DP
8518981*PED Jul 30, 2024
8598218 Jan 30, 2024 DP
8598218*PED Jul 30, 2024
8598219 Jan 30, 2024 DP
8598219*PED Jul 30, 2024
PALONOSETRON HYDROCHLORIDE - ALOXI
N 022233 001 5202333 Apr 13, 2015 DS DP U-528
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PERTZYE
N 022175 001 NCE May 17, 2017
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PERTZYE
N 022175 002 NCE May 17, 2017
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - ZENPEP
N 022210 007 8221747 Feb 20, 2028 DP
8562978 Feb 20, 2028 DP
8562979 Feb 20, 2028 DP U-1274
8562980 Feb 20, 2028 DP U-1274
8562981 Feb 20, 2028 U-1274
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 166 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PANCREAZE
N 022523 001 NCE Apr 12, 2015
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PANCREAZE
N 022523 002 NCE Apr 12, 2015
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PANCREAZE
N 022523 003 NCE Apr 12, 2015
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE) - PANCREAZE
N 022523 004 NCE Apr 12, 2015
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - CREON
N 020725 004 M-93 Jul 29, 2019
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - CREON
N 020725 005 M-93 Jul 29, 2019
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - ZENPEP
N 022210 001 7658918 Feb 20, 2028 DP NCE Aug 27, 2014
8221747 Feb 20, 2028 DP
8246950 Feb 20, 2028 U-1274
8562978 Feb 20, 2028 DP
8562979 Feb 20, 2028 DP U-1274
8562980 Feb 20, 2028 DP U-1274
8562981 Feb 20, 2028 U-1274
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - ZENPEP
N 022210 002 7658918 Feb 20, 2028 DP NCE Aug 27, 2014
8221747 Feb 20, 2028 DP
8246950 Feb 20, 2028 U-1274
8562978 Feb 20, 2028 DP
8562979 Feb 20, 2028 DP U-1274
8562980 Feb 20, 2028 DP U-1274
8562981 Feb 20, 2028 U-1274
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - ZENPEP
N 022210 003 7658918 Feb 20, 2028 DP NCE Aug 27, 2014
8221747 Feb 20, 2028 DP
8246950 Feb 20, 2028 U-1274
8562978 Feb 20, 2028 DP
8562979 Feb 20, 2028 DP U-1274
8562980 Feb 20, 2028 DP U-1274
8562981 Feb 20, 2028
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - ZENPEP
N 022210 004 7658918 Feb 20, 2028 DP NCE Aug 27, 2014
8221747 Feb 20, 2028 DP
8246950 Feb 20, 2028 U-1274
8562978 Feb 20, 2028 DP
8562979 Feb 20, 2028 DP U-1274
8562980 Feb 20, 2028 DP U-1274
8562981 Feb 20, 2028 U-1274
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - ZENPEP
N 022210 005 8221747 Feb 20, 2028 DP NCE Aug 27, 2014
8562978 Feb 20, 2028 DP
8562979 Feb 20, 2028 DP U-1274
8562980 Feb 20, 2028 DP U-1274
8562981 Feb 20, 2028 U-1274
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - ZENPEP
N 022210 006 8221747 Feb 20, 2028 DP NCE Aug 27, 2014
8562978 Feb 20, 2028 DP
8562979 Feb 20, 2028 DP U-1274
8562980 Feb 20, 2028 DP U-1274
8562981 Feb 20, 2028 U-1274
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 167 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - ULTRESA
N 022222 001 NCE Mar 01, 2017
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - ULTRESA
N 022222 002 NCE Mar 01, 2017
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - ULTRESA
N 022222 003 NCE Mar 01, 2017
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - VIOKACE
N 022542 001 NCE Mar 01, 2017
PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE (AMYLASE;LIPASE;PROTEASE); PANCRELIPASE
(AMYLASE;LIPASE;PROTEASE) - VIOKACE
N 022542 002 NCE Mar 01, 2017
PANTOPRAZOLE SODIUM - PROTONIX
N 020987 001 5997903 Dec 07, 2016
PANTOPRAZOLE SODIUM - PROTONIX
N 020987 002 5997903 Dec 07, 2016
PANTOPRAZOLE SODIUM - PROTONIX IV
N 020988 001 6780881 Nov 17, 2021 DP
7351723 Nov 17, 2021 DP
8754108 Nov 17, 2021 DP
8754108*PED May 17, 2022
PANTOPRAZOLE SODIUM - PROTONIX
N 022020 001 7544370 Jun 07, 2026 DP
7550153 Sep 30, 2024 U-859
7553498 Sep 30, 2024 U-859
7838027 Sep 30, 2024 DP U-859
PARICALCITOL - ZEMPLAR
N 020819 001 5597815 Jul 13, 2015 U-1195
6136799 Apr 08, 2018
6361758 Apr 08, 2018 DP
PARICALCITOL - ZEMPLAR
N 020819 002 5597815 Jul 13, 2015 U-1195
6136799 Apr 08, 2018
6361758 Apr 08, 2018 DP
PARICALCITOL - ZEMPLAR
N 020819 003 5597815 Jul 13, 2015 U-1195
5597815*PED Jan 13, 2016
6136799 Apr 08, 2018
6136799*PED Oct 08, 2018
6361758 Apr 08, 2018 DP
6361758*PED Oct 08, 2018
PARICALCITOL - ZEMPLAR
N 021606 001 5597815 Jul 13, 2015 U-1195
PARICALCITOL - ZEMPLAR
N 021606 002 5597815 Jul 13, 2015 U-1195
PARICALCITOL - ZEMPLAR
N 021606 003 5597815 Jul 13, 2015 U-1195
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 168 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PAROXETINE HYDROCHLORIDE - PAXIL
N 020031 001 5872132 May 19, 2015
5900423 May 19, 2015
6113944 Dec 14, 2014
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
PAROXETINE HYDROCHLORIDE - PAXIL
N 020031 002 5872132 May 19, 2015
5900423 May 19, 2015
6113944 Dec 14, 2014
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
PAROXETINE HYDROCHLORIDE - PAXIL
N 020031 003 5872132 May 19, 2015
5900423 May 19, 2015
6113944 Dec 14, 2014
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
PAROXETINE HYDROCHLORIDE - PAXIL
N 020031 004 5872132 May 19, 2015
5900423 May 19, 2015
6113944 Dec 14, 2014
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
PAROXETINE HYDROCHLORIDE - PAXIL
N 020031 005 5872132 May 19, 2015
5900423 May 19, 2015
6113944 Dec 14, 2014
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
PAROXETINE HYDROCHLORIDE - PAXIL
N 020710 001 5811436 Sep 22, 2015
5872132 May 19, 2015
5900423 May 19, 2015
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
PAROXETINE HYDROCHLORIDE - PAXIL
N 020885 001 5872132 May 19, 2015
5900423 May 19, 2015
6063927 Apr 23, 2019
6080759 May 19, 2015
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
6172233 Jan 15, 2018
PAROXETINE HYDROCHLORIDE - PAXIL
N 020885 002 5872132 May 19, 2015
5900423 May 19, 2015
6063927 Apr 23, 2019
6080759 May 19, 2015
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
6172233 Jan 15, 2018
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 169 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PAROXETINE HYDROCHLORIDE - PAXIL
N 020885 003 5872132 May 19, 2015
5900423 May 19, 2015
6063927 Apr 23, 2019
6080759 May 19, 2015
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
6172233 Jan 15, 2018
PAROXETINE HYDROCHLORIDE - PAXIL
N 020885 004 5872132 May 19, 2015
5900423 May 19, 2015
6063927 Apr 23, 2019
6080759 May 19, 2015
6121291 Mar 17, 2017 U-286
6121291 Mar 17, 2017 U-431
6133289 May 19, 2015 U-358
6172233 Jan 15, 2018
PAROXETINE HYDROCHLORIDE - PAXIL CR
N 020936 001 5872132 May 19, 2015
5900423 May 19, 2015
6121291 Mar 17, 2017 U-286
6133289 May 19, 2015 U-286
6548084 Jul 19, 2016
7229640 Jul 19, 2016 DP U-816
PAROXETINE HYDROCHLORIDE - PAXIL CR
N 020936 002 5872132 May 19, 2015
5900423 May 19, 2015
6121291 Mar 17, 2017 U-286
6133289 May 19, 2015 U-286
6548084 Jul 19, 2016
7229640 Jul 19, 2016 DP U-816
PAROXETINE HYDROCHLORIDE - PAXIL CR
N 020936 003 5872132 May 19, 2015
5900423 May 19, 2015
6121291 Mar 17, 2017 U-286
6133289 May 19, 2015 U-286
6548084 Jul 19, 2016
7229640 Jul 19, 2016 DP U-816
PAROXETINE MESYLATE - PEXEVA
N 021299 001 5874447 Jun 10, 2017 U-46
5874447 Jun 10, 2017 U-286
5874447 Jun 10, 2017 U-518
7598271 Feb 12, 2023 DS DP
PAROXETINE MESYLATE - PEXEVA
N 021299 002 5874447 Jun 10, 2017 U-46
5874447 Jun 10, 2017 U-286
5874447 Jun 10, 2017 U-518
7598271 Feb 12, 2023 DS DP
PAROXETINE MESYLATE - PEXEVA
N 021299 003 5874447 Jun 10, 2017 U-46
5874447 Jun 10, 2017 U-286
5874447 Jun 10, 2017 U-518
7598271 Feb 12, 2023 DS DP
PAROXETINE MESYLATE - PEXEVA
N 021299 004 5874447 Jun 10, 2017 U-46
5874447 Jun 10, 2017 U-286
5874447 Jun 10, 2017 U-518
7598271 Feb 12, 2023 DS DP
PAROXETINE MESYLATE - BRISDELLE
N 204516 001 5874447 Jun 10, 2017 DS NP Jun 28, 2016
7598271 Feb 12, 2023 DS
8658663 Apr 06, 2029 DS DP U-904
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 170 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT
PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION
PATENT DELIST EXCLUSIVITY EXPIRATION
DATE
CODES REQUESTED CODE(S) DATE
PASIREOTIDE DIASPARTATE - SIGNIFOR
N 200677 001 6225284 Jun 28, 2016
DS DP NCE Dec 14, 2017
7473761 Jul 29, 2025
DS DP ODE Dec 14, 2019
8299209 Dec 27, 2025
DS DP
PASIREOTIDE DIASPARTATE - SIGNIFOR
N 200677 002 6225284 Jun 28, 2016
DS DP NCE Dec 14, 2017
7473761 Jul 29, 2025
DS DP ODE Dec 14, 2019
8299209 Dec 27, 2025
DS DP
PASIREOTIDE DIASPARTATE - SIGNIFOR
N 200677 003 6225284 Jun 28, 2016
DS DP NCE Dec 14, 2017
7473761 Jul 29, 2025
DS DP ODE Dec 14, 2019
8299209 Dec 27, 2025
DS DP
PASIREOTIDE PAMOATE - SIGNIFOR LAR
N 203255 001 6225284 Jun 28, 2016
DS DP U-1628 NCE Dec 14, 2017
7473761 Jul 29, 2025
DS DP NP Dec 15, 2017
7759308 Oct 25, 2026
DP ODE Dec 15, 2021
8822637 Aug 06, 2023
U-1629
PASIREOTIDE PAMOATE - SIGNIFOR LAR
N 203255 002 6225284 Jun 28, 2016
DS DP U-1628 NCE Dec 14, 2017
7473761 Jul 29, 2025
DS DP NP Dec 15, 2017
7759308 Oct 25, 2026
DP ODE Dec 15, 2021
8822637 Aug 06, 2023
U-1629
PASIREOTIDE PAMOATE - SIGNIFOR LAR
N 203255 003 6225284 Jun 28, 2016
DS DP U-1628 NCE Dec 14, 2017
7473761 Jul 29, 2025
DS DP NP Dec 15, 2017
7759308 Oct 25, 2026
DP ODE Dec 15, 2021
8822637 Aug 06, 2023
U-1629
PAZOPANIB HYDROCHLORIDE - VOTRIENT
N 022465 001 7105530 Oct 19, 2023
DS DP I-649 Apr 26, 2015
7262203 Dec 19, 2021
DS DP NCE Oct 19, 2014
8114885 Dec 19, 2021
DS DP ODE Apr 26, 2019
PAZOPANIB HYDROCHLORIDE - VOTRIENT
N 022465 002 7105530 Oct 19, 2023
DS DP I-649 Apr 26, 2015
7262203 Dec 19, 2021
DS DP NCE Oct 19, 2014
8114885 Dec 19, 2021
DS DP ODE Apr 26, 2019
PEGAPTANIB SODIUM - MACUGEN
N 021756 001 5932462 Aug 03, 2016
DS
6011020 Jan 04, 2017
DS
6051698 May 19, 2015
DS U-622
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 171 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE
N 202799 001 7084245 May 12, 2024 DS DP U-1238 NCE Mar 27, 2017
7414105 May 12, 2024 DS DP U-1238
7528104 May 12, 2024 DS DP
7550433 Jun 02, 2026 U-1238
7919118 May 12, 2024 DS DP
7919461 Jun 02, 2026 U-1238
PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE
N 202799 002 7084245 May 12, 2024 DS DP U-1238 NCE Mar 27, 2017
7414105 May 12, 2024 DS DP U-1238
7528104 May 12, 2024 DS DP
7550433 Jun 02, 2026 U-1238
7919118 May 12, 2024 DS DP
7919461 Jun 02, 2026 U-1238
PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE
N 202799 003 7084245 May 12, 2024 DS DP U-1238 NCE Mar 27, 2017
7414105 May 12, 2024 DS DP U-1238
7528104 May 12, 2024 DS DP
7550433 Jun 02, 2026 U-1238
7919118 May 12, 2024 DS DP
7919461 Jun 02, 2026 U-1238
PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE
N 202799 004 7084245 May 12, 2024 DS DP U-1238 NCE Mar 27, 2017
7414105 May 12, 2024 DS DP U-1238
7528104 May 12, 2024 DS DP
7550433 Jun 02, 2026 U-1238
7919118 May 12, 2024 DS DP
7919461 Jun 02, 2026 U-1238
PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE
N 202799 005 7084245 May 12, 2024 DS DP U-1238 NCE Mar 27, 2017
7414105 May 12, 2024 DS DP U-1238
7528104 May 12, 2024 DS DP
7550433 Jun 02, 2026 U-1238
7919118 May 12, 2024 DS DP
7919461 Jun 02, 2026 U-1238
PEGINESATIDE ACETATE - OMONTYS PRESERVATIVE FREE
N 202799 006 7084245 May 12, 2024 DS DP U-1238 NCE Mar 27, 2017
7414105 May 12, 2024 DS DP U-1238
7528104 May 12, 2024 DS DP
7550433 Jun 02, 2026 U-1238
7919118 May 12, 2024 DS DP
7919461 Jun 02, 2026 U-1238
PEGINESATIDE ACETATE - OMONTYS
N 202799 007 7084245 May 12, 2024 DS DP U-1238
7414105 May 12, 2024 DS DP U-1238
7528104 May 12, 2024 DS DP
7550433 Jun 02, 2026 U-1238
7919118 May 12, 2024 DS DP
7919461 Jun 02, 2026 U-1238
PEGINESATIDE ACETATE - OMONTYS
N 202799 008 7084245 May 12, 2024 DS DP U-1238
7414105 May 12, 2024 DS DP U-1238
7528104 May 12, 2024 DS DP
7550433 Jun 02, 2026 U-1238
7919118 May 12, 2024 DS DP
7919461 Jun 02, 2026 U-1238
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 172 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PEGVISOMANT - SOMAVERT
N 021106 001 5849535 Mar 25, 2017 DS
6057292 Sep 21, 2015 U-507
PEGVISOMANT - SOMAVERT
N 021106 002 5849535 Mar 25, 2017 DS
6057292 Sep 21, 2015 U-507
PEGVISOMANT - SOMAVERT
N 021106 003 5849535 Mar 25, 2017 DS
6057292 Sep 21, 2015 U-507
PEGVISOMANT - SOMAVERT
N 021106 004 5849535 Mar 25, 2017 DS
6057292 Sep 21, 2015 U-507
PEGVISOMANT - SOMAVERT
N 021106 005 5849535 Mar 25, 2017 DS
6057292 Sep 21, 2015 U-507
PEMETREXED DISODIUM - ALIMTA
N 021462 001 5344932 Jul 24, 2016 DS DP M-122 Oct 17, 2015
7772209 Nov 24, 2021 U-1077 PED Sep 17, 2014
7772209 Nov 24, 2021 U-1296
PEMETREXED DISODIUM - ALIMTA
N 021462 002 5344932 Jul 24, 2016 DS DP M-122 Oct 17, 2015
7772209 Nov 24, 2021 U-1296 PED Sep 17, 2014
PENCICLOVIR SODIUM - DENAVIR
N 020629 001 5840763 Sep 01, 2015 U-501
5866581 Oct 04, 2014 U-501
5916893 Sep 01, 2015 U-501
6124304 Oct 04, 2014 U-501
6469015 Oct 22, 2019 U-501
6579981 Jun 17, 2020 U-501
PERAMIVIR - RAPIVAB
N 206426 001 6503745 Nov 05, 2019 DS NCE Dec 19, 2019
6562861 Dec 17, 2018 DS
8778997 May 07, 2027 U-1627
PERAMPANEL - FYCOMPA
N 202834 001 6949571 Jun 08, 2021 DS DP U-106 NCE Oct 22, 2017
8772497 May 16, 2026 DS
PERAMPANEL - FYCOMPA
N 202834 002 6949571 Jun 08, 2021 DS DP U-106 NCE Oct 22, 2017
8772497 May 16, 2026 DS
PERAMPANEL - FYCOMPA
N 202834 003 6949571 Jun 08, 2021 DS DP U-106 NCE Oct 22, 2017
8772497 May 16, 2026 DS
PERAMPANEL - FYCOMPA
N 202834 004 6949571 Jun 08, 2021 DS DP U-106 NCE Oct 22, 2017
8772497 May 16, 2026 DS
PERAMPANEL - FYCOMPA
N 202834 005 6949571 Jun 08, 2021 DS DP U-106 NCE Oct 22, 2017
8772497 May 16, 2026 DS
PERAMPANEL - FYCOMPA
N 202834 006 6949571 Jun 08, 2021 DS DP U-106 NCE Oct 22, 2017
8772497 May 16, 2026 DS
PERFLUOROPOLYMETHYLISOPROPYL ETHER; POLYTETRAFLUOROETHYLENE - SKIN EXPOSURE REDUCTION PASTE AGAINST
CHEMICAL WARFARE AGENTS
N 021084 001 5607979 May 30, 2015
PERFLUTREN - DEFINITY
N 021064 001 5527521 Feb 22, 2015 DP U-665
6033645 Jun 19, 2016 U-665
8658205 Apr 20, 2019 DP
8685441 Jan 13, 2019 U-665
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 173 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PHENTERMINE HYDROCHLORIDE - SUPRENZA
N 202088 001 6149938 Jul 23, 2018 DP
8440170 Mar 14, 2029 DP
PHENTERMINE HYDROCHLORIDE - SUPRENZA
N 202088 002 6149938 Jul 23, 2018 DP
8440170 Mar 14, 2029 DP
PHENTERMINE HYDROCHLORIDE - SUPRENZA
N 202088 003 6149938 Jul 23, 2018 DP U-1243
8440170 Mar 14, 2029 DP
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA
N 022580 001 6071537 Jun 23, 2017 U-1262 NC Jul 17, 2015
7056890 Jun 14, 2020 DP U-1262
7553818 Jun 14, 2020 U-1262
7659256 Jun 14, 2020 DP U-1262
7674776 Jun 14, 2020 DP U-1262
8580298 May 15, 2029 DP
8580299 Jun 14, 2029 U-1262
8895057 Jun 09, 2028 U-1262
8895058 Jun 09, 2028 DP
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA
N 022580 002 6071537 Jun 23, 2017 U-1262 NC Jul 17, 2015
7056890 Jun 14, 2020 DP U-1262
7553818 Jun 14, 2020 U-1262
7659256 Jun 14, 2020 DP U-1262
7674776 Jun 14, 2020 DP U-1262
8580298 May 15, 2029 DP
8580299 Jun 14, 2029 U-1262
8895057 Jun 09, 2028 U-1262
8895058 Jun 09, 2028 DP
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA
N 022580 003 6071537 Jun 23, 2017 U-1262 NC Jul 17, 2015
7056890 Jun 14, 2020 DP U-1262
7553818 Jun 14, 2020 U-1262
7659256 Jun 14, 2020 DP U-1262
7674776 Jun 14, 2020 DP U-1262
8580298 May 15, 2029 DP
8580299 Jun 14, 2029 U-1262
8895057 Jun 09, 2028 U-1262
8895058 Jun 09, 2028 DP
PHENTERMINE HYDROCHLORIDE; TOPIRAMATE - QSYMIA
N 022580 004 6071537 Jun 23, 2017 U-1262 NC Jul 17, 2015
7056890 Jun 14, 2020 DP U-1262
7553818 Jun 14, 2020 U-1262
7659256 Jun 14, 2020 DP U-1262
7674776 Jun 14, 2020 DP U-1262
8580298 May 15, 2029 DP
8580299 Jun 14, 2029 U-1262
8895057 Jun 09, 2028 U-1262
8895058 Jun 09, 2028 DP
PHENTOLAMINE MESYLATE - ORAVERSE
N 022159 001 6764678 May 11, 2021 U-967
6872390 May 11, 2021 DP
7229630 Jun 20, 2023 DP
7569230 Oct 17, 2023 U-967
7575757 Apr 21, 2025 DP
PHENYLEPHRINE HYDROCHLORIDE - PHENYLEPHRINE HYDROCHLORIDE
N 203510 001 8859623 Nov 14, 2033 U-1594
PHENYLEPHRINE HYDROCHLORIDE - PHENYLEPHRINE HYDROCHLORIDE
N 203510 002 8859623 Nov 14, 2033 U-1594
PIMECROLIMUS - ELIDEL
N 021302 001 5912238 Jun 15, 2016
6352998 Oct 26, 2015
6423722 Jun 26, 2018
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 174 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PIOGLITAZONE HYDROCHLORIDE - ACTOS
N 021073 001 5965584 Jun 19, 2016 U-753
6150383 Jun 19, 2016 U-418
6150384 Jun 19, 2016 U-419
6166042 Jun 19, 2016 U-414
6166043 Jun 19, 2016 U-415
6172090 Jun 19, 2016 U-416
6211205 Jun 19, 2016 U-410
6271243 Jun 19, 2016 U-411
6303640 Aug 09, 2016 U-425
6329404 Jun 19, 2016 U-753
PIOGLITAZONE HYDROCHLORIDE - ACTOS
N 021073 002 5965584 Jun 19, 2016 U-753
6150383 Jun 19, 2016 U-418
6150384 Jun 19, 2016 U-419
6166042 Jun 19, 2016 U-414
6166043 Jun 19, 2016 U-415
6172090 Jun 19, 2016 U-416
6211205 Jun 19, 2016 U-410
6271243 Jun 19, 2016 U-411
6303640 Aug 09, 2016 U-425
6329404 Jun 19, 2016 U-753
PIOGLITAZONE HYDROCHLORIDE - ACTOS
N 021073 003 5965584 Jun 19, 2016 U-753
6150383 Jun 19, 2016 U-418
6150384 Jun 19, 2016 U-419
6166042 Jun 19, 2016 U-414
6166043 Jun 19, 2016 U-415
6172090 Jun 19, 2016 U-416
6211205 Jun 19, 2016 U-410
6271243 Jun 19, 2016 U-411
6303640 Aug 09, 2016 U-425
6329404 Jun 19, 2016 U-753
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN
N 050684 001 6900184 Apr 14, 2023 DP U-282
7915229 Apr 14, 2023 DP
8133883 Apr 14, 2023 DP U-282
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN
N 050684 002 6900184 Apr 14, 2023 DP U-282
7915229 Apr 14, 2023 DP
8133883 Apr 14, 2023 DP U-282
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN
N 050684 003 6900184 Apr 14, 2023 DP U-282
7915229 Apr 14, 2023 DP
8133883 Apr 14, 2023 DP U-282
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN
N 050684 004 6900184 Apr 14, 2023 DP U-282
7915229 Apr 14, 2023 DP
8133883 Apr 14, 2023 DP U-282
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN IN PLASTIC CONTAINER
N 050750 001 6207661 Feb 22, 2019 DP
6900184 Apr 14, 2023 DP U-282
7915229 Apr 14, 2023 DP
8133883 Apr 14, 2023 DP U-282
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN IN PLASTIC CONTAINER
N 050750 002 6207661 Feb 22, 2019 DP
6900184 Apr 14, 2023 DP U-282
7915229 Apr 14, 2023 DP
8133883 Apr 14, 2023 DP U-282
PIPERACILLIN SODIUM; TAZOBACTAM SODIUM - ZOSYN IN PLASTIC CONTAINER
N 050750 003 6207661 Feb 22, 2019 DP
6900184 Apr 14, 2023 DP U-282
7915229 Apr 14, 2023 DP
8133883 Apr 14, 2023 DP U-282
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 175 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PIRFENIDONE - ESBRIET
N 022535 001 7566729 Apr 22, 2029 U-1600 NCE Oct 16, 2019
7635707 Apr 22, 2029 U-1609 ODE Oct 15, 2021
7696326 Dec 18, 2027 U-1601
7767225 Sep 22, 2026 DP U-1602
7767700 Dec 18, 2027 U-1601
7816383 Jan 08, 2030 U-1603
7910610 Jan 08, 2030 U-1604
7988994 Sep 22, 2026 DP U-1602
8013002 Jan 08, 2030 U-1603
8084475 Jan 08, 2030 U-1605
8318780 Jan 08, 2030 U-1606
8383150 Sep 22, 2026 DP U-1607
8420674 Dec 18, 2027 DP U-1608
8592462 Apr 22, 2029 U-1609
8609701 Apr 22, 2029 U-1610
8648098 Jan 08, 2030 U-1611
8753679 Sep 22, 2026 DP U-1602
8754109 Jan 08, 2030 U-1612
8778947 Aug 30, 2033 U-1613
PITAVASTATIN CALCIUM - LIVALO
N 022363 001 5753675 May 19, 2015 DS DP U-998 NCE Aug 03, 2014
5854259 Dec 29, 2015 DP
5856336 Dec 25, 2020 DS U-998
6465477 Dec 20, 2016 DP
7022713 Feb 19, 2024 U-998
8557993 Feb 02, 2024 DP
PITAVASTATIN CALCIUM - LIVALO
N 022363 002 5753675 May 19, 2015 DS DP U-998 NCE Aug 03, 2014
5854259 Dec 29, 2015 DP
5856336 Dec 25, 2020 DS U-998
6465477 Dec 20, 2016 DP
7022713 Feb 19, 2024 U-998
8557993 Feb 02, 2024 DP
PITAVASTATIN CALCIUM - LIVALO
N 022363 003 5753675 May 19, 2015 DS DP U-998 NCE Aug 03, 2014
5854259 Dec 29, 2015 DP
5856336 Dec 25, 2020 DS U-998
6465477 Dec 20, 2016 DP
7022713 Feb 19, 2024 U-998
8557993 Feb 02, 2024 DS DP
PLERIXAFOR - MOZOBIL
N 022311 001 6987102 Jul 22, 2023 U-936 ODE Dec 15, 2015
7897590 Jul 22, 2023 U-936
RE42152 Dec 10, 2018 DP
POLIDOCANOL - ASCLERA
N 021201 001 NCE Mar 30, 2015
POLIDOCANOL - ASCLERA
N 021201 002 NCE Mar 30, 2015
POLIDOCANOL - VARITHENA
N 205098 001 6572873 May 26, 2020 U-1461
6846412 Jul 19, 2022 DP
6942165 May 26, 2020 DP
7025290 May 26, 2020 DP U-1461
7357336 May 26, 2020 U-1461
7604185 May 26, 2020 DS DP U-1462
7731986 Nov 17, 2024 DS DP U-1463
7814943 Nov 19, 2027 DP U-1461
7842282 May 26, 2020 U-1461
7842283 May 26, 2020 DP
8122917 Sep 09, 2024 DP
8323677 May 26, 2020 DS
8734833 May 26, 2020 DS DP
RE38919 Oct 14, 2014 DS DP
RE40640 Oct 14, 2015 DS DP U-1462
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 176 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
POMALIDOMIDE - POMALYST
N 204026 001 5635517 Jul 24, 2016 U-1359 NCE Feb 08, 2018
6045501 Aug 28, 2018 U-1361 ODE Feb 08, 2020
6315720 Oct 23, 2020 U-1361
6316471 Aug 10, 2016 DP U-1360
6476052 Jul 24, 2016 DP U-1360
6561976 Aug 28, 2018 U-1361
6561977 Oct 23, 2020 U-1361
6755784 Oct 23, 2020 U-1361
6908432 Aug 28, 2018 U-1361
8158653 Aug 10, 2016 DP
8198262 Oct 19, 2024 U-1360
8204763 Aug 28, 2018 U-1361
8315886 Oct 23, 2020 U-1361
8589188 Aug 28, 2018 U-1361
8626531 Oct 23, 2020 U-1361
8673939 May 15, 2023 U-1360
8735428 May 15, 2023 U-1360
8828427 Jun 21, 2031 DS DP
POMALIDOMIDE - POMALYST
N 204026 002 5635517 Jul 24, 2016 U-1359 NCE Feb 08, 2018
6045501 Aug 28, 2018 U-1361 ODE Feb 08, 2020
6315720 Oct 23, 2020 U-1361
6316471 Aug 10, 2016 DP U-1360
6476052 Jul 24, 2016 DP U-1360
6561976 Aug 28, 2018 U-1361
6561977 Oct 23, 2020 U-1361
6755784 Oct 23, 2020 U-1361
6908432 Aug 28, 2018 U-1361
8158653 Aug 10, 2016 DP
8198262 Oct 19, 2024 U-1360
8204763 Aug 28, 2018 U-1361
8315886 Oct 23, 2020 U-1361
8589188 Aug 28, 2018 U-1361
8626531 Oct 23, 2020 U-1361
8673939 May 15, 2023 U-1360
8735428 May 15, 2023 U-1360
8828427 Jun 21, 2031 DS DP
POMALIDOMIDE - POMALYST
N 204026 003 5635517 Jul 24, 2016 U-1359 NCE Feb 08, 2018
6045501 Aug 28, 2018 U-1361 ODE Feb 08, 2020
6315720 Oct 23, 2020 U-1361
6316471 Aug 10, 2016 DP U-1360
6476052 Jul 24, 2016 DP U-1360
6561976 Aug 28, 2018 U-1361
6561977 Oct 23, 2020 U-1361
6755784 Oct 23, 2020 U-1361
6908432 Aug 28, 2018 U-1361
8158653 Aug 10, 2016 DP
8198262 Oct 19, 2024 U-1360
8204763 Aug 28, 2018 U-1361
8315886 Oct 23, 2020 U-1361
8589188 Aug 28, 2018 U-1361
8626531 Oct 23, 2020 U-1361
8673939 May 15, 2023 U-1360
8735428 May 15, 2023 U-1360
8828427 Jun 21, 2031 DS DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 177 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
POMALIDOMIDE - POMALYST
N 204026 004 5635517 Jul 24, 2016 U-1359 NCE Feb 08, 2018
6045501 Aug 28, 2018 U-1361 ODE Feb 08, 2020
6315720 Oct 23, 2020 U-1361
6316471 Aug 10, 2016 DP U-1360
6476052 Jul 24, 2016 DP U-1360
6561976 Aug 28, 2018 U-1361
6561977 Oct 23, 2020 U-1361
6755784 Oct 23, 2020 U-1361
6908432 Aug 28, 2018 U-1361
8158653 Aug 10, 2016 DP
8198262 Oct 19, 2024 U-1360
8204763 Aug 28, 2018 U-1361
8315886 Oct 23, 2020 U-1361
8589188 Aug 28, 2018 U-1361
8626531 Oct 23, 2020 U-1361
8673939 May 15, 2023 U-1360
8735428 May 15, 2023 U-1360
8828427 Jun 21, 2031 DS DP
PONATINIB HYDROCHLORIDE - ICLUSIG
N 203469 001 8114874 Dec 22, 2026 DS DP NCE Dec 14, 2017
ODE Dec 14, 2019
PONATINIB HYDROCHLORIDE - ICLUSIG
N 203469 002 8114874 Dec 22, 2026 DS DP NCE Dec 14, 2017
ODE Dec 14, 2019
POSACONAZOLE - NOXAFIL
N 022003 001 5661151 Jul 19, 2019 DS DP U-760
5703079 Aug 26, 2014 DS DP U-760
6958337 Oct 05, 2018 DS DP U-760
8263600 Apr 01, 2022 DP
POSACONAZOLE - NOXAFIL
N 205053 001 5661151 Jul 19, 2019 DS DP U-1454
5703079 Aug 26, 2014 DS DP U-1454
POSACONAZOLE - NOXAFIL
N 205596 001 5661151 Jul 19, 2019 DS DP U-1454
5703079 Aug 26, 2014 DS DP U-1454
8410077 Mar 13, 2029 DP
PRALATREXATE - FOLOTYN
N 022468 001 6028071 Jul 16, 2022 DS DP U-1004 NCE Sep 24, 2014
7622470 May 31, 2025 U-1015 ODE Sep 24, 2016
8299078 May 31, 2025 U-1004
PRALATREXATE - FOLOTYN
N 022468 002 6028071 Jul 16, 2022 DS DP U-1004 NCE Sep 24, 2014
7622470 May 31, 2025 U-1015 ODE Sep 24, 2016
8299078 May 31, 2025 U-1004
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 178 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX
N 020667 001 6001861 Jan 16, 2018 U-784
6194445 Jan 16, 2018 U-784
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX
N 020667 002 6001861 Jan 16, 2018 U-784
6194445 Jan 16, 2018 U-784
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX
N 020667 003 6001861 Jan 16, 2018 U-784
6194445 Jan 16, 2018 U-784
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX
N 020667 005 6001861 Jan 16, 2018 U-784
6194445 Jan 16, 2018 U-784
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX
N 020667 006 6001861 Jan 16, 2018 U-784
6194445 Jan 16, 2018 U-784
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX
N 020667 007 6001861 Jan 16, 2018 U-784
6194445 Jan 16, 2018 U-784
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER
N 022421 001 7695734 Apr 26, 2028 DP
8679533 Sep 08, 2029 DP U-219
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER
N 022421 002 7695734 Apr 26, 2028 DP
8679533 Sep 08, 2029 DP U-219
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER
N 022421 003 7695734 Apr 26, 2028 DP
8679533 Sep 08, 2029 DP U-219
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER
N 022421 004 7695734 Apr 26, 2028 DP
8679533 Sep 08, 2029 DP U-219
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER
N 022421 005 7695734 Apr 26, 2028 DP
8679533 Sep 08, 2029 DP U-219
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER
N 022421 006 7695734 Apr 26, 2028 DP
8679533 Sep 08, 2029 DP U-219
PRAMIPEXOLE DIHYDROCHLORIDE - MIRAPEX ER
N 022421 007 7695734 Apr 26, 2028 DP
8679533 Sep 08, 2029 DP U-219
PRAMLINTIDE ACETATE - SYMLIN
N 021332 001 5686411 Mar 16, 2019 DS DP U-638
5814600 Sep 29, 2015 U-639
6114304 Sep 05, 2017 U-640
PRAMLINTIDE ACETATE - SYMLIN
N 021332 002 5686411 Mar 16, 2019 DS DP U-638
5814600 Sep 29, 2015 U-637
5814600 Sep 29, 2015 U-638
5814600 Sep 29, 2015 U-639
6114304 Sep 05, 2017 U-637
6114304 Sep 05, 2017 U-640
PRAMLINTIDE ACETATE - SYMLIN
N 021332 003 5686411 Mar 16, 2019 DS DP U-638
5814600 Sep 29, 2015 U-637
5814600 Sep 29, 2015 U-638
5814600 Sep 29, 2015 U-639
6114304 Sep 05, 2017 U-637
6114304 Sep 05, 2017 U-640
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 179 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PRASUGREL HYDROCHLORIDE - EFFIENT
N 022307 001 5288726 Apr 14, 2017 DS DP U-991 NCE Jul 10, 2014
8404703 Jan 02, 2023 U-1381
8569325 Jan 02, 2023 U-1381
PRASUGREL HYDROCHLORIDE - EFFIENT
N 022307 002 5288726 Apr 14, 2017 DS DP U-991 NCE Jul 10, 2014
8404703 Jan 02, 2023 U-1381
8569325 Jan 02, 2023 U-1381
PREDNISOLONE ACETATE - FLO-PRED
N 022067 001 5881926 Mar 16, 2016 DP
6071523 Jun 03, 2018 DP
6399079 Jun 03, 2018 DP
6656482 Jun 03, 2018 DP
7799331 Oct 11, 2028 DP U-139
7799331 Oct 11, 2028 DP U-1068
PREDNISOLONE ACETATE - FLO-PRED
N 022067 002 5881926 Mar 16, 2016 DP
6071523 Jun 03, 2018 DP
6399079 Jun 03, 2018 DP
6656482 Jun 03, 2018 DP
7799331 Oct 11, 2028 DP U-139
7799331 Oct 11, 2028 DP U-1068
PREDNISOLONE SODIUM PHOSPHATE - PREDNISOLONE SODIUM PHOSPHATE
A 202179 001 PC Jun 06, 2015
PREDNISOLONE SODIUM PHOSPHATE - PREDNISOLONE SODIUM PHOSPHATE
A 202179 002 PC Jun 06, 2015
PREDNISOLONE SODIUM PHOSPHATE - PREDNISOLONE SODIUM PHOSPHATE
A 202179 003 PC Jun 06, 2015
PREDNISOLONE SODIUM PHOSPHATE - ORAPRED ODT
N 021959 001 6024981 Apr 09, 2018 DP Y
6221392 Apr 09, 2018 DP Y
6740341 Nov 24, 2019 DP
PREDNISOLONE SODIUM PHOSPHATE - ORAPRED ODT
N 021959 002 6024981 Apr 09, 2018 DP Y
6221392 Apr 09, 2018 DP Y
6740341 Nov 24, 2019 DP
PREDNISOLONE SODIUM PHOSPHATE - ORAPRED ODT
N 021959 003 6024981 Apr 09, 2018 DP Y
6221392 Apr 09, 2018 DP Y
6740341 Nov 24, 2019 DP
PREDNISONE - RAYOS
N 202020 001 6488960 Mar 14, 2020 DP U-1267 M-128 Jul 26, 2015
6677326 Mar 14, 2020 DP U-1268
8309124 Apr 23, 2024 U-1292
8394407 Apr 23, 2024 DP U-1362
PREDNISONE - RAYOS
N 202020 002 6488960 Mar 14, 2020 DP U-1267 M-128 Jul 26, 2015
6677326 Mar 14, 2020 DP U-1268
8309124 Apr 23, 2024
8394407 Apr 23, 2024 DP U-1362
PREDNISONE - RAYOS
N 202020 003 8168218 Jan 07, 2028 DP U-1269 M-128 Jul 26, 2015
8309124 Apr 23, 2024 U-1292
8394407 Apr 23, 2024 DP U-1362
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 180 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PREGABALIN - LYRICA
N 021446 001 6001876 Dec 30, 2018 U-55 Y I-651 Jun 20, 2015
6001876 Dec 30, 2018 U-819 Y
6197819 Dec 30, 2018 DS DP
RE41920 Dec 30, 2018 U-1250
PREGABALIN - LYRICA
N 021446 002 6001876 Dec 30, 2018 U-55 Y I-651 Jun 20, 2015
6001876 Dec 30, 2018 U-819 Y
6197819 Dec 30, 2018 DS DP
RE41920 Dec 30, 2018 U-1250
PREGABALIN - LYRICA
N 021446 003 6001876 Dec 30, 2018 U-55 Y I-651 Jun 20, 2015
6001876 Dec 30, 2018 U-819 Y
6197819 Dec 30, 2018 DS DP
RE41920 Dec 30, 2018 U-1250
PREGABALIN - LYRICA
N 021446 004 6001876 Dec 30, 2018 U-55 Y I-651 Jun 20, 2015
6001876 Dec 30, 2018 U-819 Y
6197819 Dec 30, 2018 DS DP
RE41920 Dec 30, 2018 U-1250
PREGABALIN - LYRICA
N 021446 005 6001876 Dec 30, 2018 U-55 Y I-651 Jun 20, 2015
6001876 Dec 30, 2018 U-819 Y
6197819 Dec 30, 2018 DS DP
RE41920 Dec 30, 2018 U-1250
PREGABALIN - LYRICA
N 021446 006 6001876 Dec 30, 2018 U-55 Y I-651 Jun 20, 2015
6001876 Dec 30, 2018 U-819 Y
6197819 Dec 30, 2018 DS DP
RE41920 Dec 30, 2018 U-1250
PREGABALIN - LYRICA
N 021446 007 6001876 Dec 30, 2018 U-55 Y I-651 Jun 20, 2015
6001876 Dec 30, 2018 U-819 Y
6197819 Dec 30, 2018 DS DP
RE41920 Dec 30, 2018 U-1250
PREGABALIN - LYRICA
N 021446 008 6001876 Dec 30, 2018 U-55 Y I-651 Jun 20, 2015
6001876 Dec 30, 2018 U-819 Y
6197819 Dec 30, 2018 DS DP
RE41920 Dec 30, 2018 U-1250
PREGABALIN - LYRICA
N 022488 001 6001876 Dec 30, 2018 U-55 Y I-651 Jun 20, 2015
6001876 Dec 30, 2018 U-819 Y
6197819 Dec 30, 2018 DS DP
RE41920 Dec 30, 2018 U-1250
PROGESTERONE - ENDOMETRIN
N 022057 001 7300664 Nov 17, 2019 U-856
7320800 Nov 17, 2019 U-856
7393543 Nov 17, 2019 DP U-880
PROPAFENONE HYDROCHLORIDE - RYTHMOL SR
N 021416 001 5681588 Oct 28, 2014
PROPAFENONE HYDROCHLORIDE - RYTHMOL SR
N 021416 002 5681588 Oct 28, 2014
PROPAFENONE HYDROCHLORIDE - RYTHMOL SR
N 021416 003 5681588 Oct 28, 2014
PROPOFOL - DIPRIVAN
N 019627 002 5714520 Mar 22, 2015
5731355 Mar 22, 2015 U-217
5731356 Mar 22, 2015 U-218
5908869 Mar 22, 2015 U-270
8476010 Dec 01, 2024 DS DP
8476010*PED Jun 01, 2025
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 181 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
PROPRANOLOL HYDROCHLORIDE - INNOPRAN XL
N 021438 001 6500454 Oct 04, 2021 DP
PROPRANOLOL HYDROCHLORIDE - INNOPRAN XL
N 021438 002 6500454 Oct 04, 2021 DP
PROPRANOLOL HYDROCHLORIDE - HEMANGEOL
N 205410 001 8338489 Oct 16, 2028 U-1496 NP Mar 14, 2017
ODE Mar 14, 2021
QUAZEPAM - DORAL
N 018708 001 7608616 Jun 03, 2028 U-1012
QUAZEPAM - DORAL
N 018708 003 7608616 Jun 03, 2028 U-1012
QUETIAPINE FUMARATE - SEROQUEL XR
N 022047 001 5948437 May 28, 2017 DP U-601
5948437 May 28, 2017 DP U-814
5948437 May 28, 2017 DP U-839
QUETIAPINE FUMARATE - SEROQUEL XR
N 022047 002 5948437 May 28, 2017 DP U-601
5948437 May 28, 2017 DP U-814
5948437 May 28, 2017 DP U-839
QUETIAPINE FUMARATE - SEROQUEL XR
N 022047 003 5948437 May 28, 2017 DP U-601
5948437 May 28, 2017 DP U-814
5948437 May 28, 2017 DP U-839
QUETIAPINE FUMARATE - SEROQUEL XR
N 022047 004 5948437 May 28, 2017 DP U-601
5948437 May 28, 2017 DP U-814
5948437 May 28, 2017 DP U-839
QUETIAPINE FUMARATE - SEROQUEL XR
N 022047 005 5948437 May 28, 2017 DP U-601
5948437 May 28, 2017 DP U-814
5948437 May 28, 2017 DP U-839
QUINAPRIL HYDROCHLORIDE - ACCUPRIL
N 019885 001 5684016 Nov 04, 2014 U-210
QUINAPRIL HYDROCHLORIDE - ACCUPRIL
N 019885 002 5684016 Nov 04, 2014 U-210
QUINAPRIL HYDROCHLORIDE - ACCUPRIL
N 019885 003 5684016 Nov 04, 2014 U-210
QUINAPRIL HYDROCHLORIDE - ACCUPRIL
N 019885 004 5684016 Nov 04, 2014 U-210
RABEPRAZOLE SODIUM - ACIPHEX SPRINKLE
N 204736 001 NDF Mar 26, 2016
PED Sep 26, 2016
RABEPRAZOLE SODIUM - ACIPHEX SPRINKLE
N 204736 002 NDF Mar 26, 2016
PED Sep 26, 2016
RADIUM RA-223 DICHLORIDE - XOFIGO
N 203971 001 6635234 Jan 03, 2020 U-1405 NCE May 15, 2018
RALOXIFENE HYDROCHLORIDE - RALOXIFENE HYDROCHLORIDE
A 078193 001 PC Sep 24, 2014
RALOXIFENE HYDROCHLORIDE - EVISTA
N 020815 001 6458811 Mar 10, 2017 DS DP U-825 ODE Sep 13, 2014
6797719 Mar 10, 2017 DP
6894064 Mar 10, 2017 DP U-657
8030330 Mar 10, 2017 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 182 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
RALTEGRAVIR POTASSIUM - ISENTRESS
N 022145 001 7169780 Oct 03, 2023 DS DP M-114 Mar 28, 2015
7217713 Oct 21, 2022 U-257 NPP Dec 21, 2014
7435734 Oct 21, 2022 U-257
7435734 Oct 21, 2022 U-900
7754731 Mar 11, 2029 DS DP U-257
RALTEGRAVIR POTASSIUM - ISENTRESS
N 203045 001 7169780 Oct 03, 2023 DS DP M-114 Mar 28, 2015
7217713 Oct 21, 2022 U-257 NDF Dec 21, 2014
7435734 Oct 21, 2022 U-257
7754731 Mar 11, 2029 DS DP U-257
RALTEGRAVIR POTASSIUM - ISENTRESS
N 203045 002 7169780 Oct 03, 2023 DS DP M-114 Mar 28, 2015
7217713 Oct 21, 2022 U-257 NDF Dec 21, 2014
7435734 Oct 21, 2022 U-257
7754731 Mar 11, 2029 DS DP U-257
RALTEGRAVIR POTASSIUM - ISENTRESS
N 205786 001 7169780 Oct 03, 2023 DS DP NDF Dec 20, 2016
7217713 Oct 21, 2022 U-257
7435734 Oct 21, 2022 U-257
7754731 Mar 11, 2029 DS DP U-257
RAMELTEON - ROZEREM
N 021782 001 6034239 Jul 22, 2019 DS DP U-674
RAMIPRIL - ALTACE
N 019901 001 7368469 Aug 30, 2020 U-871
RAMIPRIL - ALTACE
N 019901 002 7368469 Aug 30, 2020 U-871
RAMIPRIL - ALTACE
N 019901 003 7368469 Aug 30, 2020 U-871
RAMIPRIL - ALTACE
N 019901 004 7368469 Aug 30, 2020 U-871
RAMIPRIL - ALTACE
N 022021 001 7368469 Aug 30, 2020 U-871
RAMIPRIL - ALTACE
N 022021 002 7368469 Aug 30, 2020 U-871
RAMIPRIL - ALTACE
N 022021 003 7368469 Aug 30, 2020 U-871
RAMIPRIL - ALTACE
N 022021 004 7368469 Aug 30, 2020 U-871
RANOLAZINE - RANEXA
N 021526 001 6303607 May 27, 2019 U-705
6369062 May 27, 2019 DP Y
6479496 May 27, 2019 U-705
6503911 May 27, 2019 DP
6525057 May 27, 2019 U-705
6562826 May 27, 2019 U-705
6617328 May 27, 2019 DP
6620814 May 27, 2019 U-705
6852724 May 27, 2019 U-705
6864258 May 27, 2019 U-705
RANOLAZINE - RANEXA
N 021526 002 6303607 May 27, 2019 U-705
6369062 May 27, 2019 DP
6479496 May 27, 2019 U-705
6503911 May 27, 2019 DP
6525057 May 27, 2019 U-705
6562826 May 27, 2019 U-705
6617328 May 27, 2019 DP
6620814 May 27, 2019 U-705
6852724 May 27, 2019 U-705
6864258 May 27, 2019 U-705
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 183 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
RASAGILINE MESYLATE - AZILECT
N 021641 001 5453446 Feb 07, 2017 U-219 I-685 May 29, 2017
6126968 Sep 18, 2016 DP
7572834 Dec 05, 2026 DP
7815942 Aug 27, 2027 DS DP U-219
RASAGILINE MESYLATE - AZILECT
N 021641 002 5453446 Feb 07, 2017 U-219 I-685 May 29, 2017
6126968 Sep 18, 2016 DP
7572834 Dec 05, 2026 DP
7815942 Aug 27, 2027 DS DP U-219
REGADENOSON - LEXISCAN
N 022161 001 6403567 Apr 10, 2022 DS DP
U-869
6642210 Jun 22, 2019 DS DP
U-869
7144872 Jun 22, 2019 DS DP
U-116
7144872 Jun 22, 2019 DS DP
U-869
7144872 Jun 22, 2019 DS DP
U-870
7183264 Jun 22, 2019 DP
U-116
7183264 Jun 22, 2019 DP
U-869
7183264 Jun 22, 2019 DP
U-870
7582617 Jun 22, 2019 U-1003
7655636 Jun 22, 2019 U-869
7655637 Jun 22, 2019 DS DP U-869
7683037 Jun 22, 2019 U-1042
8106029 Jun 22, 2019 U-1042
8106183 Feb 02, 2027 DS
8133879 Jun 22, 2019 DP
8183226 Jun 22, 2019 U-116
8470801 Jun 22, 2019 U-116
8536150 Jun 22, 2019 U-116
REGORAFENIB - STIVARGA
N 203085 001 7351834 Jan 12, 2020 DS I-667 Feb 25, 2016
8637553 Jul 08, 2029 DS DP NCE Sep 27, 2017
8680124 Jul 20, 2028 U-1506 ODE Feb 25, 2020
REMIFENTANIL HYDROCHLORIDE - ULTIVA
N 020630 001 5866591 Sep 10, 2017 DP
REMIFENTANIL HYDROCHLORIDE - ULTIVA
N 020630 002 5866591 Sep 10, 2017 DP
REMIFENTANIL HYDROCHLORIDE - ULTIVA
N 020630 003 5866591 Sep 10, 2017 DP
RETAPAMULIN - ALTABAX
N 022055 001 7875630 Feb 14, 2027 DS
RE39128 Apr 12, 2021 DS DP U-805
RE43390 Apr 12, 2021 DS DP U-805
RIBAVIRIN - VIRAZOLE
N 018859 001 6150337 Nov 21, 2017 U-400
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 184 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
RIBAVIRIN - REBETOL
N 020903 001 6172046 Sep 21, 2017 U-377
6172046 Sep 21, 2017 U-1014
6177074 Nov 01, 2016 U-454
6177074 Nov 01, 2016 U-1013
6461605 Nov 01, 2016 U-478
6461605 Nov 01, 2016 U-1013
6472373 Sep 21, 2017 U-479
6472373 Sep 21, 2017 U-1014
6524570 Nov 01, 2016 U-499
6524570 Nov 01, 2016 U-1013
RIBAVIRIN - REBETOL
N 020903 002 6172046 Sep 21, 2017 U-377
6172046 Sep 21, 2017 U-1014
6177074 Nov 01, 2016 U-454
6177074 Nov 01, 2016 U-1013
6461605 Nov 01, 2016 U-478
6461605 Nov 01, 2016 U-1013
6472373 Sep 21, 2017 U-479
6472373 Sep 21, 2017 U-1014
6524570 Nov 01, 2016 U-499
6524570 Nov 01, 2016 U-1013
RIBAVIRIN - COPEGUS
N 021511 001 NPP Aug 09, 2014
RIBAVIRIN - REBETOL
N 021546 001 6172046 Sep 21, 2017 U-521
6172046 Sep 21, 2017 U-1014
6177074 Nov 01, 2016 U-1013
6461605 Nov 01, 2016 U-521
6461605 Nov 01, 2016 U-1013
6472373 Sep 21, 2017 U-521
6524570 Nov 01, 2016 U-1013
6790837 Apr 05, 2023 DP
RIFAXIMIN - XIFAXAN
N 021361 001 7045620 Jun 19, 2024 DS DP
7612199 Jun 19, 2024 DS DP
7902206 Jun 19, 2024 DS DP
7906542 Jun 01, 2025 DS DP
7928115 Jul 24, 2029 U-1121
8158644 Jun 19, 2024 DP
8158781 Jun 19, 2024 DS
8193196 Sep 02, 2027 DS DP
8518949 Feb 27, 2026 DP
8741904 Feb 27, 2026 DS U-1526
8835452 Jun 19, 2024 DS DP
8853231 Jun 19, 2024 DP
RIFAXIMIN - XIFAXAN
N 022554 001 7045620 Jun 19, 2024 DS ODE Mar 24, 2017
7612199 Jun 19, 2024 DS DP
7902206 Jun 19, 2024 DS DP
7906542 Jun 01, 2025 DS DP
8158644 Jun 19, 2024 DP
8158781 Jun 19, 2024 DS
8193196 Sep 02, 2027 DS DP
8518949 Feb 27, 2026 DP
8642573 Oct 02, 2029 U-1481
8741904 Feb 27, 2026 DS U-1526
8829017 Jul 24, 2029 U-1562
8835452 Jun 19, 2024 DS DP
8853231 Jun 19, 2024 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 185 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
RILPIVIRINE HYDROCHLORIDE - EDURANT
N 202022 001 6838464 Feb 26, 2021 DS DP NCE May 20, 2016
7067522 Dec 20, 2019 DS DP
7125879 Apr 14, 2023 DS DP U-1153
7125879 Apr 14, 2023 DS DP U-1307
7638522 Apr 14, 2023 DP
8080551 Apr 11, 2023 DS DP
8101629 Aug 09, 2022 DP
RIOCIGUAT - ADEMPAS
N 204819 001 6743798 Jul 16, 2019 DS DP NCE Oct 08, 2018
7173037 Apr 25, 2023 DS DP ODE Oct 08, 2020
RIOCIGUAT - ADEMPAS
N 204819 002 6743798 Jul 16, 2019 DS DP NCE Oct 08, 2018
7173037 Apr 25, 2023 DS DP ODE Oct 08, 2020
RIOCIGUAT - ADEMPAS
N 204819 003 6743798 Jul 16, 2019 DS DP NCE Oct 08, 2018
7173037 Apr 25, 2023 DS DP ODE Oct 08, 2020
RIOCIGUAT - ADEMPAS
N 204819 004 6743798 Jul 16, 2019 DS DP NCE Oct 08, 2018
7173037 Apr 25, 2023 DS DP ODE Oct 08, 2020
RIOCIGUAT - ADEMPAS
N 204819 005 6743798 Jul 16, 2019 DS DP NCE Oct 08, 2018
7173037 Apr 25, 2023 DS DP ODE Oct 08, 2020
RISEDRONATE SODIUM - ACTONEL
N 020835 001 6165513 Jun 10, 2018
RISEDRONATE SODIUM - ACTONEL
N 020835 002 6165513 Jun 10, 2018
RISEDRONATE SODIUM - ACTONEL
N 020835 003 5994329 Jul 17, 2018 U-353
6015801 Jul 17, 2018 U-353
6165513 Jun 10, 2018 DP
6432932 Jul 17, 2018 U-595
6465443 Aug 14, 2018 DP
RISEDRONATE SODIUM - ACTONEL
N 020835 004 6165513 Jun 10, 2018 DP
RISEDRONATE SODIUM - ACTONEL
N 020835 005 6165513 Jun 10, 2018 DP
7192938 May 06, 2023 U-353
7718634 May 06, 2023 U-662
RISEDRONATE SODIUM - ATELVIA
N 022560 001 7645459 Jan 09, 2028 DP U-662
7645460 Jan 09, 2028 DP U-662
8246989 Jan 16, 2026 DP
RISPERIDONE - RISPERDAL
N 020588 001 5453425 Jul 11, 2014 DP
RE39181 Jul 11, 2014 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 186 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
RISPERIDONE - RISPERDAL CONSTA
N 021346 001 5688801 Nov 18, 2014 U-543
5688801 Nov 18, 2014 U-972
5792477 May 02, 2017 DP
5916598 May 02, 2017 DP
6194006 Dec 30, 2018 DP
6379703 Dec 30, 2018 DP
6403114 May 02, 2017 DP
6596316 Dec 30, 2018 DP
6667061 May 25, 2020 DP
RISPERIDONE - RISPERDAL CONSTA
N 021346 002 5688801 Nov 18, 2014 U-543
5688801 Nov 18, 2014 U-972
5792477 May 02, 2017 DP
5916598 May 02, 2017 DP
6194006 Dec 30, 2018 DP
6379703 Dec 30, 2018 DP
6403114 May 02, 2017 DP
6596316 Dec 30, 2018 DP
6667061 May 25, 2020 DP
RISPERIDONE - RISPERDAL CONSTA
N 021346 003 5688801 Nov 18, 2014 U-543
5688801 Nov 18, 2014 U-972
5792477 May 02, 2017 DP
5916598 May 02, 2017 DP
6194006 Dec 30, 2018 DP
6379703 Dec 30, 2018 DP
6403114 May 02, 2017 DP
6596316 Dec 30, 2018 DP
6667061 May 25, 2020 DP
RISPERIDONE - RISPERDAL CONSTA
N 021346 004 5688801 Nov 18, 2014 U-543
5688801 Nov 18, 2014 U-972
5792477 May 02, 2017 DP
5916598 May 02, 2017 DP
6194006 Dec 30, 2018 DP
6379703 Dec 30, 2018 DP
6403114 May 02, 2017 DP
6596316 Dec 30, 2018 DP
RISPERIDONE - RISPERDAL
N 021444 001 5648093 Jul 15, 2014 DP
6224905 Jun 10, 2017 DP
RISPERIDONE - RISPERDAL
N 021444 002 5648093 Jul 15, 2014 DP
6224905 Jun 10, 2017 DP
RISPERIDONE - RISPERDAL
N 021444 003 5648093 Jul 15, 2014 DP
6224905 Jun 10, 2017 DP
RISPERIDONE - RISPERDAL
N 021444 004 5648093 Jul 15, 2014 DP
6224905 Jun 10, 2017 DP
RISPERIDONE - RISPERDAL
N 021444 005 5648093 Jul 15, 2014 DP
6224905 Jun 10, 2017 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 187 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
RITONAVIR - NORVIR
N 020659 001 5648497 Jul 15, 2014
6037157 Jun 26, 2016
6703403 Jun 26, 2016 U-564
RITONAVIR - NORVIR
N 020680 001 5648497 Jul 15, 2014
RITONAVIR - NORVIR
N 020945 001 5648497 Jul 15, 2014
6037157 Jun 26, 2016 U-895
6232333 Nov 07, 2017
6703403 Jun 26, 2016 U-564
7141593 May 22, 2020 DP
7432294 May 22, 2020 DP
RITONAVIR - NORVIR
N 022417 001 5648497 Jul 15, 2014 DS
6037157 Jun 26, 2016 U-688
6703403 Jun 26, 2016 U-688
7148359 Jul 19, 2019 DP
7364752 Nov 10, 2020 DP U-688
8268349 Aug 25, 2024 DP
8399015 Aug 25, 2024 DP
8399015*PED Feb 25, 2025
8470347 Sep 17, 2026 DP
8470347*PED Mar 17, 2027
8691878 Aug 25, 2024 U-688
8691878*PED Feb 25, 2025
RIVAROXABAN - XARELTO
N 022406 001 7157456 Feb 08, 2021 DS DP U-1301 I-660 Nov 02, 2015
7157456 Feb 08, 2021 DS DP U-1302 I-661 Nov 02, 2015
7585860 Dec 11, 2020 DS U-1303 I-662 Nov 02, 2015
7592339 Dec 11, 2020 U-1167 NCE Jul 01, 2016
7592339 Dec 11, 2020 U-1200
7592339 Dec 11, 2020 U-1301
7592339 Dec 11, 2020 U-1302
7592339 Dec 11, 2020 U-1303
RIVAROXABAN - XARELTO
N 022406 002 7157456 Feb 08, 2021 DS DP U-1301 I-643 Nov 04, 2014
7157456 Feb 08, 2021 DS DP U-1302 I-660 Nov 02, 2015
7585860 Dec 11, 2020 DS U-1303 I-661 Nov 02, 2015
7592339 Dec 11, 2020 U-1167 I-662 Nov 02, 2015
7592339 Dec 11, 2020 U-1200 NCE Jul 01, 2016
7592339 Dec 11, 2020 U-1301
7592339 Dec 11, 2020 U-1302
7592339 Dec 11, 2020 U-1303
RIVAROXABAN - XARELTO
N 022406 003 7157456 Feb 08, 2021 DS DP U-1301 I-643 Nov 04, 2014
7157456 Feb 08, 2021 DS DP U-1302 I-660 Nov 02, 2015
7585860 Dec 11, 2020 DS U-1303 I-661 Nov 02, 2015
7592339 Dec 11, 2020 U-1167 I-662 Nov 02, 2015
7592339 Dec 11, 2020 U-1200 NCE Jul 01, 2016
7592339 Dec 11, 2020 U-1301
7592339 Dec 11, 2020 U-1302
7592339 Dec 11, 2020 U-1303
RIVASTIGMINE - EXELON
N 022083 001 6316023 Jan 08, 2019 DP
6335031 Jan 08, 2019 DP
RIVASTIGMINE - EXELON
N 022083 002 6316023 Jan 08, 2019 DP
6335031 Jan 08, 2019 DP
RIVASTIGMINE - EXELON
N 022083 005 6316023 Jan 08, 2019 DP NPP Jun 27, 2016
6335031 Jan 08, 2019 DP NS Aug 31, 2015
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 188 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
RIZATRIPTAN BENZOATE - MAXALT
N 020864 001 NPP Dec 16, 2014
PED Jun 16, 2015
RIZATRIPTAN BENZOATE - MAXALT
N 020864 002 NPP Dec 16, 2014
PED Jun 16, 2015
RIZATRIPTAN BENZOATE - MAXALT-MLT
N 020865 001 NPP Dec 16, 2014
PED Jun 16, 2015
RIZATRIPTAN BENZOATE - MAXALT-MLT
N 020865 002 NPP Dec 16, 2014
PED Jun 16, 2015
ROFECOXIB - VIOXX
N 021042 001 5691374 May 18, 2015
6063811 May 06, 2017 U-602
ROFECOXIB - VIOXX
N 021042 002 5691374 May 18, 2015
6063811 May 06, 2017 U-602
ROFECOXIB - VIOXX
N 021042 003 5691374 May 18, 2015
6063811 May 06, 2017 U-602
ROFECOXIB - VIOXX
N 021052 001 5691374 May 18, 2015
6063811 May 06, 2017 U-266
ROFECOXIB - VIOXX
N 021052 002 5691374 May 18, 2015
6063811 May 06, 2017 U-266
ROFLUMILAST - DALIRESP
N 022522 001 5712298 Jan 27, 2015 DS DP U-1115 NCE Feb 28, 2016
8431154 Feb 19, 2023 DP
8536206 Mar 08, 2024 U-1115
8604064 Mar 08, 2024 U-1115
8618142 Mar 08, 2024 DP
ROMIDEPSIN - ISTODAX
N 022393 001 7608280 Aug 22, 2021 DS NCE Nov 05, 2014
7611724 Aug 22, 2021 DS ODE Nov 05, 2016
ODE Jun 16, 2018
ROPINIROLE HYDROCHLORIDE - REQUIP XL
N 022008 001 7927624 Dec 02, 2021 DP U-20
8303986 Apr 12, 2021 DP
ROPINIROLE HYDROCHLORIDE - REQUIP XL
N 022008 002 7927624 Dec 02, 2021 DP U-20
8303986 Apr 12, 2021 DP
ROPINIROLE HYDROCHLORIDE - REQUIP XL
N 022008 003 7927624 Dec 02, 2021 DP U-20
8303986 Apr 12, 2021 DP
ROPINIROLE HYDROCHLORIDE - REQUIP XL
N 022008 004 7927624 Dec 02, 2021 DP U-20
8303986 Apr 12, 2021 DP
ROPINIROLE HYDROCHLORIDE - REQUIP XL
N 022008 005 7927624 Dec 02, 2021 DP U-20
8303986 Apr 12, 2021 DP
ROPINIROLE HYDROCHLORIDE - REQUIP XL
N 022008 006 7927624 Dec 02, 2021 DP U-20
8303986 Apr 12, 2021 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 189 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT
PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION
PATENT DELIST EXCLUSIVITY EXPIRATION
DATE
CODES REQUESTED CODE(S) DATE
ROPIVACAINE HYDROCHLORIDE - NAROPIN
N 020533 001 5670524 Sep 23, 2014
DS DP U-833
7828787 Oct 18, 2025
DP
7857802 Nov 28, 2026
DP
8118802 May 18, 2023
DP
8162915 May 23, 2024
DP
ROPIVACAINE HYDROCHLORIDE - NAROPIN
N 020533 003 5670524 Sep 23, 2014
DS DP U-833
ROPIVACAINE HYDROCHLORIDE - NAROPIN
N 020533 004 5670524 Sep 23, 2014
DS DP U-833
ROPIVACAINE HYDROCHLORIDE - NAROPIN
N 020533 005 5670524 Sep 23, 2014
DS DP U-833
ROSIGLITAZONE MALEATE - AVANDIA
N 021071 002 5741803 Apr 21, 2015
DS DP U-329 Y
5741803 Apr 21, 2015
DS DP U-628 Y
6288095 Feb 11, 2017
U-420 Y
7358366 Apr 19, 2020
DS
ROSIGLITAZONE MALEATE - AVANDIA
N 021071 003 5741803 Apr 21, 2015
DS DP U-329 Y
5741803 Apr 21, 2015
DS DP U-628 Y
6288095 Feb 11, 2017
U-420 Y
7358366 Apr 19, 2020
DS
ROSIGLITAZONE MALEATE - AVANDIA
N 021071 004 5741803 Apr 21, 2015
DS DP U-329 Y
5741803 Apr 21, 2015
DS DP U-628 Y
6288095 Feb 11, 2017
U-420 Y
7358366 Apr 19, 2020
DS
ROSUVASTATIN CALCIUM - CRESTOR
N 021366 002 6316460 Aug 04, 2020
DP
6858618 Dec 17, 2021
U-618
7030152 Apr 02, 2018
U-1032
7964614 Apr 02, 2018
U-1032
RE37314 Jan 08, 2016
DS
ROSUVASTATIN CALCIUM - CRESTOR
N 021366 003 6316460 Aug 04, 2020
DP
6858618 Dec 17, 2021
U-618
7030152 Apr 02, 2018
U-1032
7964614 Apr 02, 2018
U-1032
RE37314 Jan 08, 2016
DS
ROSUVASTATIN CALCIUM - CRESTOR
N 021366 004 6316460 Aug 04, 2020
DP
6858618 Dec 17, 2021
U-618
7030152 Apr 02, 2018
U-1032
7964614 Apr 02, 2018
U-1032
RE37314 Jan 08, 2016
DS
ROSUVASTATIN CALCIUM - CRESTOR
N 021366 005 6316460 Aug 04, 2020
DP
6858618 Dec 17, 2021
U-618
7030152 Apr 02, 2018
U-1032
7964614 Apr 02, 2018
U-1032
RE37314 Jan 08, 2016
DS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 190 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
PATENT
PATENT EXCLUSIVITY
NO PATENT NO
EXPIRATION
PATENT DELIST EXCLUSIVITY EXPIRATION
DATE
CODES REQUESTED CODE(S) DATE
ROTIGOTINE - NEUPRO
N 021829 001 6699498
Nov 27, 2020
DP I-646 Apr 02, 2015
6884434
Mar 30, 2021
DP I-647 Apr 02, 2015
7413747
Mar 18, 2019
DP
8246979
Sep 01, 2027
DP U-1272
8246979
Sep 01, 2027
DP U-1273
8246980
Nov 27, 2025
DP
8617591
Jul 22, 2023
DP U-1474
ROTIGOTINE - NEUPRO
N 021829 002 6699498
Nov 27, 2020
DP I-646 Apr 02, 2015
6884434
Mar 30, 2021
DP I-647 Apr 02, 2015
7413747
Mar 18, 2019
DP
8246979
Sep 01, 2027
DP U-1272
8246979
Sep 01, 2027
DP U-1273
8246980
Nov 27, 2025
DP
8617591
Jul 22, 2023
DP U-1474
ROTIGOTINE - NEUPRO
N 021829 003 6699498
Nov 27, 2020
DP I-646 Apr 02, 2015
6884434
Mar 30, 2021
DP I-647 Apr 02, 2015
7413747
Mar 18, 2019
DP
8246979
Sep 01, 2027
DP U-1272
8246979
Sep 01, 2027
DP U-1273
8246980
Nov 27, 2025
DP
8617591
Jul 22, 2023
DP U-1474
ROTIGOTINE - NEUPRO
N 021829 004 6699498
Nov 27, 2020
DP I-646 Apr 02, 2015
6884434
Mar 30, 2021
DP I-647 Apr 02, 2015
7413747
Mar 18, 2019
DP
8246979
Sep 01, 2027
DP U-1272
8246979
Sep 01, 2027
DP U-1273
8246980
Nov 27, 2025
DP
8617591
Jul 22, 2023
DP U-1474
ROTIGOTINE - NEUPRO
N 021829 005 6699498
Nov 27, 2020
DP I-646 Apr 02, 2015
6884434
Mar 30, 2021
DP I-647 Apr 02, 2015
7413747
Mar 18, 2019
DP
8246979
Sep 01, 2027
DP U-1272
8246979
Sep 01, 2027
DP U-1273
8246980
Nov 27, 2025
DP
8617591
Jul 22, 2023
DP U-1474
ROTIGOTINE - NEUPRO
N 021829 006 6699498
Nov 27, 2020
DP I-646 Apr 02, 2015
6884434
Mar 30, 2021
DP I-647 Apr 02, 2015
7413747
Mar 18, 2019
DP
8246979
Sep 01, 2027
DP U-1272
8246979
Sep 01, 2027
DP U-1273
8246980
Nov 27, 2025
DP
8617591
Jul 22, 2023
DP U-1474
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 191 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
PATENT PATENT EXCLUSIVITY
NO PATENT NO
EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
RUFINAMIDE - BANZEL
N 021911 001 6740669
Nov 14, 2022 DS DP ODE Nov 14, 2015
6740669*PED
May 14, 2023 PED May 14, 2016
7750028
Oct 19, 2018 U-106
7750028*PED
Apr 19, 2019
8076362
Jun 08, 2018 DP
8076362*PED
Dec 08, 2018
RUFINAMIDE - BANZEL
N 021911 002 6740669
Nov 14, 2022 DS DP ODE Nov 14, 2015
6740669*PED
May 14, 2023 PED May 14, 2016
7750028
Oct 19, 2018 U-106
7750028*PED
Apr 19, 2019
8076362
Jun 08, 2018 DP
8076362*PED
Dec 08, 2018
RUFINAMIDE - BANZEL
N 021911 003 6740669
Nov 14, 2022 DS DP ODE Nov 14, 2015
6740669*PED
May 14, 2023 PED May 14, 2016
7750028
Oct 19, 2018 U-106
7750028*PED
Apr 19, 2019
8076362
Jun 08, 2018 DP
8076362*PED
Dec 08, 2018
RUFINAMIDE - BANZEL
N 201367 001 6740669
Nov 14, 2022 DS DP ODE Nov 14, 2015
6740669*PED
May 14, 2023 PED May 14, 2016
7750028
Oct 19, 2018 U-106
7750028*PED
Apr 19, 2019
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 192 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
RUXOLITINIB PHOSPHATE - JAKAFI
N 202192 001 7598257 Dec 24, 2027 DS DP U-1201 I-699 Dec 04, 2017
7598257 Dec 24, 2027 DS DP U-1622 NCE Nov 16, 2016
8415362 Dec 24, 2027 DS DP ODE Nov 16, 2018
8722693 Jun 12, 2028 DS DP ODE Dec 04, 2021
8822481 Jun 12, 2028 U-1573
8829013 Jun 12, 2028 U-1201
8829013 Jun 12, 2028 U-1622
RUXOLITINIB PHOSPHATE - JAKAFI
N 202192 002 7598257 Dec 24, 2027 DS DP U-1201 I-699 Dec 04, 2017
7598257 Dec 24, 2027 DS DP U-1622 NCE Nov 16, 2016
8415362 Dec 24, 2027 DS DP ODE Nov 16, 2018
8722693 Jun 12, 2028 DS DP ODE Dec 04, 2021
8822481 Jun 12, 2028 U-1573
8829013 Jun 12, 2028 U-1201
8829013 Jun 12, 2028 U-1622
RUXOLITINIB PHOSPHATE - JAKAFI
N 202192 003 7598257 Dec 24, 2027 DS DP U-1201 I-699 Dec 04, 2017
7598257 Dec 24, 2027 DS DP U-1622 NCE Nov 16, 2016
8415362 Dec 24, 2027 DS DP ODE Nov 16, 2018
8722693 Jun 12, 2028 DS DP ODE Dec 04, 2021
8822481 Jun 12, 2028 U-1573
8829013 Jun 12, 2028 U-1201
8829013 Jun 12, 2028 U-1622
RUXOLITINIB PHOSPHATE - JAKAFI
N 202192 004 7598257 Dec 24, 2027 DS DP U-1201 I-699 Dec 04, 2017
7598257 Dec 24, 2027 DS DP U-1622 NCE Nov 16, 2016
8415362 Dec 24, 2027 DS DP ODE Nov 16, 2018
8722693 Jun 12, 2028 DS DP ODE Dec 04, 2021
8822481 Jun 12, 2028 U-1573
8829013 Jun 12, 2028 U-1201
8829013 Jun 12, 2028 U-1622
RUXOLITINIB PHOSPHATE - JAKAFI
N 202192 005 7598257 Dec 24, 2027 DS DP U-1201 I-699 Dec 04, 2017
7598257 Dec 24, 2027 DS DP U-1622 NCE Nov 16, 2016
8415362 Dec 24, 2027 DS DP ODE Nov 16, 2018
8722693 Jun 12, 2028 DS DP ODE Dec 04, 2021
8822481 Jun 12, 2028 U-1573
8829013 Jun 12, 2028 U-1201
8829013 Jun 12, 2028 U-1622
SALMETEROL XINAFOATE - SEREVENT
N 020692 001 5873360 Feb 23, 2016 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 193 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
SAPROPTERIN DIHYDROCHLORIDE - KUVAN
N 022181 001 7566462 Nov 16, 2025 DP NPP Apr 23, 2017
7566462*PED May 16, 2026 ODE Dec 13, 2014
7566714 Nov 17, 2024 U-989 PED Jun 13, 2015
7566714*PED May 17, 2025 PED Oct 23, 2017
7612073 Nov 17, 2024 U-1010
7612073*PED May 17, 2025
7727987 Nov 17, 2024 DP
7727987*PED May 17, 2025
7947681 Nov 17, 2024 U-1156 Y
7947681*PED May 17, 2025
8003126 Nov 16, 2025
8003126*PED May 17, 2015
8067416 Nov 17, 2024 U-989
8067416*PED May 17, 2025
8318745 Nov 17, 2024 DP
8318745*PED May 17, 2025
RE43797 Nov 17, 2024 U-1156
RE43797*PED May 17, 2025
SAPROPTERIN DIHYDROCHLORIDE - KUVAN
N 205065 001 7566714 Nov 17, 2024 U-1589
7612073 Nov 17, 2024 U-1010
8067416 Nov 17, 2024 U-1589
RE43797 Nov 17, 2024 U-1590
SAQUINAVIR - FORTOVASE
N 020828 001 6008228 Jun 06, 2015
6352717 Nov 16, 2019
SAQUINAVIR MESYLATE - INVIRASE
N 020628 001 M-61 Nov 30, 2015
PED May 30, 2016
SAQUINAVIR MESYLATE - INVIRASE
N 021785 001 M-61 Nov 30, 2015
PED May 30, 2016
SAXAGLIPTIN HYDROCHLORIDE - ONGLYZA
N 022350 001 7951400 Nov 30, 2028 DP M-108 Dec 16, 2014
RE44186 Jul 31, 2023 DS DP U-995 M-134 May 24, 2016
NCE Jul 31, 2014
SAXAGLIPTIN HYDROCHLORIDE - ONGLYZA
N 022350 002 7951400 Nov 30, 2028 DP M-108 Dec 16, 2014
RE44186 Jul 31, 2023 DS DP U-995 M-134 May 24, 2016
NCE Jul 31, 2014
SELEGILINE - EMSAM
N 021336 001 7070808 May 10, 2018 DS DP
7150881 Jun 12, 2018 DS DP
7638140 May 10, 2018 DP
SELEGILINE - EMSAM
N 021336 002 7070808 May 10, 2018 DS DP
7150881 Jun 12, 2018 DS DP
7638140 May 10, 2018 DP
SELEGILINE - EMSAM
N 021336 003 7070808 May 10, 2018 DS DP
7150881 Jun 12, 2018 DS DP
7638140 May 10, 2018 DP
SELEGILINE HYDROCHLORIDE - ZELAPAR
N 021479 001 5648093 Jul 15, 2014 DP
6423342 Mar 01, 2016 DP
SERTRALINE HYDROCHLORIDE - ZOLOFT
N 020990 001 6727283 Oct 11, 2019 DP U-580
7067555 Oct 11, 2019 DP
7067555*PED Apr 11, 2020
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 194 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
SEVELAMER CARBONATE - RENVELA
N 022127 001 5667775 Sep 16, 2014 U-246
7985418 Oct 27, 2025 DP
SEVELAMER CARBONATE - RENVELA
N 022318 001 5667775 Sep 16, 2014 U-246
SEVELAMER CARBONATE - RENVELA
N 022318 002 5667775 Sep 16, 2014 U-246
SEVELAMER HYDROCHLORIDE - RENAGEL
N 020926 001 5667775 Sep 16, 2014 U-246
SEVELAMER HYDROCHLORIDE - RENAGEL
N 021179 001 5667775 Sep 16, 2014 U-246
6733780 Oct 18, 2020 DP
SEVELAMER HYDROCHLORIDE - RENAGEL
N 021179 002 5667775 Sep 16, 2014 U-246
6733780 Oct 18, 2020 DP
SEVOFLURANE - ULTANE
N 020478 001 5990176 Jan 27, 2017
6074668 Jan 09, 2018
6288127 Jan 27, 2017
6444859 Jan 27, 2017
SILDENAFIL CITRATE - VIAGRA
N 020895 001 6469012 Oct 22, 2019 U-155
SILDENAFIL CITRATE - VIAGRA
N 020895 002 6469012 Oct 22, 2019 U-155
SILDENAFIL CITRATE - VIAGRA
N 020895 003 6469012 Oct 22, 2019 U-155
SILDENAFIL CITRATE - REVATIO
N 021845 001 D-137 Jan 31, 2017
M-133 Jan 31, 2017
M-61 Aug 30, 2015
PED Mar 01, 2016
SILDENAFIL CITRATE - REVATIO
N 022473 001 D-137 Jan 31, 2017
M-133 Jan 31, 2017
M-61 Aug 30, 2015
PED Mar 01, 2016
SILDENAFIL CITRATE - REVATIO
N 203109 001 D-137 Jan 31, 2017
M-133 Jan 31, 2017
NDF Aug 30, 2015
PED Mar 01, 2016
SILODOSIN - RAPAFLO
N 022206 001 5387603 Dec 01, 2018 DS DP
SILODOSIN - RAPAFLO
N 022206 002 5387603 Dec 01, 2018 DS DP
SIMEPREVIR SODIUM - OLYSIO
N 205123 001 7671032 May 19, 2025 DS DP I-697 Nov 05, 2017
8148399 Sep 05, 2029 DS DP U-1467 NCE Nov 22, 2018
8349869 Jul 28, 2026 DS DP U-1467
8741926 Jul 28, 2026 DS U-1467
8754106 Jul 28, 2026 DS U-1467
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 195 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT
PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION
PATENT DELIST EXCLUSIVITY EXPIRATION
DATE
CODES REQUESTED CODE(S) DATE
SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC
N 202343 001 6303661 Apr 24, 2017
U-1188
6699871 Jul 26, 2022
DS DP U-1188
6890898 Feb 02, 2019
U-1189
6890898 Feb 02, 2019
U-1190
6890898 Feb 02, 2019
U-1191
7078381 Feb 02, 2019
U-1188
7125873 Jul 26, 2022
DP U-1189
7125873 Jul 26, 2022
DP U-1190
7125873 Jul 26, 2022
DP U-1192
7125873 Jul 26, 2022
DP U-1193
7326708 Apr 11, 2026
DS DP U-1188
7459428 Feb 02, 2019
U-1189
8168637 Jun 26, 2022
DP U-1188
SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC
N 202343 002 6303661 Apr 24, 2017
U-1188
6699871 Jul 26, 2022
DS DP U-1188
6890898 Feb 02, 2019
U-1189
6890898 Feb 02, 2019
U-1190
6890898 Feb 02, 2019
U-1191
7078381 Feb 02, 2019
U-1188
7125873 Jul 26, 2022
DP U-1189
7125873 Jul 26, 2022
DP U-1190
7125873 Jul 26, 2022
DP U-1192
7125873 Jul 26, 2022
DP U-1193
7326708 Apr 11, 2026
DS DP U-1188
7459428 Feb 02, 2019
U-1189
8168637 Jun 26, 2022
DP U-1188
SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC
N 202343 003 6303661 Apr 24, 2017
U-1188
6699871 Jul 26, 2022
DS DP U-1188
6890898 Feb 02, 2019
U-1189
6890898 Feb 02, 2019
U-1190
6890898 Feb 02, 2019
U-1191
7078381 Feb 02, 2019
U-1188
7125873 Jul 26, 2022
DP U-1189
7125873 Jul 26, 2022
DP U-1190
7125873 Jul 26, 2022
DP U-1192
7125873 Jul 26, 2022
DP U-1193
7326708 Apr 11, 2026
DS DP U-1188
7459428 Feb 02, 2019
U-1189
8168637 Jun 26, 2022
DP U-1188
SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC
N 202343 004 6303661 Apr 24, 2017
U-1188
6699871 Jul 26, 2022
DS DP U-1188
6890898 Feb 02, 2019
U-1189
6890898 Feb 02, 2019
U-1190
6890898 Feb 02, 2019
U-1191
7078381 Feb 02, 2019
U-1188
7125873 Jul 26, 2022
DP U-1189
7125873 Jul 26, 2022
DP U-1190
7125873 Jul 26, 2022
DP U-1192
7125873 Jul 26, 2022
DP U-1193
7326708 Apr 11, 2026
DS DP U-1188
7459428 Feb 02, 2019
U-1189
8168637 Jun 26, 2022
DP U-1188
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 196 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC
N 202343 005 6303661 Apr 24, 2017 U-1188
6699871 Jul 26, 2022 DS DP U-1188
6890898 Feb 02, 2019 U-1189
6890898 Feb 02, 2019 U-1190
6890898 Feb 02, 2019 U-1191
7078381 Feb 02, 2019 U-1188
7125873 Jul 26, 2022 DP U-1189
7125873 Jul 26, 2022 DP U-1190
7125873 Jul 26, 2022 DP U-1192
7125873 Jul 26, 2022 DP U-1193
7326708 Apr 11, 2026 DS DP U-1188
7459428 Feb 02, 2019 U-1189
8168637 Jun 26, 2022 DP U-1188
SIMVASTATIN; SITAGLIPTIN PHOSPHATE - JUVISYNC
N 202343 006 6303661 Apr 24, 2017 U-1188
6699871 Jul 26, 2022 DS DP U-1188
6890898 Feb 02, 2019 U-1189
6890898 Feb 02, 2019 U-1190
6890898 Feb 02, 2019 U-1191
7078381 Feb 02, 2019 U-1188
7125873 Jul 26, 2022 DP U-1189
7125873 Jul 26, 2022 DP U-1190
7125873 Jul 26, 2022 DP U-1192
7125873 Jul 26, 2022 DP U-1193
7326708 Apr 11, 2026 DS DP U-1188
7459428 Feb 02, 2019 U-1189
8168637 Jun 26, 2022 DP U-1188
SINCALIDE - KINEVAC
N 017697 001 6803046 Aug 16, 2022 DP
SINECATECHINS - VEREGEN
N 021902 001 5795911 Oct 31, 2020 U-172
5968973 Apr 10, 2017 U-172
7858662 Oct 02, 2026 DP U-172
SIROLIMUS - SIROLIMUS
A 201676 003 PC Jul 15, 2014
SIROLIMUS - RAPAMUNE
N 021110 001 5989591 Mar 11, 2018 DP
SIROLIMUS - RAPAMUNE
N 021110 002 5989591 Mar 11, 2018 DP
SIROLIMUS - RAPAMUNE
N 021110 003 5989591 Mar 11, 2018 DP
SIROLIMUS - RAPAMUNE
N 021110 004 5989591 Mar 11, 2018 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 197 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
SITAGLIPTIN PHOSPHATE - JANUVIA
N 021995 001 6303661 Apr 24, 2017 U-774
6699871 Jul 26, 2022 DS DP U-774
6890898 Feb 02, 2019 U-775
6890898 Feb 02, 2019 U-1036
6890898 Feb 02, 2019 U-1039
7078381 Feb 02, 2019 U-775
7078381 Feb 02, 2019 U-1036
7078381 Feb 02, 2019 U-1037
7078381 Feb 02, 2019 U-1038
7125873 Jul 26, 2022 U-775
7125873 Jul 26, 2022 U-1036
7125873 Jul 26, 2022 U-1037
7125873 Jul 26, 2022 U-1038
7326708 Apr 11, 2026 DS DP U-802
SITAGLIPTIN PHOSPHATE - JANUVIA
N 021995 002 6303661 Apr 24, 2017 U-774
6699871 Jul 26, 2022 DS DP U-774
6890898 Feb 02, 2019 U-775
6890898 Feb 02, 2019 U-1036
6890898 Feb 02, 2019 U-1039
7078381 Feb 02, 2019 U-775
7078381 Feb 02, 2019 U-1036
7078381 Feb 02, 2019 U-1037
7078381 Feb 02, 2019 U-1038
7125873 Jul 26, 2022 U-775
7125873 Jul 26, 2022 U-1036
7125873 Jul 26, 2022 U-1037
7125873 Jul 26, 2022 U-1038
7326708 Apr 11, 2026 DS DP U-802
SITAGLIPTIN PHOSPHATE - JANUVIA
N 021995 003 6303661 Apr 24, 2017 U-774
6699871 Jul 26, 2022 DS DP U-774
6890898 Feb 02, 2019 U-775
6890898 Feb 02, 2019 U-1036
6890898 Feb 02, 2019 U-1039
7078381 Feb 02, 2019 U-775
7078381 Feb 02, 2019 U-1036
7078381 Feb 02, 2019 U-1037
7078381 Feb 02, 2019 U-1038
7125873 Jul 26, 2022 U-775
7125873 Jul 26, 2022 U-1036
7125873 Jul 26, 2022 U-1037
7125873 Jul 26, 2022 U-1038
7326708 Apr 11, 2026 DS DP U-802
SODIUM NITRITE - SODIUM NITRITE
N 203922 001 8568793 Dec 24, 2031 DS DP ODE Jan 14, 2018
SODIUM NITRITE; SODIUM THIOSULFATE - NITHIODOTE
N 201444 001 8496973 Mar 29, 2031 DS DP U-1419 ODE Jan 14, 2018
8568793 Dec 24, 2031 DS DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 198 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
SODIUM OXYBATE - XYREM
N 021196 001 6780889 Jul 04, 2020 DP
7262219 Jul 04, 2020 DP
7668730 Jun 16, 2024 U-1110
7765106 Jun 16, 2024 U-1069
7765107 Jun 16, 2024 U-1070
7851506 Dec 22, 2019 U-1101
7851506 Dec 22, 2019 U-1102
7895059 Dec 17, 2022 U-1110
8263650 Dec 22, 2019 DP U-1101
8263650 Dec 22, 2019 DP U-1102
8324275 Dec 22, 2019 U-1101
8324275 Dec 22, 2019 U-1102
8457988 Dec 17, 2022 U-1110
8589182 Dec 17, 2022 U-1110
8731963 Dec 17, 2022 U-1110
8772306 Mar 15, 2033 U-1532
8859619 Dec 22, 2019 DP
SODIUM PHOSPHATE, DIBASIC, ANHYDROUS; SODIUM PHOSPHATE, MONOBASIC, MONOHYDRATE - OSMOPREP
N 021892 001 7687075 Jun 22, 2028 DS DP
SODIUM THIOSULFATE - SODIUM THIOSULFATE
N 203923 001 8496973 Mar 29, 2031 DS DP U-1419 ODE Jan 14, 2018
SOFOSBUVIR - SOVALDI
N 204671 001 7964580 Mar 26, 2029 DS DP U-1470 NCE Dec 06, 2018
8334270 Mar 21, 2028 DS DP U-1470
8580765 Mar 21, 2028 DS DP U-1470
8618076 Dec 11, 2030 DS DP U-1470
8633309 Mar 26, 2029 DS DP U-1470
8889159 Mar 26, 2029 DP U-1470
SOLIFENACIN SUCCINATE - VESICARE
N 021518 001 6017927 Nov 19, 2018 DS DP
SOLIFENACIN SUCCINATE - VESICARE
N 021518 002 6017927 Nov 19, 2018 DS DP
SOMATROPIN RECOMBINANT - SAIZEN
N 019764 002 5898030 Apr 27, 2016 DP
SOMATROPIN RECOMBINANT - SAIZEN
N 019764 003 5898030 Apr 27, 2016 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 199 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 001 5716338 Feb 10, 2015 DP
6152897 Nov 20, 2018 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 002 5716338 Feb 10, 2015 DP
6152897 Nov 20, 2018 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 003 5716338 Feb 10, 2015 DP
6152897 Nov 20, 2018 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 005 5716338 Feb 10, 2015 DP
6152897 Nov 20, 2018 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 008 5716338 Feb 10, 2015 DP
6152897 Nov 20, 2018 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 009 5716338 Feb 10, 2015 DP
6152897 Nov 20, 2018 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 010 5716338 Feb 10, 2015 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 011 5716338 Feb 10, 2015 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 012 5716338 Feb 10, 2015 DP
SOMATROPIN RECOMBINANT - GENOTROPIN PRESERVATIVE FREE
N 020280 013 5716338 Feb 10, 2015 DP
SOMATROPIN RECOMBINANT - NUTROPIN AQ
N 020522 001 5763394 Jun 09, 2015 DP
SOMATROPIN RECOMBINANT - NUTROPIN AQ PEN
N 020522 002 5763394 Jun 09, 2015 DP
SOMATROPIN RECOMBINANT - SEROSTIM
N 020604 001 5898030 Apr 27, 2016 DP
SOMATROPIN RECOMBINANT - SEROSTIM
N 020604 002 5898030 Apr 27, 2016 DP
SOMATROPIN RECOMBINANT - SEROSTIM
N 020604 003 5898030 Apr 27, 2016 DP
SOMATROPIN RECOMBINANT - SEROSTIM
N 020604 004 5898030 Apr 27, 2016 DP
SOMATROPIN RECOMBINANT - NUTROPIN DEPOT
N 021075 001 5654010 Aug 05, 2014
5656297 Jul 25, 2014
SOMATROPIN RECOMBINANT - NUTROPIN DEPOT
N 021075 002 5654010 Aug 05, 2014
5656297 Jul 25, 2014
SOMATROPIN RECOMBINANT - NUTROPIN DEPOT
N 021075 003 5654010 Aug 05, 2014
5656297 Jul 25, 2014
SOMATROPIN RECOMBINANT - NORDITROPIN
N 021148 001 5849700 Dec 15, 2015 U-340
5849704 Dec 15, 2015
SOMATROPIN RECOMBINANT - NORDITROPIN
N 021148 002 5849700 Dec 15, 2015 U-340
5849704 Dec 15, 2015
SOMATROPIN RECOMBINANT - NORDITROPIN
N 021148 003 5849700 Dec 15, 2015 U-340
5849704 Dec 15, 2015
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 200 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX
N 021148 004 5849700 Dec 15, 2015 U-340
5849704 Dec 15, 2015 DP U-340
6004297 Jan 28, 2019 DP
6235004 Jan 28, 2019 DP
RE41956 Jan 21, 2021 DP
SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX
N 021148 005 5849700 Dec 15, 2015 U-340
5849704 Dec 15, 2015 DP U-340
6004297 Jan 28, 2019 DP
6235004 Jan 28, 2019 DP
RE41956 Jan 21, 2021 DP
SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX
N 021148 006 5849700 Dec 15, 2015 U-340
5849704 Dec 15, 2015 DP U-340
6004297 Jan 28, 2019 DP
6235004 Jan 28, 2019 DP
RE41956 Jan 21, 2021 DP
SOMATROPIN RECOMBINANT - NORDITROPIN NORDIFLEX
N 021148 007 5849700 Dec 15, 2015 U-340
5849704 Dec 15, 2015 DP U-340
6004297 Jan 28, 2019 DP
8841252 Dec 26, 2017 DP
RE41956 Jan 21, 2021 DP
RE43834 Jan 28, 2019 DP
SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO
N 021148 008 5849700 Dec 15, 2015 U-1041
5849704 Dec 15, 2015 DP U-1041
6899699 Jan 02, 2022 DP
7686786 Aug 03, 2026 DP
8672898 Jan 02, 2022 DP
8684969 Oct 20, 2025 DP
8841252 Dec 26, 2017 DP
SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO
N 021148 009 5849700 Dec 15, 2015 U-1041
5849704 Dec 15, 2015 DP U-1041
6899699 Jan 02, 2022 DP
7686786 Aug 03, 2026 DP
8672898 Jan 02, 2022 DP
8684969 Oct 20, 2025 DP
8841252 Dec 26, 2017 DP
SOMATROPIN RECOMBINANT - NORDITROPIN FLEXPRO
N 021148 010 5849700 Dec 15, 2015 U-1041
5849704 Dec 15, 2015 DP U-1041
6899699 Jan 02, 2022 DP
7686786 Aug 03, 2026 DP
8672898 Jan 02, 2022 DP
8684969 Oct 20, 2025 DP
8841252 Dec 26, 2017 DP
SOMATROPIN RECOMBINANT - ZORBTIVE
N 021597 004 5898030 Apr 27, 2016 DP
SORAFENIB TOSYLATE - NEXAVAR
N 021923 001 7235576 Jan 12, 2020 DS DP I-677 Nov 22, 2016
7351834 Jan 12, 2020 DS ODE Nov 16, 2014
7897623 Jan 12, 2020 DP ODE Nov 22, 2020
8124630 Jul 13, 2022 U-1459
8618141 Feb 11, 2023 U-1480
8877933 Dec 24, 2027 DS DP U-1624
SOTALOL HYDROCHLORIDE - SOTALOL HYDROCHLORIDE
N 022306 001 ODE Jul 02, 2016
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 201 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
SPINOSAD - NATROBA
N 022408 001 6063771 Jun 22, 2019 DP U-1105 NCE Jan 18, 2016
6342482 Jun 22, 2019 DP U-1105
7030095 Jul 02, 2021 DP U-1105
STAVUDINE - ZERIT XR
N 021453 001 7135465 Feb 18, 2023 DP U-167
STAVUDINE - ZERIT XR
N 021453 002 7135465 Feb 18, 2023 DP U-167
STAVUDINE - ZERIT XR
N 021453 003 7135465 Feb 18, 2023 DP U-167
STAVUDINE - ZERIT XR
N 021453 004 7135465 Feb 18, 2023 DP U-167
SUCROFERRIC OXYHYDROXIDE - VELPHORO
N 205109 001 6174442 Dec 19, 2016 DS U-1468 NP Nov 27, 2016
SULFUR HEXAFLUORIDE LIPID-TYPE A MICROSPHERES - LUMASON
N 203684 001 NCE Oct 10, 2019
SUMATRIPTAN SUCCINATE - SUMAVEL DOSEPRO
N 022239 001 5891086 Jul 27, 2014 DP
5957886 Mar 08, 2016 DP
6135979 Mar 21, 2017 DP
6174304 Dec 13, 2015 DP
6251091 Dec 09, 2016 DP
6280410 Mar 27, 2017 DP
6681810 Dec 13, 2015 DP
7776007 Nov 22, 2026 DP
7901385 Jul 31, 2026 DP
8118771 Aug 10, 2023 DP
8241243 Aug 10, 2023 DP
8241244 Nov 21, 2022 DP
8267903 Mar 18, 2023 DP
8287489 Dec 06, 2024 DP
8343130 Oct 18, 2022 DP
8491524 Nov 21, 2022 DP
SUMATRIPTAN SUCCINATE - ALSUMA
N 022377 001 7811254 Aug 26, 2027 DP U-1083
SUMATRIPTAN SUCCINATE - ZECUITY
N 202278 001 6745071 Feb 21, 2023 DP NDF Jan 17, 2016
7973058 Apr 12, 2027 U-1328
8155737 Apr 12, 2027 U-1328
8366600 Apr 21, 2029 U-1327
8470853 Apr 12, 2027 U-1328
8597272 Apr 12, 2027 DP
SUNITINIB MALATE - SUTENT
N 021938 001 6573293 Feb 15, 2021 DS DP U-1154
7125905 Feb 15, 2021 DS DP
7211600 Dec 22, 2020 U-883
SUNITINIB MALATE - SUTENT
N 021938 002 6573293 Feb 15, 2021 DS DP U-1154
7125905 Feb 15, 2021 DS DP
7211600 Dec 22, 2020 U-883
SUNITINIB MALATE - SUTENT
N 021938 003 6573293 Feb 15, 2021 DS DP U-1154
7125905 Feb 15, 2021 DS DP
7211600 Dec 22, 2020 U-883
SUNITINIB MALATE - SUTENT
N 021938 004 6573293 Feb 15, 2021 DS DP U-1154
7125905 Feb 15, 2021 DS DP
7211600 Dec 22, 2020 U-883
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 202 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
SUVOREXANT - BELSOMRA
N 204569 001 7951797 Nov 20, 2029 DS DP U-620 NCE Aug 13, 2019
SUVOREXANT - BELSOMRA
N 204569 002 7951797 Nov 20, 2029 DS DP U-620 NCE Aug 13, 2019
SUVOREXANT - BELSOMRA
N 204569 003 7951797 Nov 20, 2029 DS DP U-620 NCE Aug 13, 2019
SUVOREXANT - BELSOMRA
N 204569 004 7951797 Nov 20, 2029 DS DP U-620 NCE Aug 13, 2019
TACROLIMUS - PROTOPIC
N 050777 001 5665727 Sep 09, 2014 U-919
TACROLIMUS - PROTOPIC
N 050777 002 5665727 Sep 09, 2014 U-919
TACROLIMUS - ASTAGRAF XL
N 204096 001 6440458 Mar 25, 2019 DP NDF Jul 19, 2016
6576259 Mar 25, 2019 DP U-1420
6884433 Mar 25, 2019 DP U-1420
8551522 Mar 25, 2019 DP
TACROLIMUS - ASTAGRAF XL
N 204096 002 6440458 Mar 25, 2019 DP NDF Jul 19, 2016
6576259 Mar 25, 2019 DP U-1420
6884433 Mar 25, 2019 DP U-1420
8551522 Mar 25, 2019 DP
TACROLIMUS - ASTAGRAF XL
N 204096 003 6440458 Mar 25, 2019 DP NDF Jul 19, 2016
6576259 Mar 25, 2019 DP U-1420
6884433 Mar 25, 2019 DP U-1420
8551522 Mar 25, 2019 DP
TADALAFIL - CIALIS
N 021368 001 5859006 Nov 21, 2017 DS DP I-641 Oct 06, 2014
6140329 Jul 11, 2016 DP U-155 I-642 Oct 06, 2014
6140329 Jul 11, 2016 DP U-1184
6821975 Nov 19, 2020 DS DP U-533
6821975 Nov 19, 2020 DS DP U-614
6821975 Nov 19, 2020 DS DP U-1184
6943166 Apr 26, 2020 U-155
6943166 Apr 26, 2020 U-614
6943166 Apr 26, 2020 U-1184
7182958 Apr 26, 2020 DP U-155
7182958 Apr 26, 2020 DP U-1184
TADALAFIL - CIALIS
N 021368 002 5859006 Nov 21, 2017 DS DP I-641 Oct 06, 2014
6140329 Jul 11, 2016 DP U-155 I-642 Oct 06, 2014
6821975 Nov 19, 2020 DS DP U-533
6821975 Nov 19, 2020 DS DP U-614
6943166 Apr 26, 2020 U-155
6943166 Apr 26, 2020 U-614
7182958 Apr 26, 2020 DP U-155
TADALAFIL - CIALIS
N 021368 003 5859006 Nov 21, 2017 DS DP I-641 Oct 06, 2014
6140329 Jul 11, 2016 DP U-155 I-642 Oct 06, 2014
6821975 Nov 19, 2020 DS DP U-533
6821975 Nov 19, 2020 DS DP U-614
6943166 Apr 26, 2020 U-614
7182958 Apr 26, 2020 DP U-155
TADALAFIL - CIALIS
N 021368 004 5859006 Nov 21, 2017 DS DP I-641 Oct 06, 2014
6140329 Jul 11, 2016 DP U-155 I-642 Oct 06, 2014
6821975 Nov 19, 2020 DS DP U-533
6821975 Nov 19, 2020 DS DP U-614
6943166 Apr 26, 2020 U-155
7182958 Apr 26, 2020 DP U-155
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 203 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
PATENT
PATENT EXCLUSIVITY
NO PATENT NO
EXPIRATION
PATENT DELIST EXCLUSIVITY EXPIRATION
DATE
CODES REQUESTED CODE(S) DATE
TADALAFIL - ADCIRCA
N 022332 001 5859006
Nov 21, 2017
DS DP U-975 ODE May 22, 2016
6821975
Nov 19, 2020
DS DP
7182958
Apr 26, 2020
DP
TAFLUPROST - ZIOPTAN
N 202514 001 5886035
Dec 18, 2017
DS DP U-778 NCE Feb 10, 2017
TALIGLUCERASE ALFA - ELELYSO
N 022458 001 8227230
Feb 24, 2024
DS DP NCE May 01, 2017
8741620
Feb 24, 2024
DS DP NPP Aug 27, 2017
8790641
Oct 18, 2025
U-1564
8790641
Oct 18, 2025
U-1574
TAMOXIFEN CITRATE - SOLTAMOX
N 021807 001 6127425
Jun 26, 2018
DP
TAPENTADOL HYDROCHLORIDE - NUCYNTA
N 022304 001 6071970 Jun 06, 2017 U-931
7994364 Jun 27, 2025 DS DP U-931
RE39593 Aug 05, 2022 DS DP U-931
TAPENTADOL HYDROCHLORIDE - NUCYNTA
N 022304 002 6071970 Jun 06, 2017
U-931
7994364 Jun 27, 2025
DS DP U-931
RE39593 Aug 05, 2022
DS DP U-931
TAPENTADOL HYDROCHLORIDE - NUCYNTA
N 022304 003 6071970 Jun 06, 2017
U-931
7994364 Jun 27, 2025
DS DP U-931
RE39593 Aug 05, 2022
DS DP U-931
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 204 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT
PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION
PATENT DELIST EXCLUSIVITY EXPIRATION
DATE
CODES REQUESTED CODE(S) DATE
TAPENTADOL HYDROCHLORIDE - NUCYNTA ER
N 200533 001 6071970 Jun 06, 2017
U-1178 I-656 Aug 28, 2015
6071970 Jun 06, 2017
U-1276 NDF Aug 25, 2014
7994364 Jun 27, 2025
DS DP U-1178
7994364 Jun 27, 2025
DS DP U-1276
8075872 Nov 20, 2023
DP
8114383 Oct 10, 2024
DP Y
8309060 Nov 20, 2023
DP U-1178
8309060 Nov 20, 2023
DP U-1276
8420056 Nov 20, 2023
DP
8536130 Sep 22, 2028
U-1276
RE39593 Aug 05, 2022
DS DP U-1178
RE39593 Aug 05, 2022
DS DP U-1276
TAPENTADOL HYDROCHLORIDE - NUCYNTA ER
N 200533 002 6071970 Jun 06, 2017
U-1178 I-656 Aug 28, 2015
6071970 Jun 06, 2017
U-1276 NDF Aug 25, 2014
7994364 Jun 27, 2025
DS DP U-1178
7994364 Jun 27, 2025
DS DP U-1276
8075872 Nov 20, 2023
DP
8114383 Oct 10, 2024
DP Y
8309060 Nov 20, 2023
DP U-1178
8309060 Nov 20, 2023
DP U-1276
8420056 Nov 20, 2023
DP
8536130 Sep 22, 2028
U-1276
RE39593 Aug 05, 2022
DS DP U-1178
RE39593 Aug 05, 2022
DS DP U-1276
TAPENTADOL HYDROCHLORIDE - NUCYNTA ER
N 200533 003 6071970 Jun 06, 2017
U-1178 I-656 Aug 28, 2015
6071970 Jun 06, 2017
U-1276 NDF Aug 25, 2014
7994364 Jun 27, 2025
DS DP U-1178
7994364 Jun 27, 2025
DS DP U-1276
8075872 Nov 20, 2023
DP
8114383 Oct 10, 2024
DP Y
8309060 Nov 20, 2023
DP U-1178
8309060 Nov 20, 2023
DP U-1276
8420056 Nov 20, 2023
DP
8536130 Sep 22, 2028
U-1276
RE39593 Aug 05, 2022
DS DP U-1178
RE39593 Aug 05, 2022
DS DP U-1276
TAPENTADOL HYDROCHLORIDE - NUCYNTA ER
N 200533 004 6071970 Jun 06, 2017
U-1178 I-656 Aug 28, 2015
6071970 Jun 06, 2017
U-1276 NDF Aug 25, 2014
7994364 Jun 27, 2025
DS DP U-1178
7994364 Jun 27, 2025
DS DP U-1276
8075872 Nov 20, 2023
DP
8114383 Oct 10, 2024
DP Y
8309060 Nov 20, 2023
DP U-1178
8309060 Nov 20, 2023
DP U-1276
8420056 Nov 20, 2023
DP
8536130 Sep 22, 2028
U-1276
RE39593 Aug 05, 2022
DS DP U-1178
RE39593 Aug 05, 2022
DS DP U-1276
TAPENTADOL HYDROCHLORIDE - NUCYNTA ER
N 200533 005 6071970 Jun 06, 2017
U-1178 I-656 Aug 28, 2015
6071970 Jun 06, 2017
U-1276 NDF Aug 25, 2014
7994364 Jun 27, 2025
DS DP U-1178
7994364 Jun 27, 2025
DS DP U-1276
8075872 Nov 20, 2023
DP
8114383 Oct 10, 2024
DP Y
8309060 Nov 20, 2023
DP U-1178
8309060 Nov 20, 2023
DP U-1276
8420056 Nov 20, 2023
DP
8536130 Sep 22, 2028
U-1276
RE39593 Aug 05, 2022
DS DP U-1178
RE39593 Aug 05, 2022
DS DP U-1276
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 205 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TAPENTADOL HYDROCHLORIDE - NUCYNTA
N 203794 001 6071970 Jun 06, 2017 U-1289
7994364 Jun 27, 2025 DS DP U-1289
RE39593 Aug 05, 2022 DS DP U-1289
TASIMELTEON - HETLIOZ
N 205677 001 5856529 Dec 09, 2017 DS DP U-1486 NCE Jan 31, 2019
8785492 Jan 25, 2033 U-1486 ODE Jan 31, 2021
TAVABOROLE - KERYDIN
N 204427 001 7582621 May 26, 2027 U-718 NCE Jul 07, 2019
7767657 May 22, 2027 DP
TAZAROTENE - FABIOR
N 202428 001 8808716 Feb 24, 2030 DP NDF May 11, 2015
TECHNETIUM TC-99M APCITIDE - ACUTECT
N 020887 001 5645815 Jul 08, 2014
TECHNETIUM TC-99M SULFUR COLLOID KIT - AN-SULFUR COLLOID
N 017858 001 ODE Aug 13, 2019
TECHNETIUM TC-99M TEBOROXIME KIT - CARDIOTEC
N 019928 001 6056941 Jul 28, 2019 DP
TECHNETIUM TC-99M TILMANOCEPT - LYMPHOSEEK KIT
N 202207 001 6409990 May 12, 2020 DS I-687 Jun 13, 2017
NCE Mar 13, 2018
ODE Jun 13, 2021
TEDIZOLID PHOSPHATE - SIVEXTRO
N 205435 001 7816379 Feb 23, 2028 DS DP U-282 NCE Jun 20, 2019
8420676 Feb 23, 2028 DS DP U-282 GAIN Jun 20, 2024
8426389 Dec 31, 2030 DS DP U-282
TEDIZOLID PHOSPHATE - SIVEXTRO
N 205436 001 7816379 Feb 23, 2028 DS DP U-282 NCE Jun 20, 2019
8420676 Feb 23, 2028 DS DP U-282 GAIN Jun 20, 2024
8426389 Dec 31, 2030 DS DP U-282
TEDUGLUTIDE RECOMBINANT - GATTEX KIT
N 203441 001 5789379 Apr 14, 2015 DS DP U-1320 NCE Dec 21, 2017
7056886 Sep 18, 2022 DP U-1320 ODE Dec 21, 2019
7847061 Nov 01, 2025 U-1320
TELAPREVIR - INCIVEK
N 201917 001 7820671 Feb 25, 2025 DS DP NCE May 23, 2016
8431615 May 30, 2028 U-1398
8529882 Aug 31, 2021 U-1398
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 206 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TELAVANCIN HYDROCHLORIDE - VIBATIV
N 022110 001 6635618 Sep 11, 2023 DS DP U-728 I-673 Jun 21, 2016
6858584 Aug 24, 2022 DP NCE Sep 11, 2014
6872701 Jun 05, 2021 DP
7008923 May 06, 2021 U-1005
7208471 May 01, 2021 DS DP
7351691 May 01, 2021 DS DP U-728
7531623 Jan 01, 2027 DS
7544364 May 01, 2021 DP
7700550 May 01, 2021 U-282
8101575 May 01, 2021 DP
8158580 May 01, 2021 DP
TELAVANCIN HYDROCHLORIDE - VIBATIV
N 022110 002 6635618 Sep 11, 2023 DS DP U-728 I-673 Jun 21, 2016
6858584 Aug 24, 2022 DP NCE Sep 11, 2014
6872701 Jun 05, 2021 DP
7008923 May 06, 2021 U-1005
7208471 May 01, 2021 DS DP
7351691 May 01, 2021 DS DP U-728
7531623 Jan 01, 2027 DS
7544364 May 01, 2021 DP
7700550 May 01, 2021 U-282
8101575 May 01, 2021 DP
8158580 May 01, 2021 DP
TELBIVUDINE - TYZEKA
N 022011 001 6395716 Aug 10, 2019 U-782 M-124 Jan 28, 2016
6444652 Aug 10, 2019 U-782
6566344 Aug 10, 2019 U-782
6569837 Oct 25, 2020 U-782
6569837 Oct 25, 2020 U-999
7589079 Sep 11, 2023 DS DP U-999
7795238 Aug 10, 2019 U-999
7858594 Sep 11, 2023 DS DP U-999
TELBIVUDINE - TYZEKA
N 022154 001 6395716 Aug 10, 2019 U-999 M-124 Jan 28, 2016
6444652 Aug 10, 2019 U-999
6566344 Aug 10, 2019 U-999
6569837 Oct 25, 2020 U-999
7795238 Aug 10, 2019 U-999
7858594 Sep 11, 2023 DS DP U-999
TELITHROMYCIN - KETEK
N 021144 001 5635485 Apr 01, 2018 DS DP U-578
D459798 Sep 24, 2015 DP
TELITHROMYCIN - KETEK
N 021144 002 5635485 Apr 01, 2018 DS DP U-578
D459798 Sep 24, 2015 DP
TELMISARTAN - TELMISARTAN
A 078710 001 PC Jul 07, 2014
TELMISARTAN - TELMISARTAN
A 078710 002 PC Jul 07, 2014
TELMISARTAN - TELMISARTAN
A 078710 003 PC Jul 07, 2014
TELMISARTAN - MICARDIS
N 020850 001 6358986 Jan 10, 2020
TELMISARTAN - MICARDIS
N 020850 002 6358986 Jan 10, 2020
7998953 Jun 06, 2020 U-1177
8003679 Oct 06, 2022 U-1176
TELMISARTAN - MICARDIS
N 020850 003 6358986 Jan 10, 2020
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 207 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TEMOZOLOMIDE - TEMODAR
N 022277 001 6987108 Sep 08, 2023 DP
7786118 Feb 21, 2023 DP
8623868 Feb 21, 2023 DP
TEMSIROLIMUS - TORISEL
N 022088 001 5362718 Feb 15, 2019 DS DP Y M-61 May 30, 2015
5362718*PED Aug 15, 2019 PED Nov 30, 2014
8026276 Jan 20, 2026 DP PED Nov 30, 2015
8299116 Jul 25, 2023 DP
8455539 Jul 25, 2023 DP
8455539*PED Jan 25, 2024
8722700 Jul 25, 2023 DP
8722700*PED Jan 25, 2024
8791097 May 10, 2032 U-1550
8791097 May 10, 2032 U-1551
RE44768 Feb 15, 2019 DS DP
RE44768*PED Aug 15, 2019
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 208 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TENOFOVIR DISOPROXIL FUMARATE - VIREAD
N 021356 001 5922695 Jul 25, 2017 DS U-248 M-128 Jul 24, 2016
5922695 Jul 25, 2017 DS U-250 NPP Jan 18, 2015
5922695 Jul 25, 2017 DS U-256 NPP Aug 16, 2015
5922695 Jul 25, 2017 DS U-999 ODE Mar 24, 2017
5922695 Jul 25, 2017 DS U-1275 PED Jul 18, 2015
5935946 Jul 25, 2017 DS DP U-248 PED Sep 24, 2017
5935946 Jul 25, 2017 DS DP U-250
5935946 Jul 25, 2017 DS DP U-256
5935946 Jul 25, 2017 DS DP U-999
5935946 Jul 25, 2017 DS DP U-1275
5977089 Jul 25, 2017 DS DP U-248
5977089 Jul 25, 2017 DS DP U-250
5977089 Jul 25, 2017 DS DP U-256
5977089 Jul 25, 2017 DS DP U-999
5977089 Jul 25, 2017 DS DP U-1275
6043230 Jul 25, 2017 U-248
6043230 Jul 25, 2017 U-250
6043230 Jul 25, 2017 U-256
6043230 Jul 25, 2017 U-999
6043230 Jul 25, 2017 U-1275
TENOFOVIR DISOPROXIL FUMARATE - VIREAD
N 021356 002 5922695 Jul 25, 2017 DS U-248 M-128 Jul 24, 2016
5922695 Jul 25, 2017 DS U-250 NPP Jan 18, 2015
5922695 Jul 25, 2017 DS U-256 NPP Aug 16, 2015
5922695 Jul 25, 2017 DS U-999 ODE Mar 24, 2017
5922695 Jul 25, 2017 DS U-1275 PED Jul 18, 2015
5935946 Jul 25, 2017 DS DP U-248 PED Sep 24, 2017
5935946 Jul 25, 2017 DS DP U-250
5935946 Jul 25, 2017 DS DP U-256
5935946 Jul 25, 2017 DS DP U-999
5935946 Jul 25, 2017 DS DP U-1275
5977089 Jul 25, 2017 DS DP U-248
5977089 Jul 25, 2017 DS DP U-250
5977089 Jul 25, 2017 DS DP U-256
5977089 Jul 25, 2017 DS DP U-999
5977089 Jul 25, 2017 DS DP U-1275
6043230 Jul 25, 2017 U-248
6043230 Jul 25, 2017 U-250
6043230 Jul 25, 2017 U-256
6043230 Jul 25, 2017 U-999
6043230 Jul 25, 2017 U-1275
TENOFOVIR DISOPROXIL FUMARATE - VIREAD
N 021356 003 5922695 Jul 25, 2017 DS U-248 M-128 Jul 24, 2016
5922695 Jul 25, 2017 DS U-250 NPP Jan 18, 2015
5922695 Jul 25, 2017 DS U-256 NPP Aug 16, 2015
5922695 Jul 25, 2017 DS U-999 ODE Mar 24, 2017
5922695 Jul 25, 2017 DS U-1275 PED Jul 18, 2015
5935946 Jul 25, 2017 DS DP U-248 PED Sep 24, 2017
5935946 Jul 25, 2017 DS DP U-250
5935946 Jul 25, 2017 DS DP U-256
5935946 Jul 25, 2017 DS DP U-999
5935946 Jul 25, 2017 DS DP U-1275
5977089 Jul 25, 2017 DS DP U-248
5977089 Jul 25, 2017 DS DP U-250
5977089 Jul 25, 2017 DS DP U-256
5977089 Jul 25, 2017 DS DP U-999
5977089 Jul 25, 2017 DS DP U-1275
6043230 Jul 25, 2017 U-248
6043230 Jul 25, 2017 U-250
6043230 Jul 25, 2017 U-256
6043230 Jul 25, 2017 U-999
6043230 Jul 25, 2017 U-1275
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 209 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TENOFOVIR DISOPROXIL FUMARATE - VIREAD
N 021356 004 5922695 Jul 25, 2017 DS U-248 M-128 Jul 24, 2016
5922695 Jul 25, 2017 DS U-250 NPP Jan 18, 2015
5922695 Jul 25, 2017 DS U-256 NPP Aug 16, 2015
5922695 Jul 25, 2017 DS U-999 ODE Mar 24, 2017
5922695 Jul 25, 2017 DS U-1275 PED Jul 18, 2015
5935946 Jul 25, 2017 DS DP U-248 PED Sep 24, 2017
5935946 Jul 25, 2017 DS DP U-250
5935946 Jul 25, 2017 DS DP U-256
5935946 Jul 25, 2017 DS DP U-999
5935946 Jul 25, 2017 DS DP U-1275
5977089 Jul 25, 2017 DS DP U-248
5977089 Jul 25, 2017 DS DP U-250
5977089 Jul 25, 2017 DS DP U-256
5977089 Jul 25, 2017 DS DP U-999
5977089 Jul 25, 2017 DS DP U-1275
6043230 Jul 25, 2017 U-248
6043230 Jul 25, 2017 U-250
6043230 Jul 25, 2017 U-256
6043230 Jul 25, 2017 U-999
6043230 Jul 25, 2017 U-1275
TENOFOVIR DISOPROXIL FUMARATE - VIREAD
N 022577 001 5922695 Jul 25, 2017 DS U-248 M-128 Jul 24, 2016
5922695 Jul 25, 2017 DS U-250 NDF Jan 18, 2015
5922695 Jul 25, 2017 DS U-256 NPP Aug 16, 2015
5922695 Jul 25, 2017 DS U-999 ODE Mar 24, 2017
5922695 Jul 25, 2017 DS U-1275 PED Jul 18, 2015
5935946 Jul 25, 2017 DS DP U-248 PED Sep 24, 2017
5935946 Jul 25, 2017 DS DP U-250
5935946 Jul 25, 2017 DS DP U-256
5935946 Jul 25, 2017 DS DP U-999
5935946 Jul 25, 2017 DS DP U-1275
5977089 Jul 25, 2017 DS DP U-248
5977089 Jul 25, 2017 DS DP U-250
5977089 Jul 25, 2017 DS DP U-256
5977089 Jul 25, 2017 DS DP U-999
5977089 Jul 25, 2017 DS DP U-1275
6043230 Jul 25, 2017 U-248
6043230 Jul 25, 2017 U-250
6043230 Jul 25, 2017 U-256
6043230 Jul 25, 2017 U-999
6043230 Jul 25, 2017 U-1275
TERBINAFINE - LAMISIL
N 020846 001 5681849 Oct 28, 2014 DP
TERBINAFINE - LAMISIL AT
N 021958 001 5681849 Oct 28, 2014 DP
TERBINAFINE HYDROCHLORIDE - LAMISIL AT
N 021124 001 5681849 Oct 28, 2014
TERBINAFINE HYDROCHLORIDE - LAMISIL AT
N 021124 002 5681849 Oct 28, 2014
TERIFLUNOMIDE - AUBAGIO
N 202992 001 5679709 Oct 21, 2014 DP U-1285 NCE Sep 12, 2017
6794410 Apr 15, 2022 U-1285
8802735 Sep 14, 2030 DP
TERIFLUNOMIDE - AUBAGIO
N 202992 002 5679709 Oct 21, 2014 DP U-1285 NCE Sep 12, 2017
6794410 Apr 15, 2022 U-1285
8802735 Sep 14, 2030 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 210 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TERIPARATIDE RECOMBINANT HUMAN - FORTEO
N 021318 001 6770623 Dec 08, 2018 DP U-597
6977077 Aug 19, 2019 U-597
7144861 Dec 08, 2018 DP
7163684 Aug 19, 2019 U-790
7351414 Aug 19, 2019 U-865
7517334 Mar 25, 2025 DP
7550434 Dec 08, 2018 DP U-982
TERIPARATIDE RECOMBINANT HUMAN - FORTEO
N 021318 002 6770623 Dec 08, 2018 DP U-982
6977077 Aug 19, 2019 U-982
6977077 Aug 19, 2019 U-994
7144861 Dec 08, 2018 DP
7163684 Aug 19, 2019 U-983
7163684 Aug 19, 2019 U-994
7351414 Aug 19, 2019 U-984
7351414 Aug 19, 2019 U-994
7517334 Mar 25, 2025 DP
7550434 Dec 08, 2018 DP U-982
TESAMORELIN ACETATE - EGRIFTA
N 022505 001 5861379 May 26, 2020 DS DP U-1100 NCE Nov 10, 2015
6020311 May 26, 2015 DS DP U-1100
7144577 Jul 14, 2020 U-1100
7316997 Aug 14, 2023 U-1100
TESAMORELIN ACETATE - EGRIFTA
N 022505 002 5861379 May 26, 2015 DS DP U-1100 NCE Nov 10, 2015
6020311 May 26, 2015 DS DP U-1100
7144577 Jul 14, 2020 U-1100
7316997 Aug 14, 2023 U-1100
TESTOSTERONE - TESTODERM
N 019762 001 5840327 Aug 15, 2016
TESTOSTERONE - TESTODERM
N 019762 002 5840327 Aug 15, 2016
TESTOSTERONE - ANDRODERM
N 020489 003 NS Oct 20, 2014
TESTOSTERONE - ANDRODERM
N 020489 004 NS Oct 20, 2014
TESTOSTERONE - TESTODERM TTS
N 020791 001 6348210 Nov 10, 2019 U-440
TESTOSTERONE - ANDROGEL
N 021015 001 6503894 Aug 30, 2020 U-490
TESTOSTERONE - ANDROGEL
N 021015 002 6503894 Aug 30, 2020 U-490
TESTOSTERONE - ANDROGEL
N 021015 003 6503894 Aug 30, 2020 U-490
TESTOSTERONE - TESTIM
N 021454 001 7320968 Jan 18, 2025 U-843
7608605 Apr 21, 2023 U-1009
7608606 Apr 21, 2023 U-1009
7608607 Apr 21, 2023 U-1009
7608608 Apr 21, 2023 U-1009
7608609 Apr 21, 2023 U-1009
7608610 Apr 21, 2023 U-1009
7935690 Apr 21, 2023 U-1009
8063029 Apr 21, 2023 U-843
8178518 Apr 21, 2023 DP
TESTOSTERONE - FORTESTA
N 021463 001 6319913 Nov 09, 2018 U-490
6579865 Nov 09, 2018 DP
TESTOSTERONE - STRIANT
N 021543 001 6248358 Aug 23, 2019 U-527
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 211 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TESTOSTERONE - ANDROGEL
N 022309 001 6503894 Aug 30, 2020 U-1103
8466136 Oct 12, 2026 DP
8466137 Oct 12, 2026 U-1103
8466138 Oct 12, 2026 U-1103
8486925 Oct 12, 2026 DP
8729057 Oct 12, 2026 DP
8741881 Oct 12, 2026 U-1103
8754070 Oct 12, 2026 DP
8759329 Oct 12, 2026 DP
TESTOSTERONE - ANDROGEL
N 022309 002 6503894 Aug 30, 2020 U-1103
8466136 Oct 12, 2026 DP
8466137 Oct 12, 2026 U-1103
8466138 Oct 12, 2026 U-1103
8486925 Oct 12, 2026 DP
8729057 Oct 12, 2026 DP
8741881 Oct 12, 2026 U-1103
8754070 Oct 12, 2026 DP
8759329 Oct 12, 2026 DP
TESTOSTERONE - ANDROGEL
N 022309 003 6503894 Aug 30, 2020 U-1103
8466136 Oct 12, 2026 DP
8466137 Oct 12, 2026 U-1103
8466138 Oct 12, 2026 U-1103
8486925 Oct 12, 2026 DP
8729057 Oct 12, 2026 DP
8741881 Oct 12, 2026 U-1103
8754070 Oct 12, 2026 DP
8759329 Oct 12, 2026 DP
TESTOSTERONE - AXIRON
N 022504 001 6299900 Feb 19, 2017 DP U-1103
6818226 Feb 19, 2017 DP U-1103
6923983 Feb 19, 2017 DP U-1103
8071075 Feb 19, 2017 DP U-1103
8419307 Feb 26, 2027 U-1386
8435944 Jul 05, 2027 U-1390
8784878 Jul 13, 2023 DP U-1545
8807861 Feb 26, 2027 DP U-1563
TESTOSTERONE - TESTOSTERONE
N 202763 001 NP Feb 14, 2015
TESTOSTERONE - TESTOSTERONE
N 203098 001 NP Jan 31, 2016
TESTOSTERONE - TESTOSTERONE
N 203098 002 NP Jan 31, 2016
TESTOSTERONE - TESTOSTERONE
N 203098 003 NP Jan 31, 2016
TESTOSTERONE - VOGELXO
N 204399 002 8785426 Feb 11, 2034 DP U-1531 NP Jun 04, 2017
TESTOSTERONE - VOGELXO
N 204399 003 8785426 Feb 11, 2034 DP U-1531 NP Jun 04, 2017
TESTOSTERONE - NATESTO
N 205488 001 8574622 Feb 04, 2024 DP NP May 28, 2017
8784869 Feb 04, 2024 DP
8784882 Feb 04, 2024 DP U-1557
8877230 Feb 04, 2024 U-1616
TESTOSTERONE UNDECANOATE - AVEED
N 022219 001 7718640 Mar 14, 2027 DP NP Mar 05, 2017
8338395 Feb 27, 2026 U-1500
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 212 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TETRABENAZINE - XENAZINE
N 021894 001 ODE Aug 15, 2015
TETRABENAZINE - XENAZINE
N 021894 002 ODE Aug 15, 2015
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 213 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
THALIDOMIDE - THALOMID
N 020785 001 6045501 Aug 28, 2018 U-371
6045501 Aug 28, 2018 U-731
6315720 Oct 23, 2020 U-442
6315720 Oct 23, 2020 U-731
6561976 Aug 28, 2018 U-371
6561976 Aug 28, 2018 U-731
6561977 Oct 23, 2020 U-371
6561977 Oct 23, 2020 U-731
6755784 Oct 23, 2020 U-371
6755784 Oct 23, 2020 U-731
6869399 Oct 23, 2020 U-371
6869399 Oct 23, 2020 U-731
6869399 Oct 23, 2020 U-732
6869399 Oct 23, 2020 U-733
6908432 Aug 28, 2018 U-371
6908432 Aug 28, 2018 U-731
7141018 Oct 23, 2020 U-371
7141018 Oct 23, 2020 U-731
7141018 Oct 23, 2020 U-732
7141018 Oct 23, 2020 U-733
7230012 Dec 09, 2023 DP
7435745 Nov 03, 2017 U-899
7874984 Aug 28, 2018 U-371
7874984 Aug 28, 2018 U-442
7874984 Aug 28, 2018 U-732
7874984 Aug 28, 2018 U-733
7874984 Aug 28, 2018 U-1109
7959566 Oct 23, 2020 U-1155
8204763 Aug 28, 2018 U-1249
8315886 Oct 23, 2020 U-1249
8589188 Aug 28, 2018 U-1465
8626531 Oct 23, 2020 U-1465
THALIDOMIDE - THALOMID
N 020785 002 6045501 Aug 28, 2018 U-371
6045501 Aug 28, 2018 U-731
6315720 Oct 23, 2020 U-442
6315720 Oct 23, 2020 U-731
6561976 Aug 28, 2018 U-371
6561976 Aug 28, 2018 U-731
6561977 Oct 23, 2020 U-371
6561977 Oct 23, 2020 U-731
6755784 Oct 23, 2020 U-371
6755784 Oct 23, 2020 U-731
6869399 Oct 23, 2020 U-371
6869399 Oct 23, 2020 U-731
6869399 Oct 23, 2020 U-732
6869399 Oct 23, 2020 U-733
6908432 Aug 28, 2018 U-371
6908432 Aug 28, 2018 U-731
7141018 Oct 23, 2020 U-371
7141018 Oct 23, 2020 U-731
7141018 Oct 23, 2020 U-732
7141018 Oct 23, 2020 U-733
7230012 Dec 09, 2023 DP
7435745 Nov 03, 2017 U-899
7874984 Aug 28, 2018 U-371
7874984 Aug 28, 2018 U-442
7874984 Aug 28, 2018 U-732
7874984 Aug 28, 2018 U-733
7874984 Aug 28, 2018 U-1109
7959566 Oct 23, 2020 U-1155
8204763 Aug 28, 2018 U-1249
8315886 Oct 23, 2020 U-1249
8589188 Aug 28, 2018 U-1465
8626531 Oct 23, 2020 U-1465
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 214 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
THALIDOMIDE - THALOMID
N 020785 003 6045501 Aug 28, 2018 U-371
6045501 Aug 28, 2018 U-731
6315720 Oct 23, 2020 U-442
6315720 Oct 23, 2020 U-731
6561976 Aug 28, 2018 U-371
6561976 Aug 28, 2018 U-731
6561977 Oct 23, 2020 U-371
6561977 Oct 23, 2020 U-731
6755784 Oct 23, 2020 U-371
6755784 Oct 23, 2020 U-731
6869399 Oct 23, 2020 U-371
6869399 Oct 23, 2020 U-731
6869399 Oct 23, 2020 U-732
6869399 Oct 23, 2020 U-733
6908432 Aug 28, 2018 U-371
6908432 Aug 28, 2018 U-731
7141018 Oct 23, 2020 U-371
7141018 Oct 23, 2020 U-731
7141018 Oct 23, 2020 U-732
7141018 Oct 23, 2020 U-733
7230012 Dec 09, 2023 DP
7435745 Nov 03, 2017 U-899
7874984 Aug 28, 2018 U-371
7874984 Aug 28, 2018 U-442
7874984 Aug 28, 2018 U-732
7874984 Aug 28, 2018 U-733
7874984 Aug 28, 2018 U-1109
7959566 Oct 23, 2020 U-1155
8204763 Aug 28, 2018 U-1249
8315886 Oct 23, 2020 U-1249
8589188 Aug 28, 2018 U-1465
8626531 Oct 23, 2020 U-1465
THALIDOMIDE - THALOMID
N 020785 004 6045501 Aug 28, 2018 U-731
6315720 Oct 23, 2020 U-731
6561976 Aug 28, 2018 U-731
6561977 Oct 23, 2020 U-731
6755784 Oct 23, 2020 U-731
6869399 Oct 23, 2020 U-731
6908432 Aug 28, 2018 U-731
7141018 Oct 23, 2020 U-731
7435745 Nov 03, 2017 U-899
7874984 Aug 28, 2018 U-371
7874984 Aug 28, 2018 U-442
7874984 Aug 28, 2018 U-732
7874984 Aug 28, 2018 U-733
7874984 Aug 28, 2018 U-1109
7959566 Oct 23, 2020 U-1155
8204763 Aug 28, 2018 U-1249
8315886 Oct 23, 2020 U-1249
8589188 Aug 28, 2018 U-1465
8626531 Oct 23, 2020 U-1465
THYROTROPIN ALFA - THYROGEN
N 020898 001 5840566 Nov 24, 2015 ODE Dec 14, 2014
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 215 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT
PATENT
EXCLUSIVITY
NO PATENT NO EXPIRATION
PATENT DELIST
EXCLUSIVITY EXPIRATION
DATE
CODES REQUESTED
CODE(S) DATE
TIAGABINE HYDROCHLORIDE - GABITRIL
N 020646 001 5866590 Apr 29, 2016
5958951 Jun 10, 2017
TIAGABINE HYDROCHLORIDE - GABITRIL
N 020646 002 5866590 Apr 29, 2016
5958951 Jun 10, 2017
TIAGABINE HYDROCHLORIDE - GABITRIL
N 020646 003 5866590 Apr 29, 2016
5958951 Jun 10, 2017
TIAGABINE HYDROCHLORIDE - GABITRIL
N 020646 004 5866590 Apr 29, 2016
5958951 Jun 10, 2017
TIAGABINE HYDROCHLORIDE - GABITRIL
N 020646 005 5866590 Apr 29, 2016
5958951 Jun 10, 2017
TICAGRELOR - BRILINTA
N 022433 001 6251910 Jul 15, 2018
DS
NCE Jul 20, 2016
6525060 Dec 02, 2019
DS DP U-1171
7250419 Dec 02, 2019
DS DP U-1171
7265124 Jul 09, 2021
DS DP U-1171
8425934 Apr 17, 2030
DP
TIGECYCLINE - TYGACIL
N 021821 001 7879828 Feb 05, 2029
DP
8372995 Oct 08, 2030
DP
RE40183 Apr 09, 2016
DS DP
TIMOLOL MALEATE - TIMOLOL MALEATE
N 020963 001 6174524 Mar 26, 2019
DP
TIMOLOL MALEATE - TIMOLOL MALEATE
N 020963 002 6174524
Mar 26, 2019
DP
TIMOLOL MALEATE - ISTALOL
N 021516 001 6335335
Nov 02, 2018
DP
6645963
Nov 16, 2018
DP
TIOTROPIUM BROMIDE - SPIRIVA
N 021395 001 6777423
Sep 24, 2021
DS DP
6908928
Sep 24, 2021
DS DP U-566
6908928
Sep 24, 2021
DS DP U-762
7070800
Jan 22, 2022
DP U-566
7309707
Sep 24, 2021
DS DP
7642268
Sep 24, 2021
DS DP
7694676
Mar 12, 2027
DP
8022082
Jan 19, 2026
DP U-1186
RE38912
Oct 11, 2021
DP
RE39820
Jan 30, 2018
DS DP U-566
TIOTROPIUM BROMIDE - SPIRIVA RESPIMAT
N 021936 001 5964416 Oct 04, 2016 DP
NP Sep 24, 2017
6149054 Dec 16, 2016 DP
6176242 May 31, 2016 DP
6453795 Dec 05, 2016 DP
6726124 Oct 04, 2016 DP
6846413 Aug 28, 2018 DP
6977042 Aug 28, 2018 DP
6988496 Feb 23, 2020 DP
7104470 Oct 04, 2016 DP
7246615 May 31, 2016 DP
7284474 Aug 26, 2024 DP
7396341 Oct 10, 2026 DP
7802568 Feb 26, 2019 DP
7837235 Mar 13, 2028 DP
7896264 May 26, 2025 DP
7988001 Aug 04, 2021 DP
RE39820 Jan 30, 2018 DS DP U-1593
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 216 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TIPRANAVIR - APTIVUS
N 021814 001 5852195 Jun 22, 2019 DS
6147095 Oct 29, 2019 U-670
6231887 Jul 27, 2018 DP
TIPRANAVIR - APTIVUS
N 022292 001 5852195 Jun 22, 2019 DS
6147095 Oct 29, 2019 U-670
TIROFIBAN HYDROCHLORIDE - AGGRASTAT
N 020912 001 5733919 Oct 23, 2016
5965581 Oct 23, 2016
5972967 Oct 23, 2016
5978698 Oct 08, 2017
6136794 Jan 29, 2019
6770660 May 01, 2023
TIROFIBAN HYDROCHLORIDE - AGGRASTAT
N 020913 001 5733919 Oct 23, 2016
5965581 Oct 23, 2016
5972967 Oct 23, 2016
5978698 Oct 08, 2017
6136794 Jan 29, 2019
6770660 Jun 01, 2023
TIROFIBAN HYDROCHLORIDE - AGGRASTAT
N 020913 002 5733919 Oct 23, 2016
5965581 Oct 23, 2016
5972967 Oct 23, 2016
5978698 Oct 08, 2017
6136794 Jan 29, 2019
6770660 Jun 01, 2023
TIROFIBAN HYDROCHLORIDE - AGGRASTAT
N 020913 003 5733919 Oct 23, 2016
5965581 Oct 23, 2016
5972967 Oct 23, 2016
5978698 Oct 08, 2017
6136794 Jan 29, 2019
6770660 Jun 01, 2023
TOBRAMYCIN - TOBI
N 050753 001 5508269 Oct 19, 2014 DP U-909
TOBRAMYCIN - TOBI PODHALER
N 201688 001 7097827 Apr 16, 2016 DP NP Mar 22, 2016
7368102 Dec 19, 2022 DP U-909
7442388 May 10, 2020 DP
7516741 Jan 11, 2024 DP
7559325 Oct 27, 2025 DP
8069851 Sep 24, 2024 DP
8349294 May 10, 2020 DP
8715623 Dec 19, 2022 DP U-909
TOBRAMYCIN - BETHKIS
N 201820 001 6987094 Sep 22, 2022 DP
7696178 Mar 17, 2023 DP
7939502 Jun 14, 2022 U-1324
TOFACITINIB CITRATE - XELJANZ
N 203214 001 6956041 Dec 08, 2020 DP M-135 Feb 21, 2017
6965027 Mar 25, 2023 DS NCE Nov 06, 2017
7091208 Dec 08, 2020 U-247
7265221 Dec 08, 2020 DS
7301023 May 23, 2022 DS
RE41783 Dec 08, 2020 DS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 217 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TOLTERODINE TARTRATE - DETROL LA
N 021228 001 6630162 Nov 11, 2019 DP U-544
6770295 Aug 26, 2019 DP U-544
6911217 Nov 11, 2019 DP U-544
6911217*PED May 11, 2020
TOLTERODINE TARTRATE - DETROL LA
N 021228 002 6630162 Nov 11, 2019 DP U-544
6770295 Aug 26, 2019 DP U-544
6911217 Nov 11, 2019 DP U-544
6911217*PED May 11, 2020
TOLVAPTAN - SAMSCA
N 022275 001 5753677 May 19, 2020 U-978
8501730 Sep 01, 2026 DS
TOLVAPTAN - SAMSCA
N 022275 002 5753677 May 19, 2020 U-978
8501730 Sep 01, 2026 DS
TOLVAPTAN - SAMSCA
N 022275 003 5753677 May 19, 2020 U-978
8501730 Sep 01, 2026 DS
TOPIRAMATE - TOPAMAX
N 020505 001 5998380 Oct 13, 2015 U-598 NPP Jul 15, 2014
6503884 Oct 13, 2015 U-598 NPP Mar 28, 2017
7018983 Oct 13, 2015 U-723
7498311 Oct 13, 2015 U-955
TOPIRAMATE - TOPAMAX
N 020505 002 5998380 Oct 13, 2015 U-598 NPP Jul 15, 2014
6503884 Oct 13, 2015 U-598 NPP Mar 28, 2017
7018983 Oct 13, 2015 U-723
7498311 Oct 13, 2015 U-955
TOPIRAMATE - TOPAMAX
N 020505 003 5998380 Oct 13, 2015 U-598 NPP Mar 28, 2017
6503884 Oct 13, 2015 U-598
7018983 Oct 13, 2015 U-723
7498311 Oct 13, 2015 U-955
TOPIRAMATE - TOPAMAX
N 020505 004 5998380 Oct 13, 2015 U-598 NPP Jul 15, 2014
6503884 Oct 13, 2015 U-598 NPP Mar 28, 2017
7018983 Oct 13, 2015 U-723
7498311 Oct 13, 2015 U-955
TOPIRAMATE - TOPAMAX
N 020505 005 5998380 Oct 13, 2015 U-598 NPP Jul 15, 2014
6503884 Oct 13, 2015 U-598 NPP Mar 28, 2017
7018983 Oct 13, 2015 U-723
7498311 Oct 13, 2015 U-955
TOPIRAMATE - TOPAMAX
N 020505 006 5998380 Oct 13, 2015 U-598 NPP Mar 28, 2017
6503884 Oct 13, 2015 U-598
7018983 Oct 13, 2015 U-723
7498311 Oct 13, 2015 U-955
TOPIRAMATE - TOPAMAX
N 020844 001 5998380 Oct 13, 2015 U-598 NPP Jul 15, 2014
6503884 Oct 13, 2015 U-598 NPP Mar 28, 2017
7018983 Oct 13, 2015 U-723
7125560 Mar 01, 2019 U-766
7498311 Oct 13, 2015 U-955
TOPIRAMATE - TOPAMAX
N 020844 002 5998380 Oct 13, 2015 U-598 NPP Jul 15, 2014
6503884 Oct 13, 2015 U-598 NPP Mar 28, 2017
7018983 Oct 13, 2015 U-723
7125560 Mar 01, 2019 U-766
7498311 Oct 13, 2015 U-955
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 218 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TOPIRAMATE - TOPAMAX SPRINKLE
N 020844 003 5998380 Oct 13, 2015 U-598 NPP Mar 28, 2017
6503884 Oct 13, 2015 U-598
7018983 Oct 13, 2015 U-723
7125560 Mar 01, 2019 U-766
7498311 Oct 13, 2015 U-955
TOPIRAMATE - TROKENDI XR
N 201635 001 8298576 Mar 18, 2029 DP U-106
8298580 Nov 16, 2027 DP U-106
8663683 Nov 16, 2027 DP U-106
8877248 Nov 16, 2027 DP U-106
8889191 Nov 16, 2027 U-106
TOPIRAMATE - TROKENDI XR
N 201635 002 8298576 Mar 18, 2029 DP U-106
8298580 Nov 16, 2027 DP U-106
8663683 Nov 16, 2027 DP U-106
8877248 Nov 16, 2027 DP U-106
8889191 Nov 16, 2027 U-106
TOPIRAMATE - TROKENDI XR
N 201635 003 8298576 Mar 18, 2029 DP U-106
8298580 Nov 16, 2027 DP U-106
8663683 Nov 16, 2027 DP U-106
8877248 Nov 16, 2027 DP U-106
8889191 Nov 16, 2027 U-106
TOPIRAMATE - TROKENDI XR
N 201635 004 8298576 Mar 18, 2029 DP U-106
8298580 Nov 16, 2027 DP U-106
8663683 Nov 16, 2027 DP U-106
8877248 Nov 16, 2027 DP U-106
8889191 Nov 16, 2027 U-106
TOPIRAMATE - QUDEXY XR
N 205122 001 8652527 Mar 19, 2033 DP
8889190 Mar 19, 2033 DP
TOPIRAMATE - QUDEXY XR
N 205122 002 8652527 Mar 19, 2033 DP
8889190 Mar 19, 2033 DP
TOPIRAMATE - QUDEXY XR
N 205122 003 8652527 Mar 19, 2033 DP
8889190 Mar 19, 2033 DP
TOPIRAMATE - QUDEXY XR
N 205122 004 8652527 Mar 19, 2033 DP
8889190 Mar 19, 2033 DP
TOPIRAMATE - QUDEXY XR
N 205122 005 8652527 Mar 19, 2033 DP
8889190 Mar 19, 2033 DP
TOPOTECAN HYDROCHLORIDE - HYCAMTIN
N 020671 001 5674872 Oct 07, 2014 U-910
TOPOTECAN HYDROCHLORIDE - HYCAMTIN
N 020981 001 8158645 Dec 10, 2024 DP
TOPOTECAN HYDROCHLORIDE - HYCAMTIN
N 020981 002 8158645 Dec 10, 2024 DP
TRAMADOL HYDROCHLORIDE - ULTRAM
N 020281 001 6339105 Oct 12, 2019 U-435
TRAMADOL HYDROCHLORIDE - ULTRAM
N 020281 002 6339105 Oct 12, 2019 U-435
TRAMADOL HYDROCHLORIDE - RYBIX ODT
N 021693 001 6106861 Dec 05, 2017 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 219 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TRAMADOL HYDROCHLORIDE - RYZOLT
N 021745 001 6607748 Jun 29, 2020 DP
7988998 Oct 27, 2023 DP
TRAMADOL HYDROCHLORIDE - RYZOLT
N 021745 002 6607748 Jun 29, 2020 DP
7988998 Oct 27, 2023 DP
TRAMADOL HYDROCHLORIDE - RYZOLT
N 021745 003 6607748 Jun 29, 2020 DP
7988998 Oct 27, 2023 DP
TRAMADOL HYDROCHLORIDE - CONZIP
N 022370 001 7858118 Apr 11, 2022 DP U-1104
TRAMADOL HYDROCHLORIDE - CONZIP
N 022370 002 7858118 Apr 11, 2022 DP U-1104
TRAMADOL HYDROCHLORIDE - CONZIP
N 022370 003 7858118 Apr 11, 2022 DP U-1104
TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST
N 204114 001 7378423 Sep 13, 2025 DS DP I-678 Jan 08, 2017
8580304 Jan 28, 2032 DP NCE May 29, 2018
8835443 Sep 13, 2025 U-1581 ODE May 29, 2020
8835443 Sep 13, 2025 U-1582 ODE Jan 08, 2021
TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST
N 204114 002 7378423 Sep 13, 2025 DS DP I-678 Jan 08, 2017
8580304 Jan 28, 2032 DP NCE May 29, 2018
8835443 Sep 13, 2025 U-1581 ODE May 29, 2020
8835443 Sep 13, 2025 U-1582 ODE Jan 08, 2021
TRAMETINIB DIMETHYL SULFOXIDE - MEKINIST
N 204114 003 7378423 Sep 13, 2025 DS DP I-678 Jan 08, 2017
8580304 Jan 28, 2032 DP NCE May 29, 2018
8835443 Sep 13, 2025 U-1581 ODE May 29, 2020
8835443 Sep 13, 2025 U-1582 ODE Jan 08, 2021
TRANDOLAPRIL - MAVIK
N 020528 001 5744496 Apr 28, 2015 U-229
TRANDOLAPRIL - MAVIK
N 020528 002 5744496 Apr 28, 2015 U-229
TRANDOLAPRIL - MAVIK
N 020528 003 5744496 Apr 28, 2015 U-229
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA
N 020591 001 5721244 Feb 24, 2015
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA
N 020591 002 5721244 Feb 24, 2015
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA
N 020591 003 5721244 Feb 24, 2015
TRANDOLAPRIL; VERAPAMIL HYDROCHLORIDE - TARKA
N 020591 004 5721244 Feb 24, 2015
TRANEXAMIC ACID - LYSTEDA
N 022430 001 7947739 Mar 04, 2025 DP
8022106 Mar 04, 2025 U-1182
8273795 Mar 04, 2025 U-1182
8487005 Mar 04, 2025 DP U-1182
8791160 Mar 04, 2025 DP U-1182
8809394 Mar 04, 2025 DP U-1182
TRAVOPROST - TRAVATAN
N 021257 001 5631287 Dec 22, 2014 U-382
5849792 Dec 22, 2014 DP U-383
5889052 Dec 02, 2014 DP U-383
6011062 Dec 22, 2014 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 220 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TRAVOPROST - TRAVATAN Z
N 021994 001 5889052 Dec 02, 2014 DP U-383
8268299 Oct 13, 2029 DP
8323630 Sep 20, 2027 DP
8388941 Sep 20, 2027 DP
TRAVOPROST - IZBA
N 204822 001 8722735 Oct 10, 2029 DP NP May 15, 2017
8754123 May 19, 2029 DP
TRAZODONE HYDROCHLORIDE - OLEPTRO
N 022411 001 6607748 Jun 29, 2020 DP
7829120 Mar 27, 2027 DP U-796
8133893 Mar 13, 2029 DS DP
TRAZODONE HYDROCHLORIDE - OLEPTRO
N 022411 002 6607748 Jun 29, 2020 DP
7829120 Mar 27, 2027 DP U-796
8133893 Mar 13, 2029 DS DP
TREPROSTINIL - REMODULIN
N 021272 001 5153222 Oct 06, 2014 U-455
6765117 Oct 24, 2017 DS
7999007 Mar 29, 2029 DP U-1437
8497393 Dec 15, 2028 DS
8653137 Sep 05, 2028 U-1437
8658694 Sep 05, 2028 U-1437
TREPROSTINIL - REMODULIN
N 021272 002 5153222 Oct 06, 2014 U-455
6765117 Oct 24, 2017 DS
7999007 Mar 29, 2029 DP U-1437
8497393 Dec 15, 2028 DS
8653137 Sep 05, 2028 U-1437
8658694 Sep 05, 2028 U-1437
TREPROSTINIL - REMODULIN
N 021272 003 5153222 Oct 06, 2014 U-455
6765117 Oct 24, 2017 DS
7999007 Mar 29, 2029 DP U-1437
8497393 Dec 15, 2028 DS
8653137 Sep 05, 2028 U-1437
8658694 Sep 05, 2028 U-1437
TREPROSTINIL - REMODULIN
N 021272 004 5153222 Oct 06, 2014 U-455
6765117 Oct 24, 2017 DS
7999007 Mar 29, 2029 DP U-1437
8497393 Dec 15, 2028 DS
8653137 Sep 05, 2028 U-1437
8658694 Sep 05, 2028 U-1437
TREPROSTINIL - TYVASO
N 022387 001 5153222 Oct 16, 2014 U-1019 M-145 May 20, 2017
6521212 Nov 13, 2018 U-1018 ODE Jul 30, 2016
6756033 Nov 13, 2018 U-1018
6765117 Oct 24, 2017 DS
8497393 Dec 15, 2028 DS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 221 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TREPROSTINIL DIOLAMINE - ORENITRAM
N 203496 001 5153222 Oct 16, 2014 U-1475 NDF Dec 20, 2016
6765117 Oct 24, 2017 DS
7417070 Aug 30, 2026 DS
7544713 Jul 14, 2024 U-1475
8252839 May 24, 2024 DP
8349892 Jan 22, 2031 DP
8410169 Feb 13, 2030 DP
8497393 Dec 15, 2028 DS
8747897 Oct 08, 2029 DP
TREPROSTINIL DIOLAMINE - ORENITRAM
N 203496 002 5153222 Oct 16, 2014 U-1475 NDF Dec 20, 2016
6765117 Oct 24, 2017 DS
7417070 Aug 30, 2026 DS
7544713 Jul 14, 2024
8252839 May 24, 2024 DP
8349892 Jan 22, 2031 DP
8410169 Feb 13, 2030 DP
8497393 Dec 15, 2028 DS
8747897 Oct 08, 2029 DP
TREPROSTINIL DIOLAMINE - ORENITRAM
N 203496 003 5153222 Oct 16, 2014 U-1475 NDF Dec 20, 2016
6765117 Oct 24, 2017 DS
7417070 Aug 30, 2026 DS
7544713 Jul 14, 2024
8252839 May 24, 2024 DP
8349892 Jan 22, 2031 DP
8410169 Feb 13, 2030 DP
8497393 Dec 15, 2028 DS
8747897 Oct 08, 2029 DP
TREPROSTINIL DIOLAMINE - ORENITRAM
N 203496 004 5153222 Oct 16, 2014 U-1475 NDF Dec 20, 2016
6765117 Oct 24, 2017 DS
7417070 Aug 30, 2026 DS
7544713 Jul 14, 2024
8252839 May 24, 2024 DP
8349892 Jan 22, 2031 DP
8410169 Feb 13, 2030 DP
8497393 Dec 15, 2028 DS
8747897 Oct 08, 2029 DP
TRETINOIN - RETIN-A MICRO
N 020475 001 5955109 Sep 21, 2016 DP U-134
TRETINOIN - RETIN-A MICRO
N 020475 002 5955109 Sep 21, 2016 U-134
TRETINOIN - RENOVA
N 021108 001 6531141 Mar 07, 2020
TRETINOIN - ATRALIN
N 022070 001 5670547 Sep 23, 2014 DP
TRIAMCINOLONE ACETONIDE - NASACORT ALLERGY 24 HOUR
N 020468 002 5976573 Jul 03, 2016 DP
6143329 Jul 03, 2016 DP
7977045 Jul 03, 2016 DP
TRIAMCINOLONE ACETONIDE - TRIESENCE
N 022048 001 6395294 Jan 13, 2020 DP U-846
8128960 Dec 17, 2029 DP
8211880 Mar 10, 2029 U-1257
8211880 Mar 10, 2029 U-1258
TRIMETHOPRIM HYDROCHLORIDE - PRIMSOL
N 074973 001 5763449 Aug 07, 2016
5962461 Aug 07, 2016
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 222 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
TRIMETREXATE GLUCURONATE - NEUTREXIN
N 020326 001 6017922 May 18, 2018
TRIMETREXATE GLUCURONATE - NEUTREXIN
N 020326 002 6017922 May 18, 2018
TRIPTORELIN PAMOATE - TRELSTAR
N 020715 001 5776885 Jul 07, 2015
TRIPTORELIN PAMOATE - TRELSTAR
N 021288 001 5776885 Jul 07, 2015 DP
TRIPTORELIN PAMOATE - TRELSTAR
N 022437 001 5776885 Jul 07, 2015 DP
TROGLITAZONE - PRELAY
N 020719 001 5859037 Nov 13, 2017 U-251
6011049 Nov 13, 2017 U-301
TROGLITAZONE - PRELAY
N 020719 002 5859037 Nov 13, 2017 U-251
6011049 Nov 13, 2017 U-301
TROGLITAZONE - PRELAY
N 020719 003 5859037 Nov 13, 2017 U-251
6011049 Nov 13, 2017 U-301
TROGLITAZONE - REZULIN
N 020720 001 5859037 Nov 13, 2017 U-251
6011049 Nov 13, 2017 U-301
TROGLITAZONE - REZULIN
N 020720 002 5859037 Nov 13, 2017 U-251
6011049 Nov 13, 2017 U-301
TROGLITAZONE - REZULIN
N 020720 003 5859037 Nov 13, 2017 U-251
6011049 Nov 13, 2017 U-301
TROSPIUM CHLORIDE - SANCTURA XR
N 022103 001 7410978 Feb 01, 2025 DP
7759359 Nov 04, 2024 U-1071
7763635 Nov 04, 2024 U-1071
7781448 Nov 04, 2024 U-1071
7781449 Nov 04, 2024 U-1071
TROVAFLOXACIN MESYLATE - TROVAN
N 020759 001 5763454 Jun 15, 2015 U-282
6187341 Jan 20, 2019
TROVAFLOXACIN MESYLATE - TROVAN
N 020759 002 5763454 Jun 15, 2015 U-282
6187341 Jan 20, 2019
TRYPAN BLUE - MEMBRANEBLUE
N 022278 001 ODE Feb 20, 2016
ULIPRISTAL ACETATE - ELLA
N 022474 001 8426392 Jun 12, 2030 U-1389 NCE Aug 13, 2015
8512745 Feb 14, 2030 DP
8735380 Feb 20, 2029 DP
UMECLIDINIUM BROMIDE - INCRUSE ELLIPTA
N 205382 001 5873360 Feb 23, 2016 DP
7488827 Apr 27, 2025 DS DP
7498440 Apr 27, 2025 DS DP
8113199 Oct 23, 2027 DP
8161968 Feb 05, 2028 DP
8183257 Jul 27, 2025 U-1476
8201556 Feb 05, 2029 DP
8309572 Apr 27, 2025 U-1476
8534281 Aug 10, 2029 DP
8746242 Oct 11, 2030 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 223 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
UMECLIDINIUM BROMIDE; VILANTEROL TRIFENATATE - ANORO ELLIPTA
N 203975 001 5873360 Feb 23, 2016 DP NP Dec 18, 2016
7439393 Sep 11, 2022 DS DP U-1476
7488827 Apr 27, 2025 DS DP
7498440 Apr 27, 2025 DS DP
7776895 Sep 11, 2022 DP
8113199 Oct 23, 2027 DP
8161968 Feb 05, 2028 DP
8183257 Jul 27, 2025 U-1476
8309572 Apr 27, 2025 U-1476
8511304 Nov 11, 2025 DP U-1476
8534281 Aug 10, 2029 DP
8746242 Oct 11, 2030 DP
RE44874 Mar 23, 2023 DS DP U-1476
UNOPROSTONE ISOPROPYL - RESCULA
N 021214 001 6458836 Jul 09, 2021 U-333
6458836 Jul 09, 2021 U-1315
6770675 Nov 24, 2018 DP U-1322
UROFOLLITROPIN - FERTINEX
N 019415 004 5767067 Jun 16, 2015
UROFOLLITROPIN - FERTINEX
N 019415 005 5767067 Jun 16, 2015
UROFOLLITROPIN - BRAVELLE
N 021289 001 D-139 Feb 19, 2017
VALACYCLOVIR HYDROCHLORIDE - VALTREX
N 020487 001 5879706 Jan 19, 2016 DP U-530
5879706 Jan 19, 2016 DP U-894
6107302 Jan 19, 2016 DS U-530
6107302 Jan 19, 2016 DS U-894
VALACYCLOVIR HYDROCHLORIDE - VALTREX
N 020487 002 5879706 Jan 19, 2016 DP U-530
5879706 Jan 19, 2016 DP U-894
6107302 Jan 19, 2016 DS U-530
6107302 Jan 19, 2016 DS U-894
VALDECOXIB - BEXTRA
N 021341 002 5633272 Feb 13, 2015 U-462
VALDECOXIB - BEXTRA
N 021341 003 5633272 Feb 13, 2015 U-462
VALGANCICLOVIR HYDROCHLORIDE - VALCYTE
N 021304 001 6083953 Mar 29, 2015 DS DP U-384
6083953 Mar 29, 2015 DS DP U-854
VALGANCICLOVIR HYDROCHLORIDE - VALCYTE
N 022257 001 6083953 Mar 29, 2015 DS DP U-384
6083953 Mar 29, 2015 DS DP U-854
6083953*PED Sep 29, 2015
VALSARTAN - VALSARTAN
A 077492 001 PC Jan 03, 2015
VALSARTAN - VALSARTAN
A 077492 002 PC Jan 03, 2015
VALSARTAN - VALSARTAN
A 077492 003 PC Jan 03, 2015
VALSARTAN - VALSARTAN
A 077492 004 PC Jan 03, 2015
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 224 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
VALSARTAN - DIOVAN
N 021283 001 5972990 Oct 26, 2016 U-692
6294197 Jun 18, 2017 U-3
VALSARTAN - DIOVAN
N 021283 002 5972990 Oct 26, 2016 U-692
6294197 Jun 18, 2017 U-3
VALSARTAN - DIOVAN
N 021283 003 5972990 Oct 26, 2016 U-692
6294197 Jun 18, 2017 U-3
VALSARTAN - DIOVAN
N 021283 004 5972990 Oct 26, 2016 U-692
6294197 Jun 18, 2017 U-3
VANDETANIB - CAPRELSA
N 022405 001 7173038 Aug 14, 2021 DS DP NCE Apr 06, 2016
8067427 Aug 08, 2028 DP ODE Apr 06, 2018
8642608 Feb 06, 2022 U-1490
RE42353 Sep 23, 2017 DS DP
VANDETANIB - CAPRELSA
N 022405 002 7173038 Aug 14, 2021 DS DP NCE Apr 06, 2016
8067427 Aug 08, 2028 DP ODE Apr 06, 2018
8642608 Feb 06, 2022 U-1490
RE42353 Sep 23, 2017 DS DP
VARDENAFIL HYDROCHLORIDE - LEVITRA
N 021400 001 6362178 Oct 31, 2018 DS DP U-533
7696206 Oct 31, 2018 DS DP U-533
8273876 Jul 23, 2027 U-1288
8841446 Jul 03, 2023 DP
VARDENAFIL HYDROCHLORIDE - LEVITRA
N 021400 002 6362178 Oct 31, 2018 DS DP U-533
7696206 Oct 31, 2018 DS DP U-533
8273876 Jul 23, 2027 U-1288
8841446 Jul 03, 2023 DP
VARDENAFIL HYDROCHLORIDE - LEVITRA
N 021400 003 6362178 Oct 31, 2018 DS DP U-533
7696206 Oct 31, 2018 DS DP U-533
8273876 Jul 23, 2027 U-1288
8841446 Jul 03, 2023 DP
VARDENAFIL HYDROCHLORIDE - LEVITRA
N 021400 004 6362178 Oct 31, 2018 DS DP U-533
7696206 Oct 31, 2018 DS DP U-533
8273876 Jul 23, 2027 U-1288
8841446 Jul 03, 2023 DP
VARDENAFIL HYDROCHLORIDE - STAXYN
N 200179 001 6362178 Oct 31, 2018 U-155
7696206 Oct 31, 2018 U-155
8613950 Dec 23, 2028 DP
VARENICLINE TARTRATE - CHANTIX
N 021928 001 6410550 May 10, 2020 DS DP U-56 M-105 Jul 22, 2014
6890927 May 06, 2022 DS DP U-56 M-143 Oct 15, 2017
7265119 Aug 03, 2022 DS DP U-56 M-144 Oct 15, 2017
VARENICLINE TARTRATE - CHANTIX
N 021928 002 6410550 May 10, 2020 DS DP U-56 M-105 Jul 22, 2014
6890927 May 06, 2022 DS DP U-56 M-143 Oct 15, 2017
7265119 Aug 03, 2022 DS DP U-56 M-144 Oct 15, 2017
VELAGLUCERASE ALFA - VPRIV
N 022575 001 M-130 Nov 21, 2016
NCE Feb 26, 2015
VELAGLUCERASE ALFA - VPRIV
N 022575 002 M-130 Nov 21, 2016
NCE Feb 26, 2015
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 225 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
VEMURAFENIB - ZELBORAF
N 202429 001 7504509 Oct 22, 2026 DS DP NCE Aug 17, 2016
7863288 Jun 20, 2029 DS DP ODE Aug 17, 2018
8143271 Jun 21, 2026 DS DP
8470818 Aug 02, 2026 U-1418
8741920 Jul 27, 2030 DS DP
VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR
N 020699 001 6274171 Mar 20, 2017
6403120 Mar 20, 2017 U-451
6403120 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-459
6419958 Mar 20, 2017 U-535
VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR
N 020699 002 6274171 Mar 20, 2017
6403120 Mar 20, 2017 U-451
6403120 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-459
6419958 Mar 20, 2017 U-535
VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR
N 020699 003 6274171 Mar 20, 2017
6403120 Mar 20, 2017 U-451
6403120 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-459
6419958 Mar 20, 2017 U-535
VENLAFAXINE HYDROCHLORIDE - EFFEXOR XR
N 020699 004 6274171 Mar 20, 2017
6403120 Mar 20, 2017 U-451
6403120 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-459
6419958 Mar 20, 2017 U-535
VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE
N 022104 001 6403120 Mar 20, 2017 U-535
6403120 Mar 20, 2017 U-839
6419958 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-839
VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE
N 022104 002 6403120 Mar 20, 2017 U-535
6403120 Mar 20, 2017 U-839
6419958 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-839
VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE
N 022104 003 6403120 Mar 20, 2017 U-535
6403120 Mar 20, 2017 U-839
6419958 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-839
VENLAFAXINE HYDROCHLORIDE - VENLAFAXINE HYDROCHLORIDE
N 022104 004 6403120 Mar 20, 2017 U-535
6403120 Mar 20, 2017 U-839
6419958 Mar 20, 2017 U-535
6419958 Mar 20, 2017 U-839
VERAPAMIL HYDROCHLORIDE - COVERA-HS
N 020552 001 6096339 Apr 04, 2017 U-365
VERAPAMIL HYDROCHLORIDE - COVERA-HS
N 020552 002 6096339 Apr 04, 2017 U-365
VERTEPORFIN - VISUDYNE
N 021119 001 5707608 Aug 02, 2015
5756541 Mar 11, 2016 U-357
5770619 Jan 06, 2015 U-357
5798349 Aug 25, 2015 U-357
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 226 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
VIGABATRIN - SABRIL
N 020427 001 NCE Aug 21, 2014
NPP Oct 26, 2016
PED Feb 21, 2015
PED Apr 26, 2017
VIGABATRIN - SABRIL
N 022006 001 NCE Aug 21, 2014
NPP Oct 26, 2016
ODE Aug 21, 2016
PED Feb 21, 2015
PED Feb 21, 2017
PED Apr 26, 2017
VILAZODONE HYDROCHLORIDE - VIIBRYD
N 022567 001 5532241 Sep 29, 2019 DS DP NCE Jan 21, 2016
7834020 Jun 05, 2022 DS DP U-839
8193195 Jun 05, 2022 U-839
8236804 Jun 05, 2022 U-839
8673921 Jun 05, 2022 DS DP
VILAZODONE HYDROCHLORIDE - VIIBRYD
N 022567 002 5532241 Sep 29, 2019 DS DP NCE Jan 21, 2016
7834020 Jun 05, 2022 DS DP U-839
8193195 Jun 05, 2022 U-839
8236804 Jun 05, 2022 U-839
8673921 Jun 05, 2022 DS DP
VILAZODONE HYDROCHLORIDE - VIIBRYD
N 022567 003 5532241 Sep 29, 2019 DS DP NCE Jan 21, 2016
7834020 Jun 05, 2022 DS DP U-839
8193195 Jun 05, 2022 U-839
8236804 Jun 05, 2022 U-839
8673921 Jun 05, 2022 DS DP
VINCRISTINE SULFATE - MARQIBO KIT
N 202497 001 6723338 Mar 31, 2020 U-1271 NP Aug 09, 2015
7247316 Sep 25, 2020 DP ODE Aug 09, 2019
7887836 Mar 31, 2020 U-1271
VISMODEGIB - ERIVEDGE
N 203388 001 7888364 Nov 11, 2028 DS DP NCE Jan 30, 2017
VORAPAXAR SULFATE - ZONTIVITY
N 204886 001 7235567 Jun 13, 2021 DS DP NCE May 08, 2019
7304078 Apr 06, 2024 DS DP U-1512
VORICONAZOLE - VFEND
N 021266 001 5567817 May 24, 2016 DS DP U-540
VORICONAZOLE - VFEND
N 021266 002 5567817 May 24, 2016 DS DP U-540
VORICONAZOLE - VFEND
N 021267 001 5567817 May 24, 2016 DS DP U-540
6632803 Jun 02, 2018 DP
VORICONAZOLE - VFEND
N 021630 001 5567817 May 24, 2016 DS DP U-540
VORINOSTAT - ZOLINZA
N 021991 001 7399787 Feb 09, 2025 U-892
7456219 Mar 11, 2027 DS
7652069 Mar 04, 2023 DP
7732490 Mar 04, 2023 U-892
7851509 Feb 21, 2024 DP U-892
8067472 Mar 04, 2023 U-892
8093295 May 16, 2026 DP
8101663 Mar 04, 2023 U-892
8450372 Mar 18, 2028 U-892
RE38506 Jul 07, 2015 DS DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 227 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
VORTIOXETINE HYDROBROMIDE - BRINTELLIX
N 204447 001 7144884 Jan 09, 2023 DS DP U-1439 NCE Sep 30, 2018
8476279 Oct 02, 2022 DP U-1439
8722684 Nov 11, 2030 DS DP
VORTIOXETINE HYDROBROMIDE - BRINTELLIX
N 204447 002 7144884 Jan 09, 2023 DS DP U-1439 NCE Sep 30, 2018
8476279 Oct 02, 2022 DP U-1439
8722684 Nov 11, 2030 DS DP
VORTIOXETINE HYDROBROMIDE - BRINTELLIX
N 204447 003 7144884 Jan 09, 2023 DS DP U-1439 NCE Sep 30, 2018
8476279 Oct 02, 2022 DP U-1439
8722684 Nov 11, 2030 DS DP
VORTIOXETINE HYDROBROMIDE - BRINTELLIX
N 204447 004 7144884 Jan 09, 2023 DS DP U-1439 NCE Sep 30, 2018
8476279 Oct 02, 2022 DP U-1439
8722684 Nov 11, 2030 DS DP
ZANAMIVIR - RELENZA
N 021036 001 5648379 Jul 15, 2014 U-274
5648379 Jul 15, 2014 U-721
5648379 Jul 15, 2014 U-722
6294572 Dec 15, 2014 DS DP
ZICONOTIDE ACETATE - PRIALT
N 021060 001 5364842 Dec 30, 2016 U-48
5364842 Dec 30, 2016 U-55
5795864 Jun 27, 2015 DP
8653033 Oct 01, 2024 U-48
8653033 Oct 01, 2024 U-55
8765680 Oct 01, 2024 U-48
8765680 Oct 01, 2024 U-55
ZICONOTIDE ACETATE - PRIALT
N 021060 002 5364842 Dec 30, 2016 U-48
5364842 Dec 30, 2016 U-55
5795864 Jun 27, 2015 DP
8653033 Oct 01, 2024 U-48
8653033 Oct 01, 2024 U-55
8765680 Oct 01, 2024 U-48
8765680 Oct 01, 2024 U-55
ZICONOTIDE ACETATE - PRIALT
N 021060 003 5364842 Dec 30, 2016 U-48
5364842 Dec 30, 2016 U-55
5795864 Jun 27, 2015 DP
8653033 Oct 01, 2024 U-48
8653033 Oct 01, 2024 U-55
8765680 Oct 01, 2024 U-48
8765680 Oct 01, 2024 U-55
ZICONOTIDE ACETATE - PRIALT
N 021060 004 5364842 Dec 30, 2016 U-48
5364842 Dec 30, 2016 U-55
5795864 Jun 27, 2015 DP
8653033 Oct 01, 2024 U-48
8653033 Oct 01, 2024 U-55
8765680 Oct 01, 2024 U-48
8765680 Oct 01, 2024 U-55
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 228 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD PATENT PATENT EXCLUSIVITY
NO PATENT NO EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ZIPRASIDONE HYDROCHLORIDE - GEODON
N 020825 001 6150366 May 27, 2019 DP
6245766 Dec 18, 2018 U-601
ZIPRASIDONE HYDROCHLORIDE - GEODON
N 020825 002 6150366 May 27, 2019 DP
6245766 Dec 18, 2018 U-601
ZIPRASIDONE HYDROCHLORIDE - GEODON
N 020825 003 6150366 May 27, 2019 DP
6245766 Dec 18, 2018 U-601
ZIPRASIDONE HYDROCHLORIDE - GEODON
N 020825 004 6150366 May 27, 2019 DP
6245766 Dec 18, 2018 U-601
ZIPRASIDONE HYDROCHLORIDE - GEODON
N 021483 001 6150366 May 27, 2019 DP U-719
6245766 Dec 18, 2018 U-601
7175855 May 18, 2020 DP
ZIPRASIDONE MESYLATE - GEODON
N 020919 001 6110918 Mar 26, 2017
6232304 Apr 01, 2017
6399777 Apr 01, 2017
ZOLEDRONIC ACID - ZOMETA
N 021223 002 8324189 May 29, 2025 U-53
8324189 May 29, 2025 U-1308
8324189 May 29, 2025 U-1309
ZOLEDRONIC ACID - ZOMETA
N 021223 003 7932241 Feb 05, 2028 DP
8324189 May 29, 2025 U-53
8324189 May 29, 2025 U-1308
8324189 May 29, 2025 U-1309
ZOLEDRONIC ACID - RECLAST
N 021817 001 7932241 Feb 05, 2028 DP
8052987 Oct 27, 2023 U-1199
ZOLMITRIPTAN - ZOMIG
N 021450 003 6750237 Nov 28, 2020 DP
6750237*PED May 28, 2021
7220767 Nov 28, 2020 DP
7220767*PED May 28, 2021
ZOLMITRIPTAN - ZOMIG
N 021450 004 6750237 Nov 28, 2020 DP
7220767 Nov 28, 2020 DP
ZOLPIDEM TARTRATE - AMBIEN CR
N 021774 001 6514531 Dec 01, 2019 DP
ZOLPIDEM TARTRATE - AMBIEN CR
N 021774 002 6514531 Dec 01, 2019 DP
ZOLPIDEM TARTRATE - EDLUAR
N 021997 001 6761910 Sep 24, 2019 DP U-674
8512747 Sep 24, 2019 U-674
ZOLPIDEM TARTRATE - EDLUAR
N 021997 002 6761910 Sep 24, 2019 DP U-674
8512747 Sep 24, 2019 U-674
ZOLPIDEM TARTRATE - ZOLPIMIST
N 022196 001 7632517 Oct 01, 2017 U-70
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST ADA 229 of 229
PRESCRIPTION AND OTC DRUG PRODUCT PATENT AND EXCLUSIVITY LIST
See report footnote for information regarding report content
APPL/PROD
PATENT PATENT EXCLUSIVITY
NO PATENT NO
EXPIRATION PATENT DELIST EXCLUSIVITY EXPIRATION
DATE CODES REQUESTED CODE(S) DATE
ZOLPIDEM TARTRATE - INTERMEZZO
N 022328 001 7658945
Apr 15, 2027 DP U-1194 NP Nov 23, 2014
7682628
Feb 16, 2025 U-1194
8242131
Aug 20, 2029 U-1266
8252809
Feb 16, 2025 DP
ZOLPIDEM TARTRATE - INTERMEZZO
N 022328 002 7658945
Apr 15, 2027 DP U-1194 NP Nov 23, 2014
7682628
Feb 16, 2025 U-1194
8242131
Aug 20, 2029 U-1266
8252809
Feb 16, 2025 DP
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 1 of 67
PATENT & EXCLUSIVITY ABBREVIATIONS
D NEW DOSING SCHEDULE (SEE INDIVIDUAL REFERENCES)
I NEW INDICATION (SEE INDIVIDUAL REFERENCES)
M MISCELLANEOUS EXCLUSIVITY CODES (SEE INDIVIDUAL REFERENCES)
NC NEW COMBINATION
NCE NEW CHEMICAL ENTITY
NCE* NEW CHEMICAL ENTITY (AN ENANTIOMER OF PREVIOUSLY APPROVED RACEMIC MIXTURE. SEE
SECTION 505(U) OF THE FEDERAL FOOD AND DRUG COSMETIC ACT).
NDF NEW DOSAGE FORM
NE NEW ESTER OR SALT OF AN ACTIVE INGREDIENT
NP NEW PRODUCT
NP* NEW PRODUCT (MINT FLAVORED)
NPP NEW PATIENT POPULATION
NR NEW ROUTE
NS NEW STRENGTH
ODE ORPHAN DRUG EXCLUSIVITY
PC PATENT CHALLENGE
PED PEDIATRIC EXCLUSIVITY
RTO RX TO OTC SWITCH OR OTC USE
RTO* OTC USE FOR WOMEN AGES 15 AND 16
RTO** OTC USE FOR WOMEN 14 AND BELOW
U PATENT USE CODE
W EXCLUSIVITY ON THIS APPLICATION EXPIRING ON THIS DATE HAS BEEN WAIVED BY SPONSOR
- SEE SECTION 1.8 OF ORANGE BOOK PREFACE WAIVED EXCLUSIVITY
EXCLUSIVITY DOSING SCHEDULE
D-1 ONCE A DAY APPLICATION
D-2 ONCE DAILY DOSING
D-3 SEVEN DAYS/SEVEN DAYS/SEVEN DAYS DOSING SCHEDULE
D-4 SEVEN DAYS/FOURTEEN DAYS DOSING SCHEDULE
D-5 TEN DAYS/ELEVEN DAYS DOSING SCHEDULE
D-6 SEVEN DAYS/NINE DAYS/FIVE DAYS DOSING SCHEDULE
D-7 BID DOSING
D-8 INTRAVENOUS, EPIDURAL AND INTRATHECAL DOSING
D-9 NARCOTIC OVERDOSE IN ADULTS
D-10 NARCOTIC OVERDOSE IN CHILDREN
D-11 POSTOPERATIVE NARCOTIC DEPRESSION IN CHILDREN
D-12 BEDTIME DOSING OF 800MG FOR TREATMENT OF ACTIVE DUODENAL ULCER
D-13 INCREASED MAXIMUM DAILY DOSAGE RECOMMENDATION
D-14 BEDTIME DOSING OF 800MG FOR TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
D-15 SINGLE DAILY DOSE OF 25MG/37.5MG
D-16 CONTINUOUS INTRAVENOUS INFUSION
D-17 400MG EVERY 12 HOURS FOR THREE DAYS FOR UNCOMPLICATED URINARY TRACT INFECTIONS
D-18 LOWER RECOMMENDED STARTING DOSE GUIDELINES
D-19 BOLUS DOSING GUIDELINES
D-20 SINGLE 32MG DOSE
D-21 ALTERNATIVE DOSAGE OF 300MG ONCE DAILY AFTER THE EVENING MEAL
D-22 REDUCTION IN INFUSION TIME FROM 24 TO 4 HOURS FOR THE 60MG DOSE
D-23 INCREASE MAXIMUM DOSE AND VARIATIONS IN THE DOSING REGIMEN
D-24 FOR OVARIAN CANCER THE RECOMMENDED REGIMEN IS 135MG/M2 OR 175MG/M2 INTRAVENOUSLY
OVER THREE HOURS EVERY THREE WEEKS
D-25 ADDITIONAL DOSAGE REGIMEN EQUAL TO HALF THE ORIGINAL DOSING REGIMEN
D-26 ONCE WEEKLY APPLICATION
D-27 BID DOSING IN PATIENTS 12 YEARS OF AGE AND OLDER FOR PREVENTION OF NAUSEA AND
VOMITING ASSOCIATED WITH MODERATE EMETOGENIC CANCER CHEMOTHERAPY
D-28 USE OF ISOVUE-370 IN EXCRETORY UROGRAPHY AT EQUIVALENT GRAMS OF IODINE TO THE
CURRENTLY APPROVED ISOVUE-250 AND ISOVUE-300
D-29 INCREASE OF CUMULATIVE DOSE TO 0.3MMOL/KG FOR MRI OF CNS IN ADULTS
D-30 5000 IU DOSE FOR PHOPHYLAXIX AGAINST DEEP VEIN THROMBOSIS
D-31 CHANGE IN RECOMMENDED TOTAL DAILY DOSE TO 80MG (40MG BID)
D-32 REMOVAL OF THE RESTRICTIONS LIMITING TREATMENT TO TWO CONSECUTIVE WEEKS AND TO
SMALL AREAS
D-33 ONCE DAILY DOSING FOR PLAQUE PSORIASIS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 2 of 67
EXCLUSIVITY DOSING SCHEDULE
D-34 EVERY FOUR MONTHS DOSAGE REGIMEN
D-35 FOR A ONE WEEK DOSING OF INTERDIGITAL TINEA PEDIS
D-36 FOR A SINGLE 2MG DOSE AS AN ALTERNATIVE TO THE 1MG DOSE GIVEN TWICE DAILY
D-37 DOSING REGIMEN FOR ADMINISTRATION EITHER ONCE DAILY (QD) OR TWICE DAILY (BID)
D-38 CONTINUOUS INFUSION AS AN ALTERNATE METHOD OF ADMINISTRATION
D-39 CHANGE IN TIME TO TAKE THE DRUG PRIOR TO A MEAL TO PREVENT MEAL-INDUCED HEARTBURN
SYMPTOMS FROM "..1/2 TO 1 HOUR BEFORE EATING" TO ".. RIGHT BEFORE EATING OR UP TO
60MIN BEFORE CONSUMING..."
D-40 ONCE-A-DAY DOSING REGIMEN
D-41 DRUG MAY BE DOSED RIGHT BEFORE A MEAL OR ANY TIME UP TO 30MIN BEFORE EATING OR
DRINKING FOOD AND BEVERAGES THAT WOULD BE EXPECTED TO CAUSE SYMPTOMS
D-42 TEN DAY DOSING REGIMEN FOR TRIPLE THERAPY, PREVACID IN COMBINATION WITH
CLARITHROMYCIN AND AMOXICILLIN, FOR THE ERADICATION OF H.PYLORI IN PATIENTS WITH
DUODENAL ULCER DISEASE
D-43 INITIATION OF TREATMENT WITH 900MG/DAY BY DELETION OF THE REQUIREMENT TO TITRATE
TO 900MG/DAY OVER A 3-DAY PERIOD
D-44 IN A CLINICAL TRIAL, FEWER DISCONTINUATIONS DUE TO ADVERSE EVENTS, ESPECIALLY
DIZZINESS AND VERTIGO, WERE OBSERVED WHEN TITRATING THE DOSE IN INCREMENTS OF
50MG/DAY EVERY 3 DAYS UNTIL AN EFFECTIVE DOSE (NOT EXCEEDING 400MG/DAY) WAS
REACHED
D-45 ONCE DAILY DOSING FOR MAINTENANCE ONLY
D-46 NEW DOSING REGIMEN OF 80MG DAILY
D-47 PREVENTION OF HEARTBURN SYMPTOMS WHEN ADMINISTERED FROM 15 MINUTES UP TO, BUT NOT
INCLUDING, 1 HOUR PRIOR TO A PROVOCATIVE MEAL
D-48 ADIMISTRATION OF CISATRICURIUM A NEUROMUSCULAR BLOCKING AGENT AT DOSES OF 3 AND 4X
THE ED95 OF CISATRICURIUM FOLLOWING INDUCTION WITH THIOPENTAL
D-49 PEDIATRIC DOSING GUIDELINES
D-50 INFORMATION FOR USE OF CORVERT IN POST-CARDIAC SURGERY PATIENTS
D-51 OPTIONAL STARTING DOSE OF 40MG/DAY
D-52 ALTERNATE DOSING REGIMEN OF 1250MG TWICE DAILY
D-53 USE IN PEDIATRIC PATIENTS FROM 1 MONTH TO 16 YEARS OF AGE
D-54 USE OF ZYBAN FOR MAINTENANCE THERAPY. TREATMENT UP TO 6 MONTHS WAS SHOWN
EFFICACIOUS
D-55 ADDITION OF A HIGHER DOSE OF NUTROPIN FOR PUBERTAL PATIENTS (PUBERTAL DOSE LESS
THAN OR EQUAL TO 0.7MG/KG/WEEK)
D-56 ADDITION OF POSTPRANDIAL DOSING
D-57 3-HOUR INFUSION OF TAXOL GIVEN EVERY THREE WEEKS AT A DOSE OF 175MG/M2 FOLLOWED BY
CISPLATIN AT A DOSE OF 75MG/M2 FOR THE FIRST-LINE TREATMENT OF ADVANCED OVARIAN
CANCER
D-58 CHANGE IN DOSING INTERVAL TO ONCE-DAILY ADMINISTRATION
D-59 REDUCTION OF ELEVATED LDL-C IN A NEW, HIGHER STRENGTH TABLET, 0.8MG, AND FOR
EXTENSION OF THE DOSAGE RANGE TO 0.8MG DAILY
D-60 ADDITION OF A POST-OPERATIVE DOSING REGIMEN
D-61 ONCE WEEKLY DOSING FOR THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
D-62 ONCE WEEKLY DOSING FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
D-63 TO ALLOW A TITRATION DOSING REGIMEN USING A 25MG DOSE
D-64 INCREASING DOSAGE FOR NERVE BLOCK ANESTHESIA USING NAROPIN 7.5MG/ML AND FOR
EXTENDING THE DURATION OF TREATMENT FOR POSTOPERATIVE ANALGESIA USING NAROPIN
2MG/ML
D-65 CHANGE DOSING AND ADMINISTRATION TO INDICATE MAINTENANCE OF WEIGHT LOSS OVER AN 18
MONTH PERIOD THUS EXTENDING THE USE OF THIS DRUG FROM ONE TO TWO YEARS
D-66 DOSING RECOMMENDATIONS FOR PATIENTS UNDERGOING PCI
D-67 SHORTER TREATMENT COURSE OF THREE DAYS IN THE TREATMENT OF RECURRENT EPISODES OF
GENITAL HERPES
D-68 CHANGE OF ADMIN RATE FOR INFUSION OF AREDIA FOR TREATMENT OF MODERATE AND SEVERE
HYPERCALCEMIA OF MALIGNANCY FROM 24 HOURS TO 2 HOURS UP TO BUT NOT INCLUDING 24
HOURS
D-69 SHORTENED DOSING REGIMEN TO 5 DAYS FOR THE TREATMENT OF ACUTE EXACERBATION OF
CHRONIC BRONCHITIS
D-70 80MG ONCE DAILY DOSING REGIMEN
D-71 EIGHT WEEK DOSING REGIMEN
D-72 INFORMATION REGARDING INCREASED RATE OF INFUSION FOR DEPACON
D-73 ONCE A WEEK DOSING FOR THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
D-74 ONCE A WEEK DOSING FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
D-75 INTERMITTENT DOSING REGIMEN, STARTING DAILY DOSE 14 DAYS PRIOR TO THE ANTICIPATED
ONSET OF MENSTRUATION THROUGH THE FIRST FULL DAY OF MENSES AND REPEATING WITH EACH
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 3 of 67
EXCLUSIVITY DOSING SCHEDULE
NEW CYCLE
D-76 FOR USE ON AN "AS NEEDED" OR PRN BASIS FOR THE MANAGEMENT OF NASAL SYMPTOMS IN
PATIENTS FOR WHOM THE DRUG IS INDICATED
D-77 ADDITION OF 20MG AND 40MG DAILY AS OPTIONAL STARTING DOSES WITH 40MG INTENDED FOR
PATIENTS WHO REQUIRE A LARGE REDUCTION IN LDL-C (MORE THAN 45%)
D-78 USE OF FLEXERIL 5MG FOR THE RELIEF OF MUSCLE SPASM ASSOCIATED WITH ACUTE, PAINFUL,
MUSCULOSKELETAL CONDITIONS
D-79 NEW LOWER STARTING DOSE FOR TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS
AND/OR MODERATE TO SEVERE SYMPTOMS OF VULVAR AND VAGINAL ATROPHY ASSOCIATED W/ THE
MENOPAUSE
D-80 CHANGE OF DOSING SCHEDULE FOR LANTUS FROM ONCE DAILY AT BEDTIME TO FLEXIBLE DAILY
DOSING
D-81 NEW LOWER STARTING DOSE FOR THE PREVENTION OF POSTMENOPAUSAL OSTEOPORSIS
D-82 USE OF PREMARIN 0.3 MG AND 0.45 MG FOR THE PREVENTION OF POSTMENOPAUSAL
OSTEOPOROSIS
D-83 750 MG, ONCE DAILY FOR 5 DAYS FOR COMMUNITY ACQUIRED PNEUMONIA (CAP)
D-84 ONCE-A-DAY DOSING OF FLOXACIN OTIC FOR THE TREATMENT OF ADULTS AND PEDIATRIC
PATIENTS(AGES 6 MO & OLDER) W/ OTITIS EXTERNA CAUSED BY SUSCEPTIBLE STRAINS OF
E.COLI, P.AERUGINOSA AND S.AUREUS
D-85 LOWER RECOMMENDED STARTING DOSE GUIDELINES FOR TREATMENT OF MODERATE TO SEVERE
VASOMOTOR SYMPTOMS ASSOCIATED WITH THE MENOPAUSE
D-86 FOR USE IN SELECT EXTERNAL INSULIN PUMPS
D-87 ADDITION OF ONCE-WEEKLY DOSING FOR THE TREATMENT TO INCREASE BONE MASS IN MEN WITH
OSTEOPOROSIS
D-88 NEW DOSING RANGE OF 200-400MG PER DAY IN TWO DIVIDED DOSES FOR ADULTS WITH PARTIAL
SEIZURES
D-89 USE OF REYATAZ 300 MG/RITONAVIR 100 MG ONCE DAILY FOR TREATMENT IN HIV-INFECTED
ANTIRETROVIRAL-EXPERIENCED PATIENTS
D-90 ADDITION OF DAYTIME ADMINISTRATION TO TREAT VULVOVAGINAL CANDIDIASIS
D-91 ALTERNATE INTERMITTENT DOSING REGIMEN
D-92 ALTERNATIVE DOSAGE OF 1000MG ONCE DAILY AT BEDTIME
D-93 ALTERNATE TWO OR THREE TIMES DAILY DOSING REGIMENS
D-94 NEW MAXIMUM DOSAGE OF 72 MG/DAY IN ADOLESCENTS 13-17 YEARS OF AGE WITH ATTENTION
DEFECIT HYPERACTIVITY DISORDER (ADHD)
D-95 BROADENED INITIAL STARTING DOSE FOR HYPERTENSION FROM 50 MG TO 100 MG TO 25 MG TO
100 MG DOSE RANGE
D-96 ONCE-MONTHLY TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS WITH BONIVA (IBANDRONATE
SODIUM) 150 MG TABLETS
D-97 PED CANCER PT POPULATION EXPANDED TO INCLUDE PTS 6 MOS UP TO BUT NOT INCLUDING 4
YRS AND DOSING INSTRUCTIONS TO ADMIN 30 MIN BEFPRE CHEMO WITH SECOND AND THIRD
DOSES 4 & 8 HOURS AFTER FIRST DOSE
D-98 DOSING FOR PED SURGICAL PTS EXPANDED TO INCLUDE PTS 1 MONTH UP TO BUT NOT
INCLUDING 2 YEARS OF AGE
D-99 ONCE DAILY ADMINISTRATION FOR THE TREATMENT OF HIV INFECTION IN THERAPY NAIVE
ADULT PATIENTS
D-100 750 MG ONCE DAILY FOR FIVE DAYS FOR THE TREATMENT OF ACUTE BACTERIAL SINUSITIS
D-101 ONCE DAILY IN CHRONIC IDIOPATHIC UTICARIA FOR ADULTS AND CHILDREN 12 YEARS OF AGE
AND OLDER
D-102 NEW DOSING REGIMEN OF ONE SPRAY TWICE DAILY FOR SEASONAL ALLERIC RHINITIS IN
PATIENTS 12 YRS OF AGE AND OLDER
D-103 NEW DOSING RECOMMENDATION FOR THE TREATMENT OF RECURRENT GENITAL HERPES IN
IMMUNOCOMPETENT PATIENTS, SPECIFICALLY A REDUCTION IN COURSE OF THERAPY FROM
FAMCICLOVIR 125 MG TWICE-A-DAY FOR 5 DAYS TO 1000 MG TWICE-A-DAY FOR 1 DAY.
D-104 0.5MG/0.1MG FOR THE TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED
WITH MENOPAUSE IN WOMEN WHO HAVE A UTERUS
D-105 USE OF ACTONEL 75MG TWO CONSECUTIVE DAYS PER MONTH FOR THE PREVENTION AND
TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
D-106 FIVE DAY TREATMENT OF SELECTED SUSCEPTIBLE STRAINS OF STREPTOCOCCUS PNEUMONIAE,
HAEMOPHILUS INFLUENZA, MYCOPLASMA PNEUMONIAE, AND CHLAMYDIA PNEUMONIAE FOR
COMMUNITY-ACQUIRED PNEUMONIA
D-107 PROVIDES FOR THE COMBINATION TABLET OF 70MG ALENDRONATE AND 5600 IU OF VITAMIN D3
FOR THE TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN AND TO INCREASE BONE
MASS IN MEN WITH OSTEOPOROSIS
D-108 TREATMENT OF COMPLICATED URINARY TRACT INFECTION AND ACUTE PYELONEPHRITIS WITH
LEVAQUIN 750MG ONCE DAILY FOR FIVE DAYS
D-109 PROVIDE FOR THE USE OF A LOWER DOSE FOR THE TREATMENT OF ADULTS WITH CHRONIC PHASE
CHRONIC MYELOID LEUKEMIA (CML) WITH RESISTANCE OR INTOLERANCE TO PRIOR THERAPY
INCLUDING IMATINIB MESYLATE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 4 of 67
EXCLUSIVITY DOSING SCHEDULE
D-110 TREATMENT OF SCHIZOPHRENIA IN ADOLESCENTS AGED 13-17
D-111 PROVIDES FOR ONCE DAILY USE OF CIALIS, 2.5 MG AND 5 MG, FOR THE TREAMTENT OF
ERECTILE DYSFUNCTION
D-112 PROVIDES FOR PEDIATRIC PUMP USE
D-113 ONCE DAILY DOSING REGIMEN FOR PATIENTS WHO BECOME CONSTIPATED ON TWICE DAILY
REGIMEN
D-114 NEW DOSING RECOMMENDATIONS FOR USE OF SIROLIMUS IN COMBINATION WITH CYCLOSPORINE
FOR THE PROPHYLAXIS OF REJECTION IN HIGH-RISK RENAL TRANSPLANT RECIPIENTS
D-115 STARTING DOSE OF 15MG/DAY FOR MONOTHERAPY IN ACUTE TREATMENT OF BIPOLAR DISORDER,
MANIC OR MIXED
D-116 ALTERNATIVE DOSING REGIMEN ATAZANAVIR SULATE CO-ADMINISTERED WITH RITONAVIR FOR
THE TREATMENT OF HIV-1 INFECTION IN TREATMENT NAIVE PATIENTS
D-117 50 MG TABLET FOR INITIATION OF DOSE TITRATION FOR BIPOLAR DISORDER
D-118 TWO 400MG TABLETS ONCE DAILY, CO-ADMINISTERED WITH 100MG RITONAVIR
D-119 DOSING RECOMMENDATIONS FOR HIV INFECTED PEDIATRIC PATIENTS 6 TO LESS THAN 18 YEARS
OF AGE
D-120 DOSING REGIMEN ADJUSTMENTS
D-121 CHANGE TO REMOVE 20 MG MAXIMUM DOSAGE RESTRICTION
D-122 USE OF VAGIFEM 10 MCG FOR THE TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE
D-123 ALTERNATIVE DOSING REGIMEN DOSE OF 20 MG/METER SQUARE BY CONTINUOUS INTRAVENOUS
INFUSION OVER 1 HOUR REPEATED DAILY FOR 5 DAYS
D-124 ONCE DAILY DOSING REGIMEN IN ADULT PATIENTS WITH LESS THAN THREE LOPINAVIR
RESISTANCE-ASSOCIATED SUBSTITUTIONS
D-125 EXTEND CURRENT DOSING REGIMEN TO 900MG (2-450MG TABLETS) ONCE A DAY WITHIN 10 DAYS
OF TRANSPLANTATION UNTIL 200 DAYS POST-TRANSPLANTATION FOR THE PREVENTION OF
CYTOMEGALOVIRUS (CMV) DISEASE IN ADULT KIDNEY TRANSPLANT PATIENTS AT HIGH RISK.
D-126 CHANGE DOSAGE REGIMEN FROM 250MG TO 500MG
D-127 DOSING REGIMEN FOR ADULT PATIENTS WITH CHRONIC HEPATITIS B (CHB) AND DECOMPENSATED
LIVER DESEASE
D-128 SINGLE IV DOSE OF FOSAPREPITANT 150MG, DOSED CONCOMITANTLY WITH 5HT3 RECEPTOR
ANTAGONIST & CORTICOSTEROID, FOR PREVENTION OF ACUTE & DELAYED NAUSEA & VOMITING
ASSOCIATED WITH INITIAL AND REPEAT COURSES OF HIGHLY EMETOGENIC CANCER CHEMO
D-129 800/100 MG DARUNAVIR/RITONAVIR, ONCE DAILY, IN TREATMENT -EXPERIENCED HIV-1
INFECTED PATIENTS WITH NO DARUNIVIR RESISTANCE ASSOCIATED SUBSITUTIONS
D-130 DOSING RECOMMENDATIONS FOR TREATMENT OF HIV-1 INFECTION DURING PREGNANCY BASED ON
DATA FROM STUDY AI424-182, A STUDY OF ATAZANAVIR/RITONAVIR IN COMBINATION WITH
ZIDOVUDINE/LAMIVUDINE IN HIV INFECTED PREGNANT WOMEN
D-131 EVERY 6 TO 8 WEEKS FOR THE 120MG STRENGTH FOR PATIENTS WHO ARE CONTROLLED ON
SOMATULINE DEPOT 60MG OR 90MG
D-132 45MG FOR 6 MONTH ADMINISTRATION
D-133 NEW EFFICACY DATA AND DOSING REGIMEN FOR PREGNANCY IN NORMAL OVULATORY WOMEN
UNDERGOING CONTROLLED OVARIAN STIMULATION AS PART OF AN IVF OR INTRACYTOPLASMIC
SPERM INJECTION (ICSI) CYCLE
D-134 INCREASING MAXIMUM DOSING OF PATIENTS WITH SCHIZOPHRENIA TO 160 MG/DAY
D-135 UPDATE LABELING WITH ONCE DAILY DOSING IN HIV-1 INFECTED, TREATMENT-NAIVE
PEDIATRIC PATIENTS 12 TO LESS THAN 18 YEARS OF AGE
D-136 ALTERNATE DOSING REGIMEN FOR UNCOMPLICATED URETHRAL OR ENDOCERVICAL INFECTION
CAUSED BY CHLAMYDIA TRACHOMATIS, ADMINISTER 200 MG BY MOUTH ONCE-A-DAY FOR 7 DAYS
D-137 NEW LOWER DOSING REGIMEN FOR REVATIO IN THE TREATMENT OF PULMONARY ARTERIAL
HYPERTENSION (WHO GROUP 1) IN ADULTS
D-138 80 MG DOSING REGIMEN FOR THE RISK REDUCTION OF REBLEEDING OF GASTRIC AND DUODENAL
ULCERS IN THE FIRST 72 HOURS FOLLOWING THERAPEUTIC ENDOSCOPY IN ADULTS
D-139 Additional information added to the Dosing and Administration section of the
labeling regarding the administration of Bravelle and Menopur in the same syringe
to ovulatory women as part of an ART cycle
D-140 REVISED DOSING SCHEDULE TO ADMINISTER AVANAFIL 15 MINUTES PRIOR TO SEXUAL ACTIVITY
D-141 DOSING INFORMATION IN PREVIOUSLY UNTREATED MANTLE CELL LYMPHOMA
D-142 DOSE MODIFICATION GUIDELINES FOR BORTEZOMIB WHEN GIVEN IN COMBINATION WITH
RITUXIMAB, CYCLOPHOSPHAMIDE, DOXORUBICIN, AND PREDNISONE
D-143 INITIATION OF VIMPAT THERAPY WITH A LOADING DOSE OF 200MG
D-144 LOWER LIMIT OF 15 MINUTES FOR THE INFUSION DURATION
D-145 UPDATES TO THE DOSAGE AND ADMINISTRATION SECTION OF THE LABELING TO REFLECT THE
RESULTS OF TWO SHORT TERM STUDIES EVALUATING THE SAFETY AND EFFICACY OF INTUNIV IN
CHILDREN AND ADOLESCENTS AGES 6 TO 17 WITH ADHD.
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 5 of 67
EXCLUSIVITY INDICATION
I-1 DYSMENORRHEA
I-2 CHOLANGIOPANCREATOGRAPHY
I-3 INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY
I-4 PERIPHERAL VENOGRAPHY (PHLEBOGRAPHY)
I-5 HYSTEROSALPINGOGRAPHY
I-6 TREATMENT OF JUVENILE ARTHRITIS
I-7 BIOPSY PROVEN MINIMAL CHANGE NEPHROTIC SYNDROME IN CHILDREN
I-8 ADULT INTRAVENOUS CONTRAST-ENHANCED COMPUTED TOMOGRAPHY OF THE HEAD AND BODY
I-9 PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING
I-10 PREVENTION OF POSTOPERATIVE DEEP VENOUS THROMBOSIS AND PULMONARY EMBOLISM IN TOTAL
HIP REPLACEMENT SURGERY
I-11 RELIEF OF MILD TO MODERATE PAIN
I-12 TREATMENT OF CUTANEOUS CANDIDIASIS
I-13 URINARY TRACT INFECTION (UTI) PREVENTION FOR PERIODS UP TO FIVE MONTHS IN WOMEN
WITH A HISTORY OF RECURRENT UTI
I-14 SEBORRHEIC DERMATITIS
I-15 PHOTOPHERESIS IN THE PALLIATIVE TREATMENT OF SKIN MANIFESTATIONS OF CUTANEOUS T-
CELL LYMPHOMA IN PERSONS NOT RESPONSIVE TO OTHER TREATMENT
I-16 STIMULATE THE DEVELOPMENT OF MULTIPLE FOLLICLES/OOCYTES IN OVULATORY PATIENTS
PARTICIPATING IN AN IN VITRO FERTILIZATION PROGRAM
I-17 MANAGEMENT OF CONGESTIVE HEART FAILURE
I-18 ENDOSCOPIC RETROGRADE PANCREATOGRAPHY
I-19 HERNIOGRAPHY
I-20 KNEE ARTHROGRAPHY
I-21 HIGH DOSE METHOTREXATE WITH LEUCOVORIN RESCUE IN COMBINATION WITH OTHER
CHEMOTHERAPEUTIC AGENTS TO DELAY RECURRENCE IN PATIENTS WITH NONMETASTATIC
OSTEOSARCOMA WHO HAVE UNDERGONE SURGICAL RESECTION OR AMPUTATION FOR THE PRIMARY
TUMOR
I-22 RESCUE AFTER HIGH-DOSE METHOTREXATE THERAPY IN OSTEOSARCOMA
I-23 SHORT-TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
I-24 TREATMENT OF RHEUMATOID ARTHRITIS
I-25 ADULT INTRA-ARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY OF THE HEAD, NECK, ABDOMINAL,
RENAL AND PERIPHERAL VESSELS
I-26 TREATMENT OF LIVER FLUKES
I-27 ADJUNCTIVE THERAPY TO DIET TO REDUCE THE RISK OF CORONARY ARTERY DISEASE
I-28 SELECTIVE ADULT VISCERAL ARTERIOGRAPHY
I-29 METASTATIC BREAST CANCER IN PREMENOPAUSAL WOMEN AS AN ALTERNATIVE TO OOPHORECTOMY
OR OVARIAN IRRADIATION
I-30 TREATMENT OF TINEA PEDIS
I-31 CONTRAST ENHANCEMENT AGENT TO FACILITATE VISUALIZATION OF LESIONS IN THE SPINE AND
ASSOCIATED TISSUES
I-32 PEDIATRIC MYELOGRAPHY
I-33 ORAL USE OF DILUTED OMNIPAQUE INJECTION IN ADULTS FOR CONTRAST ENHANCED COMPUTED
TOMOGRAPHY OF THE ABDOMEN
I-34 ORAL USE IN ADULTS FOR PASS-THROUGH EXAMINATION OF THE GASTROINTESTINAL TRACT
I-35 PEDIATRIC CONTRAST ENHANCEMENT OF COMPUTED TOMOGRAPHIC HEAD IMAGING
I-36 ARTHROGRAPHY OF THE SHOULDER JOINTS IN ADULTS
I-37 RADIOGRAPHY OF THE TEMPOROMANDIBULAR JOINT IN ADULTS
I-38 CONTRAST ENHANCEMENT AGENT TO FACILITATE VISUALIZATION OF LESIONS OF THE CENTRAL
NERVOUS SYSTEM IN CHILDREN (2 YEARS OF AGE AND OLDER)
I-39 TREATMENT OF ACUTE MYOCARDIAL INFARCTION
I-40 PRIMARY NOCTURNAL ENURESIS
I-41 MIGRAINE HEADACHE PROPHYLAXIS
I-42 HERPES ZOSTER
I-43 HERPES SIMPLEX ENCEPHALITIS
I-44 MAINTENANCE THERAPY IN HEALED DUODENAL ULCER PATIENTS AT DOSE OF 1 GRAM TWICE
DAILY
I-45 ACUTE TREATMENT OF VARICELLA ZOSTER VIRUS
I-46 USE IN PEDIATRIC COMPUTED TOMOGRAPHIC HEAD AND BODY IMAGING
I-47 TREATMENT OF PEDIATRIC PATIENTS WITH SYMPTOMATIC HUMAN IMMUNODEFICIENCY VIRUS
(HIV) DISEASE
I-48 PEDIATRIC ANGIOCARDIOGRAPHY
I-49 TREATMENT OF TRAVELERS' DIARRHEA DUE TO SUSCEPTIBLE STRAINS OF ENTEROTOXIGENIC
ESCHERICHIA COLI
I-50 FOR USE IN WOMEN WITH AXILLARY NODE-NEGATIVE BREAST CANCER
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 6 of 67
EXCLUSIVITY INDICATION
I-51 TREATMENT OF PRIMARY DYSMENORRHEA AND FOR THE TREATMENT OF IDIOPATHIC HEAVY
MENSTRUAL BLOOD LOSS
I-52 PEDIATRIC EXCRETORY UROGRAPHY
I-53 TREATMENT OF PANIC DISORDER, WITH OR WITHOUT AGORAPHOBIA
I-54 RENAL CONCENTRATION CAPACITY TEST
I-55 HYPERTENSION
I-56 EROSIVE GASTROESOPHAGEAL REFLUX DISEASE
I-57 SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER
I-58 INITIAL TREATMENT OF ADVANCED OVARIAN CARCINOMA IN COMBINATION WITH OTHER APPROVED
CHEMOTHERAPEUTIC AGENTS
I-59 ENDOSCOPICALLY DIAGNOSED ESOPHAGITIS, INCLUDING EROSIVE AND ULCERATIVE
ESOPHAGITIS, AND ASSOCIATED HEARTBURN DUE TO GASTROESOPHAGEAL REFLUX DISEASE
I-60 SINGLE APPLICATION TREATMENT OF HEAD LICE IN CHILDREN TWO MONTHS TO TWO YEARS IN
AGE
I-61 FEMALE ANDROGENETIC ALOPECIA
I-62 PREVENTION AND TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
I-63 ONCE DAILY TREATMENT AS INITIAL THERAPY IN THE TREATMENT OF HYPERTENSION
I-64 PREVENTION OF SUPRAVENTRICULAR TACHYCARDIAS
I-65 PREVENTION OF UPPER GASTROINTESTINAL BLEEDING IN CRITICALLY ILL PATIENTS
I-66 UNCOMPLICATED GONORRHEA
I-67 TREATMENT OF ACUTE ASTHMATIC ATTACKS IN CHILDREN SIX YEARS OF AGE AND OLDER
I-68 CENTRAL PRECOCIOUS PUBERTY
I-69 SHORT TERM TREATMENT OF PATIENTS WITH SYMPTOMS OF GASTROESOPHAGEAL REFLUX DISEASE
(GERD), AND FOR THE SHORT TERM TREATMENT OF ESOPHAGITIS DUE TO GERD INCLUDING
ULCERATIVE DISEASE DIAGNOSED BY ENDOSCOPY
I-70 USE IN COMBINATION WITH 5-FLUOROURACIL TO PROLONG SURVIVAL IN THE PALLIATIVE
TREATMENT OF PATIENTS WITH ADVANCED COLORECTAL CANCER
I-71 VARICELLA INFECTIONS (CHICKENPOX)
I-72 PREVENTION OF CMV DISEASE IN TRANSPLANT PATIENTS AT RISK FOR CMV DISEASE
I-73 INITIATE AND MAINTAIN MONITORED ANESTHESIA CARE (MAC) SEDATION DURING DIAGNOSTIC
PROCEDURES
I-74 INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY
I-75 TREATMENT OF ENDOSCOPICALLY DIAGNOSED EROSIVE ESOPHAGITIS
I-76 PREVENTION OF OSTEOPOROSIS
I-77 DERMAL INFECTIONS-TINEA PEDIS, TINEA CORPORIS, TINEA CRURIS DUE TO EPIDERMOPHYTON
FLOCCOSUM
I-78 CONTRAST ENHANCED COMPUTED TOMOGRAPHIC IMAGING OF THE HEAD AND BODY AND
INTRAVENOUS EXCRETORY UROGRAPHY
I-79 MANAGEMENT OF CHRONIC STABLE ANGINA AND ANGINA DUE TO CORONARY ARTERY SPASM
I-80 DIAGNOSIS AND LOCALIZATION OF ISCHEMIA AND CORONARY HEART DISEASE
I-81 PROPHYLAXIS IN DESIGNATED IMMUNOCOMPROMISED CONDITIONS TO REDUCE THE INCIDENCE OF
OROPHARYNGEAL CANDIDIASIS
I-82 TREATMENT OF TRAVELERS' DIARRHEA
I-83 ANGIOCARDIOGRAPHY, CONTRAST ENHANCED COMPUTED TOMOGRAPHIC IMAGING OF THE HEAD AND
BODY, AND INTRAVENOUS EXCRETORY UROGRAPHY IN CHILDREN
I-84 INTRAOPERATIVE AND POSTOPERATIVE TACHYCARDIA AND/OR HYPERTENSION
I-85 TREATMENT OF ANOREXIA ASSOCIATED WITH WEIGHT LOSS IN PATIENTS WITH AIDS
I-86 TREATMENT OF SECONDARY CARNITINE DEFICIENCY
I-87 RENAL IMAGING AGENT FOR USE IN CHILDREN
I-88 MANAGEMENT OF ENDOMETRIOSIS
I-89 EPIDURAL USE IN LABOR AND DELIVERY AS AN ANALGESIC ADJUNCT TO BUPIVACAINE
I-90 INTENSIVE CARE UNIT SEDATION
I-91 MONOTHERAPY USE FOR HYPERTENSION
I-92 ADJUNCTIVE THERAPY IN THE MANAGEMENT OF HEART FAILURE
I-93 PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN CHILDREN AGES 4-11 YEARS
I-94 USE WITH MRI IN ADULTS TO PROVIDE CONTRAST ENHANCEMENT AND FACILITATE
VISUALIZATION OF LESIONS IN THE BODY [EXCLUDING THE HEART]
I-95 TREATMENT OF LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL INFARCTION
I-96 TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA
I-97 ORAL OR RECTAL USE IN CHILDREN FOR THE EXAMINATION OF THE GASTROINTESTINAL TRACT
I-98 TREATMENT OF CHILDREN WHO HAVE GROWTH FAILURE ASSOCIATED WITH CHRONIC RENAL
INSUFFICIENCY
I-99 PEDIATRIC ANESTHESIA IN CHILDREN 3 YEARS AND OLDER
I-100 TO DECREASE THE INCIDENCE OF CANDIDIASIS IN PATIENTS UNDERGOING BONE MARROW
TRANSPLANTATION WHO RECEIVE CYTOTOXIC CHEMOTHERAPY AND/OR RADIATION THERAPY
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 7 of 67
EXCLUSIVITY INDICATION
I-101 TREATMENT OF DIABETIC NEPHROPATHY IN PATIENTS WITH TYPE I INSULIN-DEPENDENT
DIABETES MELLITUS AND RETINOPATHY
I-102 TREATMENT OF OBSESSIVE-COMPULSIVE DISORDER
I-103 PROPHYLAXIS AGAINST PNEUMOCYSTIS CARINII PNEUMONIA IN INDIVIDUALS WHO ARE
IMMUNOCOMPROMISED AND CONSIDERED TO BE AT RISK OF DEVELOPING PNEUMOCYSTIS CARINII
PNEUMONIA
I-104 TREATMENT OF PULMONARY AND EXTRAPULMONARY ASPERGILLOSIS IN PATENTS WHO ARE
INTOLERANT OF OR WHO ARE REFRACTORY TO AMPHOTERICIN B THERAPY
I-105 TREATMENT OF METASTATIC CARCINOMA OF THE BREAST AFTER FAILURE OF FIRST-LINE OR
SUBSEQUENT CHEMOTHERAPY
I-106 TREATMENT OF ACROMEGALY
I-107 VAGINAL CANDIDIASIS
I-108 EXPANDED USE-FOR ICU PATIENTS UNDERGOING LONG-TERM INFUSION DURING MECHANICAL
VENTILATION
I-109 TYPHOID FEVER
I-110 PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH RADIOTHERAPY
I-111 TREATMENT OF PAGET'S DISEASE OF BONE
I-112 MANAGEMENT OF MODERATE TO SEVERE PAIN
I-113 TREATMENT OF PROSTATITIS
I-114 USE IN CHILDREN TO VISUALIZE LESIONS WITH ABNORMAL VASCULARITY IN THE BRAIN
(INTRACRANIAL LESIONS), SPINE, AND ASSOCIATED TISSUE
I-115 USE IN MRI IN ADULTS TO VISUALIZE LESIONS IN THE HEAD AND NECK
I-116 MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
I-117 TO SLOW THE PROGRESSION FO CORONANY ATHEROSCLEROSIS IN PATIENTS WITH CORONARY
HEART DISEASE
I-118 PREVENTION OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM FOLLOWING
KNEE REPLACEMENT SURGERY
I-119 TREATMENT OF ANEMIA CAUSED BY UTERINE LEIOMYOMATA IN WOMEN WHO FAIL IRON THERAPY
I-120 MAINTENANCE THERAPY FOR GASTRIC ULCER PATIENTS AT REDUCED DOSAGE AFTER HEALING
ACUTE ULCERS
I-121 EXPANDED PATIENT POPULATION -- USE IN ICU PATIENTS
I-122 PSORIASIS OF THE SCALP
I-123 RELIEF OF MILD TO MODERATE PAIN IN PATIENTS AGED 6 MONTHS AND OLDER
I-124 LEUCOCYTE LABELED SCINTIGRAPHY AS AN ADJUNCT IN THE LOCALIZATION OF INTRA-
ABDOMINAL INFECTION AND INFLAMMATORY BOWEL DISEASE
I-125 EXPANSION OF CONSCIOUS SEDATION INDICATION TO INCLUDE SHORT THERAPEUTIC PROCEDURES
I-126 ADJUNCT TO THALLIUM- 201 MYOCARDIAL PERFUSION IN PATIENTS UNABLE TO EXERCISE
ADEQUATELY
I-127 TREATMENT OF ACYCLOVIR-RESISTANT HERPES IN IMMUNOCOMPROMISED PATIENTS
I-128 IN PT W/ CH DISEASE AND HYPERCHOLESTEROLEMIA: REDUCE RISK TOTAL MORTALITY BY
REDUCING CORONARY DEATH; REDUCE RISK NON-FATAL MI; REDUCE RISK UNDERGOING
MYOCARDIAL REVASCULARIZATION PROCEDURES; REDUCTION ELEVATED TOTAL AND LDL CHOL
LEVELS...
I-129 TREATMENT OF ALCOHOL DEPENDENCE
I-130 MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
I-131 PERIPHERAL ARTERIOGRAPHY
I-132 TREATMENT OF MANIC PHASE OF BIPOLAR DISORDER
I-133 MANAGEMENT OF CHRONIC STABLE ANGINA
I-134 HEART FAILURE POST MYOCARDIAL INFARCTION
I-135 BONE METASTASES ASSOCIATED WITH MULTIPLE MYELOMA
I-136 IDIOPATHIC CHRONIC URTICARIA
I-137 PREVENTION OF METAL-INDUCED HEART BURN, ACID INDIGESTION, AND SOUR STOMACH WHEN
TAKEN 30 MINUTES PRIOR TO CONSUMING FOOD OR BEVERAGES
I-138 TREATMENT OF ACUTE RECURRENT GENITAL HERPES
I-139 PALLIATIVE TREATMENT OF ADVANCED BREAST CANCER IN PRE- AND PERIMENOPAUSAL WOMEN
I-140 PREVENTION OF CYTOMEGALOVIRUS (CMV) DISEASE IN INDIVIDUALS WITH HIV INFECTION AT
RISK FOR DEVELOPING CMV DISEASE
I-141 TREATMENT OF HEMODYNAMICALLY STABLE PATIENTS WITHIN 24 HOURS OF ACUTE MYOCARDIAL
INFARCTION TO IMPROVE SURVIVAL
I-142 LOCALIZE MYOCARDIAL ISCHEMIA(REVERSIBLE DEFECT) AND INFARCTION (NON-REVERSIBLE
DEFECTS) IN EVALUATING MYOCARDIAL FUNCTION
I-143 EPISODIC TREATMENT OF RECURRENT GENITAL HERPES IN IMMUNOCOMPETENT ADULTS
I-144 ENHANCEMENT OF MRI OF THE ADULT BODY INTERNAL ORGANS
I-145 0.1MMOL/KG AS A SINGLE INTRAVEOUS BOLUS FOR MRI OF THE CNS IN CHILDREN
I-146 CONTRAST ENHANCEMENT AND FACILITATION OF VISUALIZATION OF EXTRACRANIAL HEAD AND
NECK LESIONS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 8 of 67
EXCLUSIVITY INDICATION
I-147 PREVENTION OF GALLSTONE FORMATION IN OBESE PATIENTS EXPERIENCING RAPID WEIGHT LOSS
I-148 TREATMENT OF ACUTE PNEUMOCYSTIC CARINI PNEUMONIA (PCP) IN HIV-INFECTED PATIENTS
WHOSE ALVEOLAR-ARTERIAL OXYGEN DIFFERENCE (AaDO2) IS LESS THAN OR EQUAL TO 55 TORR
I-149 TREATMENT OF PATIENTS WITH NON-SMALL CELL LUNG CANCER
I-150 TREATMENT OF OBSESSIVE COMPULSIVE DISORDER AND PANIC DISORDER
I-151 PREVENTION OF AND PREVENTION OF FURTHER POSTOPERATIVE NAUSEA AND VOMITING IN
PEDIATRIC PATIENTS RECEIVING GENERAL ANESTHESIA
I-152 SLOWING THE PROGRESSION OF CORONARY ATHEROSCLEROSIS AND REDUCING THE RISK OF ACUTE
CORONARY EVENTS
I-153 MANAGEMENT OF SEVERE SPASTICITY [ENCOMPASES SPINAL AND CEREBRAL ORIGIN]
I-154 PATIENT POPULATION ALTERED TO INCLUDE PEDIATRIC USE
I-155 TREATMENT OF ONCHOMYCOSIS DUE TO DERMATOPHYTES (TINEA UNGUIUM) OF THE TOENAIL WITH
OR WITHOUT FINGERNAIL INVOLVEMENT
I-156 ADDITIONAL DATA REGARDING THE SAFE USE OF NORVASC IN PATIENTS WITH HEART FAILURE
I-157 TREATMENT OF ACUTE UNCOMPLICATED CYSTITIS IN FEMALES
I-158 TREATMENT OF OSTEOLYTIC BONE METASTASES OF BREAST CANCER
I-159 FOR HYPERCHOLESTEROLEMIC PATIENTS WITHOUT CLINICALLY EVIDENT HEART DISEASE REDUCE
THE RISK OF MYOCARDIAL INFARCTION, REVASCULARIZATION, AND DEATH DUE TO
CARDIOVASCULAR CAUSES WITH NO INCREASE IN DEATH FROM NON-CARDIOVASCULAR CAUSES
I-160 TREATMENT OF BACTERIAL CORNEAL ULCERS
I-161 TREATMENT OF ADULT-ONSET OR CHILDHOOD-ONSET ADULT GROWTH HORMONE DEFICIENCY
I-162 FOR USE IN PATIENTS 6-11 YEARS OF AGE
I-163 TREATMENT OF PHOTOPHOBIA
I-164 CHRONIC BACTERIAL PROSTATITIS
I-165 MANAGEMENT OF ADULTS WITH ACTIVE, CLASSIC AND DEFINITIVE RHEUMATOID ARTHRITIS WHO
HAVE HAD INSUFFICIENT THERAPEUTIC RESPONSE TO OR ARE INTOLERANT OF AN ADEQUATE
TRIAL OF FULL DOSES OF ONE OR MORE NON-STEROIDAL ANTI-INFLAMMATORY DRUGS
I-166 TREATMENT OF BULIMIA
I-167 COMPLICATED INTRA-ABDOMINAL INFECTIONS (USED IN COMBINATION WITH METRONIDAZOLE)
CAUSED BY MIXED AEROBIC/ANAEROBIC PATHOGENS
I-168 MANAGEMENT OF LOCALLY CONFINED STAGE B2-C METASTATIC CARCINOMA OF THE PROSTATE (IN
COMBINATION WITH LHRH AGONISTS)
I-169 USE IN COMBINATION WITH CORTICOSTEROIDS AS INITIAL CHEMOTHERAPY FOR THE TREATMENT
OF PATIENTS WITH PAIN RELATED TO ADVANCED HORMONE-REFRACTORY PROSTATE CANCER
I-170 PROPHYLACTIC USE DURING HEAD LICE EPIDEMICS
I-171 RELIEF OF SYMPTOMS OF THE COMMON COLD
I-172 TREATMENT OF INITIAL EPISODE OF GENITAL HERPES
I-173 PREOPERATIVELY FOR THE PREVENTION OF INFECTION IN TRANSRECTAL PROSTATE BIOPSY
I-174 PELVIC INFLAMMATORY DISEASE
I-175 TREATMENT OF TINEA CORPORIS AND TINEA CRURIS
I-176 TREATMENT OF POSTOPERATIVE INFLAMMATION IN PATIENTS WHO HAVE UNDERGONE CATARACT
EXTRACTION
I-177 TX OF MODERATE ACNE VULGARIS IN FEMALES,GREATER OR EQUAL TO 15YRS OF AGE,WHO HAVE
NO KNOWN CONTRAINDICATIONS TO ORAL CONTRACEPTIVE THERAPY,DESIRE CONTRACEPTION,HAVE
ACHIEVED MENARCHE AND ARE UNRESPONSIVE TO TOPICAL ANTI-ACNE MEDICATIONS
I-178 TREATMENT OF ONCHOMYCOSIS OF THE FINGERNAIL WITHOUT CONCOMITANT ONCHOMYCOSIS OF
THE TOENAIL WITH A PULSE DOSING REGIMEN
I-179 NOSOCOMIAL PNEUMONIA-MILD TO MODERATE AND SEVERE CAUSED BY HAEMOPHILUS INFLUENZAE
OR KLEBSIELLA PNEUMONIAE
I-180 TREATMENT OF PLANTAR TINEA PEDIS (MOCCASIN TYPE)
I-181 TREATMENT OF PATIENTS WITH COMPLEX PARTIAL SEIZURES WITH AND WITHOUT SECONDARY
GENERALIZATION
I-182 TREATMENT OF GROWTH FAILURE ASSOCIATED WITH TURNER SYNDROME
I-183 MAINTENANCE THERAPY IN THE MANAGEMENT OF MILD TO MODERATE ASTHMA IN PEDIATRIC
PATIENTS AGES 6-11
I-184 TREATMENT OF PANIC DISORDER AT A RECOMMENDED DOSE RANGE OF 1 TO 2MG/DAY (MAXIMUM
OF 4MG)
I-185 PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
I-186 TREATMENT OF TINEA (PITYRIASIS) VERSICOLOR CAUSED BY OR PRESUMED TO BE CAUSED BY
PITYROSPORUM ORBICULARE (ALSO KNOWN AS MALASSEZIA FURFUR OR M. ORBICULARE)
I-187 PREVENTION OF FRACTURES IN THE TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
I-188 TREATMENT OF ACUTE SINUSITIS AND ACUTE EXACERBATION OF CHRONIC SINUSITIS
I-189 TREATMENT OF ACUTE OTITIS MEDIA IN PEDIATRIC PATIENTS
I-190 PLANAR IMAGING AS A SECOND LINE DIAGNOSTIC DRUG AFTER MAMMOGRAPHY TO ASSIST IN THE
EVALUATION OF BREAST LESIONS IN PATIENTS WITH AN ABNORMAL MAMMOGRAM OR A PALPABLE
BREAST MASS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 9 of 67
EXCLUSIVITY INDICATION
I-191 ENDOMETRIAL THINNING AGENT PRIOR TO ENDOMETRIAL ABLATION FOR DYSFUNCTIONAL UTERINE
BLEEDING
I-192 THE PREVENTION OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY EMBOLISM, IN
PATIENTS UNDERGOING ABDOMINAL SURGERY WHO ARE AT RISK FOR THROMBOEMBOLIC
COMPLICATIONS AND A NEW DOSAGE REGIMEN, 40MG ONCE DAILY, FOR THIS INDICATION
I-193 TREATMENT OF PANIC DISORDER IN A RECOMMENDED DOSE RANGE OF 50 TO 200MG/DAY
I-194 CONGESTIVE HEART FAILURE
I-195 FOR USE OF LANSOPRAZOLE IN COMBINATION WITH CLARITHROMYCIN AND AMOXICILLIN FOR THE
ERADICATION OF HELICOBACTER PYLORI IN PATIENTS WITH ACTIVE DUODENAL ULCER DISEASE
OR A ONE-YEAR HISTORY OF DUODENAL ULCER
I-196 ACUTE TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
I-197 MAINTENANCE OF HEALING OF DUODENAL ULCER
I-198 FOR THE USE OF LANSOPRAZOLE IN COMBINATION WITH AMOXICILLIN FOR THE ERADICATION OF
HELICOBACTER PYLORI IN PATIENTS WITH ACTIVE DUODENAL ULCER DISEASE OR A ONE-YEAR
HISTORY OF A DUODENAL ULCER
I-199 MONOTHERAPY AND COMBINATION THERAPY WITH SULFONYL UREAS IN THE TREATMENT OF TYPE
II DIABETES
I-200 TREATMENT OF TINEA (PITYRIASIS) VERSICOLOR
I-201 EMPIRICAL THERAPY FOR FEBRILE NEUTROPENIC PATIENTS
I-202 SECOND-LINE TREAMENT OF AIDS-RELATED KAPOSI'S SARCOMA
I-203 MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS
I-204 USE IN PEDIATRIC PATIENTS BETWEEN THE AGES OF 6 AND 11 FOR THE TREATMENT OF THE
NASAL SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS
I-205 INITIAL ANTICONVULSANT TREATMENT OF STATUS EPILEPTICUS
I-206 TREATMENT OF EDEMA ASSOCIATED WITH CHRONIC RENAL FAILURE
I-207 FOR THE SUPPRESSION OF RECURRENT EPISODES OF GENITAL HERPES IN IMMUNOCOMPETENT
ADULTS
I-208 TREATMENT OF OBSESSIVE COMPULSIVE DISORDER IN THE PEDIATRIC POPULATION
I-209 PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA (PSVT)
I-210 TO SLOW THE PROGRESSION OF CORONARY ATHEROSCLEROSIS IN PATIENTS WITH CORONARY
HEART DISEASE AS PART OF A TREATMENT STRATEGY TO LOWER TOTAL AND LDL CHOLESTEROL
TO TARGET LEVELS
I-211 FOR USE IN PEDIATRIC POPULATION
I-212 TREATMENT OF SYMPTOMS OF DRY MOUTH IN PATIENTS WITH SJOGREN'S SYNDROME
I-213 TEMPORARY RELIEF OF PAIN AND PHOTOPHOBIA IN PATIENTS UNDERGOING CORNEAL REFRACTIVE
SURGERY
I-214 TREATMENT OF OSTEOPOROSIS
I-215 PRE-PROCEDURAL APPLICATION TO ADULT MALE GENITAL SKIN PRIOR TO SITE-SPECIFIC
SUBCUTANEOUS INFILTRATION WITH LIDOCAINE FOR THE REMOVAL OF GENITAL WARTS
I-216 FOR THE LONG-TERM TWICE-DAILY (MORNING AND EVENING) ADMINISTRATION IN THE
MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD, INCLUDING CHRONIC
BRONCHITIS AND EMPHYSEMA
I-217 PREVENTION (DURING AND FOLLOWING HOSPITALIZATION) OF DEEP VEIN THROMBOSIS, WHICH
MAY LEAD TO PULMONARY EMBOLISM, IN PATIENTS UNDERGOING HIP REPLACEMENT SURGERY
I-218 USE OF LIPITOR AS AN ADJUNCTIVE THERAPY TO DIET FOR THE TREATMENT OF PATIENTS WITH
ELEVATED SERUM TRIGLYCERIDE LEVELS (FREDERICKSON TYPE IV)
I-219 USE OF LIPITOR BY PATIENTS WITH PRIMARY DYSBETALIPOPROTEINEMIA (FREDERICKSON TYPE
III) WHO DO NOT RESPOND ADEQUATELY TO DIET
I-220 TREATMENT OF EPISODIC- HEARTBURN, ACID INDIGESTION AND SOUR STOMACH
I-221 TREATMENT OF BENIGN PROSTATIC HYPERPLASIA (BPH) IN MEN WITH AN ENLARGED PROSTATE
TO IMPROVE SYMPTOMS, REDUCE THE RISK OF ACUTE URINARY RETENTION AND REDUCE THE
RISK OF THE NEED OF SURGERY
I-222 PREVENTION OF ISCHEMIC COMPLICATIONS OF UNSTABLE ANGINA AND NON-Q-WAVE MYOCARDIAL
INFARCTION, WHEN CONCURRENTLY ADMINISTERED WITH ASPIRIN
I-223 USE IN THE SYMPTOMATIC RELIEF OF RHINORRHEA ASSOCIATED WITH ALLERGIC AND
NONALLERGIC-PERENNIAL RHINITIS IN CHILDREN AGE 6-11 YEARS
I-224 FOR THE USE IN PEDIATRIC PATIENTS 4 TO 11 YEARS OF AGE FOR THE MANAGEMENT OF THE
NASAL SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS
I-225 USE IN PATIENTS WITH PREVIOUS MI AND NORMAL CHOLESTEROL LEVELS, TO REDUCE RISK OF
RECURRENT MI, MYOCARDIAL REVASCULARIZATION, AND CEREBROVASCULAR DISEASE EVENTS
I-226 FIRST-LINE THERAPY FOR THE TREATMENT OF ADVANCED CARCINOMA OF THE OVARY IN
COMBINATION WITH CISPLATIN
I-227 SHORT-TERM TREATMENT OF SYMPTOMATIC GASTROESPHAGEAL REFLUX DISEASE (GERD)
I-228 PREVENTION OF MEAL INDUCED HEARTBURN AT A DOSE OF 75MG TAKEN 30-60MIN PRIOR TO A
MEAL
I-229 PRILOSEC (OMEPRAZOLE), AMOXICILLIN, AND CLARITHROMYCIN FOR THE ERADICATION OF H.
PYLORI IN PATIENTS WITH DUODENAL ULCER DISEASE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 10 of 67
EXCLUSIVITY INDICATION
I-230 IN COMBINATION WITH CIS-PLATIN, FOR THE FIRST LINE TREATMENT OF NON-SMALL CELL
LUNG CANCER IN PATIENTS WHO ARE NOT CANDIDATES FOR POTENTIALLY CURATIVE SURGERY
AND/OR RADIATION
I-231 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC BREAST CANCER AFTER
FAILURE OF PRIOR CHEMOTHERAPY
I-232 TREATMENT OF RECURRENT MUCOCUTANEOUS HERPES SIMPLEX INFECTIONS IN HIV-AFFECTED
PATIENTS AT A DOSE OF 500MG TWICE DAILY
I-233 PROPHYLACTIC USE TO REDUCE PERIOPERATIVE BLOOD LOSS AND THE NEED FOR BLOOD
TRANSUFSION IN PATIENTS UNDERGOING CARDIOPULMONARY BYPASS IN THE COURSE OF
CORONARY ARTERY BYPASS GRAFT SURGERY
I-234 FOR USE IN COMBINATION WITH CISPLATIN FOR THE FIRST-LINE TREATMENT OF PATIENTS
WITH INOPERABLE LOCALLY ADVANCED (STAGE IIIA OR IIIB) OR METASTATIC (STAGE IV)
NON-SMALL CELL LUNG CANCER
I-235 PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN PATIENTS 12 YEARS OF AGE AND OLDER
I-236 PREVENTION OF EXERCISE-INDUCED BRONCHOSPASM IN PATIENTS 4 YEARS OF AGE AND OLDER
I-237 MAINTENANCE TREATMENT OF ASTHMA AND PREVENTION OF BRONCHOSPASM IN PATIENTS 4 YEARS
OF AGE AND OLDER
I-238 ADJUNCTIVE TREATMENT OF LENNOX-GASTAUT SYNDROME IN PEDIATRIC AND ADULT PATIENTS
I-239 TREATMENT OF PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
I-240 MANAGEMENT OF SECONDARY HYPERPARATHYROIDISM AND RESULTANT METABOLIC BONE DISEASE
IN PATIENTS WITH MODERATE TO SEVERE CHRONIC RENAL FAILURE (CCR 15 TO 55ML/MIN) NOT
YET ON DIALYSIS
I-241 USE IN PHOTODYNAMIC THERAPY (PDT) FOR REDUCTION OF OBSTRUCTION AND PALLIATION OF
SYMPTOMS IN PATIENTS WITH COMPLETELY OR PARTIALLY OBSTRUCTING ENDOBRONCHIAL
NONSMALL CELL LUNG CANCER
I-242 TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH THE MENOPAUSE
AND IN THE TREATMENT OF VULVAR AND VAGINAL ATROPHY IN WOMEN WITH AN INTACT UTERUS
I-243 USE IN THE SYMPTOMATIC RELIEF OF RHINORRHEA ASSOCIATED WITH THE COMMON COLD IN
CHILDREN AGE 5 TO 11 YEARS
I-244 REDUCE THE INCIDENCE OF BREAST CANCER IN WOMEN AT HIGH RISK FOR BREAST CANCER
I-245 TREATMENT OF ACUTE SINUSITIS
I-246 TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS
I-247 USE IN CONVERSION TO MONOTHERAPY IN ADULTS WITH PARTIAL SEIZURES WHO ARE RECEIVING
TREATMENT WITH A SINGLE ENZYME-INDUCING ANTIEPILEPTIC DRUG
I-248 INPATIENT TREATMENT OF ACUTE DEEP VEIN THROMBOSIS WITH/WITHOUT PULMONARY EMBOLISM
WHEN ADMIN WITH WARFARIN SODIM AND OUTPATIENT TREATMENT OF ACUTE DEEP VEIN
THROMBOSIS WITHOUT PULMONARY EMBOLISM WHEN ADMIN WITH WARFARIN SODIUM
I-249 TREATMENT OF CHRONIC HEPATITIS C IN PATIENTS WITH COMPENSATED LIVER DISEASE
PREVIOUSLY UNTREATED WITH ALPHA INTERFERON THERAPY
I-250 PRIMARY PREVENTION OF CORONARY HEART DISEASE IN PATIENTS WITHOUT SYMPATOMATIC
CARDIOVASCULAR DISEASE WHO HAVE AVERAGE TO MODERATELY ELEVATED TOTAL-C AND LDL-C
AND BELOW AVERAGE HDL-C
I-251 TREATMENT OF GENERALIZED ANXIETY DISORDER
I-252 NEW COMBINATION USE OF PRECOSE FOR PATIENTS WITH TYPE 2 DIABETES TREATED WITH DIET
PLUS METFORMIN
I-253 COMBINATION USE OF PRECOSE FOR PATIENTS WITH TYPE 2 DIABETES TREATED WITH DIET
PLUS INSULIN
I-254 PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS (LOSS OF BONE MASS)
I-255 PREVENTION OF PNEUMOCYSTIS CARINII PNEUMONIA (PCP)
I-256 USE IN TREATMENT OF SMALL CELL LUNG CANCER SENSITIVE DISEASE AFTER FAILURE OF
FIRST-LINE CHEMOTHERAPY
I-257 TREATMENT OF CHRONIC HEPATITIS B ASSOCIATED WITH EVIDENCE OF HEPATITIS B VIRAL
REPLICATION AND ACTIVE LIVER INFLAMATION
I-258 FOR PERENNIAL NONALLERGIC RHINITIS FOR AGES 4 AND ABOVE
I-259 PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT), WHICH MAY LEAD TO PULMONARY EMBOLISM,
IN PATIENTS UNDERGOING HIP REPLACEMENT SURGERY
I-260 EXPANDED PEDIATRIC USE IN CHILDREN YOUNGER THAN ONE MONTH OF AGE TO BIRTH (WITH A
GESTATIONAL AGE OF 37 WEEKS OR GREATER)
I-261 TREATMENT OF SOCIAL ANXIETY DISORDER
I-262 TREATMENT OR PREVENTION OF BRONCHOSPASM WITH REVERSIBLE OBSTRUCTIVE AIRWAY DISEASE
AND FOR THE PREVENTION OF EXERCISE INDUCED BRONCHOSPASM IN CHILDREN AGES 4-12
I-263 TREATMENT OF UNSTABLE ANGINA AND NON-Q-WAVE MYOCARDIAL INFARCTION FOR THE
PREVENTION OF ISCHEMIC COMPLICATIONS IN PATIENTS ON CONCURRENT ASPIRIN THERAPY
I-264 PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH RADIATION, INCLUDING TOTAL BODY
IRRADIATION (TBI) AND FRACTIONATED ABDOMINAL RADIATION
I-265 TREATMENT OF ATOPIC DERMATITIS IN PEDIATRIC PATIENTS 6 YEARS AND OLDER
I-266 USE OF TOPAMAX AS ADJUNCTIVE THERAPY IN PEDIATRIC PATIENTS AGES 2-16 YEARS WITH
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 11 of 67
EXCLUSIVITY INDICATION
PARTIAL ONSET SEIZURES
I-267 USE IN PEDIATRIC PATIENTS 3 MONTHS OLD AND OLDER - FOR CORTICOSTEROID-RESPONSIVE
DERMATOSES
I-268 PROPHYLAXIS AND CHRONIC TREATMENT OF ASTHMA IN PATIENTS 7-11 YEARS OF AGE
I-269 PREVENTION OF NAUSEA AND VOMITING ASSOCIATED WITH HIGHLY EMETOGENIC CANCER
CHEMOTHERAPY, INCLUDING CISPLATIN
I-270 ADJUVANT TREATMENT OF NODE-POSITIVE BREAST CANCER ADMINISTRERED SEQUENTIALLY TO
STANDARD DOXORUBICIN-CONTAINING COMBINATION CHEMOTHERAPY
I-271 TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
I-272 TREATMENT OF GLUCOCORTICOID-INDUCED OSTEOPOROSIS IN MEN AND WOMEN RECEIVING
GLUCOCORTICOIDS IN A DAILY DOSE EQUIVALENT TO 7.5MG OR GREATER OF PREDNISONE AND
WHO HAVE LOW BONE MINERAL DENSITY
I-273 ADJUNCT TO DIET TO INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
(HETEROZYGOUS FAMILIAL AND NON FAMILIAL) AND MIXED DYSLIPIDEMIA (FREDERICKSON
TYPES IIA AND IIB)
I-274 USE OF TOPAMAX AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED
TONIC-CLONIC SEIZURES
I-275 USE IN COMBINATION WITH METFORMIN AND SULFONYLUREA IN PATIENTS WITH TYPE 2
DIABETES
I-276 USE OF REZULIN IN COMBINATION WITH METFORMIN AND SULFONYLUREAS IN PATIENTS WITH
TYPE 2 DIABETES
I-277 TREATMENT OF TYPE III HYPERLIPOPROTEINEMIA
I-278 TREATMENT OF PATIENTS WITH ISOLATED HYPERTRIGLYCERIDEMIA (FREDERICKSON TYPE IV)
I-279 TREATMENT OF POST-TRAUMATIC STRESS DISORDER
I-280 USE OF CARNITOR INJECTION FOR THE PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY
IN PATIENTS WITH END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS
I-281 INCREASING HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA (HETEROZYGOUS
FAMILIAL AND NONFAMILIAL) AND MIXED DYSLIPIDEMIA (FREDERICKSON TYPES IIA AND IIB)
I-282 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG
CANCER AFTER FAILURE OF PRIOR PLATINUM-BASED CHEMOTHERAPY
I-283 TO REDUCE THE INCIDENCE OF MODERATE TO SEVERE XEROSTOMIA IN PATIENTS UNDERGOING
POST-OPERATIVE RADIATION TREATMENT FOR HEAD AND NECK CANCER, WHERE THE RADIATION
PORT INCLUDES A SUBSTANTIAL PORTION OF THE PAROTID GLANDS
I-284 TO REDUCE THE NUMBER OF ADENOMATOUS COLORECTAL POLYPS IN FAMILIAL ADENOMATOUS
POLYPOSIS PATIENTS AS AN ADJUNCT TO USUAL CARE
I-285 TREATMENT OF NASAL SYMPTOMS OF SEASONAL AND PERENNIAL RHINITIS IN ADULTS AND
CHILDREN 3 YEARS OF AGE AND OLDER
I-286 TREATMENT OF PATIENTS WITH FREDERICKSON TYPE III
I-287 USE OF PRAVASTATIN IN PATIENTS WITH EVIDENT CORONARY HEART DISEASE TO REDUCE THE
RISK OF TOTAL MORTALITY BY REDUCING CORONARY DEATH
I-288 CHANGES IN SEVERAL SECTIONS OF THE INSERT TO INCORPORATE STATEMENTS CONCERNING THE
USE OF HIGH DOSES OF LISINOPRIL TO REDUCE THE RISK OF THE COMBINED OUTCOMES OF
MORTALITY AND HOSPITALIZATION IN PATIENTS WITH CONGESTIVE HEART FAILURE
I-289 USE OF AVANDIA IN COMBINATION WITH A SULFONYLUREA IN PATIENTS WITH TYPE 2 DIABETES
MELLLITUS WHEN DIET AND EXERCISE WITH EITHER SINGLE AGENT DOES NOT ACHIEVE
ADEQUATE GLYCEMIC CONTROL
I-290 PREVENTION OF CORTICOSTEROID-INDUCED OSTEOPOROSIS
I-291 PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
I-292 TREATMENT OF POSTMENOPAUSAL OSTEOPOROSIS
I-293 TREATMENT OF CORTICOSTEROID-INDUCED OSTEOPOROSIS
I-294 TREATMENT OF UNCOMPLICATED ACUTE ILLNESS DUE TO INFLUENZA A AND B IN PEDIATRIC
PATIENTS 7 YEARS AND OLDER WHO HAVE BEEN SYMPTOMATIC FOR NO MORE THAN 2 DAYS
I-295 PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS FOR WOMEN WITH AN INTACT UTERUS
I-296 LONG-TERM INTRAVENOUS TREATMENT OF PULMONARY HYPERTENSION ASSOCIATED WITH THE
SCLERODERMA SPECTRUM OF DISEASE IN NYHA CLASS III AND CLASS IV PATIENTS WHO DO NOT
RESPOND TO CONVENTIONAL THERAPY
I-297 SHORT-TERM TREATMENT OF ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
I-298 TREATMENT OF PATIENTS WITH FREDERICKSON TYPE IIA AND IIB HYPERLIPOPROTEINEMIA
I-299 USE OF CAMPTOSAR AS A COMPONENT OF FIRST-LINE THERAPY IN COMBINATION WITH 5-
FLUROURACIL AND LEUCOVARIN FOR PATIENTS WITH METASTATIC CARCINOMA OF THE COLON OR
RECTUM
I-300 PROPHYLAXIS FOR ASTHMA IN CHILDREN 2-5 YEARS OF AGE
I-301 TREATMENT OF SIGNS AND SYMPTOMS OF ALLERGIC CONJUNCTIVITIS
I-302 TREATMENT OF PEDIATRIC PATIENTS WITH PRADER-WILLI SYNDROME
I-303 INCREASING HDL-CHOLESTEROL IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA AND MIXED
DYSLIPIDEMIAS
I-304 TREATMENT OF PATIENTS WITH FREDERICKSON TYPE IV
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 12 of 67
EXCLUSIVITY INDICATION
I-305 TREATMENT OF LEVOFLOXACIN SUSCEPTIBLE STRAINS OF PENICILLIN-RESISTANT
STREPTOCOCCUS PNEUMONIAE IN PATIENTS WITH COMMUNITY ACQUIRED PNEUMONIA
I-306 INDUCTION OF SPERMATOGENESIS IN MEN WITH PRIMARY AND SECONDARY HYPOGONADOTROPIC
HYPOGONADISM IN WHOM THE CAUSE OF INFERTILITY IS NOT DUE TO PRIMARY TESTICULAR
FAILURE
I-307 NEW COMBINATION USE OF METFORMIN AND INSULIN IN TYPE 2 DIABETES
I-308 TREATMENT OF PEDIATRIC PATIENTS WITH POLYARTICULAR COURSE JUVENILE RHEUMOTOID
ARTHRITIS WHO RESPONDED INADEQUATELY TO SALICYLATES OR OTHER NSAIDS
I-309 USE OF ACTONEL 35MG ONCE A WEEK TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
I-310 REDUCTION IN RISK OF MYOCARDIAL INFARCTION, STROKE, AND DEATH FROM CARDIOVASCULAR
CAUSES
I-311 ADJUNCTIVE THERAPY IN THE TREATMENT OF PARTIAL SEIZURES IN PEDIATRIC PATIENTS AGE
3 TO 12 YEARS
I-312 FIRST LINE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE OR
HORMONE RECEPTOR UNKNOWN LOCALLY ADVANCED OR METASTATIC BREAST CANCER
I-313 EXTENSION OF INDICATION TO PROVIDE FOR MAINTENANCE OF RESPONSE
I-314 TOPICAL ANESTHETIC FOR SUPERFICIAL MINOR SURGERY OF GENITAL MUCOUS MEMBRANES AND
AS AN ADJUNCT FOR LOCAL INFILTRATION ANESTHESIA IN GENITAL MUCOUS MEMBRANES
I-315 THROMBOPROPHYLAXIS OF DEEP VEIN THROMBOSIS, WHICH MAY LEAD TO PULMONARY
EMBOLISM,IN MEDICAL PATIENTS WHO ARE AT RISK FOR THROMBOEMBOLIC COMPLICATIONS DUE
TO SEVERELY RESTRICTED MOBILITY DURING ACUTE ILLNESS
I-316 TREATMENT OF NSAID-ASSOCIATED GASTRIC ULCER PATIENTS WHO CONTINUE NSAID USE AND
REDUCING RISK OF NSAID-ASSOCIATED GASTRIC ULCERS IN PATIENTS WITH HISTORY OF
DOCUMENTED GASTRIC ULCER WHO REQUIRE USE OF AN NSAID
I-317 PROPHYLAXIS OF INFLUENZA IN ADULTS AND ADOLESCENTS 13 YEARS AND OLDER
I-318 FIRSTLINE TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE OR
HORMONE RECEPTOR UNKNOWN LOCALLY ADVANCED OR METASTATIC BREAST CANCER
I-319 USE FOR SUSPECTED OR CONFIRMED METHANOL POISONING, EITHER ALONE OR IN COMBINATION
WITH HEMODIALYSIS
I-320 TREATMENT OF TYPE 2 DIABETES IN PEDIATRIC PATIENTS (AGES 10-16 YEARS)
I-321 JUVENILE RHEUMATOID ARTHRITIS
I-322 USE OF DIPRIVAN IN PATIENTS 3 MONTHS TO 16 YEARS
I-323 COLORECTAL CANCER
I-324 REDUCING NEUROLOGIC DISABILITY AND/OR FREQUENCY OF CLINICAL RELAPSES IN PATIENTS
WITH SECONDARY (CHRONIC) PROGRESSIVE, PROGRESSIVE RELAPSING, OR WORSENING
RELAPSING-REMITTING MULTIPLE SCLEROSIS
I-325 PREVENTION OF RELAPSE AND RECURRENCE OF DEPRESSION
I-326 GENERALIZED ANXIETY DISORDER
I-327 SYMPTOMATIC RELIEF OF RHINORRHEA ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN
PATIENTS 5 YEARS AND OLDER
I-328 PROPHYLAXIS AND CHRONIC TREATMENT OF ASTHMA IN PATIENTS 5-6 YEARS OF AGE
I-329 UNCOMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
I-330 MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND CONTROL OF DAYTIME AND NIGHTTIME
HEARTBURN SYSTOMS IN PATIENTS WITH GERD
I-331 TREATMENT OF MODERATE ACNE VULGARIS
I-332 EMPIRIC THERAPY IN FEBRILE NEUTROPENIC PATIENTS WITH SUSPECTED FUNGAL INFECTIONS
(EFTN)
I-333 TOPICAL TREATMENT OF TINEA (PITYRIASIS) VERSICOLOR DUE TO MALASSEZIA FURFUR
(FORMERLY PITYROSPORUM ORBICULARE)
I-334 LONG-TERM TREATMENT OF GROWTH FAILURE IN CHILDREN BORN SMALL FOR GESTATIONAL AGE
WHO FAIL TO MANIFEST CATCH-UP GROWTH BY TWO YEARS OF AGE
I-335 ADJUNCTIVE THERAPY IN PATIENTS TWO YEARS AND OLDER WITH SEIZURES ASSOCIATED WITH
LENNOX-GASTAUT SYNDROME
I-336 EXPANSION OF INDICATION TO INCLUDE THE TREATMENT OF PATIENTS WITH PREDOMINATELY
CLASSIC SUBFOVEAL CHOROIDAL NEOVASCULARIZATION DUE TO PATHOLOGIC MYOPIA OR
PRESUMED OCULAR HISTOPLASMOSIS
I-337 PATHOLOGICAL HYPERSECRETION ASSOCIATED WITH ZOLLINGER-ELLISON SNYDROME
I-338 MANAGEMENT OF ACUTE PAIN IN ADULTS AND TREATMENT OF PRIMARY DYSMENORRHEA
I-339 TREATMENT OF HEPATITIS B IN PEDIATRIC PATIENTS AGES 2-17 YEARS
I-340 ATOPIC DERMATITIS IN PEDIATRIC PATIENTS AGES 2-5
I-341 BREAST CANCER COMBINATION THERAPY
I-342 USE OF FORADIL FOR LONG-TERM, TWICE DAILY (MORNING AND EVENING) ADMINISTRATION IN
THE MAINTENANCE TREATMENT OF BRONCHO-CONSTRICTION IN PATIENTS WITH COPD INCLUDING
CHRONIC BRONCHITIS AND EMPHYSEMA
I-343 USE OF COREG FOR SEVERE HEART FAILURE
I-344 ACNE VULGARIS
I-345 TREATMENT OF POSTTRAUMATIC STRESS DISORDER
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 13 of 67
EXCLUSIVITY INDICATION
I-346 TREATMENT OF SYMPTOMATIC GASTRO ESOPHAGEAL REFLUX DISEASE (GERD)
I-347 TREATMENT OR PREVENTION OF BRONCHOSPASM IN CHILDREN 6 YEARS OF AGE AND OLDER WITH
OBSTRUCTIVE AIRWAY DISEASE
I-348 LONG-TERM, TWICE-DAILY (MORNING AND EVENING) ADMINISTRATION IN THE MAINTENANCE
TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD (INCLUDING EMPHYSEMA AND CHRONIC
BRONCHITIS)
I-349 ACUTE CORONARY SYNDROME
I-350 TREATMENT OF HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN ADOLESCENT BOYS AND
GIRLS AT LEAST ONE YEAR POSTMENARCHAL, AGES 10 TO 17 YEARS, WITH A RECOMMENDED
DOSING RANGE OF 10 TO 40MG ONCE DAILY
I-351 PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS FOR ALL STRENGTHS
I-352 ANTICOAGULANT IN PATIENTS WITH OR AT RISK FOR HEPARIN-INDUCED THROMBOCYTOPENIA
UNDERGOING PERCUTANEOUS CORONARY INTERVENTIONS (PCI)
I-353 TREATMENT OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS
I-354 MANAGEMENT OF POST HERPETIC NEURALGIA
I-355 PREMENSTRUAL DYSPHORIC DISORDER
I-356 TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS, INCLUDING ZOLLINGER-ELLISON
SYNDROME
I-357 TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS
I-358 TREATMENT OF PANIC DISORDER
I-359 TREATMENT OF VULVAR AND VAGINAL ATROPHY ASSOCIATED WITH THE MENOPAUSE
I-360 TREATMENT OF NASAL SYMPTOMS OF SEASONAL AND PERENNIAL RHINITIS IN CHILDREN AGES
TWO UP TO AGE THREE
I-361 TREATMENT OF MULTIPLE MYELOMA AND DOCUMENTED BONE METASTASES FROM SOLID TUMORS, IN
CONJUNCTION WITH STANDARD ANTINEOPLASTIC THERAPY. PROSTATE CANCER SHOULD HAVE
PROGRESSED AFTER TREATMENT WITH AT LEAST ONE HORMONAL THERAPY
I-362 TREATMENT OF PANIC DISORDER, WITH OR WITHOUT AGORAPHOBIA
I-363 ADJUVANT TREATMENT OF POST MENOPAUSAL WOMEN WITH HORMONE RECEPTOR POSITIVE EARLY
BREAST CANCER
I-364 TREATMENT OF COMMUNITY-ACQUIRED PNEUMONIA IN ADULTS
I-365 TREATMENT OF HEART FAILURE (NYHA CLASS II-IV) IN PATIENTS WHO ARE INTOLERANT TO AN
ACE INHIBITOR
I-366 PREVENTION OF RELAPSE FOLLOWING LONG-TERM TREATMENT OF MAJOR DEPRESSIVE DISORDER
I-367 COMBINATION THERAPY WITH THIAZOLIDINEDIONE TO LOWER BLOOD GLUCOSE IN PTS WHOSE
HYPERGLYCEMIA CANNOT BE CONTROLLED BY DIET/EXERCISE PLUS MONOTHERAPY WITH ANY OF
THE FOLLOWING AGENTS:METFORMIN,SULFONYLUREAS,REPAGLINIDE,OR THIAZOLIDINEDIONES
I-368 USE OF GLUCOVANCE WITH A THIAZOLIDINEDIONE WHEN GLYCEMIC CONTROL IS NOT OBTAINED
WITH GLUCOVANCE ALONE
I-369 PREVENTION AND TREATMENT OF POSTOPERATIVE NAUSEA AND VOMITING
I-370 TREATMENT OF HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN CHILDREN, AGES 8-13
YEARS, WITH RECOMMENDED DOSE OF 20MG ONCE DAILY AND IN ADOLESCENTS, AGES 14-18
WITH A RECOMMENDED DOSE OF 40MG ONCE DAILY
I-371 HELICOBACTER PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
I-372 NOSOCOMIAL PNEUMONIA
I-373 TREATMENT OF TYPE 2 DIABETIC NEPHROPATHY
I-374 SHORT TERM TOPICAL TREATMENT OF MILD TO MODERATE PLAQUE-TYPE PSORIASIS OF NON
SCALP REGIONS
I-375 FIRST LINE THERAPY FOR THE REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH
OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION
I-376 TREATMENT OF NEWLY DIAGNOSED ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE
CHRONIC MYELOID LEUKEMIA (CML)
I-377 USE OF BRAVELLE FOR MULTIPLE FOLLICULAR DEVELOPMENT (CONTROLLED OVARIAN
STIMULATION) DURING ASSISTED REPRODUCTIVE TECHNOLOGY CYCLES IN PATIENTS WHO HAVE
PREVIOUSLY RECEIVED PITUITARY SUPPRESSION
I-378 RELIEF OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS IN ADULTS AND PEDIATRIC PATIENTS
2 YEARS OF AGE AND OLDER
I-379 USE TAXOTERE IN COMBINATION WITH CISPLATIN FOR THE TREATMENT OF PATIENTS WITH
UNRESECTABLE, LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER WHO HAVE
NOT PREVIOUSLY RECEIVED CHEMOTHERAPY FOR THIS CONDITION
I-380 TO TREAT PATIENTS WITH SCHIZOPHRENIA OR SCHIZOAFFECTIVE DISORDER AT RISK FOR
EMERGENT SUICIDAL BEHAVIOR
I-381 TREATMENT OF COLD SORES (HERPES LABIALIS) IN ADULT AND ADOLESCENT PATIENTS 12
YEARS OF AGE AND OLDER
I-382 FOR NEWLY-DIAGNOSED HIGH GRADE MALIGNANT GLIOMA PATIENTS AS AN ADJUNCT TO SURGERY
AND RADIATION
I-383 TREATMENT OF TYPE 2 DIABETIC NEPHROPATHY
I-384 USE IN COMBINATION WITH INSULIN FOR THE TREATMENT OF PATIENTS WITH TYPE 2 DIABETES
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 14 of 67
EXCLUSIVITY INDICATION
MELLITUS
I-385 MODIFICATION OF THE INDICATION FOR COMMUNITY ACQUIRED PNEUMONIA TO ADD"INCLUDING
PENICILLIN-RESISTANT STRAINS, MIC PENICILLIN>=2MCG/ML TO STREPTOCOCCUS PNEUMONIAE
I-386 RAPAMUNE (SIROLIMUS) WITHIN AN IMMUNOSUPPRESSIVE REGIMEN THAT WOULD ALLOW FOR THE
WITHDRAWAL OF CYCLOSPORINE 2 TO 4 MONTHS AFTER RENAL TRANSPLANTATION IN PATIENTS
CONSIDERED AT LOW TO MODERATE IMMUNOLOGIC RISK FOR RENAL TRANSPLANT REJECTION
I-387 ADJUNCTIVE THERAPY OF PARTIAL SEIZURES IN PEDIATRIC PATIENTS GREATER THAT OR EQUAL
TO 2 YEARS OF AGE
I-388 TREATMENT OF PATIENTS WITH LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL
INFARCTION
I-389 SUPRESSION OF RECURRENT GENITAL HERPES IN HIV-INFECTED INDIVIDUALS
I-390 USE IN PTS AT HIGH RISK CORONARY EVENTS DUE TO EXISTING CORONARY HEART
DISEASE,DIABETES,PERIPHERAL VESSEL DISEASE,STROKE HISTORY,OTHER CV DISEASE TO
REDUCE RISK TOTAL MORTALITY BY REDUCING CORONARY DEATH,REDUCE NONFATAL MI &
I-391 ABLATION OF HIGH-GRADE DYSPLASIA IN BARRETT'S ESOPHAGUS PATIENTS WHO DO NOT
UNDERGO ESOPHAGECTOMY
I-392 TX OF PED PATIENTS W/PH+ CHRONIC PHASE CML DISEASE RECUR AFTER STEM CELL TRNSPLT
OR RESIST TO INTERFERON ALPHA THERAPY.NO CONTROLLED TRIALS DEMONSTRATING A
CLINICAL BENEFIT SUCH AS IMPROVE IN DISEASE RELATED SX OR INCREASED SURVIVAL
I-393 CHRONIC BACTERIAL PROSTATITIS
I-394 USE IN PATIENTS WITH CORONARY HEART DISEASE TO REDUCE THE RISK OF UNDERGOING
CORONARY REVASCULARIZATION PROCEDURES
I-395 TO IMPROVE PHYSICAL FUNCTION
I-396 EXPANDED INDICATION TO INCLUDE THE ASSESSMENT OF VENTRICULAR FUNCTION IN SUBJECTS
BEING EVALUATED FOR HEART DISEASE AND/OR VENTRICULAR FUNCTION
I-397 EXTENDED PROPHYLAXIS IN PATIENTS UNDERGOING HIP FRACTURE SURGERY
I-398 IDIOPATHIC SHORT STATURE
I-399 TREATMENT OF CANDIDEMIA AND THE FOLLOWING CANDIDA INFECTIONS: INTRA-ABDOMINAL
ABSCESSES, PERITONITIS AND PLEURAL SPACE INFECTIONS
I-400 USE OF OLANZAPINE IN COMBINATION WITH LITHIUM OR VALPROATE FOR THE TREATMENT OF
ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR DISORDER
I-401 LONGER-TERM EFFICACY OF ARIPIPRAZOLE IN THE TREATMENT OF SCHIZOPHRENIA
I-402 DIABETIC FOOT INFECTIONS WITHOUT CONCOMITANT OSTEOMYELITIS
I-403 USE OF VALTREX IN COMBINATION WITH SAFER SEX PRACTICES FOR THE REDUCTION OF THE
RISK OF TRANSMISSION OF GENITAL HERPES DURING SUPPRESIVE THERAPY OF THE SOURCE
PARTNER IN A HETEROSEXUAL COUPLE
I-404 MAINTENANCE TREATMENT OF BIPOLAR I DISORDER TO DELAY THE TIME TO OCCURRENCE OF
MOOD EPISODES (DEPRESSION, MANIA, HYPOMANIA, MIXED EPISODES) IN PATIENTS TREATED
FOR ACUTE MOOD EPISODES WITH STANDARD THERAPY
I-405 TREATMENT OF PREMENSTRUAL DYSPHORIC DISORDER (PMDD) USING AN INTERMITTENT DOSING
REGIMEN
I-406 PREVENTION OF CYTOMEGALOVIRUS DISEASE IN KIDNEY, HEART, AND KIDNEY-PANCREAS
TRANSPLANT PATIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV
SERONEGATIVE)
I-407 IMPROVE SURVIVAL OF STABLE PATIENTS WITH LEFT VENTRICULAR SYSTOLIC DYSFUNCTION
(EJECTION FRACTION<=40%) AND CLINICAL EVIDENCE OF CONGESTIVE HEART FAILURE AFTER
AN ACUTE MYOCARDIAL INFARCTION
I-408 STIMULATION OF PANCREATIC SECRETIONS TO FACILITATE THE INDENTIFICATION OF THE
AMPULLA OF VATER AND ACCESSORY PAPILLA DURING ENDOSCOPIC RETROGRADE CHOLANGIO-
PANCREATOGRAPHY (ERCP)
I-409 ESOPHAGEAL CANDIDIASIS
I-410 USE OF ADVAIR DISKUS 250/50 FOR CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
ASSOCIATED WITH CHRONIC BRONCHITIS
I-411 EXPANDED INDICATION FOR USE IN COMBINATION WITH ANTIDIABETIC DRUGS IN THE
THIAZOLIDINEDIONE CLASS
I-412 MONOTHERAPY FOR THE SHORT TERM TREATMENT OF ACUTE MANIC OR MIXED EPISODES
ASSOCIATED WITH BIPOLAR I DISORDER
I-413 ADJUNCTIVE THERAPY FOR THE SHORT TERM TREATMENT OF ACUTE MANIC OR MIXED EPISODES
ASSOCIATED WITH BIPOLAR I DISORDER
I-414 PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT), WHICH MAY LEAD TO PULMONARY EMBOLISM
(PE) IN MEDICAL PATIENTS WHO ARE AT RISK FOR THROMBOEMBOLIC COMPLICATIONS DUE TO
SEVERELY RESTRICTED MOBILITY DURING ACUTE ILLNESS
I-415 SEVERE HYPERTENSION WHEN THE VALUE OF ACHIEVING PROMPT BLOOD PRESSURE CONTROL
EXCEEDS THE RISK OF INITIATING COMBINATION THERAPY
I-416 THE USE OF CIPRO XR FOR COMPLICATED URINARY TRACT INFECTIONS AND ACUTE
UNCOMPLICATED PYELONEPHRITIS
I-417 USE IN THE LONG TERM TREATMENT OF BIPOLAR I DISORDER
I-418 ADJUNCTIVE THERAPY W/ MOOD STABILIZERS (LITHIUM OR DIVALPROEX) IN THE TREATMENT OF
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 15 of 67
EXCLUSIVITY INDICATION
ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR I DISORDERS
I-419 MONOTHERAPY IN THE TREATMENT OF ACUTE MANIC EPISODES ASSOCIATED WITH BIPOLAR I
DISORDER
I-420 TOPICAL TREATMENT OF CLINICALLY TYPICAL, NONHYPERKERATOTIC, NONHYPERTROPHIC
ACTINIC KERATOSES ON THE FACE OR SCALP IN IMMUNOCOMPETENT ADULTS
I-421 TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS AND PYELONEPHRITIS DUE TO E.COLI
FOR PED PATIENTS (1-17) NOT AS FIRST CHOICE
I-422 INDICATED FOR THE IN-HOSPITAL SHORT-TERM (UP TO 4 HOURS) REDUCTION IN BLOOD
PRESSURE IN PEDIATRIC PATIENTS
I-423 ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
I-424 MANAGEMENT OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS WITH MODERATE TO SEVERE
CHRONIC RENAL INSUFFICIENCY NOT YET ON DIALYSIS
I-425 FLOXATIN IN COMBINATION WITH INFUSIONAL 5-FLUOROURACIL (5-FU) AND LEUCOVORIN (LV)
FOR THE TREATMENT OF PATIENTS PREVIOUSLY UNTREATED FOR ADVANCED COLORECTAL CANCER
I-426 TREATMENT OF ACUTE PULMONARY EMBOLISM WHEN ADMINISTERED IN CONJUNCTION WITH
WARFARIN SODIUM
I-427 TREATMENT OF ACUTE DEEP VEIN THROMBOSIS WITHOUT PULMONARY EMBOLISM WHEN
ADMINISTERED IN CONJUNCTION WITH WARFARIN SODIUM
I-428 FOR USE IN COMBINATION WITH PACLITAXEL FOR THE FIRST-LINE TREATMENT OF PATIENTS
WITH METASTATIC BREAST CANCER AFTER FAILURE OF PRIOR ANTHRACYCLINE CONTAINING
ADJUVANT CHEMOTHERAPY UNLESS ANTHRACYCLINES WERE CLINICALLY CONTRAINDICATED
I-429 FOR USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH ANDROGEN
INDEPENDENT (HORMONE REFRACTORY) METASTATIC PROSTATE CANCER
I-430 FOR USE IN THE RELIEF OF THE SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS IN ADULTS
I-431 NOSOCOMIAL PNEUMONIA AND COMMUNITY-ACQUIRED PNEUMONIA CAUSED BY STREPTOCOCCUS
PNEUMONIAE INDICATION EXPANDED TO INCLUDE MULTI-DRUG RESISTANT STRAINS
I-432 TREATMENT OF COMMUNITY ACQUIRED PNEUMONIA CAUSED BY MULTI-DRUG RESISTANT
STREPTOCOCCUS PNEUMONIAE
I-433 TREATMENT OF BIOPSY-CONFIRMED, PRIMARY SUPERFICIAL BASAL CELL CARCINOMA IN
IMMUNOCOMPETENT ADULTS, WITH A MAXIMUM TUMOR DIAMETER OF 2.0CM, LOCATED ON THE
TRUNK (EXCLUDING ANOGENITAL SKIN), NECK, OR EXTREMITIES (EXCLUDING HANDS AND FEET)
I-434 PREVENTION OF CARDIOVASCULAR DISEASE IN ADULT PATIENTS WITHOUT CLINICALLY EVIDENT
HEART DISEASE, BUT WITH MULTIPLE RISK FACTORS FOR CORONARY HEART DISEASE TO REDUCE
RISK OF MI AND RISK FOR REVASCULARIZATION PROCEDURES AND ANGINA
I-435 CHRONIC IDIOPATHIC CONSTIPATION
I-436 FOR USE IN COMBINATION WITH DOXORUBICIN AND CYCLOPHOSPHAMIDE FOR THE ADJUVANT
TREATMENT OF PATIENTS WITH OPERABLE NODE-POSITIVE BREAST CANCER
I-437 TREATMENT OF ACUTE MANIC AND MIXED EPISODES ASSOCIATED WITH BIPOLAR DISORDER
I-438 EMPIRICAL THERAPY FOR PRESUMED FUNGAL INFECTIONS IN FEBRILE, NEUTROPENIC PATIENTS
I-439 USED TO TREAT ADULTS WITH GROWTH HORMONE DEFICIENCY
I-440 FOR THE REPLACEMENT OF ENDOGENOUS GROWTH HORMONE IN ADULTS WITH GROWTH HORMONE
DEFICIENCY
I-441 USE COMBINATION WITH INFUSIONAL 5-FU/LV FOR ADJUVANT TREATMENT STAGE III COLON
CANCER PTS WHO HAVE UNDERGONE COMPLETE RESECTION PRIMARY TUMOR-BASED ON
IMPROVEMENT IN DISEASE FREE SURVIVAL, NO DEMONSTRATED BENEFIT OVERALL SURVIVAL
AFTER 4YRS
I-442 USED FOR CANDIDEMIA IN NONNEUTROPENIC PATIENTS AND THE FOLLOWING CANDIDA
INFECTIONS: DISSEMINATED INFECTIONS IN SKIN & INFECTIONS IN ABDOMEN, KIDNEY,
BLADDER WALL, AND WOUNDS
I-443 TREATMENT OF NASAL POLYPS IN PATIENTS 18 YEARS OF AGE AND OLDER
I-444 USE OF PROTONIX IV FOR INJECTION AS STAND ALONE THERAPY FOR THE SHORT-TERM
TREATMENT OF PATIENTS HAVING GASTROESOPHAGEAL REFLUX (GERD) WITH A HISTORY OF
EROSIVE ESOPHAGITIS
I-445 TO IMPROVE (COMPARED TO 4.25% DEXTROSE) LONG-DWELL ULTRAFILTRATION AND CLEARANCE
OF CREATININE AND UREA NITROGEN IN PATIENTS WITH HIGH AVERAGE OR GREATER TRANSPORT
CHARACTERISTICS, AS DEFINED USING THE PERITONEAL EQUILIBRATION TEST (PET)
I-446 EXTENDED ADJUVANT TREATMENT OF EARLY BREAST CANCER IN POSTMENOPAUSAL WOMEN WHO
HAVE RECEIVED 5 YRS ADJUVANT TAMOXIFEN THERAPY-EFFECTIVENESS BASED ON AN ANALYSIS
OF DISEASE FREE SURVIVAL IN PATIENTS TREATED FOR A MEDIAN 24 MONTHS
I-447 USE OF COPEGUS (RIBAVIRIN) FOR TREATMENT OF CHRONIC HEPATITIS C IN ADULT PATIENTS
COINFECTED WITH HIV IN COMBINATION WITH PEGASYS (PEGINTERFERON ALFA-2A)
I-448 TREATMENT OF HEART FAILURE (NYHA CLASS II-IV AND EJECTION FRACTION <=40%) TO
REDUCE THE RISK OF DEATH FROM CARDIOVASCULAR CAUSES AND TO REDUCE HOSPITALIZATIONS
FOR HEART FAILURE
I-449 TO IMPROVE WAKEFULNESS IN TWO NEW PATIENT POPULATIONS WITH EXCESSIVE SLEEPINESS:
THOSE WITH OBSTRUCTIVE SLEEP APNEA/HYPOPNEA SYNDROME AND THOSE WITH SHIFT WORK
SLEEP DISORDER
I-450 TREATMENT OF PATIENTS WITH NEWLY DIAGNOSED HIGH GRADE GLIOMAS CONCOMITANTLY WITH
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 16 of 67
EXCLUSIVITY INDICATION
RADIOTHERAPY AND THEN AS ADJUVANT TREATMENT
I-451 MANAGEMENT OF ENDOMETRIOSIS ASSOCIATED PAIN
I-452 EXPANDED INDICATION TO INCLUDE TREATMENT OF MULTIPLE MYELOMA PATIENTS WHO HAVE
RECEIVED AT LEAST 1 PRIOR THERAPY
I-453 USE IN COMBINATION WITH A SULFONYLUREA PLUS METFORMIN WHEN DIET, EXERCISE AND BOTH
AGENTS DO NOT RESULT IN ADEQUATE GLYCEMIC CONTROL (TRIPLE THERAPY)
I-454 MAINTENANCE OF CLINICAL REMISSION OF MILD TO MODERATE CHRON'S DISEASE INVOLVING
THE ILEUM AND/OR THE ASCENDING COLON FOR UP TO 3 MONTHS
I-455 MODIFIED HEART FAILURE INDICATION TO INCLUDE TREATMENT OF HEART FAILURE IN
PATIENTS WITH LEFT VENTRICULAR SYSTOLIC DYSFUNCTION (NYHA CLASS II-IV; EJECTION
FRACTION LESS THAN OR EQUAL TO 40%
I-456 TO REDUCE CARDIOVASCULAR DEATH AND TO REDUCE HEART FAILURE HOSPITALIZATIONS.
INCLUDES ADDITIONAL INFORMATION ON THE ADDED EFFECT ON THESE OUTCOMES WHEN USED
WITH AN ACE INHIBITOR
I-457 TREATMENT OF PATIENTS UNDERGOING ABDOMINAL SUREGERY WHO ARE AT RISK FOR
THROMBOEMBOLIC COMPLIATIONS
I-458 USE OF BIVALIRUDIN FOR INJECTION WITH PROVISIONAL USE OF GLYCOPROTEIN IIB/IIA
INHIBITOR (GPI) AS LISTED IN THE CLINICAL TRIALS REPLACE-2 SECTION FOR USE AS AN
ANTICOAGULANT IN PATIENTS UNDERGOING PERCUTANEOUS CORONARY INTERVENTION (PCI)
I-459 NON-DIALYSIS DEPENDENT CHRONIC KIDNEY DISEASE (NDD-CKD) PATIENTS RECEIVING OR NOT
RECEIVING AN ERYTHROPOIETIN
I-460 TREATMENT OF DIARRHEA CAUSED BY CRYPTOSPORIDIUM PARVUM IN NON-HIV INFECTED
PATIENTS 12 YEARS OF AGE AND OLDER
I-461 USE AS A SINGLE AGENT FOR ADJUVANT TREATMENT IN PATIENTS WITH DUKES' C COLON
CANCER WHO HAVE UNDERGONE COMPLETE RESECTION OF THE PRIMARY TUMOR WHEN TREATMENT
WITH FLUOROPYRIMIDINE THERAPY ALONE IS PREFERRED
I-462 LONG TERM TREATMENT OF IDIOPATHIC SHORT STATURE
I-463 TREATMENT OF PATIENTS POST MYOCARDIAL INFARCTION
I-464 TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME
I-465 PERENNIAL ALLERGIC RHINITIS IN ADULTS AND PEDIATRIC PATIENTS 6 MONTHS OF AGE AND
OLDER
I-466 FOR RELIEF OF THE SIGNS AND SYMPTOMS OF ANKYLOSING SPONDYLITIS
I-467 USE OF TOPIRAMATE AS INITIAL MONOTHERAPY IN PATIENTS 10 YEARS OF AGE AND OLDER
WITH PARTIAL ONSET OR PRIMARY GENERALIZED TONIC CLONIC SEIZURES
I-468 USE IN PATIENTS WITH STABLE CORONARY ARTERY DISEASE TO REDUSE THE RISK OF
CARDIOVASCULAR MORTALITY OR NON-FATAL MYOCARDIAL INFECTION
I-469 RELIEF OF THE SIGNS AND SYMPTOMS OF PAUCIARTICULAR OR POLYARTICULAR COURSE
JUVENILE RHEUMATOID ARTHRITIS IN PATIENTS 2 YEARS OF AGE AND OLDER
I-470 DIABETIC PERIPHERAL NEUROPATHIC PAIN
I-471 INDICATED TO REDUCE THE RISK OF MYOCARDIAL INFARCTION AND STROKE IN PATIENTS WITH
TYPE 2 DIABETES AND WITHOUT CLINICALLY EVIDENT CORONARY HEART DISEASE BUT WITH
MULTIPLE RISK FACTORS FOR CORONARY HEART DISEASE
I-472 USE IN PATIENTS WITH ANGIOGRAPHICALLY DOCUMENTED CORONARY ARTERY DISEASE
I-473 USE IN COMBINATION WITH GEMCITABINE FOR THE FIRST LINE TREATMENT OF PATIENTS WITH
LOCALLY ADVANCED UNRESECTABLE OR METASTATIC PANCREATIC CANCER
I-474 TREATMENT OF IRON DEFICIENCY ANEMIA IN PERITONEAL DIALYSIS DEPENDANT CHRONIC
KIDNEY DISEASE IN PATIENTS RECIEVING AN ERYTHROPOIETIN
I-475 PREVENTION OF NAUSEA AND VOMITTING ASSOCIATED WITH INITIAL AND REPEAT COURSES OF
MODERATELY EMETOGENIC CANCER CHEMOTHERAPY
I-476 TREATMENT OF DIABETIC FOOT INFECTIONS WITHOUT OSTEOMYELITIS
I-477 TREATMENT OF COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS CAUSED BY METHICILLIN
SUSCEPTIBLE STAPHYLOCOCCUS AUREUS, ESCHERICHIA COLI, KLEBSIELLA PNEUMONIAE, OR
ENTEROBACTER CLOACAE
I-478 FOR USE AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PARTIAL SEIZURES IN CHILDREN
WITH EPILEPSY AGED 2-4 YEARS
I-479 TREATMENT OF COMPLICATED INTRA-ABDOMINAL INFECTIONS CAUSED BY E.COLI, B. FRAGILIS,
S.ANGINOSUS, S.CONSTELLATUS, E. FAECALIS, P. MIRABILIS, C. PERFRINGENS, B.
THETAIOTAOMICRON OR PEPTOSTREPTOCOCCUS SPECIES
I-480 PROPHYLAXIS OF INFLUENZA FOR PATIENTS BETWEEN 1-12 YEARS OF AGE
I-481 INDICATED FOR THE ADJUVANT TREATMENT OF POSTMENOPAUSAL WOMEN WITH HORMONE RECEPTOR
POSITIVE EARLY BREAST CANCER
I-482 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER WITH
OR WITHOUT PSYCHOTIC FEATURES
I-483 PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
I-484 FOR THE RISK REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCERS
I-485 TREATMENT OF POSTOPERATIVE INFLAMMATION AND REDUCTION OF OCULAR PAIN IN PATIENTS
WHO HAVE UNDERGONE CATARACT EXTRACTION
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 17 of 67
EXCLUSIVITY INDICATION
I-486 ANGIOMAX IS INDICATED FOR PATIENTS WITH, OR AT RISK OF, HIT/HITTS UNDERGOING PCI
I-487 INDICATED FOR THE RELIEF OF THE INFAMMATORY AND PRURITIC MANIFESTATIONS OF
CORTICOSTEROID RESPONSIVE DERMATOSES IN PATIENTS 12 YRS OF AGE OR OLDER
I-488 MAINTENANCE THERAPY IN BIPOLAR I DISORDER
I-489 FOR USE IN PEDIATRIC PATIENTS WITH TYPE I DIABETES
I-490 FOR USE IN COMBINATION WITH CISPLATIN AND FLUOROURACIL FOR THE TREATMENT OF
PATIENTS WITH ADVANCED GASTRIC ADENOCARCINOMA, INCLUDING ADENOCARCINOMA OF
GASTROESOPHAGEAL JUNCTION, WHO HAVE NOT RECEIVED PRIOR CHEMOTHERAPY FOR ADVANCED
DISEASE
I-491 INFLUENZA PROPHYLAXIS
I-492 MONOTHERAPY IN THE TREATMENT OF ACUTE MANIC OR MIXED EPISODES IN BIPOLAR I
DISORDER, WITH OR WITHOUT PSYCHOTIC FEATURES
I-493 ADMINISTERED IN COMBINATION WITH FENOFIBRATE, AS ADJUNCTIVE THERAPY TO DIET FOR
THE REDUCTION OF ELEVATED TOTAL-C, LDL-C, APO B, AND NON-HDL-C IN PATIENTS WITH
MIXED HYPERLIPIDEMIA
I-494 CLINICAL DATA IN SUPPORT OF AVANDAMET AS AN ADJUNCT TO DIET AND EXERCISE TO
IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHEN TREATMENT
WITH DUAL ROSIGLITAZONE AND METFORMIN THERAPY IS APPROPRIATE
I-495 ADJUVANT TX OF POSTMENOPAUSAL WOMEN WITH ESTROGEN-RECEPTOR POSITIVE EARLY BREAST
CANCER WHO HAVE RECEIVED 2 TO 3 YRS OF TAMOXIFEN AND ARE SWITCHED TO AROMASIN FOR
COMPLETION OF A TOTAL OF 5 CONSECUTIVE YRS OF ADJUVANT HORMONAL THERAPY
I-496 LONG TERM TREATMENT OF GROWTH FAILURE ASSOCIATED WITH TURNER SYNDROME IN PATIENTS
WHO HAVE OPEN EPIPHYSES
I-497 PREVENTION OF SEASONAL MAJOR DEPRESSIVE EPISODES IN PATIENTS WITH SEASONAL
AFFECTIVE DISORDER
I-498 PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING
I-499 USE OF GEMZAR IN COMBINATION WITH CARBOPLATIN FOR THE TREATMENT OF PATIENTS WITH
ADVANCED OVARIAN CANCER THAT HAS RELAPSED AT LEAST 6 MONTHS AFTER COMPLETION OF
PLATINUM-BASED THERAPY
I-500 FOR USE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF MULTIPLE MYELOMA
PATIENTS WHO HAVE RECEIVED AT LEAST ONE PRIOR THERAPY
I-501 TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) IN IMMUNOCOMPETANT PATIENTS
WITH A SINGLE DOSE OF FAMCICLOVIR 1500 MG.
I-502 FOR PTS WITH ST-SEGMENT ELEVATION ACUTE MYOCARDIAL INFARCTION, PLAVIX TO REDUCE
RATE OF DEATH FROM ANY CAUSE AND THE RATE OF A COMBINED ENDPOINT OF DEATH,
REINFARCTION OR STROKE. NOT KNOWN TO PERTAIN TO PTS WHO RECEIVE PRIMARY
ANGIOPLASTY
I-503 TREATMENT OF MAJOR DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER
I-504 TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON
SYNDROME
I-505 TREATMENT OF STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA), INCLUDING
THOSE WITH RIGHT SIDED INFECTIVE ENDOCARDITIS, CAUSED BY METHICILLIN-SUSCEPTIBLE
AND METHICILLIN-RESISTANT ISOLATES
I-506 ADJUNCTIVE THERAPY OF MYOCLONIC SEIZURES IN ADULTS AND ADOLESCENTS AGE 12 AND OVER
WITH JUVENILE MYOCLONIC EPILEPSY
I-507 ADJUNCT TO DIET TO REDUCE TOTAL-C, LDL-C AND APO B LEVELS IN ADOLESCENT BOYS AND
GIRLS WHO ARE AT LEAST ONE YEAR POST-MENARCHE, 10-16 YEARS OF AGE, WITH
HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
I-508 PREMENSTRUAL DYSPHONIC DISORDER
I-509 TREATMENT OF IRRATABILITY ASSOCIATED WITH AUTISTIC DISORDER
I-510 ADULT DERMAFIBROSARCOMA PROTUBERANS (DFSP)
I-511 ADULT MYELODYSPLASTIC SYNDROME/MYELOPROLIFERATIVE DISEASES (MDS/MDP)
I-512 ADULT PH+ ACUTE LYMPHOBLASTIC LEUKEMIA (ALL) MONOTHERAPY
I-513 ADULT AGGRESSIVE SYSTEMIC MASTOCYTOSIS (ASM)
I-514 ADULT HYPEREOSINOPHILIC SYNDROME/CHRONIC EOSINOPHILIC LEUKEMIA (HES/CEL)
I-515 PROPHYLAXIS OF SURGICAL SITE INFECTION FOLLOWING ELECTIVE COLORECTAL SURGERY
I-516 PRIMARY GENERALIZED TONIC CLONIC SEIZURES IN ADULTS AND PEDIATRIC PATIENTS 2 YEARS
OF AGE AND OLDER
I-517 TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEG SYNDROME (RLS)
I-518 TREATMENT OF SHORT STATURE OR GROWTH FAILURE IN CHILDREN WITH SHOX (SHORT STATURE
HOMEOBOX CONTAINING GENE) DEFICIENCY WHOSE EPIPHYSES ARE NOT CLOSED
I-519 USE OF TAXOTERE (DOCETAXEL) INJECTION CONCENTRATE IN COMBINATION WITH CISPLATIN
AND FLUOROURACIL FOR THE INDUCTION OF PATIENTS WITH INOPERABLE LOCALLY ADVANCED
SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK (SCCHN)
I-520 USE OF EXENATIDE IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE USING A
THIAZOLIDINEDIONE ALONE OR IN COMBINATION WITH METFORMIN BUT HAVE NOT ACHIEVED
ADEQUATE GLYCEMIC CONTROL
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 18 of 67
EXCLUSIVITY INDICATION
I-521 TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST 1 YEAR
PRIOR THERAPY
I-522 TREATMENT OF MODERATE ACNE VULGARIS IN WOMEN AT LEAST 14 YRS OF AGE, WHO HAVE NO
KNOWN CONTRAINDICATIONS TO ORAL CONTRACEPTIVE THERAPY, AND HAVE ACHIEVED MENARCHE,
IF THE PATIENT DESIRES AN ORAL CONTRACEPTIVE FOR BIRTH CONTROL.
I-523 USE IN ADULT PATIENTS WITH CLINICALLY EVIDENT CORONARY HEART DISEASE TO REDUCE THE
RISK OF NONFATAL MYOCARDIAL INFARCTION, FATAL AND NONFATAL STROKE, ANGINA,
REVASCULARIZATION PROCEDURES AND HOSPITALIZATION FOR CONGESTIVE HEART FAILURE
I-524 GENERALIZED ANXIETY DISORDER (GAD)
I-525 USE OF 0.5MG/0.1MG FOR PREVENTION OF POST-MENOPAUSAL OSTEOPOROSIS
I-526 TREATMENT OF HYPONATREMIA IN HOSPITALIZED PATIENTS
I-527 ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SEIZURES
IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER WITH IDIOPATHIC GENERALIZED
EPILEPSY
I-528 TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE,
SYMPTOMS OF VULVAR AND VAGINAL ATROPHY ASSOCIATED WITH MENOPAUSE
I-529 TREATMENT OF DEMENTIA OF THE ALZHEIMER'S TYPE IN PATIENTS WITH SEVERE ALZHEIMER'S
DISEASE
I-530 PREVENTION OF EXERCISE-INDUCED BRONCHOCONSTRICTION IN PATIENTS 15 YEARS OF AGE AND
OLDER
I-531 MAINTENANCE TREATMENT OF SCHIZOPHRENIA
I-532 TREATMENT OF BACTERIAL VAGINOSIS IN NON-PREGNANT FEMALES
I-533 ACUTE ST-SEGMENT ELEVATION MYOCARDIAL INFARCTION (STEMI)
I-534 EXTENDED TREATMENT OF SYMPTOMATIC VENOUS THROMBOEMBOLISM (VTE) AND/OR PULMONARY
EMBOLISM TO REDUCE THE RECCURENCE OF VTE IN PATIENTS WITH CANCER
I-535 MANAGEMENT OF FIBROMYALGIA
I-536 FOR THE TREATMENT OF SHORT STATURE IN CHILDREN WITH NOONAN SYNDROME
I-537 LONG TERM TREATMENT OF PANIC DISORDER
I-538 SHORT TERM TREATMENT OF PANIC DISORDER
I-539 REDUCTION IN RISK OF INVASIVE BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH
OSTEOPOROSIS OR AT HIGH RISK FOR INVASIVE BREAST CANCER
I-540 TREATMENT OF SCHIZOPHRENIA IN ADOLESCENTS AGES 13-17
I-541 TREATMENT OF BIPOLAR I DISORDER IN CHILDREN AGES 10-12 AND ADOLESCENTS AGES 13-17
I-542 EXPANSION OF PATIENT POPULATION FOR HEAD AND NECK CANCER FROM "INOPERABLE"
PATIENTS TO ALL PATIENTS
I-543 USE IN COMBINATION WITH CISPLATIN AND FLUOROURACIL FOR THE INDUCTION TREATMENT OF
PATIENTS WITH LOCALLY ADVANCED SQUAMOUS CELL CARCINOMA OF THE HEAD AND NECK
(SCCHN)
I-544 ADJUNCTIVE THERAPY OF MYOCLONIC SEIZURES IN ADULTS AND ADOLESCENTS AGE 16 AND OVER
WITH JUVENILE MYOCLONIC EPILEPSY
I-545 ADJUNCTIVE TREATMENT TO TREAT PATIENTS WITH MAJOR DEPRESSIVE DISORDER
I-546 TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA
I-547 ADJUNCTIVE THERAPY TO DIET TO SLOW THE PROGRESSION OF ARTHEROSCLEROSIS IN ADULT
PATIENTS AS PART OF A TREATMENT STRATEGY TO LOWER TOTAL-C AND LDL-C TO TARGET
LEVELS
I-548 SEASONAL ALLERGIC RHINITIS IN PATIENTS 6 THROUGH LESS THAN 12 YEARS OF AGE
I-549 USE OF AVALIDE TABLETS AS INITIAL THERAPY IN PATIENTS WHO ARE LIKELY TO NEED
MULTIPLE DRUGS TO ACHIEVE THEIR BLOOD PRESSURE GOALS
I-550 TREATMENT OF HYPERTENSION IN PEDIATRIC PATIENTS 6-16 YEARS OF AGE
I-551 TREATMENT OF SHORT STATURE IN CHILDREN WITH TURNER'S SYNDROME
I-552 ADJUNCTIVE TREATMENT FOR RADIOIODINE ABLATION OF THYROID TISSUE REMNANTS IN
PATIENTS WHO HAVE UNDERGONE THYROIDECTOMY FOR WELL-DIFFERENTIATED THYROID CANCER
AND WHO DO NOT HAVE EVIDENCE OF METASTATIC THYROID CANCER
I-553 FOR USE AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS
WITH TYPE 2 DIABETES MELLITUS
I-554 TREATMENT OF PATIENTS WITH CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, CANDIDA
PERITONIS AND ABSCESSES
I-555 TREATMENT OF ACUTE MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER IN
PEDIATRIC PATIENTS AGED 10-17 YEARS
I-556 PREVENTION OF POST OPERATIVE NAUSEA AND VOMITING FOR UP TO 24 HOURS FOLLOWING
SURGERY
I-557 USE OF AMITIZA (LUBIPROSTONE) 8 MCG TWICE DAILY FOR TREATMENT OF IRRITABLE BOWEL
SYNDROME WITH CONSTIPATION IN WOMEN GREATER THAN OR EQUAL TO 18 YEARS OLD
I-558 MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION AND REDUCING EXACERATIONS IN PATIENTS
WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) INCLUDING CHRONIC BRONCHITIS AND
EMPHYSEMA
I-559 ADJUNCTIVE THERAPY ADDED TO LITHIUM OR VALPROATE IN SHORT TERM TREATMENT OF
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 19 of 67
EXCLUSIVITY INDICATION
BIPOLAR DISORDER, MANIC OR MIXED
I-560 MAINTENANCE TREATMENT FOR BIPOLAR I DISORDER, AS ADJUNCTIVE THERAPY TO LITHIUM OR
DIVALPROEX
I-561 LONG-TERM TREATMENT OF SOCIAL ANXIETY DISORDER
I-562 MAINTENANCE TREATMENT OF ATTENTION-DEFICIT DISORDER (ADHD) IN CHILDREN AND
ADOLESCENTS
I-563 ADJUNCTIVE THERAPY IN THE TREATMENT OF PRIMARY GENERALIZED TONIC-CLONIC SIEZURES
IN ADULTS AND CHILDREN 16 YEARS OF AGE AND OLDER WITH IDIOPATHIC GENERALIZED
EPILEPSY
I-564 TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA
I-565 USE OF DUTASTERIDE IN COMBINATION WITH TAMSULOSIN FOR THE TREATMENT OF SYMPTOMATIC
BENIGN PROSTATIC HYPERPLASIA (BPH)
I-566 MANAGEMENT OF FIBROMYALGIA
I-567 INITIAL THERAPY IN PATIENTS LIKELY TO NEED MULTIPLE DRUGS TO ACHIEVE THEIR BLOOD
PRESSURE GOALS
I-568 USE OF APTIVUS, CO-ADMINISTERED W/RITONAVIR, FOR COMBINATION ANTIRETROVIRAL
TREATMENT OF HIV-1 INFECTED PED (AGE 2-18 YRS) PATIENTS WHO ARE TREATMENT-
EXPERIENCED AND INFECTED W/HIV-1 STRAINS RESISTANT TO MORE THAN ONE PROTEASE
INHIBITOR
I-569 TREATMENT OF CHRONIC HEPATITIS B
I-570 TREATMENT OF CHICKEN POX IN IMMUNOCOMPETENT PEDIATRIC PATIENTS 2 TO <18 YEARS OF
AGE
I-571 NON-SMALL CELL LUNG CANCER IN COMBINATION WITH CISPLATIN AND AS SINGLE AGENT FOR
NONSQAUMOUS NON-SMALL CELL LUNG CANCER
I-572 TREATMENT OF GROWTH FAILURE IN CHILDREN BORN SMALL FOR GESTATIONAL AGE (SGA) WITH
NO CATCH-UP BY AGE 2-4 YRS.
I-573 TO TREAT PATIENTS WITH PRIMARY DYSBETALIPOPROTEINEMIA (FREDICKSON TYPE III
HYPERLIPOPROTEINEMIA) AS AN ADJUNCT TO DIET
I-574 MONOTHERAPY IN THE TREATMENT OF BIPOLAR DEPRESSION
I-575 MONOTHERAPY IN THE TREATMENT OF BIPOLAR MANIA
I-576 ADJUNCTIVE THERAPY IN THE TREATMENT OF BIPOLAR MANIA
I-577 SEDATION OF NON-INTUBATED PATIENTS PRIOR TO AND/OR DURING SURGICAL AND OTHER
PROCUDURES
I-578 EXPANSION OF INDICATION TO INCLUDE TREATMENT OF HIV IN TREATMENT NAIVE ADULTS
I-579 TREATMENT OF MODERATE TO SEVERE DYSPAREUNIA, A SYMPTOM OF VULVAR AND VAGINAL
ATROPHY, DUE TO MENOPAUSE AND NEW TWICE WEEKLY DOSING REGIMEN FOR THIS INDICATION
I-580 INDOLENT B-CELL NON-HODGKINS LYMPHOMA (NHL) THAT HAS PROGRESSED DURING OR WITHIN
SIX MONTHS OF TREATMENT WITH RITUXIMAB OR A RITUXIMAB CONTAINING REGIMEN
I-581 TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
I-582 TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
I-583 ADJUVANT TREATMENT OF ADULT PATIENTS FOLLOWING COMPLETE GROSS RESECTION OF KIT
(CD117) POSITIVE GASTOINTESTINAL STROMAL TUMORS (GIST)
I-584 TREATMENT AND PREVENTION OF GLUCOCORTICOID-INDUCED OSTEOPOROSIS IN PATIENTS
EXPECTED TO BE ON GLUCOCORTICOIDS FOR AT LEAST 12 MONTHS
I-585 TREATMENT OF SHORT STATURE IN PEDIATRIC PATIENTS SMALL FOR GESTATIONAL AGE WHO DO
NOT MANIFEST CATCH UP GROWTH BY AGE 2 TO 4 YEARS
I-586 COMMUNITY ACQUIRED BACTERIAL PNEUMONIA
I-587 ADDITIONAL PATHOGENS TO COMPLICATED SKIN AND SKIN STRUCTURE INFECTIONS INDICATION
I-588 ADDITIONAL PATHOGENS TO COMPLICATED INTRA-ABDOMINAL INFECTIONS INDICATION
I-589 TREATMENT OF TREATMENT RESISTANT DEPRESSION (TRD) IN COMBINATION WITH OLANZAPINE
I-590 ACUTE TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER (IN
COMBINATION WITH OLANZAPINE)
I-591 TREATMENT OF TREATMENT RESISTANT DEPRESSION (TRD) IN COMBINATION WITH FLUOXETINE
I-592 ACUTE TREATMENT OF DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR DISORDER (IN
COMBINATION WITH FLUOXETINE)
I-593 TREATMENT OF TREATMENT RESISTANT DEPRESSION (TRD)
I-594 INDICATION EXPANDED TO INCLUDE PATIENTS WHO HAVE EXPERIENCED A FIRST CLINICAL
EPISODE AND HAVE MRI FEATURES CONSISTENT WITH MULTIPLE SCLEROSIS
I-595 PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
I-596 USE AS ADJUNCTIVE THERAPY WITH LITHIUM OR VALPROATE FOR THE MAINTENANCE TREATMENT
OF BIPOLAR I DISORDER
I-597 MONOTHERAPY FOR THE MAINTENANCE TREATMENT OF BIPOLAR I DISORDER
I-598 TREATMENT OF PULMONARY ARTERIAL HYPERTENSION INDICATION EXPANDED TO INCLUDE DELAY
IN CLINICAL WORSENING
I-599 PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC
KIDNEY DISEASE (CKD) STAGE 5 IN PATIENTS ON HEMODIALYSIS OR PERITONEAL DIALYSIS
I-600 FOR USE AS INITIAL THERAPY IN PATIENTS WHO ARE LIKELY TO NEED MULTIPLE DRUGS TO
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 20 of 67
EXCLUSIVITY INDICATION
ACHIEVE THEIR BLOOD PRESSURE GOALS
I-601 MAINTENANCE TREATMENT IN PATIENTS WITH ADVANCED OR METASTATIC NONSQUAMOUS NON-
SMALL CELL LUNG CANCER WHOSE DISEASE HAS NOT PROGRESSED AFTER FOUR CYCLES OF
PLATINUM-BASED FIRST LINE CHEMOTHERAPY
I-602 TREATMENT OF MEN AND WOMEN WITH OSTEOPOROSIS ASSOCIATED WITH SUSTAINED SYSTEMIC
GLUCOCORTICOID THERAPY AT HIGH RISK FOR FRACTURE
I-603 GOUT FLARES
I-604 PREVENTION OF CMV DISEASE IN KIDNEY AND HEART TRANSPLANT PATIENTS 4 MONTHS TO 16
YEARS AT HIGH RISK
I-605 ADJUNCT TO MOOD STABILIZERS AND/OR ANTIDEPRESSANTS FOR SCHIZOAFFECTIVE DISORDER
I-606 TREATMENT OF SCHIZOAFFECTIVE DISORDER AS MONOTHERAPY
I-607 INDICATION EXPANDED TO INCLUDE TREATMENT OF PULMONARY ARTENAL HYPERTENSION (WHO
GROUP I) IN PATIENTS WITH CLASS II SYMPTOMS
I-608 REDUCE LDL-C LEVELS IN BOYS AND POSTMENARCHAL GIRLS, 10 TO 17 YEARS OF AGE, WITH
HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA AS MONOTHERAPY OR IN COMBINATION WITH A
STATIN AFTER FAILING AN ADEQUATE TRIAL OF DIET THERAPY
I-610 TREATMENT OF HEAVY MENSTRUAL BLEEDING FOR WOMEN WHO CHOOSE TO USE INTRAUTERINE
CONTRACEPTION AS THEIR METHOD OF CONTRACEPTION
I-611 TREATMENT OF HETEROZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA IN ADOLESCENT BOYS AND
POSTMENARCHAL GIRLS, AGES 10 TO 17 YEARS, WITH A RECOMMENDATION DOSING RANGE OF 5
TO 20 MG ONCE DAILY
I-612 MICARDIS 80 MG FOR REDUCTION OF THE RISK OF MYOCARDIAL INFARCTION, STROKE, OR
DEATH FROM CARDIOVASCULAR CAUSES IN PATIENTS 55 YEARS OF AGE OR OLDER AT HIGH RISK
OF DEVELOPING MAJOR CARDIOVASCULAR EVENTS WHO ARE UNABLE TO TAKE ACE INHIBITORS
I-613 MILD TO MODERATE ATOPIC DERMATITIS IN PATIENTS 3 MONTHS OF AGE TO LESS THAN 18
YEARS OF AGE
I-614 SHORT TERM TREATMENT OF EROSIVE ESOPHAGITIS ASSOCIATED WITH GERD IN PEDIATRIC
PATIENTS AGES FIVE YEARS AND OLDER
I-615 MAINTENANCE TREATMENT OF BIPOLAR DISORDER AS AN ADJUNCT TO LITHIUM OR VALPROATE
I-616 TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER IN PEDIATRIC PATIENTS
AGES 6-17 YEARS OF AGE
I-617 MAINTENANCE OF GENERALIZED ANXIETY DISORDER (GAD)
I-618 ADJUNCTIVE THERAPY IN THE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
I-619 INTRAVENOUS CONTRAST ENHANCED COMPUTER TOMOGRAPHY OF THE HEAD AND BODY
I-620 FOR USE IN COMBINATION WITH LETROZOLE FOR THE TREATMENT OF POSTMENOPAUSAL WOMEN
WITH HORMONE RECEPTOR POSITIVE METASTATIC BREAST CANCER THAT OVEREXPRESSES THE
HER2 RECEPTOR FOR WHOM HORMONAL THERAPY IS INDICATED
I-621 PRIMARY PREVENTION OF CARDIOVASCULAR DISEASE, BASED ON THE RESULTS OF
JUSTIFICATION FOR THE USE OF STATINS IN PRIMARY PREVENTION; AN INTERVENTION TRIAL
EVALUATING ROSUVASTATIN (JUPITER)
I-622 ADJUNCTIVE THERAPY FOR PRIMARY GENERALIZED TONIC-CLONIC SEIZURES IN PATIENTS
THIRTEEN YEARS OF AGE AND OLDER
I-623 TREATMENT OF SIGNS AND SYMPTOMS OF ADVANCED IDIOPATHIC PARKINSON'S DISEASE
I-624 MAINTENANCE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NON-SMALL
CELL LUNG CANCER WHOSE DISEASE HAS NOT PROGRESSED AFTER FOUR CYCLES OF PLATINUM-
BASED FIRST-LINE CHEMOTHERAPY
I-625 PANCREATIC INSUFFICIENCY DUE TO CHRONIC PANCREATITIS AND PANCREATECTOMY
I-626 RELIEF OF NASAL CONGESTION ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN ADULTS
AND PEDIATRIC PATENTS 2 YEARS OF AGE AND OLDER
I-627 TREATMENT OF NEWLY DIAGNOSED ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME POSITIVE
CHRONIC MYELOID LEUKEMIA (PH & CML) IN CHRONIC PHASE.
I-628 MAINTENANCE TREATMENT OF SCHIZOPHRENIA IN ADULTS
I-629 ADJUNCTIVE THERAPY WITH EITHER LITHIUM OR VALPROATE FOR THE ACUTE TREATMENT OF
MANIC OR MIXED EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
I-630 TREATMENT OF PATIENTS WITH SUBEPENDYMAL GIANT CELL ASTROCYTOMA (SEGA) ASSOCIATED
WITH TUBEROUS SCLEROSIS (TS) WHO REQUIRE THERAPEUTIC INTERVENTION BUT ARE NOT
CANDIDATES FOR CURATIVE SURGICAL RESECTION.
I-631 PREVENTION OF RELAPSE TO OPIOID DEPENDENCE FOLLOWING OPIOID DETOXIFICATION
I-632 MANAGEMENT OF CHRONIC MUSCULOSKELETAL PAIN
I-633 MAINTENANCE TREATMENT OF BIPOLAR I DISORDER AS AN ADJUNCT TO LITHIUM OR VALPROATE
I-634 TREATMENT OF SEVERE HYPERCALCEMIA IN PATIENTS WITH PRIMARY HYPERPARATHYROIDISM WHO
ARE UNABLE TO UNDERGO PARATHYROIDECTOMY
I-635 ADJUNCTIVE TREATMENT WITH LONG-ACTING ORAL PSYCHOSTIMULANTS FOR THE TREATMENT OF
ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
I-636 TREATMENT OF EXTERNAL GENITAL AND PERIANAL WARTS/CONDYLOMA ACUMINATA IN PATIENTS
12 YEARS OR OLDER
I-637 USE IN COMBINATION CHEMOTHERAPY WITH 5-FLUOROURACIL IN THE PALLIATIVE TREATMENT OF
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 21 of 67
EXCLUSIVITY INDICATION
PATIENTS WITH ADVANCED METASTATIC COLORECTAL CANCER
I-638 FOR PATIENTS WITH PROGRESSIVE NEUROENDOCRINE TUMORS OF PANCREATIC ORIGIN (PNET)
THAT ARE UNRESECTABLE, LOCALLY ADVANCED, OR METASTATIC.
I-639 TREATMENT OF PROGRESSIVE, WELL-DIFFERENTIATED PANCREATIC NEUROENDOCRINE TUMORS IN
PATIENTS WITH UNRESECTABLE, LOCALLY ADVANCED, OR METASTATIC DISEASE
I-640 MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS
I-641 TREATMENT OF THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA (BPH)
I-642 TREATMENT OF ERECTILE DYSFUNCTION (ED) AND THE SIGNS AND SYMPTOMS OF BENIGN
PROSTATIC HYPERPLASIA (BPH)
I-643 REDUCE THE RISK OF STROKE AND SYSTEMIC EMBOLISM IN PATIENTS WITH NONVALVULAR
ATRIAL FIBRILLATION.
I-644 MONOTHERAPY IN PATIENTS 13 YEARS OF AGE AND OLDER WITH PARTIAL SEIZURES WHO ARE
RECEIVING THERAPY WITH A SINGLE ANTIEPILEPTIC DRUG (AED)
I-645 MAINTENANCE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN ADULTS
I-646 SIGNS AND SYMPTOMS OF ADVANCED PARKINSON'S DISEASE (APD)
I-647 SIGNS AND SYMPTOMS OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS)
I-648 TREATMENT OF HEAVY MENSTRUAL BLEEDING IN WOMEN WITHOUT ORGANIC PATHOLOGY WHO
CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION
I-649 TREATMENT OF PATIENTS WITH ADVANCED SOFT TISSUE SARCOMA (STS) WHO HAVE RECEIVED
PRIOR CHEMOTHERAPY
I-650 TREATMENT OF ADULTS WITH RENAL ANGIOMYOLIPOMA AND TUBEROUS SCLEROSIS COMPLEX
(TSC), NOT REQUIRING IMMEDIATE SURGERY
I-651 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH SPINAL CORD INJURY
I-652 MANAGEMENT OF POSTHERPETIC NEURALGIA
I-653 TREATMENT OF ENDOGENOUS ANTERIOR UVEITIS
I-654 MAGNETIC RESONANCE ANGIOGRAPHY (MRA) TO EVALUATE ADULTS WITH KNOWN OR SUSPECTED
RENAL OR AORTO-ILIO-FEMORAL OCCLUSIVE VASCULAR DISEASE
I-655 TREATMENT OF POSTMENOPAUSAL WOMEN WITH ADVANCED HORMONE RECEPTOR-POSITIVE,HER2-
NEGATIVE BREAST CANCER (ADVANCED HR+BC) IN COMBINATION WITH EXEMESTANE, AFTER
FAILURE OF TREATMENT WITH LETROZOLE OR ANASTROZOLE
I-656 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
(DPN) IN ADULTS WHEN A CONTINUOUS, AROUND-THE-CLOCK OPIOID ANALGESIC IS NEEDED FOR
AN EXTENDED PERIOD OF TIME
I-657 PLAQUE PSORIASIS OF THE SCALP
I-658 FIRST-LINE TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON-SMALL CELL LUNG CANCER,
IN COMBINATION WITH CARBOPLATIN, IN PATIENTS WHO ARE NOT CANDIDATES FOR CURATIVE
SURGERY OR RADIATION THERAPY
I-659 PLAQUE PSORIASIS OF THE BODY
I-660 TREATMENT OF DEEP VEIN THROMBOSIS
I-661 TREATMENT OF PULMONARY EMBOLISM
I-662 REDUCTION IN RISK FOR DEEP VEIN THROMBOSIS AND THE REDUCTION IN RISK FOR PULMONARY
EMBOLISM
I-663 IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC
CASTRATION-RESISTANT PROSTATE CANCER
I-664 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE
INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
I-665 TREATMENT OF CHRONIC IRON OVERLOAD IN PATIENTS 10 YRS OF AGE AND OLDER WITH
(NTDT)SYNDROMES AND WITH A (LIC) OF AT LEAST 5 MG OF IRON PER GRAM OF LIVER DRY
WEIGHT (MG FE/G DW) AND SERUM FERRITIN GREATER THAN 300MCG/L
I-666 TREATMENT OF PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME-
POSITIVE ACUTE LYMPHOBLASTIC LEUKEMIA (PH+ALL) IN COMBINATION WITH CHEMOTHERAPY
I-667 TREATMENT OF PATIENTS WITH LOCALLY ADVANCED, UNRESECTABLE OR METASTATIC
GASTROINTESTINAL STROMAL TUMOR (GIST) WHO HAVE BEEN PREVIOUSLY TREATED WITH
IMATINIB MESYLATE AND SUNITINIB MALATE
I-668 PROPHYLAXIS OF ALLOGRAFT REJECTION IN ADULT PATIENTS RECEIVING A LIVER TRANSPLANT
I-669 SCINTIGRAPIC ASSESSMENT OF SYMPATHETIC INNERVATION OF THE MYOCARDIUM BY
MEASUREMENT OF THE HEART TO MEDIASTINUM (H/M) RATIO OF RADIOACTIVITY UPTAKE IN
PATIENTS WITH NYHA CLASS II OR CLASS III HEART FAILURE AND LVEF LESS THAN 35%
I-670 TREATMENT OF OPIOID-INDUCED CONSTIPATION (OIC) IN ADULTS WITH CHRONIC, NON-CANCER
PAIN
I-671 FIRSTLINE TREATMENT OF PATIENTS WITH METASTATIC NON- SMALL CELL LUNG CANCER
(NSCLC) WHOSE TUMORS HAVE EPIDERMAL GROWTH FACTOR RECEPTOR (EGFR) EXON 19
DELETIONS OR EXON 21(L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA- APPROVED
TEST
I-672 USE IN PATIENTS WITH MANTLE CELL LYMPHOMA WHOSE DISEASE HAS RELAPSED OR PROGRESSED
AFTER TWO PRIOR THERAPIES, ONE OF WHICH INCLUDED BORTEZOMIB
I-673 TREATMENT OF HOSPITAL-ACQUIRED BACTERIAL PNEUMONIA/VENTILATOR-ASSOCIATED BACTERIAL
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 22 of 67
EXCLUSIVITY INDICATION
PNEUMONIA (HABP/VABP) CAUSED BY SUSCEPTIBLE ISOLATES OF S. AUREUS (INCL.
METHICILLIN-SUSCEPTIBLE AND -RESISTANT ISOLATES) WHEN ALTERNATIVE TREATMENTS ARE
NOT SUITABLE
I-674 TREATMENT OF PATIENTS WITH DEPRESSIVE EPISODES ASSOCIATED WITH BIPOLAR I DISORDER
(BIPOLAR DEPRESSION) AS MONOTHERAPY AND AS ADJUNCTIVE THERAPY WITH LITHIUM OR
VALPROATE
I-675 MAINTENANCE TREATMENT OF MAJOR DEPRESSIVE DISORDER
I-676 FIRST-LINE TREATMENT OF PATIENTS WITH METASTATIC ADENOCARACINOMA OF THE PANCREAS,
IN COMBINATION WITH GEMCITABINE
I-677 TREATMENT OF PATIENTS WITH LOCALLY RECURRENT OR METASTATIC, PROGRESSIVE,
DIFFERENTIATED THYROID CARCINOMA (DTC) THAT IS REFRACTORY TO RADIOCACTIVE IODINE
TREATMENT
I-678 TRAMETINIB, IN COMBINATION WITH DABRAFENIB, FOR THE TREATMENT OF PATIENTS WITH
UNRESECTABLE OR METASTATIC MELANOMA WITH BRAF V600E OR V600K MUTATIONS AS DETECTED
BY AN FDA-APPROVED TEST
I-679 RISK REDUCTION OF REBLEEDING OF GASTRIC OR DUODENAL ULCERS FOLLOWING THERAPEUTIC
ENDOSCOPY IN ADULTS
I-680 TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WHO HAVE RECEIVED AT
LEAST ONE PRIOR THERAPY
I-681 PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT) WHICH MAY LEAD TO PULMONARY EMBOLISM
(PE), IN ADULT PATIENTS WHO HAVE UNDERGONE HIP OR KNEE REPLACEMENT
I-682 TREATMENT OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY EMBOLISM (PE) IN PATIENTS
WHO HAVE BEEN TREATED WITH A PARENTERAL ANTICOAGULANT FOR 5-10 DAYS
I-683 TO REDUCE THE RISK OF RECURRENCE OF DVT AND PE IN PATIENTS WHO HAVE BEEN
PREVIOUSLY TREATED
I-684 PREVENTION OF ACUTE NAUSEA AND VOMITING ASSOCIATED WITH INITIAL AND REPEAT COURSES
OF EMETOGENIC CANCER CHEMOTHERAPY, INCLUDING HIGHLY EMETOGENIC CANCER CHEMOTHERAPY
IN PEDIATRIC PATIENTS AGED 1 MONTH TO LESS THAN 17 YEARS
I-685 EXPANDED INDICATION OF RASAGILINE AS AN ADD-ON THERAPY TO STABLE DOSES OF DOPAMINE
AGONISTS IN THE TREATMENT OF EARLY PARKINSON'S DISEASE
I-686 INDICATED FOR THE TREATMENT OF DIABETIC MACULAR EDEMA IN PATIENTS WHO ARE
PSEUDOPHAKIC OR ARE PHAKIC AND SCHEDULED FOR CATARACT SURGERY
I-687 GUIDING SENTINEL LYMPH NODE BIOPSY, USING A HAND-HELD GAMMA COUNTER IN PATIENTS
WITH CLINICALLY NODE NEGATIVE SQUAMOUS CELL CARCINOMA OF THE ORAL CAVITY
I-688 GADAVIST IS INDICATED WITH MRI TO DETECT THE PRESENCE AND EXTENT OF MALIGNANT
BREAST DISEASE
I-689 TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL) WITH 17P DELETION
I-690 INDICATED FOR THE TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
I-691 INDICATED TO REDUCE THE RISK OF RECURRENT DEEP VEIN THROMBOSIS (DVT) AND PULMONARY
EMBOLISM (PE) FOLLOWING INITIAL THERAPY
I-692 INDICATED FOR MANAGEMENT OF OSTEOARTHRITIS PAIN.
I-693 TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-REISISTANT PROSTATE CANCER (CRPC)
I-694 TREATMENT OF PATIENTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS WHO ARE CANDIDATES
FOR PHOTOTHERAPY OR SYSTEMIC THERAPY
I-695 REVISED INDICATION FOR BORTEZOMIB IN THE TREATMENT OF PATIENTS WITH MANTLE CELL
LYMPHOMA
I-696 USE AS MONOTHERAPY IN THE TREATMENT OF PARTIAL-ONSET SEIZURES IN PATIENTS WITH
EPILEPSY AGE 17 YEARS AND OLDER
I-697 FOR USE IN COMBINATION WITH SOFOSBUVIR FOR THE TREATMENT OF PATIENTS WITH CHRONIC
HEPATITIS C VIRUS GENOTYPE 1 INFECTION
I-698 SCHIZOAFFECTIVE DISORDER AS MONOTHERAPY AND AS AN ADJUNCT TO MOOD STABILIZERS OR
ANTIDEPRESSANTS
I-699 FOR TREATMENT OF PATIENTS WITH POLYCYTHEMIA VERA WHO HAVE HAD AN INADEQUATE
RESPONSE TO OR ARE INTOLERANT OF HYDROXYUREA
I-700 TREATMENT OF PEDIATRIC PATIENTS WITH TOURETTE'S DISORDER (6-18 YEARS)
I-701 FOR THE TREATMENT OF PATIENTS WITH UNRESECTABLE, WELL-OR MODERATELY-
DIFFERENTIATED, LOCALLY ADVANCED OR METASTATIC GASTROENTEROPANCREATIC
NEUROENDOCRINE TUMORS (GEP-NETS) TO IMPROVE PROGRESSIONFREE SURVIVAL.
EXCLUSIVITY MISCELLANEOUS
M-1 INFORMATION REGARDING SUPERIORITY CLAIM OVER RANITIDINE FOR DAY AND NIGHT
HEARTBURN ADDED TO CLINICAL STUDIES SECTION
M-2 APPROVAL FOR ADDTION TO CLINICAL PHARMACOLOGY SECTION OF THE LABEL REGARDING (1)
IMPROVEMENT IN BONE MINERAL DENSITY IN CHILDHOOD-ONSET ADULT GROWTH HORMONE
DEFICIENT PATIENTS AND (2) INCREASES IN SERUM ALKALINE PHOSPHATASE
M-3 ADDITION OF EFFICACY AND SAFETY INFORMATION IN WHICH FOSAMAX WAS USED
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 23 of 67
EXCLUSIVITY MISCELLANEOUS
CONCOMITANTLY WITH ESTROGEN ALONE OR WITH ESTROGEN PLUS PROGESTIN
M-4 CHANGES TO PEDIATRIC USE SECTION TO PROVIDE INFORMATION REGARDING SAFETY AND
EFFICACY IN PEDIATRIC PATIENTS AS YOUNG AS 2 YEARS OLD
M-5 INFORMATION REGARDING EFFECTS IN PATIENTS WITH ASTHMA ON CONCOMITANT INHALED
CORTICOSTEROIDS IN CLINICAL PHARMACOLOGY SECTION
M-6 ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES DONE WITH GLUCOPHAGE/GLYBURIDE
COMBINATION ADDED TO CLINICAL PHARMACOLOGY AND DOSING AND ADMINISTRATION
M-7 CLINICAL PHARMACOLOGY IN PEDIATRIC PATIENTS; DOSAGE AND ADMINISTRATION INFORMATION
M-8 ADDITIONAL INFORMATION FOR THE USE OF SONATA CAPSULES FOR UP TO 5 WEEKS (35
NIGHTS) OF TREATMENT IN A CONTROLLED TRIAL SETTING
M-9 ADDITION TO THE CLINICAL STUDIES SECTION OF THE LABELING OF TEXT AND TWO TABLES
CONTAINING INFORMATION FOR THE PRESCRIBING PHYSICIAN ON BLOOD PRESSURE, HEART
RATE, AND HEART RATE VARIABILITY
M-10 INFORMATION REGARDING MAINTENANCE OF AN ANTIDEPRESSANT EFFECT UP TO 1 YEAR OF
DOSING
M-11 USE FOR LONG-TERM TREATMENT OF POSTTRAUMATIC STRESS DISORDER
M-12 NEW LANGUAGE FOR PEDIATRIC USE
M-13 INFORMATION FROM PEDIATRIC STUDIES ADDED TO CLINICAL PHARMACOLOGY, PRECAUTIONS,
AND DOSAGE AND ADMINISTRATION
M-14 ADDITIONAL CLINICAL TRIAL INFORMATION ADDED TO PEDIATRIC USE SUBSECTION
M-15 LONGER TERM EFFICACY INFORMATION FOR RISPERIDONE IN THE TREATMENT OF SCHIZOPHRENIA
M-16 CHANGE IN WORDING OF THE PEDIATRIC SECTION OF THE PACKAGE INSERT
M-17 INFORMATION REGARDING USE OF ULTANE IN PEDIATRIC PATIENTS WITH CONGENITAL HEART
DISEASE
M-18 INFORMATION DENOTING THE EFFICACY OF REMERON IN MAINTAINING A RESPONSE IN PATIENTS
WITH MAJOR DEPRESSIVE DISORDER (MDD)
M-19 INFORMATION REGARDING USE IN PEDIATRIC PATIENTS TWO YEARS OF AGE AND OLDER
M-20 LABELING REVISIONS RELATED TO MCCUNE ALBRIGHT SYNDROME
M-21 COMPARISON DATA ON THE ANTIHYPERTENSIVE EFFECTS OF ATACAND AND COZAAR
M-22 CHANGE IN TIME TO ONSET OF ACTION
M-23 INFORMATION REGARDING ELIMINATION ADDED TO CLINICAL PHARMACOLOGY, STUDY RESULTS IN
PATIENTS WITH HEPATIC AND RENAL IMPAIRMENT
M-24 INFORMATION ON RESULTS OF A LONG TERM LONGITUDINAL GROWTH STUDY AND PEDIATRIC
SAFETY INFORMATION
M-25 ADDITIONAL SAFETY & PK INFORMATION IN CHILDREN 6 MONTHS TO LESS THAN 6 YEARS OF
AGE ADDED TO PKG INSERT
M-26 INCORPORATION OF INFORMATION CONTAINED IN THE PEG-INTRON PACKAGE INSERT INTO THE
REBETOL PACKAGE INSERT AND MEDGUIDE-PEG-INTRON WAS APPROVED FOR USE IN COMBINATION
WITH REBETOL FOR TREATMENT OF CHRONIC HEPATITIS C VIRUS INFECTION ON 8/7/01
M-27 INFORMATION DESCRIBING ASPIRIN ENDOSCOPY STUDY AND THE MAXIMUM RECOMMENDED DOSE
FOR PATIENTS WITH MODERATE HEPATIC INSUFFICIENCY
M-28 INFORMATION FROM A STUDY IN PEDIATRIC PATIENTS IN ASSOCIATION WITH A NEUROLOGICAL
CONDITION
M-29 LABELING CHANGES TO PROVIDE INFORMATION IN THE MANAGEMENT OF OBESITY IN
ADOLESCENTS AGED 12 TO 16 YEARS
M-30 CHANGES TO CLINICAL PHARMACOLOGY, PRECAUTIONS, AND DOSAGE AND ADMINISTRATION
SECTIONS OF LABELING CONCERNING USE OF LOTENSIN IN PEDIATRIC PATIENTS WITH
HYPERTENSION
M-31 INFORMATION FOR USE IN PEDIATRIC PATIENTS WITH CHRONIC KIDNEY DISEASE STAGE 5
(END-STAGE RENAL DISEASE)
M-32 ADDITIONAL LANGUAGE TO CLINICAL PHARMACOLOGY AND CLINICAL STUDIES
M-33 INFORMATION FOR USE OF ADVAIR DISKUS 100/50 IN CHILDREN 4 TO 11 YEARS OF AGE WITH
ASTHMA
M-34 EXPANDED INFORMATION TO PEDIATRIC USE SUBSECTION OF LABELING IN RESPONSE TO
PEDIATRIC WRITTEN REQUEST
M-35 ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES DONE WITH ACTOS IN COMBINATION
WITH METFORMIN, A SULFONYLUREA, OR INSULIN ADDED TO CLINICAL PHARMACOLOGY
M-36 ADDITION OF INFORMATION TO CLINICAL STUDIES REGARDING PREVENTION OF CARDIOVASCULAR
DISEASE
M-37 INFORMATION ADDED TO THE LABELING THAT DETAILS INFORMATION RELATIVE TO STUDIES
DONE IN PEDIATRIC POPULATIONS IN THE CLINICAL PHARMACOLOGY AND PEDIATRIC USE
SUBSECTIONS
M-38 SAFETY AND IOP-LOWERING EFFECTS OF TRUSOPT HAVE BEEN DEMONSTRATED IN PEDIATRIC
PATIENTS IN A 3 MONTH, MULTI-CENTER DOUBLE MASKED ACTIVE-TREATMENT-CONTROLLED
TRIAL
M-39 FOR LABELING CHANGES BASED ON RESULTS OF THE SPD422-202 CLINICAL STUDY REPORT
(CSR) SUBMITTED IN RESPONSE TO THE WRITTEN REQUEST
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 24 of 67
EXCLUSIVITY MISCELLANEOUS
M-40 ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES PERFORMED IN PEDIATRIC PATIENTS
WITH LEUKEMIA ADDED TO PRECAUTIONS
M-41 REVISION TO THE PEDIATRIC USE PRECAUTIONS OF THE PRESCRIBING INFORMATION TO
INCORPORATE THE RESULTS FROM THE CAPPS-169 STUDY ENTITLED "THE EFFECT OF ORTHO
TRICYCLEN ON BONE MINERAL DENISTY IN PEDIATRIC SUBJECTS WITH ANOREXIA NERVOSA"
M-42 ADDITION OF A GERIATRIC USE SUBSECTION TO THE PRECAUTIONS SECTION OF THE PACKAGE
INSERT AND GERIATRIC DOSING INFORMATION
M-43 INCLUSION OF RESULTS OF STUDY-"PLACEBO-CONTROLLED STUDY TO EVALUATE SAFETY AND
PILOT EFFICACY OF ILOPROST AS ADD ON THERAPY WITH BOSENTAN IN SUBJECTS WITH
PULMONARY ARTERIAL HYPERTENSION
M-44 CLINICAL INFORMATION ADDED TO THE PEDIATRIC USE SUBSECTION OF PRECAUTIONS
REGARDING THE USE OF NOVOLOG IN ADOLESCENTS WITH TYPE I DIABETES AGE 6 TO 18
M-45 INFORMATION ADDED TO CLINICAL TRIALS SECTION OF LABELING - EFFECTS OF HUMATROPE
TREATMENT IN ADULTS WITH GROWTH HORMONE DEFICIENCY
M-46 PROVISION OF RESULTS OF STUDY AND PROPOSED REVISIONS TO PACKAGE INSERT SEE SECTION
ON CARDIAC ELECTROPHYSIOLOGY
M-47 PROVIDES FOR USE OF ANTARA WITHOUT REGARD TO MEALS
M-48 CHANGES TO THE LABELING DESCRIBING THE RESULTS OF A STUDY OF THE USE OF NOVOLOG
MIX 70/30 WITH ORAL ANTIDIABETIC AGENTS IN PATIENTS WITH TYPE 2 DIABETES
M-49 CLINICAL DATA ADDED TO THE CLINICAL PHARMACOLOGY SECTION REGARDING EFFECT OF
SINGULAIR ON GROWTH RATES IN PREPUBERTAL CHILDREN
M-50 NEW INFO TO THE CLINICAL STUDIES, ADULT GROWTH HORMONE DEFICIENCY (GHD) SUBSECTION
OF THE NUTROPIN AQ PACKAGE INSERT DESCRIBING THE EFFECTS OF SOMATROPIN ON VISCERAL
ADIPOSE TISSUE IN THE ADULT GROWTH HORMONE DEFICIENT PATIENT POPULATION
M-51 INFORMATION ADDED TO LABELING REGARDING OSTEOGENESIS IMPERFECTA STUDY
M-52 INFORMATION ADDED TO THE CLINICAL PHARMACOLOGY/CLINICAL STUDIES SECTION REGARDING
THE USE OF RISEDRONATE ADMINISTERED ONCE A WEEK IN THE PREVENTION OF OSTEOPOROSIS
IN POSTMENOPAUSAL WOMEN
M-53 FOR LABELING CHANGES TO THE QUALITY OF LIFE (QOL) STATEMENT IN THE APPROVED
PACKAGE INSERT
M-54 INFORMATION FROM PEDIATRIC STUDIES ADDED TO LABEL
M-55 INFORMATION ON RESULTS OF A STUDY OF THE USE OF SANDOSTATIN LAR DEPOT IN PEDIATRIC
PATIENTS WITH HYPOTHALAMIC OBESITY.
M-56 INFORMATION ADDED TO CLINICAL TRIAL SECTION WITH INFORMATION ON "GEMINI" TRIAL
M-57 CLINICAL DATA ADDED TO THE CLINICAL PHARMACOLOGY SECTION REGARDING THE
PHARMACOKINETICS OF EZETIMIBE IN ASIAN SUBJECTS
M-58 CHANGES TO THE CLINICAL STUDIES, PRIMARY HYPERCHOLESTEROLEMIA, VYTORIN SUBSECTION
OF THE PACKAGE INSERT TO ADD EFFICACY DATA FOR THE EZETIMIBE/SIMVASTATIN
COMBINATION PRODUCT AND FOR AN ATORVASTATIN PRODUCT ON LDL-C AND OTHER LIPID
PRMTRS
M-59 RESULTS OF THE T20-310 STUDY WHICH EVALUATED THE PHARMACOKINETICS, SAFETY, AND
ANTIVIRAL ACTIVITY OF FUZEON IN TREATMENT EXPERIENCED PEDIATRIC SUBJECTS AND
ADOLSCENTS WAS ADDED TO THE PEDIATRIC SUBSECTION OF PRECAUTIONS
M-60 CHANGES TO CLINICAL STUDIES, PRIMARY HYPERCHOLESTEROLEMIA, TO ADD EFFICACY DATA
FOR THE EZETIMIBE/SIMVASTATIN COMBINATION PRODUCT AND FOR A ROSUVASTATIN PRODUCT
ON LDL-C AND OTHER LIPID PARAMETERS IN PATIENTS WTH HYPERCHOLESTEROLEMIA
M-61 REVISIONS TO LABELING BASED ON DATA SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN
REQUEST
M-62 CLINICAL INFORMATION FROM ONE CLINICAL STUDY INVESTIGATING THE USE OF AVANDAMET
PLUS INSULIN IN PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE NOT ACHIEVED
ADEQUATE GLYCEMIC CONTROL WITH PREVIOUS ANTI-DIABETIC THERAPIES
M-63 DETAILED INFORMATION ON AN INCONCLUSIVE PEDIATRIC STUDY
M-64 CHANGES TO CLINICAL PHARMACOLOGY DETAILING STUDY RESULTS
M-65 ADDITION OF INFORMATION TO LABEL TO INCLUDE INFORMATION REGARDING USE IN PATIENTS
WITH HIV-ASSOCIATED ADIPOSE REDISTRIBUTION SYNDROME (HARS)
M-66 USE IN SPECIFIC POPULATIONS - PATIENTS WITH CONCOMITANT ILLNESS SUBSECTION OF THE
LABELING REGARDING USE OF STRATTERA IN PATIENTS WITH ADHD WHO HAVE COMORBID TIC
DISORDER
M-67 INDICATION EXPANDED TO INCLUDE PATIENTS ON PERITONEAL DIALYSIS
M-68 DESCRIPTION OF RESULTS OF STUDY OF INITIAL THERAPY IN COMBINATION WITH METFORMIN
WHEN DIET AND EXERCISE DO NOT PROVIDE GLYCEMIC CONTROL
M-69 RESULTS OF STUDY OF COMBINATION THERAPY AND NON-INFERIORITY STUDY
M-70 PROVISION OF INFORMATION OF THE RESULTS OF A PHASE 2 RANDOMIZED TRIAL OF SPRYCEL
70MG TWICE DAILY OR IMATINIB 800MG DAILY
M-71 REVISIONS TO PROVIDE FOR RESULTS OF MAINTENANCE DATA IN ADULT PATIENTS WITH MAJOR
DEPRESSIVE DISORDER
M-72 INFORMATION ABOUT USE OF INSPRA (EPLERENONE) FOR HYPERTENSION IN PEDIATRIC
PATIENTS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 25 of 67
EXCLUSIVITY MISCELLANEOUS
M-73 NEW INFORMATION ADDED REGARDING THE TUMOR SHRINKING POTENTIAL OF SANDOSTATIN LAR
DEPOT INJECTION ON GH - SECRETING PITUITARY ADENOMAS
M-74 REVISIONS TO CLINICAL STUDIES - CHILDREN AND ADOLSCENTS BASED ON CLINICAL TRIAL
DATA TO SUPPORT A DURATION OF ACTION CLAIM UP TO 12 HOURS
M-75 PROVISION FOR USE OF ARGAGATROBAN IN CERTAIN PEDIATRIC PATIENTS WITH HEPARIN-
INDUCED THROMBOCYTOPENIA (HIT) OR HEPARIN-INDUCED THROMBOCYTOPENIA WITH THROMBOSIS
(HITTS)
M-76 REMOVAL OF SCREEN REQUIREMENT IN PTS WITH G6PD DEFICIENCY PRIOR TO INITIATING
ACZONE TREATMENT; REMOVAL OF BLOOD COUNT & RETICULOCYTE MONITORING DURING
TREATMENT IN G6PD DEFICIENT PTS AND IN PATIENTS WITH HISTORY OF ANEMIA
M-77 USE IN COMBINATION WITH THE NEW AKTILITE CL128 LAMP FOR THE TREATMENT OF THIN AND
MODERATELY THICK, NON-HYPERKERATOTIC, NON-PIGMENTED ACTINIC KERATOSES OF THE FACE
AND SCALP IN IMMUNOCOMPETENT PATIENTS
M-78 CLINICAL TRIAL INFO ON USE OF STRATTERA IN PATIENTS WITH ATTENTION DEFICIT
HYPERACTIVITY DISORDER (ADHD) AND COMORBID ANXIETY DISORDER WITHOUT CAUSING
WORSENING OF ANXIETY
M-79 LABELING REVISIONS RELATED TO SMOKING AND ERLOTIMB EXPOSURE
M-80 ADDITIONAL TIME POINT OF 30 MINUTES (0.5 HOUR) IN CHILDREN AGED 6-12 YEARS WITH A
DIAGNOSIS OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER (ADHD)
M-81 ADDITIONAL INFO FOR PEDIATRIC USE FOR CASODEX (STUDIED IN COMBINATION WITH
ARIMIDEX) IN THE PEDIATRIC POPULATION, SPECIFICALLY BOYS WITH FAMILIAL MALE-
LIMITED PRECOCIOUS PUBERTY (TESTOXICOSIS)
M-82 LABELING REVISIONS RELATED TO CLINICAL STUDIES
M-83 ADDITIONAL INFORMATION ADDED TO LABELING REGARDING ESTABLISHMENT OF EFFICACY IN
ADDITIONAL CLINICAL TRIALS AND ONE MAINTENANCE TRIAL
M-84 STUDY INFORMATION ADDED TO LABEL REGARDING BONE MINERAL DENSITY
M-85 INFORMATION ADDED TO LABELING REGARDING USE OF PREVACID IN PATIENTS LESS THAN 1
YEAR WITH SYMPTOMATIC GERD
M-86 LABELING CHANGES SUBMITTED IN RESPONSE TO PEDIATRIC WRITTEN REQUEST FOR INFANTS
AGES BIRTH TO 11 MONTH INCLUSIVE REFLECTING LACK OF EFFICACY FOR GERD INDICATION
FOR THIS PATIENT POPULATION
M-87 INCLUSION OF RESULTS FROM TWO DRUG INTERACTION STUDIES WITH LIPITOR AND CRESTOR IN
CLINICAL PHARMACOLOGY SECTION
M-88 ADDITION OF INFORMATION REGARDING ABUSE POTENTIAL OF CONCERTA VERSUS IMMEDIATE-
RELEASE METHYLPHENIDATE
M-89 PROVIDES FOR REVISIONS TO MULTIPLE SECTIONS OF THE PACKAGE INSERT TO REFLECT
RESULTS OF CLINICAL TRIALS 205.235 (UPLIFT) AND 205.266 (VA STUDY) IN SUPPORT OF
EXACERBATION CLAIM
M-90 LABELING CHANGES BASED ON DATA FROM CLINICAL STUDIES NV20235 AND NV20236 STUDIES
OF SEASONAL PROPHYLAXIS OF INFLUENZA IN IMMUNOCOMPROMISED PATIENTS AND CHILDREN
AGES 1-12
M-91 UPDATED LABELING BASED UPON STUDY: A SINGLE-DOSE, SINGLE-BLIND, PLACEBO-AND
MOXIFLOXACIN-CONTROLLED 2-PERIOD, RANDOMIZED, CROSSOVER, 3RD PERIOD SEQUENTIAL
STUDY OF SIDE EFFECTS OF TEMSIROLIMUS ON CARDIAC REPOLARIZATION IN HEALTHY
SUBJECTS
M-92 UPDATES TO THE PACKAGE INSERT BASED UPON THE TRIAL ENTITLED "A PHASE I
PHARMACOKINETIC AND PHARMACODYNAMIC STUDY OF TEMSIROLIMUS IN PATIENTS WITH
ADVANCED MALIGNANCIES AND NORMAL AND IMPAIRED LIVER FUNCTION
M-93 EXPANSION OF LABELING TO INCLUDE INFORMATION ON SAFETY AND EFFICACY OF CREON IN
PATIENTS AGES 7 YEARS THROUGH 11 YEARS WITH PANCREATIC EXOCRINE INSUFFICIENCY DUE
TO CYSTIC FIBROSIS
M-94 INFO ADDED TO LABEL RELATED TO NEWLY DIAGNOSED PHILADELPHIA CHROMOSOME POSITIVE
(PH+) CHRONIC MYELOID LEUKEMIA IC CHRONIC PHASE
M-95 INFORMATION FOR TREATMENT OF CHRONIC HEPATITIS B (CHB) IN ADULT PATIENTS WITH
DECOMPENSATED LIVER DISEASE BASED ON DATA FROM CLINICAL TRIAL GS-US-174-0108
M-96 UPDATED INFORMATION IN THE CLINICAL STUDIES SECTION RELATED TO THE LOSS AND
RECOVERY OF BONE MINERAL DENSITY IN ADOLESCENT GIRLS DURING AND FOLLOWING THE USE
OF DEPO-PROVERA CONTRACEPTIVE INJECTION
M-97 LABELING CHANGES IN RESPONSE TO PEDIATRIC STUDIES - NOT INDICATED FOR USE IN
PEDIATRIC POPULATION
M-98 NEW INFORMATION FROM A STUDY WHICH EVALUATED THE SAFETY AND EFFICACY OF FAMVIR IN
TREATING RECURRENT GENITAL HERPES IN IMMUNOCOMPETENT BLACK/AFRICAN AMERICAN
SUBJECTS.
M-99 ADDITION OF FINDINGS FROM A SINGLE PEDIATRIC CLINICAL TRIAL (P04292) OF NASONEX
NASAL SPRAY IN THE TREATMENT OF NASAL POLYPS IN PATENTS 6 TO <18 YEARS OF AGE TO
THE PACKAGE INSERT.
M-100 INFORMATION ADDED TO LABEL BASED UPON COMPLETED CLINICAL TRIAL REPORTS
M-101 INCLUSION OF DATA FROM AN ADDITIONAL 19 SUBJECTS WITH HYPERCALCEMIA FROM
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 26 of 67
EXCLUSIVITY MISCELLANEOUS
PARATHYROID CARCINOMA TO THE INFORMATION CURRENTLY PRESENTED IN THE LABEL
M-102 INFORMATION FROM PEDIATRIC STUDY REPORT ML16633, "INTRAVENOUS GRANISETRON (KYTRIL)
IN THE PREVENTION OF POST-OPERATIVE NAUSEA AND VOMITING (PONV) IN PEDIATRIC
SUBJECTS UNDERGOING TONSILLECTOMY OR ADENOTONSILLECTOMY."
M-103 SAFETY, EFFICACY AND PHARMACOKINETIC INFO FOR FASLODEX IN THE PEDIATRIC
POPULATION, SPECIFICALLY FOR GIRLS WITH PROGRESSIVE PRECOCIOUS PUBERTY ASSOCIATED
WITH MCCUNE-ALBRIGHT SYNDROME ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING
M-104 INFORMATION ADDED TO DOSING AND ADMINISTRATION REGARDING A 26 WEEK STUDY
M-105 NEW LANGUAGE ADDED TO CLINICAL STUDIES REGARDING USE IN SMOKERS WITH
CARDIOVASCULAR DISEASE, CHRONIC OBSTRUCTIVE PULMONARY DISEASE, AND USE ACCORDING
TO AN ALTERNATIVE SET OF DIRECTIONS FOR SETTING A QUIT DATE
M-106 ADDITION OF THE T1-WEIGHTED GD-ENHANCED LESION EFFICACY VARIABLE IN THE CLINICAL
STUDIES SECTION 14 OF THE PACKAGE INSERT
M-107 INFORMATION TO THE CLINICAL STUDIES SECTION OF THE LUPRON DEPOT-PED,1-MONTH,BASED
UPON THE PHASE 3/4 COMPLETED CLINICAL STUDY REPORT FOR STUDY M90-516, ENTITLED
"STUDY OF LUPRON DEPOT IN THE TREATMENT OF CENTRAL PRECOCIOUS PUBERTY".
M-108 CHANGES ARE BASED ON RESULTS FROM STUDY CV181057
M-109 CHANGES TO THE PACKAGE INSERT TO REFLECT THE RESULTS OF THE STUDY OF HEART AND
RENAL PROTECTION (SHARP) TRIAL
M-110 CHANGES TO THE PACKAGE INSERT TO REFLECT THE RESULTS OF THE STUDY OF HEART AND
RENAL PROTECTION (SHARP) TRIAL
M-111 LABELING CHANGES BASED ON STUDY HW80-EW-GWCI ENTITLED A PLACEBO AND POSITIVE
CONTROLLED STUDY OF THE ELECTROPHYSIOLOGICAL EFFECTS OF A SINGLE 10 MCG DOSE OF
EXENATIDE ON THE 12 LEAD ELECTROCARDIOGRAM QT INTERVAL IN HEALTHY SUBJECTS
M-112 REVISIONS TO THE PEDIATRIC USE SECTION OF THE PACKAGE INSERT TO ADD INFORMATION
FROM A PEDIATRIC STUDY IN PATIENTS AGED 12 YEARS TO LESS THAN 18 YEARS OF AGE WITH
RECURRENT HERPES LABIALIS
M-113 LABELING CHANGES BASED ON STUDY H80-US-GWCO ENTITLED A RANDOMIZED TRIAL COMPARING
EXENATIDE WITH PLACEBO IN SUBJECTS WITH TYPE 2 DIABETES ON INSULIN GLARGINE WITH
OR WITHOUT ORAL ANTIHYPERGLYCEMIC MEDICATIONS
M-114 CHANGES IN SECTION 14 OF THE PACKAGE INSERT TO INCLUDE DATA FROM THE SWITCHMRK
STUDIES (SWITCH OF SUPPRESSED SUBJECTS FROM LOPINAVIR/RITONAVIR TO RALTEGRAVIR)
M-115 REVISIONS TO THE PI BASED ON RESULTS FROM STUDY NN2211-1842, ENTITLED THE EFFECT
OF INSULIN DETEMIR IN COMBINATION WITH LIRAGLUTIDE AND METFORMIN COMPARED TO
LIRAGLUTIDE AND METFORMIN IN SUBJECTS WITH TYPE 2 DIABETES
M-116 LABELING CHANGES BASED ON RESULTS FROM CLINICAL STUDY 01-06-TL-OPIMET-008
M-117 ADDITION OF RESULTS OF PEDIATRIC TRIAL TO LABEL
M-118 LABELING CHANGES BASED UPON SAFETY AND EFFICACY RESULTS FROM TRIAL 1218.36
M-119 LABELING CHANGES REGARDING MISSED DOSES
M-120 CHANGES TO CLINICAL TRIALS DETAILING STUDY RESULTS
M-121 LABELING CHANGES BASED UPON SAFETY AND EFFICACY RESULTS FROM TRIAL 1218.43
M-122 LABELING CHANGES TO INCLUDE THE RESULTS OF THE PARAMOUNT TRIAL
M-123 UPDATED RESULTS OF OVERALL SURVIVAL FROM 'CONFIRM' STUDY
M-124 LONG TERM SAFETY AND EFFICACY DATA FROM STUDY CLDT600A2303 FOR SUBJECTS PREVIOUSLY
ENROLLED IN THE ORIGINAL TWO YEAR GLOBE (NV-02B-007/CLDT600A2302) AND NV02B-015
STUDIES WHO CONTINUED TELBIVUDINE TREATMENT FOR UP TO 208 WEEKS
M-125 LABELING CHANGES TO INCLUDE LACK OF EFFICACY IN CHILDREN 6 MONTHS TO 4 YEARS OF
AGE
M-126 UPDATES TO THE CLINICAL STUDIES SECTION 14, OF THE PACKAGE INSERT (PI), WITH THE
RESULTS OF CLINICAL TRIAL P06086
M-127 REVISIONS TO THE PEDIATRIC USE SECTION OF THE PACKAGE INSERT TO REFLECT THE
RESULTS FROM CLINICAL STUDY C-10-004
M-128 CLINICAL TRIAL STUDY RESULTS
M-129 RESULTS OF A CLINICAL STUDY REPORT WHICH ASSESSES THE SAFETY AND EFFICACY IN
CHILDREN AGES 6 TO 12 YEARS OF AGE
M-130 ADDITION OF INFORMATION ON LONG-TERM TREATMENT WITH VPRIV IN THE CLINICAL TRIALS
SECTION OF THE PACKAGE INSERT
M-131 INFORMATION FROM STUDIES CONDUCTED IN PEDIATRIC PATIENTS WITH NEWLY DIAGNOSED NON-
DISSEMINATED DIFFUSED INTRINSIC BRAINSTEM GLIOMAS
M-132 REVISIONS TO THE CLINICAL TRIALS SECTION IN THE INOMAX LABEL TO REFLECT RESULTS
FROM THE PEDIATRIC STUDY REPORTS
M-133 INFORMATION ADDED TO THE LABELING REGARDING THE ADDITION OF SILDENAFIL TO BOSENTAN
THERAPY
M-134 ADDITIONAL INFORMATION REGARDING CLINICAL STUDIES PERFORMED WITH SAXAGLIPTIN IN
COMBINATION WITH METFORMIN AND A SULFONYLUREA ADDED TO THE LABELING
M-135 ADDITION OF INFORMATION TO THE CLINICAL STUDIES - RADIOGRAPHIC RESPONSE SECTION OF
THE PACKAGE INSERT
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 27 of 67
EXCLUSIVITY MISCELLANEOUS
M-136 ADDITIONAL INFORMATION ADDED TO THE USE IN SPECIFIC POPULATIONS SECTION OF THE
LABELING REGARDING POST-OPERATIVE NAUSEA AND VOMITING STUDIES IN PEDIATRIC
PATIENTS
M-137 LABELING REVISIONS RESULTING FROM A MAINTENANCE TRIAL IN PEDIATRIC PATIENTS WITH
IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
M-138 INFORMATION ADDED TO THE 8.4 PEDIATRIC USE SECTION ON THE USE OF MEMANTINE IN
CHILDREN AGES 6-12 YEARS WITH AUTISM SPECTRUM DISORDER
M-139 INFORMATION ADDED TO THE DOSING AND ADMINISTRATION SECTION OF THE PACKAGE INSERT
REGARDING RETREATMENT WITH VELCADE FOR PATIENTS WITH MULTIPLE MYELOMA
M-140 INFORMATION ADDED TO THE PEDIATRIC USE SECTION OF THE LABELING REGARDING USE OF
LATISSE IN PATIENTS WHO WERE POST-CHEMOTHERAPY OR HAD ALOPECIA AREATA, AND
ADOLESCENTS WHO HAD HYPERTRICHOSIS WITH NO ASSOCIATED MEDICAL CONDITION
M-141 REVISIONS TO THE PEDIATRIC USE SECTION OF THE LABELING TO INCORPORATE STUDY
RESULTS FOR TREATMENT OF MAJOR DEPRESSIVE DISORDER IN ADOLESCENTS (AGES 12-17)
M-142 ADDITIONS TO THE LABELING DESCRIBING RESULTS FROM STUDY H6P-MC-HDAY
M-143 INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF VARENICLINE
FOR SMOKING CESSATION IN PATIENTS WITH CURRENT OR PAST HISTORY OF MAJOR DEPRESSIVE
DISORDER
M-144 INFORMATION ADDED TO THE LABELING REGARDING THE SAFETY AND EFFICACY OF VARENICLINE
FOR SMOKING CESSATION IN PATIENTS WHO HAD BEEN PREVIOUSLY TREATED WITH VARENICLINE
M-145 ADDITION OF INFORMATION ABOUT LONG-TERM TREATMENT OF PULMONARY ARTERIAL
HYPERTENSION TO THE CLINICAL STUDIES SECTION OF THE LABELING
M-146 INFORMATION ADDED TO THE CLINICAL STUDIES SECTION ON INITIAL COMBINATION THERAPY
WITH LINAGLIPTIN AND METFORMIN VS. LINAGLIPTIN MONOTHERAPY IN TREATMENT NAIVE
PATIENTS
M-147 OTC USE FOR TEMPORARY RELIEF OF OCULAR SYMPTOMS DUE TO HAY FEVER OR OTHER UPPER
RESPIRATORY ALLERGIES
M-148 LABELING CHANGES BASED ON STUDY H80-EW-GWDM
M-149 INFORMATION ADDED TO THE LABELING REGARDING MAINTENANCE MONOTHERAPY FOR ADHD
M-150 ADDITION OF THE RESULTS OF A CONTROLLED CLINICAL STUDY TREATING ADULT PATIENTS
WITH SCHIZOPHRENIA EXPERIENCING AN ACUTE RELAPSE
PATENT USE
U-1 PREVENTION OF PREGNANCY
U-2 TREATMENT OR PROPHYLAXIS OF ANGINA PECTORIS AND ARRHYTHMIA
U-3 TREATMENT OF HYPERTENSION
U-4 PROVIDING PREVENTION AND TREATMENT OF EMESIS AND NAUSEA IN MAMMALS
U-5 METHOD OF PRODUCING BRONCHODILATION
U-6 METHOD OF PRODUCING SYMPATHOMIMETIC EFFECTS
U-7 INCREASING CARDIAC CONTRACTILITY
U-8 ACUTE MYOCARDIAL INFARCTION
U-9 CONTROL OF EMESIS ASSOCIATED WITH ANY CANCER CHEMOTHERAPY AGENT
U-10 DIAGNOSTIC METHOD FOR DISTINGUISHING BETWEEN HYPOTHALMIC MALFUNCTIONS OR LESIONS
IN HUMANS
U-11 TREATMENT OR PROPHYLAXIS OF CARDIAC DISORDERS
U-12 METHOD OF TREATING [A] HUMAN SUFFERING FROM DEPRESSION
U-13 A METHOD FOR TREATING ANXIETY IN A HUMAN SUBJECT IN NEED OF SUCH TREATMENT
U-14 ADJUNCTIVE THERAPY FOR THE PREVENTION AND TREATMENT OF HYPERAMMONEMIA IN THE
CHRONIC MANAGEMENT OF PATIENTS WITH UREA CYCLE ENZYMOPATHIES
U-15 METHOD OF LOWERING INTRAOCULAR PRESSURE
U-16 USE IN LUNG SCANNING PROCEDURES
U-17 TREATMENT OF VENTRICULAR AND SUPRAVENTRICULAR ARRHYTHMIAS
U-18 METHOD FOR INHIBITING GASTRIC SECRETION IN MAMMALS
U-19 TREATMENT OF INFLAMMATION
U-20 A PROCESS FOR TREATING A PATIENT SUFFERING FROM PARKINSON'S SYNDROME AND IN NEED
OF TREATMENT
U-21 TREATMENT OF HUMANS SUFFERING UNDESIRED UROTOXIC SIDE EFFECTS CAUSED BY
CYTOSTATICALLY ACTIVE ALKYLATING AGENTS
U-22 METHOD OF COMBATTING PATHOLOGICALLY REDUCED CEREBRAL FUNCTIONS AND PERFORMANCE
WEAKNESSES, CEREBRAL INSUFFICIENCY AND DISORDERS IN CEREBRAL CIRCULATION AND
METABOLISM IN WARM-BLOODED ANIMALS
U-23 METHOD FOR TREATING PROSTATIC CARCINOMA COMPRISING ADMINISTERING FLUTAMIDE
U-24 METHOD FOR TREATING PROSTATE ADENOCARCINOMA COMPRISING ADMINISTERING AN
ANTIANDROGEN INCLUDING FLUTAMIDE AND AN LHRH AGONIST
U-25 REDUCING CHOLESTEROL IN CHOLELITHIASIS PATIENTS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 28 of 67
PATENT USE
U-26 REDUCING CHOLESTEROL GALLSTONES AND/OR FRAGMENTS THEREOF
U-27 DISSOLVING CHOLESTEROL GALLSTONES AND/OR FRAGMENTS THEREOF
U-28 CEREBRAL, CORONARY, PERIPHERAL, VISCERAL AND RENAL ARTERIOGRAPHY, AORTOGRAPHY AND
LEFT VENTRICULOGRAPHY
U-29 CT IMAGING OF THE HEAD AND BODY, AND INTRAVENOUS EXCRETORY UROGRAPHY
U-30 CEREBRAL ANGIOGRAPHY, AND VENOGRAPHY
U-31 INTRA-ARTERIAL DIGITAL SUBTRACTION ANGIOGRAPHY
U-32 PALLIATIVE TREATMENT OF PATIENTS WITH OVARIAN CARCINOMA RECURRENT AFTER PRIOR
CHEMOTHERAPY, INCLUDING PATIENTS WHO HAVE BEEN PREVIOUSLY TREATED WITH CISPLATIN
U-33 TREATING VIRAL INFECTIONS IN A MAMMAL
U-34 TREATING VIRAL INFECTIONS IN A WARM-BLOODED ANIMAL
U-35 TREATING CYTOMEGALOVIRUS IN A HUMAN WITH AN INJECTABLE COMPOSITION
U-36 METHODS OF TREATING BACTERIAL ILLNESSES
U-37 METHOD OF TREATING GASTROINTESTINAL DISEASE
U-38 TREATMENT OF PAROXYSMAL SUPRAVENTRICULAR TACHYCARDIA
U-39 ANGINA PECTORIS
U-40 METHOD OF TREATMENT OF BURNS
U-41 METHOD OF TREATING CARDIAC ARRHYTHMIAS
U-42 ADJUVANT TREATMENT IN COMBINATION WITH FLUOROURACIL AFTER SURGICAL RESECTION IN
PATIENTS WITH DUKES' STAGE C COLON CANCER
U-43 MANAGEMENT OF CHRONIC PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
U-44 RELIEF OF NAUSEA AND VOMITING
U-45 TREATMENT OF INFLAMMATION AND ANALGESIA
U-46 TREATMENT OF PANIC DISORDER
U-47 STIMULATION OF THE RELEASE OF GROWTH HORMONE
U-48 ANALGESIA
U-49 SYMPTOMATIC CANCER-RELATED HYPERCALCEMIA
U-50 USE IN TREATING INFLAMMATORY DERMATOSES
U-51 BLOOD POOL IMAGING, INCLUDING CARDIAC FIRST PASS AND GATED EQUILIBRIUM IMAGING AND
FOR DETECTION OF SITES OF GASTROINTESTINAL BLEEDING
U-52 TREATMENT OF ADULT AND PEDIATRIC PATIENTS(OVER SIX MONTHS OF AGE) WITH ADVANCED
HIV INFECTION
U-53 HYPERCALCEMIA OF MALIGNANCY
U-54 REVERSAL AGENT OR ANTAGONIST OF NONDEPOLARIZING NEUROMUSCULAR BLOCKING AGENTS
U-55 TREATMENT OF PAIN
U-56 AID TO SMOKING CESSATION
U-57 OPHTHALMIC USE OF NORFLOXACIN
U-58 METHOD OF TREATING INFLAMMATORY INTESTINAL DISEASES
U-59 METHOD OF TREATING HYPERCHOLESTEROLEMIA
U-60 NASAL ADMINISTRATION OF BUTORPHANOL
U-61 CEREBRAL AND PERIPHERAL ARTERIOGRAPHY AND CT IMAGING OF THE HEAD
U-62 CORONARY ARTERIOGRAPHY, LEFT VENTRICULOGRAPHY, CT IMAGING OF THE BODY, INTRAVENOUS
EXCRETORY UROGRAPHY, INTRAVENOUS DIGITAL SUBTRACTION ANGIOGRAPHY AND VENOGRAPHY
U-63 ISOPRENALINE ANTAGONISM ON THE HEART RATE OR BLOOD PRESSURE
U-64 TREATMENT OF VIRAL INFECTIONS
U-65 METHOD OF TREATMENT OF A PATIENT INFECTED WITH HIV
U-66 TRIPHASIC REGIMEN
U-67 METHOD OF INDUCING ANESTHESIA IN A WARM BLOODED ANIMAL
U-68 TREATMENT OF ACTINIC KERATOSIS
U-69 TREATMENT OF PNEUMOCYSTIS CARINII INFECTIONS
U-70 TREATMENT OF TRANSIENT INSOMNIA
U-71 METHOD OF TREATMENT OF HEART FAILURE
U-72 TREATMENT OF MIGRAINE
U-73 METHOD OF TREATING DISEASES OR INFECTIONS CAUSED BY MYCETES
U-74 METHOD OF PROVIDING HYPNOTIC EFFECT
U-75 RELIEF OF OCULAR ITCHING DUE TO SEASONAL ALLERGIC CONJUNCTIVITIS
U-76 USE TO IMAGE A SUBJECT WITH A MAGNETIC RESONANCE IMAGING SYSTEM
U-77 TREATMENT OF SYMPTOMS OF SEASONAL ALLERGIC RHINITIS
U-78 ULCERATIVE COLITIS
U-79 SYMPTOMATIC TREATMENT OF PATIENTS WITH NOCTURNAL HEARTBURNDUE TO GERD
U-80 METHOD OF TREATING OCULAR BACTERIAL INFECTIONS
U-81 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS
U-82 TREATMENT FOR DEMENTIA IN PATIENTS WITH ALZHEIMER'S DISEASE
U-83 TREATMENT OF SEIZURES
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 29 of 67
PATENT USE
U-84 A METHOD OF BLOCKING THE UPTAKE OF MONOAMINES BY BRAIN NEURONS IN ANIMALS
U-85 NASAL TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
U-86 METHOD OF TREATING CERTAIN FORMS OF EPILEPSY
U-87 METHOD FOR NONINVASIVE ADMINISTRATION OF SEDATIVES, ANALGESICS, AND ANESTHETICS
U-88 TREATMENT OF MODERATE PLAQUE PSORIASIS
U-89 TREATMENT OR PROPHYLAXIS OF EMESIS
U-90 TREATMENT OF PYSCHOTIC DISORDERS
U-91 ALTERNATIVE THERAPY TO TRIMETHOPRIM-SULFAMETHOXAZOLE FOR TREATMENT OF MODERATE-TO-
SEVERE PNEUMOCYSTIS CARINII PNEUMONIA IN IMMUNOCOMPROMISED AND AIDS PATIENTS
U-92 TREATMENT OF DIABETIC NEPHROPATHY IN PATIENTS WITH TYPE I INSULIN DEPENDENT
DIABETES MELLITUS AND RETINOPATY
U-93 USE AS AN ANTIHISTAMINE/DECONGESTANT
U-94 TREATMENT-ADULTS W/ ADVANCED HIV,INTOLERANT OF APPROVED THERAPIES,INTOLERANT OF
APPROVED THERAPIES W/PROVEN BENEFIT OR HAVE EXPERIENCED CLINICAL/IMMUNOLOGICAL
DETERIORATION WHILE RECEIVING..OR FOR WHOM SUCH THERAPIES-CONTRAINDICATED
U-95 SHORT TERM MANAGEMENT OF MODERATE PRURITIS IN ADULTS WITH ATOPIC DERMATITIS AND
LICHEN SIMPLEX CHRONICUS
U-96 METHOD OF TREATING VARICELLA ZOSTER (SHINGLES) INFECTIONS
U-97 A METHOD OF TREATING A PATIENT IN NEED OF MEMORY ENHANCEMENT
U-98 A METHOD OF INDUCING REGRESSION OF LEUKEMIA CELL GROWTH IN A MAMMAL
U-99 METHOD OF PROVIDING POTASSIUM TO A SUBJECT IN NEED OF POTASSIUM
U-100 METHOD OF TREATING OCULAR INFLAMMATION
U-101 ADJUNCT TO CONVENTIONAL CT OR MRI IMAGING IN THE LOCALIZATION OF STROKE IN
PATIENTS IN WHOM STROKE HAS ALREADY BEEN DIAGNOSED
U-102 METHOD OF HORMONALLY TREATING MENOPAUSAL OR POST-MENOPAUSAL DISORDERS IN WOMEN
U-103 TREATMENT OF OCULAR HYPERTENSION
U-104 TREATMENT OF AQUEOUS HUMOR FORMATION AND INTRAOCULAR PRESSURE
U-105 EMESIS
U-106 TREATMENT OF EPILEPSY
U-107 TREATMENT OF HYPERTENSION AND ANGINA PECTORIS
U-108 SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER, GASTROESOPHAGEAL REFLUX DISEASE
(GERD), SEVERE EROSIVE ESOPHAGITIS, POORLY RESPONSIVE SYMPTOMATIC GERD AND
PATHOLOGIAL HYPERSECRETORY CONDITIONS AND MAINTENANCE HEALING OF EROSIVE
ESOPHAGITIS
U-109 ADJUNCT DIET IN THE TX OF ELEVATED TOTAL CHOLESTEROL AND LDL-C LEVELS IN PTS
W/PRIMARY HYPERCHOLESTEROLEMIA WHOSE RESPONSE TO DIETARY RESTRICTION OF SAT FAT
AND CHOLESTEROL AND OTHER NONPHARMACOLOGICAL MEASURES HAS NOT BEEN ADEQUATE
U-110 USE AS A RETRIEVABLE PERSSARY
U-111 DIABETES
U-112 CONTRACEPTION
U-113 METHOD OF CONDUCTING RADIOLOGICAL EXAMINATION OF A PATIENT BY ADMINISTERING TO
SAID PATIENT A RADIOPAQUE AMOUNT OF IOPROMIDE
U-114 USE FOR INHIBITING BONE RESORPTION
U-115 USE OF VASODILATORS TO EFFECT AND ENHANCE AN ERECTION (AND THUS TREAT ERECTILE
DYSFUNCTION), BY INJECTION INTO THE PENIS
U-116 METHOD OF MYOCARDIAL IMAGING
U-117 TREATMENT OF OCULAR ALLERGIC RESPONSE IN HUMAN EYES
U-118 METHOD OF LOWERING BLOOD SUGAR LEVEL
U-119 TREATMENT OF NASAL HYPERSECRETION
U-120 CONTROLLING OR PREVENTING POST-OPERATIVE INTRAOCULAR PRESSURE RISES ASSOCIATED
WITH OPHTHALMIC LASER SURGICAL PROCEDURES
U-121 METHOD OF TREATING CONDITIONS MEDIATED THROUGH HISTAMINE H2-RECEPTORS
U-122 A THERAPEUTIC METHOD FOR CONTROLLING THROMBOSIS
U-123 METHOD FOR CONTROLLING THROMBOSIS AND DECREASING BLOOD HYPERCOAGULATION AND
HEMORRHAGING RISKS
U-124 TREATMENT OF ACNE
U-125 TREATMENT NEUROGENERATIVE DISEASES
U-126 TREATMENT OF GASTRITIS
U-127 METHOD OF PRODUCING NEUROMUSCULAR BLOCKADE
U-128 METHOD FOR TREATMENT OF TUMORS
U-129 METHOD TO DESTROY OR IMPAIR TARGET CELLS
U-130 MANAGEMENT OF PATIENTS WITH MASTOCYTOSIS
U-131 PHOTODAMAGED SKIN
U-132 INHIBITING HIV PROTEASE
U-133 MANAGEMENT OF OBESITY INCLUDING WEIGHT LOSS AND MAINTENANCE IN PATIENTS ON A
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 30 of 67
PATENT USE
REDUCED-CALORIE DIET
U-134 TREATMENT OF ACNE VULGARIS
U-135 ANTITUMOR AGENT
U-136 PROCESS FOR WASTE NITROGEN REMOVAL
U-137 METHOD OF TREATING BACTERIAL VAGINOSIS
U-138 TREATMENT OF ALLERGIC RHINITIS
U-139 TREATMENT OF ALLERGIC REACTIONS
U-140 USE OF NORVIR TO INHIBIT HIV PROTEASE OR TO INHIBIT AN HIV INFECTION
U-141 TREATMENT OF ULCERATIVE COLITIS
U-142 METHOD OF TREATING ALLERGIC REACTIONS IN A MAMMAL BY USING THIS ACTIVE METABOLITE
U-143 BIODEGRADABLE SUPERPARAMAGNETIC METAL OXIDES AS CONTRAST AGENTS FOR MR IMAGING
U-144 BIOLOGICALLY DEGRADABLE SUPERPARAMAGNETIC MATERIALS FOR USE IN CLINICAL
APPLICATIONS
U-145 BIOLOGICALLY DEGRADABLE SUPERPARAMAGNETIC PARTICLES FOR USE AS NUCLEAR MAGNETIC
RESONANCE IMAGING AGENTS
U-146 METHOD OF TREATING SUSCEPTIBLE NEOPLASMS IN MAMMALS
U-147 DETECTION OF GASTROINTESTINAL DISORDERS AND THE SUBSEQUENT BREATH COLLECTION AND
MEASUREMENT OF 13CO2
U-148 DEVICE FOR COLLECTING A BREATH SAMPLE
U-149 METHOD OF TREATING AN ANIMAL, INCLUDING A HUMAN SUFFERING FROM OR SUSCEPTIBLE TO
PSYCHOSIS, ACUTE MANIA OR MILD ANXIETY STATES
U-150 METHOD OF USE FOR CONTROLLING HYPERGLYCEMIA BY ADMINISTRATION OF THIS SUSTAINED
RELEASE DOSAGE FORM OF GLIPIZIDE
U-151 RELIEF OF SYMPTOMS OF THE COMMON COLD
U-152 METHOD OF TREATING ANXIETY RELATED DISORDERS INCLUDING OBSESSIVE COMPULSIVE
DISORDER
U-153 TREATMENT OF INITIAL EPISODE GENITAL HERPES
U-154 METHOD OF TREATING ANIMALS SUFFERING FROM AN APPETITE DISORDER
U-155 TREATMENT OF ERECTILE DYSFUNCTION
U-156 METHOD OF PROVIDING ANESTHESIA
U-157 TREATMENT OF A HUMAN SUFFERING FROM VITAMIN B12 DEFICIENCY
U-158 ANGINA
U-159 TREATMENT OF INTERSTITIAL CYSTITIS
U-160 TREATMENT OF BACTERIAL INFECTIOUS DISEASE
U-161 METHOD OF INHIBITING CHOLESTEROL BIOSYNTHESIS IN A PATIENT
U-162 METHOD OF USE TO INHIBIT CHOLESTEROL SYNTHESIS IN A HUMAN SUFFERING FROM
HYPERCHOLESTEROLEMIA
U-163 METHOD OF USING TROGLITAZONE TO TREAT IMPAIRED GLUCOSE TOLERANCE TO PREVENT OR
DELAY THE ONSET OF NONINSULIN-DEPENDENT DIABETES MELLITUS
U-164 METHOD OF USING TROGLITAZONE TO PREVENT OR DELAY THE ONSET OF NONINSULIN-DEPENDENT
DIABETES MELLITUS IN A DEFINED POPULATION OF PATIENTS
U-165 TREATMENT OF SYMPTOMATIC BENIGN PROSTATIC HYPERPLASIA
U-166 TREATMENT OF H.PYLORI-ASSOCIATED DUODENAL ULCER
U-167 METHOD FOR TREATING HIV-1 INFECTION
U-168 METHOD OF INHIBITING LIPOXYGENASE ACTIVITY IN A MAMMAL WHICH IS THE MODE OF ACTION
IN THE TREATMENT OF ASTHMA
U-169 METHODS OF USING THE COMPOUND/DRUG PRODUCT AS A CONTRAST AGENT IN MAGNETIC
RESONANCE IMAGING
U-170 METHOD OF OBTAINING AN MR IMAGE USING THE COMPOSITION/DRUG PRODUCT AS A CONTRAST
AGENT
U-171 METHODS OF USING THE COMPOUND/DRUG PRODUCT AS AN ORAL CONTRAST AGENT IN MAGNETIC
RESONANCE IMAGING OF THE GASTROINTESTINAL TRACT
U-172 TREATMENT OF GENITAL WARTS
U-173 ADMINISTRATION TO A HOST SUFFERING FROM GESTATIONAL DIABETES
U-174 USE AS AN ANTIHISTAMINE AGENT
U-175 METHOD OF TREATING MALIGNANT TUMORS
U-176 METHOD OF TREATING A PATIENT SUFFERING FROM LISTED CONDITIONS, INCLUDING SPECIFIC
PSYCHOSES
U-177 FUNGICIDE
U-178 FACILITATED ADHERENCE OF AGENTS TO SKIN
U-179 ENHANCED CUTANEOUS PENETRATION OF A DERMALLY-APPLIED PHARMACOLOGICALLY ACTIVE
AGENT
U-180 TREATMENT OF ADULT AND PEDIATRIC PATIENTS (OVER 6 MONTHS OF AGE) WITH ADVANCED HIV
INFECTION
U-181 PRODUCING ALPHA ADRENERGIC ANTAGONISTIC ACTION IN A HOST
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 31 of 67
PATENT USE
U-182 USE OF SALMETEROL IN PATIENTS WITH REVERSIBLE AIRWAY OBSTRUCTION
U-183 TREATMENT OF CONDITIONS CAUSED BY DISTURBANCE OF NEURONAL 5HT FUNCTION
U-184 TREATING ALLERGIC EYE DISEASES IN HUMANS
U-185 METHOD OF TREATING HYPERTENSION
U-186 METHOD FOR TREATING GI DISORDERS CAUSED BY H.RYLORI WHICH COMPRISES ADMINISTRATION
OF RANITIDINE BISMUTH CITRATE AND CLARITHROMYCIN FOR A GREATER THAN ADDITIVE
EFFECT
U-187 THERAPEUTIC TREATMENT OF CALCIFIC TUMORS
U-188 TREATMENT OF H.PYLORI ASSOCIATED DUODENAL ULCER
U-189 ENHANCEMENT OF THE BIOAVAILABILITY OF THE DRUG SUBSTANCE
U-190 USE OF RITONAVIR IN COMBINATION WITH ANY REVERSE TRANSCRIPTASE INHIBITOR
U-191 METHOD OF TREATMENT FOR CONTROLLING AND LOWERING INTRAOCULAR PRESSURE IN A HUMAN
U-192 USE IN TREATING ALLERGIC REACTIONS
U-193 PSORIASIS
U-194 TREATING ANGINA PECTORIS AND HIGH BLOOD PRESSURE
U-195 METHOD FOR THE DIAGNOSIS OF GASTROINTESTINAL DISORDERS BY UREA ISOTOAC OR NITROGEN
LABELED CARBON
U-196 TREATMENT OF METASTATIC BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH ESTROGEN
RECEPTOR POSITIVE TUMORS
U-197 USE IN COMBINATION WITH CERTAIN LHRH ANALOGUES FOR THE TREATMENT OF ADVANCED
PROSTATE CANCER
U-198 TREATMENT METASTATIC CARCINOMA OF OVARY AFTER 1ST LINE FAILURE OR SUBSQUENT
CHEMOTHERAPY, TREATMENT OF BREAST CANCER AFTER FAILURE OF COMBINATION CHEMOTHERAPY
FOR METASTATIC DISEASE AND 2ND LINE TREATMENT OF AIDS RELATED KAPOSI'S SARCOMA
U-199 METHOD OF TREATING INFECTIOUS UPPER GI TRACT DISORDERS CAUSED BY CAMPYLOBACTER
PYLORIDIS INFECTION COMPRISING ADMINISTRATION OF A BISMUTH AGENT AND AN
ANTIMICROBIAL AGENT
U-200 METHOD OF TREATING GI DISORDERS COMPRISING ADMINISTRATION OF A BISMUTH-CONTAINING
AGENT AND H2 RECEPTOR BLOCKING ANTI-SECRETORY AGENT
U-201 METHOD OF TREATING GI DISORDERS COMPRISING ADMINISTRATION OF CAMPYLOBACTER-
INHIBITING ANTIMICROBIAL AGENT AND H2 RECEPTOR BLOCKING ANTI-SECRETORY AGENT
U-202 METHOD OF TREATING PEPTIC ULCER DISEASE CAUSED BY CAMPYLOBACTER PYLORIDIS
COMPRISING ORAL ADMINISTRATION OF 50 TO 5,000MG BISMUTH DAILY FOR 3-56 DAYS
U-203 TREATMENT OF ADVANCED BREAST CANCER IN POSTMENOPAUSAL WOMEN WITH DISEASE
PROGRESSION FOLLOWING ANTIESTROGEN THERAPY
U-204 USE OF TAXOL IN COMBINATION WITH G-CSF FOR TREATMENT OF PATIENTS WITH AIDS-RELATED
KAPOSI'S SARCOMA
U-205 METHOD FOR TREATING HEARTBURN
U-206 METHOD OF USING FSH ALONE, WITHOUT THE PRESENCE OF EXOGENEOUS LH, IN IN VITRO
FERTILIZATION
U-207 USE AS NASAL SPRAY
U-208 VAGINAL ADMINISTRATION USING SPECIFIED FORMULATION
U-209 VAGINAL ADMINISTRATION OF PROGESTERONE USING SPECIFIED FORMULATION
U-210 METHOD OF TREATING CONGESTIVE HEART FAILURE
U-211 USE IN PATIENTS WITH REVERSIBLE AIRWAY OBSTRUCTION
U-212 METHOD OF TREATMENT OF PARKINSON'S DISEASE
U-213 METHOD OF INHIBITING CHOLESTEROL BIOSYNTHESIS AND TREATING HYPERCHOLESTEROLEMIA
AND METHOD FOR TREATING HYPERLIPIDEMIA
U-214 USE AS A BLOOD GLUCOSE-LOWERING AGENT
U-215 TREATMENT OF EPILEPSY TWICE DAILY. TREATING A PATIENT BY ADMINISTERING
CARBAMAZEPINE IN A DOSAGE FORM CAPABLE OF MAINTAINING BLOOD CONCENTRATION FROM 4-
12MCG/ML OVER 12 HOURS
U-216 TREATMENT OF ADENOCARCINOMA, INCLUDING STAGE B2-C BY ADMINISTERING AN AGONIST OF
LH-RH AND FLUTAMIDE
U-217 METHOD OF PRODUCING ANESTHESIA
U-218 METHOD FOR LIMITING THE POTENTIAL FOR MICROBIAL GROWTH IN THE DRUG PRODUCT
U-219 TREATMENT OF PARKINSON'S DISEASE
U-220 METHOD OF DIAGNOSIS
U-221 SELECTIVE VASODILATION BY CONTINUOUS ADENOSINE INFUSION
U-222 METHOD OF TREATING PAGET'S DISEASE USING ACTONEL
U-223 TREATMENT OF BACTERIAL CONJUNCTIVITIS CAUSED BY SUSCEPTIBLE STRAINS OF
MICROORGANISMS
U-224 CONTROLLING INTRAOCULAR PRESSURE
U-225 METHOD FOR DELIVERY
U-226 METHOD OF ENHANCING THE DISSOLUTION PROFILE OF A PHARMACEUTICAL FROM A SOLID
DOSAGE FORM CONTAINING THE PHARMACEUTICAL AND SIMETHICONE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 32 of 67
PATENT USE
U-227 NASAL ADMINISTRATION
U-228 ASTHMA
U-229 CARDIAC INSUFFICIENCY (CONGESTIVE HEART FAILURE)
U-230 PREVENTION OF ACUTE CARDIAC ISCHEMIC EVENTS
U-231 USE IN PARKINSON'S DISEASE
U-232 METHOD OF TREATING MIGRAINE
U-233 DECREASING MORTALITY CAUSED BY CONGESTIVE HEART FAILURE
U-234 METHOD OF USING RIBAVIRIN TO TREAT VIRAL INFECTIONS IN MAMMALS
U-235 METHOD OF MODULATING TH1 AND TH2 RESPONSE IN ACTIVATED T CELLS OF A HUMAN
COMPRISING ADMINISTERING RIBAVIRIN TO THE T CELLS IN A DOSAGE WHICH PROMOTES THE
TH1 RESPONSE AND SUPPRESSES THE TH2 RESPONSE
U-236 TREATING MALE PATTERN BALDNESS WITH 0.05 TO 3.0MG/DAY
U-237 METHOD OF PERFORMING NMR IMAGING WITH A PATIENT COMPRISING ADMINISTERING TO THE
PATIENT AN EFFECTIVE AMOUNT OF CONTRAST AGENT DISCLOSED IN THE CLAIMS
U-238 IMAGING A BODY TISSUE AND SUBJECTING TO NMR TOMOGRAPHY, ADMINISTERING AN AMOUNT OF
PHARMACEUTICAL AGENT FOR AFFECTING THE RELAXATION TIMES OF ATOMS IN BODY TISSUES
UNDERGOING NMR DIAGNOSIS, WHEREBY THE IMAGE CONTRAST IN ENHANCED....
U-239 TREATING OR CONTROLLING OCULAR INFLAMATION WHICH COMPRISES TOPICALLY ADMINISTERING
TO AFFECTED EYE A COMPOSITION COMPRISING AN NSAID, A POLYMERIC QUATERNARY AMMONIUM
COMPOUND AND BORIC ACID
U-240 TREATMENT OF ACUTE MIGRAINE ATTACKS
U-241 FOR SHORT-TERM TREATMENT ACTIVE DUODENAL ULCER, MAINTENANCE THERAPY FOR DUODENAL
ULCER PATIENTS AT REDUCED DOSAGE AFTER HEALING OF ACTIVE ULCER, SHORT-TERM
TREATMENT ACTIVE BENIGN GASTRIC ULCER & GERD, PATHOLOGICAL HYPERSECRETORY
CONDITIONS
U-242 USE OF FOLLITROPIN ALPHA ALONE IN IN-VITRO FERTILIZATION
U-243 TOPICAL ADMINISTRATION
U-244 PLATELET AGGREGATION INHIBITORS
U-245 TREATMENT OF SEBORRHEA DERMATITIS IN HUMANS
U-246 PHOSPHATE BINDING
U-247 TREATMENT OF RHEUMATOID ARTHRITIS
U-248 TREATMENT OF HIV
U-249 METHOD OF TREATING ALLERGIC OR NON-ALLERGIC RHINITIS IN PATIENTS BY ADMINISTERING
AEROSOLIZED PARTICLES OF MOMETASONE FUROATE
U-250 TREATMENT OF HEPATITIS B INFECTION
U-251 USE OF TROGLITAZONE IN COMBINATION WITH SULFONYLUREAS IN THE TREATMENT OF TYPE II
DIABETES
U-252 METHOD OF TREATING A HUMAN SUBJECT HAVING GAUCHER'S DISEASE
U-253 ORAL TRANSMUCOSAL USE
U-254 USE OF AGGRASTAT IN COMBINATION WITH HEPARIN
U-255 IMPROVED WAKEFULNESS IN PATIENTS WITH EXCESSIVE DAYTIME SLEEPINESS ASSOCIATED WITH
NARCOLEPSY
U-256 TREATMENT OF HIV INFECTION IN COMBINATION WITH ONE OR MORE ADDITIONAL HIV
ANTIVIRAL AGENTS
U-257 TREATMENT OF HIV INFECTION
U-258 TREATMENT OF NEURODEGENERATIVE DISEASES
U-259 TREATMENT OF ANDROGENIC ALOPECIA BY ORAL ADMINISTRATION DRUG SUBSTANCE
U-260 REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA AND OCULAR
HYPERTENSION WHO ARE INTOLERANT OF OTHER IOP LOWERING MEDICATIONS OR
INSUFFICIENTLY RESPONSIVE TO ANOTHER IOP LOWERING MEDICATION
U-261 TREATING BENIGN PROSTATIC HYPERPLASIA WITH A GENUS OF COMPOUNDS, INCLUDING
FINASTERIDE
U-262 TREATING BENIGN PROSTATIC HYPERTROPHY WITH FINASTERIDE
U-263 METHOD OF TREATING A MALIGNANT CONDITION THROUGH INTRAVASCULAR ADMINISTRATION OF
BUSULFAN. METHOD FOR TREATING LEUKEMIA OR LYMPHOMA IN A PATIENT UNDERGOING A BONE
MARROW TRANSPLANT THROUGH INTRAVENOUS ADMINISTRATION OF BUSULFAN
U-264 METHOD OF TREATING A MALIGNANT DISEASE THROUGH PARENTERAL ADMINISTRATION OF
BUSULFAN. METHOD FOR TREATING A PATIENT UNDERGOING A BONE MARROW TRANSPLANT
THROUGH INTRAVASCULAR ADMINISTRATION OF BUSULFAN
U-265 USE AS LAXATIVE
U-266 RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS; RELIEF OF THE SIGNS AND
SYMPTOMS OF RHEUMATOID ARTHRITIS IN ADULTS; MANAGEMENT OF ACUTE PAIN IN ADULTS;
TREATMENT OF PRIMARY DYSMENNORRHEA; ACUTE TREATMENT OF MIGRAINE ATTACKS IN ADULTS
U-267 PREVENTING HEARTBURN EPISODES FOLLOWING INGESTION OF HEARTBURN-INDUCING
FOOD/BEVERAGE, COMPRISING ADMIN TO PT, 30 MIN PRIOR TO CONSUMPTION BY THE PT THE
FOOD/BEVERAGE, A COMPOSITION COMPRISING 10MG FAMOTIDINE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 33 of 67
PATENT USE
U-268 ACROMEGALY
U-269 EXCESS GH-SECRETION OR GASTRO-INTESTINAL DISORDERS
U-270 METHOD OF IMPROVING THE TIME FOR ADMINISTRATION OR THE TIME BETWEEN CHANGES OF
GIVING SETS FOR THE DRUG PRODUCT
U-271 METHOD OF TREATING TUMORS
U-272 METHOD OF TREATING CARCINOMA
U-273 CUTANEOUS T-CELL LYMPHOMA
U-274 ZANAMIVIR FOR INHALATION
U-275 METHOD OF USE OF THE DRUG SUBSTANCE
U-276 METHOD OF USE OF LEVOBUPIVACAINE
U-277 NEUROLOGICAL AND OTHER DISORDERS (TREATMENT OF EPILEPSY, BID ORAL DOSING)
U-278 METHOD OF USE OF THE INDICATION OF THE DRUG PRODUCT
U-279 METHOD OF USE OF THE APPROVED PRODUCT
U-280 TREATING PRECIPITATED ACUTE URINARY RETENTION WITH FINASTERIDE
U-281 ANTIMYCOTIC USES, SPECIFICALLY TREATMENT OF ONYCHOMYCOSIS
U-282 METHOD OF TREATING BACTERIAL INFECTIONS
U-283 METHOD FOR TREATING MENOPAUSAL SYMPTOMS IN A POSTMENOPAUSAL FEMALE
U-284 MENOPAUSAL AND POSTMENOPAUSAL DISORDERS (INCLUDING VASOMOTOR SYMPTOMS ASSOCIATED
WITH MENOPAUSE, AND VULVAR AND VAGINAL ATROPHY) AND OSTEOPOROSIS
U-285 DEPRESSION AND SOCIAL ANXIETY DISORDER/SOCIAL PHOBIA
U-286 DEPRESSION
U-287 TREATMENT OR PREVENTION OF OSTEOPOROSIS
U-288 THERAPY OF INFLUENZA
U-289 TREATMENT OF NON-HYPERKERATOTIC ACTINIC KERATOSES OF FACE AND SCALP
U-290 INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS)
U-291 INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH
CYCLOSPORIN
U-292 INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH
AZATHIOPRINE
U-293 INHIBITING TRANSPLANT REJECTION USING RAPAMYCIN (SIROLIMUS) IN COMBINATION WITH A
CORTICOSTEROID
U-294 TREATMENT OF HYPERPIGMENTARY DISORDERS
U-295 TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
U-296 TREATING MIGRAINE PAIN AND ONE OR MORE OF A CLUSTER OF SYMPTOMS CHARACTERISTIC OF
A MIGRAINE ATTACK SYMPTOMS BEING SELECTED FROM PHOTOPHOBIA, PHONOPHOBIA NAUSEA AND
FUNCTIONAL DISABILITY
U-297 PREVENTION OR TREATMENT OF REVERSIBLE VASOCONSTRICTION BY THE INHALATION OF NITRIC
OXIDE WITH AN OXYGEN CONTAINING GAS
U-298 METHOD OF COMBATING BACTERIA IN A PATIENT
U-299 TREATMENT OF ADENOMATOUS POLYPS
U-300 INDICATED FOR THE REDUCTION OF ELEVATED TOTAL AND LDL CHOLESTEROL LEVELS IN
PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA
U-301 USE OF TROGLITAZONE IN COMBINATION WITH SULFONYLUREAS AND BIGUANIDES IN THE
TREATMENT OF TYPE II DIABETES
U-302 TO REDUCE THE RISK OF STROKE IN PATIENTS WHO HAVE HAD TRANSIENT ISCHEMIA OF THE
BRAIN OR COMPLETED ISCHEMIC STROKE DUE TO THROMBOSIS
U-303 METHOD OF USE PATENT-PRODUCT APPROVED FOR TREATMENT OF OSTEOPOROSIS, PAGET'S
DISEASE, PREVENTION AND TREATMENT OF GLUCOCORTICOID INDUCED OSTEOPOROSIS
U-304 A METHOD OF TREATMENT OF A CONDITION INVOLVING AN ANTIBODY ANTIGEN REACTION
U-305 METHODS FOR USING THE DRUG PRODUCT
U-306 TREATMENT OF POST-MENOPAUSAL UROGENITAL SYMPTOMS ASSOCIATED WITH ESTROGEN
DEFICIENCY
U-307 CLAIMS AN OLANZAPINE POLYMORPH USEFUL FOR TREATING ANY NUMBER OF LISTED
CONDITIONS, INCLUDING SPECIFIC PSYCHOSES,EMPLOYING OLANZAPINE AS PER THE
INDICATION OF THIS NDA
U-308 CLAIMS A SOLID ORAL FORMULATION INCLUDING TABLETS AND GRANULES OF OLANZAPINE
USEFUL FOR TREATING ANY NUMBER OF LISTED CONDITIONS, INCLUDING SPECIFIC PSYCHOLES,
EMPLOYING OLANZAPINE AS PER THE INDICATIONS OF THIS NDA
U-309 TREATING SJOEGREN SYNDROME
U-310 TREATMENT OF XEROSTOMIA
U-311 HORMONE REPLACEMENT
U-312 PANIC DISORDER, OBSESSIVE-COMPULSIVE DISORDER, POSTTRAUMATIC STRESS DISORDER
U-313 TREATMENT OF CONGESTIVE HEART FAILURE
U-314 METHOD FOR TREATING HYPERPARATHYROIDISM WHICH COMPRISES SUPPRESSING PARATHYROID
ACTIVITY
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 34 of 67
PATENT USE
U-315 METHOD FOR ADMINISTERING DRUG TO GASTROINTESTINAL TRACT
U-316 METHOD OF TREATING A SUBJECT SUFFERING FROM PROSTATE CANCER
U-317 METHOD OF USING TROGLITAZONE TO TREAT PATIENTS HAVING INSULIN RESISTANCE
U-318 TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER WITH SYMPTOMS OF URINARY
FREQUENCY, URGENCY, OR URGE INCONTINENCE
U-319 TREATMENT OF MICROBIAL INFECTIONS
U-320 INHIBITING OR ELIMINATING ACUTE MYELOID LEUKEMIA
U-321 REDUCTION OF ELEVATED IPTH LEVELS IN THE MGT OF SECONDARY HYPERPARATHYROIDISM IN
PATIENTS UNDERGONG CHRONIC RENAL DIALYSIS
U-322 TREATMENT OF ALZHEIMER'S DEMENTIA
U-323 USE AS A BILE ACID SEQUESTRANT
U-324 METHOD OF TREATING AN ANIMAL, INCLUDING A HUMAN, SUFFERING FROM OR SUSCEPTIBLE TO
PSYCHOSIS OR ACUTE MANIA EMPLOYING OLANZAPINE
U-325 METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF LISTED CONDITIONS,
INCLUDING "BIPOLAR DISORDER NOS" EMPLOYING OLANZAPINE
U-326 METHOD OF TREATING SCHIZOPHRENIA AND BIPOLAR DISORDER
U-327 METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF LISTED PSYCHOTIC
CONDITONS EMPLOYING OLANZAPINE
U-328 METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF LISTED CONDITIONS
INCLUDING "A PSYCHOTIC CONDITION" EMPLOYING AN OLANZAPINE POLYMORPH
U-329 USE OF AVANDIA AS MONOTHERAPY, IN COMBINATION WITH METFORMIN, AND IN COMBINATION
WITH SULFONYLUREAS TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES
MELLITUS
U-330 TREATMENT OF NAUSEA AND VOMITING
U-331 METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID BY DOSING ONCE PER DAY IN
THE EVENING OR AT NIGHT
U-332 TREATMENT OR PREVENTION OF BRONCHOSPASM
U-333 METHOD OF TREATING OCULAR HYPERTENSION
U-334 TREATMENT OF EXCESSIVE FEMALE FACIAL HAIR
U-335 USE OF PRAVASTATIN SODIUM FOR SECONDARY PREVENTION OF CORONARY EVENTS IN MEN AND
WOMEN WHO HAVE HAD A MYOCARDIAL INFARCTION AND HAVE NORMAL CHOLESTEROL LEVELS
U-336 DIAGNOSTIC RADIOIMAGING
U-337 USE OF CARDIOLITE/MIRALUMA KIT FOR THE PREPARATION OF TC99M SESTAMIBI
U-338 METHODS FOR TREATING DISTURBANCES OF MOOD, DISTURBANCES OF APPETITE, DEPRESSED
MOOD, OR CARBOHYDRATE CRAVING ALL ASSOCIATED WITH PREMENSTRUAL SYNDROME
U-339 PREVENTION OF CARDIO-TOXICITY CAUSED BY THE ADMINISTRATION OF DOXORUBICIN
U-340 THE LONG TERM TREATMENT OF GROWTH FAILURE DUE TO LACK OF ADEQUATE ENDOGENOUS
GROWTH HORMONE SECRETION IN CHILDREN
U-341 METHOD FOR ENHANCING THE TREATMENT OF ... LATE LUTEAL PHASE DYSPHORIC DISORDER
U-342 METHOD FOR TREATMENT OF LATE LUTEAL PHASE DYSPHORIC DISORDER
U-343 REDUCTION OF INTESTINAL GAS, CRAMPING AND ANORECTAL IRRITATION
U-344 METHOD FOR INHIBITING HIV INFECTION BY ADMINISTERING RITONAVIR IN COMBINATION WITH
ANOTHER HIV PROTEASE INHIBITOR
U-345 RITONAVIR AND ANOTHER HIV PROTEASE INHIBITOR FOR CONCOMITANT ADMINISTRATION FOR
THE TREATMENT OF AN HIV INFECTION
U-346 METHOD FOR INHIBITING CYTOCHROME P450 MONOOXYGENASE WITH RITONAVIR AND A METHOD
FOR IMPROVING THE PHARMCOKINETICS OF A DRUG THAT IS MTABOLIZED BY CYTOCHROME P450
MONOOXYGENASE BY ADMIN THE DRUG AND RITONAVIR
U-347 METHOD OF USE IN COMBINATION WITH REVERSE TRANSCRIPTASE INHIBITORS
U-348 METHOD OF USE FOR INHIBITING HIV INFECTION
U-349 METHOD OF USE WHICH IS SUBJECT OF THE APPLICATION
U-350 PREPARATION OF A PHARMACEUTICAL COMPOSITION FOR CONCOMITANT ADMIN WITH A REVERSE
TRANSCRIPTASE INHIBITOR
U-351 INHIBITING PROTEASE WITH LOPINAVIR AND INHIBITING AN HIV INFECTION WITH LOPINAVIIR
U-352 INHIBITING HIV INFECTION BY ADMINISTERING RITONAVIR IN COMBINATION WITH A REVERSE
TRANSCRIPTASE INHIBITOR
U-353 PREVENTION AND TREATMENT OF OSTEOPOROSIS
U-354 METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID WITHOUT CAUSING TREATMENT-
LIMITING ELEVATIONS IN URIC ACID OR GLUCOSE LEVELS OR CAUSING LIVER DAMAGE, BY
DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
U-355 METHOD OF ASSISTING PERSON TO QUIT SMOKING...TRANSDERMALLY ADMIN NICOTINE
VIA..PATCH ADHERED TO SKIN AT DOSING RATE APPROX SAME AS ABSORBED FROM SMOKING
U-356 DELIVERING A MEDICINAL AEROSOL FORMULATION USING CFC-FREE PROPELLANT 134A.
U-357 USE OF THE DRUG PRODUCT IN PHOTODYNAMIC THERAPEUTIC PROTOCOLS FOR THE TREATMENT OF
AGE-RELATED MACULAR DEGENERATION AND RELATED CONDITIONS INVOLVING UNWANTED
NEOVASCULATURE IN THE EYE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 35 of 67
PATENT USE
U-358 DEPRESSION, OBSESSIVE COMPULSIVE DISORDER, PANIC DISORDER AND SOCIAL ANXIETY
DISORDER
U-359 METHOD OF USE OF VISICOL
U-360 METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF PATHOLOGICAL
PSYCHOLOGICAL CONDITIONS INCLUDING MENTAL DISORDERS EMPLOYING OLANZAPINE AS PER
THE INDICATION WHICH IS THE SUBJECT MATTER OF THIS SNDA-011
U-361 MANAGEMENT OF ANXIETY DISORDERS AND THE SHORT-TERM RELIEF OF THE SYMPTOMS OF
ANXIETY
U-362 USE OF APPROVED FORMULATIONS TO TREAT ALL APPROVED DISEASE INDICATIONS
U-363 METHOD OF TREATING A PATIENT SUFFERING FROM ANY OF A NUMBER OF PATHOLOGICAL
PSYCHOLOGICAL CONDITIONS THAT RELATE TO THE USE OF A PSYCHOACTIVE SUBSTANCE
EMPLOYING OLANZAPINE AS PER THE INDICATION THE SUBJECT MATTER OF SUPPLEMENT 011
U-364 TREATING A PATIENT SUFFERING FROM OR SUSCEPTIBLE TO ANY NUMBER OF LISTED
CONDITIONS INCLUDING PSYCHOSIS, EMPLOYING OLANZAPINE AS PER THE INDICATION WHICH
IS THE SUBJECT MATTER OF THIS SNDA-011
U-365 METHOD FOR THE TREATMENT OF CARDIOVASCULAR DISEASE THROUGH THE ADMINISTRATION OF A
CALCIUM BLOCKING VASODILATOR IN OUR EXTENDED, CONTROLLED RELEASE FORMULATION
U-366 METHOD FOR THE TREATMENT OF CARDIOVASCULAR DISEASE THROUGH THE ADMINISTRATION OF A
CALCIUM BLOCKING VASODILATOR IN A DELAYED RELEASE FORMULATION
U-367 TREATMENT OF CARDIOVASCULAR DISORDERS
U-368 HEARTBURN
U-369 METHOD OF CONTROLLING AND LOWERING INTRAOCULAR PRESSURE
U-370 INTRAVAGINAL TREATMENT OF VAGINAL INFECTIONS WITH BUFFERED METRONIDAZOLE
COMPOSITIONS
U-371 APPROVAL FOR MARKETING ONLY UNDER A SPECIAL RESTRICTION PROGRAM APPROVED BY FDA
CALLED "SYSTEM FOR THALIDOMIDE EDUCATION AND PRESCRIBING SAFETY" (S.T.E.P.S.)
U-372 METHOD FOR ADMINISTERING A BENEFICIAL DRUG TO THE GI TRACT OF AN ANIMAL, WHICH
METHOD COMPRISES ADMITTING AN OSMOTIC DEVICE ORALLY INTO THE ANIMAL...
U-373 GENERAL USE CLAIM SUBMITTED FOR 12 NEXIUM PATIENTS STATING "PERTINENT TO THE
CAPSULE FORMULATION FOR NEXIUM AND ITS INDICATIONS FOR THE TREATMENT OF GERD AND
ERADICATION OF H.PYLORI TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
U-374 KIT ADAPTED AND DESIGNED TO PROVIDE BOTH DATA ON THE CURRENT REPRODUCTIVE STATUS
OF A PATIENT AND CONTRACEPTION FOR THOSE WHO ARE NOT PREGNANT, BUT RECENTLY
ENGAGED IN UNPROTECTED SEX
U-375 METHOD OF USING RIBAVIRIN FOR TREATING A DISEASE RESPONSIVE TO RIBAVIRIN, E.G.
HEPATITIS C
U-376 TREATMENT OF INFLUENZA
U-377 METHOD OF TREATING PT WITH CHRONIC HEPATITIS C HAVING HCV GENOTYPE 1 AND VIRAL
LOAD GREATER THAN 2 MILLION COPIES/ML TO ERADICATE DETECTABLE HCV-RNA BY ADMIN
COMBINATION OF RIBAVIRIN AND INTERFERON ALFA-2B FOR A LEAST 24 WEEKS
U-378 METHOD FOR TREATING INCONTINENCE
U-379 METHOD OF TREATING ONYCHROMYCOSIS
U-380 COMBINATIONS OF TAXOL (PACLITAXEL) AND CISPLATIN WHICH ARE SUITABLE FOR THE
TREATMENT OF OVARIAN AND NON-SMALL CELL LUNG CARCINOMAS
U-381 TREATMENT OF HYPERPHOSPHATEMIA
U-382 METHOD OF STABLIZING PROSTAGLANDIN
U-383 METHOD FOR TREATING GLAUCOMA AND OCULAR HYPERTENSION
U-384 TREATMENT OF CMV RETINITIS
U-385 TREATMENT OF PEPTIC ULCERS
U-386 TREATMENT OF PATIENTS SUFFERING FROM A LATE ASTHMATIC REACTION OR LATE PHASE
ASTHMA
U-387 TREATMENT OF PATIENTS WITH RESPIRATORY DISORDERS
U-388 SMOKING CESSATION AID APPLIED TO THE SKIN
U-389 SMOKING CESSATION AID APPLIED TO THE SKIN ON WAKING AND REMOVED PRIOR TO SLEEP
AFTER ABOUT 16 HOURS
U-390 METHOD OF USING THE DRUG TO TREAT NEUROIMMUNOLOGIC DISEASES (INCLUDING MULTIPLE
SCLEROSIS)
U-391 USE OF CASODEX IN COMBINATION WITH LHRH AGONISTS FOR THE TREATMENT OF PROSTATE
CANCER
U-392 TREATMENT OF PATIENTS FOR INFLAMMATION
U-393 MANAGEMENT OF INCONTINENCE, MGT OF HORMONE REPLACEMENT THERAPY, TREATMENT OF
INVOLUNTARY INCONTINENCE, MGT OVERACTIVE BLADDER AND INCREASING COMPLIANCE IN SUCH
PT
U-394 METHOD OF USE OF ALPHAGAN
U-395 METHOD OF USE OF ALPHAGAN P
U-396 METHOD OF TREATING PEOPLE SUFFERING FROM DEPRESSION
U-397 METHOD OF TREATING PEOPLE SUFFERING FROM DEPRESSION WITHOUT AN INCREASE IN NAUSEA
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 36 of 67
PATENT USE
U-398 TREATMENT OF GENERALIZED ANXIETY DISORDER
U-399 IN-THE-EYE USE OF CHLORINE DIOXIDE CONTAINING COMPOSITIONS
U-400 USE OF RIBAVIRIN TO INCREASE TYPE 1 CYTOKINE RESPONSE AND SUPPRESS TYPE 2 CYTOKINE
RESP0NSE TO LYMPHOCYTES, INCLUDING METHODS THAT TAKE ADVANTAGE OF SUCH MODULATION
TO TREAT INFECTIONS AND INFESTATIONS
U-401 USE OF LOPINAVIR IN COMBINATION WITH REVERSE TRANSCRIPTASE INHIBITORS FOR TREATING
HIV INFECTION AND IN COMBO WITH OTHER HIV PROTEASE INHIBITORS
U-402 TREATMENT OF ACTINIC KERATOSES
U-403 ANTI-ALLERGIC FOR VARIOUS ALLERGIC DISEASES
U-404 TREATMENT OF ALLERGIC CONJUNCTIVITIS
U-405 FOR WOMEN WITH SEVERE DIARRHEA-PREDOMINANT IRRITABLE BOWEL SYNDROME (IBS)
U-406 METHOD OF USE OF ATOVAQUONE AND PROGUANIL
U-407 METHOD OF TREATING OTOPATHY
U-408 FOR INDUCING OVULATION IN CONJUNCTION WITH A GONADOTROPIN RELEASING FACTOR
ANTAGONIST AND RECRUITING OOCYTES FOR IN-VITRO FERTILIZATION
U-409 METHOD OF TREATING INFLAMMATION USING DRUG SUBSTANCE
U-410 METHOD OF REDUCING AMOUNT OF RESPECTIVE ACTIVE COMPONENTS ADMINISTERED TO A
DIABETIC PATIENT BY ADMINISTERING A CHEMICAL COMPOUND HAVING A PARTICULAR FORMULA
(INCLUDING PIOGLITAZONE) IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
U-411 METHOD OF REDUCING THE SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A
DIABETIC PATIENT BY ADMINISTERING A CHEMICAL COMPOUND HAVING A PARTICULAR FORMULA
(WHICH INCLUDES PIOGLITAZONE) IN COMBINATION WITH AN INSULIN PREPARATION
U-412 TREATMENT OF TYPE 2 DIABETES
U-413 USE OF THE ACTIVE INGREDIENT FOR INHIBITING THE BIOSYNTHESIS OF CHOLESTEROL AND
TREATMENT OF ATHEROSCLEROSIS
U-414 A METHOD OF TREATING GLYCOMETABOLISM DISORDERS BY ADMINISTERING AN INSULIN
SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE
U-415 A METHOD FOR REDUCING THE AMOUNT OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC
PATIENT BY ADMINISTERING AN INSULIN SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE)
IN COMBINATION WITH A BIGUANIDE AS SAID ACTIVE COMPONENTS
U-416 A METHOD FOR REDUCING SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC
PATIENT BY ADMINISTERING AN INSULIN SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE)
IN COMBINATION WITH A BIGUANIDE AS SAID ACTIVE COMPONENTS
U-417 COMBINATION USE OF AD-4833 WITH A BIGUANIDE
U-418 A METHOD OF TREATING LIPID METABOLISM DISORDERS BY ADMINISTERING A CHEMICAL
COMPOUND HAVING A PARTICULAR FORMULA (WHICH INCLUDES PIOGLITAZONE) IN COMBINATION
WITH AN INSULIN SECRETION ENHANCER
U-419 A METHOD OF TREATING LIPID METABOLISM DISORDERS BY ADMINISTERING AN INSULIN
SENSITIVITY ENHANCER (INCLUDING PIOGLITAZONE) IN COMBINATION WITH A BIGUANIDE
U-420 METHOD OF TREATMENT OF TYPE II DIABETES
U-421 USE FOR SEDATION
U-422 METHOD OF TREATING AT LEAST ONE OF ATTENTION DEFICIT DISORDER AND ATTENTION
DEFICIT HYPERACTIVITY DISORDER
U-423 METHOD OF TREATING AT LEAST ONE OF ATTENTION DEFICIT DISORDER, ATTENTION DEFICIT
HYPERACTIVITY DISORDER, OR AIDS RELATED DEMENTIA
U-424 FOR ONCE DAILY, BOLUS ADMINISTRATION TO A PATIENT IN ORDER TO ENGENDER TREATMENT
FOR A NERVOUS DISORDER FOR SUBSTANTIALLY AN ENTIRE DAY ON A CHRONIC BASIS
U-425 METHOD OF REDUCING SIDE EFFECTS OF ACTIVE COMPONENTS ADMIN TO A DIABETIC BY ADMIN
A CHEMICAL COMPOUND HAVING FORMULA (INCL PIOGLITAZONE) IN COMBINATION WITH AN
INSULIN SECRETION ENHANCER
U-426 PREVENTION OF PREMATURE LH SURGES IN WOMEN UNDERGOING CONTROLLED OVARIAN
STIMULATION
U-427 METHOD OF TREATING ALLERGIC REACTIONS IN MAMMALS
U-428 METHOD OF TREATING ALLERGY IN A MAMMAL USING THIS ACTIVE METABOLITE
U-429 METHOD OF USING DESLORATADINE TO TREAT ALLERGIC RHINITIS
U-430 METHOD OF TREATING A DIABETIC BY ADMINISTERING AN INSULIN SENSITIZER IN
COMBINATION WITH AN INSULIN SECRETION ENHANCER, AND A DRUG PRODUCT C0MPRISING AN
INSULIN SENSITIZER AND AN INSULIN SECRETION ENHANCER
U-431 POSTTRAUMATIC STRESS DISORDER
U-432 REDUCTION OF ATHEROSCLEROTIC EVENTS (MYOCARDIAL INFARCTION, STROKE, AND VASCULAR
DEATH) IN PATIENTS WITH ATHEROSCLEROSIS DOCUMENTED BY RECENT STROKE, RECENT
MYOCARDIAL INFARCTION OR ESTABLISHED PERIPHERAL ARTERIAL DISEASE
U-433 USE OF LEVOCARITINE IN PREVENTION AND TREATMENT OF CARNITINE DEFICIENCY IN
PATIENTS WITH END STAGE RENAL DISEASE WHO ARE UNDERGOING DIALYSIS
U-434 CONTROLLED SYMPTOMS OF DIARRHEA, BLOATING PRESSURE AND CRAMPS, COMMONLY REFERRED
TO AS GAS
U-435 A TITRATION DOSING REGIMEN FOR THE TREATMENT OF PAIN USING AN INITIAL DOSE OF
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 37 of 67
PATENT USE
ABOUT 25MG
U-436 ACUTE TREATMENT OF MIGRAINE ATTACKS WITH OR WITHOUT AURA IN ADULTS
U-437 METHOD OF USE EQUAL TO PROCESS OF PREPARATION
U-438 TREATMENT/PREVENTION OF NEURODEGENERATIVE DISEASE
U-439 TREATMENT OF OBESITY
U-440 METHOD FOR TRANSDERMAL ADMINISTRATION OF A DRUG THROUGH NON-SCROTAL SKIN USING A
TRANSDERMAL DRUG DELIVERY DEVICE CONTAINING THE DRUG AND HAVING AN ADHESIVE
SURFACE
U-441 METHOD OF TREATING MS BY ADMINISTERING COPAXONE
U-442 METHOD FOR DELIVERING A DRUG TO A PATIENT IN NEED OF THE DRUG, WHILE AVOIDING THE
OCCURENCE OF AN ADVERSE SIDE EFFECT KNOWN OR SUSPECTED OF BEING CAUSED BY SAID
DRUG
U-443 MANAGEMENT OF MODERATE TO SEVERE PAIN WHEN A CONTINUOUS, AROUND-THE-CLOCK
ANALGESIC IS NEEDED FOR AN EXTENDED PERIOD OF TIME
U-444 TREATMENT OF MIGRAINE
U-445 USE AS AN ANTIMYCOTIC AGENT
U-446 TOPICAL TREATMENT OF OCULAR HYPERTENSION AND GLAUCOMA
U-447 METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID BY DOSING ONCE PER DAY IN
THE EVENING OR AT NIGHT
U-448 METHOD OF TREATING HYPERLIPIDEMIA WITH NICOTINIC ACID WITHOUT CAUSING TREATMENT-
LIMITING ELEVATIONS IN URIC ACID OR GLUCOSE LEVELS OR CAUSING LIVER DAMAGE, BY
DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
U-449 USE IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN FOR THE TREATMENT OF
METASTATIC COLORECTAL CANCER WHERE THE DOSE OF LEUCOVORIN IS AT LEAST 200MG PER
SQUARE METER
U-450 INTERMEDIATE REL NICOTINIC ACID FORMULATIONS HAVING UNIQUE URINARY METAB PROFILES
RESULTING FROM ABSORPTION PROFILES OF NICOTINIC ACID FROM THE INTERMEDIATE
NICOTINIC ACID FORMULATIONS,SUITABLE FOR TX HYPERLIPIDEMIA FOLLOWING QD DOSING
U-451 TREATMENT OF DEPRESSION AND GENERALIZED ANXIETY DISORDER
U-452 USE OF LANSOPRAZOLE FOR COMBATTING DISEASES CAUSED BY THE GENUS CAMPYLOBACTER
(C.PYLORI=H.PYLORI)
U-453 TREATMENT OF PLATELET ASSOCIATED ISCHEMIC DISORDERS
U-454 METHOD OF TX A PT SUSPECTED OF HAVING HEPATITIS C BY ADMIN, IN COMBINATION, A
CONJUGATE COMPRISING PEG 12000 & INTERFERON ALFA-2B IN AN AMT OF FROM 0.5MCG/KG TO
2MCG/KG, ONCE WEEKLY, AND RIBAVIRIN
U-455 TREATMENT OF PULMONARY HYPERTENSION WITH UT-15
U-456 METHOD OF DECREASING THE PRODUCTION OF A-BETA USING A COMPOSITION WHICH DECREASES
BLOOD CHOLESTEROL IN PATIENTS AT RISK OF OR EXHIBITING SYMPTOMS OF ALZHEIMER'S
DISEASE
U-457 METHOD OF TREATING A VAGINAL FUNGAL INFECTION IN A FEMALE HUMAN
U-458 METHOD OF USE OF IMAGENT
U-459 TREATMENT OF DEPRESSION AND GENERALIZED ANXIETY DISORDER
U-460 METHOD OF TREATING PSYCHIATRIC SYMPTOMS ASSOCIATED WITH PREMENSTRUAL DISORDERS
USING SERTRALINE
U-461 METHOD OF TREATMENT OF LATE LUTEAL PHASE DYSPHORIC DISORDER (PMDD) USING
SERTRALINE
U-462 SIGNS AND SYMPTOMS OF OSTEOARTHRITIS AND ADULT RHEUMATOID ARTHRITIS AND TREATMENT
OF PRIMARY DYSMENORRHEA
U-463 VENOGRAPHY
U-464 PERIPHERAL ARTERIOGRAPHY
U-465 CT IMAGING OF THE HEAD
U-466 TREATMENT OF IRRITABLE BOWEL SYNDROME
U-467 USE OF EPLERENONE IN COMBINATION WITH AN ANGIOTENSIN CONVERTING ENZYME (ACE)
INHIBITOR FOR TREATING HYPERTENSION
U-468 METHOD OF USING FEXOFENADINE HCL IN TREATING ALLERGIC RHINITIS
U-469 TREATMENT OF GASTROESOPHAGEAL REFLEX DISEASE (GERD) AND ERADICATION OF H.PYLORI TO
REDUCE RISK OF DUODENAL ULCER RECURRENCE
U-470 THERAPY IN CHRONIC HEPATITIS B VIRUS INFECTION
U-471 METHOD OF TREATING A PATIENT SUFFERING FROM DIABETES MELLITUS
U-472 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING METHYLPHENIDATE BI-
MODAL RELEASE PROFILE EXTENDED-RELEASE CAPSULES
U-473 TO REDUCE PLASMA CHOLESTEROL LEVELS IN A MAMMAL
U-474 TO REDUCE PLASMA CHOLESTEROL LEVELS BY ADMIN EZETIMIBE IN COMBO WITH CHOLESTEROL
BIOSYNTHESIS INHIB SELECTED FROM GROUP CONSISTING OF HMG COA REDUCTASE INHIBITORS
INCL SIMVASTATIN
U-475 TREATMENT OF CUTANEOUS MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 38 of 67
PATENT USE
ARE REFRACTORY TO AT LEAST ONE PRIOR SYSTEMIC THERAPY
U-476 METHOD OF TREATING ANDROGEN RESPONSIVE/MEDIATED CONDITION IN MAMMAL BY ADMIN A
SAFE, EFFECTIVE AMOUNT OF DUTASTERIDE OR PHARMACEUTICALLY ACCEPTABLE DERIVATIVE
THEREOF..CONDITIONS INCLUDE BENIGN PROSTATIC HYPERTROPHY
U-477 METHOD OF INHIBITING 5 ALPHA TESTOSTERONE REDUCTASE ENZYME WITH DUTASTERIDE OR ITS
DERIVATIVE AND TREATING ANDROGEN RESPONSIVE/MEDIATED DISEASE INCLUDING BENIGN
PROSTATIC HYPERPLASIA
U-478 METHOD OF TREATING HEPATITIS C VIRAL INFECTION BY CONTINUOUS PARENTERAL ADMIN
INTERFERON ALPHA 2-10 MILLION IU WEEKLY, SUBCUTANEOUSLY, INJECTION OF POLYMER-
INTERFERON ALPHA CONJUGATE-POLYMER IS PEG-INTERFERON IS ALPHA 2B
U-479 METHOD OF USING PEG-INTRON/REBETOL COMBINATION THERAPY AND INTRON/REBETOL
COMBINATION THERAPY
U-480 CONTRAST AGENT FOR MRI
U-481 DISUBSTITUTED ACETYLENES BEARING HETEROAROMATIC AND HETEROBICYCLIC GROUPS HAVING
RETINOID-LIKE ACTIVITY
U-482 METHOD OF IN VITRO FERTILIZATION THERAPY INCLUDING MEANS FOR INDUCING
OVULATION....
U-483 METHOD FOR THE ADMINISTRATION OF DRUGS USING THAT COMPOUND
U-484 METHOD OF TREATING A SKIN DISEASE WITH A CORTICOSTEROID-CONTAINING PHARMACEUTICAL
COMPOSITION
U-485 METHOD AND COMPOSITION FOR REDUCING NERVE INJURY PAIN ASSOCIATED WITH SHINGLES
(HERPES ZOSTER AND POST-HERPETIC NEURALGIA)
U-486 EXTERNAL PREPARATION FOR APPLICATION TO THE SKIN CONTAINING LIDOCAINE-DRUG
RETAINING LAYER PLACED ON SUPPORT AND COMPRISES ADHESIVE GEL BASE 1-10% BY WEIGHT
OF LIDOCAINE
U-487 METHOD AND COMPOSITION FOR REDUCING NERVE INJURY PAIN ASSOCIATED WITH SHINGLES
(HERPES ZOSTER AND POST-HERPETIC NEURALGIA)
U-488 METHOD FOR REDUCING THE PAIN ASSOCIATED WITH HERPES-ZOSTER AND POST-HERPETIC
NEURALGIA
U-489 EXPECTORANT
U-490 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A
DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
U-491 METHOD OF DELIVERING A DRUG TO THE LUNG
U-492 METHOD FOR THE TREATMENT OF SKIN, SUFFERING FROM A CONDITION SELECTED FROM A GROUP
CONSISTING OF NONACNE INFLAMMATORY DERMATOSES... COMPRISING APPLYING TO AFFECTED
AREA. A THERAPEUTICALLY EFFECTIVE AMT AZELAIC ACID
U-493 TREATMENT OF TYPE 2 DIABETES MELLITUS
U-494 TREATMENT OF ATTENTION-DEFICIT HYPERACTIVITY DISORDER
U-495 PERITONEAL DIALYSIS SOLUTION
U-496 METHOD FOR TREATING CHRONIC RENAL FAILURE
U-497 RELIEF OF THE SIGNS AND SYMPTOMS OF OSTEOARTHRITIS AND RHEUMATOID ARTHRITIS
U-498 INTRA-ARTERIAL AND INTRAVENOUS USES OF ULTRAVIST
U-499 METHOD OF USING REBETOL CAPSULES IN COMBINATION WITH A CONJUGATE COMPRISING
POLYETHYLENE GLYCOL(PEG) AND AN ALPHA INTERFERON, INCLUDING, FOR EXAMPLE, PEG-
INTRON POWDER FOR INJECTION
U-500 USE AS AN ANTIHYPERTENSIVE AGENT
U-501 TREATMENT OF RECURRENT HERPES LABIALIS (COLD SORES) IN ADULTS
U-502 PITYRIASIS VERSICOLOR
U-503 GENERATOR MUST BE USED WITH INFUSION SYSTEM SPECIFICALLY LABELED FOR USE WITH
GENERATOR
U-504 TINEA PEDIS, TINEA CRURIS, TINEA CORPORIS
U-505 ULTRASOUND CONTRAST AGENT
U-506 PHARM PRODUCT CONTAINER 1ST CHAMBER IS DISPOSED AQUEOUS DILUENT SOL 2ND CHAMBER
PHARM ACTIVE AGENT COMPRISING ACETYLCHOLINE,BUFFER IN 1ST CHAM IS SUFFICIENT TO
BUFFER PH OF MIXED SOL RESULTING MIXTURE OF AQUEOUS DILUENT SOL & PHARM ACTIVE..
U-507 ACROMEGALY IN PATIENTS W/INADEQUATE RESPONSE TO SURGERY AND/OR RADIATION THERAPY
AND/OR MEDICAL THERAPIES, OR FOR WHOM THESE THERAPIES ARE NOT APPROPRIATE
U-508 METHOD OF RELEASING 17-BETA OESTRADIOL PRECURSOR IN A SUBSTANTIALLY ZERO ORDER
PATTERN FOR AT LEAST THREE WEEKS
U-509 TREATMENT OF CUTANEOUS MANIFESTATIONS OF CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO
ARE REFRACTORY TO AT LEAST ONE PRIOR SYSTEMIC THERAPY
U-510 TOPICAL TREATMENT OF CUTANEOUS LESIONS IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA
(STAGE IA AND IB) WHO HAVE REFRACTORY OR PERSISTENT DISEASE AFTER OTHER THERAPIES
OR WHO HAVE NOT TOLERATED OTHER THERAPIES
U-511 USE OF QUINOLONE COMPOUNDS AGAINST ANAEROBIC PATHOGENIC BACTERIA
U-512 USE OF QUINOLONE COMPOUNDS AGAINST ATYPICAL UPPER RESPIRATORY PATHOGENIC BACTERIA
U-513 METHODS OF USE OF ANTIMICROBIAL COMPOUNDS AGAINST PATHOGENIC AMYCOPLASMA BACTERIA
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 39 of 67
PATENT USE
U-514 PREVENTION OF OVULATION IN A WOMAN
U-515 TREATMENT OF MULTIPLE MYELOMA PATIENTS WHO HAVE RECEIVED AT LEAST TWO PRIOR
THERAPIES AND HAVE DEMONSTRATED DISEASE PROGRESSION ON THE LAST THERAPY
U-516 METHOD OF TREATING A PSYCHOTIC DISEASE
U-517 STABLE GEL FORMULATION FOR TOPICAL TREATMENT OF SKIN CONDITIONS
U-518 OBSESSIVE COMPULSIVE DISORDER
U-519 POST OPERATIVE NAUSEA AND VOMITING
U-520 PREMENOPAUSAL OSTEOPOROSIS
U-521 METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTRON A (INTERFERON ALPHA-2 B
RECOMBINANT) INJECTION TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
U-522 TREATMENT OF CMV RETINITIS BY INTRAVITREAL ADMIN OF A PHOSPHOROTHIOATE
OLIGONUCLEOTIDE CAPABLE OF HYBRIDIZING WITH CMV MRNA
U-523 METHOD OF TREATING INFECTION BY CRYPTOSPORIDIUM PARVUM IN AN IMMUNOCOMPROMISED
MAMMAL
U-524 METHOD OF TREATING DIARRHEA
U-525 METHOD OF TREATING PARASITIC INFECTIONS
U-526 METHOD OF PROVIDING CONTROLLED RELEASE OF A TREATING AGENT USING A CONTROLLED
RELEASE COMPOSITION
U-527 METHOD OF DELIVERING AN ACTIVE INGREDIENT USING A PROGRESSIVE HYDRATION
BIOADHESIVE
U-528 PREVENTION OF CHEMOTHERAPY-INDUCED NAUSEA AND VOMITING
U-529 ONCE DAILY TREATMENT OF ASTHMA WITH NEBULIZED BUDESONIDE
U-530 TREATMENT OF HERPES ZOSTER, TREATMENT OF GENITAL HERPES, TREATMENT OF COLD SORES,
SUPPRESSION OF GENITAL HERPES IN IMMUNOCOPETENT AND HIV-INFECTED INDIVIDUALS,
REDUCTION OF RISK OF HETEROSEXUAL TRANSMISSION OF GENITAL HERPES
U-531 TREATMENT OF PATIENTS WITH ESSENTIAL HYPERTENSION. MAY BE USED ALONE OR GIVEN
WITH OTHER CLASSES OF ANTIHYPERTENSIVES, ESPECIALLY THIAZIDE DERIVATIVES
U-532 TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD IN PATIENTS REQUIRING MORE THAN ONE
BRONCHO DILATOR
U-533 ERECTILE DYSFUNCTION
U-534 HUMALOG IS AN INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT OF PATIENTS WITH
DIABETES MELLITUS FOR THE CONTROL OF HYPERGLYCEMIA
U-535 TREATMENT OF SOCIAL ANXIETY DISORDER
U-536 CONTRAST AGENT FOR MAGNETIC RESONACE IMAGING
U-537 TREATMENT OF CONDITIONS RELATED TO HYPERALDOSTERONISM SUCH AS HYPERTENSION AND
CARDIAC INSUFFICIENCY, WITH EPLERENONE
U-538 FIRST LINE TREATMENT OF SEVERE HYPERTENSION, IN PATIENTS WITH HYPERTENSION SEVERE
ENOUGH THAT THE VALUE OF ACHIEVING PROMPT BLOOD PRESSURE CONTROL EXCEEDS THE RISK
OF INITIATING COMBINATION THERAPY IN THESE PATIENTS
U-539 TREATMENT OF MODERATE TO SEVERE DEMENTIA OF THE ALZHEIMER'S TYPE
U-540 TREATMENT OF FUNGAL INFECTIONS
U-541 METHOD OF TREATMENT OF ADULTS INFECTED WITH HIV-1
U-542 METHOD OF TREATING PATIENT WITH TYPE 2 DIABETES BY ONCE DAILY ADMINISTRATION
U-543 TREATMENT OF SCHIZOPHRENIA
U-544 TREATMENT OF OVERACTIVE BLADDER. TREATMENT OF URINARY INCONTINENCE.
U-545 METHOD FOR THE PREVENTION AND/OR TREATMENT OF THROMBOTIC EPISODES, SUCH AS
MYOCARDIAL INFARCTION, IN A HUMAN PATIENT AND METHOD FOR THE PREVENTION OF VENOUS
THROMBOSIS IN A POSTOPERATIVE HUMAN PATIENT
U-546 USE OF REPAGLINIDE IN COMBINATION WITH METFORMIN TO LOWER BLOOD GLUCOSE
U-547 MAINTENANCE MONOTHERAPY FOR BIPOLAR DISORDER
U-548 A METHOD OF REDUCING FLUSH IN AN INDIVIDUAL BEING TREATED FOR A LIPIDEMIC DISORDER
AND EFFECTIVELY TREATING THE LIPIDEMIC DISORDER
U-549 USE IN THE TREATMENT OF MEN WITH ADVANCED SYMPTOMATIC PROSTATE CANCER
U-550 TREATMENT OF BIPOLAR DISORDER AND SCHIZOPHRENIA
U-551 METHOD FOR REDUCING TOXICITY OF ALIMTA TREATED PATIENTS BY ADMINISTERING FOLIC
ACID
U-552 TREATMENT OF HYPERTENSION AND HYPERLIPIDEMIA WITH A SINGLE COMPOSITION
U-553 MANAGEMENT OF PAIN AND DISCOMFORT ASSOCIATED WITH PERIDONTAL SCALING AND ROOT
PLANNING PROCEDURES BY APPLICATION OF AN EUTECTIC MIXTURE OF LOCAL ANESTHETICS TO
PERIDONTAL POCKETS
U-554 TREATING HIV INFECTION WITH INDINAVIR SULFATE IN COMBINATION WITH ANTIRETROVIRAL
AGENTS
U-555 TREATMENT OF COMPLICATED URINARY TRACT INFECTIONS AND ACUTE UNCOMPLICATED
PYELONEPHRITIS
U-556 USE AS ADJUNCT DIAGNOSTIC FOR SERUM THYROGLOBULIN (TG) TESTING
U-557 NASAL TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 40 of 67
PATENT USE
U-558 INDICATED FOR THE RELIEF OF BRONCHOSPASM IN PATIENTS 2-12 YEARS OF AGE WITH ASTHMA
(REVERSIBLE OBSTRUCTIVE AIRWAY DISEASE)
U-559 METHOD OF DECREASING OR REDUCING PARATHYROID HORMONE LEVEL; METHOD OF MODULATING
PARATHYROID HORMONE SECRETION;METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF
REDUCING SERUM IONIZED CALCIUM LEVEL
U-560 METHOD OF DECREASING PARATHYROID HORMONE LEVEL;METHOD OF TREATING
HYPERPARATHYROIDISM
U-561 COSOPT IS INDICATED FOR THE REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS
WITH OPEN-ANGLE GLAUCOMA OR OCULAR HYPERTENSION WHO ARE INSUFFICIENTLY RESPONSIVE
TO BETA BLOCKERS
U-562 TOPICAL TREATMENT OF CUTANEOUS LESIONS IN PATIENTS WITH AIDS-RELATED KAPOSI'S
SARCOMA
U-563 MARINOL IS INDICATED FOR, INTER ALIA, ANOREXIA ASSOCIATED WITH WEIGHT LOSS IN
PATIENTS WITH AIDS
U-564 TREATMENT OF HIV IN CONCOMITANT THERAPY
U-565 TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS, AND CHRONIC
URTICARIA
U-566 FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED
WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS
AND EMPHYSEMA
U-567 METHOD OF TREATING INFERTILITY
U-568 METHOD OF USING FSH ALONE (WITHOUT EXOGENOUS LH) IN IN VITRO FERTILIZATION
U-569 METHOD OF USING FSH ALONE (WITHOUT EXOGENOUS LH) IN IN VITRO FERTILIZATION AND
WHEREIN THEREAFTER AN OVULATORY INDUCING AMOUNT OF HCG IS ADMINISTERED
U-570 METHOD OF USING FSH ALONE (WITHOUT EXOGENOUS LH) IN IN VITRO FERTILIZATION AND
WHEREIN THE DAILY AMOUNT OF FSH IS ABOUT 5-10 IU/KG
U-571 TREATMENT OF AGITATION ASSOCIATED WITH SCHIZOPHRENIA AND BIPOLAR I MANIA
U-572 INTENSIVE CARE UNIT SEDATION
U-573 TREATMENT OF ACUTE PROMYELOGENOUS LEUKEMIA (APL)
U-574 PROPHYLAXIS AND TREATMENT OF THE NASAL SYMPTOMS OF SEASONAL ALLERGIC RHINITIS AND
TREATMENT OF THE NASAL SYMPTOMS OF PERENNIAL ALLERGIC RHINITIS IN ADULTS AND
PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
U-575 LOTEMAX OPTHALMIC SUSPENSION IS INDICATED FOR THE TREATMENT OF STEROID RESPONSIVE
CONDITIONS OF THE PALPEBRAL BULBAR CONJUNCTIVA, CORNEA AND ANTERIOR SEGMENT OF THE
GLOBE.
U-576 ALREX OPTHALMIC SUSPENSION IS INDICATED FOR THE TEMPORARY RELIEF OF THE SIGNS AND
SYMPTOMS OF SEASONAL ALLERGIC CONJUNCTIVITIS.
U-577 TREATMENT OF BENIGN PROSTATIC HYPERPLASIA WITH FINASTERIDE IN COMBINATION WITH
DOXAZOSIN
U-578 TREATMENT OF COMMUNITY ACQUIRED PNEUMONIA, ACUTE EXACERBATION OF CHRONIC
BRONCHITIS, AND ACUTE BACTERIAL SINUSITIS CAUSED BY SUSCEPTIBLE STRAINS OF
DESIGNATED MICROORGANISMS IN PATIENTS 18 YEARS AND OLDER.
U-579 TREATMENT OF EPILEPSY AND/OR MIGRAINE.
U-580 TREATMENT OF DISORDERS OF THE SEROTONERGIC SYSTEM SUCH AS DEPRESSION AND ANXIETY-
RELATED DISORDERS
U-581 METHOD OF TREATING A CONDITION CAPABLE OF TREATMENT BY INHALATION, E.G. ASTHMA,
COMPRISING ADMINISTRATION OF A FORMULATION CLAIMED IN US PATENT NO. 6743413
U-582 METHOD FOR THE TREATMENT OF A RESPIRATORY DISORDER, E.G. ASTHMA, COMPRISING
ADMINISTERING AN EFFECTIVE AMOUNT OF AN AEROSOL COMPOSITION TO A PATIENT FROM A
METERED DOSE INHALER SYSTEM AS CLAIMED IN US PATENT NO. 6253762
U-583 METHOD FOR THE TREATMENT OF A RESPIRATORY DISORDER, E.G. ASTHMA, COMPRISING
ADMINISTERING TO A PATIENT BY INHALATION, A METERED AEROSOL DOSE OF A DRUG
FORMULATION FROM THE METERED DOSE INHALER SYSTEM CLAIMED IN US 6546928
U-584 SINGLE-DOSE ADMINISTRATION BY THE EPIDURAL ROUTE, AT THE LUMBAR LEVEL, FOR THE
TREATMENT OF PAIN FOLLOWING MAJOR SURGERY
U-585 TO PROMOTE WEIGHT GAIN AFTER WEIGHT LOSS IN CERTAIN TYPES OF PATIENTS
U-586 AN INTERMEDIATE RELEASE NICOTINIC ACID FORMULATION SUITABLE FOR ORAL
ADMINISTRATION ONCE-A-DAY AS A SINGLE DOSE FOR TREATING HYPERLIPIDEMIA WITHOUT
CAUSING DRUG-INDUCED HEPATOTOXICITY OR ELEVATIONS IN URIC ACID OR GLUCOSE OR BOTH
U-587 USE OF EPLERENONE IN COMBINATION WITH AN ANGIOTENSIN CONVERTING ENZYME (ACE)
INHIBITOR (AND OPTIONALLY A DIURETIC) FOR TREATING CONGESTIVE HEART FAILURE AND
HYPERTENSION
U-588 SHORT-TERM TREATMENT OF ACTIVE DUODENAL ULCER; TREATMENT OF HEARTBURN AND OTHER
SYMPTOMS ASSOCIATED WITH GERD; SHORT-TERM TREATMENT OF EROSIVE ESOPHAGITIS;
MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS
U-589 METHOD FOR TREATMENT OF A RESPIRATORY DISORDER, E.G., BRONCHOSPASM, COMPRISING
ADMINISTERING AN EFFECTIVE AMOUNT OF AN AEROSOL COMPOSITION TO A PATIENT FROM A
METERED DOSE INHALER SYSTEM AS CLAIMED IN U.S. PATENT NO. 6131966
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 41 of 67
PATENT USE
U-590 METHOD FOR TREATMENT OF A RESPIRATORY DISORDER,E.G.,BRONCHOSPASM,COMPRISING
ADMINISTERING TO A PATIENT BY ORAL OR NASAL INHALATION A DRUG FORMULATION BY USING
THE METERED DOSE INHALER SYSTEM AS CLAIMED IN US PATENT NO.6532955
U-591 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER USING A DOSAGE FORM WHICH
PROVIDES ONCE-DAILY ORAL ADMINISTRATION OF A PHENIDATE DRUG
U-592 TREATMENT OF PRIMARY HYPERCHOLESTEROLEMIA, MIXED HYPERLIPIDEMIA AND/OR HOMOZYGOUS
FAMILIAL HYPERCHOLESTEROLEMIA (HOFH)
U-593 TREATMENT OF PRIMARY HYPERCHOLESTEROLEMIA, MIXED HYPERLIPIDEMIA AND/OR HOMOZYGOUS
FAMILIAL HYPERCHOLESTEROLEMIA (HOFH)
U-594 PREVENTION OF POSTMENOPAUSAL OSTEOPOROSIS
U-595 35 MG ORALLY ONCE A WEEK FOR PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN;
35 MG ORALLY ONCE A WEEK FOR TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
U-596 TREATMENT OF HORMONE RECEPTOR POSITIVE METASTATIC BREAST CANCER IN POSTMENOPAUSAL
WOMEN WITH DISEASE PROGRESSION FOLLOWING ANTIESTROGEN THERAPY
U-597 FORTEO IS INDICATED FOR THE TREATMENT OF POST MENOPAUSAL WOMEN WITH OSTEOPOROSIS
WHO ARE AT HIGH RISK FOR FRACTURE
U-598 PROPHYLACTIC TREATMENT OF MIGRAINE
U-599 METHOD FOR TREATING ALLERGIC CONJUNCTIVITIS
U-600 A METHOD OF TREATING A PATIENT IN NEED OF OPHTHALMIC ANTIMICROBIAL THERAPY WITH
LEVOFLOXACIN
U-601 TREATMENT OF BIPOLAR DISORDER
U-602 SIGNS AND SYMPTOMS OF OSTEOARTHRITIS, RHEUMATOID ARTHRITIS IN ADULTS, AND/OR
PAUCIARTICULAR OR POLYARTICULAR COURSE JUVENILE RHEUMATOID ARTHRITIS, ACUTE PAIN
IN ADULTS; PRIMARY DYSMENORRHEA; AND/OR ACUTE MIGRAINE ATTACKS IN ADULTS
U-603 METHOD OF TREATING INFECTIONS COMPRISING ORALLY ADMINISTERING AN EFFECTIVE AMOUNT
OF THE FDA APPROVED ORAL SUSPENSION
U-604 METHOD OF LOWERING BLOOD GLUCOSE BY ONCE DAILY ADMINISTRATION
U-605 TREATMENT OF MAJOR DEPRESSIVE DISORDER(MDD);ALTHOUGH THE MEHCHANISM OF THE
ANTIDEPRESSANT ACTION OF DULOXETINE IN HUMANS IS UNKNOWN, IT IS BELIEVED TO BE
RELATED TO ITS POTENTIATION OF SERATONERGIC AND NORADRENERGIC ACTIVITY IN THE CNS
U-606 USE OF IRINOTECAN IN COMBINATION WITH 5-FLUOROURACIL AND LEUCOVORIN FOR THE
TREATMENT OF METASTATIC COLRECTAL CANCER
U-607 CANCIDAS IS INDICATED FOR EMPIRICAL THERAPY FOR PRESUMED FUNGAL INFECTIONS IN
FEBRILE, NEUTROPENIC PATIENTS.
U-608 USE OF QUINOLONE COMPOUNDS AGAINST PNEUMOCOCCAL PATHOGENIC BACTERIA
U-609 USE OF QUINOLONE COMPOUNDS AGAINST QUINOLONE-RESISTANT PNEUMOCOCCAL PATHOGENIC
BACTERIA
U-610 ATROVENT HFA (IPRATROPIUM BROMIDE HFA) INHALATION AEROSOL IS INDICATED AS A
BRONCHODILATOR FOR MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH CHRONIC
OBSTRUCTIVE PULMONARY DISEASE, INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA.
U-611 METHOD OF USING DESLORATADINE TO TREAT SEASONAL AND PERENNIAL ALLERGIC RHINITIS,
PRURITIS, AND CHRONIC IDIOPATHIC URTICARIA IN PATIENTS 2 YEARS OF AGE AND OLDER
U-612 TREATMENT OF SEASONAL ALLERGY SYMPTOMS WITH NASAL CONGESTION IN ADULTS AND
CHILDREN 12 YEARS OF AGE AND OLDER
U-613 REDUCTION OF SERUM PHOSPHATE
U-614 TREATMENT OF SEXUAL DYSFUNCTION
U-615 ADJUNCTIVE THERAPY TO DIET IN ADULTS TO REDUCE LDL-C, TOTAL-C, TRIGLYCERIDES AND
APO B, AND INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED
DYSLIPIDEMIA (TYPES IIA, IIB) AND TO TREAT HYPERTRIGLYCERIDEMIA (TYPES IV, V)
U-616 MANAGEMENT OF PERSISTENT, MODERATE TO SEVERE PAIN IN PATIENTS REQUIRING
CONTINUOUS, AROUND-THE-CLOCK ANALGESIA WITH A HIGH POTENCY OPIOID FOR AN EXTENDED
PERIOD OF TIME GENERALLY WEEKS TO MONTHS OR LONGER
U-617 TREATMENT OF ACUTE PROMYELOGENOUS LEUKEMIA (APL)
U-618 USE OF ROSUVASTATIN CALCIUM TO REDUCE ELEVATED TOTAL-C, LDL-C, APOB, NONHDL-C OR
TG LEVELS; TO INCREASE HDL-C IN ADULT PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR
MIXED DYSLIPIDEMIA; AND TO SLOW THE PROGRESSION OF ATHEROSCLEROSIS.
U-619 TREATMENT OF MALIGNANT NEOPLASM
U-620 TREATMENT OF INSOMNIA
U-621 METHOD OF TREATING CANCER
U-622 TREATMENT OF VEGF MEDIATED OCULAR DISEASE.
U-623 SHORT TERM TREATMENT OF ACTIVE BENIGN GASTRIC ULCER
U-624 REDUCTION OF RISK OF UPPER GASTROINTESTINAL BLEEDING IN CRITICALLY ILL PATIENTS
U-625 ALLERGIC RHINITIS OR NASAL POLYPS
U-626 CLOLAR IS INDICATED FOR THE TREATMENT OF PEDIATRIC PATIENTS 1 TO 21 YEARS OLD WITH
RELAPSED OR REFRACTORY ACUTE LYMPHOBLASTIC LEUKEMIA AFTER AT LEAST TWO PRIOR
REGIMENS
U-627 TREATMENT OF PATIENTS USING EXTENDED-RELEASE CARBAMAZEPINE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 42 of 67
PATENT USE
U-628 USE OF AVANDIA IN COMBINATION WITH A SULFONYLUREA, AND IN COMBINATION WITH
METFORMIN AND A SULFONYLUREA TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2
DIABETES MELLITUS
U-629 METHOD OF INDUCING A HYPNOTIC OR SEDATIVE EFFECT IN A HUMAN BY ADMINISTERING
ESZOPICLONE
U-630 TREATING URINARY INCONTINENCE BY ADMINISTERING AN EXTENDED-RELEASE FORM OF
DARIFENACIN
U-631 TREATING A DISEASE OF ALTERED MOTILITY OR TONE OF SMOOTH MUSCLE BY ADMINISTERING A
MUSCARINIC RECEPTOR ANTAGONIZING AMOUNT OF DARIFENACIN
U-632 METHOD OF TREATMENT OF CANCER BY ADMINISTERING PARTICLES OF PACLITAXEL THAT HAVE A
PROTEIN COATING
U-633 METHOD FOR TREATMENT OF TUMORS BY ADMINISTERING PACLITAXEL AT A DOSE IN THE RANGE
OF ABOUT 30MG/METER SQUARE TO ABOUT 100MG/METER SQUARE IN A PHARMACEUTICALLY
ACCEPTABLE FORMULATION THAT DOES NOT CONTAIN CREMOPHOR
U-634 METHOD FOR DELIVERY OF A BIOLOGIC (INCLUDING ANTINEOPLASTIC AGENTS) BY
ADMINISTERING TO A PATIENT AN EFFECTIVE AMOUNT OF A BIOLOGIC AS A SOLID OR LIQUID
WITH A POLYMERIC BIOCOMPATIBLE MATERIAL
U-635 TREATMENT OF GERD, MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND RISK
REDUCTION OF NSAID ASSOCIATED GASTRIC ULCERS
U-636 TREATMENT OR PREVENTION OF BRONCHOSPASM OR ASTHMATIC SYMPTOMS
U-637 TREATMENT OF DIABETES WITH AN AMYLIN AGONIST
U-638 TREATMENT OF DIABETES WITH AN AMYLIN AGONIST, INCLUDING WITH INSULIN
U-639 TREATMENT OF A MAMMAL HAVING A NEED OF OR REDUCED ABILITY TO PRODUCE INSULIN WITH
AN INSULIN AND AN AMYLIN SUCH AS PRAMLINTIDE
U-640 USE OF AN AMYLIN AGONIST TO REDUCE GASTRIC MOTILITY AND TREAT POST PRANDIAL
HYPERGYLCEMIA
U-641 USE OF AN AMYLIN AGONIST HAVING SPECIFIED BINDING ACTIVITY TO REDUCE GASTRIC
MOTILITY, INCLUDING USE THROUGH PARENTERAL ADMINISTRATION
U-642 TREATMENT AND PREVENTION OF OSTEOPOROSIS
U-643 THE SHORT TERM TREATMENT (UP TO 10 DAYS) IN PTS HAVING GASTROESOPHAGEAL REFLUX
DISEASE (GERD) AS AN ALTERNATIVE TO ORAL THERAPY IN PTS WHEN THERAPY WITH NEXIUM
CAPSULES IS NOT POSSIBLE OR APPROPRIATE
U-644 TREATMENT OF SEASONAL ALLERGIC RHINITIS
U-645 TREATMENT OF ASTHMA
U-646 METHOD OF TREATING OTITIS
U-647 TREATMENT OF OSTEOPOROSIS IN POST MENOPAUSAL WOMEN AND/OR THE TREATMENT TO
INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
U-648 THE TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN AND/OR THE TREATMENT TO
INCREASE BONE MASS IN MEN
U-649 A METHOD FOR TREATING A TUMOR DISEASE
U-650 TREATMENT OF ESOPHAGEAL CANDIDIASIS AND PROPHYLAXIS OF CANDIDA INFECTIONS IN HSCT
PATIENTS
U-651 TREATMENT OF ACUTE PROMYELOCYTIC LEUKEMIA (APL)
U-652 TREATMENT OF CARDIAC ARRHYTHMIA
U-653 STIMULATING INSULIN RELEASE BY ADMINISTERING EXENATIDE
U-654 LOWERING PLASMA GLUCAGON IN A SUBJECT IN NEED THEREOF, INCLUDING ONE WITH TYPE 2
DIABETES, BY ADMINISTERING AN EXEDIN OR ANALOG, SUCH AS EXENDIN-4
U-655 TREATMENT OF MILD TO MODERATE ACTIVE CHROHN'S DISEASE INVOLVING THE ILEUM AND/OR
THE ASCENDING COLON AND THE MAINTENANCE OF CLINICAL REMISSION OF MILD TO MODERATE
CROHN'S DISEASE INVOLVING THE ILEUM AND/OR ASCENDING COLON FOR UP TO 3 MONTHS
U-656 REDUCING GASTRIC MOTILITY OR DELAYING GASTRIC EMPTYING BY ADMINISTERING AN
EXENDIN, SUCH AS EXENDIN-4
U-657 PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
U-658 TREATMENT OF ADVANCED HORMONE-DEPENDENT BREAST CANCER
U-659 TREATMENT OF LOCALLY ADVANCED OR METASTATIC NON SMALL-CELL LUNG CANCER (NSCLC)
AFTER FAILURE OF AT LEAST ONE PRIOR CHEMOTHERAPY REGIMEN
U-660 TREATMENT OF HYPERTENSION AND TREATMENT OF HEART FAILURE
U-661 TREATMENT OF SEIZURE DISORDER
U-662 TREATMENT OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
U-663 THE TREATMENT OF UNCOMPLICATED URINARY TRACT INFECTIONS
U-664 TREATMENT OF CONDITIONS FOR WHICH AN ALDOSTERONE RECEPTOR BLOCKER IS INDICATED,
SUCH AS HYPERTENSION, HEART FAILURE, AND POST-MYOCARDIAL INFARCTION
U-665 METHOD OF USING THE DRUG SUBSTANCE/DRUG PRODUCT FOR ULTRASOUND IMAGING
U-666 METHOD OF TREATING ADHD
U-667 MANAGEMENT OF INCONTINENCE; METHOD FOR TREATING INCONTINENCE
U-668 LEVEMIR IS A LONG-ACTING BASAL INSULIN ANALOG THAT IS INDICATED IN THE TREATMENT
OF PATIENTS WITH DIABETES MELLITUS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 43 of 67
PATENT USE
U-669 INDICATION OF TYPE II DIABETES
U-670 TREATMENT OF HIV-1 INFECTION BY THE CO-ADMINISTRATION OF TIPRANAVIR AND RITONAVIR.
U-671 PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC
KIDNEY DISEASE (CKD) STAGE 3 AND 4
U-672 TREATMENT OF INFLAMMATION OR AN INFLAMMATION-ASSOCIATED DISORDER
U-673 METHOD OF TREATMENT WITH ONCE-DAILY DOSES OF 625MG/5ML
U-674 METHOD OF TREATING INSOMNIA CHARACHTERIZED BY DIFFICULTY WITH SLEEP ONSET
U-675 PROPHYLAXIS AND CHRONIC TREATMENT OF ASTHMA; RELIEF OF SYMPTOMS OF ALLERGIC
RHINITIS
U-676 METHOD OF TREATING ATTENTION DEFICIT DISORDER USING ORAL ADMINISTRATION OF A BI-
MODAL OR PULSATILE RELEASE COMPOSITION
U-677 A METHOD OF TREATING DISEASE AMENABLE TO TREATMENT WITH A PHENIDATE DRUG BY ONCE
DAILY ORAL ADMINISTRATION OF AN EXTENDED RELEASE DOSAGE FORM
U-678 METHOD OF TREATING ATTENTION DEFICIT DISORDER AND/OR ATTENTION DEFICIT
HYPERACTIVITY DISORDER
U-679 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2
DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN
U-680 A METHOD OF TREATING DYSLIPIDEMIA AND DYSLIPOPROTEINEMIA USING A DOSAGE FORM THAT
CAN PROVIDE AN EFFECTIVE AMOUNT OF FENOFIBRATE TO A PATIENT IN A FASTED STATE
WHICH IS AT LEAST 90% OF THE AUC AMOUNT PROVIDED BY THE DOSAGE FORM
U-681 TREATMENT OF PRIMARY IGF-1 DEFICIENCY
U-682 NON-BENZODIAZEPINE HYPNOTIC AGENT INDICATED FOR TREATMENT OF INSOMNIA,
CHARACTERIZED BY DIFFICULTIES WITH SLEEP ONSET AND/OR SLEEP MAINTENANCE
U-683 PREVENTION OR TREATMENT OF ISCHEMIC HEART DISEASE
U-684 TREATMENT OF UNCOMPLICATED SKIN MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA IN
ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER
U-685 EXPECTORANT AND COUGH SUPPRESSANT
U-686 EXPECTORANT AND NASAL DECONGESTANT
U-687 REDUCING FOOD INTAKE IN A SUBJECT WITH TYPE 2 DIABETES BY ADMINISTERING AN
EXENDIN, SUCH AS EXENDIN-4
U-688 TREATMENT OF HIV-INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
U-689 TREATMENT OF PATIENTS WITH T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA WHOSE DISEASE HAS
NOT RESPONDED TO OR HAS RELAPSED FOLLOWING TREATMENT WITH AT LEAST TWO
CHEMOTHERAPY REGIMENS
U-690 TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
U-691 USE AS A MONOTHERAPY, IN COMBINATION WITH A SULFONYLUREA, METFORMIN OR INSULIN OR
IN COMBINATION WITH A SULFONYLUREA PLUS METFORMIN TO IMPROVE GLYCEMIC CONTROL IN
PATIENTS WITH TYPE 2 DIABETES MELLITUS
U-692 USE OF VALSARTAN TO REDUCE CARDIOVASCULAR MORTALITY IN CLINICALLY STABLE PATIENTS
WITH LEFT VENTRICULAR FAILURE OR LEFT VENTRICULAR DYSFUNCTION FOLLOWING MYOCARDIAL
INFARCTION
U-693 THE RECOMMENDED INITIAL DOSE OF EQUETRO IS 400MG/DAY GIVEN IN DIVIDED DOSES, TWICE
DAILY. THE DOSE SHOULD BE ADJUSTED IN 200MG DAILY INCREMENTS TO ACHIEVE OPTIMAL
CLINICAL RESPONSE.
U-694 LENALIDOMIDE IS AN ANALOGUE OF THALIDOMIDE. THALIDOMIDE IS A KNOWN HUMAN TERATOGEN
THAT CAUSES SEVERE LIFE-THREATENING HUMAN BIRTH DEFECTS. IF LENALIDOMIDE IS TAKEN
DURING PREGNANCY, IT MAY CAUSE BIRTH DEFECTS OR DEATH TO AN UNBORN BABY.
U-695 TREATMENT OF PATIENTS WITH T-CELL ACUTE LYMPHOBLASTIC LEUKEMIA AND T-CELL
LYMPHOBLASTIC LYMPHOMA WHOSE DISEASE HAS NOT RESPONDED TO OR HAS RELAPSED
FOLLOWING TREATMENT WITH AT LEAST TWO CHEMOTHERAPY REGIMENS
U-696 TREATMENT OF PATIENTS WITH T-CELL LYMPHOBLASTIC LYMPHOMA WHOSE DISEASE HAS NOT
RESPONDED TO OR HAS RELAPSED FOLLOWING TREATMENT WITH AT LEAST TWO CHEMOTHERAPY
REGIMENS
U-697 A METHOD OF USING RINFABATE RECOMBINANT (RHIGFBP-3) WITH MECASERMIN RECOMBINANT
(RHIGF-1) TO PROMOTE LINEAR GROWTH IN THE TRATMENT OF PRIMARY IGF-1 DEFICIENCY
U-698 METHOD OF USING ANTAGONIST OF ARGININE VASOPRESSIN (AVA) V1A AND V2 RECEPTORS FOR
INTRAVENOUS TREATMENT OF PATEINTS WITH EUVOLEMIC HYPONATREMIA
U-699 NASAL TREATMENT OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS SYMPTOMS
U-700 TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN
U-701 TREATMENT OF HYPERCHOLESTEROLEMIA AND/OR HYPERTRIGLYCERIDEMIA
U-702 TOPICAL AEROSOL HAIR REGROWTH TREATMENT
U-703 TREATMENT OF PROTEIN KINASE RELATED DISORDERS, SUCH AS GASTROINTESTINAL STROMAL
TUMOR AND RENAL CELL CARCINOMA WITH SUNITINIB
U-704 METHOD OF ADMINISTERING INSULIN VIA INHALATION
U-705 TREATING CHRONIC ANGINA BY ADMINISTERING AN EXTENDED RELEASE FORM OF RANOLAZINE
U-706 TREATMENT OF BENIGN PROSTATIC HYPERPLASIA
U-707 ALLERGIC RHINITIS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 44 of 67
PATENT USE
U-708 TREATMENT OF CHRONIC NON-INFECTIOUS UVEITIS AFFECTING THE POSTERIOR SEGMENT OF THE
EYE
U-709 METHOD OF COMBATING BACTERIA IN A PATIENT
U-710 A METHOD OF TREATING RESPIRATORY DISORDERS, E.G., ASTHMA, WHICH COMPRISES
ADMINISTRATION BY INHALATION OF AN EFFECTIVE AMOUNT OF A PHARMACEUTICAL
FORMULATION AS CLAIMED IN US PATENT NO. 5658549
U-711 ACUTE AND LONGER-TERM TREATMENT OF MAJOR DEPRESSIVE DISORDER
U-712 A METHOD OF USING A NICOTINIC ACID FORMULATION TO REDUCE ELEVATED TC, LDL-C AND TG
LEVELS, AND RAISE HDL-C LEVELS IN PATIENTS WITH HYPERLIPIDEMIA
U-713 TREATMENT OF MILD TO MODERATE DEMENTIA OF THE ALZHEIMER'S TYPE
U-714 TOPICAL TREATMENT OF INTERDIGITAL TINEA PEDIS AND TINEA CORPORIS DUE TO
TRICHOPHYTON RUBRUM, TRICHOPHYTON MENTAGROPHYTES OR EPIDERMOPHYTON FLOCCOSUM
U-715 FOR CLEANSING THE BOWEL IN PREPARATION FOR COLONOSCOPY, IN ADULTS 18 YEARS OF AGE
OR OLDER
U-716 THE TREATMENT OR PREVENTION OF BRONCHOSPASM IN ADULTS AND CHILDREN 4 YEARS OF AGE
AND OLDER WITH REVERSIBLE OBSTRUCTIVE AIRWAYS DISEASE AND THE PREVENTION OF
EXERCISED-INDUCED BRONCHOSPASM IN PATIENTS 4 YEARS OF AGE AND OLDER
U-717 METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN CONSTIPATED PATIENT
U-718 TREATMENT OF FUNGAL INFECTIONS
U-719 TREATENT OF PSYCHOSIS
U-720 TREATMENT OF NEUROLEPTIC DISEASES
U-721 TREATMENT OF INFLUENZA
U-722 PROPHYLAXIS OF INFLUENZA
U-723 PROPHYLACTIC TREATMENT OF MIGRAINE
U-724 METHOD OF TREATING SEIZURES
U-725 ALLERGIC RHINITIS AND URTICARIA
U-726 ALLERGIC RHINITIS
U-727 FOR THE TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD)
U-728 METHOD FOR TREATING BACTERIAL INFECTION
U-729 TREATMENT OF GASTROESOPHAGEAL REFLUX DISEASE (GERD), RISK-REDUCTION OF NSAID-
ASSOCIATED GASTRIC ULCER, H. PYLORI ERADICATION TO REDUCE THE RISK OF DUODENAL
ULCER RECURRENCE
U-730 USE AS A NASAL SPRAY FOR TREATMENT OF THE SYMPTOMS OF SEASONAL ALLERGIC RHINITIS
AND VASOMOTOR RHINITIS
U-731 USE IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE TREATMENT OF PATIENTS
WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
U-732 ACUTE TREATMENT OF THE CUTANEOUS MANIFESTATIONS OF MODERATE TO SEVERE ERYTHEMA
NODOSUM LEPROSUM (ENL)
U-733 MAINTENANCE THERAPY FOR PREVENTION AND SUPRESSION OF THE CUTANEOUS MANIFESTATIONS
OF ENL RECURRENCE
U-734 FIRST LINE THERAPY FOR TYPE 2 DIABETES MELLITUS
U-735 METHOD OF TREATING CHRONIC IRON OVERLOAD
U-736 METHOD FOR IONTOPHORETIC TRANSDERMAL DELIVERY OF FENTANYL HYDROCHLORIDE
U-737 DISINFECTION OF PATIENT SKIN PRIOR TO AN INVASIVE PROCEDURE
U-738 INDICATED FOR THE LONG-TERM, TWICE-DAILY MAINTENANCE TREATMENT OF ASTHMA IN
PATIENTS 12 YEARS OF AGE OR OLDER
U-739 METHOD FOR TREATING CONSTIPATION BY OPENING CIC CHANNELS IN A MAMALIAN SUBJECT
U-740 FOR THE TREATMENT OF PATIENTS WITH PRIMARY BILIARY CIRRHOSIS
U-741 COMBINATION THERAPY WITH CISPLATIN FOR THE TREATMENT OF LATE STAGE CERVICAL CANCER
U-742 TWICE DAILY TOPICAL TREATMENT OF MODERATE TO SEVERE PLAQUE PSORIASIS.
U-743 ONCE A DAY TOPICAL TREATMENT OF THE INFLAMMATORY LESIONS OF ROSACEA
U-744 TREATMENT OF HIV INFECTION IN ANTIRETROVIRAL TREATMENT-EXPERIENCED ADULT PATIENTS
U-745 TREATMENT OR PREVENTION OF EMESIS
U-746 PREVENTION OR TREATMENT OF NAUSEA OR EMESIS INDUCED BY A CANCER CHEMOTHERAPEUTIC
AGENT
U-747 PREVENTION OR TREATMENT OF POST-OPERATIVE NAUSEA AND VOMITING
U-748 A METHOD FOR THE TREATMENT OF A PROTEIN TYROSINE KINASE-ASSOCIATED DISORDER
U-749 METHOD OF CONTRACEPTION
U-750 TREATMENT OF HIV-1 INFECTION IN ADULTS
U-751 ONCE DAILY DOSING OF BUDESONIDE VIA NEBULIZER FOR THE TREATMENT OF ASTHMA
U-752 SUNSCREEN
U-753 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH
TYPE 2 DIABETES
U-754 USE FOR THE LONG-TERM MAINTENANCE TREATMENT OF ASTHMA
U-755 TREATMENT OF ANOREXIA, CACHEXIA, OR AN UNEXPLAINED, SIGNIFICANT WEIGHT LOSS IN
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 45 of 67
PATENT USE
PATIENTS WITH A DIAGNOSIS OF ACQUIRED IMMUNODEFICIENCY SYNDROME (AIDS)
U-756 ADDITION OF ONCE-WEEKLY DOSING FOR THE TREATMENT TO INCREASE BONE MASS IN MEN WITH
OSTEOPOROSIS
U-757 USE AS A BILE ACID SEQUESTRANT FOR LOWERING CHOLESTEROL
U-758 TREATMENT OF SYMPTOMS OF PREMENSTRUAL DYSPHORIC DISORDER
U-759 METHOD OF USE OF ADMINISTERING LEVOTHYROXINE
U-760 PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS AND TREATMENT OF
OROPHARYNGEAL CANDIDAIASIS
U-761 TREATMENT OF SCHIZOPHRENIA INCLUDING MAINTAINING STABILITY IN PATIENTS WITH
SCHIZOPHRENIA
U-762 TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE
U-763 ADMINISTRATION OF ARIPIPRAZOLE BY INJECTION
U-764 TREATMENT OF SCHIZOPHRENIA
U-765 METHOD OF TREATING ALLERGIC CONJUNCTIVITIS
U-766 TREATMENT OF SEIZURES
U-767 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER
U-768 A METHOD OF REDUCING THE CAPACITY OF EXTENDED RELEASE NICOTINIC ACID TO PROVOKE A
FLUSHING REACTION BY PRETREATING AN INDIVIDUAL WITH A FLUSH INHIBITING AGENT PRIOR
TO THE ADMINISTRATION OF THE EXTENDED RELEASE NICOTINIC ACID
U-769 REVLIMID (LENALIDOMIDE) IN COMBINATION WITH DEXAMETHASONE IS INDICATED FOR THE
TREATMENT OF MULTIPLE MYELOMA PATIENTS WHO HAVE RECEIVED AT LEASET ONE PRIOR
THERAPY
U-770 LONG-TERM TREATMENT OF PATHOLOGICAL HYPERSECRETORY CONDITIONS
U-771 METHOD FOR THE TREATMENT OF DIABETES MELLITUS, SUCH AS TYPE 1 DIABETES MELLITUS OR
TYPE 2 DIABETES MELITUS, IN A HUMAN PATIENT
U-772 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN CHILDREN 2 TO 11
YEARS AND FOR THE RELIEF OF SYMPTOMS ASSOCIATED WITH UNCOMPLICATED SKIN
MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA IN CHILDREN 6 MONTHS TO 11 YEARS
U-773 PATHOLOGICAL HYPERSECRETORY CONDITIONS
U-774 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASTE-IV INHIBITOR
U-775 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN AND/OR A SULFONYLUREA
U-776 TREATMENT OF CUTANEOUS MANIFESTATION IN PATIENTS WITH CUTANEOUS T-CELL LYMPHOMA
(CTCL) WHO HAVE PROGRESSIVE, PERSISTENT OR RECURRENT DISEASE ON OR FOLLOWING TWO
SYSTEMIC THERAPIES.
U-777 DECREASING MORTALITY CAUSED BY CONGESTIVE HEART FAILURE
U-778 REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATEINTS WITH OPEN ANGLE GLAUCOMA OR
OCULAR HYPERTENSION
U-779 A METHOD FOR TREATMENT OF A CANCER, WHEREIN THE CANCER IS CHRONIC MYELOGENOUS
LEUKEMIA
U-780 A METHOD FOR THE TREATMENT OF CANCER
U-781 FOR TREATMENT OF ADULT PATIENTS WITH TYPE 2 DIABETES MELLITUS WHO ARE NAIVE TO
PHARMACOLOGIC THERAPY
U-782 TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS WITH EVIDENCE OF VIRAL
REPLICATION AND EITHER EVIDENCE OF PERSISTANT ELEVATIONS IN SERUM
AMINOTRANSFERASES (ALT OR AST) OR HISTOLOGICALLY ACTIVE DISEASE
U-783 DESONATE GEL IS INDICATED FOR THE TREATMENT OF MILD TO MODERATE ATOPIC DERMATITIS
IN PATIENTS 3 MONTHS OF AGE AND OLDER
U-784 TREATMENT OF MODERATE TO SEVERE PRIMARY RESTLESS LEGS SYNDROME (RLS)
U-785 USE AS REPLACEMENT SOLUTION, HEMOFILTRATION SOLUTION OR HEMODIAFILTRATION SOLUTION
IN CONTINUOUS RENAL REPLACEMENT THERAPY
U-786 PRODUCT IS APPROVED FOR THE TOPICAL TREATMENT OF TINEA PEDIS
U-787 MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN ADULT AND PEDIATRIC
PATIENTS SIX YEARS OF AGE OR OLDER, INCLUDING PATIENTS REQUIRING ORAL
CORTICOSTEROID THERAPY FOR ASTHMA
U-788 METHOD OF TREATING PSYCHIATRIC SYMPTOMS ASSOCIATED WITH PREMENSTRUAL DISORDERS
USING PAROXETINE
U-789 TREATMENT OF KNOWN OR SUSPECTED CYANIDE POISONING
U-790 FORTEO IS INDICATED FOR THE TREATMENT OF POST MENOPAUSAL WOMEN WITH OSTEOPOROSIS
WHO ARE AT RISK FOR FRACTURE. FORTEO CAN BE USED BY PEOPLE WHO HAVE HAD A FRACTURE
RELATED TO OSTEOPOROSIS
U-791 GLEEVEC IS ALSO INDICATED FOR THE TREATMENT OF PATIENTS WITH KIT (CD117) POSITIVE
UNRESECTABLE AND/OR METASTATIC MALIGNANT GASTROINTESTINAL STROMAL TUMORS (GIST)
U-792 TREATMENT OF SEBORRHEA DERMATITIS IN HUMANS
U-793 FOR THE LONG TERM TREATMENT, TWICE DAILY (MORNING AND EVENING) MAINTENANCE
TREATMENT OF BRONCHOCONSTRICTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 46 of 67
PATENT USE
DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA
U-794 CLOSURE OF A CLNICALLY SIGNIFICANT PATENT DUCTUS ARTERIOSUS IN PREMATURE INFANTS
WEIGHING BETWEEN 500 AND 1500G, WHO ARE NO MORE THAN 32 WEEKS GESTATIONAL AGE WHEN
USUAL MEDICAL MANAGEMENT IS INEFFECTIVE
U-795 METHOD FOR INHIBITING NOREPINEPHRINE UPTAKE
U-796 METHOD OF TREATING DEPRESSION
U-797 METHOD OF TREATING ANXIETY
U-798 TREATMENT AND PREVENTION OF OSTEOPOROSIS IN POSTMENOPAUSAL WOMEN BY ONCE-MONTHLY
ORAL ADMINISTRATION OF IBANDRONATE SODIUM MONOHYDRATE EQUIVALENT TO 150MG OF
IBANDRONIC ACID
U-799 METHOD FOR INHIBITING SEROTONIN UPTAKE
U-800 TREATMENT OF PATIENTS WITH ADVANCED OR METASTATIC BREAST CANCER WHOSE TUMORS
OVEREXPRESS HER2 AND WHO HAVE RECEIVED PRIOR THERAPY INCLUDING ANTHRACYCLINE, A
TAXANE AND TRASTUZUMAB
U-801 METHOD OF TREATING CANCER
U-802 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-IV INHIBITOR
U-803 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-IV INHIBITOR IN COMBINATION WITH METFORMIN
U-804 TREATMENT OF ACTINIC KERATOSES BY PHOTODYNAMIC THERAPY
U-805 TREATMENT OF IMPETIGO DUE TO STAPHYLOCOCCUS AUREUS OR STREPTOCOCCUS PYOGENES
U-806 INTRATHECAL TREATMENT OF LYMPHOMATOUS MENINGITIS
U-807 PREVENTION OF EXERCISE-INDUCED BRONCHOCONSTRICTION
U-808 THE TREATMENT OF THE SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN
PATIENTS 2 YEARS OF AGE AND OLDER
U-809 TREATMENT OF CHRONIC IDIOPATHIC URTICARIA
U-810 METHOD OF TREATMENT TO ALLEVIATE INFLAMMATION OF THE EYE
U-811 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS AND
TREATMENT OF THE UNCOMPLICATED SKIN MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA
U-812 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS
U-813 MAINTENANCE TREATMENT OF BRONCHOCONSTRICTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE
PULMONARY DISEASE (COPD)
U-814 TREATMENT OF SCHIZOPHRENIA
U-815 TREATS COLD SORES/FEVER BLISTERS ON THE FACE OR LIPS. SHORTENS HEALING TIME AND
DURATION OF SYMPTOMS: TINGLING, PAIN, BURNING AND/OR ITCHING
U-816 DEPRESSION, PANIC DISORDER, PREMENSTRUAL DISORDERS AND SOCIAL ANXIETY DISORDER
U-817 NASAL ADMINISTRATION OF CYANOCOBALAMIN
U-818 TOPICAL TREATMENT OF ACNE VULGARIS
U-819 MANAGEMENT OF FIBROMYALGIA
U-820 IMPROVED WAKEFULNESS IN PATIENTS WITH EXCESSIVE SLEEPINESS ASSOCIATED WITH
NARCOLEPSY, OBSTRUCTIVE SLEEP APNEA/HYPOPNEA SYNDROME, AND SHIFT WORK SLEEP
DISORDER
U-821 METHOD OF INHIBITING ENTHOTHELIN RECEPTORS BY ADMINISTERING AMBRISENTAN TO A
PATIENT TO TREAT PULMONARY ARTERIAL HYPERTENSION.
U-822 USE IN LIPID MANAGEMENT
U-823 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS AND FOR THE
TREATMENT OF UNCOMPLCATED SKIN MANIFESTATIONS OF CHRONIC IDIOPATHIC URTICARIA IN
CHILDREN 6 TO 11 YEARS OF AGE
U-824 METHOD OF TREATING PATIENTS INFECTED WITH CCR5-TROPIC HIV-1
U-825 USE FOR PREVENTION OF BREAST CANCER
U-826 RELIEF OF MODERATE TO SEVERE PAIN
U-827 USE FOR TREATMENT OF DIABETES, PARTICULARLY TYPE 2 DIABETES
U-828 PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO USE ORAL CONTRACEPTIVES AS A METHOD
OF CONTRACEPTION
U-829 TREATMENT OF EXTRAVASATION RESULTING FROM IV ANTHRACYCLINE CHEMOTHERAPY
U-830 TREATMENT OF RELAPSED SMALL CELL LUNG CANCER
U-831 METHOD OF ADMINISTERING LANREOTIDE ACETATE
U-832 ZINGO IS INDICATED FOR THE USE ON INTACT SKIN TO PROVIDE LOCAL ANALGESIA PRIOR TO
VENIPUNCTURE OR INTRAVENOUS CANNULATION.
U-833 METHOD OF TREATING PAIN USING A PHARMACEUTICALLY ACCEPTABLE SALT OF ROPIVACAINE
AND ADMINISTERING A COMPOSITION CONTAINING LESS THAN 0.25% BY WEIGHT OF
ROPIVACAINE
U-834 INVIRASE IN COMBINATION WITH RITONAVIR AND OTHER ANTIRETROVIRAL AGENTS IS
INDICATED FOR THE TREATMENT OF HIV INFECTION
U-835 RELIEF OF THE INFLAMMATORY AND PRURITIC MANIFESTATIONS OF ATOPIC DERMATITIS IN
PATIENTS ONE YEAR OF AGE OR OLDER
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 47 of 67
PATENT USE
U-836 A METHOD FOR THE TREATMENT OF LEUKEMIAS
U-837 GASTROINTESTINAL LAVAGE INDICATED FOR CLEANSING OF THE COLON AS A PREPARATION FOR
COLONOSCOPY IN ADULTS
U-838 METHOD OF TREATING PAIN USING A PHARMACEUTICALLY ACCEPTABLE SALT OF ROPIVACAINE
AND ADMINISTERING A COMPOSITION CONTAINING LESS THAN 0.5% BY WEIGHT OF ROPIVACAINE
U-839 TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
U-840 TREATMENT FOR TYPE 2 DIABETES MELLITUS
U-841 INDICATED FOR THE LONG-TERM, MAINTENANCE TREATMENT OF ASTHMA IN PATIENTS 12 YEARS
OF AGE AND OLDER
U-842 INDICATED FOR THE TREATMENT OF ATTENTION-DEFICIT/HYPERACTIVITY DISORDER (ADHD)
U-843 METHOD FOR ADMINISTRATION OF TESTOSTERONE
U-844 PREFEST IS INDICATED IN WOMEN WHO HAVE A UTERUS FOR THE TREATMENT OF MODERATE TO
SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE; TREATMENT OF VULVAR AND
VAGINAL ATROPHY; PREVENTION OF OSTEOPOROSIS
U-845 TREATMENT OF PATIENTS WITH CANDIDEMIA, ACUTE DISSEMINATED CANDIDIASIS, CANDIDA
PERITONITIS AND ABCESSES
U-846 USE FOR DELINEATION (VISUALIZATION) DURING A VITRECTOMY SURGICAL PROCEDURE
U-847 ADJUNCTIVE THERAPY TO DIET IN ADULTS TO REDUCE LDL-C, TRIGLYCERIDES AND APO B, AND
INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA OR MIXED DYSLIPIDEMIA
(TYPES IIA, IIB) AND TO TREAT HYPERTRIGLYCERIDEMIA (TYPES IV, V)
U-848 ACUTE TREATMENT OF MIGRAINE WITH OR WITHOUT AURA
U-849 REDUCTION OF ELEVATED INTRAOCULAR PRESSURE (IOP) IN PATIENTS WITH GLAUCOMA OR
OCULAR HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO
INADEQUATELY CONTROLLED IOP. DOSE IS ONE DROP OF COMBIGAN IN THE AFFECTED EYE
TWICE DAILY
U-850 PREVENTION OR TREATMENT OF NAUSEA OR EMESIS INDUCED BY A CANCER CHEMOTHERAPEUTIC
AGENT
U-851 TREATMENT OF TYPE 2 DIABETES MELLITUS
U-852 RELIEF OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS
U-853 TREATMENT OR PREVENTION OF EMESIS
U-854 PREVENTION OF CMV DISEASE IN KIDNEY, HEART, AND KIDNEY-PANCREAS TRANSPLANT
PATIENTS AT HIGH RISK (DONOR CMV SEROPOSITIVE/RECIPIENT CMV SERONEGATIVE)
U-855 METHOD TO INDUCE NATRIURESIS, DIURESIS AND/OR VASODILATION
U-856 SUPPORT EMBRYO IMPLANTATION AND EARLY PREGNANCY BY SUPPLEMENTATION OF CORPUS
LUTEAL FUNCTION AS PART OF AN ASSISTED REPORDUCTIVE TECHNOLOGY (ART) TREATMENT
PROGRAM FOR INFERTILE WOMEN
U-857 INHIBITION OF TRANSPLANT REJECTION
U-858 PEDIATRIC USE AGED 1-11 YEARS, GERD AND EROSIVE ESOPHAGITIS
U-859 EROSIVE ESOPHAGITIS, HYPERSECRETORY CONDITIONS INCLUDING ZOLLINGER-ELLISON
SYNDROME, MAINTENANCE OF HEALING OF EROSIVE ESOPHAGITIS AND REDUCTION OF SYMPTOMS
IN PATIENTS WITH GERD
U-860 FOR THE APPROVED USES AND CONDITIONS OF USE, INCLUDING DEPRESSION
U-861 RELIEF OF THE INFLAMMATORY AND PRURITIC MANIFESTATIONS OF CORTICOSTEROID
RESPONSIVE DERMATOSES IN PATIENTS 12 YEARS OF AGE OR OLDER
U-862 ADJUNCT TO DIET TO REDUCE ELEVATED TOTAL-C, LDL-C, NON-HDL-C, APO B, TG, AND LP(A)
LEVELS AND TO INCREASE HDL-C IN PATIENTS WITH PRIMARY HYPERCHOLESTEROLEMIA, MIXED
DYSLIPIDEMIA, AND HYPERTRIGLYCERIDEMIA
U-863 TAKING ASPIRIN OR NON-STEROIDAL ANTI-INFLAMMATORY MEDICATIONS APPROXIMATELY 30
MINUTES BEFORE DOSING CAN MINIMIZE FLUSHING, A COMMON SIDE EFFECT OF NIACIN
THERAPY
U-864 PEDIATRIC USE AGES 1-2 YEARS, GERD AND EROSIVE ESOPHAGITIS
U-865 TREATMENT OF A WOMAN WITH OSTEOPOROSIS AND A HIGH RISK FOR BONE FRACTURE BY
REDUCING THE RISK OF VERTEBRAL AND NONVERTEBRAL BONE FRACTURE
U-866 THE LABEL REFERENCES THE EFFECTS OF THE ACTIVE INGREDIENT OF REVLIMID UPON
CYTOKINES
U-867 TREATMENT OF MIGRAINE
U-868 METHOD OF USING ANTAGONIST OF ARGININE VASOPRESSIN (AVA) V1A AND V2 RECEPTORS FOR
INTRAVENOUS TREATMENT OF PATIENTS WITH HYPERVOLEMIC HYPONATREMIA
U-869 METHOD FOR STIMULATING CORONOARY VASODILATION FOR PURPOSES OF IMAGING THE HEART
U-870 METHOD OF PRODUCING CORONARY VASODILATION WITHOUT PERIPHERAL VASODILATION
U-871 METHOD OF REDUCING RISK OF MYOCARDIAL INFARCTION, STROKE AND DEATH
U-872 TWICE DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PATIENTS WITH CHRONIC
OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING CHRONIC BRONCHITIS AND EMPHYSEMA.
TO REDUCE EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS
U-873 METHOD OF TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL SYNDROME BY
OPENING CHLORIDE CHANNELS (CIC)
U-874 METHOD OF TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL SYNDROME
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 48 of 67
PATENT USE
U-875 FIRST-LINE TREATMENT OF LOCALLY ADVANCED UNRESECTABLE OR METASTATIC PANCREATIC
CANCER, IN COMBINATION WITH GEMCITABINE
U-876 TREATMENT OF MIGRAINE WITH OR WITHOUT AURA
U-877 FOR USE AS ADJUNCTIVE THERAPY IN THE TREATMENT OF PEPTIC ULCER
U-878 A METHOD FOR BINDING A PERIPHERAL OPIOID RECEPTOR
U-879 A METHOD OF TREATING OR PREVENTING ILEUS
U-880 ENDOMETRIN IS A PROGESTERONE INDICATED TO SUPPORT EMBRYO IMPLANTATION AND EARLY
PREGNANCY BY SUPPLEMENTATION OF CORPUS LUTEAL FUNCTION AS PART OF AN ASSISTED
REPRODUCTIVE TECHNOLOGY (ART) TREATMENT PROGRAM FOR INFERTILE WOMEN
U-881 TREATMENT OF NON-SMALL CELL LUNG CANCER
U-882 MANAGEMENT OF FIBROMYALGIA (FM)
U-883 TREATMENT OF GASTROINTESTINAL STROMAL TUMOR WITH SUNITINIB
U-884 TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA
U-885 TREATMENT OF PATIENTS WITH MANTLE CELL LYMPHOMA WHO HAVE RECEIVED AT LEAST 1 PRIOR
THERAPY
U-886 ADMINISTERING DESLORATADINE TO TREAT THE SYMPTOMS OF PERENNIAL ALLERGIC RHINITIS,
SEASONAL ALLERGIC RHINITIS, OR CHRONIC IDIOPATHIC URTICARIA
U-887 TREATMENT AND PREVENTION OF OSTEOPOROSIS
U-888 FEMALE HORMONE REPLACEMENT THERAPY FOR POSTMENOPAUSAL WOMEN
U-889 MENOPAUSAL AND POSTMENOPAUSAL DISORDERS (INCLUDING VASOMOTOR SYMPTOMS ASSOCCIATED
WITH MENOPAUSE)
U-890 REDUCTION OF SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE
U-891 USE AS AN INTRAOCULAR IRRIGATING SOLUTION DURING SURGICAL PROCEDURES INVOLVING
PERFUSION OF THE EYE
U-892 TREATMENT OF CUTANEOUS MANIFESTATIONS IN PATIENTS WTIH CUTANEOUS T-CELL LYMPHOMA
(CTCL)
U-893 CLEVIPREX IS A DIHYDROPYRIDINE CALCIUM CHANNEL BLOCKER INDICATED FOR THE REDUCTION
OF BLOOD PRESSURE WHEN ORAL THERAPY IS NOT FEASIBLE OR NOT DESIRABLE
U-894 TREATMENT OF COLD SORES IN PEDIATRIC PATIENTS TWELVE YEARS OF AGE AND OLDER
U-895 TREATMENT OF HIV INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
U-896 TREATMENT OF NASAL SYMPTOMS OF SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN ADULTS
AND CHILDREN TWO YEARS OF AGE AND OLDER
U-897 METHOD OF TREATING TONSILLITIS AND/OR PHARYNGITIS SECONDARY TO STREPTOCOCCUS
PYOGENES IN A ONCE-A-DAY AMOXICILLIN PRODUCT
U-898 USE OF GLUTAMINE TOGETHER WITH GROWTH HORMONE FOR THE TREATMENT OF PATIENTS WITH
SHORT BOWEL SYNDROME
U-899 USE OF THALIDOMIDE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF PATIENTS
WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
U-900 INTEGRASE INHIBITION FOR THE TREATMENT OF HIV INFECTION
U-901 PREVENTION OF POSTOPERATIVE NAUSEA AND VOMITING
U-902 USE IN THE TREATMENT OF THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC HYPERPLASIA
(BPH)
U-903 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN ADULT PATIENTS
U-904 TREATMENT OF MODERATE TO SEVERE VASOMOTOR SYMPTOMS ASSOCIATED WITH MENOPAUSE
U-905 TREATMENT OF MODERATE TO SEVERE VAGINAL DRYNESS AND PAIN WITH INTERCOURSE,
SYMPTOMS OF VULVAR AND VAGINAL ATROPHY, ASSOCIATED WITH MENOPAUSE
U-906 PROPHYLAXIS OF ORGAN REJECTION IN KIDNEY, LIVER AND HEART ALLOGENIC TRANSPLANTS;
TREATMENT OF PATIENTS WITH SEVERE ACTIVE, RHEUMATOID ARTHRITIS; TREATMENT OF
ADULT, NONIMMUNOCOMPROMISED PATIENTS WITH SEVERE, RECALCITRANT, PLAQUE PSORIASIS
U-907 FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS IN SUBJECTS 18 YEARS OF AGE
AND OLDER
U-908 PROPHYLAXIS OF ORGAN REJECTION IN PATIENTS RECEIVING ALLOGENEIC RENAL TRANSPLANTS
U-909 TREATMENT OF CYSTIC FIBROSIS PATIENTS WITH PSEUDOMONAS AERUGINOSA
U-910 TREATMENT OF METASTATIC CARCINOMA OF THE OVARY AFTER FAILURE OF INITIAL OR
SUBSEQUENT CHEMOTHERAPY
U-911 METHOD OF TREATING, AS ADJUNCTIVE THERAPY, PARTIAL-ONSET SEIZURES IN A PATIENT
WITH EPILEPSY AGED 17 YEARS AND OLDER WHEN ORAL TREATMENT IS TEMPORARILY NOT
FEASIBLE
U-912 SEDATION OF NON-INTUBATED PATIENTS PRIOR TO AND/OR DURING SURGICAL AND OTHER
PROCEDURES
U-913 TREATMENT OF OVERACTIVE BLADDER WITH SYMPTOMS OF URGE URINARY INCONTINENCE,
URGENCY, AND FREQUENCY
U-914 METHOD OF TREATING, AS ADJUNCTIVE THERAPY, PARTIAL-ONSET SEIZURES IN A PATIENT
WITH EPILEPSY AGED 17 YEARS AND OLDER
U-915 TREATMENT OF MUSCULOSKELETAL CONDITIONS
U-916 TOPICAL TREATMENT OF ACNE VULGARIS IN PATIENTS 12 YEARS OR OLDER
U-917 TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 49 of 67
PATENT USE
U-918 TO TREAT OR PREVENT INFECTIONS CAUSED BY SUSCEPTIBLE BACTERIA USING DELAYED-
RELEASE TABLETS CONSISTING OF DOXYCYCLINE HYCLATE COATED PELLETS IN A TABLET
U-919 FOR THE TREATMENT OF DERMATITIS
U-920 STEROID-RESPONSIVE INFLAMMATORY OCULAR CONDITIONS FOR WHICH A CORTICOSTEROID IS
INDICATED AND WHERE SUPERFICIAL BACTERIAL OCULAR INFECTION OR A RISK OF BACTERIAL
OCULAR INFECTION EXISTS
U-921 TREATMENT OF ACNE VULGARIS
U-922 FOR THE TREATMENT OF FUNGAL INFECTIONS
U-923 METHOD OF TREATING OPHTHALMIC INFLAMMATION AND INFECTION
U-924 TREATMENT OF MILD TO MODERATE INFECTION CAUSED ABY SUSCEPTIBLE STRAINS
U-925 TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTILES) OF ROSACEA
U-926 MGT SPECIFIC BACTERIAL INFECTIONS. TREATMENT PTS W/ COMMUNITY ACQUIRED PNEUMONIA
OR BACTERIAL SINUSITIS DUE TO CONFIRMED, OR SUSPECTED B-LACTAMASE PRODUCING
PATHOGENS & S. PNEUMONIAE WITH REDUCED SUSCEPTIBILITY TO PENICILLIN (MIC=2MC/ML)
U-927 METHOD FOR INCREASING TEAR PRODUCTION
U-928 TREATMENT OF BACTERIAL INFECTIOUS DISEASE
U-929 TREATMENT OF OBSESSIVE COMPULSIVE DISORDER TREATABLE WITH AN SSRI
U-930 TREATMENT OF IDIOPATHIC THROMBOCYTOPENIC PURPURA (ITP)
U-931 RELIEF OF MODERATE TO SEVERE ACUTE PAIN
U-932 PYLERA CAPSULES, IN COMBINATION WITH OMEPRAZOLE ARE INDICATED FOR THE TREATMENT OF
PATIENTS WITH HELICOBACTER PYLORI INFECTION AND DUODENAL ULCER DISEASE TO
ERADICATE H. PYLORI
U-933 FOR THE TREATMENT OF PATIENTS WITH HELICOBACTER PYLORI INFECTION AND DUODENAL
ULCER DISEASE TO ERADICATE H. PYLORI. THE ERADICATION OF HELICOBACTER PYLORI HAS
BEEN SHOWN TO REDUCE THE RISK OF DUODENAL ULCER RECURRENCE
U-934 IN COMBINATION WITH GRANULOCYTE-COLONY STIMULATING FACTOR (G-CSF) TO MOBILIZE
HEMATOPOIETIC STEM CELL TO THE PERIPHERAL BLOOD FOR COLLECTION AND SUBSEQUENT
AUTOLOGOUS TRANSPLANTATION WITH NON-HODGKINS LYMPHOMA AND MULTIPLE MYELOMA
U-935 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND
TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) IN PEDIATRIC PATIENTS 6 YEARS OF
AGE AND OLDER
U-936 USE IN COMBINATION WITH GRANULOCYTE-COLONY STIMULATING FACTOR (G-CSF) TO MOBILIZE
HEMATOPOIETIC STEM CELLS TO PERIPHERAL BLOOD FOR COLLECTION & SUBSEQUENT
AUTOLOGOUS TRANSPLANTATION IN PATIENTS WITH NON-HODGKIN'S LYMPHOMA & MULTIPLE
MYELOMA
U-937 TREATMENT OF PROSTATE CANCER
U-938 TREATMENT OF HAIR LOSS AND HYPOTRICHOSIS OF THE EYELASHES BY INCREASING THEIR
GROWTH INCLUDING LENGTH, THICKNESS AND DARKNESS
U-939 TREATMENT OF HYPOTRICHOSIS OF THE EYELASHES BY INCREASING AND STIMULATING THEIR
GROWTH INCLUDING LENGTH, THICKNESS AND DARKNESS
U-940 METHOD TO TREAT AIDS-RELATED KAPOSI'S SARCOMA
U-941 METHOD TO TREAT OVARIAN CANCER
U-942 METHOD TO TREAT MULTIPLE MYELOMA
U-943 GNRH ANTAGONIST INDICATED FOR TREATMENT OF PATIENTS WITH ADVANCED PROSTATE CANCER
U-944 TREATMENT OF PATIENTS WITH B-CELL CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
U-945 SEDATIVE-HYPNOTIC AGENT INDICATED FOR MONITORED ANESTHESIA CARE (MAC) SEDATION
U-946 TREATMENT OF BREAST CANCER
U-947 WHEN PATIENTS ARE UNABLE TO TAKE THE ORAL FORMULATIONS, PREVACID IV, FOR INJECTION
IS INDICATED AS AN ALTERNATIVE FOR THE SHORT-TERM TREATMENT (UP TO 7 DAYS) OF ALL
GRADES OF EROSIVE ESOPHAGITIS
U-948 TREATMENT OF DIABETES MELLITUS
U-949 HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 8 WEEKS
U-950 MAINTAIN HEALING OF EROSIVE ESOPHAGITIS (EE) FOR UP TO 6 MONTHS
U-951 TREATMENT OF HEARTBURN ASSOCIATED WITH NON-EROSIVE GASTROESOPHAGEAL REFLUX DISEASE
(GERD) FOR 4 WEEKS
U-952 USE AS AN ANALGESIC
U-953 METHOD OF TREATING OPHTHALMIC INFLAMMATION AND INFECTION
U-954 CHRONIC MANAGEMENT OF HYPERURICEMIA IN PATIENTS WITH GOUT. NOT RECOMMENDED FOR THE
TREATMENT OF ASYMPTOMATIC HYPERURICEMIA
U-955 PROPHYLACTIC TREATMENT OF MIGRAINE
U-956 TREATMENT OF PATIENTS WITH H. PYLORI INFECTION AND DUODENAL ULCER DISEASE
U-957 A METHOD OF TREATING CANCER IN A PATIENT COMPRISING ADMINISTERING IXABEPILONE OR
PHARMACEUTICAL COMPOSITIONS COMPRISING IXABEPILONE
U-958 METHOD OF TREATING PATIENT COMPRISING MIXING FIRST AND SECOND VIALS OF PRODUCT
COMPRISING LYOPHILIZED IXABEPILONE TO PROVIDE AN EPOTHILONE ANALOG SOLUTION,
DILUTING SOLUTION WITH A SUITABLE DILUENT TO PREPARE INTRAVENOUS FORMULATION FOR
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 50 of 67
PATENT USE
PT
U-959 METHOD OF TREATING CANCER, IV ADMIN, LYOPHYLIZED IXABEPILONE DILUTED, EVERY WEEK
OR 3 WEEKS; LYOPHILIZED IXABEPILONE WITH SOLVENT(DEHYDRATED ETHANOL) DILUTED TO
CONCENTRATION OF 0.1MG/ML TO 0.9MG/ML
U-960 METHOD OF TREATING CANCER IN A PATIENT COMPRISING INTRAVENOUSLY ADMINISTERING TO
THE PATIENT IXABEPILONE DILUTED IN A PARENTERAL DILUENT
U-961 METHOD OF TREATING BREAST CANCER BY ADMINISTERING IXABEPILONE; A METHOD OF
TREATING A CANCER RESPONSIBLE TO MICROTUBULE STABILIZATION BY ADMINISTERING
IXABEPILONE
U-962 SYMBYAX IS INDICATED FOR THE ACUTE TREATMENT OF TREATMENT RESISTANT DEPRESSION IN
ADULTS
U-963 PROZAC AND OLANZAPINE IN COMBINATION FOR THE ACUTE TREATMENT OF TREATMENT
RESISTANT DEPRESSION IN ADULTS
U-964 ZYPREXA ZYDIS AND FLUOXETINE IN COMBINATION FOR THE ACUTE TREATMENT OF TREATMENT
RESISTANT DEPRESSION IN ADULTS
U-965 USE OF IXABEPILONE IN COMBINATION WITH CAPECITABINE IN TREATMENT OF METASTASIS
BREAST CANCER
U-966 TREATMENT OF ASTHMA (MAINTENANCE AND PROPHYLACTIC THERAPY)
U-967 A METHOD OF REVERSING SOFT-TISSUE ANESTHESIA I.E. ANESTHESIA OF THE LIP AND
TONGUE, AND THE ASSOCIATED FUNCTIONAL DEFICITS RESULTING FROM AN INTRAORAL
SUBMUCOSAL INJECTION OF A LOCAL ANESTHETIC
U-968 A METHOD FOR IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
U-969 TREATMENT OF MIGRAINE
U-970 TOPICAL TREATMENT OF LICE INFESTATIONS
U-971 INDICATED FOR THE ACUTE TREATMENT OF ADULTS WITH SCHIZOPHRENIA
U-972 MONOTHERAPY OR AS ADJUNCTIVE THERAPY TO LITHIUM OR VALPROATE FOR THE MAINTENANCE
TREATMENT OF BIPOLAR I DISORDER
U-973 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2
DIABETES MELLITUS WHO ARE ALREADY TREATED WITH PIOGLITAZONE AND METFORMIN OR WHO
HAVE INADEQUATE GLYCEMIC CONTROL ON PIOGLITAZONE OR METFORMIN ALONE
U-974 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN PATIENTS WITH TYPE 2
DIABETES WHO ARE ALREADY TREATED WITH A PIOGLITAZONE AND METFORMIN
U-975 TREATMENT OF PULMONARY HYPERTENSION
U-976 IMPROVEMENT OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES
U-977 TREATMENT OF ACUTE, UNCOMPLICATED MALARIA INFECTION DUE TO PLASMODIUM FALCIPARUM
IN PATIENTS OF 5KG BODYWEIGHT AND ABOVE
U-978 METHOD OF TREATING HYPONATREMIA
U-979 RELIEF OF MUSCLE SPASM
U-980 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE
PAIN
U-981 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN
ADJUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI-INFLAMMATORY,
ANALGESIC, AND ANTIPYRETIC ACTIVITY
U-982 A METHOD OF TREATING OSTEOPOROSIS
U-983 METHOD OF TREATING OSTEOPOROSIS IN A POST-MENOPAUSAL WOMAN AT RISK FOR FRACTURE
U-984 METHOD FOR THE TREATMENT OF A WOMAN WITH OSTEOPOROSIS AND AT RISK FOR BONE
FRACTURE
U-985 TREATMENT OF MACULAR EDEMA FOLLOWING BRANCH RETINAL VEIN OCCLUSION (BRVO) OR
CENTRAL RETINAL VEIN OCCLUSION (CRVO)
U-986 TREATMENT OF PATIENTS INFECTED WITH PEDICULUS HUMANUS CAPITIS (HEAD LICE AND THEIR
OVA) OF THE SCALP HAIR
U-987 TREATMENT OF SECONDARY HYPERPARATHYROIDISM IN PATIENTS WITH CHRONIC KIDNEY DISEASE
ON DIALYSIS
U-988 TREATMENT OF RHINITIS COMPRISING THE NASAL APPLICATION OF A PHARMACEUTICAL
FORMULATION AS CLAIMED IN US PATENT 7541350
U-989 FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM
HYPERPHENYLALANINEMIA
U-990 TREATMENT OF PROTOZOAL INFECTION
U-991 TREATMENT OR PROPHYLAXIS OF THROMBOSIS OR EMBOLISMS
U-992 REDUCTION OF THE RISK OF CARDIOVASCULAR HOSPITALIZATION
U-993 METHOD OF TREATING INFERTILITY
U-994 METHOD OF TREATMENT OF OSTEOPOROSIS WHEREIN THE OSTEOPOROSIS IS STEROID-INDUCED
U-995 METHOD FOR TREATING TYPE II DIABETES BY ADMINISTERING SAXAGLIPTIN
U-996 AN ADJUNCTIVE THERAPY TO DIET TO REDUCT ELEVATED TOTAL CHLORESTEROL (TC), LOW-
DENSITY LIPOPROTEIN CHOLESTEROL, APOLIPOPROTEIN B, TRIGLYCERIDES, AND TO INCREASE
HDL-C IN ADULT PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIX DYSLIPIDEMIA
U-997 TREATMENT OF MAJOR DEPRESSIVE DISORDER BY DOSING AT INTERVALS OF 24 HOURS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 51 of 67
PATENT USE
U-998 ADJUNCITVE THERAPY TO DIET TO REDUCE ELEVATED TOTAL CHOLESTEROL, LOW-DENSITY
LIPOPROTEIN CHOLESTEROL, APOLIPOPRTEIN B, TRIGLYCERIDES AND TO INCREASE HDL-C IN
ADULT PATIENTS WITH PRIMARY HYPERLIPIDEMIA OR MIXED DYSLIPIDEMIA
U-999 TREATMENT OF CHRONIC HEPATITIS B IN ADULT PATIENTS
U-1000 ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH HYPERLIPIDEMIAS
U-1001 METHOD FOR DELIVERING DRUG TO LUNG OF MAMMAL, COMPRISING ADMINISTERING DRUG
PRODUCT BY INHALATION. TREATING A MAMMAL HAVING A CONDITION CAPABLE OF TREATMENT
BY INHALATION, COMPRISING ADMINISTERING TO THE LUNG THE DRUG PRODUCT BY INHALATION
U-1002 METHOD OF TREATING INFLAMMATORY CONDITIONS
U-1003 A METHOD OF MYOCARDIAL PERFUSION IMAGING AND INCREASING CORONARY BLOOD FLOW
U-1004 TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
U-1005 METHOD OF TREATING A STAPHYLOCOCCAL INFECTION
U-1006 NEW COMBINATION PRODUCT FOR THE EARLY TREATMENT OF RECURRENT HERPES LABIALIS (COLD
SORES) TO REDUCE THE LIKELIHOOD OF ULCERATIVE COLD SORES AND TO SHORTEN THE LESION
HEALING TIME IN ADULTS AND ADOLESCENTS (12 YEARS OF AGE AND OLDER)
U-1007 METHOD OF TREATING GOUT FLARES
U-1008 APPLICATION OF ANTISEPTIC WITH MOISTURIZERS FOR SURGICAL AND HEALTHCARE PERSONNEL
SKIN DISINFECTION
U-1009 METHOD FOR ADMINISTRATION OF TESTOSTERONE
U-1010 TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH HYPERPHENYLALANINEMIA DUE TO
TETRA HYDROBIOPTERIN RESPONSIVE PHENYLKETONURIA. KUVAN SHOULD BE TAKEN ORALLY WITH
FOOD TO INCREASE ABSORPTION
U-1011 USE OF GRANISETRON TRANSDERMAL SYSTEM TO TREAT/PREVENT CHEMOTHERAPY INDUCED NAUSEA
AND VOMITING
U-1012 METHOD FOR TREATING INSOMNIA WHILE REDUCING THE RISK OF AN ADVERSE DRUG
INTERACTION
U-1013 METHOD OF USING RIBAVIRIN IN COMBINATION WITH PEGYLATED INTERFERON ALPHA-2B TO
TREAT PATIENTS WITH CHRONIC HEPATITIS C
U-1014 METHOD OF USING RIBAVIRIN IN COMBINATION WITH INTERFERON ALPHA-2B(PEGYLATED AND
NONPEGYLATED) TO TREAT PATIENTS WITH CHRONIC HEPATITIS C
U-1015 TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
U-1016 IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1
INFECTION IN TREATMENT-EXPERIENCED ADULT PATIENTS, WHO HAVE EVIDENCE OF VIRAL
REPLICATION AND HIV-1 STRAINS RESISTANT TO AN NNRTI AND OTHER ANTIRETROVIRAL
AGENTS
U-1017 A METHOD OF TREATING NASAL AND NON-NASAL SYMPTOMS OF SEASONAL ALLERGIC RHINITIS
U-1018 TREATMENT OF PULMONARY HYPERTENSION BY INHALATION
U-1019 TREATMENT OF PULMONARY HYPERTENSION
U-1020 METHOD OF USING COLCHICINE FOR THE PROPHYLAXIS OF GOUT FLARES
U-1021 SHORT-TERM TREATMENT (4-8 WEEKS) OF ACTIVE BENIGN GASTRIC ULCER
U-1022 FOR THE PREPARATION OF SKIN PRIOR TO SURGERY; HELPS REDUCE BACTERIA THAT CAN
POTENTIALLY CAUSE SKIN INFECTION
U-1023 TREATMENT OF ATROPHIC VAGINITIS DUE TO MENOPAUSE
U-1024 REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH GLAUCOMA OR OCULAR
HYPERTENSION WHO REQUIRE ADJUNCTIVE OR REPLACEMENT THERAPY DUE TO INADEQUATELY
CONTROLLED IOP
U-1025 TREATING FREQUENT HEARTBURN
U-1026 A METHOD OF TREATING HUMAN SUFFERING FROM OR SUSCEPTIBLE TO PSYCHOSIS.
U-1027 REDUCTION OF ELEVATED PLASMA STEROL AND/OR STANOL LEVELS IN A MAMMAL
U-1028 A METHOD OF DISTRIBUTING SODIUM OXYBATE UNDER CONTROL OF A CENTRAL PHARMACY
U-1029 METHOD FOR TREATING ACUTE ELEVATIONS OF BLOOD PRESSURE IN HUMAN SUBJECT IN NEED
THEREOF
U-1030 IMPROVEMENT OF WALKING IN PATIENTS WITH MULTIPLE SCLEROSIS (MS)
U-1031 IMPROVE RESPIRATORY SYMPTOMS IN CYSTIC FIBROSIS IN PATIENTS WITH PSEUDOMONAS
AERUGINOSA
U-1032 USE OF ROSUVASTATIN CALCIUM FOR THE PRIMARY PREVENTION OF CARDIOVASCULAR DISEASE
IN INDIVIDUALS WITHOUT CLINICALLY EVIDENT CORONARY HEART DISEASE BUT WITH
INCREASED RISK FACTORS
U-1033 TOPICAL TREATMENT OF ACNE VULGARIS
U-1034 TREATMENT OF ATTENTION DEFICIT HYPERACTIVITY DISORDER (ADHD) IN ADULTS
U-1035 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE
PAIN
U-1036 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-4 INHIBITOR IN COMBINATION WITH INSULIN
U-1037 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-IV INHIBITOR IN COMBINATION WITH A PPAR-GAMMA AGONIST
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 52 of 67
PATENT USE
U-1038 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN AND A PPAR-GAMMA AGONIST
U-1039 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-4 INHIBITOR IN COMBINATION WITH METFORMIN
U-1040 INHIBITION OF THROMBIN IN A PATIENT
U-1041 TREATMENT OF DISORDERS RESPONSIVE TO GROWTH HORMONE
U-1042 METHOD FOR STIMULATING CORONARY VASODILATION FOR PURPOSES OF IMAGING THE HEART
U-1043 MANAGEMENT OF MODERATE TO SEVERE PAIN
U-1044 TOPICAL TREATMENT OF SCALP PSORIASIS
U-1045 MAINTENANCE TREATMENT IN PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NSCLC WHO
HAVE NOT PROGRESSED ON 1ST-LINE TREATMENT WTH PLATINUM-BASED CHEMOTHERAPY
U-1046 MAINTENANCE TREATMENT OF PATIENTS WITH LOCALLY ADVANCED OR METASTATIC NSCLC WHOSE
DISEASE HAS NOT PROGRESSED AFTER FOUR CYCLES PLATINUM-BASED CHEMOTHERAPY
U-1047 TREATMENT OF BIOPSY-CONFIRMED, PRIMARY SUPERFICIAL BASAL CELL CARCINOMA (SBCC)
U-1048 WORKS THROUGH THE INDUCTION OF INTERFERON AND OTHER CYTOKINES
U-1049 PROPHYLAXIS OF ORGAN REJECTION IN ADULT PATIENTS AT LOW-MODERATE IMMUNOLOGIC RISK
RECEIVING A RENAL TRANSPLANT
U-1050 USE OF METAXALONE FOR TREATMENT OF MUSCULSKELETAL CONDITIONS
U-1051 TREATMENT OF OROPHARYNGEAL CANDIDIASIS
U-1052 RELIEF OF SIGNS AND SYMPTOMS OF ARTHRITIS AND RISK-REDUCTION OF NSAID-ASSOCIATED
GASTRIC ULCER
U-1053 RISK-REDUCTION OF NSAID-ASSOCIATED GASTRIC ULCER
U-1054 ONYCHOMYCOSIS OF THE TOENAIL CAUSED BY TRICOPHYTON RUBRUM OR TRICHOPHYTON
MENTAGROPHYTES, ONCE DAILY USE FOR 12 CONSECUTIVE WEEKS
U-1055 AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2
DIABETES MELLITUS WHO ARE ALREADY TREATED WITH A THIAZOLIDINEDIONE (TZD) AND
METFORMIN OR WHO HAVE INADEQUATE GLYCEMIC CONTROL ON A TZD OR METFORMIN ALONE
U-1056 TREATMENT OF PAIN USING A NASAL SPRAY OF KETOROLAC TROMETHAMINE
U-1057 TREATMENT OF INFLAMMATION AND PAIN USING A NASAL SPRAY OF KETOROLAC TROMETHAMINE
U-1058 USE OF THALIDOMIDE IN COMBINATION WITH DEXAMETHASONE FOR THE TREATMENT OF PATIENTS
WITH NEWLY DIAGNOSED MULTIPLE MYELOMA
U-1059 ADJUNCTIVE THERAPY TO DIET TO PATIENTS WITH HYPERTRIGLYCERIDEMIA
U-1060 ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH ELEVATED CHOLESTEROL AND/OR LIPID
LEVELS
U-1061 ADJUNCTIVE THERAPY TO DIET IN PATIENTS WITH MIXED DYSLIPIDEMIA
U-1062 ADMINISTRATION OF APPROVED PRODUCT FOR TREATMENT OF ALZHEIMER'S DISEASE
U-1063 TREATMENT OF ONLY INFLAMMATORY LESIONS (PAPULES AND PUSTULES) OF ROSACEA
U-1064 TREATMENT OF BIPOLAR DISORDER AND SCHIZOPHRENIA
U-1065 METHOD OF TREATING ANDROGEN RESPONSIVE OR MEDICATED CONDITION IN A MAMMAL BY
ADMINISTERING A SAFE & EFFECTIVE AMOUNT OF DUTASTERIDE OR A PHARMACEUTICALLY
ACCEPTABLE SOLVATE THEREOF.. CONDITIONS INCLUDE BENIGN PROSTATIC HYPERTROPHY
U-1066 METHOD OF TREATING AN ANDROGEN RESPONSE OR MEDIATED DISEASE IN A MAMMAL BY
ADMININSTERING AN EFFECTIVE ANDROGEN RESPONSIVE OR MEDICATED DISEASE AMOUNT OF
DUTASTERIDE..CONDITIONS INCLUDE BENIGN PROSTATIC HYPERPLASIA
U-1067 TREATMENT OF CANCER
U-1068 TREATMENT OF ASTHMA
U-1069 A METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING AN EXCLUSIVE
COMPUTER DATABASE IN A COMPUTER SYSTEM FOR DISTRIBUTION
U-1070 A METHOD TO CONTROL ABUSE OF A SENSITIVE DRUG BY CONTROLLING WITH A COMPUTER
PROCESSOR THE DISTRIBUTION OF THE SENSITIVE DRUG VIA AN EXCLUSIVITY CENTRAL
PHARMACY THAT MAINTAINS A CENTRAL DATABASE
U-1071 METHOD OF TREATING BLADDER DSYFUNCTION WITH ONCE A DAY TROSPIUM SALT FORMULATION
U-1072 THE MANAGEMENT OF MODERATE TO SEVERE CHRONIC PAIN IN PATIENTS REQUIRING A
CONTINUOUS, AROUND-THE-CLOCK OPIOID ANALGESIC FOR AN EXTENDED PERIOD OF TIME
U-1073 USE FOR THE TREATMENT OF ASTHMA AND COPD
U-1074 USE OF EXENATIDE MAY RESULT IN REDUCTION IN BODY WEIGHT
U-1075 USE FOR THE TREATMENT OF ASTHMA
U-1076 REDUCE CHRONIC SEVERE DROOLING (I.E., SIALORRHEA) IN PATIENTS WITH NEUROLOGIC
CONDITIONS ASSOCIATED WITH PROBLEM DROOLING
U-1077 PRETREATMENT OF PATIENTS WITH VITAMIN B12 AND FOLIC ACID PRIOR TO PEMETREXED
DISODIUM ADMINISTRATION
U-1078 TREATMENT OF ACNE
U-1079 REVLIMID (LENALIDOMIDE) IS INDICATED FOR THE TREATMENT OF PATIENTS WITH
TRANSFUSION-DEPENDENT ANEMIA IN MYELODYSPLASTIC SYNDROMES (MDS)
U-1080 METHOD TO TREAT PULMONARY HYPERTENSION BY ADMINISTERING AMBRISENTAN TO A PATIENT
U-1081 LUMIGAN IS A PROSTAGLANDIN ANALOG INDICATED FOR THE REDUCTION OF ELEVATED
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 53 of 67
PATENT USE
INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA OR OCULAR HYPERTENSION
U-1082 USE OF A COMBINATION OF TOBRAMYCIN AND DEXAMETHASONE TO TREAT OCULAR INFLAMMATION
WHERE AN INFECTION OR RISK OF INFECTION EXISTS
U-1083 ACUTE TREATMENT OF MIGRAINE ATTACKS, WITH OR WITHOUT AURA, AND THE TREATMENT OF
CLUSTER HEADACHE EPISODES
U-1084 RELIEF OF THE INFLAMMATORY AND PRURITIC MANIFESTATIONS OF CORTICOSTEROID
RESPONSIVE DERMATOSES IN PATIENTS 12 YEARS OF AGE OR OLDER
U-1085 METHOD FOR TREATING IRRITABLE BOWEL SYNDROME AND METHOD FOR TREATING ABDOMINAL
DISCOMFORT ASSOCIATED WITH IRRITABLE BOWEL SYNDROME
U-1086 TREATMENT OF AUTOIMMUNE DISEASE
U-1087 DETECTION OF NON-MUSCLE INVASIVE PAPILLARY CANCER OF THE BLADDER BY PHOTODYNAMIC
CYSTOSCOPY
U-1088 RELIEF OF MUSCLE SPASM
U-1089 INHIBITION OF THROMBIN
U-1090 LO LOESTRIN FE IS INDICATED FOR THE PREVENTION OF PREGNANCY IN WOMEN WHO ELECT TO
USE ORAL CONTRACEPTIVES AS A METHOF OF CONTRACEPTION
U-1091 ASSESSMENT OF BRONCHIAL HYPERRESPONSIVENESS IN PATIENTS 6 YEARS OF AGE OR OLDER
WHO DO NOT HAVE CLINICALLY APPARENT ASTHMA
U-1092 TREATMENT OF BREAST CANCER
U-1093 TREATMENT OF PSEUDOBULBAR AFFECT
U-1094 MANAGEMENT OF CHRONIC MUSCULOSKELETAL PAIN
U-1095 METHOD OF TREATING OCULAR INFLAMMATION
U-1096 TREATMENT OF PATIENTS WITH METASTATIC BREAST CANCER
U-1097 ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE 2
DIABETES MELLITUS WHEN TREATMENT WITH BOTH SAXAGLIPTIN AND METFORMIN IS
APPROPRIATE
U-1098 METHOD OF TREATING HYPERPARATHYROIDISM; METHOD OF TREATING HYPERCALCEMIA
U-1099 TREATMENT OF PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL
NEUROPATHY, POSTHERPETIC NEURALGIA, AND FIBROMYALGIA
U-1100 REDUCTION OF EXCESS ABDOMINAL FAT IN HIV-INFECTED PATIENTS WITH LIPODYSTROPHY
U-1101 METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY
U-1102 METHOD OF TREATING CATAPLEXY IN PATIENTS WITH NARCOLEPSY
U-1103 TESTOSTERONE REPLACEMENT THERAPY IN MALES FOR CONDITIONS ASSOCIATED WITH A
DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
U-1104 USE OF TRAMADOL FOR THE MANAGEMENT OF MODERATE TO MODERATELY SEVERE CHRONIC PAIN
U-1105 TOPICAL TREATMENT OF HEAD LICE INFESTATION IN PATIENTS FOUR (4) YEARS OF AGE AND
OLDER
U-1106 TREATING HYPERTRIGLYCERIDEMIAS WITH REDUCTION OF FOOD EFFECT
U-1107 TREATING HYPERCHOLESTEROLEMIAS WITH REDUCTION OF FOOD EFFECT
U-1108 TREATING TYPE 2 DIABETES MELLITUS WITH EXENATIDE BY STIMULATING INSULIN RELEASE
U-1109 TREATMENT OF CUTANEOUS MANIFESTATIONS OF ERYTHEMA NODOSUM LEPROSUM (ENL) IN
CONNECTION WITH A SPECIAL PROGRAM APPROVED BY FDA CALLED "SYSTEM FOR THALIDOMIDE
EDUCATION AND PRESCRIBING SAFETY" (S.T.E.P.S.)
U-1110 METHOD OF TREATING A PATIENT WITH A PRESCRIPTION DRUG USING A COMPUTER DATABASE IN
A COMPUTER SYSTEM FOR DISTRIBUTION
U-1111 NONSTEROIDAL ANTI-INFLAMMATORY DRUG INDICATED FOR RELIEF OF MILD TO MODERATE ACUTE
PAIN
U-1112 METHOD OF MR IMAGING OF A MAMMAL
U-1113 TREATMENT AND PROPHYLAXIS OF INFLUENZA
U-1114 TREATMENT WITH GABAPENTIN, INCLUDING TREATMENT OF NEUROPATHIC PAIN, INCLUDING
NEUROPATHIC PAIN ASSOCIATED WITH POSTHERPETIC NEURALGIA
U-1115 TREATMENT TO REDUCE THE RISK OF COPD EXACERBATIONS IN PATIENTS WITH SEVERE COPD
ASSOCIATED WITH CHRONIC BRONCHITIS AND A HISTORY OF EXACERBATIONS
U-1116 METHOD OF ADMINISTERING COLCHICINE TO FAMILIAL MEDITERRANEAN FEVER PATIENTS
U-1117 TREATMENT OF BREAST CANCER
U-1118 USE FOR THE TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), INCLUDING
CHRONIC BRONCHITIS AND EMPHYSEMA
U-1119 CONTRAST AGENT FOR MAGNETIC RESONANCE IMAGING
U-1120 TO REDUCE GASTROINTESTINAL SIDE EFFECTS ADMINISTER WITH A MEAL; AS STARTING DOSE
ADMINISTER ONCE DAILY WITH EVENING MEAL
U-1121 METHOD OF TREATING TRAVELERS' DIARRHEA
U-1122 TREATMENT OF SECONDARILY INFECTED TRAUMATIC SKIN LESIONS DUE TO S. AUREUS AND S.
PYOGENES
U-1123 TREATMENT OF ALCOHOL DEPENDENCE
U-1124 PREVENTION OF RELAPSE TO OPIOID DEPENDENCE, FOLLOWING OPIOID DETOXIFICATION
U-1125 METHOD FOR THE DETECTION OF NEUROENDOCRINE TUMORS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 54 of 67
PATENT USE
U-1126 USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC
CASTRATION-RESISTANT PROSTATE CANCER WHO HAVE RECEIVED PRIOR CHEMOTHERAPY
CONTAINING DOCETAXEL
U-1127 TREATMENT OF PATENT DUCTUS ARTERIOSUS
U-1128 TREATMENT OF CHRONIC HEPATITIS C (CHC) GENOTYPE 1 INFECTION IN COMBINATION WITH
PEGINTERFERON ALFA AND RIBAVIRIN IN ADULT PATIENTS (>=18 YEARS OF AGE) WITH
COMPENSATED LIVER DISEASE
U-1129 TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT SUCH AS ASPIRIN
U-1130 SECONDARY PREVENTION OF CARDIOVASCULAR EVENTS BY DOSING ONCE PER DAY IN THE
EVENING OR A NIGHT WITH PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN
U-1131 TREATMENT OF HYPERTRIGLYDERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT SUCH AS ASPIRIN
U-1132 TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT
U-1133 SECONDARY PREVENTION OF CARDIOVASCULAR EVENTS BY DOSING ONCE PER DAY IN THE
EVENING OR AT NIGHT
U-1134 TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT
U-1135 TREATMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT, THROUGH REDUCTION OF LDL-C, TC, TG, LP(A) AND INCREASE OF HDL-C
U-1136 SECONDARY PREVENTION OF CARDIOVASCULAR EVENTS BY DOSING ONCE PER DAY IN THE
EVENING OR AT NIGHT, THROUGH REDUCTION OF LDL-C, TC, TG, LP(A), AND INCREASE OF
HDL-C
U-1137 TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT, THROUGH REDUCTION OF LDL-C, TC, TG, LP(A), AND INCREASE OF HDL-C
U-1138 TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING
OR AT NIGHT
U-1139 REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER
DAY IN THE EVENING OR AT NIGHT
U-1140 REDUCTION IN ELEVATED TC AND LDL-C BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT
U-1141 REDUCTION IN TG BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT
U-1142 TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING
OR AT NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN
U-1143 REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER
DAY IN THE EVENING OR A T NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT
SUCH AS ASPIRIN
U-1144 REDUCTION IN ELEVATED TC AND LDL-C BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITIN AGENT SUCH AS ASPIRIN
U-1145 REDUCTION IN TG BY DOSING ONCE PER DAY IN THE EVENING OR AT NIGHT, WITH
PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN
U-1146 REDUCTION IN TG WITH REDUCED FLUSHING BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT
U-1147 TREATMENT OF PRIMARY AND MIXED DYSLIPIDEMIA BY DOSING ONCE PER DAY IN THE EVENING
OR AT NIGHT, THROUGH REDUCTION OF LDL-C, TC, TG, LP(A), AND INCREASE OF HDL-C
U-1148 REDUCTION IN RISK OF RECURRENT NONFATAL MYOCARDIAL INFARCTION BY DOSING ONCE PER
DAY IN THE EVENING OR AT NIGHT, THROUGH REDUCTINO OF LDL-C, TC, TG, LP(A), AND
INCREASE OF HDL-C
U-1149 TREATMENT OF HYPERTRIGLYCERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT, WITH PRETREATMENT WITH A FLUSH INHIBITING AGENT SUCH AS ASPIRIN
U-1150 TRETMENT OF HYPERCHOLESTEROLEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT, THROUGH REDUCTION IN TOTAL-C, LDL-C, TG, LP(A), AND INCREASE OF HDL-C
U-1151 TREATMENT OF HYPERTRIGLYCDERIDEMIA BY DOSING ONCE PER DAY IN THE EVENING OR AT
NIGHT, THROUGH REDUCTION IN TOTAL-C, LDL-C, LP(A), AND INCREASE OF HDL-C
U-1152 CYANOCOBALAMIN ADMINISTRATION THROUGH NASAL INFUSION
U-1153 IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS, IS INDICATED FOR THE TREATMENT OF
HUMAN IMMUNODEFICIENCY VIRUS TYPE 1 (HIV-1) INFECTION IN ANTIRETROVIRAL TREATMENT-
NAIVE ADULT PATIENTS, AS SET FORTH IN THE LABELING, INCLUDING I&U SECTION
U-1154 TREATMENT OF PROTEIN KINASE RELATED DISORDERS, SUCH AS GASTROINTESTINAL STROMAL
TUMORS, RENAL CELL CARCINOMA AND ADVANCED PANCREATIC NEUROENDOCRINE TUMORS, WITH
SUNITINIB
U-1155 USE OF THALIDOMIDE IN TREATMENT OF CUTANEOUS MANIFESTATIONS OF ERYTHEMA NODOSUM
LEPROSUM (ENL)
U-1156 TO REDUCE BLOOD PHENYLALANINE (PHE) LEVELS IN PATINETS WITH HYPERPHENYLALANINEMIA
(HPA)
U-1157 RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES IN ADULTS AND CHILDREN 2
YEARS OF AGE AND OLDER AND FOR THE RELIEF OF SYMPTOMS ASSOCIATED WITH HIVES
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 55 of 67
PATENT USE
(URTICARIA) IN ADULTS AND CHILDREN 6 YEARS OF AGE AND OLDER
U-1158 RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES AND FOR THE RELIEF OF
SYMPTOMS ASSOCIATED WITH HIVES (URTICARIA) IN ADULTS AND CHILDREN 6 YEARS OF AGE
AND OLDER
U-1159 RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES, SWELLING OF THE NASAL
PASSAGES AND SINUS CONGESTION AND PRESSURE IN ADULTS AND CHILDREN 12 YEARS OF AGE
AND OLDER
U-1160 RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES AND FOR THE RELIEF OF
SYMPTOMS ASSOCIATED WITH HIVES (URTICARIA) IN ADULTS AND CHILDREN 6 YEARS OF AGE
AND OLDER AND 12 YEARS OF AGE AND OLDER
U-1161 FOR THE TREATMENT AND PROPHYLAXIS OF GOUT FLARES & THE TREATMENT OF FAMILIAL
MEDITERRANEAN FEVER
U-1162 TREATMENT OF SEBORRHEIC DERMATITIS OF THE SCALP
U-1163 METHOD OF TREATING THROMBOSIS
U-1164 METHOD OF TREATING AN ARGATROBAN TREATABLE CONDITION
U-1165 USE FOR THE TREATMENT OF MULTIPLE MYELOMA
U-1166 A METHOD FOR TREATMENT OF GOUT FLARES DURING PROPHYLAXIS
U-1167 PROPHYLAXIS OF DEEP VEIN THROMBOSIS (DVT)
U-1168 THE LONG TERM, ONCE-DAILY MAINTENANCE BROCHODILATOR TREATMENT OF AIRFLOW
OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD),
INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA
U-1169 MANAGEMENT OF BREAKTHROUGH PAIN IN CANCER PATIENTS 18 YEARS OF AGE AND OLDER WHO
ARE RECEIVING AND TOLERANT TO OPIOID THERAPY FOR THEIR UNDERLYING PERSISTENT
CANCER PAIN
U-1170 TREATMENT OF HIV-1 INFECTION IN PEDIATRIC PATIENTS 12 YEARS OF AGE AND OLDER
U-1171 REDUCTION OF THE RATE OF THROMBOTIC EVENTS IN PATIENTS WITH ACUTE CORONARY
SYNDROME
U-1172 TO REDUCE ELEVATED TOTAL-C, APO B, AND NON-HDL-C IN PATIENTS WIHT PRIMARY
HYPERLIPIDEMIA BY ADMINISTRATION OF EZETIMIBE IN COMBINATION WITH A STATIN
U-1173 TO REDUCE ELEVATED TOTAL-C, LDL-C, APO B AND NON-HDL-C IN PATIENTS WITH PRIMARY
HYPERLIPIDEMIA BY ADMINISTRATION OF EZETIMIBE ALONE OR IN COMBINATION WITH A
STATIN OR WITH FENOFIBRATE
U-1174 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE WATER
FOR INJECTION, 0.9% SODIUM CHLORIDE INJECTION, OR FLOLAN STERIILE DILUENT FOR
INJECTION PRIOR TO ADMINISTRATION
U-1175 REDUCTION OF CARDIAC TISSUE DAMAGE ASSOCIATED WITH MYOCARDIAL INFARCTION
U-1176 TREATMENT OR PREVENTION OF STROKE
U-1177 REDUCTION OF CARDIAC TISSUE DAMAGE ASSOCIATED WITH MYOCARDIAL INFARCTION
U-1178 RELIEF OF MODERATE TO SEVERE CHRONIC PAIN
U-1179 TREATMENT OF A CANCER MEDIATED BY AN ANAPLASTIC LYMPHOMA KINASE (ALK)
U-1180 TREATMENT OF THE FOLLOWING INFECTIONS: COMPLICATED SKIN AND SKIN STRUCTURE
INFECTIONS AND STAPHYLOCOCCUS AUREUS BLOODSTREAM INFECTIONS (BACTEREMIA) INCLUDING
THOSE WITH RIGHT-SIDED INFECTIVE ENDOCARDITIS
U-1181 A METHOD OF TREATING OR PREVENTING OCULAR PAIN IN A PATIENT
U-1182 TREATMENT OF CYCLIC HEAVY MENSTRUAL BLEEDING
U-1183 A METHOD FOR ADMINISTERING FOLLICLE STIMULATING HORMONE (FSH) FOR OVARIAN FOLLICLE
OR TESTICULAR STIMULATION IN THE HUMAN
U-1184 TREATMENT OF ERECTILE DYSFUNCTION AND THE SIGNS AND SYMPTOMS OF BENIGN PROSTATIC
HYPERPLASIA
U-1185 TREATMENT OF OPIOID-INDUCED CONSTIPATION
U-1186 ADMINISTRATION OF AN INHALABLE POWDER COMPRISING TIOTROPIUM VIA DEVICE
U-1187 TREATMENT OF PATHOLOGICAL STATE BY ANTAGONIZING BRADYKININ RECEPTOR INCLUDING
TREATMENT OF ACUTE ATTACKS OF HEREDITARY ANGIOEDEMA (HAE)
U-1188 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH
BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE
U-1189 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH
BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH METFORMIN
U-1190 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH
BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH INSULIN
U-1191 METHOD OF TX TYPE 2 DM IN PTS FOR WHOM TREATMENT WITH BOTH SITAGLIPTIN AND
SIMVASTATIN IS APPROPRIATE, IN COMBO WITH AN AGENT ACTING ON AN ATP-DEPENDENT
CHANNEL IN BETA CELLS SUCH AS A SULFYONYLUREA(INCL GLIPIZIDE, GLIMEPIRIIDE &
GLYBURIDE)
U-1192 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH
BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A
SULFONYLUREA (SUCH AS GLIPIZIDE, GLIMEPIRIDE AND GLYBURIDE)
U-1193 METHOD OF TREATING TYPE 2 DIABETES MELITUS IN PATIENTS FOR WHOM TREATMENT WITH
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 56 of 67
PATENT USE
BOTH SITAGLIPTIN AND SIMVASTATIN IS APPROPRIATE, IN COMBINATION WITH A PPAR-GAMMA
AGONIST (SUCH AS PIOGLITAZONE AND ROSIGLITAZONE)
U-1194 METHOD FOR TREATING INSOMNIA
U-1195 PREVENTION AND TREATMENT OF SECONDARY HYPERPARATHYROIDISM ASSOCIATED WITH CHRONIC
KIDNEY DISEASE (CKD) STAGE 5, WHICH MAY RESULT IN RENAL OSTEODYSTROPHY, WHILE
AVOIDING HYPERPHOSPHATEMIA
U-1196 RELIEF OF SIGNS AND SYMPTOMS OF RHEUMATOID ARTHRITIS AND OSTEOARTHRITIS AND TO
DECREASE RISK OF DEVELOPING UPPER GASTROINTESTINAL ULCERS IN PATIENTS WHO ARE
TAKING IBUPROFEN FOR THOSE INDICATIONS
U-1197 METHOD OF TREATMENT OF CHILDREN WITH CENTRAL PRECOCIOUS PUBERTY
U-1198 RECTIV IS A NITRATE VASODILATOR INDICATED FOR THE TREATMENT OF MODERATE TO SEVERE
PAIN ASSOCIATED WITH CHRONIC ANAL FISSURE
U-1199 TREATMENT AND PREVENTION OF POSTMENOPAUSAL OR GLUCOCORTICOID-INDUCED OSTEOPOROSIS
AND TREATMENT TO INCREASE BONE MASS IN MEN WITH OSTEOPOROSIS
U-1200 REDUCING THE RISK OF STROKE AND SYSTEMIC EMBOLISM
U-1201 FOR THE TREATMENT OF INTERMEDIATE OR HIGH-RISK MYELOFIBROSIS
U-1202 METHOD FOR RELIEVING OR TREATING CONSTIPATION IN A PATIENT WITH IRRITABLE BOWEL
SYNDROME
U-1203 METHOD FOR RELIEVING OR TREATING CONSTIPATION IN A HUMAN CONSTIPATED PATIENT
U-1204 TREATMENT OF UVEITIS
U-1205 TREATMENT OF MACULAR EDEMA
U-1206 DELIVERING AN OCULAR IMPLANT AS DESCRIBED IN THE DOSAGE AND ADMINISTRATION SECTION
OF THE APPROVED LABELING OF OZURDEX
U-1207 INFANT USE AGED 1 MONTH TO LESS THAN ONE YEAR, GERD AND EROSIVE ESOPHAGITIS
U-1208 TREATMENT OF HYPOTRICHOSIS OF THE EYELASHES BY INCREASING THEIR GROWTH INCLUDING
LENGTH, THICKNESS AND DARKNESS
U-1209 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN ADULT PATIENTS, AND
TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION IN PEDIATRIC PATIENTS 3
YEARS OF AGE AND OLDER
U-1210 USE OF REVLIMID (LENALIDOMIDE) WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER
CONTRAINDICATED INDIVIDUAL TO REVLIMID (LENALIDOMIDE)
U-1211 USE OF REVLIMID (LENALIDOMIDE) TO INHIBIT THE SECRETION OF PRO-INFLAMMATORY
CYTOKINES, INCLUDING TUMOR NECROSIS FACTOR ALPHA
U-1212 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF MULTIPLE MYELOMA AND
TRANSFUSION-DEPENDENT ANEMIA IN MYELODYSPLASTIC SYNDROMES (MDS)
U-1213 TOPICAL TREATMENT OF SEBORRHEIC DERMATITIS IN IMMUNOCOMPETETENT PATIENTS 12 YEARS
OF AGE AND OLDER
U-1214 METHOD FOR RELIEVING CONSTIPATION IN A HUMAN PATIENT THAT COMPRISES ADMINISTERING
TO THE PATIENT A DOSAGE UNIT COMPRISING (I) 24MCG+/- 10% OF A DRUG SUBSTANCE AND
(II) A PHARMACEUTICALLY SUITABLE EXCIPIENT
U-1215 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF TRANSFUSION-DEPENDENT ANEMIA
IN MYELODYSPLASTIC SYNDROMES (MDS)
U-1216 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF MULTIPLE MYELOMA
U-1217 METHOD OF INCREASING HAIR GROWTH
U-1218 METHOD OF STIMULATING HAIR GROWTH
U-1219 METHOD OF INCREASING THE NUMBER OF HAIRS
U-1220 TREATMENT OF RENAL CELL CARCINOMA
U-1221 TO STIMULATE THE IMMUNE SYSTEM TO INDUCE T CELL PROLIFERATION
U-1222 TO INHIBIT THE PROLIFERATIVE ACTIVITY OF NEOPLASTIC CELLS
U-1223 METHOD FOR TREATING TYPE 2 DIABETES USING A SUSTAINED-RELEASE COMPOSITION
CONTAINING EXENATIDE
U-1224 REDUCTIONS IN BODY WEIGHT ARE OBSERVED WITH EXENATIDE
U-1225 ACCELERATING THE TIME TO UPPER AND LOWER GASTROINTESTINAL RECOVERY FOLLOWING
PARTIAL LARGE OR SMALL BOWEL RESECTION SURGERY WITH PRIMARY ANASTOMOSIS
U-1226 A METHOD OF PROVIDING A PREDETERMINED CONCENTRATION OF NITRIC OXIDE TO A PATIENT
U-1227 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH
BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE
U-1228 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS FOR WHOM TREATMENT WITH
BOTH SITAGLIPTIN AND METFORMIN HCL EXTENDED RELEASE IS APPROPRIATE ALONE OR IN
COMBINATION WITH INSULIN
U-1229 TREATMENT OF MILDLY TO MODERATELY ACTIVE ULCERATIVE COLITIS IN MALE PATIENTS
U-1230 A METHOD OF PROVIDING NITRIC OXIDE THERAPY TO A PATIENT
U-1231 TREATMENT OF MODERATE-TO-SEVERE PRIMARY RESTLESS LEG SYNDROME IN ADULTS
U-1232 USE AS ANTICOAGULANT IN PTS W/ UNSTABLE ANGINA UNDERGOING PTCA; W/ PROVISIONAL USE
OF GLYCOPROTEIN IIB/IIIA INHIBITOR, AS ANTICOAGULANT IN PTS UNDERGOING PCI AND FOR
PTS W/, OR AT RISK OF, HIT/HITTS UNDERGOING PCI.INTENTED FOR USE W/ASPIRIN
U-1233 TREATMENT OF CHRONIC HEPATITIS C (CHC) GENOTYPE 1 INFECTION, ADMINISTERED WITH
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 57 of 67
PATENT USE
FOOD
U-1234 FOR REDUCING TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-LIPOPROTEIN B, OR TOTAL
TRIGLYCERIDES, AND TREATING HYPERTRIGLYCERIDEMIA
U-1235 REDUCTION OF ELEVATED INTRAOCULAR PRESSURE IN PATIENTS WITH GLAUCOMA OR OCULAR
HYPERTENSION
U-1236 USE OF THALOMID (THALIDOMIDE) FOR THE TREATMENT OF MULTIPLE MYELOMA
U-1237 COMBO W/ OTHER ANTIRETROVIRALS FOR TX OF HIV-1 IN ANTIRETROVIRAL TX-EXPERIENCED PT
6 YEARS UP, WHO HAVE EVIDENCE OF VIRAL REPLICATION AND HIV-1 STRAINS RESISTANT TO
NON-NUCLEOSIDE REVERSE TRANSCRIPTASE INHIBITOR AND OTHER ANTIRETROVIRALS
U-1238 TREATMENT OF ANEMIA DUE TO CHRONIC KIDNEY DISEASE
U-1239 MAGNETIC RESONANCE IMAGING OF THE LIVER
U-1240 TREATMENT OF HEAVY MENSTRUAL BLEEDING IN WOMEN WITHOUT ORGANIC PATHOLOGY WHO
CHOOSE TO USE AN ORAL CONTRACEPTIVE AS THEIR METHOD OF CONTRACEPTION
U-1241 MANAGEMENT OF MODERATE TO SEVERE PAIN BY ORALLY ADMINISTERING AN INTACT
COMPOSITION AS CLAIMED
U-1242 PREVENTION OF RESPIRATORY DISTRESS (RDS) IN PREMATURE INFANTS
U-1243 WITH DRY HANDS, GENTLY REMOVE THE SUPRENZA (PHENTERMINE HYDROCHLORIDE ODT) TABLET
FROM THE BOTTLE. IMMEDIATELY PLACE THE SUPRENZA TABLET ON TOP OF THE TONGUE WHERE
IT WILL DISSOLVE, THEN SWALLOW WITH OR WITHOUT WATER
U-1244 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-4 INHIBITOR IN COMBINATION WITH SULFONLYUREA
U-1245 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING A DIPEPTIDYL
PEPTIDASE-4 INHIBITOR IN COMBINATION WITH PIOGLITAZONE
U-1246 SINGLE DOSE ADMINISTRATION INTO THE SURGICAL SITE TO PRODUCE POSTSURGICAL
ANALGESIA
U-1247 MANAGEMENT OF POSTHERPETIC NEURALGIA (PHN) IN ADULTS
U-1248 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL MEDICATION ON THE SAME
KNEE
U-1249 TREATMENT OF MALE PATIENT HAVING A DISEASE OR CONDITION RESPONSIVE TO A
TERATOGENIC DRUG
U-1250 TREATMENT OF PAIN, INCLUDING NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL
NEUROPATHY OR SPINAL CORD INJURY, POSTHERPETIC NEURALGIA, AND FIBROMYALGIA
U-1251 A METHOD OF CONTROLLING POSTOPERATIVE OCULAR PAIN AND BURNING/STINGING IN A
PATIENT
U-1252 METHOD FOR CHRONIC WEIGHT MANAGEMENT BY DECREASING FOOD INTAKE
U-1253 METHOD FOR CHRONIC WEIGHT MANAGEMENT BY INDUCING SATIETY
U-1254 METHOD FOR CHRONIC WIEGHT MANAGEMENT BY CONTROLLING WEIGHT GAIN
U-1255 METHOD FOR CHRONIC WEIGHT MANAGEMENT BY TREATING OBESITY
U-1256 TREATMENT OF SEBORRHEIC DERMATITIS
U-1257 TREATMENT OF OPHTHALMIC DISORDERS
U-1258 VISUALIZATION DURING VITRECTOMY PROCEDURES
U-1259 PROPHYLAXIS OF HIV-1 INFECTION
U-1260 TREATMENT OF PATIENTS WITH MULTIPLE MYELOMA WHO HAVE RECEIVED AT LEAST TWO PRIOR
THERAPIES INCLUDING BORTEZOMIB AND AN IMMUNOMODULATORY AGENT AND HAVE DEMONSTRATED
DISEASE PROGRESSION ON OR WITHIN 60 DAYS OF COMPLETION OF THE LAST THERAPY
U-1261 REDUCTION OF THE RISK OF HOSPITALIZATION FOR ATRIAL FIBRILLATION
U-1262 USE OF QSYMIA (PHENTERMINE AND TOPIRAMATE) FOR WEIGHT MANAGEMENT, INCLUDING, BUT
NOT LIMITED TO EFFECTING WEIGHT LOSS, TREATING OBESITY, AND/OR TREATING OVERWEIGHT
U-1263 TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD) OR CHRONIC BRONCHITIS
U-1264 TREATMENT OF A RESPIRATORY DISEASE
U-1265 PATENTED METHOD OF USING REPAGLINIDE IN COMBINATION WITH METFORMIN AS INDICATED
FOR IMPROVING GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS
U-1266 METHOD OF TREATING MIDDLE-OF-THE-NIGHT INSOMNIA
U-1267 TREATMENT OF RHEUMATOID ARTHRITIS BY DELAYED RELEASE FORMULATION OF 1MG OR 2MG OF
PREDNISONE
U-1268 TREATMENT OF PULMONARY, GASTROINTESTINAL AND/OR RHEUMATOLOGICAL DISEASES OR
CONDITIONS BY USE OF DELAYED RELEASE FORMULATIONS OF 1MG OR 2MG PREDNISONE
U-1269 TREATMENT OF RHEUMATOLOGIC, ALLERGIC, PULMONARY, GASTROINTESTINAL, DERMATOLOGIC
DISEASES OR CONDITIONS BY THE USE OF A DELAYED RELEASE 5MG PREDNISONE TABLET
U-1270 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN
COMBINATION WITH INSULIN (WITH OR WITHOUT METFORMIN AND/OR PIOGLITAZONE)
U-1271 TREATMENT OF ADULT PATIENTS WITH PHILADELPHIA CHROMOSOME-NEGATIVE(PH-) ACUTE
LYMPHOBLASTIC LEUKEMIA (ALL) IN SECOND OR GREATER RELAPSE OR WHOSE DISEASE HAS
PROGRESSED FOLLOWING TWO OR MOR ANTI-LEUKEMIA THERAPIES
U-1272 TREATMENT OF SIGNS AND SYMPTOMS OF PARKINSON'S DISEASE BY APPLICATION OF CLAIMED
TRANSDERMAL SYSTEM
U-1273 TREATMENT OF RESTLESS LEGS SYNDROME BY APPLICATION OF CLAIMED TRANSDERMAL DELIVERY
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 58 of 67
PATENT USE
SYSTEM
U-1274 TREATMENT OF EXOCRINE PANCREATIC INSUFFICIENCY DUE TO CYSTIC FIBROSIS OR OTHER
CONDITIONS
U-1275 TREATMENT OF CHRONIC HEPATITIS B IN ADULTS AND PEDIATRIC PATIENTS 12 YEARS OF AGE
AND OLDER
U-1276 MANAGEMENT OF NEUROPATHIC PAIN ASSOCIATED WITH DIABETIC PERIPHERAL NEUROPATHY
U-1277 METHOD OF INCREASING EYELASH GROWTH INCLUDING LENGTH, THICKNESS, DARKNESS AND/OR
NUMBER OF EYELASHES BY ADMINISTERING BIMATOPROST TO AN EYELID MARGIN
U-1278 METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULTS
U-1279 TREATMENT OF HIV INFECTION USING A COMPOSITION CONTAINING A PHARMACOKNIETIC
ENHANCER THAT INHIBITS CYTOCHROME P450 MONOOXYGENASE
U-1280 USE OF A CALCIPOTRIENE CONTAINING FOAM FOR THE TREATMENT OF PSORIASIS
U-1281 THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER WHO
HAVE PREVIOUSLY RECEIVED DOCETAXEL
U-1282 PREVENTION OF ACUTE AND DELAYED NAUSEA AND VOMITING
U-1283 A METHOD OF TREATING CHRONIC MYELOGENOUS LEUKEMIA
U-1284 A METHOD OF TREATING A NEOPLASM
U-1285 TREATMENT OF PATIENTS WITH RELAPSING FORMS OF MULTIPLE SCLEROSIS
U-1286 A METHOD OF REDUCING THE RISK OF PULMONARY EDEMA IN PATIENTS IN NEED OF TREATMENT
WITH INHALED NITRIC OXIDE
U-1287 METHOD OF REDUCING TG LEVELS IN PATIENT SUFFERING FROM SEVERE HYPERTRIGLYCERIDEMIA
U-1288 TREATEMENT OF ERECTIILE DYSFUNCTION BY ADMINISTERING A FILM-COATED TABLET
U-1289 MANAGEMENT OF MODERATE TO SEVERE ACUTE PAIN
U-1290 TREATMENT OF LUNG CANCER
U-1291 TREATMENT OF ACUTE PROMYELOCYTIC LEUKEMIA (APL) IN PATIENTS WHOSE APL IS
CHARACTERIZED BY THE PRESENCE OF THE (15;17) TRANSLOCATION OR PML/RAR-ALPHA GENE
EXPRESSION
U-1292 TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED RELEASE 1, 2, OR 5 MG
PREDNISONE TABLET
U-1293 A METHOD OF LOWERING INTRAOCULAR PRESSURE IN A PATIENT WITH OPEN ANGLE GLAUCOMA OR
OCULAR HYPERTENSION
U-1294 METHOD OF TREATING GLAUCOMA IN A PATIENT
U-1295 A METHOD OF TREATING A PATIENT WITH GLAUCOMA OR OCULAR HYPERTENSION
U-1296 USE OF PEMETREXED WITH PRIOR AND/OR REPEATED VITAMIN B12 AND FOLIC ACID
ADMINISTRATION
U-1297 TREATMENT OF PULMONARY ARTERIAL HYPERTENSION BY INHIBITING ENDOTHELIN RECEPTORS
U-1298 ADJUNCTIVE THERAPY IN THE TREATMENT OF PARTIAL SEIZURES
U-1299 TREATMENT OF PATIENTS WITH LEUKEMIA INCLUDING CHRONIC MYELOID/MYELOGENOUS LEUKEMIA
(CML)
U-1300 TREATMENT OF PATIENTS WITH TYROSINE KINASE INHIBITOR (TKI) RESISTANT OR INTOLERANT
CHRONIC MYELOID/MYELOGENOUS LEUKEMIA (CML)
U-1301 TREATMENT OF DEEP VEIN THROMBOSIS (DVT)
U-1302 TREATMENT OF PULMONARY EMBOLISM (PE)
U-1303 REDUCTION IN THE RISK OF RECURRENCE OF DEEP VEIN THROMBOSIS (DVT) AND PULMONARY
EMBOLISM
U-1304 USE OF ONCE-A-DAY AMOXICILLIN PRODUCT TO TREAT TONSILLITIS AND/OR PHARYNGITIS
SECONDARY TO STREPTOCOCCUS PYOGENES
U-1305 TREATMENT OF HIV-1INFECTION IN ADULT PATIENTS, AND TREATMENT OF HIV-1 INFECTION IN
PEDIATRIC PATIENTS 3 YEARS OF AGE AND OLDER, CO-ADMINISTERED WITH RITONAVIR
(PREZISTA/RITONAVIR) AND WITH OTHER ANTIRETROVIRAL AGENTS
U-1306 TREATMENT OF THROMBOCYTOPENIA IN PATIENTS WITH CHRONIC HEPATITIS C TO ALLOW THE
INITIATION AND MAINTENANCE OF INTERFERON-BASED THERAPY
U-1307 IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS FOR THE TREATMENT OF HIV-1
INFECTION IN TREATMENT-NAIVE ADULT PATIENTS WITH HIV-1 RNA LESS THAN OR EQUAL TO
100,000 AT THE START OF THERAPY
U-1308 MULTIPLE MYELOMA
U-1309 BONE METASTASES
U-1310 FOR THE MAINTENANCE OF REMISSION OF ULCERATIVE COLITIS
U-1311 METHOD OF TREATING CYSTIC FIBROSIS
U-1312 USE FOR THE TREATMENT OF HYPERGLYCEMIA
U-1313 AS AN ADJUNCT TO DIET AND EXERCISE TO IMPROVE GLYCEMIC CONTROL IN ADULTS WITH TYPE
2 DIABETES MELLITUS
U-1314 USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC
CASTRATION-RESISTANT PROSTATE CANCER
U-1315 THE LONG TERM TREATMENT OF PROPHYLACTIC MANAGEMENT OF OCULAR HYPERTENSION AND
GLAUCOMA
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 59 of 67
PATENT USE
U-1316 A DOSING REGIMEN FOR THE TREATMENT OF HYPERCHOLESTEROLEMIA AND HYPERLIPIDEMIA IN
PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA USING AT LEAST THREE STEP-
WISE INCREASING DOSES
U-1317 TREATMENT OF HYPERCHOLESTEROLEMIA, HYPERLIPIDEMIA AND HYPERLIPOPROTEINEMIA IN
PATIENTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
U-1318 TREATMENT OF HYPERCHOLESTEROLEMIA BY DECREASING THE AMOUNT OR ACTIVITY OF
MICROSOMAL TRIGLYCERIDE TRANSFER PROTEIN IN PATIENTS WITH HOMOZYGOUS FAMILIAL
HYPERCHOLESTEROLEMIA
U-1319 SYMPTOMATIC RELIEF OF NON-INFECTIOUS DIARRHEA
U-1320 TREATMENT OF ADULT PATIENTS WITH SHORT BOWEL SYNDROME WHO ARE DEPENDENT ON
PARENTERAL SUPPORT
U-1321 TREATMENT OF PULMONARY MULTI-DRUG RESISTANT TUBERCULOSIS
U-1322 METHOD OF REDUCING OCULAR HYPERTENSION
U-1323 REDUCING THE RISK OF STROKE
U-1324 MANAGEMENT OF CYSTIC FIBROSIS PATIENTS
U-1325 INDUCTION OF REMISSION IN PATIENTS WITH ACTIVE, MILD TO MODERATE ULCERATIVE
COLITIS
U-1326 METHOD OF INDUCING CONTRACEPTION IN A FEMALE OF REPRODUCTIVE AGE WHO HAS NOT YET
REACHED PREMENOPAUSE
U-1327 METHOD FOR TREATING ACUTE MIGRAINE IN ADULTS, WITH OR WITHOUT AURA, COMPRISING
IONTOPHORETIC TRANSDERMAL DELIVERY OF SUMATRIPTAN OR A SALT THEREOF, USING A
FLOWABLE HYDROGEL FORMULATION
U-1328 METHOF FOR TREATING ACUTE MIGRAINE IN ADULTS, WITH OR WITHOUT AURA, COMPRISING
IONTOPHORETIC TRANSDERMAL DELIVERY OF SUMATRIPTAN OR A SALT THEREOF
U-1329 TREATMENT OF PATIENTS WITH AN OVERACTIVE BLADDER
U-1330 METHODS OF TREATING LIPID METABOLISM AND GLYCOMETABOLISM DISORDERS COMPRISING
ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION
WITH AN INSULIN SECRETION ENHANCER
U-1331 METHODS OF REDUCING THE AMOUNT OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC
PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS
PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
U-1332 METHODS OF REDUCING THE SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A
DIABETIC PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS
PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
U-1333 METHODS OF LOWERING ELEVATED POST PRANDIAL BLOOD GLUCOSE LEVELS COMPRISING
ADMINISTERING A DIPEPTIDYL PEPTIDASE INHIBITOR
U-1334 METHODS OF TREATING DIABETES COMPRISING ADMINISTERING AN INSULIN SENSITIVITY
ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH AN INSULIN SECRETION ENHANCER
U-1335 METHODS OF MODIFYING GLUCOSE METABOLISM AND TREATING DIABETES COMPRISING
ADMINISTERING A DIPEPTIDYL PEPTIDASE INHIBITOR AND ONE OR MORE OTHER THERAPEUTIC
AGENTS SUCH AS METFORMIN
U-1336 METHODS OF TREATING DIABETES COMPRISING ADMINISTERING A DIPEPTIDYL PEPTIDASE
INHIBITOR AND METFORMIN
U-1337 METHOD OF TREATING DIABETES COMPRISING ADMINISTERING ALOGLIPTIN
U-1338 METHOD OF TREATING DIABETES COMPRISING ADMINISTERING A COMPOUND SUCH AS ALOGLIPTIN
U-1339 METHODS OF TREATING DIABETES COMPRISING ADMINISTERING AN INSULIN SENSITIVITY
ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS METFORMIN
U-1340 METHODS OF TREATING LIPID METABOLISM DISORDERS COMPRISING ADMINISTERING AN INSULIN
SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS
METFORMIN
U-1341 METHODS OF TREATING GLYCOMETABOLISM DISORDERS COMPRISING ADMINISTERING AN INSULIN
SENSITIVITY ENHANCER SUCH AS PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS
METFORMIN
U-1342 METHODS OF REDUCING THE AMOUNT OF ACTIVE COMPONENTS ADMINISTERED TO A DIABETIC
PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS
PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS METFORMIN
U-1343 METHODS OF REDUCING THE SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A
DIABETIC PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS
PIOGLITAZONE IN COMBINATION WITH A BIGUANIDE SUCH AS METFORMIN
U-1344 METHODS OF REDUCING THE SIDE EFFECTS OF ACTIVE COMPONENTS ADMINISTERED TO A
DIABETIC PATIENT COMPRISING ADMINISTERING AN INSULIN SENSITIVITY ENHANCER SUCH AS
PIOGLITAZONE IN COMBINATION WITH AN INSULIN PREPARATION
U-1345 USE IN RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN PATIENT WITH A DOSAGE UNIT
COMPRISING 24MICROG+/- 10% OF A DRUG SUBSTANCE AND A PHARMACEUTICALLY SUITABLE
EXCIPIENT
U-1346 USE OF FEBUXOSTAT FOR THE MANAGEMENT OF HYPERURICEMIA IN PATIENTS SUFFERING FROM
GOUT AND, WHEN USED WITH THEOPHYLLINE WITHOUT THE NEED FOR DOSE ADJUSTMENT OF
THEOPHYLLINE
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 60 of 67
PATENT USE
U-1347 TREATMENT OF A SKIN DISORDER
U-1348 TREATMENT OF OSTEOARTHRITIS
U-1349 TREATMENT OF JUVENILE RHEUMATOID ARTHRITIS
U-1350 TREATMENT OF ANKYLOSING SPONDYLITIS
U-1351 TREATMENT OF ACUTE PAIN
U-1352 TREATMENT OF PRIMARY DYSMENORRHEA
U-1353 ADJUNCTIVE THERAPY TO LIPID-LOWERING MEDICATIONS AND DIET TO REDUCE LOW DENSITY
LIPOPROTEIN-CHOLESTEROL, APOLIPOPROTEIN B, TOTAL CHOLESTEROL, AND NON-HIGH DENSITY
LIPOPROTEIN CHOLESTEROL IN PTS WITH HOMOZYGOUS FAMILIAL HYPERCHOLESTEROLEMIA
U-1354 INHIBITION OF PREMATURE LH SURGES IN WOMEN UNDERGOING CONTROLLED OVARIAN
HYPERSTIMULATION WITH FSH
U-1355 MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC THERAPY IN ADULT AND ADOLESCENT
PATIENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHOD FOR TREATING A
RESPIRATORY DISEASE IN A CHILD
U-1356 TREATMENT OF NASAL SYMPTOMS ASSOCIATED WITH SEASONAL ALLERGIC RHINITIS IN ADULTS
AND CHILDREN 6 YEARS OF AGE AND OLDER. TREATMENT OF NASAL SYMPTOMS ASSOCIATED W
PERENNIAL ALLERGIC RHINITIS IN ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER
U-1357 TREATMENT OF SYMPTOMS ASSOCIATED WITH SEASONAL AND PERENNIAL ALLERGIC RHINITIS IN
ADULTS AND ADOLESCENTS 12 YEARS OF AGE AND OLDER. PATENT CLAIMS METHODS FOR
TREATING A RESPIRATORY DISEASE IN A CHILD
U-1358 TREATMENT OF BACTERIAL INFECTIONS IN THE NASAL PASSAGE OF ADULT PATIENTS AND
HEALTH CARE WORKERS WITH METHICILLIN RESISTANT S. AUREUS
U-1359 USE OF POMALIDOMIDE TO INHIBIT THE SECRETION OF PRO-INFLAMMATION CYTOKINES,
INCLUDING TUMOR NECROSIS FACTOR ALPHA
U-1360 USE OF POMALIDOMIDE FOR THE TREATMENT OF MULTIPLE MYELOMA
U-1361 USE OF POMALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER
CONTRAINDICATED INDIVIDUAL TO POMALIDOMIDE
U-1362 TREATMENT OF DISEASES OR CONDITIONS BY THE USE OF A DELAYED-RELEASE 1,2, OR 5MG
PREDNISONE TABLET
U-1363 A METHOD OF TREATING OR PREVENTING OCULAR PAIN AND BURNING/STINGING FOLLOWING
CORNEAL SURGERY
U-1364 MAINTENANCE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
U-1365 PROPHYLAXIS OF ALLOGRAFT REJECTION IN ADULT PATIENTS RECEIVING A LIVER TRANSPLANT
U-1366 TREATMENT OF INFERTILITY THROUGH INDUCTION OF OVULATION AND PREGNANCY TO
ANOVULATORY INFERTILE WOMEN
U-1367 METHOD OF ADMINISTERING FSH FOR THE TREATMENT OF INFERTILITY THROUGH INDUCTION OF
OVULATION AND PREGNANCY IN ANOVULATORY INFERTILE WOMEN
U-1368 TREATMENT OF SOLID EXCRETORY SYSTEM TUMORS; ADVANCED RENAL CELL CARCINOMA (RCC),
AFTER FAILURE OF TREATMENT WITH SUNITINIB OR SORAFENIB
U-1369 TREATMENT OF VAGINAL SYMPTOMS OF UROGENITAL ATROPHY BY ORALLY ADMINISTERING
OSPEMIFENE WITH FOOD TO ENHANCE BIOAVAILABILITY OF OSPEMIFENE
U-1370 TREATMENT OF DYSPAREUNIA ASSOCIATED WITH MENOPAUSE
U-1371 REDUCTION OF INTRAOCULAR PRESSURE IN PATIENTS WITH ELEVATED INTRAOCULAR PRESSURE
OR GLAUCOMA
U-1372 ADMINISTRATION WITHOUT FOOD FOR TREATMENT OF HIV-1 INFECTION
U-1373 METHOD OF TREATING ACETAMINOPHEN OVERDOSE WITH ACETYLCYSTEINE SOLUTIONS
U-1374 TREATMENT OF PHILADELPHIA CHROMOSOME POSITIVE CHRONIC MYELOID LEUKEMIA (PH+CML)
U-1375 ADASUVE IS A TYPICAL ANTIPSYCHOTIC INDICATED FOR THE ACUTE TREATMENT OF AGITATION
ASSOCIATED WITH SCHIZOPHRENIA OR BIPOLAR I DISORDER IN ADULTS
U-1376 TREATMENT OF INFLAMMATORY LESIONS OF NON-NODULAR MODERATE TO SEVERE ACNE VULGARIS
U-1377 IMPROVE RESPIRATORY SYMPTOMS IN CYSTIC FIBROSIS IN PATIENTS WITH PSEUDOMONAS
AERUGINOSA
U-1378 TREATMENT OF A NITROGEN METAOLISM DISORDER
U-1379 IMPROVEMENT OF GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE
ONE OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS
U-1380 IMPROVEMENT OF GLYCEMIC CONTROL IN ADULTS WITH TYPE 2 DIABETES MELLITUS WHO HAVE
ONE OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS WHEREIN THE PATIENT HAS
CARDIOVASCULAR DISEASE
U-1381 USE OF PRASUGREL AND ASPIRIN IN PATIENTS REQUIRING THE REDUCTION OF THROMBOTIC
CARDIOVASCULAR EVENTS
U-1382 TREATMETN OF NAUSEA AND VOMITING OF PREGNANCY IN WOMEN WHO DO NOT RESPOND TO
CONSERVATIVE MANAGEMENT
U-1383 DOSAGE ADJUSTMENT OF A NITROGEN SCAVENGING DRUG IN THE TREATMENT OF A UREA CYCLE
DISORDER
U-1384 METHOD OF TREATING MULTIPLE SCLEROSIS
U-1385 METHOD OF TREATING AN AUTOIMMUNE DISEASE SELECTED FROM AUTOIMMUNE POLYARTHRITIS
AND MULTIPLE SCLEROSIS BUT NOT TREATING PSORIATIC ARTHRITIS
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 61 of 67
PATENT USE
U-1386 A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF A PERSON IN NEED THEREOF
U-1387 REDUCTION IN RISK OF HOSPITALIZATION IN PATIENTS WITH A HISTORY OF PAROXYSMAL OR
PERSISTENT AF WITHOUT SEVERE HEART FAILURE AND WITH ONE OR MORE RISK FACTORS BY
ADMINISTRATION TWICE A DAILY WITH MORNING AND EVENING MEALS
U-1388 TREATMENT OF PATIENTS WITH A HISTORY OF PAROXYSMAL OR PERSISTENT AF WITHOUT SEVERE
HEART FAILURE AND WITH ONE OR MORE RISK FACTORS BY ADMINISTRATION TWICE A DAY WITH
MORNING AND EVENING MEALS
U-1389 ELLA IS AN PROGESTERONE AGONIST/ANTAGONIST EMERGENCY CONTRACEPTION INDICATED FOR
THE PREVENTION OF PREGNANCY FOLLOWING UNPROTECTED INTERCOURSE OR A KNOWN OR
SUSPECTED CONTRACEPTIVE FAILURE. ELLA CAN BE TAKEN WITH OR WITHOUT FOOD
U-1390 A METHOD OF INCREASING THE TESTOSTERONE BLOOD LEVEL OF AN ADULT MALE SUBJECT IN
NEED THEREOF
U-1391 METHOD FOR TREATING OPIOID-INDUCED CONSTIPATION
U-1392 METHOD OF RELIEVING OR PREVENTING CONSTIPATION IN A HUMAN PATIENT WITH OPIOID-
INDUCED CONSTIPATION
U-1393 METHOD FOR RELIEVING OR TREATING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED
CONSTIPATION
U-1394 METHOD FOR RELIEVING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION
THAT COMPRISES ADMINISTERING TO THE PATIENT A DOSAGE UNIT COMPRISING(I)24MICROG+/-
10% OF A DRUG SUBSTANCE AND (II) A PHARMACEUTICALLY SUITABLE EXCIPIENT
U-1395 USE IN RELIEVING OR PREVENTING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED
CONSTIPATION WITH A DOSAGE UNIT COMPRISING 24MICROG +/- 10% OF A DRUG SUBSTANCE
AND A PHARMACEUTICALLY SUITABLE EXCIPIENT
U-1396 TREATMENT OF ADVANCED HORMONE RECEPTOR POSITIVE, HER2-NEGATIVE BREAST CANCER IN
COMBINATION WITH EXEMESTANE AFTER FAILURE OF TREATMENT WITH LETROZOLE OR
ANASTROZOLE
U-1397 USE AS AN ANTISEPTIC FOR THE PREPARATION OF A PATIENT'S SKIN PRIOR TO SURGERY
U-1398 METHOD OF TREATING CHRONIC HEPATITIS C
U-1399 MANAGEMENT OF NEPHROPATHIC CYSTINOSIS BY ADMINISTERING A TOTAL DAILY DOSE IN TWO
DIVIDED DOSES
U-1400 FOR THE TREATMENT OF PRIMARY HYPERLIPIDEMIA, MIXED HYPERLIPIDEMIA OR HOMOZYGOUS
FAMILIAL HYPERCHOLESTEROLEMIA
U-1401 INDICATED FOR LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION
IN PTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE
EXACERBATIONS OF COPD IN PTS WITH A HISTORY OF EXACERBATIONS
U-1402 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA (CLL)
AND/OR INDOLENT B-CELL NON-HODGKIN LYMPHOMA (NHL)
U-1403 FIRST-LINE TREATMENT OF METASTATIC NON SMAL-CELL LUNG CANCER (NSCLC) WITH EGFR
EXON 19 DELETIONS OR EXON 21 (L858R) SUBSTITUTION MUTATIONS AS DETECTED BY AN FDA-
APPROVED TEST
U-1404 METHOD FOR TREATING CONSTIPATION IN A PATIENT WITH OPIOID-INDUCED CONSTIPATION BY
OPENING CIC CHANNELS
U-1405 THERAPEUTIC TREATMENT OF BONE METASTASES
U-1406 TREATMENT OF MELANOMA
U-1407 TREATMENT OF NEWLY DIAGNOSED PHILADELPIA CHROMOSOME POSITIVE CHRONIC MYELOID
LEUKEMIA (PH + CML)
U-1408 TREATMENT OF PLAQUE PSORIASIS IN PATIENTS 18 YEARS OF AGE OR OLDER
U-1409 TREATMENT OF HIV-1 BY ONCE DAILY ADMINISTRATION
U-1410 TREATMENT OF CORTICOSTEROID-RESPONSIVE DERMATOSES
U-1411 THIS DRUG IS ADMINISTERED BY SUBLINGUAL ROUTE TO HUMANS FOR MAINTENANCE TREATMENT
OF OPIOID DEPENDENCE
U-1412 TREATMENT OF ATOPIC DERMATITIS
U-1413 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH FLOLAN STERILE
DILUENT FOR INJECTION PRIOR TO INFUSION
U-1414 USE OF REVLIMID (LENALIDOMIDE) FOR THE TREATMENT OF MANTLE CELL LYMPHOMA (MCL)
U-1415 TREATMING A PATIENT HAVING A CONDITION SUSCEPTIBLE TO TREATMENT WITH
METHYLPHENIDATE, SUCH AS ADHD, BY ADMINISTERING THE FORMULATION RECITED IN CLAIMS
1 OR 2
U-1416 USE OF FENOFIBRATE FOR REDUCING ELEVATED TOTAL CHOLESTEROL (TOTAL-C), LDL-C, APO-
LIPOPROTEIN B, OR TOTAL TRIGLYCERIDES
U-1417 USE FOR TREATMENT OF HELICOBACTER INFECTIONS
U-1418 TREATMENT OF PATIENTS WITH UNRESECTABLE OR METASTATIC MELANOMA WITH BRAFV600E
MUTATION AS DETECTED BY AN FDA APPROVED TEST
U-1419 TREATMENT OF ACUTE CYANIDE POISONING THAT IS JUDGED TO BE LIFE THREATENING
U-1420 METHOD OF ONCE A DAY ADMINISTRATION
U-1421 SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE
U-1422 METHOD OF TREATING PATIENTS NEEDING AN IRON SUPPLEMENT
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 62 of 67
PATENT USE
U-1423 AMYVID IS A RADIOACTIVE DIAGNOSTIC AGENT FOR POSITRON EMISSION TOMOGRAPHY (PET)
IMAGING OF THE BRAIN TO ESTIMATE BETA-AMYLOID NEURITIC PLAQUE DENSITY IN ADULT
PATIENTS WITH COGNITIVE IMPAIRMENT
U-1424 LONG-TERM, ONCE DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN PTS WITH
COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSOTO REDUCE EXACERBATIONS
OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS
U-1425 SUBLINGUAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING BUPRENORPHINE
AND NALOXONE
U-1426 USE FOR TREATMENT OF DIAPER DERMATITIS COMPLICATED BY CANDIDIASIS
U-1427 ALKYLATING DRUG INDICATED FOR THE TOPICAL TREATMENT OF STAGE IA AND IB MYCOSIS
FUNGOIDES-TYPE CUTANEOUS T-CELL LYMPHOMA IN PATIENTS WHO HAVE RECEIVED PRIOR SKIN
DIRECTED THERAPY
U-1428 TOPICAL TREATMENT OF FACIAL ERYTHEMA OF ROSACEA
U-1429 TREATMENT OF PATIENTS WITH BREAST CANCER WHOSE TUMORS OVEREXPRESS THE HER2
RECEPTOR
U-1430 TREATMENT OF ALLERGIC RHINITIS, INCLUDING SEASONAL AND PERENNIAL ALLERGIC RHINITIS
U-1431 METHOD OF TREATING HYPERGLYCEMIA TO IMPROVE GLYCEMIC CONTROL IN A PATIENT BY ORAL
ADMIN OF ONCE A DAY OSMOTIC DOSAGE FORM OF GLIPIZIDE WITH POLYETHYLENE OXIDE,
HYDROXYPROPYLMETHYLCELLULOSE, CELLULOSE ACETATE, AND SODIUM CHLORIDE
U-1432 METHOD OF TREATMENT OF IRON-RELATED CONDITIONS WITH AT LEAST 0.6 GRAMS OF
ELEMENTAL IRON VIA AN IRON CARBOHYDRATE COMPLEX
U-1433 IMPROVEMENTS OF GLYCEMIC CONTROL IN INDIVIDUALS WITH TYPE 2 DIABETES WHO HAVE ONE
OR MORE SPECIFIED CARDIOVASCULAR RISK FACTORS
U-1434 TREATMENT OF PANCREATIC CANCER
U-1435 COMBINATION USE OF TOPICAL DICLOFENAC ON THE KNEE AN DADMINISTRATION OF AN ORAL
NSAID.
U-1436 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL AGENT SELECTED FROM
SUNSCREEN AND INSECT REPELLANT
U-1437 ADMINISTRATION OF REMODULIN DILUTED FOR INTRAVENOUS INFUSION WITH STERILE DILUENT
FOR FLOLAN OR STERILE DILUENT FOR EPOPROSTENOL SODIUM PRIOR TO ADMINISTRATION
U-1438 ZINGO INTRADERMAL INJECTION SYSTEM IS A DRUG DELIVERY SYSTEM THAT IS CAPABLE OF
DELIVERING FINE DRY POWDERED LIDOCAINE HYDROCHLORIDE MONOHYDRATE FOR LOCAL
ANESTHETIC ACTION
U-1439 METHOD OF TREATING AN AFFECTIVE DISORDER SUCH AS DEPRESSION
U-1440 USE OF INGENOL MEBUTATE TO TREAT ACTINIC KERATOSIS
U-1441 A METHOD OF TREATING OR REDUCING OCULAR PAIN AND BURNING/STINGING
U-1442 SUBCUTANEOUS INJECTION OF METHOTREXATE
U-1443 ACCELERATING THE TIME TO UPPER AND LOWER GASTROINTESTINAL RECOVERY FOLLOWING
SURGERIES THAT INCLUDE PARTIAL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS
U-1444 A DOSING REGIMEN OF AGGRASTAT (TIROFIBAN HYDROCHLORIDE)(25MCG/KG FOLLOWED BY
0.15MCG/KG/MIN) TO REDUCE THE RATE OF THROMBOTIC CORONARY EVENTS ASSOCIATED WITH
ACUTE CORONARY SYNDROME (ACS) IN PATIENTS WITH NON-ST ELEVATION ACS
U-1445 METHOD OF TREATING PULMONARY ARTERIAL HYPERTENSION BY ADMINISTERING A
PHARMACEUTICAL COMPOSITION COMPRISING MACITENTAN AND A POLYSORBATE, WHERIN THE
POLYSORBATE REPRESENTS 0.1 TO 1% OF THE WEIGHT OF SAID PHARMACEUTICAL COMPOSITION
U-1446 METHOD OF TREATING PULMONARY HYPERTENSION COMPRISING ADMINISTERING MACITENTAN IN
COMBINATION WITH A COMPOUND HAVING PHOSPHODIESTERASE-5 INHIBITORY PROPERTIES
U-1447 TREATING PRIMARY HYPERCHOLESTEROLEMIA AND MIXED DYSLIPIDEMIA
U-1448 TREATING SEVERE HYPERTRIGLYCERIDEMIA
U-1449 METHOD OF ALLEVIATING A SKIN CONDITION
U-1450 TREATMENT OF ALLERGIC RHINITIS SYMPTOMS
U-1451 APPROVED INDICATIONS: APTIOM (ESLICARBAZEPINE ACETATE) IS INDICATED AS ADJUNCTIVE
TREATMENT OF PARTIAL-ONSET SEIZURES AND APPROVED IN PATIENTS WITH EPILEPSY.
PATENT CLAIMS: IN A METHOD OF TREATING A SUBJECT AFFLICTED WITH EPILEPSY
U-1452 METHOD FOR CHRONIC WEIGHT MANAGEMENT
U-1453 A METHOD OF TREATING HYPOXIC RESPIRATORY FAILURE BY VERIFYING GAS INFORMATION OF
NITRIC OXIDE PRIOR TO DELIVERY TO PATIENT
U-1454 PROPHYLAXIS OF INVASIVE ASPERGILLUS AND CANDIDA INFECTIONS
U-1455 TREATMENT OF PERIANAL WARTS
U-1456 TREATMENT OF MANTLE CELL LYMPHOMA
U-1457 A METHOD OF PURGING A NITRIC OXIDE DELIVERY SYSTEM
U-1458 A METHOD OF REDUCING INTRAOCULAR PRESSURE IN PATIENTS WITH OPEN ANGLE GLAUCOMA OR
OCULAR HYPERTENSION
U-1459 TREATMENT OF CARCINOMA OF THE THYROID
U-1460 TREATMENT OF HERPES LABIALIS
U-1461 A METHOD OF GENERATING AN INJECTABLE FOAM OF CONTROLLED DENSITY AND BUBBLE SIZE
U-1462 A METHOD OF USING A SCLEROSING AGENT FOR THE TREATMENT OF INCOMPETENT GREAT
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 63 of 67
PATENT USE
SAPHENOUS VEINS, ACCESSORY SAPHENOUS VEINS AND VISIBLE VARICOSITIES OF THE GREAT
SAPHENOUS (GSV) SYSTEM ABOVE AND BELOW THE KNEE
U-1463 A METHOD OF INTRAVENOUS INJECTION USING ULTRASOUND GUIDANCE, ADMINISTERED VIA A
SINGLE CANNULA INTO THE LUMEN OF THE TARGET INCOMPETENT TRUNK VEINS OR BY DIRECT
INJECTION INTO VARICOSITIES
U-1464 TREATMENT OF OPIOID DEPENDENCE/SUBLINGUAL OR BUCCAL APPLICATION
U-1465 USE OF THALIDOMIDE WHILE PREVENTING THE EXPOSURE OF A FETUS OR OTHER
CONTRAINDICATED INDIVIDUAL TO THALIDOMIDE
U-1466 RELIEF OF SYMPTOMS ASSOCIATED WITH RESPIRATORY ALLERGIES ADULTS AND CHILDREN 6
YEARS OF AGE AND OLDER
U-1467 METHOD OF TREATING HEPATITIS C
U-1468 CONTROL OF PHOSPHOROUS LEVELS IN PATIENTS
U-1469 USE OF PHOSYLRA FOR REDUCTION OF SERUM PHOSPHOROUS IN PATIENTS
U-1470 FOR THE TREATMENT OF HEPATITIS C
U-1471 A METHOD FOR TREATING CARDIOVASCULAR DISEASE COMPRISING ADMINISTERING A
RECONSTITUTED LYOPHILIZED PHARMACEUTICAL COMPOSITION COMPRISING EPOPROSTENOL,
ARGININE AND SODIUM HYDROXIDE.
U-1472 INTENSIVE CARE UNIT SEDATION, INCLUDING SEDATION OF NON-INTUBATED PATIENTS PRIOR
TO AND/OR DURING SURGICAL AND OTHER PROCEDURES
U-1473 MANAGEMENT OF RISK OF DRONEDARONE/BETA-BLOCKER INTERACTION IN PATIENTS IN SINUS
RYTHM WITH A HISTORY OF PAROXYSMAL OR PERSISTENT AF
U-1474 A METHOD FOR THE TREATMENT OF A PATIENT SUFFERING FROM A DISEASE TREATABLE WITH
ROTIGOTINE, COMPRISING APPLYING THE CLAIMED TRANSDERMAL DELIVERY SYSTEM (TDS) TO
THE SKIN OF THE PATIENT
U-1475 USE OF ORENITRAM FOR THE TREATMENT OF PULMONARY ARTERIAL HYPERTENSION (PAH) (WHO
GROUP 1).
U-1476 INDICATED FOR THE LONG-TERM, ONCE-DAILY, MAINTENANCE TREATMENT OF AIRFLOW
OBSTRUCTION IN PATIENTS WITH CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD),
INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA.
U-1477 USE OF TOPICAL DICLOFENAC ON THE KNEE AND A SECOND TOPICAL PRESCRIPTION MEDICATION
ON THE SAME KNEE
U-1478 METHOD OF REDUCING TG LEVELS IN PATIENT ON STATIN THERAPY SUFFERING FROM SEVERE
HYPERTRIGLYCERIDEMIA
U-1479 INCREASE TEAR PRODUCTION TO TREAT PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY
EYE).
U-1480 TREATMENT OF ADVANCED RENAL CELL CARCINOMA
U-1481 REDUCTION IN RISK OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE
U-1482 DICLOFENAC POTASSIUM FOR RELIEF OF MILD TO MODERATE ACUTE PAIN
U-1483 INCREASE TEAR PRODUCTION IN PATIENTS WITH KERATOCONJUNCTIVITIS SICCA (DRY EYE).
U-1484 COMBINATION PRODUCT FOR THE EARLY TREATMENT OF RECURRENT HERPES LABIALIS (COLD
SORES) TO REDUCE THE LIKELIHOOD OF ULCERATIVE COLD SORES AND TO SHORTEN THE LESION
HEALING TIME IN ADULTS AND CHILDREN (6 YEARS OF AGE AND OLDER)
U-1485 TREATING A SUBJECT UNDERGOING ABDOMINAL SURGERY BY ADMINISTERING ALVIMOPAN TO
ACCELERATE THE TIME TO UPPER AND LOWER GASTROINTESTINAL RECOVERY FOLLOWING
SURGERIES THAT INCLUDE PARTIAL BOWEL RESECTION WITH PRIMARY ANASTOMOSIS
U-1486 TREATMENT OF NON-24-HOUR SLEEP-WAKE DISORDER
U-1487 METHOD OF INCREASING EYELASH GROWTH
U-1488 USE OF TOPICAL DICLOFENAC FOR TREATING PAIN
U-1489 USE OF TOPICAL DICLOFENAC ON A JOINT FOR TREATING OSTEOARTHRITIS
U-1490 FOR USE IN PATIENTS HAVING SYMPTOMATIC OR PROGRESSIVE MEDULLARY THYROID CANCER,
WITH UNRESECTABLE LOCALLY ADVANCED OR METASTATIC DISEASE
U-1491 TREATMENT OF CHRONIC LYMPHOCYTIC LEUKEMIA
U-1492 TREATMENT OF IRRITABILITY ASSOCIATED WITH AUTISTIC DISORDER
U-1493 METHOD FOR PREVENTING ITCHING ASSOCIATED WITH ALLERGIC CONJUNCTIVITIS
U-1494 SUBLINGUAL OR BUCCAL ADMINISTRATION OF A PHARMACEUTICAL COMPOSITION COMPRISING
BUPRENORPHINE AND NALOXONE
U-1495 RISK REDUCTION OF REBLEEDING IN PTS FOLLOWING THERAPEUTIC ENDOSCOPY FOR ACUTE
BLEEDING GASTRIC OR DUODENAL ULCERS IN ADULTS.
U-1496 METHOD TO TREAT HEMANGIOMA.
U-1497 NEURACEQ IS A RADIOACTIVE DIAGNOSTIC AGENT FOR POSITRON EMISSION TOMOGRAPHY (PET)
IMAGING OF THE BRAIN TO ESTIMATE P-AMYLOID NEURITIC PLAQUE DENSITY IN ADULT
PATIENTS WITH COGNITIVE IMPAIRMENT
U-1498 METHOD OF TREATING PATIENTS WITH GASTRIC RETENTIVE DOSAGE FORM
U-1499 MANAGEMENT OF ACUTE PAIN IN PATIENTS REQUIRING OPIOID ANALGESIA
U-1500 TESTOSTERONE REPLACEMENT THERAPY IN ADULT MALES FOR CONDITIONS ASSOCIATED WITH A
DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE; PRIMARY HYPOGONADISM (CONGENITAL
OR ACQUIRED); HYPOGONADOTROPIC HYPOGONADISM (CONGENITAL OR ACQUIRED).
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 64 of 67
PATENT USE
U-1501 PROPHYLAXIS OF DEEP VEIN THROMBOSIS AND PULMONARY EMBOLISM
U-1502 PROPHYLAXIS OF PULMONARY EMBOLISM
U-1503 METHOD OF TREATING TYPE 2 DIABETES MELLITUS BY ADMINISTERING LINAGLIPTIN IN
COMBINATION WITH METFORMIN
U-1504 USE OF OTEZLA (APREMILAST) FOR INHIBITING PDE4
U-1505 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
U-1506 TREATMENT OF PATIENTS WITH GASTROINTESTINAL STROMAL TUMOR (GIST), INCLUDING BUT
NOT LIMITED TO PATIENTS PREVIOUSLY TREATED WITH IMATINIB AND PATIENTS WITH GIST
HAVING RESISTANCE TO A KIT TYROSINE KINASE INHIBITOR
U-1507 TO MAINTAIN HEALING OF EE AND RELIEF OF HEARTBURN
U-1508 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM
OPIOID TREATMENT BY ORALLY ADMINISTERING A PLURALITY OF COMPOSITE SUBUNITS AS
CLAIMED
U-1509 TREATMENT OF FREQUENT HEARTBURN BY ADMINISTERING A GASTRIC ACID REDUCER
U-1510 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM
OPIOD TREATEMENT BY ORALLY ADMINISTERING AN INTACT COMPOSITION AS CLAIMED.
U-1511 TREATMENT OF HYPERTRIGLYCERIDEMIA
U-1512 REDUCTION OF THROMBOTIC CARDIOVASCULAR EVENTS
U-1513 TREATMENT OF HIV-1 INFECTION IN COMBINATION WITH OTHER ANTIRETROVIRAL AGENTS
U-1514 MANAGEMENT OF BREAKTHROUGH PAIN IN PATIENTS WITH CANCER BY BUCCAL OR SUBLINGUAL
ADMINISTRATION OF FENTANYL
U-1515 METHOD OF TREATING IRRITABLE BOWEL SYNDROME WITH CONSTIPATION IN ADULT PATIENTS.
U-1516 METHOD OF TREATING CHRONIC IDIOPATHIC CONSTIPATION IN ADULT PATIENTS.
U-1517 TREATMENT OF BACTERIAL INFECTIONS USING A TWO-DOSE REGIMEN OF DALBAVANCIN.
U-1518 MAINTAINING PUPIL SIZE BY PREVENTING INTRAOPERATIVE MIOSIS AND REDUCING
POSTOPERATIVE OCULAR PAIN
U-1519 METHOD FOR THE LONG TERM TREATMENT OF CHRONIC CONSTIPATION IN A HUMAN SUBJECT WITH
IRRITABLE BOWEL SYNDROME
U-1520 METHOD FOR THE LONG TERM TREATMENT OF CHRONIC CONSTIPATION IN A HUMAN SUBJECT
U-1521 MAINTENANCE TREATMENT OF OPIOID DEPENDENCE
U-1522 TREATMENT OF TYPE 2 DIABETES MELLITUS IN A PATIENT, WHEREIN GLYCEMIC CONTROL
(HBA1C < 7.0%) IS NOT ACHIEVABLE USING ONE OR MORE OF INSULIN, METFORMIN,
PIOGLITAZONE, OR ROSIGLITAZONE
U-1523 METHOD OF INDUCING TOPICAL ANESTHESIA IN THE EYE
U-1524 REDUCTION OF ELEVATED INTRAOCULAR PRESSURE
U-1525 METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS IN PATIENTS WITH NARCOLEPSY
U-1526 THE TREATMENT OF PATIENTS WITH TRAVELERS' DIARRHEA (TD) OR THE REDUCTION IN RISK
OF OVERT HEPATIC ENCEPHALOPATHY (HE) RECURRENCE
U-1527 FOR THE TREATMENT OF OVERACTIVE BLADDER (OAB) WITH SYMPTOMS OF URGE URINARY
INCONTINENCE, URGENCY, AND URINARY FREQUENCY
U-1528 A METHOD OF LOWERING INTRAOCULAR PRESSURE
U-1529 ADJUNCTIVE TREATMENT OF MAJOR DEPRESSIVE DISORDER (MDD)
U-1530 USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION
U-1531 METHOD FOR TRANSDERMAL DELIVERY OF TESTOSTERONE
U-1532 METHOD OF TREATING EXCESSIVE DAYTIME SLEEPINESS AND/OR CATAPLEXY IN NARCOLEPSY
PATIENTS WITH SODIUM OXYBATE WHEN DIVALPROEX SODIUM IS CONCOMITANTLY ADMINISTERED.
U-1533 PULMONARY ADMINISTRATION OF PARTICLES COMPRISING A DIKETOPIPERAZINE AND INSULIN.
U-1534 ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN COMPLEXED WITH A
DIKETOPIPERAZINE.
U-1535 ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN COMPLEXED WITH MICROPARTICLES
OF A DIKETOPIPERAZINE.
U-1536 ADMINISTRATION OF A COMPOSITION COMPRISING A DIKETOPIPERAZINE AND INSULIN.
U-1537 TREATMENT OF A PATIENT HAVING DIABETES MELLITUS WITH A PRANDIAL RAPID ACTING
INSULIN.
U-1538 ADMINISTRATION OF FDKP MICROPARTICLES COMPRISING INSULIN.
U-1539 PULMONARY ADMINISTRATION OF AN INSULIN COMPOSITION COMPRISING FDKP AT THE
BEGINNING OF A MEAL TO A PATIENT ALSO BEING TREATED WITH A LONG-ACTING INSULIN.
U-1540 BUTRANS IS A PARTIAL OPIOID AGONIST PRODUCT INDICATED FOR THE MANAGEMENT OF PAIN
SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG TERM OPIOID TREATMENT FOR
WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
U-1541 TREATMENT OF PATIENTS WITH TUBEROUS SCLEROSIS COMPLEX (TSC) WHO HAVE SUBEPENDYMAL
GIANT CELL ASTROCYTOMA (SEGA) THAT REQUIRES THERAPEUTIC INTERVENTION BUT CANNOT BE
CURATIVELY RESECTED.
U-1542 FOR USE IN THE TREATMENT OF PATIENTS WITH CHRONIC LYMPHOCYTIC LEUKEMIA AND/OR NON-
HODGKINS LYMPHOMA
U-1543 TREATMENT OF A PATIENT BY ADMINISTERING THE FORMULATION RECITED IN CLAIM 1 OR
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 65 of 67
PATENT USE
CLAIM 23
U-1544 TREATMENT OF PATIENTS WITH RELAPSED OR REFRACTORY PERIPHERAL T-CELL LYMPHOMA
(PTCL).
U-1545 A METHOD OF TRANSDERMALLY DELIVERING TESTOSTERONE
U-1546 FOR USE IN THE TREATMENT OF MALIGNANT HYPERTHERMIA IN CONJUNCTION WITH APPROPRIATE
SUPPORTIVE MEASURES AND FOR THE PREVENTION OF MALIGNANT HYPERTHERMIA IN PATIENTS
AT HIGH RISK.
U-1547 TREATMENT OF CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD), CHRONIC BRONCHITIS OR
EMPHYSEMA
U-1548 FOR THE LONG-TERM, ONCE-DAILY MAINTENANCE TREATMENT OF AIRFLOW OBSTRUCTION IN
PATIENTS WITH COPD, INCLUDING CHRONIC BRONCHITIS AND/OR EMPHYSEMA, ALSO TO REDUCE
EXACERBATIONS OF COPD IN PATIENTS WITH A HISTORY OF EXACERBATIONS
U-1549 FOR THE TREATMENT OF PATIENTS WITH RELAPSED CHRONIC LYMPHOCYTIC LEUKEMIA
U-1550 METHOD OF TREATING METASTATIC PAPILLARY RENAL CELL CARCINOMA WITH TEMSIROLIMUS.
U-1551 METHOD OF TREATING PAPILLARY RENAL CELL CARCINOMA WITH TEMSIROLIMUS, IN THE
ABSENCE OF INTERFERON ALPHA.
U-1552 FOR HEALING OF ALL GRADES OF EROSIVE ESOPHAGITIS (EE)
U-1553 TO MAINTAIN HEALING OF EE AND RELIEF OF HEARTBURN
U-1554 FOR THE TREATMENT OF HEARTBURN ASSOCIATED WITH SYMPTOMATIC NON-EROSIVE
GASTROESOPHAGEAL DISEASE (GERD)
U-1555 MANAGEMENT OF MODERATE TO SEVERE PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-
CLOCK, LONG-TERM OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE
INADEQUATE.
U-1556 MANAGEMENT OF PAIN SEVERE ENOUGH TO REQUIRE DAILY, AROUND-THE-CLOCK, LONG-TERM
OPIOID TREATMENT AND FOR WHICH ALTERNATIVE TREATMENT OPTIONS ARE INADEQUATE.
U-1557 A METHOD OF TESTOSTERONE REPLACEMENT THERAPY COMPRISING THE STEP OF NASALLY
ADMINISTERING TO A PATIENT IN NEED OF SUCH TREATMENT AN EFFECTIVE AMOUNT OF
TESTOSTERONE GEL FORMULATION.
U-1558 FOR THE TREATMENT OF PATIENTS WITH RELAPSED FOLLICULAR B-CELL NON-HODGKIN LYMPHOMA
OR [RELAPSED] SMALL LYMPHOCYTIC LYMPHOMA
U-1559 INDICATED FOR THE ONCE-DAILY MAINTENANCE TREATMENT OF ASTHMA AS PROPHYLACTIC
THERAPY IN PATIENTS AGED 12 YEARS OF AGE AND OLDER
U-1560 A METHOD OF DISRUPTING LEUKOCYTE FUNCTION, INCLUDING AS AN INHIBITOR OF PI3KDELTA
KINASE
U-1561 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIATIC ARTHRITIS
U-1562 TREATMENT OF PATIENTS WITH HEPATIC ENCEPHALOPATHY (HE)
U-1563 A METHOD OF TRANSDERMAL ADMINISTRATION OF A PHYSIOLOGICALLY ACTIVE AGENT TO A
SUBJECT.
U-1564 A METHOD OF TREATING GAUCHER'S DISEASE
U-1565 METHOD OF TREATING, AS INTITIAL LOADING DOSE FOR MONOTHERAPY OR ADJUNCTIVE
THERAPY, PARITAL ONSET-SEIZURES IN A PATIENT WITH EPILEPSY AGED 17 YEARS OR OLDER
WHEN ORAL ADMINISTRATION IS TEMPORARILY NOT FEASIBLE
U-1566 METHOD OF TREATING, AS MONOTHERAPY OR ADJUNCTIVE THERAPY, PARTIAL-ONSET SEIZURES
IN A PATIENT WITH EPILEPSY AGED 17 YEARS AND OLDER
U-1567 METHOD OF TREATING, AS INTITIAL LOADING DOSE FOR MONOTHERAPY OR ADJUNCTIVE
THERAPY, PARITAL ONSET-SEIZURES IN A PATIENT WITH EPILEPSY AGED 17 YEARS OR OLDER
U-1568 METHOD OF TREATING, AS MONOTHERAPY OR ADJUNCTIVE THERAPY, PARTIAL-ONSET SEIZURES
IN A PATIENT WITH EPILEPSY AGED 17 YEARS AND OLDER WHEN ORAL ADMINISTRATION IS
TEMPORARILY NOT FEASIBLE
U-1569 TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS
U-1570 TREATMENT OF BACTERIAL SKIN AND SKIN STRUCTURE INFECTIONS USING A SINGLE DOSE
U-1571 TREATMENT OF GAUCHER DISEASE TYPE 1
U-1572 TREATMENT OF HUMAN IMMUNODEFICIENCY VIRUS (HIV) INFECTION.
U-1573 USE OF RUXOLITINIB (JAKAFI) FOR INHIBITING JANUS ASSOCIATED KINASES (JAKS) JAK1
AND/OR JAK2.
U-1574 A METHOD OF CATALYZING THE HYDROLYSIS OF GLUCOCEREBROSIDE TO GLUCOSE AND CERAMIDE.
U-1575 PATIENTS WITH SEVERE APLASTIC ANEMIA WHO HAVE HAD AN INSUFFICIENT RESPONSE TO
IMMUNOSUPPRESSIVE THERAPY
U-1576 TREATMENT OF LEUKEMIA
U-1577 CONTROL OF SERUM PHOSPHOROUS LEVELS
U-1578 TREATMENT OF ACUTE OTITIS MEDIA
U-1579 USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC
CASTRATION-RESISTANT PROSTATE CANCER
U-1580 USE IN COMBINATION WITH PREDNISONE FOR THE TREATMENT OF PATIENTS WITH METASTATIC
CASTRATION-RESISTANT PROSTATE CANCER WHO HAD RECEIVED PRIOR DOCETAXEL CHEMOTHERAPY
U-1581 IN COMBINATION WITH DABRAFENIB FOR THE TREATMENT OF UNRESECTABLE OR METASTATIC
MELANOMA.
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 66 of 67
PATENT USE
U-1582 TREATMENT OF UNRESECTABLE OR METASTATIC MELANOMA
U-1583 FOR CHRONIC WEIGHT MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
U-1584 USE OF NALTREXONE AND BUPROPION IN A LAYERED FORMULATION FOR CHRONIC WEIGHT
MANAGEMENT FOR AFFECTING WEIGHT LOSS
U-1585 USE OF NALTREXONE AND BUPROPION BASED ON AN ESCALATING DOSE SCHEDULE
U-1586 FOR EFFECT ON BLOOD GLUCOSE PARAMETERS IN PATIENTS WITH INSULIN RESISTANCE
U-1587 SINGLE-DOSE INFILTRATION INTO THE SURGICAL SITE TO PRODUCE POSTSURGICAL ANALGESIA.
U-1588 THE TREATMENT OF PATIENTS WITH METASTATIC CASTRATION-RESISTANT PROSTATE CANCER
(CRPC).
U-1589 METHOD OF USE FOR REDUCING BLOOD PHENYLALANINE LEVELS IN A HUMAN SUFFERING FROM
HYPERPHENYLALANINEMIA
U-1590 KUVAN IS INDICATED TO REDUCE BLOOD PHENYLALANINE LEVELS IN PATIENTS WITH
HYPERPHENYLALANINEMIA
U-1591 TREATMENT OF ASTHMA IN PATIENTS AGED 12 YEARS AND OLDER
U-1592 TO REDUCE SERUM PHOSPHATE IN PATIENTS WITH END STAGE RENAL DISEASE
U-1593 MAINTENANCE TREATMENT OF BRONCHOSPASM ASSOCIATED WITH COPD, INCLUDING CHRONIC
BRONCHITIS AND EMPHYSEMA, AND REDUCTION OF EXACERBATIONS IN COPD PATIENTS.
U-1594 DILATION OF THE PUPIL
U-1595 USE OF OTEZLA (APREMILAST) FOR THE TREATMENT OF PSORIASIS
U-1596 LAMICTAL IS AN ANTIEPILEPTIC DRUG (AED) INDICATED FOR: EPILEPSY-ADJUNCTIVE THERAPY
IN PATIENTS ≥ 2 YEARS OF AGE: (1.1) PARTIAL SEIZURES PRIMARY GENERALIZED TONIC-
CLONIC SEIZURES
U-1597 TREATMENT OF DIABETIC MACULAR EDEMA
U-1598 METHOD OF ADMINISTRATION OF CONTROLLED RELEASE OXYMORPHONE
U-1599 MANAGEMENT OF MILD TO MODERATE PAIN, MANAGEMENT OF MODERATE TO SEVERE PAIN AS AN
ADNUNCT TO OPIOID ANALGESICS, REDUCTION IN FEVER THROUGH ANTI INFLAMMATORY,
ANALGESIC, AND ANTIPYRETIC ACTIVITY
U-1600 DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN TREATMENT OF IDIOPATHIC
PULMONARY FIBROSIS
U-1601 DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
U-1602 METHOD OF ADMINISTERING PIRFENIDONE CAPSULES TO TREAT A FIBROTIC CONDITION
U-1603 METHOD FOR ADMINISTERING PIRFENDONE TO REDUCE DRUG INTERACTIONS WITH FLUVOXAMINE
U-1604 METHOD FOR ADMINISTERING PIRFENDONE TO REDUCE DRUG INTERACTIONS WITH A STRONG
INHIBITOR OF CYP1A2
U-1605 METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY DISCONTINUING
SMOKING OR BY DISCONTINUING OR AVOIDING ANOTHER STRONG CYP1A2 INDUCER
U-1606 METHOD FOR ADMINISTERING PIRFENIDONE WHILE AVOIDING OR DISCONTINUING CONCOMITANT
USE OF A MODERATE TO STRONG INHIBITOR OF BOTH CYP1A2 AND ANOTHER CYP ENZYME
INVOLVED IN PIRFENIDONE METABOLISM
U-1607 METHOD OF ADMINISTERING A DOSAGE FORM THAT INCLUDES A GRANULATE FORMULATION OF
PIRFENIDONE TO TREAT A FIBROTIC CONDITION
U-1608 DOSE ESCALATION OVER 14 DAYS FOR TREATMENT OF A FIBROSIS CONDITION
U-1609 CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELEVATED LIVER ENZYMES IN
TREATMENT OF IDIOPATHIC PULMONARY FIBROSIS
U-1610 CONTINUED DOSING OR DOSAGE MODIFICATION FOLLOWING ELVATED LIVER ENZYMES IN USE OF
PIRFENIDONE
U-1611 METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY DISCONTINUING
SMOKING OR BY DISCONTINUING A STRONG CYP1A2 INDUCER
U-1612 METHOD FOR ADMINISTERING PIRFENIDONE TO AVOID REDUCED EFFICACY BY AVOIDING SMOKING
OR BY AVOIDING ANOTHER STRONG CYP1A2 INDUCER
U-1613 DOSAGE MODIFICATION IN TREATMENT WITH PIRFENIDONE TO REDUCE DRUG INTERACTIONS WITH
CIPROFLOXACIN
U-1614 USE OF TOPICAL DICLOFENAC SODIUM FOR TREATING PAIN
U-1615 FOR THE TREATMENT OF PATIENTS WITH CCL, FL, OR SLL
U-1616 NASAL ADMINISTRATION OF A TESTOSTERONE GEL TO A PATIENT TO TREAT THE PATIENT FOR A
CONDITION ASSOCIATED WITH A DEFICIENCY OR ABSENCE OF ENDOGENOUS TESTOSTERONE
U-1617 METHOD OF TREATING MEDULLARY THYROID CANCER
U-1618 A METHOD OF TREATING A PATIENT SUFFERING FROM A PAIN ASSOCIATED SLEEP DISTURBANCE
COMPRISING ADMINISTERING A LIQUID COMPOSITION FONNULATED INSIDE A SOFT GEL
CAPSULE, AS CLAIMED, TO THE PATIENT
U-1619 TREATMENT OF IMMUNE (IDIOPATIC) THROMBOCYTOPENIA (ITP)
U-1620 METHOD OF TREATMENT OF IRON-RELATED CONDITIONS WITH AT LEAST 0.6 GRAMS OF
ELEMENTAL IRON VIA AN IRON CARBOHYDRATE COMPLEX, WITH A SUBSTANTIALLY NON-
IMMUNOGENIC CARBOHYDRATE COMPONENT, IN ABOUT 15 MINUTES OR LESS.
U-1621 PULMONARY ADMINISTRATION OF A COMPOSITION COMPRISING INSULIN BOUND TO A COMPLEXING
AGENT.
U-1622 FOR THE TREATMENT OF POLYCYTHEMIA VERA
35TH EDITION - 2015 - APPROVED DRUG PRODUCT LIST
PATENT AND EXCLUSIVITY TERMS ADB 67 of 67
PATENT USE
U-1623 USE OF EXENATIDE MAY RESULT IN REDUCTION IN APPETITE.
U-1624 TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA, ADVANCED RENAL CELL CARCINOMA,
OR DIFFERENTIATED THYROID CARCINOMA.
U-1625 METHOD OF TREATING SCHIZOPHRENIA BY ADMINISTERING ILOPERIDONE TO A PATIENT BY
REDUCING THE DOSE IN PATIENTS WHO ARE POOR METABOLIZERS OF CYP2D6
U-1626 A METHOD OF TREATING OR PREVENTING OCULAR PAIN AND BURNING
U-1627 TREATMENT OF ACUTE UNCOMPLICATED INFLUENZA IN ADULTS
U-1628 METHOD OF TREATING DISORDERS WITH AN ETIOLOGY COMPRISING OR ASSOCIATED WITH EXCESS
GH-SECRETION
U-1629 METHOD OF TREATING ACROMEGALY
U-1630 TREATMENT IN COMBINATION WITH A CORTICOID SUCH AS PREDNISONE OF PROSTATE CANCER
PREVIOUSLY TREATED IWTH DOCETAXEL
U-1631 TREATMENT OF INFLAMMATORY LESIONS OF ROSACEA.
U-1632 TREATMENT OF SCHIZOPHRENIA, WITH EFFICACY IN TREATING ACUTE EPISODES OF
SCHIZOPHRENIA
U-1633 USE OF ARIPIPRAZOLE IN EXTENDED RELEASE INJECTABLE SUSPENSION IN TREATING ACUTE
EPISODES OF SCHIZOPHRENIA
U-1634 TREATMENT OF BRCA MUTATED OVARIAN CANCER USING PARP INHIBITOR
U-1635 USE OF RITONAVIR AS A POTENT CYP3A INHIBITOR TO INCREASE PLASMA DRUG CONCENTRATION
OF PARITAPREVIR AND OVERALL DRUG EXPOSURE FOR TREATMENT OF HCV INFECTION
U-1636 USE OF DASABUVIR TO INHIBIT VIRAL REPLICATION FOR THE TREATMENT OF HCV INFECTION.
U-1637 TREATMENT OF HCV INFECTION USING PARITAPREVIR, OMBITASVIR, RITONAVIR, AND
DASABUVIR WITH RIBAVIRIN.
U-1638 TREATMENT OF HCV INFECTION USING PARITAPREVIR
U-1639 USE OF NALTREXONE AND BUPROPION IN EXTENDED-RELEASE FORM FOR CHRONIC WEIGHT
MANAGEMENT FOR TREATING OVERWEIGHT OR OBESITY
U-1640 TREATMENT OF MODERATE TO SEVERE CHRONIC PAIN BY ADMINISTERING AN INTACT
COMPOSITION AS CLAIMED
U-1641 MEMANTINE HCL/DONEPEZIL HCL COMBINATION FOR THE TREATMENT OF MODERATE TO SEVERE
DEMENTIA OF THE ALZHEIMER'S TYPE
U-1642 METHOD OF TREATING TYPE 2 DIABETES MELLITUS IN PATIENTS WITH SEVERE CHRONIC RENAL
IMPAIRMENT AND FOR WHOM METFORMIN THERAPY IS INAPPROPRIATE BY ADMINISTERING
LINAGLIPTIN